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Monsieur Richard, Paul, Louis BONNE
le 16 décembre 2013
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A PRESENTATION OF TWO ORIGINAL METHODS TARGETED TO FACILITATE THE
IMPLEMENTATION BY FOOD BUSINESSES OF THE CODEX ALIMENTARIUS
PRINCIPLES OF "GOOD HYGIENE PRACTICES AND GOOD MANUFACTURING
PRACTICES AND HACCP METHOD"
²DPMF EPDUPSBMF et discipline ou spécialité ED SEVAB : Pathologie, Toxicologie, Génétique et Nutrition
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Laboratoire de Biotechnologies Agro-alimentaires et Environnementales (LBAE - UPS - IUTA)
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Directeur: Pr GABRIEL Bruno, UPS - UTA, Toulouse
Co-directrice, Docteur GABRIEL Valérie, Maître de Conférences, UPS - UTA, Toulouse
Jury :
Présidente: Professeur BENARD Geneviève, ENV, Toulouse
Rapporteur Docteur MONTET Didier, Chef de l'UMR - Qualisud, CIRAD, Montpellier
Rapporteur: Professeur CACHON Rémy, Agrossup, Dijon
Examinateur: Docteur LE GOSLES Jacky, Advisor, DG-SANCO, CE, Bruxelles
Traduction en anglais:
Mme TIMMONS Nelly (UC Berkeley) & Mr BERRI Kenneth
Résumé
La mise en place d’un Plan de Maîtrise Sanitaire (PMS) basé sur des bonnes pratiques
d’hygiène et de fabrication (BPH/BPF) et la méthode HACCP, est une obligation
réglementaire imposée aux industries du secteur agroalimentaire (IAA) par la réglementation
communautaire, qui est une transposition des prescriptions du Codex Alimentarius. Cette mise
en place d’un PMS, s’avère être une démarche difficile pour beaucoup de responsables
d’IAA, en particulier du fait de la complexité des documents et méthodes d’application qui
leur sont proposés. Ce mémoire de thèse décrit deux méthodes originales de facilitation pour
la mise en œuvre de certaines prescriptions du Codex Alimentarius. La « méthode de gestion
globale de l’hygiène dans les IAA » constitue un système rationnel d’organisation pour
l’application des BPH/BPF, tandis que la « méthode alternative à l’arbre de décision » permet
d’éviter les échecs fréquents, rencontrés dans l’utilisation de « l’arbre de décision du Codex »
pour l’identification des CCP. Ces deux méthodes innovantes ont été établies en prenant
comme base de raisonnement, un schéma validé d’apparition des accidents alimentaires,
qu’ils soient sanitaires ou économiques.
Abstract
The implementation of a food safety management system (FSMS), based on good hygiene
and good manufacturing practices (GHP / GMP) and HACCP, is a mandatory requirement
imposed on the food businesses (FB) and established by the European Regulation which is a
transposition of the Codex Alimentarius prescriptions. This FSMS implementation turns out
to be a difficult process for many FB managers because of the complexity of the available
documents and methods. This thesis describes two original facilitating methods for the
implementation of specific Codex requirements. The method known as "comprehensive
hygiene management in food industries" is a rational system of organization for the
implementation of GHP / GMP, while the “decision tree alternative method" makes it
possible to avoid frequent failures in the use of "the Codex decision tree” for CCPs
determination. These two innovative methods were developed by applying a deductive
reasoning procedure on a validated scheme of occurrence of health and/or economical food
accidents.
Mots clefs: Application HACCP - BPH/BPF – détermination des CCP, deux méthodes de
facilitation, sécurité sanitaire des aliments, Codex Alimentarius, choléra.
Key words: HACCP – GHP/GMP implementation - CCPs determining, two facilitating
methods, food safety, Codex Alimentarius, cholera
A NOTRE JURY DE THESE
Madame le Professeur Geneviève BENARD, HDR, à l’Ecole Nationale Vétérinaire de
Toulouse
Qui nous a fait l’honneur d’accepter la présidence de notre jury de thèse
Remerciements respectueux et confraternels.
Monsieur Didier MONTET, HDR, Chef de l’UMR - QUALISUD du CIRAD de
Montpellier et,
Monsieur le Professeur Rémy CACHON, HDR, Unité Pédagogique Biotechnologie et
Microbiologie Alimentaire d’AgroSup Dijon
Qui ont accepté de juger de ce travail et de l’évaluer en tant que rapporteurs
Qu’ils trouvent ici l’expression de notre très profonde gratitude
Monsieur le Professeur Bruno GABRIEL, HDR, à l’IUT Paul Sabatier d’Auch, qui a
accepté d’accueillir notre travail de thèse dans le cadre de son Laboratoire de Biologie
Agroalimentaire et Environnemental (LBAE) ;
Nous lui sommes très reconnaissant d’avoir hébergé et soutenu notre travail de thèse dans le
cadre de son laboratoire.
Madame Valérie GABRIEL, Maître de Conférences, à l’IUT Paul Sabatier d’Auch qui a
accompagné notre travail de thèse de ses conseils avisés et précieux.
Qu’elle reçoive pour cette aide, nos remerciements les plus sincères.
Monsieur Jacky LE GOSLES, « Adisor » de la DG-SANCO de la Commission Européenne
qui nous a fait l’honneur d’accepter de siéger à notre jury de thèse.
Nous lui adressons nos vifs remerciements d’avoir accepté par sa participation à ce jury de
représenter la Commission Européenne dont les programmes d’aide au développement ont été
le cadre dans lequel nos travaux ont pu être réalisés.
REMERCIEMENTS
L’expérience de terrain a été un élément majeur ayant permis de mener à bien ce travail de
thèse qui représente la synthèse, sur l’étendue de ma carrière, d’observations réalisées ainsi
que d’actions et méthodes mises en œuvre dans le domaine de la sécurité sanitaire des
aliments.
Pour être mené à bien il a bénéficié, de soutiens, d’aides et collaborations
Il nous est agréable de remercier les personnes qui nous ont apporté leur concours très
précieux dans la réalisation de ces activités
Les membres de la DG-SANCO de la Commission Européenne et en particulier Messieurs
J.LE GOSLES, S.MAGAZZU, T.CHALUS, L.PANELLA, M.MAGUMU
Madame Catherine BESSY, membre de la FAO
Les principaux experts du programme ASEAN/CEN avec qui nous avons réalisé le premier
guide de bonnes pratiques d’hygiène et HACCP, Messieurs F.BOCCAS, L.CAMBEROU et
N.WRIGHT
Les membres de la société AETS ainsi que les principaux experts qui sont intervenus dans le
programme BTSF en Afrique : John, Barbara, Fatou, Babacar, Fabrice et Claudie
Les membres de la société AESA qui ont participé au programme BTSF en Afrique : MariaDomenica, Gennaro, Matteo.
Le syndicat des producteurs de « Piment d’Espelette » et M.BENOIT de la Mission
Agroalimentaire Pyrénées ainsi que le Dr Emilie BONNE
Mr André DAGUIN président de l’UMIH et sa vaillante équipe de restaurateurs du GERS
Enfin mes remerciements les plus vifs vont à Mme Nelly. A.TIMMONS et Mr Kenneth
BERRI pour s’être impliqués sans réserves dans la traduction en langue anglaise de ce
mémoire de thèse.
A tous mes proches, parents et amis, fidèles et sincères … Ils se reconnaîtront
Summary
Introduction ……………………………………………………………………………………… 1
Chapter n°1 Organization of sanitary and phytosanitary risks management at the international
level: complexity and difficulties of implementation …………………………………………… 3
1 History …………………………………………………………………………………………. 4
2. The World Trade Organization ……………………………………………………………….. 5
3. The SPS Agreement (Sanitary and Phytosanitary) and the TBT Agreement
(Technical Barriers to Trade). ……………………………………………………………………5
o 3.1General ………………………………………………………………………………... 5
o 3.2 The SPS Agreement ………………………………………………………………….. 6
• 3.2.1 Basic Objectives of the SPS Agreement ……………………………………….. 6
• 3.2.2 Obligations made to WTO Members …………………………………………... 6
• 3.2.3 exercising the precaution principle ……………………………………………. 7
• 3.2.4 Example of issuance of European Approval to third countries and to the FB
(Food business) of these countries. …………………………………………………... 8
4. Taking into account the WTO regulations of the SPS Agreement by
the European Community Regulation .…………………………………………………...……... 9
o 4.1 Taking the WTO regulations into account …...………………………………………10
o 4.2 taking into account the SPS Agreement and Codex Alimentarius principles ……… 11
o 4.3 Conditions of implementation of the HACCP ………………………………………. 13
5. Practical aspects and difficulties relative to the implementation of the rules governing
international trade, and proposed facilitating solutions. ……………………………………….. 16
o 5.1 Obstacles to the implementation of international trade regulations
for WTO Member States ………………………………………………………………... 14
o 5.2 Obstacles to the implementation of the principles of the
Codex Alimentarius by the FBs managers ……………………………………………… 15
• 5.2.1 Obstacle relative to the organization of the prerequisites
(GHP/GMP) stated by the Codex Alimentarius. …………………………………… 15
• 5.2.2. Obstacles linked to failures in the utilization of the
“Codex Decision Tree” for the identification of the CCP ………………………… 15
Conclusion …………………………………………………………………………………….. 16
Chapter 2: Schematization of mechanism of occurrence of
food-related accidents causing economic loss or food poisoning ……………………………... 17
1. Introduction ………………………………………………………………………………….. 18
2. Qualitative components of a foodstuff ……………………………………………………… 18
3. Various safety hazards that can affect foodstuffs …………………………………………… 20
o 3.1 Parasitic hazards ……………………………………………………………………… 20
o 3.2 Toxic hazards ………………………………………………………………………… 21
• 3.2.1 Toxic substances used internally by Food Businesses ……………………….. 21
3.2.1.1 Detergents and disinfectants ………………………………………….. 21
3.2.1.2 Insecticides and rodenticides ……………………………………...…. 22
• 3.2.2 Toxic substances resulting from raw material or the production process …… 22
o 3.3 Physical hazards ……………………………………………………………………… 22
o 3.4. Microbiological hazards ……………………………………………………………... 22
• 3.4.1 Foodborne zoonosis …………………………………………………………. 23
• 3.4.2 Food Poisoning (frequently collective) ……………………………………... 23
• 3.4.3 Economic losses …………………………………………………………….. 23
o 3.5 A few remarks on allergens …………………………………………………………... 24
4. Relevant elements for establishing a diagram of the occurrence of food accidents ………… 25
o 4.1 Sources of contamination ……………………………………………….…………. 25
• 4.1.1 Environmental sources of contamination …………………………….. 25
• 4.1.2 Sources of human contamination (from operators) ………………………… 25
o 4.2 The contamination phase …………………………………………………………... 26
o 4.3 The multiplication phase …………………………………………………………… 27
• 4.3.1 Time and/or temperature loss of control ……………………………………. 27
• 4.3.2 Lack of control of the formulation parameters of food ……………………... 27
o 4.4 The potential survival phase ……………………………………………………….. 27
o 4.5 The appearance of a microbial overpopulation ……………………………………. 28
• 4.5.1 Overpopulation of common germs ………………………………………….. 28
• 4.5.2 The overpopulation of pathogenic germs …………………………………… 28
5. Diagram of the mode of appearance of food-related accidents ……………………………... 29
6. Validation of the diagram of the appearance of economic losses or food
poisoning by reference to the food preservation methods ……………………………………... 29
Conclusion …………………………………………………………………………………….. 32
Chapter 3: Applying the “Comprehensive Hygiene Management Method”
in food businesses to implement the prerequisites of the Codex Alimentarius . ………………. 33
1. General ………………………………………………………………………………………. 34
2. The “Recommended International Code of Practice”
- General Principles of Food Hygiene” ……………………………………………………… 35
o 2.1 Organizational plan of prerequisites established by the Codex Alimentarius .…….. 35
o 2.2 Organizational scattering and replication of information in listing food
safety provisions in the “ Recommended international code of practice” ……..………. 36
o 2.3 An example of the application of the Codex Alimentarius prerequisites
with the regulatory body of the European Union: Regulation (EC) 852/2004
of the European Parliament and of the Council, of 29 April 2004 on the
hygiene of foodstuffs. ……………………..................................................................… 37
3. The “Comprehensive Hygiene Management Method” for food businesses …………….….. 38
o 3.1 Reminder from Chapter 2: diagram of the mode of appearance
of food-related accidents ……………………………………………………………… 38
o 3.2 Diagram of the “Comprehensive Hygiene Management Method”
for Food Businesses ……………………………………………………………...…… 39
o 3.3. Synthetic presentation box by box of the requirements taken into account by the
comprehensive hygiene management method ………………………………………… 41
o 3.4 Comparison of the organization of the prerequisites
in the “international code of practices” with
the “Comprehensive Hygiene Management Method for Food Businesses” ………….... 42
o 3.5 Examples of diagrams that compare the organization of prerequisites in the Codex
with the “Comprehensive Method of Hygiene Management for Food Businesses …… 44
Conclusion ……...…………………………………………………………….…… 46
Chapitre 4: Practical application of the “Comprehensive Hygiene Management
Method in FBs”: the “Reference Framework for Harmonization of the Management
of Food Hygiene in Africa” ……………………………………………………………………. 47
1. General ………………………………………………………………………………………………... 48
2. History ……………………………………………………………………………………………...... 48
3. The African trade context. ……………………………………………………………………………. 49
4. Drafting of this referential …………………………………………………………………………….. 50
5. Field of application of the referential …………………………………………………………………. 51
6. Presentation of the referential. ………………………………………………………………………... 52
o 6.1 Subdivision of the “Reference Framework for Harmonization
of the Management of Food Hygiene in Africa” ……………………………………………….. 52
o 6.2 Comparison between the organization plan of the “Reference Framework
for Harmonization of the Management of Food Hygiene in Africa” and
the “Comprehensive Hygiene Management Method in FBs” diagram. ………………………… 52
o Organization and content of the referential ……………………………………………………... 53
o 6.4 Appendix 1: Requirements relative to the establishments and
the operators of the food sector ………………………………………………………………… 54
o 6.5 Appendix 2: Requirements relative to FBs registration and approval by the CA. ………….. 56
o 6.6 Synthesis of the study of the “Reference Framework for Harmonization
of the Management of the Food Hygiene in Africa”. …………………………………………... 56
o 6.7 Additional example of practical application of the “Comprehensive Management
Method in Food Businesses”: “Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs”. ……………………………………………………………….……… 57
Chapter 5: The “Alternative Method to the Codex Alimentarius Decision Tree”
for CCPs determination……………………………………………………………………….... 59
1. General context ……………………………………………………………………………... 60
2. Choosing the method ……………………………………………………………………….. 62
3. Reminder from Chapter 3: diagram of the mode of appearance of food-related accidents …. 63
o 3.1 Specific characteristics of contamination ………………………………………….. 64
o 3.2 Specific characteristics of multiplication and survival ……………………………. 64
4. Presentation of the alternative method to the decision tree …………………………………. 65
5. Application of the alternative method for the quick assessment of the relevance of
the FSMS of an inspected/audited FB: the example of cooked and smoked and dried fish … 69
o 5.1 Evaluating the existing FSMS ……………………………………………………... 70
• 5.1.1 The main stages of the process of producing cooked smoked fish …………... 71
• 5.1.2 The original FSMS of the fish processing establishment ……………………. 72
o 5.2 Improvement of the FSMS through the application of the “Alternative Method” …
74
6. Application of the “Alternative Method” for establishing CCP and GHP/GPP:
the example of cured ham …………………………………………………………………… 77
o 6.1 Main stages of the production process of dried salt pork ………………………….. 77
o 6.2 Applying the “Alternative Method” ……………………………………………….. 79
o 6.3 Deductions after applying the alternative method to the decision tree to the
production of cured ham ……………………………………………………………….. 81
o 6.4 Targeting our investigation to a specific bacteria: its practical application
in the case of Clostridium botulinum………………………………………………………... 82
Conclusion ……………………………………………………………………………………... 83
Chapter 6: Improvement of the microbiological quality of
the “Espelette Chilli Powder” through the practical application
of the “Alternative Method to the Codex Alimentarius Decision Tree” ……………………… 85
1. General …………………………………………………………………………………...…. 86
2. Espelette chili powder manufacturing process ……………………………………………… 86
3. Application of the “Alternative Method to the Codex Decision Tree”
to the Espelette chili pepper powder production. ………………………………………...…. 88
4. Synthesis …………………………………………………………………………………….. 91
Conclusion ……………………………………………………………………………………... 93
Chapter 7: A Study of the transmission of cholera by food consumption in rural areas
of Haiti by applying the “Alternative Method to the Codex Alimentarius Decision Tree” …... 95
1. Introduction ………………………………………………………………………………….. 96
2. Cholera ……………………………………………………………………………………… 97
o 2.1 General remarks on the disease ……………………………………………………. 97
o 2.2 Epidemiology 98
• 2.2.1 Waterborne transmission …………………………………………………...... 98
• 2.2.2 Oral transmission …………………………………………………………….. 99
3. Application of the “Alternative Method to the Codex Alimentarius’ Decision Tree”
to the analysis of risk and the proof of our hypothesis ……………………………………. 100
4. The results of our Study ……………………………………………………………………. 105
Conclusion ……………………………………………………………………………………. 106
Chapter 8: Regulatory Guides for the Implementation of “Good Manufacturing Practices,
Good Hygiene Practices, and HACCP” (Hazard Analysis Critical Control Points” ……….… 109
1. Context: guides to good practice ……………………………………………………….… 110
2. History of our guides for the implementation of “Good Manufacturing Practices,
Good Hygiene Practices and HACCP” ………………………………………….………………… 111
3. Organization of the guides to good practice ……………………………………………….. 111
o 3.1 Chapter One of the Guide: establishing prerequisites (GMP/GHP)
in accordance with the “Method of Universal Health
and Hygiene Management” for food businesses ……………………………………… 111
o 3.2 The second chapter of the guide: the HACCP study……………………………… 116
o 3.3 The third chapter of the guide: HACCP plan …………………………………….. 123
o 3.4 The fourth chapter of the Guide: Audit grids for GMP/GHP and the HACCP …... 126
• 3.4.1 Characteristics of the audit grids ……………………………………………. 126
• 3.4.2 Format of audit grids ………………………………………………………... 126
o 3.5 Numerical expression of the observations made using audit grids ……………….. 127
Conclusions ………………………………………………………………………………………….... 129
Overall conclusion …………………………………………………………………………...131
Bibliography …………………………………………………………………………………. 134
List of Illustrations
Chapter n°1 Organization of sanitary and phytosanitary risks management
at the international level: complexity and difficulties of implementation ……………………… 3
Scheme of edification and adoption of European Regulation …………………………………. 7
Diagram of European Agreement issuing system to third countries and their FB ……………… 9
Diagram of the “Hygiene Package” structure ………………………………………………….. 10
Regulation (EC) 852/2004, Annex II …………………………………………………………... 12
Chapter 2: Schematization of mechanism of occurrence of
food-related accidents causing economic loss or food poisoning ……………………………... 17
Table of qualitative components ……………………………………………………………….. 19
Table of food borne hazards …………………………………………………………………... 20
Diagram of the mode of appearance of food-related accidents ………………….…………….. 29
Key deductions from the diagram of the appearance of food-related accidents ……………….. 30
Table of action mode and duration of food preservation usual methods ………………………. 31
Chapter 3: Applying the “Comprehensive Hygiene Management Method”
in food businesses to implement the prerequisites of the Codex Alimentarius . ………………. 33
Organizational plan of prerequisites established by the Codex Alimentarius …………………. 35
Diagram of the mode of appearance of food-related accidents ………………………………... 38
Diagram of the Comprehensive Hygiene Management Method for Food Businesses ………... 39
Table illustrating the two uses of the "Comprehensive Hygiene Management Method
for Food Businesses” …………………………………………………………………………... 40
Comparison of the organization of prerequisites in the Codex with the
“Comprehensive Method of Hygiene Management for Food Businesses” ……………………43
Comparative Organization of the Requirements for Maintenance and Cleaning ……………… 45
1
Comparative Organization of the Requirements for Personnel Hygiene ……………………… 45
Comparative Organization of the Requirements for the Hygienic Control of Operations ……. 46
Chapitre 4: Practical application of the “Comprehensive Hygiene Management
Method in FBs”: the “Reference Framework for Harmonization of the Management
of Food Hygiene in Africa” ……………………………………………………………………. 47
Referential subdivision table divided in five sections ……………………….…………..……. 52
Comparative organization of the “Referential” and of the
“Comprehensive Hygiene Management Method” ……………………………………………. 53
Chapter 5: The “Alternative Method to the Codex Alimentarius Decision Tree”
for CCPs determination .……………………………………………………………………….. 59
Tables of Step 6 and Step 7 of the HACCP Method …………………………………………… 60
The “Codex Alimentarius Decision Tree” for CCPs determination ………………………….... 62
Diagram of the mode of appearance of food-related accidents ………………………………... 63
“Alternative Method” columns 1 & 2: sources of contamination …………………………….. 66
“Alternative Method” columns 3: parameters ………………………………………………… 67
“Alternative Method” columns 4: risks deduction ……………………………………………. 68
Alternative Method” columns 5: control means deduction (CCP and/or GHP/GMP) ………… 69
Table of the FSMS for the production of smoked fish established by the business …………… 73
Table of revised FSMS for the production of smoked fish after evaluation using the
Alternative Method instead of the Decision Tree ……………………………………………… 75
1. Designing the process flow chart …………………………………………………………... 79
2. Enter the three possible sources (physical, chemical, microbiological) of contamination
(inputs and contacts) in columns 1 and 2 step-by-step ………………………………………… 79
3. Enter important parameters (time, temperature, pH, Aw, etc.) in column 3 step-by-step …... 80
4. Deduce the various types of potential danger (C, M, S) from the contents
of columns 1,2, and 3 step-by-step ……..……………………………………………………… 80
2
5. Deduce the type of monitoring methods to be implemented step-by-step
from the contents of column 4: GHP/GMP or CCP ………………………………………… 81
Chapter 6: Improvement of the microbiological quality of
the “Espelette Chilli Powder” through the practical application
of the “Alternative Method to the Codex Alimentarius Decision Tree” ……………………… 85
Table 1: inputs and contacts …………………………………………………………………… 89
Table 2: relevant parameters …………………………………………………………………… 89
Table 3: Hazards identification ………………………………………………………………… 90
Tableau 4: Control means identification ………………………………………………………. 90
Table 5: optimization of the control means by changing the position of the peduncle removal
operation in the manufacturing process ………………………………………………………... 92
Chapter 7: A Study of the transmission of cholera by food consumption in rural areas
of Haiti by applying the “Alternative Method to the Codex Alimentarius Decision Tree” …... 95
Diagram One: Preparation of meat in a sauce ………………………………………………... 101
Diagram Two: Preparation of meat in a sauce referencing inputs ……………………………. 102
Diagram Three: Preparation of meat in a sauce referencing contacts ………………………... 102
Diagram Four: Preparation of meat in a sauce referencing heat treatments ………………….. 103
Diagram Five: Preparation of meat in a sauce referencing risks and safety methods ………... 103
Diagram Six: Preparation of meat in a sauce referencing risks and
safety methods that are essential when the application of
the alternative method to the decision tree is concluded ……………………………………... 104
Reminder: the classical presentation of the “Alternative Method” …………………………... 104
Diagram of the expansion and transmission of cholera ……………………………………… 106
Chapter 8: Regulatory Guides for the Implementation of “Good Manufacturing Practices,
Good Hygiene Practices, and HACCP” (Hazard Analysis Critical Control Points” ……….… 109
Table of the seven principles of the HACCP …………………………………………………. 118
Tables of the first eight steps of the HACCP method ………………………………………… 119
3
Tables of the last four steps of the HACCP method ………………………………………….. 124
Format of audit grids ………………………………………………………………………….. 126
4
List of Acronyms
AFNOR
AOC
ARSO
ASEAN
AU
AWHO (OIE)
CA
CCP
DG-SANCO
EC
ECOWAS
EU
FAO
FB
FSMS
GHP/GMP
HACCP
IPPC
ISO
PAH
REC
SME
SPS (agreement)
UN
UNIDO
WHO
WTO
Association Française de Normalisation
Appellation of origin (in French “Appellation d’origine Contrôlée”)
African Organization for Standardization
The association of Southern Asian Countries
African Union
Animal World Health Organization (Office International des Epizooties)
Competent authority
Critical Control point
DG-Health and Consumers (European Commission)
European Commission
Economic Community Of West African States
European Union
Food and Agriculture Organization
Food Business
Food Safety Management System
Good Hygiene Practice / Good Manufacturing Practice
Hazard Analysis Critical Control Point
International Plant Protection Convention
International Organization for Standardization (or International
Standard Organization)
Hydrocarbures Aromatiques Polycyclic Aromatic Hydrocarbons
Regional Economic Community
Small and Medium-sized Enterprise
Sanitary and Phytosanitary Agreement
United Nations
United Nations Industrial Development Organization
World Health Organization
World Trade Organization
….Introduction
The intensification of international trade brought about by globalization has led the WTO to
define sanitary regulations for its members that enable them to control risks linked to the
worldwide circulation of animals, plants, and the foodstuffs derived from them, while
maintaining the goal of restricting free trade as little as possible.
The SPS agreement [31] adopted in 1994 defines these regulations, which will be reviewed in the
chapter devoted to international trade. Among the partners chosen to establish these regulations
- besides the AWHO (OIE) for animal health issues and the ICPP which is more concerned with
plant health - the WTO has chosen to collaborate with the Codex Alimentarius Commission on
issues of food safety. Created in 1963, the Codex Alimentarius brings together the WHO and the
United Nations’ FAO or the “United Nations Organization for Food and Agriculture.”
Regarding issues of food safety, the Codex Alimentarius Committee published a “Recommended
International Code of Practices - General Principles of food hygiene” (CAC/RCP A-1969, Rev, 4
2003) , which was often updated, most recently in 2003 [10].
The first part of the “international code of practices” devoted to food safety defines “Good
Hygiene Practices and Good Manufacturing Practices” (GHP and GMP) - also known as
“prerequisites” - for businesses in the agro-food sector, whereas the second part is devoted to the
Hazard Analysis Critical Control Points method (HACCP). The application the principles
prescribed in both parts allows food businesses to create and implement their own Food Safety
Management System ( FSMS).
Although the relevance of this document is incontestable, the implementation of its principles
often represents an insurmountable problem for food businesses (FBs), especially for small and
medium-sized establishments (SMEs) in this sector. Each of the principles it establishes, which
aim to ensure food safety, is not only completely well-founded on the scientific level but has also
demonstrated its ability over time to contribute to the protection of consumer health.
On the organizational level, however, the document suffers from the lack of a logical structure
that connects the various principles of hygiene it contains. With this awareness, the first question
that arises is how to locate the source, if there is one, of the awkward organization of the
“international code of practices.” The second question, stemming from the first, is to determine
whether a logical process exists that is capable of providing a solution.
Although the main goal of the “international code of practices” is to prevent food-related
accidents (especially of a sanitary nature), no section of the code describes them any more
clearly than most handbooks of good practices published for professional use. The failure to
describe food-related accidents and especially the mechanisms that cause their appearance
represents a logical flaw in the approach that led to the publication of the “international guide of
practices.” The approach is faulty for the simple reason that one cannot expect to control and
manage effectively whatever one has not already correctly described. From the outset, we were
convinced that filling this gap as the first stage of our work would then allow us to integrate each
principle of food safety established by use in a more simple, logical, and coherent system.
1
This original way of conceptualizing food safety is the backbone of our argument, and its
application has proven useful over time. It has allowed us to design two methods of facilitating
the implementation of the “recommended code of practices” that speak directly to the needs of
many professionals in the agro-food business sector:
“The Comprehensive Hygiene Management Method ” to implement the prerequisites.
“The Alternative Method to the Codex Alimentarius’ Decision Tree” to determine the
“Critical Control Points” (CCP) that must be identified for the implementation of
HACCP method.
As the result of our research, we would now like to introduce the two original methods that we
have developed and successfully applied in the past fifteen years in many countries. In order to
show its practicality, we offer several examples of their application in this research paper:
-
the publication of handbooks for the application of “Good Manufacturing Practices and
Good Hygiene Practices and HACCP” that reference these two original methods and
describe their local application: they are intended for use by Food Business managers to
assist in implementing their FSMS (Food Safety Management System), but also by
professionals in charge of inspecting or auditing these businesses.
-
the application of the comprehensive hygiene management method in Food Businesses,
which allowed for the development of the “Reference Framework for the Harmonization
of the Management of Food Hygiene in Africa,” adopted as a reference document in
January 2011 by the African Union Organization (AUO) member states , in association
with the Kingdom of Morocco, which is not a member.
-
the application of the alternative method to the Codex Alimentarius’ decision tree to
solve problems of the bacteriological contamination of Espelette pepper powder (piment
d’Espelette), that led to changes in the bill of specifications for this “Appellation
d’Origine Contrôlée” (AOC) or “Controlled Designation of Origin.”
-
the application of the alternative method to the Codex Alimentarius’ decision tree for the
rapid evaluation and optimization of the FSMS of an African SME that produces cooked
and dried, and smoked fish.
-
the application of the alternative method to the Codex Alimentarius’ decision tree to the
study of the transmission by food of the choleric vibrio in the context of the FAO
program devoted to the eradication of the cholera epidemic in Haïti.
2
Chapter n°1
Organization of sanitary and phytosanitary risks management
at the international level:
complexity and difficulties of implementation
3
The adherence to good hygiene and good manufacturing practices, as well as the implementation of the
HACCP method, that guarantees the safety of foods distributed to the consumers are the result of a long
process that spans over half a century, following World War II. Gradually this concern for the control of
sanitary and phytosanitary risks to consumers, the animal populations and vegetal productions, spread to
an increasing number of countries, starting with developed countries and expanding to emerging ones.
From this standpoint the progressive globalization of commercial exchanges on a worldwide level, also
constituted a determining factor, by making the definition and the adoption of common rules aimed at
controlling sanitary and phytosanitary risks, necessary.
However these food safety rules, designed to frame and facilitate exchanges between countries, must be
such that no country be prevented from adopting or applying, within its own framework, the necessary
measures concerning the health and life of people and animals, or the conservation of plants. Moreover,
the application of these measures must not represent disguised restrictions or an arbitrary and unjustifiable
discrimination for international commerce. We will show that through the SPS Agreement (Sanitairy and
Phytosanitairy Agreement) [31,32] and the TBT Agreement (Technical Barriers to Trade Agreement)
[33], these principles govern the exchanges between Members States of the World Trade Organization
(WTO).
The best way to understand this organization and the different stages that marked its development during
the last half-century is to review how it grew to govern the exchanges between countries member of the
WTO. Their constantly evolving number corresponds to approximately three quarters of the countries in
the world. The number of countries in the world is 194 (a total that can vary slightly depending on the
criteria used) while the number of WTO Member States is 150 and still growing.
1. History
The most important dates of the establishmentof the rules of the WTO are as follows:
1947, institution of the GATT, or General Agreement on Tariffs and Trade.
1963, Creation of the Codex Alimentarius Commission.
1986, Uruguay Round: revision of all the articles of the GATT.
1992, Blair House Agreement: resolution of agricultural disputes between the European
Community and the United States.
1993: resolution of disputes concerning custom duties and access to the markets of the countries
of the so-called “Quadrilateral” formed by the United States, the European Community, Japan and
Canada.
1994 Marrakech, creation of the World Trade Organization (WTO)
4
2. The World Trade Organization
In simple terms, the WTO is in charge of the rules governing the commerce between countries, on a
global or quasi-global scale, (a little more than 150 countries out of a total 194 in the world). As such it
constitutes a negotiating framework for the resolution of commercial issues arising between its member
states. It functions based on an ensemble of rules (the WTO agreements) [34] encouraging freedom of
exchanges whenever possible and as long as these cannot constitute a source of sanitary or phytosanitary
risk.
The WTO also works to resolve all types of disputes (commercial, sanitary...) that can occur between its
Member States. Indeed, in order to resolve these disputes, the various agreements (WTO, SPS, TBT…)
often need to be interpreted with recourse to a neutral procedure, within the framework of the instances of
the WTO.
3. The SPS Agreement (Sanitary and Phytosanitary) and the TBT Agreement (Technical Barriers
to Trade).
o
3.1General
The common rules framing the dispositions of the control of sanitary risks, are established by the Sanitary
and Phytosanitary Agreement (SPS Agreement) which advocates the use of international standards, and in
particular those established by the Codex Commission. The Technical Barriers to Trade Agreement (TBT
Agreement) establishes complementary dispositions, so that the implementation of the principles of the
SPS Agreement does not constitute an obstacle to commercial exchanges and the return to a form of
protectionism by theWTO Member States.
These agreements that fulfill a normative function of reference are non binding and based by principle on
the acknowledgement of the primacy of science. Despite their non binding character, it is never the less
evident that since the participation to the WTO is voluntary on the part of the states, they willingly submit
to the principles established by these agreements (SPS and TBT).
The principle of primacy of science implies a recourse to expertise to evaluate the sanitary and
phytosanitary risks. It is equally recommended by the SPS Agreement that this expertise fulfill three
fundamental requirements : excellence, transparency and independence.
These agreements make reference to the Codex Alimentarius, which assembles an ensemble of normative
texts of international vocation, written by the Codex Commission to which the World Health
Organization (WHO) the FAO (Food and Agriculture Organization). The Codex Commission is assisted
by two other organizations to accomplish these normative works:
-
The “Office International des Epizooties” (OIE), often referred to as the animal world
health organization.
The International Plant Protection Convention (IPPC)
These three entities, Codex Commission, OIE and IPPC, that collaborate to establish international
sanitary norms, advocated by the WTO, are often referred to as the “three sisters”.
5
o
3.2 The SPS Agreement
•
3.2.1 Basic Objectives of the SPS Agreement
The SPS agreement has a double objective, which is:
to recognize the sovereign rights of WTO Member States, to insure the
appropriate
level of sanitary protection to their citizens, their animal population and their
plant production.
to make certain that the SPS measures adopted do not represent useless, arbitrary,
scientifically unjustified or hidden restrictions to international commerce.
In order to attain its objective, the SPS Agreement encourages the WTO Member States to apply
the international norms, directives or recommendations wherever they exist (in particular those of
the Codex Alimentarius to be found in the “FAO Document Repository”
(http://www.fao.org/documents/en/) [9, 19]
•
3.2.2 Obligations made to WTO Members
To participate in international commercial exchanges the WTO Member States have the following
obligations:
to present the other WTO Member States with a Competent Authority (or several competent
authorities, i.e. one per food manufacturing sector) in charge of the control and approval of
agro-food manufacturing establishments and of the health certification of batches to be
exported.
to have a regulatory corpus equivalent (but not necessarily identical) to that of other member
states, insuring the same level of consumer protection.
to recognize principles such as:
-
those of the HACCP method (Hazard Analysis, Critical Control Point) and its
prerequisites (these two particular principles established by the Codex Alimentarius
within the framework of the “Recommended International Code of Practice General Principles of Food Hygiene”, published under the reference: CAC/RCP 11969 Rev. 4 (2003) [10], are the object of the present memoire and will be thoroughly
examined in the following chapters). These principles, which serve as the foundation
of any Food Safety Management System in all agro food enterprises, must be taken
into account in the creation of the regulatory corpus of each WTO Member State.
-
those of separation of the functions of evaluation and management of food safety
risks. This condition implies that risk evaluation be effected by experts, while risk
management be the responsibility of the political power exercised through the
adoption of regulatory documents. Finally the implementation and management of the
6
policies and control of sanitary risks are insured by the Competent Authority, whose
agents are state employees of the Member States. The diagram of edification and
adoption of European Regulation, which follows, is a clear illustration of the principle
of separation between the evaluation and management of sanitary risks.
Scheme of edification and adoption of European Regulation
The core functioning principles of the system of regulatory edification and adoption assembled in this
diagram, can be summarized as follows: the European Commission has the role of composing the
documents, while the European Food Safety Authority is in charge of risk evaluation: a role it exerts by
issuing advices. The Council of Ministers which adopts (or not) the documents previously redacted by the
Commission, serves the role of risk management. Finally the mission of promotion and control of the
application of the community’s regulations, after their adoption, falls to the Competent Authority of each
European Union Member State, through its Official Control Services. Naturally, as is always the case
when enforcing regulation, an arbitrating body in charge of resolving potential conflicts between Member
States, must be available. This role, consisting in stating the law, falls to the European Court of Justice.
•
3.2.3 exercising the precaution principle
The SPS agreement provides for the application of the precaution principle ([31, 32] article 5, paragraph
7), when a new sanitary or phytosanitary risk appears or is suspected of appearing. The resulting situation
7
is often characterized by a lack of knowledge or of relevant scientific evidence, which calls for the
application of provisional measures designed to maintain a satisfactory level of food safety.
These provisional measures will derive from the information available at the time. They will be
maintained while waiting for new facts and periodically reviewed within reasonable delays.
The SPS agreement establishes that the pretext of non-verified or non-credible hazards, can in no way
allow for a limitation of exchanges or a return to protectionism. To that effect, the principles of
nondiscrimination, transparency, equivalence and coherence, will be enforced between WTO Member
States, within the frame of their exchanges.
o
3.2.4 Example of issuance of European Approval to third countries and to the FB (Food
business) of these countries.
In this system, a third country must first become approved, under certain conditions, by the European
Commission, to introduce its products into the European space. The approval is granted to the third
country one sector of activity at a time (fishery products, dairy products, poultry meat,…),and is
contingent to its capacity to satisfy the requirements of the European Commission , which are none other
than the conditions defined by the SPS Agreement:
To designate of one (or more) competent authorities.
Each third country wishing to export toward the EU must present a competent authority
(CA).This CA is in fact one of the third country’s official control services, in charge of
granting EC approvals to businesses wishing to export , and to issue exporting health
certificates for each batch sent to Europe. Some third countries designate several competent
authorities in order to trade with the EU, such as, for instance, one CA answering to the
ministry of fisheries for the exportation of fish and another one answering to the ministry of
agriculture for the exportation of meats.
To have a set of regulations based on the principles of the SPS agreement.
The exporting country must have a regulatory corpus enforcing the principles of the SPS
agreement, such as: advocating the HACCP method or an equivalent method, or else
applying the principle of separation of risk evaluation and risk management. At the national
level the CA of the third country is responsible for the promotion and control of the
enforcement of these regulations through a process of inspection and audit.
To establish a plan for the control of residues and contaminations .(Decision of the
Commission of May 16, 2007, modifying the decision 2004/432/CE concerning the approval
of third countries residue surveillance system, in accordance with the directive 96/23/EC
council).
The CA of each third country must annually submit for approval to the European
Commission, a control plan of residues and contaminants pertaining to the production sectors
wishing to export towards the EU.
8
To designate one or several accredited laboratories. Finally, the exporting country must
designate analysis laboratories, necessarily certified by an independent accrediting body that
will be in charge of implementing of the annual control plan. These laboratories must not
necessarily be located on the territory of the country wishing to export, in particular where
developing countries are concerned.
The second step for the Competent Authority of the third country consists in issuing, after inspection, on
behalf of the European authorities the European approval to FB that have expressed the desire after
having complied with community regulation.
Diagram of European Agreement issuing system to third countries and their FB
4 Taking into account the WTO regulations of the SPS Agreement by the European Community
Regulation
The corpus of the European regulations relative to the food safety has been the object of a review by the
adoption of new framework of regulations between 2002 and 2004. As we will see, all these texts refer to
the WOT regulations, as well as to the principles of the Codex Alimentarius. The Regulations (EC)
852/2004 [39], 853/2004 [40] and 854/2004 [41] constitute the “Hygiene Package”. This new regulatory
corpus was initiated by the (EC) Regulation 178/2002[38] (adopted in 2002) also called “Food Law” but
some texts are not part of the “Hygiene Package”: the (EC) regulation 183/2005 [43] laying down
requirement for feed hygiene and the (EC) Regulation 882/2004[42] relative to the organization of
Official Control Services.
9
Another look at this new regulatory corpus shows that part of the texts relative to food safety destined to
human consumption, is for the use of the professionals in charge of the FB (Regulation 852 and
853/2004) while the other part gathers texts relative to the activity and organization of the Official
Control Services depending on the Competent Authority of each Member State (Regulation 854 and
882/2004). The following diagram shows the way in which these texts are linked together.
Diagram of the “Hygiene Package” structure
Without analyzing these regulations in detail, which is not the object of this memoire, it is possible to
highlight for each of them the reference they make to the WTO regulation and to the Codex Alimentarius.
o 4.1 Taking the WTO regulations into account
(EC) Regulation 178/2002 or Food Law “laying down the general principles and requirements of
food law, establishing the European Food Safety Authority and laying down procedures in
matters of food safety”
In this first regulation, the principle of compliance to international trade is clearly underlined in the
following excerpts:
10
-
Recital no 22
“Food safety and the protection of consumer's interests is of increasing concern to the general public,
non-governmental organizations, professional associations, international trading partners and trade
organizations.”
-
Recital no 23
“The safety and confidence of consumers within the Community, and in third countries, are of paramount
importance. The Community is a major global trader in food and feed and, in this context, it has entered
into international trade agreements, it contributes to the development of international standards which
underpin food law, and it supports the principles of free trade in safe feed and safe, wholesome food in a
non-discriminatory manner, following fair and ethical trading practices.”
-
Article 5 “General objectives”
Under 3: “Where international standards exist or their completion is imminent, they shall be taken into
consideration in the development or adaptation of food law”.
-
Article 13 “International standards”
“The community and the Member States … promote consistency between international technical
standards and food law while ensuring that the high level of protection adopted in the Community is not
reduced.”
o
4.2 taking into account the SPS Agreement and Codex Alimentarius principles
(EC) Regulation 852/2004 “on the hygiene of foodstuffs”
This first regulation of the “Hygiene Package” is a general text covering all the types of foodstuffs. It no
longer refers to International trade in general, as in the previous texts, but rather to the specifics of the
norms established by the Codex Alimentarius, for the implementation of the SPS Agreement, which is to
say the HACCP and good hygiene practices:
-
Article 1: “Scope”
Under d: “general implementation of procedures based on the HACCP principles, together with the
application of good hygiene practice, should reinforce food business operators’ responsibility”
Under e: “guides to good practice are a valuable instrument to aid food business operators at all levels of
the food chain with compliance with food hygiene rules and with the application of the HACCP
principles”
Article 5 : “Hazard analysis and critical control points”
Under 1: “Food business operators shall put in place, implement and maintain a permanent procedure or
procedures based on the HACCP principles.”
-
Annex II: “General hygiene requirements for all food business operators”.
These general provisions prescribed in the annex, are nothing other than the prerequisites to the
application of the HACCP method as they are defined by the Codex Alimentarius within the framework
11
of “Recommended international code of practice –General Principles of Food Hygiene – CAC/RCP 11969, REV. 4 (2003)” These provisions are also what is generally referred to as Good Hygiene Practice
and Good manufacturing practice (GHP/GMP).
The domains where Good Hygiene Practice applies (or general hygiene provisions) are summarized in the
following table:
Regulation (EC) 852/2004, Annex II:
-
Recital n° 15
It is interesting to emphasize this point of this regulation which stipulates:
“The HACCP requirements should take account of the principles contained in the Codex Alimentarius.
They should provide sufficient flexibility to be applicable in all situations, including in small businesses.
In particular, it is necessary to recognize that, in certain food businesses, it is not possible to identify
critical control points and that, in some cases, good hygienic practices can replace the monitoring of
critical control points.”
This point introduces the idea that the HACCP method must be applied with some flexibility, in particular
within the enterprises of the primary production sector which often apply a simple manufacturing process,
as well as in small businesses. In cases where critical control points (CCP) cannot be identified, the food
safety management system can rest entirely on good practices: GHP/GHP.
In order to explain this point on flexibility in the application of the HACCP method, the European
Commission has published a guidance document
12
o
4.3 Conditions of implementation of the HACCP
“Guidance Document “on the Implementation of procedures based on the HACCP principles, and
facilitation of the implementation of the HACCP principles in certain food businesses” [14]
Dated November 16 2005, this orientation document specifies the businesses and the situations where
such flexibility is possible, and stipulates in particular that:
-
“Food hygiene is the result of the implementation by food businesses of prerequisite
requirements and procedures based on the HACCP principles. The prerequisite
requirements provide the foundation for effective HACCP implementation and should
be in place before a HACCP based procedure is established. “
-
Where the prerequisite requirements (whether or not supplemented with guides to
good practices) achieve the objective of controlling hazards in food, it should be
considered, based on the principle of proportionality, that the obligations laid down
under the food hygiene rules have been met and that there is no need to proceed with
the obligation to put in place, implement and maintain a permanent procedure based
on the HACCP principles.
since:
and finally that:
-
“Guides to good practice are a simple but efficient way to overcome difficulties that
certain food businesses may encounter in implementing a detailed HACCP procedure.
Regulation (EC) 853/2004 “laying down specific hygiene rules for food of animal origin”.
This regulation quotes in its recital n° 7: “The requirement in Regulation (EC) No 852/2004 whereby
food business operators carrying out any stage of production, processing and distribution of food after
primary production and associated operations must put in place, implement and maintain procedures
based on hazard analysis and critical control point (HACCP) principles ...”.
(EC) Regulation 854/2004 “laying down specific rules for the organization of official controls on
products of animal origin intended for human consumption.”
The regulation states clearly, in its article 4 titled “General principles for official controls in respect of all
products of animal origin falling within the scope of this Regulation” :
“The competent authority shall carry out official controls to verify food business operators’ compliance
with the requirements … [including] audits of good hygiene practices and hazard analysis and critical
control points (HACCP)-based procedures.”
(EC) Regulation 882/2004, “on official controls performed to ensure the verification of
compliance with feed and food law,animal health and animal welfare rules”
13
In the context of this memoire, this text dedicated to the organization of official control services,
which are depending on the Competent Authority of each Member State of the European Union
or of each third country member of the WTO, is cited only as a reference.
5. Practical aspects and difficulties relative to the implementation of the rules governing
international trade, and proposed facilitating solutions.
The dispositions put forward in this chapter can be summarized in two groups: dispositions
that come under the responsibility of WTO member states, and those whose implementation is the
responsibility of Food Businesses.
Among other conditions, WTO member states must be able to present as a valid representative to
partner countries with whom they trade foodstuffs, a Competent Authority administering Official
Control Services in charge of promoting and controlling the application of a set of regulations in
compliance with the principles of the SPS Agreement.
For their part , in order to comply with the rules stated in the Codex Alimentarius, food
businesses from member states must implement a Food Safety Management System (FSMS)[10]
assembling the Good Hygiene and Manufacturing Practices (GHP/GMP), constituting the prerequisites for the second phase: the implementation of the HACCP method.
The compliance and implementation of these dispositions, often creates difficulties for the WTO
Member States as well as for their Food Businesses (FB). In the following pages we will examine
the sources of these difficulties, as well as solutions of facilitation we have offered in the scope of
our professional experience and which are the object of this thesis.
o
5.1 Obstacles to the implementation of international trade regulations for WTO Member
States.
Different types of obstacles can be found mainly in emerging countries.
Even though the Competent Authority is, most of the time, clearly identifiable, profound deficiencies are
apparent in its organization, in particular these:
-
The geographical partition of the territory into administrative districts is not clearly
defined, which makes it impossible to know which area each agent of the official
controlling services inspects.
-
FBs, particularly in the primary sector are not listed or registered, so it is not possible
to include them in any administrative district in order to plan an inspection.
-
Regulations and/or standards relative to food safety are partially or totally absent.
-
Inspection or audit procedures are not clearly established.
The “Reference framework for the harmonization of the management of food hygiene in Africa” that we
drafted, (see chapter 4), a tool the African Union Organization adopted at the beginning of 2011, will
make it possible to remedy these deficiencies. For the time being it actually constitutes a normative food
14
hygiene guideline that African states and their FB can implement if they wish to, on a voluntary basis. In
total compliance with the principles of the SPS agreement and the Codex Alimentarius, this reference
framework will later be used as a roadmap by African countries as they work at drafting their own
regulations.
This is why appendix 2 of this reference framework is designed for use by Competent Authorities:
“Requirements relating to registration and approval (certification) of the establishments by the competent
authority”. Thanks to the recommendations made in this appendix 2, Competent Authorities will
themselves have the opportunity to organize and to start complying as of now with the regulations
governing international trade.
In addition, this reference framework mostly devoted to the implementation of the GHP/GMP and
logically structured along the line of the “Comprehensive Hygiene Management Method” will also allow
FBs to move ahead of future regulations by complying in advance with the principles of the Codex. In
this reference framework the HACCP Method is not taken into account yet but the GHP/GMP
constituting its preliminary steps are. In a somewhat near future though, this reference framework will
necessarily integrate the HACCP, in order to comply with the complete set of policies of the Codex
Alimentarius.
o
5.2 Obstacles to the implementation of the principles of the Codex Alimentarius by the FBs
managers.
This second ensemble is made up of greater obstacles, experienced by many enterprises independently of
their size, of their sector of activity or of the country where they are implanted:
•
5.2.1 Obstacle relative to the organization of the prerequisites (GHP/GMP) stated
by the Codex Alimentarius.
This first obstacle is what prompted us to draft the “Comprehensive Hygiene Management Method"
which constitute an original facilitating solution and which theoretical presentation will be the object of a
specific chapter (no 3) of this memoir. Two documents we study (in chapters 4 and 8) of this memoir and
which appear in their entirety in its annexes 1 & 2, constitute concrete examples of transposition of this
method: in chapter 8, the “Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs” [4] (devoted
in part to this method) and in chapter4, the “Reference Framework for Harmonization of the
Management of the Food Hygiene in Africa” [22], of which this method constitutes the structural plan.
This reference framework comes with its “Guidelines on the Application of GMP, GHP and HACCP”
(which is the most recent African version of the previous “Main guidelines on the HACCP, GHP and
GMP for the SMEs of the ASEAN”). This second document is used as a “guide of good practices”, while
the “Reference Framework” can be looked at as a “standard” representing a stepping stone in the process
of sanitary certification of foodstuffs traded between African states.
•
5.2.2. Obstacles linked to failures in the utilization of the “ Codex Decision Tree” for
the identification of the CCP
This second difficulty is what prompted us to draft an original solution of facilitation, the “Alternative
Method to the Codex Decision Tree” [10] which theoretical exposition is the object of a specific chapter
15
(no4) of this memoir. The modalities of field implementation of this method are also thoroughly presented
for the first time in “Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs”
Conclusion
In this first chapter we were able to demonstrate that on the international level, three quarters of the states
in the world engaged in commercial trade, are in compliance or near compliance with the regulations set
by the World Trade Organization.
With regard to food safety, these rules, established by the Codex Alimentarius , promote the
implementation of Food Safety Management Systems in the FB, based on the establishment of Good
Hygiene Practices and Good Manufacturing Practices (GHP/GMP) as a prerequisite preceding the
application of the HACCP Method.
FB operators, encounter two major obstacles when establishing these FSMS: lack of clarity and
redundancy in the presentation of the GHP/GMP of the Codex Alimentarius and failures in the use of the
“Decision Tree for the identification of the CCPs” of this same Codex.
It is to overcome these two obstacles that we have conceived two original methods of facilitation, which
are the principal object of the present thesis: the “Comprehensive Hygiene Management Method in FBs”
organizing the GHP/GMP, and the “Alternative Method to the Codex Decision Tree” for the
identification of the CCP.
16
Chapter 2
Schematization of mechanism of occurrence of food-related
accidents causing economic loss or food poisoning
17
1. Introduction
To implement their Food Safety Management plan, professionals now have copious
documentation at their disposal: regulations, standards, and guidelines for the application of
BPH/BPF and HACCP. Unfortunately, it appears that although these documents offers a set of
food safety principles whose relevance needs no further proof, their disappointing lack of
stringency on the organizational level was often a source of difficulty for professionals.
Furthermore, although the goal of these documents is to control the occurrence of food-related
accidents, their description and mechanism of outbreak are not usually identifiable in the preface
to these works, especially in guides to specific food sectors (fish, meat, and poultry meat, dairy
products, etc.) which are more concerned with describing characteristics of their products than
incidents that may adversely affect them. Neither does the prevailing European Community
regulation (“Food Law” and “Hygiene Package”) take into consideration the factors that cause
these food-related accidents nor to appear beyond the most broadly applied standards in the area
(ISO 22000, IFS, BRC) [5,6].
If we are to commit to a project whose goal is to facilitate the elaboration and application of a
Food Safety Management System (FSMS) in Food Businesses under these conditions, we must
be able to refer to a model that can describe the mechanism that triggers all types of food-related
accidents, of either a sanitary or an economic nature. In fact, only that which has first been
accurately described can then be effectively and efficiently controlled. The goal of the first stage
of the project is to provide a unique and valid model that is applicable to all types of food-related
accidents regardless of the food categories that are affected.
2. Qualitative components of a foodstuff
Before discussing the safety hazards to foodstuffs, we must first define the qualitative
components of a food for the consumer.
This table synthesizes the qualitative components of a food product, among which its safety is
the most important for consumers and professionals as well as for the agents representing the
quality control organizations responsible for inspection or audits of the Food Businesses.
- Taste, smell, and texture all relate to the consumer’s physical perception of the food when it
o
is ingested. Its appearance is also important, as witnessed by the increasing effort of
professionals to make food packaging more attractive. Furthermore, the culinary art of
some countries is mainly based on the visual presentation of its food (in Japan, for
instance); on the other hand, certain shades of food, like green, are spontaneously refused
by very young children.
Dietary requirements vary from one consumer to another, depending on whether or not a
specific diet has been imposed that he must or must not follow.
The relationship of quality to price is of primary concern to most consumers.
18
Table of qualitative components
It is interesting to notice that among the four aspects that we have singled out the first three
components of the quality of a food product are evaluated with some flexibility in the
consumer’s mind. In fact, he will voluntarily pay more or less depending on whether the selected
food items are more or less refined or more or less appropriate to their diet.
On the other hand, the consumer will not compromise on safety. Regardless of the price range of
the products he is considering, the consumer expects that their consumption is accompanied by
the highest possible level of health safety. It is especially important to emphasize that the safety
of food products - which, when compromised, can lead to serious consequences involving
professional responsibility - depends directly on the application of and respect for the cardinal
principles of food hygiene.
19
3. Various safety hazards that can affect foodstuffs
Table of food borne hazards
As this diagram shows, there a four kinds of food hazards: parasitic, toxic, physical, and
microbiological.
The last point in the preceding diagram describing the microbiological hazards caused by the
presence and subsequent multiplication of germs in (or on) food is the source of the majority of
hygienic rules recommended to the FB. Simply stated, it is for this reason, first and foremost,
that food hygiene is based on two fundamental principles:
- cleanliness that ensures the reduction of germs in (or on) food.
- control of thermal chains, especially refrigeration, whose goal is to prevent or limit
as much as possible the proliferation of germs in or on food.
o 3.1 Parasitic hazards
The number of parasitic illnesses transmitted by food is relatively low in Western Europe. This is
not the case, however, in other parts of the world, like the inter-tropical zone.
The following list describes the major types of parasitosis that strike Western Europe [27] :
20
- the large fluke (Fasciola hepatica)
- the taenia transmitted by beef (tapeworm: Taenia saginata). Its close cousin (Taenia
solium) transmitted by pork and not affecting the population of Western Europe.
- classic hydatidosis (Echinococcus granulosus) as well as its multilocular form
-
(Echinococcus multilocularis)
trichinosis (Trinchinella spiralis)
anisakiasis (caused by several species of anisakis)
toxoplasmosis (toxoplasma gondi)
There is no further reference in the course of our work here to the forms of parasitosis cited in
the brief reference above because they appear so infrequently. However, they could easily be
included in a Food Safety Management System simply by treating them as contaminations, since
the parasites of our hemisphere are incapable of multiplying in food. Conversely, their
destruction by freezing or their possible survival in meat, if sanitation treatment fails, depends on
the correct control (or not) of the parameters of the technology used (temperature and freezing
time).
To protect the consumer, the prevention of these forms of parasitosis and the detection of their
presence in food (especially meat carcasses and fish) is the responsibility of the food safety
control services depending on the Official Competent Authority [41, 44], whereas the preventive
capacity of the agents of the Food business in this area is minimal.
o 3.2 Toxic hazards
Consideration of these hazards can be divided into two categories, according to the source of the
poisons involved in the contamination of food. In fact, normal operations in the Food Business
require systematic internal recourse to several groups of toxic products: cleaning products and
disinfectants, rodenticides, insecticides, and other chemical substances related to the production
process (solvents, lubricants, etc.)
• 3.2.1 Toxic substances used internally by Food Businesses
3.2.1.1 Detergents and disinfectants
Professionals often wrongly assume that since the detergents and disinfectants
they use are required to be “food-grade quality,” they are devoid of toxicity.
This characteristic of cleaning and disinfecting products only means that if used
properly and properly rinsed, they leave no surface residue; in other words, they
may be used in food processing units
The avoidance of food contamination by these products is entirely the
responsibility of the management staff of each Food Business, which is
responsible for developing a cleaning plan and checking its effectiveness and
efficiency.
21
3.2.1.2 Insecticides and rodenticides
Use of these toxic products by Food Businesses is an aspect of applying a pest
management plan. Although risk prevention related to their use vis-à-vis the
consumer as well as workers is the responsibility of the Food Business
management staff, it is not advised that their own staff be allowed to use these
products. Optimal results that adhere to safety standards in the struggle against
toxic substances are obtained by calling in specialized organizations: private
companies that provide such services or specialized municipal services in certain
cities.
•
3.2.2 Toxic substances resulting from raw material or the production process
The toxic substances found in raw material come mainly from industrial (dioxins, heavy metals,
etc.) or agricultural (pesticides, residue from veterinary medication) sources. Raw material is the
main source of toxic residues detected in finished products (approximately 80% according to the
accepted value derived from the empirical application of Pareto’s “80/20” law [16]). Applying
the same law, food processing is the second significant source (approximately 20%) of toxic
residues (solvents, hydrocarbons, lubricants, etc.)
Toxic residues are inert agents that are passively introduced into food (by injection of veterinary
drugs, pesticides spreading, impurities, pollution, etc.) Their concentration remains constant after
being introduced into food, unless a liquid food substance is then diluted or concentrated, which
will also affect the concentration of residues.
Avoidance of these toxic residues resulting from the use of cleaning products or in pest control
plan is the responsibility of the management staff of the Food Business.
o 3.3 Physical hazards
Physical dangers due to the presence of foreign bodies in raw material are mainly related
to agricultural methods (stones, wood chips, pieces of glass) or animal farming
(hypodermic needles, etc.). Just as for toxic residues, raw material is responsible for
most of foreign bodies (estimated at approximately 80% according to the accepted use
value) found in finished products. Once again, just as for toxic residues, processing is the
second largest source of contamination by foreign bodies (broken blades, bolts, bits of
the oven vault, etc.)
These foreign bodies are inert agents that are passively introduced into food during
harvesting or else produced by damage to the environment or production equipment. The
level of their presence is a constant once they have become food-borne during harvest or
introduced during transformative processing.
o 3.4. Microbiological hazards
Microbiological hazards [36] may be divided into three groups: infectious animal
diseases (designated as “food-borne zoonosis”), possibly transmitted to consumers
22
through food consumption food-borne poisoning related to the presence and
multiplication of certain germs (such as salmonella or Staphylococcus aureus); and
finally, economic losses resulting from damage to food caused by common flora.
• 3.4.1 Foodborne zoonosis
Among the zoonosis agents that are transmitted by food, we can cite as examples: Malta
fever (caused by Brucella melitensis), bovine tuberculosis (caused by Mycobacterium
bovis) and Q fever (caused by Coxiella burnetii). Some food-borne zoonosis may also
present a viral etiology, such as hepatitis A transmitted by eating contaminated shellfish
[30],
Some of these diseases are accompanied by severe illnesses that, like brucellosis, enter a
definitive chronic stage after appearing in an acute paroxysmal first stage during the
days or weeks following the patient’s contamination by the pathogen.
The major characteristic of the germs causing these zoonosis and most other pathogenic
germs responsible for contagious diseases is their inability to multiply outside of a living
organism: Brucella do not develop in milk, nor can TB develop in meat or offal of cattle.
These zoonosis may be transmitted to the consumer when products consumed are from
animals who were sick when slaughtered or at the time their milk was collected.
In both these cases, prevention of the transmission of these zoonosis to humans is the
responsibility of the Official Control Services depending on the National Competent
Authority. These CA staff members are in charge of prophylactic operations on living
livestock and meat inspection in the slaughterhouse [41].
• 3.4.2 Food Poisoning (frequently collective)
The problems caused by these types of food poisoning [29] are the result of the
combined action of a large germ population found in tainted food and the toxins that
were produced as they multiplied. This is true for Salmonella and Staphylococcus
aureus. The toxin sometimes acts alone, as in botulism or its action is associated with an
infectious episode cause by germs present in the food, as in the case of salmonellosis.
These diseases most often occur when germs introduced into food that has been handled
in a non-hygienic way are allowed to multiply actively due to poor storage or
transportation condition (e.g. a breakdown in the refrigeration system). Such accidents
are also found in foodstuffs whose stability is guaranteed by specific characteristics of
composition (pH, Aw, etc.) but whose safety value could not be guaranteed because of a
breakdown in formulation that occurred during processing.
23
•
3.4.3 Economic losses
When the germs involved in contamination and multiplication are non-pathogenic and
belong to a common flora, there is a noticeable change in the affected food that can
entail significant economic losses. In this case, it is not inappropriate to consider these
losses as “businesses economic illness” jeopardizing the economic health of businesses,
while food poisoning events affect the health of consumers .
Clean working conditions and compliance with standard procedures of storage and
transportation are under the responsibility of the management staff of Food Businesses.
o 3.5 A few remarks on allergens
The hazard caused by the presence of allergens in food is intentionally absent from our study
devoted to food-related accidents for several reasons.
- No substance is essentially an allergen by nature: it only becomes an allergen at the moment
when a consumer’s body triggers an allergic reaction [2] (most often a type 1
hypersensitivity) to it as a response. Although some substances more than others, like
gluten or peanuts, may have a more marked tendency to initiate a hypersensitive reaction,
we should be mindful of one of the principles of immunology that states that “nothing is by
nature allergenic; however, anything can become one.” Although the propensity to initiate
an allergic reaction is usually observed in substances with a higher molecular mass
(minimally 500-1000 Dalton) [2] , lighter weight molecules, even very small ones, may
trigger hypersensitivity through the immunological “carrier effect” by attaching themselves
to one of the organism’s larger molecules, like a serum blood protein. Under these
conditions, the list of potential allergenic substances is practically endless, thereby posing
the problem of how to limit the amount of information provided for the consumer on the
labeling of the product.
- A consumer’s hypersensitivity and the triggering of an allergic attack are initiated in the
body by foods whose production fulfills all the principles of food hygiene and comply with
all criteria of food safety.
- The onset of a state of hypersensitivity and the triggering of attacks when this pathology has
entered the consumer’s body is in no way related to the allergenic substance amount to
which he/she has been exposed.
- In many cases the presence of an allergen (gluten, lactose, etc.) cannot be considered as a
contamination, since it is a normal component and not an incidental pollution of the given
food.
Even if it is necessary and mandatory (in most of the national regulations) to warn consumers of
the presence of a major allergen in the composition of a foodstuff, the two reasons we have just
presented explain that food allergies do not present the same logical mechanisms nor the same
determinative triggers as other food accidents.
24
In our opinion, these allergies must be considered as clinical pathologies whose prevention is
based on informing the consumer about the composition of foods and not at all on the application
of classical principles of food hygiene.
We would also note that the presence of allergens does not modify the organoleptic
characteristics of a product. For this reason, it is not a source of economic loss of value in foods.
4. Relevant elements for establishing a diagram of the occurrence of food accidents
Before we construct a diagram of the appearance of food accidents, we must identify and list the
elements to be taken into consideration in order to articulate their interrelationships according to
a model based on their chronology of intervention.
o 4.1 Sources of contamination
•
4.1.1 Environmental sources of contamination
Sites and equipment (furnishings, machinery, tools, etc.)
Broadly speaking, a food business’s premises and equipment may represent
sources of contamination because of design defects. These defects may be
due to the overall arrangement of production activities (schedule of
processing flows, location of work stations, etc.) as well as to the quality of
the building materials (floors, walls, equipment, work surfaces, tools, etc.)
These design defects are often the source of cross-contaminations due to the
proximity of or contact between elements at various work stations.
Raw material
Raw material is the source of the majority of the two types of chemical and
physical contamination. As we have seen above [16], there is general
consensus that contamination from raw material accounts for 80% of the toxic
residue or foreign bodies found in finished products. On the contrary, this is
not true in cases of microbiological contamination, which stems from
multiple sources.
Pests
Besides the damage caused to foodstuff (deterioration, loss of quality,
spoilage from their droppings, etc.), pests are vectors of pathogenic germs
including Salmonella, Leptospira, and Listeria monocytogenes.
4.1.2 Sources of human contamination (from operators)
Because they work manually, production workers can often be a major source of the
microbiological contamination of food, although possible chemical (from detergents,
hydrocarbons, etc.) or physical (hair, ball-point pen fragments) contaminations should
not be underestimated.
•
25
Healthy carriers
This class of manual workers, who are most often identified as carriers of
Staphylococcus aureus, is not a major source of contamination, provided that
workers are trained to wash their hands often and strictly comply with good
hand hygiene.
Chronic carriers
The second class of production workers who may have skin lesions
(furunculosis on the arms and hands, facial acne) or ENT (ear-nose-throat)
ailments (like chronic sinusitis) are a problematic source of contamination
because the effectiveness of regular hand washing in preventing food
contamination is subverted by abnormal movements caused by their lesions:
blowing the nose or frequently scratching the skin that recontaminates the
hands.
Chronic carriers of Salmonella who have recurring bouts of diarrhea pose the
threat of dirtying their hands and/or contaminating their whole environment
after frequent visits to the restroom during these bouts of diarrhea.
o 4.2 The contamination phase
The contamination first phase of the three possible types (chemical, physical, and
microbiological) is usually induced by a defect of hygiene in handling that occurs during
the production process, unless it is caused by the use of raw material or precontaminated packaging.
In the case of physical (foreign bodies) and chemical (toxic residues) contaminants, the
contamination alone is enough to make the food potentially dangerous. The foreign
bodies can cause traumatic lesions (sores in the mouth or digestive tract, broken teeth,
etc.) when ingested, whereas the fear that arises from the presence of residues
(pesticides, heavy metals, etc) is mainly related to a chronic rather than acute poisoning.
Of course microbiological sterility (at least at the commercial level) is not a desired goal
in most food categories, except in certain cases like canned food and irradiated products.
Contamination is characterized by the fact that contaminants play only a passive role in
this mechanism since they are introduced directly into products by a carrier (tools,
machinery) or else deposited by contact with their surface (via work surfaces, hands,
etc.).
In the case of germs, the contamination phase by itself is not enough, except in very rare
cases (like the transmission of typhoid fever) to cause food poisoning or economic loss.
In order to observe one of these two types of accidents, the contamination phases must
be followed by a phase in which these biological agents multiply.
26
o 4.3 The multiplication phase
Only living organisms are capable of actively multiplying in food. This multiplication is
most often caused by one of the two following situations involving loss of control:
• 4.3.1 Time and/or temperature loss of control
Since the composition of most food stuffs (cooked dishes, pastries, composed salads), is
analogous to that of the culture mediums used in the laboratories, the multiplication of
germs that contaminate them may be controlled by implementing the cold chain that
significantly slows down the reactions of the microbial metabolism.
When control of the cold chain is lost (by cooling too slowly, a prolonged exposure at
room temperature, an outage in the cold room), germs find favorable conditions for
multiplying rapidly, with or without the production of toxins, depending on the germs
involved.
In the case of cholera (which will be studied later in chapter 7), considered as a purely
infectious disease and not as food poisoning, we were able to observe during the cholera
epidemic that struck Haiti in 2010-2011 that the multiplication of choleric vibrio brought
about by eating food later in the day that had been prepared much earlier but had not
been kept under cold conditions was a factor that strongly exacerbated severe and even
mortal clinical forms of cholera
Similarly, loss of control of the hot chain (defined as preserving food after cooking for a
maximum of two hours at over 630 C) provides an opportunity for germs to multiply
rapidly in food as the result of having been kept at an insufficiently high temperature.
• 4.3.2 Lack of control of the formulation parameters of food
The stability and sustained preservation of certain foodstuffs are based on their chemical
composition. In fact, it is possible to make foodstuffs more or less stable either by
lowering their pH value (foodstuffs preserved in vinegar, dairy products) or water
activity (dried or salted products, etc.).
These products may be preserved (without resort to the cold chain for certain highly
acidic, dried, or salted products) as long as the value of the stability parameters of these
products is maintained.
It is clear that the active multiplication phase is a dynamic mechanism that is conditioned by the
value of specific parameters in the germ environment that can be specific to foodstuffs
(time/temperature, formulation). These parameters may be monitored in order to prevent the
appearance of the multiplication phase.
o 4.4 The potential survival phase
Failure to apply the parameters of a decontamination process (pasteurization, sterilization,
ionization, etc.) may enable the survival of a portion of the bacterial population in a food
product. In canned products this takes the form of a revivable flora inside the can; for pasteurized
products, it appears as an excess of the residual flora that is normally tolerated after processing.
27
This active survival of germs comes from a dynamic mechanism specific to living organisms,
which is avoidable by a proper monitoring of the decontaminating treatment parameters.
This potential survival phase occupies an intermediate position in the diagram of the appearance
of food-borne accidents. As a result, residual flora persists and as such constitutes a
contamination. However, because it results from an active mechanism, its appearance depends
on a loss of control in managing specific technological parameters, as in the case of
multiplication.
o 4.5 The appearance of a microbial overpopulation
When contamination (or survival) and multiplication occur concurrently, the kind of accident
observed is a function of the type of flora involved in causing the ensuing microbial
overpopulation (bacteria, yeast or mold).
4.5.1 Overpopulation of common germs
This type of overpopulation generally leads to a change in the product that modifies its
appearance and/or smell and causes the loss of all or most of its economic value.
Moreover, in the case of histaminic poisoning that can appear after eating tainted tuna
(Thunnus thynnus): the common flora can produce toxic metabolites. In this particular
case, the common flora is able to produce histamine, a main metabolite of allergic
reactions, from the histidine present in the flesh of Scombridea.
•
•
4.5.2 The overpopulation of pathogenic germs
This type of overpopulation is the source of food poisonings. Their seriousness is a
function of the microbial load that follows multiplication and also depends on the type of
pathogenic germ that is present and the subsequent violence of its toxin (if produced).
Since food-related accidents - whether sanitary or economic in scope - arise from the same chain
of events, we may safely assume that preventive methods are universally valid: what is good for
one is good for all. Consequently, the attitude of professionals in the Food Business sector who
constantly bring the politics of good hygiene into opposition with economic restrictions is
groundless because the Food Business provisions for preventing food poisoning also lead to
control of economic losses.
Comment: The following diagram of the appearance of food-borne accidents is based on the
relevant elements that we have just reviewed. The complete diagram only applies to food-borne
accidents that are caused by microbes, since only living germs are able to multiply or survive.
The left side of the diagram, however, that covers contamination and its sources may be applied
to three types of danger: toxic, physical, and microbiological. Use of the diagram is limited to the
left side when physical and toxic dangers are the issue, since the agents responsible for causing
them (physical and chemical contaminants) are inert and therefore not characterized by their
ability to multiply or survive.
28
5. Diagram of the mode of appearance of food-related accidents
Diagram of the mode of appearance of food-related accidents
6. Validation of the diagram of the appearance of economic losses or food poisoning by
reference to the food preservation methods
Before this diagram can be used as the basis of our rationale for establishing a global method of
controlling hygiene in Food Businesses, we must first determine its validity. In fact, this
validation is an indispensable prerequisite for considering and using this diagram as an accurate
representation of the chain of events that culminate in a food-borne accident, either economic or
sanitary.
The main principle that can be drawn from this diagram is that the concomitant intervention of
contamination (and/or eventual survival) and multiplication is an indispensable condition for the
outbreak of a microbial based food-borne accident. As we have seen earlier, in the case of toxic
residues or foreign bodies, only contamination intervenes and suffices to create a risk for the
consumer.
As for food-borne accidents that are microbial based, and provided that the diagram proves its
accuracy after validation, we may deduce that the absence of one of these two indispensable
phases - either contamination or multiplication - makes the appearance of any food-related
accident, whether economic or sanitary, impossible.
29
On the other hand, the control of physically or chemically based sanitary accidents will be
unilaterally based on control of the contamination phase. The contamination level will not evolve
beyond this phase, except in a few rare instances that have to do uniquely with chemical
contaminants traceable to production processes that undergo a dilution or concentration phase (in
the case of liquid food products). In this case the contamination level from chemical residues will
vary, decreasing in the case of dilution or increasing in the case of concentration.
Practically speaking, a completely controlled situation in which there is effectively no trace of
bacterial contamination is found in canned preserves, a special category of food products. In fact,
the elimination of all revivable germs by autoclave processing in a sealed container avoids any
recontamination and allows canned foods to be preserved for a long time. Preserving their
organoleptic quality and therefore their economic value, such canned foods preserve their
goodness and nutritional value for several years, as long as the seam of the can is not damaged,
which does not allow for any microbial recontamination. Furthermore, since the possibility of
microbiological contamination in these products is completely controlled, their extended shelf
life does not require storage at a controlled temperature in a cold room.
Frozen products, which nonetheless may often contain a significant microbial population, are
protected from any possibility of microbial multiplication by their very low storage temperature
that blocks the metabolism of germs. These products are preserved and are still “good” (since
they also preserve their economic value) and healthy (because sanitary risk has been effectively
controlled) since microbial multiplication is completely blocked as long as they are kept frozen,
which is possible for several months or even years.
Key deductions from the diagram of the appearance of food-related accidents
30
Pasteurized food products undergo only a partial decontamination by heat treatment, the same
sealed processing as for canned foods that avoids any recontamination. As a result, pasteurized
products, whose further contamination is only partly controlled by heat treatment, must then be
stored in a cold room to slow down the multiplication of their residual flora. Consequently, this
method, which is based solely on partial control of contamination and then multiplication,
permits only intermediate-term preservation under positive cold conditions that is limited to a
few weeks.
Finally, preservation by refrigeration, which involves storage of foodstuffs under positive cold
conditions slightly above 00 C, has a very limited effect on the multiplication phase of germs,
just slowing it down, especially in the case of psychrophilic flora. This method, which is not
effective in reducing microbial contamination, permits only a very short-term preservation
limited to merely a few days.
Based on these four examples, we see that thanks to the “diagram of the appearance of food
poisonings [29] and losses,” it is possible to elucidate the appropriate mechanism for preserving
foodstuffs using these methods and anticipate the time frame of their application. This reasoning
may be applied to all known methods of preservation (see the table below), which in turn allows
us to establish the validity of the “diagram of the appearance of food poisonings and losses”. In
fact, it is legitimate to consider that the successful application of the usual methods of food
preservation that we have systematically (or nearly) observed, whose mechanism of action may
be explained by our diagram of the appearance of food-borne accidents serves as experimental
evidence of the accuracy of this diagram.
Table of action mode and duration of food preservation usual methods
31
To broaden the scope of our presentation, some of the methods of preservation of foodstuffs that
appear in the diagram are only briefly mentioned as a reminder. They will not be studied
separately here, since the topic of this research work is not intended to be an exhaustive study of
the modes of preserving foodstuffs.
Conclusion
The material in this chapter provides us with a diagram that accurately describes foodborne accidents, either economic or sanitary in nature. Based on the assumption that we can only
control well what we have already correctly described, this diagram will serve in the following
chapters to organize the methods of prevention for food-related accidents, either sanitary or
economic.
32
Chapter 3
Applying the “Comprehensive Hygiene Management Method””
in food businesses to implement
the prerequisites of the Codex Alimentarius
33
1. General
Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP) are the prerequisites
for applying the HAACP (Hazard Analysis Critical Control Point) method as it is set forth in the
Codex Alimentarius within the framework of the “Recommended International Code of Practice
- General Principles of Food Hygiene “published under the reference CAC/RCP 1-1969 Rév. 4
(2003) [10] (http://www.mhlw.go.jp/english/topics/importedfoods/guideline/dl/04.pdf).
Established by the Codex Alimentarius Commission, this international code of practices
subscribes to the standards recommended by the Sanitary and Phytosanitary Agreement (Article
3, paragraphs 1,2,3,4 and 5) so as to standardize trade exchanges of animals, plants, and food and
feed of plant or animal origin, among the Member states of the WTO on the food safety level [9].
(http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm) .
This code of practices is also the international reference document that defines the HACCP
method. Whenever the HACCP method is mentioned here without further specification, it must
be taken as reference to the version found in the Codex that is established by this international
code of practices. The approach recommended by the Codex Alimentarius for implementing a
Food Safety Management System (FSMS) in a food business aimed at ensuring food safety may
be divided into two stages:
- Step One: implementation of GHPs and GMPs as prerequisites for the HACCP method.
- Step Two: application of the HACCP method.
In some cases (which are also considered by the European Commission [14]), the “Food Safety
Management System” of a food business may be limited to compliance with these general
principle or prerequisites or even GHP/GMP without going so far as to implement the HACCP.
In particular, this is true when there is no stage in the production process that includes the
relevant parameters necessary to establish a CCP (Critical Control Point).
As we shall see in the following paragraph, the relevance of these good practices is
incontestable, but they are presented in the form of a somewhat confusing list that can pose
serious problems for professionals who are trying to implement them.
While keeping the complete GHP/GMPs, we have rearranged these practices in a simple, logical
way to facilitate their implementation by FB managers, culminating in the design of the
“Comprehensive Hygiene Management Method.” To simplify the process, we were able to use
the “Diagram of the appearance of food-related accidents” (established and validated in chapter
2) to restructure the necessary organization of the GHP/GMP. Our approach was to coordinate
each requirement (GHP/GMP) in the Codex with its counterpart in the diagram describing the
mechanism of occurrence of a food-related accident. Since each food safety principle is focused
on only one specific component of the diagram, each GHP/GMP appearing in the
“Comprehensive Hygiene Management Method” is mentioned only once within our
organizational model.
34
Official control services staff members responsible for inspecting or auditing the implementation
of GHP/GMPs in the FBs were confronted with the same problematic lack of organization when
they tried to fulfill the mission of providing health approvals or certificates.
As we shall see when we examine, for instance, the European regulation (Regulation EC
852/2004 [39] summarizes the GHP/GMP prescribed by the Code Alimentarius in the form of a
simple list. The reorganization that was needed to simplify the application of GHP/GMP is also
not considered in this new corpus of European Community regulation referred to as the “Hygiene
Package.”
2. The “Recommended International Code of Practice” - General Principles of Food
Hygiene”
o 2.1 Organizational plan of prerequisites established by the Codex Alimentarius
CAC-RCP 1-1969, REV.4 (2003) « Recommended
Principles of Food Hygiene»
International Code of Practice - General
Organizational plan of prerequisites established by the Codex Alimentarius
CODEX
CAC-RCP 1-1969, Rev.4 (2003)
Section III : Primary production
3.1 Environmental hygiene
3.2 Hygienic production of food sources
3.3 Handling, storage and transport
3.4 Cleaning maintenance and personnel hygiene at
primary production
Section IV : Establishment: design and facilities
4.1 Location
4.2 Premises and rooms
4.3 Equipment
4.3.1 General
4.3.2 Food control and monitoring equipment
4.3.3 Containers for waste and inedible substances
4.4 Facilities
4.4.1 Water supply
4.4.2 Drainage and waste disposal
4.4.3 Cleaning
4.4.4 Personnel hygiene facilities
4.4.5 Temperature control
4.4.6 Air quality
4.4.7 Lighting
4.4.8 Storage
Section V : Control of operation
5.1 Control of food hazards
5.2.1 Time and temperature control
35
5.2.2 Specific process steps
5.2.3 Microbiological and other specifications
5.2.4 Microbiological cross contamination
5.2.5 Physical and chemical contamination
5.3 Incoming material requirements
5.4 Packaging
5.5 Water
5.6 Management and supervision
5.7 Documentation and records
5.8 Recall procedures
Section VI : Establishment: maintenance and
sanitation
6.1 Maintenance and cleaning
6.1.1 General
6.1.2 Cleaning procedures and methods
6.2 Cleaning programmes
6.3 Pest control system
6.4 Waste management
6.5 Monitoring effectiveness
Section VII : Establishment: personal hygiene
7.1 Health status
7.2 Illness and injuries
7.3 Personal cleanliness
7.4 Personal behavior
7.5 Visitors
Section VIII: Transportation
Section IX : Product information and
consumer awareness
Section X: Training
o 2.2 Organizational scattering and replication of information in listing food safety
provisions in the “ Recommended international code of practice””
To instance this aspect of the “code of practice” let us take a look at use of the cold chain
as a first example:
•
Its first mention is in Section IV, “Establishment: design and facilities” in
paragraph 4.3.2 “Food control and monitoring equipment” as follows:
“equipment used to … cool, store or freeze food should be designed to achieve the
required food temperatures as rapidly as necessary in the interests of food safety
and suitability, and maintain them effectively”
•
The second reference is in the same section in paragraph 4.4.5, “Temperature
control” as follows: “Depending on the nature of the food operations undertaken,
adequate facilities should be available for … cooling, refrigerating and freezing
food, for storing refrigerated or frozen foods, monitoring food temperatures … “
36
•
The same point is referenced a third time in section V, “Control of Operation” in
paragraph 5.2.1 “Time and temperature control” as follows: “Inadequate food
temperature control is one of the most common causes of foodborne illness or
food spoilage. Such controls include time and temperature of … cooling,
processing and storage. Systems should be in place to ensure that temperature is
controlled effectively where it is critical to the safety and suitability of food. ”
This example shows that the same almost identical recommendations are repeated several
times in different sections or paragraphs of the “code of practice”. This lack of organization
burdens the text and makes understanding and implementing it more difficult.
Other examples that we shall not develop in detail include the heat treatment of foodstuffs
(in paragraphs 4.3.2, then 4.4.5, and finally in 5.2.1 and 5.2.2) and the safety and health of
raw materials (in paragraphs 3.3, then 4.4.1 and 5.2.4, and finally in 5.3 and 5.4) suffer
from the same scattering and replication.
o 2.3 An example of the application of the Codex Alimentarius prerequisites with the
regulatory body of the European Union: Regulation (EC) 852/2004 of the European
Parliament and of the Council, of 29 April 2004 on the hygiene of foostuffs.
Since the Member countries of the European Union are also members of the WTO, Community
regulations must concord with the principles of the SPS Agreement and, in keeping with them,
adhere to and apply the requirements of the Codex Alimentarius.
In Appendix II, EC Regulation 852/2004 defines the following list of “general provisions of
hygiene” to be implemented by all food business operators (with the exception of the primary
production sector) relevant to:
-
food premises, including outside areas and sites
transport conditions
equipment
food waste
water supply
personal hygiene of operators in contact with food
foodstuffs themselves
wrapping and packaging
heat treatments which may be used to process certain foodstuffs
cold chain
staff training
cleaning and sanitation plans
pest control plan
37
In fact, these provisions correspond to the prerequisites as defined by the Codex Alimentarius’
“code of practice.” To publicize the provisions, European regulations opted simply to list them;
despite its formal simplicity, this style does not make the task of applying them any easier.
3. The “Comprehensive Hygiene Management Method”” for food businesses
- 3.1 Reminder from Chapter 2: diagram of the mode of appearance of food-related
accidents
Diagram of the mode of appearance of food-related accidents
This diagram was drafted in the context of the preceding chapter (Chapter 2), “Schematization of
mechanism of occurrence of food-related accidents causing economic loss or food poisoning”. It
was validated in reference to the complete set of the usual methods that are applicable to all
types of food and used to preserve foodstuffs. Therefore, we may legitimately assume that
regardless of the food type in question, this diagram accurately describes how and why all foodrelated accidents appear, be they economic or sanitary in nature.
38
o 3.2 Diagram of the “Comprehensive Hygiene Management Method”” for Food
Businesses
The logical approach to establishing this method was to apply the relevant provisions of control
to each element of the diagram of the appearance of food-related accidents, each provision in a
different colored box, on our schematic representation.
Diagram of the Comprehensive Hygiene Management Method for Food Businesses
When we examine these different boxes, we observe that they regroup and organize in a logical
manner all the prerequisites of the Codex Alimentarius as defined in the “international code of
practice” that we discussed at the beginning of this chapter.
Besides the fact that here each prerequisite is logically arranged, we also see that in the
"Comprehensive Hygiene Management Method” each prerequisite is mentioned only once,
which makes understanding and applying them much more efficient.
39
The primary goal of this original method is to enable professionals in the agro-food sector to
ensure the efficient implementation of the Codex Alimentarius’ prerequisites (GHP/GMP) in
their establishments. In fact, thanks to this internal audit approach, the "Comprehensive Hygiene
Management Method” enables an agro-food business to evaluate its performance level with
respect to GHP/GMP (or the prerequisites of the Codex Alimentarius) and then effectuate or
improve their application. The application stage is to be followed by a new assessment stage that
will allow the FB to optimize its GHP/GMP. The sequential stages of application and evaluation
enable the business to instate a mechanism of “continuous improvement” in applying
GHP/GMP: this is a fundamental part of a general policy of quality control that is also
indispensable to any FB, and food safety is an integral aspect of this policy.
Using of this method only for purposes of audit or inspection by the staff of audit bodies or
official control services (depending on the Competent Authority) are the second mode of
application provided for by the method.
Table illustrating the two uses of the "Comprehensive Hygiene Management Method
for Food Businesses”
The provisions for the hygienic control of foodstuffs in each box marked with a different
color as well as how to implement them will be presented in detail in Chapter 8: “A Guide to the
application of the Good Hygiene and Good Manufacturing practices and HACCP”
40
o 3.3. Synthetic presentation box by box of the requirements taken into account by the
comprehensive hygiene management method
Box 1: Control of sources of non-human contamination
Suppliers
-
Standards and regulations
The setting of the Food Business’ plant and its environment
General organization of buildings and installations, patterns of movement (staff,
production, refuse, construction material)
Equipment, machinery, small tools
- Contractual relations with suppliers (conditions for deliveries acceptance or rejection=
Specification cards of raw materials
Delivery checks (physical conformity, labeling, and traceability information)
- Pest control plan
Active and passive pest control procedures
Box 2: Control of human sources of contamination
Personnel health policy
Production staff medical follow-up (medical inspections in the workplace, screening
through analysis of chronic bearers of pathogenic germs)
Box 3: Control of contamination related to the production process
Hand hygiene
Equipment for washing hands
Procedure for washing hands
Additional rules (wearing of gloves, prohibition of jewelry and watches, etc.)
-
Premises hygiene
Cleaning plan
Verification through analyses of the effectiveness and efficiency of the cleaning plan
-
Clothing hygiene
Work clothing
Laundry organization
Box 4: Control of microbial multiplication or survival
- Cold technologies (control of the time/temperature couple)
Refrigeration
Freezing/Deep freezing
Fast cooling
Cook and chill process
41
-
Hot technologies (control of the time/temperature dyad)
Cooking
Pasteurization
Sterile canning
-
Food formulation (management of the biochemical parameters of some stable foods)
pH
Aw
Redox couple
Box 5: Conformity control of finished products
- Conformity testing
Verification that microbiological standards have been respected
Absence of residues (or compliance with maximum residue limit)
Absence of foreign bodies
- Labelling conformity
Information on traceability (batch numbers and health mark)
Food composition (dietetic value, presence of allergens)
Box 6: Staff training
Practically speaking, the FB managers will only have to comply with the requirements listed
under the colored boxes of the “Comprehensive Hygiene Management Method” that have just
been defined. In box 4 (in blue), where hot and cold technologies and the composition of food
(controlled through relevant parameters management) are found, is where the prevention of the
active phenomena of bacterial multiplication or survival characteristic of these living organisms
will be ensured. In this particular box, where the control of risks is based on proper management
of parameters, is where one should try to implement CCPs. In fact, measurable numeric values
(thanks to measurement devices) or food composition (pH, Aw) may easily be used to establish
critical values, target values, and tolerance.
o 3.4 Comparison of the organization of the prerequisites in the “international code of
practices” with the “Comprehensive Hygiene Management Method for Food
Businesses”
The following table is an attempt to establish the correspondence between the organizational
structure of the “international code of practices” proposed by the Codex Alimentarius and the
“Comprehensive Hygiene Management Method.” Although their structures are different, we can
see by examining this table that exactly the same hygienic requirements are found in both
approaches.
42
Comparison of the organization of prerequisites in the Codex with the “Comprehensive
Method of Hygiene Management for Food Businesses”
CODEX
CAC-RCP 1-1969, Rev.4 (2003)
“Comprehensive Hygiene management Method for FBs”
Section III : Primary production
3.1 Environmental hygiene
3.2 Hygienic production of food sources
3.3 Handling, storage and transport
3.4 Cleaning maintenance and personnel hygiene
at primary production
Box 1: requirements relative to manufacturing condition, raw
material control and food information (traceability)
•
Raw material specification
•
Delivery checks
•
Labelling and batch numbers
Section IV : Establishment: design and facilities
4.1 Location
4.2 Premises and rooms
4.3 Equipment
4.3.1 General
4.3.2 Food control and monitoring equipment
4.3.3 Containers for waste and inedible substances
4.4 Facilities
4.4.1 Water supply
4.4.2 Drainage and waste disposal
4.4.3 Cleaning
4.4.4 Personnel hygiene facilities
4.4.5 Temperature control
4.4.6 Air quality
4.4.7 Lighting
4.4.8 Storage
Box 1: requirements relative to FB location, surrounding,
general organization, rooms, equipment and maintenance
Box 1: general
Equipment conformity
Box 1: general
Construction rules
Box 1: Construction rules
Box 1: Equipment conformity
Box 4: Cold chain monitoring and control
Heat treatments monitoring and control
Box 1: general
Box1: general
Raw material specification: potable water supply
Box 1: construction rules
Box 3: general
Box 1: hygiene facilities and toilets
Box 4: Cold chain monitoring and control
Heat treatments monitoring and control
Box 1: Construction rules
Box 1: Construction rules
Box 1: Construction rules
Section V : Control of operation
5.1 Control of food hazards
5.2.1 Time and temperature control
5.2.2 Specific process steps
5.2.3 Microbiological and other specifications
5.2.4 Microbiological cross contamination
5.2.5 Physical and chemical contamination
5.3 Incoming material requirements
Box 4: cold chain monitoring and control
Heat treatments monitoring and control
Food formulation monitoring and control
Box 1: requirements relative to manufacturing condition, raw
materials control and food information (traceability)
•
Raw material specification
•
Delivery checks
Labelling and batch numbers
Box 5: Finish products sampling plan
Box 3: Staff hygiene procedures relative to hands and
clothing washing rules
Implementation and control of a cleaning plan
Box 1: requirements relative to raw material control and food
information (traceability)
•
Raw material specification (physic-chemical
characteristics and free from physical and chemical
contamination)
43
•
5.4 Packaging
5.5 Water
5.6 Management and supervision
5.7 Documentation and records
5.8 Recall procedures
Delivery checks
Box 1: requirements relative to manufacturing condition, raw
material control and food information (traceability)
•
Raw material specification
•
Delivery checks
Labelling and batch numbers
Box 1: potable water supply
Box 5: Finish products control and sampling plan
Box 6: education (staff training certificates)
Box 2: personnel health policy (health certificates)
HACCP documentation and records keeping not covered by
the “Comprehensive hygiene Management Method”
HACCP recall procedures not covered by the
“Comprehensive hygiene Management Method”
Section VI : Establishment: maintenance and sanitation
6.1 Maintenance and cleaning
6.1.1 General
6.1.2 Cleaning procedures and methods
6.2 Cleaning programmes
6.3 Pest control system
6.4 Waste management
6.5 Monitoring effectiveness
Box 1: Maintenance
Box 3: general
Box 3: cleaning plan implementation and control
Box 1: pest control plan
Box 1: general
Premises general organization
HACCP verification step (n°11) not covered by the
“Comprehensive hygiene Management Method”
Section VII : Establishment: personal hygiene
7.1 Health status
7.2 Illness and injuries
7.3 Personal cleanliness
7.4 Personal behavior
7.5 Visitors
Section VIII: Transportation
Box 2: personnel health policy
Box 2: personnel health policy
Box 2: personnel health policy
Box 3: Staff hygiene procedures relative to hands and
clothing washing rules
Box 3: additional rules
Clothing hygiene rules
Box 1: general (equipment)
Delivery checks
Box 3: Cleaning plan
Box 4: cold chain monitoring and control
Section IX : Product information and
consumer awareness
HACCP recall procedures not covered by the
“Comprehensive hygiene Management Method”
Section X: Training
Box 6: education
o 3.5 Examples of diagrams that compare the organization of prerequisites in the
Codex with the “Comprehensive Method of Hygiene Management for Food
Businesses
The following diagrams compare the organization of prerequisites in the Codex with the
“Comprehensive Hygiene Management Method” allowing us to illustrate how scattered the
44
information on requirements for GHP/GMP are in the structure (p.50) of the “Recommended
International Code of Practice - General Principles of Good Food Hygiene “ in the Codex.
Comparative Organization of the Requirements for Maintenance and Cleaning
Comparative Organization of the Requirements for Personnel Hygiene
45
Comparative Organization of the Requirements for the Hygienic Control of Operations
Conclusion
A FAO document [47] intended for use by trainers in the area of GHP/GMP reaches the identical
conclusion that there is complete compatibility between the “Codex Code of Practice” and the
“Comprehensive Hygiene Management Method for Food Businesses.” The document examines
diagrams like the preceding ones here and finds that the “Comprehensive Hygiene Management
Method” is an elegant solution to the problem of how to implement GHP/GMP effectively: “To
give an idea of how a GMP program can be structured and still be in consistence with Codex is
elegantly demonstrated by the Comprehensive Hygiene Management system.”; and later : “This
nicely demonstrates how all parts of Codex have been re-arranged into a system which still is in
full consistence with the original Codex text”.
The logistical organization of GHP/GMP established by the “Comprehensive Hygiene
Management Method” found a practical application in the designing of the “Reference
Framework for Harmonization of the Management of the Food Hygiene in Africa”[***] that will
be presented in the following chapter.
46
Chapitre 4
Practical application of the “Comprehensive Hygiene Management
Method in FBs”: the “Reference Framework for Harmonization of
the Management of Food Hygiene in Africa”
47
1. General
In accordance with the principles of the Codex Alimentarius [9, 10], the prerequisites or GHP/GMP
constitute the first stage of implementation of a Food Safety Management System (FSMS) in a business,
prior to the application of the HACCP method. This method however requires a certain level of
technological expertise, not yet attained in many developing countries as evidenced in the use of simple,
often traditional manufacturing processes, which food safety management must be insured primarily by
GHP/GMP.
In addition, production processes specific to the establishments of the primary production sector, do not
present all the necessary characteristics for the complete implementation of the HACCP method. In fact
the production processes of the primary production sector are often characterized by their lack of
measurable, significant parameters associated with one (or more) of their steps. Further in this chapter this
aspect will be re-examined in detail, but we can already assert that, under these conditions the
implementation of CCPs is impossible. In effect, to derive a CCP from a given step in a production
process, one must be able to associate at least one measurable relevant parameter with this operation, for
which a target value, a margin of tolerance and critical limits must be defined.
In the African context, many FBs belong in the primary production sector or present conditions of
production that do not yet correspond to the application of the HACCP method. Under these conditions,
many member states of the AUO (African Union Organization) have not yet drafted a regulatory system
concerning food safety. It is therefore reasonable for the “Reference Framework for the Harmonization of
the Management of Food Hygiene in Africa” adopted in January of 2011 by the AUO, to only take into
account compliance with the GHP/GMP, as a basis for the system of certification of African businesses
choosing to participate in the program “Better Training for Safer Food” (BTSF).
2. History
In 2009 and 2010 we were appointed “Lead Expert” of the program “Better Training for Safer Food in
Africa” by the European Commission (Health and Consumers – DG SANCO), jointly with the African
Union Commission (AUC Department for Rural Economy & Agriculture). The creation of a system for
the health certification of the FBs at the continental level constituted one of the main objectives defined
by the terms of reference of this program. Consequently the drafting of the “Reference Framework for the
Harmonization of the management of Food Hygiene in Africa” proved necessary. This reference
document is destined to be used by food businesses and official services in charge of controlling food
hygiene in the Members States of the African Union Organization, with the added participation of the
Kingdom of Morocco. In each Member State, official controlling services depend on the Competent
Authority which two principal missions consist initially in supervising the implementation of and
compliance with the sanitary regulation at the national level and next, in delivering to exporting FBs the
health approval, on behalf of the importing countries, and issuing the health certificates accompanying the
batches to be exported.
In order to draft this referential our choice went to an application of the principles of the “Comprehensive
Hygiene Management Method in FBs” making it possible during the initial period to take only into
48
account the “Good Hygiene Practice/Good manufacturing Practice”, also known under the general term of
prerequisites of the “Codex Alimentarius”. In reality, for this approach to make sense, a significant
number of FBs of the member states of the AUO would have to be able to use it successfully.
Consequently, in the short term, the implementation of the reference framework policies and the delivery
of health certification must be compatible with the actual situation in these establishments. Considering
that the implementation of the HACCP method concerns only a very small proportion of FBs in the AUO,
incorporating it in this reference framework appeared premature to us. It is only mentioned at the very end
of the document as a possible ulterior stage in establishing a FSMS in an FB, and also because the
reference framework policies constitute the totality of the preliminary conditions (or prerequisites)
essential to the application of this method by an establishment choosing to use it immediately.
In addition, businesses wishing to export toward developed countries, in particular toward the member
states of the European Union, are required to apply the principles of the HACCP method to their
production. This is the reason why, although the HACCP is not taken into account in the reference
framework of certification adopted by the AUO, we deemed it necessary to include the presentation of
this method in the version of the practical guide of implementation of the reference framework, adopted
by the AUO: “Guidelines on the Application of GMP, GHP and HACCP” [21].
3. The African trade context.
A close look at the context surrounding commercial trade between African states, particularly in the
sector of foodstuffs, is essential to understand the necessity for such a reference framework of
harmonization. We will limit ourselves here to the broad lines of this geopolitical context which is
otherwise presented in great detail in the first part of the reference document. If needed, consulting the
first part of the reference framework (annex 1 of the present thesis) will be sufficient to obtain additional
elements and details relative to the geopolitical context.
The commercial exchange of foodstuffs between states of the African continent is currently very limited
in volume, and is limited by high customs fees. The uncertainty surrounding the sanitary quality of the
foodstuffs being traded constitutes a second barrier to its development, while the final integration goal
displayed by the AUO is to establish between member states a common market within which the principle
of “free trade” would be the rule. In order to achieve this goal, harmonized health regulations (a set of
obligations made to FBs) must be defined through a reference system, as well as a process of control and
certification of the application of this reference system, allowing for a mutual recognition between
African states of sanitary guaranties provided by exporting establishments.
From the perspective of the intensification of these exchanges, compliance with the specifications of the
referential must allow FBs to comply with international standards relative food safety (WTO Regulations
and principles of the SPS and TBT agreement) and to envision the opening of markets other than the
African market to their products. Harmonization and mutual recognition of the application of the
reference system requires that the Competent Authority of each member state of the AUO be attributed a
central role of control and certification of compliance with these food safety principles.
This mutual recognition of the certification delivered by the Competent Authority of each member state
of the AUO requires a harmonization on a continental scale, of the administrative organization and
operational methods of the official services of sanitary inspection in Africa.
49
4. Drafting of this referential
This drafting based on the general code of hygiene of the joint FAO/WHO program-Codex Alimentarius
(“Recommended International Code of Practice– General Principles of food hygiene” CAC/RCP 1 –
1969, rev. 4- 2003), allows for the recognition of this reference system with regard to the SPS Agreement,
as well as a pedagogical and easier application of international standards.
In the preceding chapter we showed that the first stage of our work consisted in reorganizing the
prerequisites of the Codex Alimentarius, through the application of the “Comprehensive Hygiene
Management Method in FBs” and to actualize this reorganization through the drafting of a first Good
hygiene practice guide destined to the SMEs of the ASEAN countries, published under the title of:
“Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs”. This first guide of good practices,
presented in Chapter 8, assembles most of the rules of food hygiene to be complied with in FBs, and
served as the guiding principle for the drafting of the “Reference Framework for the Management of the
Food Hygiene in Africa”.
Subsequently, the preparation work for this reference system made it possible to recognize a number of
points forgotten in the first guide published by the ASEAN, and to incorporate them in the second,
consolidated version of the guide of practical application destined to the African countries, published
under the title: “Guidelines on the Application of GMP, GHP and HACCP” [21].
As a result, the first version of the guidelines, (with the addition of a few previously lacking elements),
following a process of reversed logic, served as the base for drafting the referential. In fact each hygiene
regulation itemized in this way, is rewritten and condensed, to constitute a standard of the referential.
Thanks to this method the referential and its practical guide of application present perfectly matching
structures. On a practical level the guide of good practices is presented as the manual of application of the
referential, but in reality the drafting of the guide of good practices preceded and allowed the drafting of
the referential.
After being drafted this project of referential was submitted to its users to be completed, amended and
validated, within the framework of five sub-regional workshops, under the joint presidency of the African
Union Commission and the European Union Commission, assembling all the African States and the
Regional Economic Communities (RECs). These workshops, thus, closely connect representatives of the
competent authorities of the African States with the regional Economic Communities (RECs), and
managers of food businesses of some of the African countries, as well as some consumer organizations.
Other major actors at the international level also participated in these workshops: representatives from the
WHO, the FAO and the Codex Alimentarius Commission, the UNIDO (United Nations Industrial
Development Organization), and ARSO (African Organization for Standardization). This procedure
which consisted in a collective reading and critique of the document rather than in a pure a simple
presentation, responds to the double objective of detecting possible omissions as well as facilitating its
adoption by future users.
In order to facilitate exchanges between the participants in these sub-regional workshops, two identical
versions of the referential project were established in the two languages most practiced on the African
continent: French and English. No major problems came up within the francophone groups and
50
discussions, incidentally on a limited number of items, were about content and almost not at all on the
form.
Quite surprisingly however, in the course of this work we came to the realization that different English
speaking African countries did not speak the same English. Many disputes emerged concerning the
vocabulary or wording, on which a consensual position could only be reached after intense discussions.
On numerous occasions, progress in the work of the English speaking groups was slowed down
considerably by these discussions. While we had planned, following the five sub-regional workshops, on
having at our disposal two versions of reference of the document (one in French and one in English) we
finally opted for a single one in French. This first version was then handed to the translation services of
the European Commission so that an English one would be established in order to avoid recurring
discussions on the wording.
In spite of this unexpected difficulty, it appears that the five sub-regional workshops only resulted in
additions and corrections of negligible importance, and that the general organization of the referential,
conceived during the drafting of the project and realized by its plan was not the object of any
modification. In return these minor additions and corrections to referential were taken into account for the
consolidation of the second edition of the guide of good practices proposed this time in the framework the
Better Training for Safer Food (BTSF) in Africa.
The actual implementation of this referential was tested in the framework of five other sub-regional
workshops, through the use the guide of application specially adapted to this end, which included in
particular grid of audit/inspection of the FBs. During these sub-regional workshops, the participants were
also introduced to the evaluation of the “Food Safety Management Systems” (FSMS) of enterprises they
visited, through the application of the “Alternative Method to the Codex Decision Tree for the
determination of CCPs” of which it is another possible use.
5. Field of application of the referential
On the one hand, this referential harmonizes the hygienic conditions of food production in food
businesses; on the other, it harmonizes the controls of application of these conditions by the Competent
Authorities. It prioritizes the control of food businesses which commercialize their products (partially or
totally) in one or several other African countries, provided that this referential be part of the normative or
regulatory corpus of the countries in question.
This referential is, indeed, designed to serve as a basis for the facilitation and intensification of foodstuff
exchanges between the member states of the African Union. The strategy that was adopted consists in
having the Competent Authority of each member state, in charge of the health control of its national food
market, grants certification to businesses implementing this referential. This strategy implies that, for this
certification to be recognized from one member state to another, the conditions of inspection and audit
must be identical in the entire African Union. Under these conditions, the referential must partially take
into account the necessary harmonization of the organization and procedures of inspection (and audit) of
the control services depending on the Competent Authority in charge of food safety in each of the
member states.
51
Ultimately, the creation of an organism which nature remains to be defined (agency, office), placed under
the aegis of the AUO, in charge of supervising and reviewing the harmonization of these official control
services will become necessary to complete the facilitation and intensification system of foodstuff
exchanges between member states. The credibility and reliability of the certification granted FBs in the
different states will likewise be reinforced by this harmonization of procedures (inspection or audit) of the
official control system.
6. Presentation of the referential.
o
6.1 Subdivision of the “Reference Framework for Harmonization of the Management of
Food Hygiene in Africa”
In fact, the subdivision of the referential into five sections closely resembles the “Comprehensive
Hygiene Management Method in FBs” in its organization and logical approach. Sections 2 to 5 are
similarly built on the “diagram of occurence of food related accidents”, with each section providing the
appropriate means of management or control.
Section1 of this referential differs from the other four in one regard only: it does not deal with the FSMS
to be implemented in FBs, but with the necessary organization of the controls and certifications delivered
by the Competent Authority.
Referential subdivision table divided in five sections
o
6.2 Comparison between the organization plan of the “Reference Framework for
Harmonization of the Management of Food Hygiene in Africa” and the “Comprehensive
Hygiene Management Method in FBs” diagram.
52
The following diagram highlights the possibility of a superposing the organizational structure of the
referential and that of the “Comprehensive Hygiene Management Method in FBs”. The numbers
appearing in the center of the different boxes correspond to chapters of the referential.
Comparative organization of the “Referential” and of the “Comprehensive Hygiene Management
Method”.
o
6.3 Organization and content of the referential.
A first part devoted to general remarks (1 to 7) is followed by a first annex including recommendations
destined to the heads of FBs (from 8 to 18), concerning the compliance of businesses and operations
applied to foodstuffs (transformation, conservation, transportation, controls…).
It is followed by a second annex containing recommendations destined to the Competent Authority (from
19 to 21), bearing specifically on the identification and the registering of the FB, indispensible to the
traceability system. This traceability is indispensible to withdrawal and recall measures in the event of a
health alert.
1. Context
2. Development of the reference framework
3. Objectives
4. Field of application of the reference framework
4.1 Hygiene of production
4.2 Controls
53
4.3 Establishments
5. Definitions
6. General principles of hygiene of the foodstuffs
6.1. Supply of water and energy
6.2. Requirements relating to the establishment, the general organization, the construction and the
maintenance of an establishment, its buildings and equipment
6.3. Operations and personnel
6.4 Climatic conditions
6.5. Water
6.6. Packaging
6.7. Traceability and eligibility of the raw materials and intermediate products
6.8. Processes of preservation
6.9. Checking of the efficiency and the effectiveness of measurements of control/management of
hygiene and risks
6.10. Staff training
6.11. Control of the application of the reference framework, granting approval, application of the
health mark and issuing of certifications
6.12. Hygienic control of the importation of the foodstuffs originating or coming from countries
outside Africa (and intended for the approved establishments)
6.13. Internal and external information systems
6.14. Guide to application of the reference framework
6.15. Monitoring of the application of the reference framework and resolution of conflicts
6.16 Revisions
7. Particular provisions
o
6.4 Appendix 1: Requirements relative to the establishments and the operators of the food
sector
8. Identification and recording of the establishments
Remark : although this point is one of the requirements made to food businesses verifying its application
is particularly important for the official control services depending on the Competent Authority. As a
matter of fact without a full identification of FBs, from the primary production sector to retailing, there is
no possible implementation of traceability. In the absence of a traceability system, and in case of a food
safety alert the application of withdrawal or recall procedures is not possible either.
The identification and registration of FBs must also take into account complementary data, such as
geographical location (city, region, administrative territorial subdivision, etc.) for each establishment,
which makes it possible to determine (for example) whether it is concerned by an accidental localized
pollution. Determining this geographic location of FBs makes it possible to know which administrative
division of the CA is in charge of their official inspection.
9. Conformity of the buildings
9.1. General principles.
9.2. Rules of construction
9.3. Conformity of the material and the equipment
9.4. Sanitary facilities.
54
9.5. Maintenance (preventive and corrective)
9.6. Storage of the chemical substances
9.7. Pest control plan
9.8. Passive controls, maintenance of the accesses and the additional buildings
9.9. Active controls
10. Suppliers and controls a reception
10.1. Suppliers
10.2. Implementation of controls at reception
11. Personnel hygiene policy
12. Hand hygiene
12.1. Wash-hand basins
12.2. Hand washing procedures
12.3. Frequency of hand washing
12.4. Complete washing of the hands after the operations or dirty situations
12.5. Quick washing of the hands before the clean operations
12.6. Hygiene of the points of contact
12.7. Additional rules
12.8. Work clothes hygiene
13. Premises hygiene cleaning plan
13.1. General principles
13.2. Cleanliness of the tools during production
14. Hot and cold technologies and product formulation.
14.1. Cold technologies
14.2. Hot technologies
14.3. Product formulation
14.4. Labelling, traceability, procedures for withdrawal (or of recall)
15. Self-checking auto controls
15.1. General principles
15.2. Self-checking of the products
15.3. Self-checking of surfaces
15.4. Staff training
16. Requirements for “the evaluation of routine” of the implementation of the good hygienic practices
(GHP) and of good manufacturing practice (GMP)
17. Requirements relating to the functional check of the procedures of traceability and withdrawal (or
recall) of food products which can present a risk for the consumer
17.1. Traceability
17.2. Withdrawal/recall
17.3. Labelling requirements
55
18. The food safety management plan (FSMP) and the implementation of the HACCP system
- 6.5 Appendix 2: Requirements relative to FBs registration and approval by the CA.
Remark: this second constituted by Annex 2, defines the rules governing the BFs certification by the
CA of the administrative geographical subdivision of their location. This set of requirements is not
(properly speaking) part of the principles stated by the “Comprehensive Management Method” but must
be regarded as necessary for:
- harmonizing and financing and funding the FBs inspection and certification procedures
- insuring the skills and authority of the CA staff members in charge of controls
- thus securing food products commercial exchanges in the space of the African Continent future
Common Market.
19. General principles
19.1. Obligations applicable to the officials responsible for controls
19.2. Obligations relating to the implementation of the tasks of official control
19.3. Information systems
19.3.1 Internal
19.3.2. External
20. Rules for the granting of certification
21. Use of the fund generated by certification (fees)
o
6.6 Synthesis of the study of the “Reference Framework for Harmonization of the
Management of the Food Hygiene in Africa”.
A closer look at the content of this referential shows that it reiterates the requirements contained in the
Codex Alimentarius document “Recommended International Code of Practice – General Principles of
Food Hygiene” but presents them in a more coherent order which is established by the “Comprehensive
Hygiene Management Method” in FBs and developed in the “Guidelines on the Application of GMP,
GHP and HACCP” [21]
Furthermore these requirements (or GHP/GMPs) are those presented by the Codex Alimentarius as the
HACCP prerequisites. Whether the FBs of the African Union countries choose to apply the HACCP
Method or not they will have to implement the GHP/GMPs in their FSMS to be in compliance with the
requirements of the “Reference Framework for Harmonization of the Management of the Food Hygiene
in Africa”. Conceived to facilitate the exchanges between AUO Member States by insuring food safety,
this referential is logically devoted in part to recommendations addressed to Official Control Services.
These recommendations aim to harmonize the inspection and/or procedures, in order to grant the health
certification to exporting FBs in equivalent conditions, which is the ultimate goal of this referential.
56
o
6.7 Additional example of practical application of the “Comprehensive Management Method
in Food Businesses”: “Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs”.
The way to practically apply the “Comprehensive Hygiene Management Method” in FBs was presented
for the first time in “Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs” pubished in 2005
within the framework of the “EC-ASEAN Economic Operation Program on Standards, Quality and
Conformity Assessment”.
Through their first chapter and their audit grids, these guidelines constitute an example of
“Comprehensive Management Method” manual for the use of FB managers as well as for that of control
services staff members in charge of GHP/GMP auditing and/or inspecting, in these food establishments.
These guidelines on the application of GHP/GMP and HACCP constitute the synthesis of the whole of
our work aimed at facilitating the implementation of the Codex Alimentarius Principles .It is the reason
why they are presented at the very end of this thesis (chapter 8) and also include the “Alternative Method
to the Codex Alimentarius Decision Tree” for CCPs determination, whose presentation will be the object
of the next chapter.
57
58
Chapter 5
The “Alternative Method to the Codex Alimentarius Decision Tree”
for CCPs determination
59
1. General context
When professionals in food businesses attempt to apply the “Recommended International Code
of Practices - General Principles of Hygiene” as it is published by the Codex Alimentarius with
the reference CAC/RCP 1-1969 Rev. 4 (2003) [10], various practical obstacles complicate the
task.
As we have seen in the preceding chapter, the first of many problems encountered has to do with
the general organization of the section on “General Principles of Food Safety” or prerequisites for
food safety, whose application aims to establish a solid preliminary base that is indispensable to
the implementation the HACCP system.
Before addressing the second problem, which has to do specifically with implementing the
HACCP method, we should mention that a comprehensive description of this method and its
practical application is presented in the handbook “Guidelines on HACCP, GHP and GMP for
ASEAN Food SMEs” presented here in chapter 8 and appended in its entirety to this study in
Appendix 2. In this chapter we limit ourselves to a reminder of steps 6 and 7 of the method
(which includes 12 steps) and the “decision tree,” since the second problem we shall discuss
occurs on this level.
The following diagram that represents Step 6 and Step 7 is transposed here from the HACCP
description found in the handbook “Guidelines on HACCP, GHP and GMP for ASEAN (the
Association of Southern Asian Countries) Food SMEs” (Appendix 2).
Tables of Step 6 and Step 7 of the HACCP Method
60
The second problem derives from the presentation of the HACCP method prescribing the use of
the “Decision Tree” to determine Critical Control Points. The authors of the Code of Practice
were well aware of the problems encountered in applying the decision tree and addressed them
accordingly by stipulating (in step 7 of the description of the HACCP) that “application of a
decision tree should be flexible” and by later reminding us that “this example of decision tree
may not be applicable to all situations. Other approaches may be used.”
Anyone who has used the decision tree with any frequency knows that it does not always lead to
a definitive conclusion as to whether or not a specific operation involved in a production
procedure is a CCP. This problem often arises when an operation designated (in Stage 7) as a
CCP by the decision tree does not conform to all requisite CCP conditions, especially those that
are recommended as follows in Stage 8 of the method: “Critical limits must be specified and
validate for each Critical Control Point ” and further on, “These critical limits should be
measurable.” Furthermore, the Codex refers primarily to physicochemical criteria and
parameters that are easily and quickly measurable: “criteria often used include measurements of
temperature, time, moisture level, pH, Aw, available chlorine”. The user’s most frequent problem
appears when an operation designated by the decision tree as a CCP is not associable with one or
more of the significant parameters. As a result, the directions prescribed in Stage 8 for defining
the critical limits, target values, and tolerance levels that must be associated with each CCP
cannot be satisfied.
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The “Codex Alimentarius Decision Tree” for CCPs determination
2. Choosing the method
Within the framework of several programs financed by the European Commission [EC-ASEAN:
the Economic Cooperation Programme on Standards, Quality and Conformity Assessment
(2004-2005) and Better Training for Safer Food Africa (2009-2010)] that we led as a “Technical
Team Leader,” we have developed and applied an alternative method in order to resolve the
second problem that encompasses the failures encountered when using the “Decision tree of the
Codex Alimentarius.”
62
As described in this chapter, the preferred method was first published under our supervision in a
practical handbook intended for use by food business in member countries of the ASEAN as
“Guidelines on HACCP, GMP, and GHP for ASEAN Food SMEs. This method was then
included in the second edition of this handbook, intended for member countries of the AUO in
the context of the Better Training For Safer Food Program (BTSF) in Africa that we have already
mentioned, and published as “Reference Framework for Harmonization of the Management of
the Food Hygiene in Africa”
We should also note that the alternative method to the Codex Alimentarius “Decision Tree” has
already been widely applied in the past several years by the official control services in some
countries, for instance Poland, after we presented it as part of a partnership program between
France and that country in 2004 (DGAL/DGCCRF/PL02/IB/EC02).
3. Reminder from Chapter 3: diagram of the mode of appearance of food-related accidents
Diagram of the mode of appearance of food-related accidents
As in the preceding chapter, our argument will be based on the “diagram of the mode of
appearance of food-related accidents” that accurately describes the principle behind the
occurrence of all food-related accidents, be they economic or sanitary in nature.
Similarly, let us quickly review the deductions that can be made with the aid of this diagram: the
concurrent intervention of contamination (as a direct result or when it is due to the survival of
bacteria following the failure of a decontamination treatment: canning, ionization, etc.) as well as
63
multiplication are indispensable to the appearance of a microbial overpopulation in foodstuffs.
Depending on the type of bacteria involved (banal flora or pathogenic bacteria), the consequence
of this overpopulation may be a sanitary or an economic-related accident: either food poisoning
(in the case of pathogenic flora) or economic loss related to the alteration of the product (banal
flora).
Of course in cases of physical (foreign bodies) and chemical contamination (residues, toxic
pollutants, etc.) caused by the intervention of inert agents, the multiplication factor is not
involved in the risk genesis.
As for the viruses that may occasionally contaminate foodstuffs, we must bear in mind that
although they are biological agents, they are able to multiply only in living organisms, and
therefore not in foodstuffs. As a result, they should be considered as inert contaminants in the
area of risk management that they represent, in other words, in the same way as chemical and
physical contaminants.
o 3.1 Specific characteristics of contamination
•
The diagram of the mode of appearance of food-related accidents regroups the different
types of contamination sources on the left (microbial, physical, or chemical), be they
human or non-human. On this point, it is customary to consider that in 80% of all cases
(the practical value according to the Pareto principle of 20/80 [16]), the chemical
contamination (pesticides, heavy metal, residues of veterinary medications), and
physical contamination (mineral, metallic, or plant origin foreign bodies) found in
finished products comes from the raw materials used, whereas only 20% of
contamination comes from the transformation process (broken bits of tool blades, traces
of machine lubricants or solvents, etc.).
•
Contamination occurs passively, regardless of whether the contaminants are microbial,
physical, or chemical. They do not play an active role when they are introduced into
foodstuffs, for instance through the administration of veterinary medication to animals,
the pollution of cultures by heavy metals or the spreading of pesticides, stones picked up
during the harvesting of cereal grains, or the use of spices contaminated by microbial
spores, etc.
•
Besides the raw materials and foreign bodies that affect foodstuffs, the source of
contamination may also be localized in the various external elements that come into
contact with foods during the production process: tools, equipment, tables, workers’
hands, etc.
o 3.2 Specific characteristics of multiplication and survival
•
Multiplication and survival are active, dynamic mechanisms that are proper to live
organisms.
64
•
It is possible to establish the kinetics of these mechanisms that is dependent on the
parameters that can be actively measured during food processing operations:
The multiplication of bacteria and its speed depend on measurable physicochemical
parameters: time, temperature, pH, water activity, etc.
The active survival of bacteria as well as the speed of their destruction also depends
on measurable physicochemical parameters: time, temperature, the intensity of
ionizing radiation, the concentration of chlorine in a decontamination bath, etc.
•
Regular monitoring and supervision of these parameters during production enables us to
avoid:
either the multiplication of bacteria, if the goal of the given stage of the production
procedure is the preservation of the product (application of the cold chain),
or the survival of bacteria, if the goal of the given stage of the production process is
the decontamination of the product (canning, ionization, etc.)
Monitoring and supervising the parameters (whose safety values have been previously defined)
associated with a specific stage of production procedure is no more no less than equivalent to
considering this stage as a CCP.
Reciprocally, if a stage of the manufacturing process is characterized by significant parameters,
this means that this stage is intended to control one of the two dynamic mechanisms
(multiplication and survival) that are proper to living organisms. It is possible to prevent these
mechanisms from activation by monitoring the parameters upon which they depend.
Consequently, this stage will correspond to a CCP.
4. Presentation of the alternative method to the decision tree
This method enables us to obtain excellent results in two different situations. When an HACCP
system is being set up, it allows the production stages that could be CCP to be readily identified.
It also enables an inspector or auditor to evaluate quickly the relevance of a Food Safety
Management System (FSMS) with which the food business has provided him, as long as he has
or himself establishes an accurate flow diagram of production (even a simple one). In fact, within
a short time span, this method will provide an auditor or inspector with the certainty, even when
faced with a very complex FSMS, that good food safety provisions (GHP/GMP and/or CCP)
have been implemented (or not) at the proper place.
As we have just seen, in order to apply this method, there should already be an available
validated flow diagram of the manufacturing process (drafted at stage 5 of the HACCP method)
of the foodstuff to be examined. Columns should be drawn (two to the left and three to the right)
of the vertical axis in the flow diagram.
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First of all, the sources of contamination should be entered on the left side of the diagram:
- input (raw materials and packaging) in column 1
- points of contact involved in the production process (worker’s hands, tools, equipment, work
schedules, etc.) in column 2
“Alternative Method” columns 1 & 2: sources of contamination
Then, the parameters should be entered for each manufacturing stage (if there are some) on the
left side of the flow diagram in column 3:
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“Alternative Method” columns 3: parameters
Using the elements in the first three columns, the risks that may be deduced from them
(Contamination, Multiplication, Survival), are entered on the right side of the diagram in
column 4:
- If for any given procedure, elements have been listed (input or contacts) in columns 1 and 2,
then a possible risk of contamination must be entered in column 4 that corresponds to one or
more of the three types: chemical, physical, or microbiological.
- If elements of a given manufacturing process have been listed in column 3 (significant
parameters), the eventual risk of multiplication or survival of microbes must be entered, , in
column 4. The first general approach to microbiological risk that indicates the possibility of
survival or multiplication must then be refined depending on the foodstuffs and bacteria that
are usually associated with it in the case of food-related accidents. Two possible examples are
the multiplication of staphylococcus in custard creams or the survival of Clostridium
botulinium in canned goods. In both cases, the parameters of the microbial ecology of these
two types of food, especially with regard not only to aerobiosis or anerobiosis but also to the
effect of the thermal treatments used, will have a selective effect on the bacteria that are
involved. In order to refine the application of the alternative method, we must recall that all
bacteria that are potentially responsible for causing food poisoning are not likely to affect all
types of food.
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“Alternative Method” columns 4: risks deduction
Finally, appropriate means of control and monitoring will be entered in column 5, according to
the logistics that enabled us to construct the diagram of the mode of appearance of food-related
accidents:
- for each operation involved in the production procedure, risks of contamination may be
controlled by implementing the Good Hygiene and Manufacturing Practices (GHP and
GMP) that were applied beforehand as prerequisites for the application of the HACCP
method, thanks to the “Comprehensive Hygiene Management Method” in FB (presented in
Chapter 3).
- for operations where risks of multiplication or survival have been identified, it will be
necessary to monitor and control the parameters that these active mechanisms,
characteristic of living organisms, depend on. The implementation of monitoring and
control of the relevant parameters takes the form of an established Critical Control Point.
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Practically speaking, of course, identifying and highlighting the relevant parameters makes
the establishing of a CCP possible, but not necessary. The choice to establish a CCP or not
for any given production procedure is a business management decision. We should note
that the decision that a stage of production is a CCP signifies a commitment to implement a
demanding management plan of parameters associated with the CCP: measurement,
recording, definition, and the eventual application of corrective actions, etc. Such a
commitment, which may burden the management of a FB is justified in turn by its inherent
advantages (better risk management and control, efficiency and convenience, etc.)
- Ultimately, most of the elements grouped in the five columns that have been correctly
filled out will then reappear in various documents, “documentation and records keeping”
that the HACCP method recommends be established in the twelfth and final step of the
method.
Alternative Method” columns 5: control means deduction (CCP and/or GHP/GMP)
- During the assessment of a FSMS column 5 will immediately allows inspectors/auditors
to determine if appropriate provisions for risk management (GHP/GMP or CCP) have been
properly established on the manufacturing process stages
5 Application of the alternative method for the quick assessment of the relevance of the
FSMS of an inspected/audited FB: the example of cooked and smoked and dried fish
As a routine part of their professional involvement with FB inspectors/auditors are often
called upon to evaluate the suitability of an FSMS. This FSMS may be both complicated and
69
unclear but still of value. In such a situation, the inspector or auditor’s job is reduced to its
lowest common denominator: it consists of assuring that in the course of the given FSMS,
appropriate food safety provisions have been integrated at the correct stages of the
production process. The evaluation of such an FSMS is often difficult and time consuming if
the auditor has to backtrack by studying the available documentation on the business and the
progressive steps that the FB professional has taken to elaborate it.
To alleviate this difficulty, there is another approach that is simpler and much more practical.
All immediately available information on the given production process should be quickly
gathered: the successive stages of the production procedure, raw materials, packaging,
operators and whatever material comes into contact with the foodstuff, important parameters
in reference to specific stages, etc.
With this information in hand, a production flow diagram may be drawn up, even a succinct
but accurate one, that can then be directly used to apply the “Alternative Method to the
Codex Decision Tree.” Use of the alternative method, which with a little practice can take
only a very short time (from 30 minutes to 2 hours) , enables the inspector to determine stage
by stage where the CCP and GHP/GMP may be inserted. At that point, the inspector or
auditor has only to compare the results that he or she has found with the information in the
documentation he has been given, to determine if “relevant food safety provisions have been
instituted at the proper stage,” thus allowing him or her to evaluate the suitability of the
FSMS.
o 5.1 Evaluating the existing FSMS
The components of the practical example we shall now develop were collected in the fall of
2012 during one of our expertise assignments in Ghana under the auspices of the “BTSF in
Africa” program at an SME that produces smoked cooked fish. The exact identity of the SME
cannot be revealed because the business is protected by a confidentiality clause.
The raw material that we saw being processed at this establishment is a pelagic fish of the
family Clupeidae. Its common name is round Sardinella; the scientific name is Sardinella
aurita. Swimming in shoals, this species lives in the tropical waters of the Atlantic. Like all
species among the Clupeids, any adulteration to the flesh of the Sardinella is accompanied by
the singularity of producing histamine [20].
The production of histamine occurs when the cold chain has not been properly respected after
the catch until the fish arrives at the processing plant. The histamine is a natural mediator of
the allergy that is responsible for food poisoning; its highly stable molecular structure is
resistant to several transformative processes, especially cooking and smoking.
The manufacturing process by smoking, the slow combustion of wood chips inside the oven
is accompanied by the production of polycyclic aromatic hydrocarbons (PAH). These
molecules, whose carcinogenic strength has been recognized [11], are found in the finished
product. Their content depends on the types of wood used but also on the humidity of the
chips introduced into the system. In third world countries, bad practice unfortunately consists
70
of using scrap wood for smoking foods, which considerably exacerbates the problem. In fact,
the burning of salvaged wood that has been painted, varnished, or tarred produces a
significant amount of PAH that is found in food.
Despite the identified risks, however, the product that results from the cooking and smoking
procedure of fish is normally found in traditional Africa markets. Its relative stability allows
it to be preserved for a long time without refrigeration. Despite skepticism over the accuracy
of statistical monitoring of food poisoning on the African continent, this foodstuff appears to
be consumed by local populations without immediate adverse effect. The problem of chronic
poisoning through the long-term ingestion of PAH remains to be addressed.
• 5.1.1 The main stages of the process of producing cooked smoked fish
Receipt at the factory
• The iced fish is delivered in large containers and presents a temperature of approximately
0º Celsius
• Monitoring upon acceptance of the raw material to ensure that the fish has been
sufficiently iced to be completely covered
De-icing/washing
• The fish is manually removed from the ice
• Set out on trays, the fish is abundantly rinsed with potable chlorinated water (addition of
sodium hypochlorite)
Cutting
• Evisceration
• Removal of heads and fins
Washing
• Full rinse with potable chlorinated water
Racking
• The fish is arranged manually on oven racks
Pre-drying
• Pre-drying in the oven for 1 to 1.5 hours at a temperature between 60 and 80º Celsius
Cooking
• Cooking in the oven for 1 to 1.5 hours at a temperature between 100° and 200º Celsius
Smoking/drying
• Smoking and drying in the oven for 3 hours at a temperature between 80º and 90º Celsius
• Prohibition of the use of salvaged wood for the smoking process
Cooling
• At room temperature (25º Celsius on the morning of our visit)
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Placement in polystyrene boxes
• Arrangement by hand in polystyrene boxes
Storage
• Storage at -12ºC prior to shipping. The foodstuff leaves the factory at a very low
temperature in insulated boxes as a guarantee of quality to clients, although the product is
not transported in refrigerated vehicles.
•
5.1.2 The original FSMS of the fish processing establishment
The original FSMS had not been previously formalized. The application of the alternative
method enables us to establish the management system succinctly (see the following
diagram) thanks to available information on the hygiene practices that were in place and
observations made during our visit to the business.
The first provision, consisting in verifying that the fish received was properly covered with
ice, ensures that the condition of the raw material had not changed since it was caught, and
consequently that the production of histamine in its flesh had not occurred. Of course there
remains some doubt as to the speed with which the icing was done on the boat, but this point
cannot be controlled in an African SME to all intents and purposes at the processing stage.
Among the hygiene practices that were originally in place, the business’ choice to use only
new wood to smoke the fish and to exclude any resort to salvaged wood is a major
consideration. In fact, it allowed the business to avoid the production of a large quantity of
carcinogenic PAH during the smoking stage that would otherwise be found in large amounts
in the finished product.
Our analysis of this SME revealed that the business was well aware of the importance of
monitoring temperatures: they considered the temperature of the cold chain that we saw
above, but also the temperatures of heating procedures. The lengths of time and the
temperatures set for the baking stages (pre-drying, cooking, smoking and drying) were
precisely monitored.
This set of food safety provisions originally implemented by the business is reflected in the
establishment of a FSMS that in conjunction with GHP/GMP offers four CCP for controlling
the processing procedure:
an initial CCP established at the stage when the fish is received, where monitoring done
to ensure the presence of a sufficient icing is equivalent to an accurate measurement of
temperature to guarantee the proper temperature of the product at approximately 0º C.
three other CCP established at the heat treatment stages of pre-cooking, cooling, and
drying/smoking. During these stages, regulating the oven through readings taken by a
temperature sensor and timer make it possible to guarantee that the previously established
72
scales for heat treatment (time and temperature) have been respected for each batch
produced.
Table of the FSMS for the production of smoked fish established by the business
Original FSMS
73
Nevertheless, our analysis of the original FSMS (as described above) through the application
of the “Alternative Method” reveals an inconsistency. During cooling at room temperature, a
significant proliferation of bacteria should ordinarily be detected. The source of this
proliferation could be a residual flora that remains in the product even after heat treatment or
it could arise from an ambient contamination. Similarly, an immediate adulteration in the
product should also occur when it is sold at traditional local markets without cold chain
protection. In reality, however, this is not the case: the consumer finds a finished product that
is neither adversely altered nor dangerous for consumption. Moreover, the product is stable,
since it is possibly preserved long term at ambient temperature. The risk created by this
situation derives from the fact that the reason for the stability acquired through drying and
smoking and its limitations are not explained by the original FSMS. Only when this point has
been clarified can the stability and innocuousness of each batch of product be guaranteed.
This finding demonstrates that the original FSMS was marred by a major flaw. An
explanation must be provided for why cooling to ambient temperature is possible without
being accompanied by a microbial multiplication, as well as for how the finished product
acquires its long-term stability. In accordance with the basic principles of the alternative
method, if microbial multiplication in the product is inhibited after oven treatment, then one
of the parameters that triggers it, which was not accounted for by the original FSMS, has
acquired a value that makes multiplication impossible.
The missing parameter in the original FSMS is water activity (Aw). In fact, the water loss that
accompanies processing procedures during the stages where the product is oven treated
significantly reduces the value of this parameter. Without changing the product, the decrease
in Aw enables it to be slowly cooled to ambient temperature and sold without refrigeration.
o 5.2 Improvement of the FSMS through the application of the “Alternative Method”
As a result, we find that in order to guarantee the stability of the dried/smoked fish, there
must be certainty that the loss of water during oven treatment allows the product to reach a
sufficiently low Aw value so as to avoid any further bacterial proliferation. This guarantee
can only be obtained by systematically controlling this parameter for each batch produced.
But in the case of an African SME, direct calibration of the Aw in finished products is not
feasible in practice, because the necessary equipment and staff with appropriate technical
skills are lacking. Otherwise, it is perfectly feasible to measure the percentage of weight loss
from dehydration between the fresh and finished product to which the drop in Aw is
proportional. For instance, the measurement could be taken on a sample of ten fish that are
weighed before they are put into the oven and once again just after they are removed from it.
Since the items are from a shoal of round Sardinella that are fairly uniform in size, it is
possible to take the two measurements with an acceptable margin of error on ten fish which
are not necessarily the same ones.
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Table of revised FSMS for the production of smoked fish after evaluation using the
Alternative Method instead of the Decision Tree
Revised FSMS
75
Consequently, to improve the suitability of the FSMS, the auditor or inspector may
judiciously recommend that two weighing stages - when the product enters and is removed
from the oven - be integrated into the management system. The two weights will enable
inspectors to ensure that the resultant loss of weight resulting in an Aw value less than 0.9
[36] is sufficient or minimally equivalent to a pre-defined percentage, which would guarantee
the stability of the product both during cooling at ambient temperature and when it is
presented for sale on local markets without protection by cold.
Monitoring by measuring the change over time in the product’s weight (and indirectly, its
Aw) during the processing procedure establishes a new CCP that was absent from the
business’ original FSMS. The purpose of the second weighing, indicating a sufficiently low
Aw value to guarantee the stability of the product, is to discharge the product safely to the
ensuing cooling stage at ambient temperature.
It is interesting to note that the function of safely discharging a product to the next stage of
processing marked by CCP is often observed in the production of traditional products: the
weight loss of salted meats prior to the curing stage, pH values that allow curds to be
advanced to the maturing room at a dairy, etc.
We should also note that if the low Aw value that guarantees stability is reached for each
batch produced and maintained over time in watertight packaging, final storage at -12ºC is no
longer necessary, except perhaps to impede the speed of the biochemical change of rancidity.
This hypothesis, however, must still be confirmed. Otherwise, weighing packaged products
regularly, which would allow to confirm that there has been no increase in weight and thus
that no rehydration has occurred over time, is an effective measure for ensuring that the
stability of the product is guaranteed long term.
To summarize this example, the application of the “Alternative Method” initially allowed
inspectors in training to quickly formalize the measures for controlling food safety
implemented by the business we visited that produces dried smoked fish. The alternative
method then enabled the inspector trainees to analyze the original FSMS and expose its
flaws, especially the fact that it did not take into account the low Aw value of the finished
product that is the main cause of its stability at ambient temperature.
The low Aw value also made it possible to explain that slow cooling at ambient temperature
after cooking could be maintained in the production process without the risk of altering the
product. It also demonstrated that the importance of storage at -12ºC (which is costly) at the
end of the process is relative. On the basis of this study conducted using the “Alternative
Method to the Codex Decision Tree,” it was possible to suggest an improved version of the
FSMS, establishing an indirect measurement of Aw value based on the evaluation of the rate
of weight loss by taking two consecutive measurements of the product’s weight - first when it
is fresh and then at the end of processing. Thus the goal of providing a quick evaluation of
the relevance of the FSMS was reached by applying the “Alternative Method to the Codex
Decision Tree.”
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6. Application of the “Alternative Method” for establishing CCP and GHP/GPP: the
example of cured ham
The second possible application of the “Alternative Method” is usually performed by
professionals. For the purpose of identifying CCP, they have no longer to turn to the
“Decision Tree of the Codex Alimentarius,” whose application in some cases leads to a
stalemate. Furthermore, using the “Alternative Method” enables them to identify not only
CCP but also the requisite GHP/GMP on the production flow chart at the same time.
FB managers may use the “Alternative Method to the Codex Alimentarius Decision Tree” to
develop their FSMS by identifying the necessary provisions for the effective monitoring of
food safety that must be established, and they may consistently apply it to evaluate the
progress made in establishing them.
Chapter 8, which is devoted to the guidelines on GHP/GMP and HACCP, presents four
auditing grids that provide a complementary professional tool to the “Alternative Method”
for designing and implementing FSMS in food businesses. Once they have been used to
establish a FSMS, the set of auditing grids may then serve periodically to evaluate and make
necessary refinements to the system.
o 6.1 Main stages of the production process of dried salt pork
Receipt of raw material (hams)
• control of the cold chain and delivery conditions
• control of the origin of the raw material
• control of the compliance with the contract technical specifications
Labeling
Use of indelible ink to mark the date of salting and the original meat salting plant
Storage
Cold storing: 3ºC / 24 hours
Weighing
Salting
• The fresh hams are rubbed and kneaded with a mixture of dry salt and spices, natural
aromatics, saltpeter, sodium nitrite, saccharose and dextrose
• 40g/Kg
• On horizontal trays
• Salting time: 1 day/Kg + 2 days at 3ºC.
Desalting
• The topical salt is brushed off the pork
• Pressing of veins and the femoral artery to exude all residual traces of blood
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Downtime
• Cold air-conditioned room < 3ºC (winter)
• Weighing at regular intervals (Weight loss goal: > 19% of fresh weight)
• Achievement of stability by the homogenization of salting and drying at low temperature:
8-10 weeks at 3ºC
Drying
• Dryer where temperature, hygrometry, and ventilation are monitored
• Addition of characteristic spices; softness is obtained
• 14ºC
Greasing and coating
A mixture of pork fat, flour, and pepper
Goal: to prevent the crusting of meaty portions not protected by the rind
Ripening
• Summer
• Between 12 and 18ºC: the final stage of curing
• Development of full aroma
Checks
• After a production period of 7 months minimum
• Using a ham taster (the tip of a horse bone instrument), various specific areas of each ham
are inspected for aroma by specialists
• Verifying wholesomeness by looking for “bone stench” (possible toxinogenesis by the
internal development of anaerobic bacteria that make the hams unfit for consumption)
• Rating the quality of each ham based on the lightness of its aroma
Labeling
• The final stage in the certification process of the cured ham
• The hams that pass the final tests are fire branded
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o 6.2 Applying the “Alternative Method”
1. Designing the process flow chart
2. Enter the three possible sources (physical, chemical, microbiological) of contamination
(inputs and contacts) in columns 1 and 2 step-by-step
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3. Enter important parameters (time, temperature, pH, Aw, etc.) in column 3 step-by-step
4. Deduce the various types of potential danger (C, M, S) from the contents of columns 1,2,
and 3 step-by-step
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Note: In the production of dried salt pork, at no stage is an attempt made to reduce bacterial
flora. Consequently, the danger of its survival is not mentioned in this study.
5. Deduce the type of monitoring methods to be implemented step-by-step from the contents
of column 4: GHP/GMP or CCP
: Switching point of the control parameters: from temperature to Aw
o 6.3 Deductions after applying the alternative method to the decision tree to the
production of cured ham
In the selected example, we note that from the beginning of processing to the end of the “rest”
stage, only the careful monitoring of the cold chain (T < 3ºC) will ensure that the meat is
properly preserved. Then, in the second part of the process, the decrease of Aw (water
activity) brought about by the addition of salt (40g/kg of meat) and by the dehydration (loss
of weigh) will be responsible of the meat preservation.
The monitoring of weight and its 19% decrease resulting from the water loss mark the end of
the “rest” stage and move the process forward to the “drying” stage. This stage is associated
with an increase in temperature during storage. In fact, under the strict conditions for salting
that have been implemented, the reduction in weight guarantees that water activity has been
reduced to a value of < .91, thus ensuring the stability of the meat in relation to adulteration
caused by common flora.
However, this value does not prevent the meat from further maturing because the salted
foods’ flora can tolerate lower Aw values than the common flora. Consequently, to guarantee
the preservation of the dried salt ham, it is imperative, as our study demonstrates, that it be
kept under cold conditions during the first phase of the processing procedure. Its Aw value
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must then be kept continuously below 0.91 during the second phase and until it reaches the
consumer’s table.
Monitoring the food safety risks related to this type of production is associated on the one
hand with the set of GHP/GMP referenced in the diagram (hand hygiene, cleaning plan, etc.)
and on the other, with the monitoring of the two main parameters that prevent detrimental
changes in the product: temperature and water activity (Aw). Proper monitoring of these two
parameters will serve as the basis for establishing CCP at specific stages.
We should also mention that in the final check of the product, the test for the possible
appearance of “bone stench” is not only a good practice, but that its application is also crucial
to food safety since it can prevent the transmission of botulism in this type of food.
In our opinion, the monitoring methods that are underlined and in boldface are paramount for
the Food Safety Management System that is to be established. However, their selection is
also a management decision. The decision that an operation defined by one or more
important parameters is a CCP means that the business must commit itself to the thorough
and ongoing monitoring of these parameters. This type of monitoring will allow for already
predefined corrective actions to be implemented in the case of a safety failure that would be
demonstrated by a deviation from the targeted parametric values. As a result, a CCP
corresponds to the implementation of a sometimes complex management system that must be
justified by both the critical level of the identified risk and by the expected efficiency of the
monitoring methods that have been implemented
In short, the Codex Alimentarius Decision Tree occasionally designates as CCP certain
operations that do not fulfill all requisite CCP conditions, especially when they are not
associated with significant parameters. For any given production process, the alternative
method that we propose allows all operations that fulfill the set of requisite conditions for the
establishment of CCP to be identified with no obligation for further action. The establishment
of a CCP for a specific operation ultimately depends on the business’ choice to implement it
or not.
o 6.4 Targeting our investigation to a specific bacteria: its practical application in the
case of Clostridium botulinum
After analyzing microbiological risk in general, it is possible to “target” our study to specific
bacteria that is recognized as being potentially responsible for hazards to the type of food
under consideration.
Clostridium botulinum is a strictly anaerobic spore-forming bacteria whose development is
accompanied by the production of a highly dangerous toxin with an extremely unpleasant
odor like the “bone stench found in cured ham.” Before consumption, it is possible to test for
this odor at the bone level by systematically testing the “heart” of the pork with a long needle.
Conditions for development [45]: these values should be compared with the values derived
from the processing procedure, especially the values of the parameters associated with the
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CCP that have been established. The values in this list, which are underlined in light purple,
should be compared with the food safety management and monitoring methods presented in
the same format in the fourth chart.
pH > 4.6
salt content < 10% [1]
Aw > 0.94
growth and sporulation: Tº > 15ºC
germination Tº > 10ºC
toxinogenesis Tº > 12ºC
The examination of these values helps us to understand the role of the cold chain in the first
part of the processing procedure, when products are kept between 0º and 4ºC. In the second
phase, the low Aw value takes over by ensuring that there will be no metabolic activity of
Clostridium botulinum of any sort.
Conclusion
Our comparison of the alternative method - which is applicable to all types of food products
as well as to all types of processing procedures - to the Codex Alimentarius “Decision Tree”
demonstrates that its logic and reasoning are completely different from the prescriptions in
the Codex, since the starting point of our method is a validated description of the mode of
appearance of all types of food-related accidents, be they sanitary or economical in nature.
Besides the added advantage of its suitability for the rapid evaluation by an inspector or
auditor of a FSMS (Food Safety Management System) already implemented in a Food
Business, its application also allows those who use the HACCP - contrary to the “Decision
Tree” - to rule out any failure or uncertainty when identifying the food safety control means,
to be established (and where they should be implemented) for a given manufacturing process:
GHP / GMP or CCP.
These failures and uncertainties when applying the decision tree are the greatest hindrance
for HACCP users and are the basis of the reluctance and reservations of some of them to use
that method. Our “Alternative Method to the Codex Decision Tree” presented here constitutes
a simple, rigorous, and efficient solution for overcoming these problems.
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Chapter 6
Improvement of the microbiological quality of the “Espelette Chilli
Powder” through the practical application of the
“Alternative Method to the Codex Alimentarius Decision Tree”
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1. General
The Espelette Chilli Pepper is the fruit of a solanaceae (Capsicum annum, of the Gorria variety)
of tropical origin (Caribbean) introduced and acclimated in the Basque Country at the end of the
15th century by a sailor of Christopher Columbus’ crew. Its consumption spread quickly across
the old continent as a substitute for expensive spices from India, which earned it the name of
“poor man’s pepper”.
Its production remains traditional and is placed under an “Appellation d’Origine Contrôlée”
(AOC) covering ten rural districts in the Basque Country and involving around sixty producers.
Among the products obtained from the Espelette chili the powder is the flagship product.
In 2005 the “Mission Agroalimentaire Pyrenées” informed us of the difficulties encountered by
the powder producers to control the microbiological contamination of their finished products.
This lack of control was affecting several criteria: the total aerobic mesophilic flora, total
coliforms, yeasts and molds. Some characteristics of the product and of its manufacturing
process were such that the solution attempted by the producers had been unsuccessful and
abandoned. Either the products had not been adequately decontaminated or their organoleptic
characteristics had been damaged. To address this situation we proposed a three steps
intervention plan:
- field observation of production conditions of the Espelette pepper powder to establish an
accurate flow chart of the manufacturing process affording all the necessary data to the
application of the “Alternative Method to the Codex Alimentarius Decision Tree”.
- application of the alternative method to analyze (step by step) hazards related to the
manufacturing process and identify ways to implement control: CCPs or GHP/GMPs.
- corroboration of hypothesis and solutions through the application of a microbiological
sampling plan, as developed by a student in her veterinary doctoral thesis [3].
In this work on risk analysis the use of the “Alternative Method” was decisive. This is why we
chose to develop here, as an example of practical use of this method, this particular point of the
study on the Espelette pepper.
2. Espelette chili powder manufacturing process
The chili powder process sequence we will study, which is the one that was applied before the
use of the “Alternative Method”, starts with the harvesting of the chili and ends with the ready to
use powder packaging, but does not take into account the field production.
For the farmers the productions stages are the following:
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- Harvesting
The chilies are manually harvested and are placed in crates. The harvest starts in
mid-July and finishes with the first autumn frosts.
- Wiping and sorting
Each pepper is then checked and wiped with a cloth to remove any trace of
dust or mud. All peppers damaged or cracked because of an excess of humidity
are removed.
- Drying on ropes or shelves (maturation stage)
As is often the case in traditional production processes, the name given to some of
the operations does not correspond to their actual function. In the case of the
pepper, the so-called drying operation (done in a plastic tunnel, shaped like a
greenhouse opened at both ends), lasts at three weeks and results in a negligible
loss of water. In fact the cuticle of the chili is naturally wax coated and therefore
prevents water loss from the pulp of the pericarp.
On the other hand when asked about the necessity of this step, producers always
answer the same: “if chilies are treated directly in the oven without being “dried”
on strings or shelves the finished product aromas are very poor”. This stage
known as “drying ” is in fact a natural maturation step of the product as can be
observed in the production of chocolate or coffee for which the richness of the
aroma is also a major criteria of quality. The organoleptic characteristics of the
chili powder derive from this “maturation” resulting in the pericarp carbohydrate
break down by endogenous enzyme complexes.
- Sorting
During the maturation stage the internal cavity of some peppers can be the site of
intense mould growth. The aspect of the chili changes totally, turning from the
normal red to white. The damaged peppers present large white spots or turn
completely white. This sorting step consists in removing all chilies showing any
white.
- Oven drying
Oven treatment is usually carried out in two steps: a first phase of 48 hours at 550
C, and a second one of 2 to 8 hours at 720 C. The taste of the finished product
depends on the duration of the second phase which can be modulated. Each
producer tries to establish the proper oven operating rate to obtain his own
finished product taste balance.
It is during this step of the process that the producers encounter the greatest
obstacles. At the time the matured chilies are introduced in the oven their water
content is still high and their impermeable cuticle considerably slows down the
dehydration. This situation creates a dilemma for producers. Either they apply a
high temperature to accelerate the drying, thus running the risk of cooking the
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chilies, or they apply a lower temperature with the possible consequence of
promoting the growth of moulds causing significant losses.
At the end of the drying step the chilies Water Activity (Aw) reaches a value of
around 0.3 [3], obtained through the final temperature elevation also aimed at
reducing the product microbial contamination. This Aw final value makes them
very brittle and further facilitates the grinding.
This problem has incited the producers to ask for the help of the “Mission
Agroalimentaire Pyrenees”.
- Sorting and peduncles removal
As we just saw, the oven treatment can result in the rapid development of moulds,
in a certain amount of the chilies. It is therefore necessary after the oven treatment
to sort them again in order to remove the chilies showing white spots or fully
discolored. The peduncles removal is also carried out at the same time.
- Grinding
Technologically this grinding must not be too abrupt. To avoid a temperature
elevation of the product whose flavor and aroma could be affected. It is also during
this stage that the seeds are grinded and release the capsaicins which are
responsible for the “heat” of the peppers.
- Packaging
After grinding the powered is packaged manually in 50 gram glass jars sealed
with a metal lid without the use of vacuum or inert gas.
3. Application of the “Alternative Method to the Codex Decision Tree” to the Espelette chili
pepper powder production.
The “Alternative Method” is applied as described in chapter 5, using of the same acronyms, as a
series of four tables drafted from the chili powder processing flow diagram:
- inputs and contacts constituting the potential sources of contamination of the three
types (microbiological, chemical and physical) are mentioned on the first table. We
chose to limit the following study to microbiological problems specific to this
production.
- the specific physical chemical parameters associated with some particular stages
figure on the second table.
- the hazards deduced from the elements gathered on first two tables are mentioned on
the third table.
- the control means are deduced from the whole of the above mentioned elements.
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Table 1: inputs and contacts
Table 2: relevant parameters
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Table 3: Hazards identification
Tableau 4: Control means identification
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4. Synthesis
As previously stated the “Comprehensive Management Method” has been applied in order to
implement the HACCP prerequisites. Consequently the GHP/GMPs mentioned in the control
means column have already been implemented (for example the cleaning plan and hand washing
plan). The GMPs are preventative measures linked to the manufacturing process. For instance it
is the purpose of the provision consisting in avoiding the accumulation of large stacks of peppers
to prevent fungal growth.
We can also observe that two of the stages are characterized by significative parameters:
maturation and oven drying.
- in the course of the maturation if the duration temperature or hygrometry values (on
which Aw depends) are not favorable, the probability of important fungal development is
high. These parameters which vary from year to year in function of annual climatic
variations are not manageable. Consequently the maturation stage cannot constitute a
CCP because the “Codex Alimentarius” specifies that “a CCP must be manageable” [10].
Remark: according to the Codex a CCP is manageable if its control is based on the
monitoring of measurable parameters, placed under the responsibility of the FB manager.
Additionally traceability must allow the unequivocal identification of each batch to make
possible the follow up of the ones subjected to corrective action.
- during the oven drying the temperature and duration parameters depend on the
adjustment of the equipment, which are fully manageable. Thus the drying stage is a
CCP: in fact the only one of this manufacturing process.
We know however, that the oven control is not sufficient by itself to overcome the: production
difficulties that we have mentioned above: cooking of the peppers in one case or fugal rapid
development in the other. In fact the real solution to the problem was to find a way to accelerate
the dehydration of the peppers at the beginning of the oven drying stage.
The increase of the heating parameters of the oven does not allow the necessary drying
acceleration without negative consequences on the quality of the product: cooking effect rather
than drying. It is through the optimization of the drying conditions by introducing an additional
GMP that we obtain the desire result. Practically this shows that the solving of food safety
problems encountered in manufacturing processes, does not necessarily depend on the
implementation of a CCP but can also be obtained by applying GMPs.
The obvious logical way consists in opening the chilies cavity before oven drying. The first
variant of this approach consisted in tearing or cutting the chilies in small test series. From the
outset the results were very positive with a significant reduction in fungal spoilage losses and
production of finished products complying with the bacteriological standards. The analysis
sampling plan carried out in a doctoral thesis confirmed more thoroughly these initial results.
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However cutting or tearing the peppers before their introduction into the oven represented an
additional step in the manufacturing process and therefore a waste of time. In re-examining the
manufacturing process we noted that after drying in the oven the peduncle was still attached to
the pepper and removed before grinding. The removal of the peduncle having the collateral
effect of opening the peppers cavity moving this operation on the flow diagram just before
drying solved the problem of the producers without any additional manufacturing step.
Consequently, on our fifth and last table relative to the application of the alternative method, a
modification in the order of the of the pepper powder manufacturing steps was then introduced.
This recommendation to simply reposition the removal of peduncles to open the peppers cavity
before drying was added in the specifications of the “AOC Poudre de piment d’Espelette” by
publication in the “Journal Officiel de la République Française”.[12]
Table 5: optimization of the control means by changing the position of the peduncle
removal operation in the manufacturing process
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Conclusion
In the example of the Espelette chili pepper powder, the application of the “Alternative Method
to the Codex Decision Tree” helped to understand the technological as well as health origin of
manufacturing non conformities endured by producers.
While this method was originally drafted as an alternative to the Codex decision tree, this
particular example shows its capacity to identify risks control means other than CCPs if they are
better adapted to the situation. This capacity to identify through a sole approach all risks control
means to be implemented (GHP/GMPs and CCPs) constitutes a considerable advantage over the
decision tree which only identifies CCPs.
In the present example the addition of a GMP consisting in opening the chilies by removing the
peduncle before drying, is the solution to the problems of non-conformity.
The relevance of the proposed food safety provisions resulting from the application of the
alternative method was confirmed through an analysis sampling plan implemented within the
framework of a research thesis [3]. This cavity opening operation through peduncle removal
before oven drying was since introduced in the specification chart of the “AOC Poudre de
piment d’Espelette” which reinforces its relevance. This modification was adopted by
ministerial decree (of French “Ministre de l’Agriculture et de la Pêche”) of 03/14/2007 bearing
modification of the decree of 05/29/2000 relative to the AOC “Piment d’Espelette -Espeletako
Biperra” published in the “Journal Officiel de la Republique Française” [12]
The first states that “…the peppers must be oven dried for a few hours ” becomes in the second
decree “…the chilies peduncle must be removed before being oven dried for a few hours…”, in
order to take into account the conclusion of the study realized by application of the “Alternative
Method to the Codex Decision Tree”.
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Chapter 7
A Study of the transmission of cholera by food consumption
in rural areas of Haiti by applying the “Alternative Method to the
Codex Alimentarius Decision Tree”
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1. Introduction
In November 2010 the DG-SANCO in Brussels organized a meeting with the participation of
FAO representatives where the results of the BTSF Program in Africa were presented. Among
the papers submitted, we were asked to give a presentation of the alternative method to the
Codex Alimentarius Decision Tree. The topic of our presentation was expected to address the
application of the method as a means of evaluating the suitability of the FSMS used by food
businesses. During the course of the meeting and informal discussions that followed the
presentations, the FAO representatives showed keen interest in our method as well as the
“Comprehensive Hygiene Management Method for Food Businesses” [47].
Following our interactions in Brussels, the FAO invited us to participate in a program to
eradicate the cholera epidemic that was rampant in Haiti since October 2010. Although
significant progress had been made thanks to sanitary and hygienic measures and precautions
that were put in place and preventive health information distributed to the local population,
especially concerning the waterborne transmission of the disease by fluids, there was still
insufficient knowledge of the mechanisms of contamination through food consumption. The
FAO invited us to collaborate with them along these lines and apply our methods of risk analysis
to refine knowledge of the mechanisms of food transmission of the disease to maximize the
impact of the prevention information distributed to the local population.
As the preceding examples have shown, there was already a well-established precedent for
referring to the “Alternative Method to the Codex Alimentarius Decision Tree” as a means of
identifying the various ways of preventing food-related accidents (GHP/GMP and CCP), either
of an economic (the sub-standard quality of chili powder in Chapter 6) or sanitary (the
transmission of botulism by cured ham in Chapter 5) nature. FAO’s invitation to intervene in
Haiti was an opportunity to expand our range of application and successfully evaluate the
relevance of our method in a new context of the fight against cholera, a contagious disease that
can evolve to epidemic proportions, transmitted by dietary intake (drinking water and food).
Since the timing of our assignment was limited to three weeks, our strategy was to direct our
analysis in two areas of inquiry. The first was to identify traditional rural cooking methods in
Haiti by observing mothers as they cooked and chatted with each other. Using the information
we gathered, we were then able to diagram the main ways of preparing food by cooking method
among rural Haitian families. Our plan was to apply the same methodology for analyzing risks in
the artisanal or industrial production of foodstuffs by FBs to the context of the traditional
preparation of food for families.
The second area consisted of meeting people who were directly involved with cholera patients:
the staff of treatment centers, regional coordinators of the eradication program, etc. Since each of
them had seen many sick people, their observations seemed to be a likely source of
commonalities or a generic profile of cholera victims.
After conducting research in these two areas, our final goal was to try and see if it were possible ,
by synthesizing the information we had gathered, to pinpoint specific ways of preparing food or
eating that were related more often than not to the observation of clinical cases of cholera. Better
96
knowledge of the conditions under which clinical cases of the often deadly disease appeared was
crucially important to our study, since the vast majority of those infected by the bacteria
temporarily become carriers, although they appear to be asymptomatic.
2. Cholera
o 2.1 General remarks on the disease
The pathogen that causes cholera is Vibrio cholerae, in the genus Vibrio, a member of the
Vibrionaceae family (that is comprised of four genus: Vibrio, Photobacterium, Plesiomonas, and
Aeromonas) [45]. The bacteria has been identified since the second half of the 19th century,
having been observed by Filippo Pacini in 1854 in the feces of cholera patients. But it was not
until 1884 that Robert Koch demonstrated that the “comma bacillus,” the name given to the
vibration at the time, was actually the agent responsible for cholera.
Characterized by the onslaught of profuse watery diarrhea caused by the choleric toxin and
accompanied by rapid dehydration that can cause death, the disease is observable only in a
minority of those infected. The incubation period lasts from a few hours to a few days,
depending on the size of the inoculum ingested by the patient. These symptoms may be further
aggravated by the appearance of repeated vomiting that intensifies dehydration. Without
treatment, the intensive dehydration can rapidly cause death only a few hours after the
appearance of initial symptoms.
The pathogenic effect is caused by the toxin secreted by the vibrions after they have attached
themselves to the epithelial cells on the intestinal wall. The intervention of the toxin that would
have been secreted in food during the hours preceding its ingestion is still suspected as well [26],
but this point remains undecided at present by scientific authorities. The toxin causes electrolytic
disorders by disturbing water exchange through the intestinal wall by reversing their flow.
Malnutrition (a frequent problem in Haiti) is responsible for achlorhydria [45] that reduces the
strength of gastric acid, thereby eliminating the protective effect of normal gastric acid against
the choleric vibrion (normal pH value round 2). The lethal effect of normal gastric acid destroys
the vibrions borne either by water or food during their passage through the stomach, thereby
preventing them from attacking the intestinal mucosa.
Even in severe cases, patients may be cured without side-effects if a parenteral or even oral
rehydration treatment is administered to the patient soon enough after the appearance of the
initial symptoms. Although it is not standard procedure, antibiotic therapy per se can be of only
supplemental importance.
In theory the vaccines that are available on the market would make the oral administration of the
cholera vaccination possible. Although effective, the protection from the vaccination
unfortunately lasts only a short time, from six months to a year and no longer. Under these
conditions, the high frequency of vaccination campaigns that would be necessary makes recourse
to this solution unfeasible [45].
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Consequently, it is more likely that the most effective prevention of cholera will be achieved by
strengthening measures related to the sanitary control of food and water all along the food chain
from primary production (agricultural and fishing products, the harvesting of fruits and
vegetables, raising and slaughtering livestock) to the consumer’s table.
o 2.2 Epidemiology
• 2.2.1 Waterborne transmission
Cholera was correctly perceived early on (John Snow, London 1854) [45] as a waterborne
disease, transmitted by the consumption or use of contaminated water via personal hygiene,
washing clothes or dishes, irrigating crops, among other possible sources. In fact, early observers
were soon struck by the fact that the spread of the epidemics followed waterways. This
phenomenon was once again observed in Haiti in fall 2010 where the cholera epidemic had
spread downriver along the course of the Artibonite River [46].
As for Haiti, a water analysis plan [Appendix 3] (that was probably based on overly restrictive
samples) applied at the very height of the epidemic did not enable researchers, however, to
isolate the vibrion either in rivers or rice fields. This does not prove that the infectious agent was
not present, nor that it was not the source of asymptomatic infections [45] in farm workers who
came in contact with this water or even drank it. The role of these asymptomatic carriers in
spreading the cholera would ordinarily be greater, but the appearance of symptoms requires the
intervention of a minimum infecting dose [7, 45] obtained by the intervention of a contributing
factor, such as the multiplication of the cholera vibrion in food that has been re-contaminated
after cooking.
The apparent absence of vibrion in the water that was analyzed may be explained by the fact that
in a watery environment the infectious agent has a natural propensity to attach itself to certain
zooplankton organisms called copepods (from 104 to 105 bacterial bodies attached to the
integument of each organism) [24, 25]. The fixation onto copepods produces dormant forms (that
are often difficult to identify in the laboratory) and enables vibrion to continue living
permanently in that environment, despite the fragility of its free forms that can never survive
longer than a few days (one to two weeks maximum). The fixation onto copepods also explains
why simple filtration of river water in India through several folds of sari cloth before drinking or
use in preparing food significantly reduces the prevalence of cholera in local populations who
apply this principle [24, 25].
The chlorination of water for domestic use (in the washing of cutlery and food or as an element
of food preparation either as a component or means of cooling food after cooking) is an excellent
way of preventing the transmission of the vibrion on the condition that it is highly concentrated
enough to be effective [7]. In fact, the chlorine level of ordinary chlorinated water is too low to
kill the choleric vibrion and risks becoming an agent that spreads the other highly pathogenic
agent through repeated contact with workers’ hands, dishes and cutlery, and foodstuffs, among
other points of contact.
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Unaware of their condition, asymptomatic carriers will not necessarily take any special
precautions, and in so doing will play a significant role in the transmission and spreading of the
epidemic in several ways:
by not paying particular attention to keeping their hands clean, although they are
carrying cholera vibrion. The lack of attention will then correspond to a
contamination of their environment either by direct contact with others (for instance,
by shaking hands) or by contaminating the foodstuffs with which they come into
contact.
by increasing the contamination of the hydrographic system (streams, rice fields,
irrigation reservoirs, etc.) via the water used to collect their waste products if the
water has not been purified before being ejected into the environment.
• 2.2.2 Oral transmission
In Haiti, the hygienic conditions for the production, transportation, and bringing to market of
foodstuffs are deplorable (due to environmental squalor and the absence of a cold chain) in all
sectors of fresh food products: fishery products, fruits and vegetables, poultry and other meats
from hooved animals. Since there are so many persons involved in providing fresh products and
an extremely high number of situations in which the basic rules of food hygiene are not
respected, it would be naive to expect a noticeable short-term improvement in the hygienic
quality of the raw materials offered to families for cooking. We must anticipate that this
improvement will only come about slowly, in tandem with a general improvement of the
hygienic situation in Haiti. In the present situation, all raw materials to be used for cooking must
be systematically considered to be potentially contaminated.
As for the Vibrio cholerae itself, it can actively multiply in a nutritive medium in general and
specifically in foodstuffs. Its potential to develop is explosive: under optimal conditions it is
capable of multiplying at the rate of one generation every eight minutes, allowing for a culture to
be identifiable in an enrichment broth or peptone water less than three hours after its
introduction. It is especially interesting to observe that the cooking of foodstuffs make them even
more susceptible, for several reasons, to the multiplication of the cholera vibrion when the
opportunity for recontamination arises after the cooking process [11, 45]:
The destruction of other competitive flora
After cooking, especially extended cooking at a high temperature, which is typical
of the Haitian culinary tradition, foodstuffs contain only a very weak residual
flora, often composed only of spore-forming bacteria. Since all other competitive
residual flora has been either highly weakened or is sometimes even essentially
absent, and since the vibrion has an extremely rapid ability to multiply, the
conditions for its recontamination of a cooked food are especially favorable.
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The elimination of the inhibitor factor present in some raw foods
Cooking often removes the inhibitor fact that is found in foods before they are
cooked [45]. This is particularly true in acidic foods that strongly resist the
multiplication or even survival of the cholera vibrion. Cooking returns the pH
value of these foods to an almost neutral level.
The production of micro-nutrients that improve growth of vibrions
Finally, the alteration of food proteins by cooking produces micronutrients that
stimulate the metabolism of the choleric vibrion [17].
Regardless of whether the contamination of humans occurs through water or food, it does not
lead to a clinical stage of infection in most cases, but rather to an asymptomatic stage as a carrier
that lasts a few days. In fact, the appearance or not of disorders is most likely dependent on a
minimal dose of 10 CFUs (colony-forming units) [18, 45]. This level of bacterial presence in a
food is only rarely reached in the case of tainted food, except perhaps in cases of contamination
through faeces carrying the cholera bacteria.
The on-site testimony that was gathered during our assignment in Haiti agrees with the scientific
literature on the subject: the delayed consumption of food that has been cooked but then stored at
improper temperatures that promote the multiplication of the vibrio is a situation that is often
associated with the appearance of severe clinical cases of the disease [18]. So it seems that food
contamination by the agent of cholera after cooking, followed by a waiting phase during which
its intense multiplication takes place, is the source of a significant proportion of severe clinical
forms.
3. Application of the “Alternative Method to the Codex Alimentarius’ Decision Tree” to the
analysis of risk and the proof of our hypothesis
The main goal of our intervention in Haiti requested by the FAO was to re-investigate the ways
in which cholera is transmitted through food consumption. Our study was conducted by applying
one of the methods first described in this paper, the “Alternative Method to the Codex
Alimentarius’ Decision Tree.”
An outline of the traditional Haitian ways of preparing food: our choices are based on a few
basic cooking methods of traditional Haitian cooking whose variations depend on the
ingredients:
• preparing vegetables
• preparing corn
• preparing puréed peas
• preparing rice
• preparing meat in a sauce
In fact, these recipes are more complex than their names suggest. The preparation of vegetables,
for instance, must include the addition of meat that has already been elaborately prepared.
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The analysis of the risks involved in preparing meat and the definition of the management
techniques to be established will be developed in the following pages. After gathering the
necessary information from Haitian mothers and observing them as they cooked, we developed a
diagram - just as we would do for a food business - of how everyday food and cooking
preparations are carried out. The “Alternative Method” was then applied to each of these
diagrams.
Since the audience that was supposed to use these documentary tools lacked experience with the
technical aspects of food safety management, we found it preferable to facilitate their
understanding to apply the method in an expanded form that differed slightly from its classical
presentation. Despite the organizational change, however, its rationale remained rigorously
unchanged.
The diagram is reproduced several times, but we match the information and variables from the
various columns of the classical presentation with each new diagram presented here.
Diagram One: Preparation of meat in a sauce
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Diagram Two: Preparation of meat in a sauce referencing inputs
Diagram Three: Preparation of meat in a sauce referencing contacts
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Diagram Four: Preparation of meat in a sauce referencing heat treatments
Diagram Five: Preparation of meat in a sauce referencing risks and safety methods
103
Diagram Six: Preparation of meat in a sauce referencing risks and safety methods that are
essential when the application of the alternative method to the decision tree is concluded
Reminder: the classical presentation of the “Alternative Method”
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In this presentation of the method utilized in our study of cholera, diagrams 2 and 3 on food
preparation correspond to columns 1 and 2 in the classical presentation that we have reproduced
here as a reminder. In these diagrams we indicate inputs on 2 and contacts on 3, the two sources
of all possible types of physical, chemical, or microbiological contamination. Since the
eradication of cholera is of course the goal of our study, we are focused on the microbiological
component of contamination.
Since a cold chain is nowhere to be found in Haiti due to the extremely low level of preventive
health measures there, the section that corresponds to column 3 in the classical presentation in
diagram 4 indicates only thermal cooking treatments. The application of satisfactory thermal
parameters (time and temperature) - which is found in the Haitian tradition where extended
cooking by boiling is done would suffice to kill the choleric vibrions that would eventually be
found in foods and thereby prevent their survival.
Finally, diagrams 5 and 6 are a synthesis of columns 4 and 5 in the classical presentation,
regrouping identifiable risks and the measures necessary for their prevention.
4. The results of our Study
In reading these results, one should keep in mind that our research was undertaken under
emergency conditions as the cholera epidemic was rapidly spreading and at a time when some
patients presented extremely serious symptoms. The brevity of our mission in Haiti limited the
number of persons we could meet, which in turn restricted the extent of our observations.
Complementing available bibliographical sources, the main sources of information for this study
- whose comparative objective is to present the alternative perception of a food hygienist in
relation to the traditional approach of the medical establishment - were the ground observation of
traditional Haitian cooking practices and information gathered from those who were responsible
for treating the sick.
Our study corroborates convergent opinions according to which the delayed consumption of food
that has been re-contaminated after cooking is significant enough to provoke clinical forms of the
disease that are often severe. In fact, such a situation most likely induces the presence of a
population of choleric vibrions in these foods that surpasses the threshold of pathogenicity and
may in some cases - although there is no certainty on this point - contain an extremely high
concentration of preformed choleric toxin. As a group, the data may be reorganized in the
“Diagram of the expansion and transmission of cholera” that leads to the appearance of severe
clinical cases of the disease among the Haitian population.
As for the preparation of meat in a sauce that we chose as an example, the final assembly of the
dish by adding fried onions to the other ingredients is based on cooked components in which any
vibrions that might have been present have already been destroyed if proper cooking times and
temperatures have been observed.
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Diagram of the expansion and transmission of cholera
Based on the likely hypothesis that these cooked components are not only free from the cholera
vibrion but are also exempt from other agents that may cause collective instances of food
poisoning (salmonella, staphylococcus, etc.), the challenge in terms of food safety is to prevent
their re-contamination by treating them with extreme caution after cooking and to avoid the
consequent multiplication of flora (residual or reintroduced) by immediately consuming these
foods in this tropical country where a cold chain is completely lacking.
Conclusion
Conducted under the emergency conditions of the cholera epidemic in Haiti, our study
demonstrates that the “Alternative Method to the Codex Alimentarius Decision Tree” normally
used in establishing Food Safety Management Systems for food businesses may also be
successfully applied to the analysis of risks related to the alimentary transmission of the
infectious agents responsible for epidemics.
The common thread running through our analysis of these risks takes the various methods of
traditional Haitian food preparation and analyzes them in the same way that industrial food
processing procedures are normally studied by businesses. This approach allowed us to integrate
the bibliographical material that was at our disposal into a sector-based approach that began with
the raw materials used and ended with the dishes served to local consumers.
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Although the traditional ways of preparing Haitian food are such that the cholera vibrion would
be destroyed by cooking, it would seem that after cooking is the crucial period when it reappears.
It is essential that the pathogenic agent not be given the opportunity to re-contaminate already
cooked foods and multiply there. From this perspective, it is interesting to observe that the
mechanism for transmitting cholera via food consumption resembles how food poisoning occur.
For this reason, preventive measures for one would then be equally effective for the others.
When the cholera epidemic exploded in fall 2010, a general-purpose set of good hygiene
practices was urgently recommended to the local population. The implementation of these safety
guidelines was able to reduce the contagiousness of the illness, at least partially. However, the
high number of hygienic precautions that were necessary on a daily basis and the apparent
regression of the disease led the population to be less vigilant in applying these guidelines.
Based on the analysis we conducted in spring 2010, we were able to present a restricted but
applicable number of crucial hygienic recommendations to the persons responsible for preparing
meals in order to more effectively prevent the transmission of cholera as well as food poisoning
in general through food consumption.
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Chapter 8
Regulatory Guides for the Implementation of “Good Manufacturing
Practices, Good Hygiene Practices, and HACCP” (Hazard Analysis
Critical Control Points”
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1. Context: guides to good practice
Having defined the principles of the method of “Comprehensive Hygiene Management for Food
Businesses” and the “Alternative Method to the Codex Alimentarius’ Decision Tree” used to
determine CCP in chapters 3 and 4, the need then arose to design a tool for their implementation.
This need was fulfilled by the creation and publication of successive versions of application
guides intended for use by professionals representing Food Businesses as well as those
responsible for auditing or inspecting these businesses.
While many guides to good practice currently available to professionals are devoted to specific
food production sectors (fishery products, milk products, meat and meat products, etc.), the use
of the “Comprehensive Hygien Management Method” in the writing of this paper enables us to
offer a unique application guide that is applicable to any kind of food production. This
versatility simplifies establishing a FSMS for businesses that engage in different types of food
production (for instance, the slaughter and cutting of poultry meat in the making canned food),
by offering them the convenience of referring to a single guide to good practice for all their
activities. It must be noted that need for one business to refer to several guides in relation to its
various production activities is felt to be a problem in setting up a FSMS.
Just as the “Comprehensive Hygiene Management Method for Food Businesses” represents an
innovation that proposes to simplify the implementation of GMP/GHP, the publication of the
“Alternative Method to the Codex Decision Tree” in the second part of the guides devoted to the
HACCP study represents yet another useful innovation. The “Alternative Method” enables
professionals to simplify, clarify, and systematically identify different operations in the
manufacturing process where it is beneficial to integrate a CCP. In fact, our experience in the
field has long since demonstrated to us that the use of the “decision tree” is a major source of
problems and even failures for food business managers in applying the HACCP method.
Furthermore, the alternative method allows them to identify necessary GHP/GMP and locate
their position sequentially on the processing diagram, an option which the “decision tree” does
not provide for.
Finally, in order to provide the professionals for whom these guides are intended with a more
long-term approach to food safety management that reaches beyond the presentation of the
prerequisites of the Codex (GMP/GHP), we have expanded the scope of their coverage by
including audit grids for the purpose of evaluating the application of Food Safety Management
Systems (FSMS) by food businesses. Beyond their general usefulness for enabling food business
operators to establish an FSMS, these manuals are innovative because they present two original
implementing methods. This was one of the catalysts for the writing of this paper.
It is important to note that before the more widespread adoption by all users of the acronym
“HACCP” throughout the world, various attempts were made to translate the name of these
methods into French: ADMPC and ARMPC (Analyse des Dangers (ou Risques), Maîtrise des
Points Critiques). For the time being, these abbreviations have been completely discarded,
although they are still to be found in older documents.
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2. History of our guides for the implementation of “Good Manufacturing Practices, Good Hygiene
Practices and HACCP”
•
•
The first of these guides in English was published in 2005, in South East Asia, in the context of
the “program of economic cooperation EC-ASEAN” concerning the standards, quality and
evaluation of compliance”, under the title: “Guidelines on HACCP, GMP and GHP, for ASEAN
Food SMEs”. Besides the French and English versions, several translations of this document have
since been published (Turkish, Arabic, and Portuguese). This first version is the one we will
present in Appendix 2.
In 2010, a second version of the “Guidelines on HACCP, BPF and BHP for ASEAN SMEs” was
written in the context of “Better Training for Safer Food in Africa”, to correct lacks in the first
edition, and to include some changes in order to adapt it to the African context. This second
version was adopted, published and translated (in French, English, Portuguese and Arabic) for use
in the African Union countries, under a different title: “Guidelines on the Application of GMP,
GHP and HACCP”. In this version as in all the previous ones, the general plan can be divided in
four main parts.
Part 1: Guide to good practice (Codex Alimentarius prerequisites or GHP/GMP)
Part 2: HACCP study
Part 3: HACCP plan
Part 4: GMP, GHP and HACCP audit grids.
3. Organization of the guides to good practice
o 3.1 Chapter One of the Guide: establishing prerequisites (GMP/GHP) in accordance
with the “Comprehensive Hygiene Management Method” for food businesses
Introducing the structure of the entire guide, the introduction (paragraph 1.1: “Constructing a
guide to good practice”) to the first section on prerequisites or GMP/GHP, presents a diagram of
how and why food-related accidents that is validated by referring to the standard methods of
preserving food (as we have demonstrated in Chapter Three of our thesis).
The five boxes containing the requirements for food safety management plus training constitute
the “Comprehensive Hygiene Management Method“ (as we have presented it in Chapter Three of
our thesis) are then applied to the diagram of how and why food-related accidents appear.
In relation to the “International Recommended Code of Practices - General Principles of Food
Hygiene” in the Codex Alimentarius, the new organization of prerequisites (GMP/GHP)
presented in our guide for implementation is exactly the same as the one developed in Chapter
Three of this paper in the section “A comparison of the organization of the prerequisites in the
“International Recommend Code of Practices” with the “Comprehensive Hygiene Management
Method for Food Businesses.”
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The compatibility of the “Comprehensive Management Method” is documented by an FAO
publication titled “Developing a GMP Program to manage food safety,” [47] which stipulates
that “To give an idea of how a GMP program can be structured and still be in consistence with
Codex is elegantly demonstrated by the Comprehensive Hygiene Management system”. The
description of its methodology is the result of lengthy observation of the problems encountered
by small and medium-sized businesses when they develop their own FSMS to satisfy European
and international requirements concerning GMP/GHP.
To help the user of the guide to implementation, the colors of the different boxes that constitute
the diagram of the “Comprehensive Hygiene Management Method for FBs” are reprinted for
guidance at the top of each page as well as the title of each paragraph in the first part of the
handbook devoted to GMP/GHP.
All prerequisites are directly presented box-by-box and in detail, according to the organization of
the “Comprehensive Hygiene Management Method” presented in Chapter Three. As is the case
for the entire guide to application, difficult or crucial points whose implement may be
problematic are set off in a box and are flagged in the margin with words like “REMARK,”
“IMPORTANT,” or “PRACTICAL ASPECTS.”
Box 1 (Heading 1.2): Building standards, suppliers control, pest control plan.
The first box is devoted to the management of sources of non-human contamination (work
spaces and equipment, pests, raw materials) as opposes to human sources represented by
workers.
The list and organization of the points addressed in the first box are as follows:
-
-
-
Conformity of premises
o General principles
o Construction regulation and standards
o Equipment conformity
o Personnel hygiene facilities and toilets
o Maintenance (preventive and corrective)
o Storage of chemical substances
Pest control plan
o Passive control, surroundings and outbuildings keeping
o Active control
Detection of pests
Rodent control plan
Insect control plan
Contractual Relationship with Suppliers and Deliveries Control
o Raw materials specification
o Preferential choice of suppliers
o Raw materials delivery checks
o Control of the raw materials labelling
o Organoleptic control of products upon receipt
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o
o
o
Other essential criteria
Admission procedure into storage rooms
Procedures for rejection
Box 2 (Heading 1.3): Health policy for workers
The second box concerns the management of sources of human contamination that workers may
carry if they are infected by chronic bacterial conditions brought about, for instance, by
salmonella or Staphylococcus aureus. One of the goals of this health policy for workers is
precisely to detect these chronic carriers, first of all to protect them - since this means that
pathological disorders afflicting them require the provision of medical care - but also to protect
the consumers, since the same bacteria may be the source of food poisonings and other foodborne diseases.
Box 3 (Heading 1.4): Hand hygiene and the clean-up plan
The third box concerns the management of physical, chemical, or microbiological contamination
caused by poor handling hygiene during the processing of foodstuffs. This box also applies to
clothing hygiene whose function is equally important in preventing the contamination of foods,
either because work clothes come into direct contact with foodstuff, as is the case for the
wholesale trade in meats where carcasses are carried on the back, or else because it can be a
source of indirect contamination when it is soiled by dirty hands.
An organized list of the points presented in the third box:
-
-
-
-
Hand hygiene
o Wash basins
o Hand-washing procedure
o Frequency of hand-washing
o Thorough washing of hands after dirty jobs or situations
o Basic hand-washing before clean jobs
o Point-of-contact hygiene
o Additional rules
Clothing hygiene
Cleanliness of boots and/or shoes
Cleanliness of material: the clean-up plan
General principles
o Applying the five wives and one husband method
o Cleanliness of tools during production
Prevention of chemical and physical contamination
o Physical contamination
o Chemical contamination
Prevention of contamination during packaging
Box 4 (Heading 1.5): Hot and cold technology and the formulation of foods
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The fourth box regroups the modes of preventing microbiological risks based on the
management of measurable parameters, the characteristics of hot and cold technology, and the
formulation of foods. Other methods of decontamination (ultra-high pressure, ionization, etc.)
that have measurable physical parameters may also be taken into consideration. In practice, they
correspond to the same rationale as temperature or the formulation of food, but almost never
intervene in the technologies applied by small and mid-sized businesses. For this reason, we
chose not to include them in this guide to good practice intended for use by those food business.
The preventive measures found in the fourth box of the “Comprehensive Hygiene Management
Method” for Food Businesses aim primarily to prevent the multiplication or survival of the
biological agents that are responsible for the alteration of foodstuffs or food poisoning [29]
(bacteria, yeasts, mold). Parasites [27] are a group of biological agents whose control can be
insured by thermal treatments: the destruction of the larvae of certain worms (trichinae,
cysticercus) by freezing raw meats [44] or eliminating encysted forms of protozoa (toxoplasmas)
by thoroughly cooking the foods that could be carrying them (meats and vegetables).
The agents responsible for physical and chemical dangers present a different profile and do not
correspond to the same control methods because they are inert and therefore not endowed with
the power to multiply or survive. Dissimilar from biological agents, as we have seen above, the
degree of their physical presence does not depend on the physicochemical parameters of the
cultured environment of a foodstuff or on the treatments that it undergoes.
It should be remembered that the interference of these two undesirable phenomena (the multiplication
and/or survival of germs in food) can be prevented by monitoring the parameters they depend on. To that
effect, the values of these parameters must be kept at a level unfavorable to their occurrence.
Implementing this type of monitoring of measurable values at certain steps in a manufacturing process, in
order to prevent biological agents from multiplying or surviving, amounts to establishing a CCP.
Following the implementation of GMP/GHP, the appropriate control points for the HACCP method
should be drawn from this fourth box, containing the critical physicochemical parameters of biological
agents’ multiplication and/or survival.
The labeling designed to inform the consumer on the formulation of food was added to this first part of
the manual as well as additional information such as manufacturing batch numbers. Since these batch
numbers represent the products entry point in the traceability system, the inclusion of this notion in this
part of the guide of implementation appears logical.
Regarding chemical contaminants, it must be noted that phases of dilution or concentration intervening in
the manufacturing process of liquid foods can cause variations in the finished product concentration. As
an exception a non-biological danger depends in rare occurrences on a parameter and can necessitate the
institution of a CCP.
The list and organization of the points addressed in this fourth box are as follow:
-
Cold chain technology
o Chilling
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-
-
o Refrigerated transport vehicles
o Quick chilling
o Storage of chilled/frozen food
o defrosting
Heat processing technology
o Rules suitable for cooking
o Suitable rules common to pasteurization and canning
Control by food formulation composition
o Labeling
o Traceability
o Withdrawal and/or recall procedures
- Box 5 (title 1.6): Finish products analysis – Own checks
Based on the principle that this guide is intended to be used in the countries of the whole African
continent, while its first version was published for the ASEAN countries, we have left out the regulatory
section on mandatory sampling plan which vary from one country to the other in a given area. We also
chose to use very simple notions of microbiology so that the information given by the laboratory is
understandable to FB operators who are a part of the audience for which this implementation guide is
destined to.
We have chosen to emphasize own checks’ general principles and ongoing objectives of finish products
analyses. It should be recalled that the self-checking approach is aimed at verifying the efficacy of the
FSMS (or HACCP plan) set up in a FB, given that the effectiveness of its implementation has previously
been verified.
In fact, it amounts to a verification process because even though microbiological analyses are done on
food samples, the time elapsed before obtaining their results (from 2 to 5 days) is such that , especially
when working with fresh products , it is not possible to wait for these results before continuing
manufacturing or putting the manufactured batches in the distribution system. Postponing shipment of
these batches would involve storing them while waiting for the results, therefore risking an adulteration
induced by a failure of the preservation means utilized, which could cause food poisoning. Storage might
also cause the loss of qualities associated with freshness sought by consumers. Consequently unfavorable
results must, under these conditions, lead FB managers, to question the effectiveness of the
implementation of their FSMS (or of their HACCP system) and its efficiency. As a result, they should
then improve its design or its implementation.
Similarly, microbiological controls of equipment surfaces and tools are presented as a way to verify the
effectiveness and efficiency of the cleaning plan. Unfavorable results from the analysis of surfaces will
not lead to taking action on the products being manufactured at the time of the sampling but to improving
the design of the cleaning plan as well as the modalities of its implementation.
In the fifth box, additional information is also given on the criteria of consistency to be respected by the
results of microbiological analysis and on the interpretation of the flora whose presence is usually the
object of the most scrutiny. Possible hygiene failures during the manufacturing process are also presented.
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The list and organization of the points addressed in this fifth box are as follow:
-
Products
Surfaces
Interpretation of the flora
o Total aerobic mesophilic flora
o Total coliforms
o Faecal coliforms
o Staphylococcus aureus
o Clostridium perfringens (anaerobic sulphite reducing bacteria)
o Salmonellae
The fact that the agents (biological, chemical, and often physical) at the origin of food-related
accidents that GHP/GMPs are designed to fight are invisible and therefore non-observable to the
naked eye implies that hygiene practices are by essence blind practices. Because operators lack
visual control of good practice and successful food safety management procedures as a resource,
they must be trained in this skill, particularly for those involved in production or cleaning.
Indeed, how can blind procedures be implemented and remain efficient in the long term if they
are not properly explained and understood?
Conveying this skill to operators, at a level of complexity suitable to one’s level, function, or task
is the core issue of the training policy for FBs. For this reason , the main practical aspects of the
implementation of a food hygiene training plan in a FB are therefore concisely presented to the
users of this guide.
o 3.2 The second chapter of the guide: the HACCP study
Before presenting the second chapter of the guide to implementing the “Guidelines to the
HACCP, GMP and GHP for the SME of the ASEAN,” we must present the logic that subtends
the HACCP method in simple terms.
The only version of the HACCP method that is referenced in this guide to implementation is the
official version in the Codex Alimentarius. Consequently, in order to use this guide, whose goal
is to facilitate either the implementation of the HACCP by the managers of FB or its evaluation
by inspectors or auditors, the document in the Codex [10] must be available for consultation in
tandem with the guide. For some stages of production, emphasis is place on the practical aspects
of implementing the HACCP on-the-job that are not found in the Codex reference document.
The production of foods, even by professionals, has always been an activity characterized by
empirical practice where recourse to the management of quantifiable values during the
production process has been excluded most of the time. A few rare traditional production
processes, however, have made use of these values: the control of the dehydration of cured hams
by following the progressive decrease in their weight, and the measurement of the acidity in milk
curds in the cheese industry. In these traditional technologies, reaching the desired value within
these parameters (a weight loss of 19% for hams and a pH value of ≤4.5 for milk curds)
represented a green light that enabled production to proceed to the next stages of the
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manufacturing process: maturation and ripening, for the two examples cited. The control and
management of such parameters represented the first signs of applying the principles of the
HACCP even before the method was conceived per se.
The originality and innovative nature of the HACCP allows the same principle to be applied by
extension to the greatest number of food productions: the HACCP method defines secure
production conditions that preventively protect against food-related accidents, based on the
choice and management of a range of values applied to specific physicochemical parameters that
are considered critical. In the context of our early work on the HACCP method, we used the
French word “crucial” to translate the English adjective “critical,” which seemed to be the correct
choice. Since then, however, common usage has established the more generalized use of the
adjective “critique” in French: we also use the word in this sense, although it seems less relevant
to our context and only adds yet another Anglicism to the French vocabulary.
By basing food safety on the management of critical parameters, the HACCP method introduces
specific logical aspects that are particular to an experimental method into the more empirical
modes of traditional food production: it defines safe and secure production conditions in relation
to food-related accidents (economic or health-related) based on quantifiable numeric values that
are considered critical. On the basis of these values, the method demands and insures that the
established conditions for health safety have been met. In the case of failure, when the goal of
managing and controlling these values has not been attained the HACCP imposes the application
of corrective action on both the questionable batch of foodstuffs and the entire system of
production in order to restore a normative level of management of food-related risks and avoid
any repetition of the same shortcomings in future batches.
The presentation of the HACCP method is structured according to the following components:
- General remarks on the method
• The double objective
o Risk analysis
o Management of critical control points
The seven principles (as specified in the Codex Alimentarius reference document: Hazard
analysis and critical control point (HACCP) system and guidelines for its application - Appendix
to the CAC/RCP 1-1969, revision 4 (2003)
Table of the seven principles of the HACCP
Principles
1 - Conduct a hazard analysis
Remarks
a - Identify the dangers associated with a food production,
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2 – Determine the Critical
Control Points (CCPs)
3 – Establish critical limit(s)
4 – Establish a system to
monitor control of the CCP
5 – Establish the corrective
action to be taken when
monitoring indicates that a
particular CCP is not under
control
6 – Establish procedures for
verification to confirm that the
HACCP system is working
effectively.
7 – Establish documentation
concerning all procedures and
records appropriate to these
principles and their application
at all the stages of this one
b - Evaluate the probability of appearance of these dangers
c - Identify the necessary preventive measures
Determine the Critical Control Points of these dangers
Critical Control Point = CCP
Establish operational criteria (limiting values, target levels,
tolerances)
Establish a monitoring system allowing to make sure of the
real and effective control of the CCP(s)
Establish by advance the corrective action to be taken when
monitoring indicates that a particular CCP is not (or no
more) under control
Establish specific procedures for verification to confirm that
the HACCP system is working really and efficiently.
Establish documentation concerning all procedures and
records appropriate to these principles and their application
- The twelve steps
- the HACCP study (steps 1 to 8 of the method)
- the HACCP plan (steps 9 to 12 of the method presented in Chapter Three of the
guide to implementation)
These twelve steps represent the practical approach to be taken in order to implement the
HACCP method in a business or to evaluate its implementation, which is the responsibility of
inspectors or auditors. Throughout this guide to implementation, specific critical or
problematic points for implementing the twelve steps are in a box and flagged in the margin
of the page as “REMARK,” “IMPORTANT,” or “PRACTICAL ASPECTS.”
- The HACCP study
In order to understand the rationale of this method, we must keep in mind that it combines the
principles of quality control with those of food safety. From this point of view, the first three
steps mainly have to do with the quality technician’s level of competency, while the next five
steps (steps 4-8) concern the technologist or food hygienist. Consequently, the four basic
principles of the quality program:
• State what is to be done
• Write it out
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• Do it effectively
• Prove that it has been done
The following overview tables that present the first eight steps of the HACCP method
summarize the organization adopted in writing the application guide, which easily matches the
organization of the Codex Alimentarius:
Tables of the first eight steps of the HACCP method
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120
121
122
The only difference between the presentation of the HACCP method and the Codex method
concerns steps 6 and 7. In fact, the alternative method for determining CCP that we propose is
a complement to the Codex Decision Tree. Although this new method does not appear in the
Codex, it corresponds nevertheless to its principles when the Codex suggests recourse to an
equivalent alternative method in the case of failure in applying the decision tree [step 7): “The
Decision Tree is not applicable to all situations. Other methods may be used.” The alternative
method that we are proposing takes into account aspects of analysis presented by the Codex in
steps 6 and 7 by synthesizing them in a kind of fusion.
In the guide, emphasis is put on the need to conduct an HACCP study in the most thorough
and precise way possible, allowing for the best possible knowledge of the inherent risks of
food production. It is a known fact that one can easily and efficiently control only what one
has already described and analyzed accurately. Compliance with this condition is therefore
crucial to the conception and application of a FSMS that is both simple and effective.
o 3.3 The third chapter of the guide: HACCP plan
This second part of the HACCP method (devoted to the HACCP plan), is based on tables
summarizing and synthesizing steps 9 to 12, that specify that was chosen in drafting the
application guide. This way of organizing the presentation of the HACCP plan easily overlaps
with that of the Codex Alimentarius.
123
Tables of the last four steps of the HACCP method
124
125
o 3.4 The fourth chapter of the Guide: Audit grids for GMP/GHP and the HACCP
•
3.4.1 Characteristics of the audit grids
The final part of the guide to application introduces audit grids that allow FB managers to do a
self-evaluation of the FSMS that has been set up for their business. These grids may also be used
by inspectors representing the competent authorities or auditors who are called in by certifying
bodies to conduct their assignments.
We prefer to use the term “audit grid” instead of “check list” because the scorecards that we have
devised may be read either vertically or horizontally. In fact, assuming that the inspection or
audit of an FB must include both a physical and a documentary component, it was clearly to us
that use of a single document (instead of two), taking both these aspects into account, would be a
practical advantage for professionals.
•
3.4.2 Format of audit grids
Format of audit grids
126
This choice determines the organizational design adopted for the construction of these audit grids:
•
A general structure consisting of two main vertical columns:
- the left column shows the list of physical criteria to be controlled
- the right column shows the list of elements that comprise the FSMS as a documentary tool.
•
A vertical correspondence between the elements of the two columns.
o 3.5 Numerical expression of the observations made using audit grids
Each time that the satisfaction of a physical criterion requires a specific document, the two
elements are juxtaposed on the same horizontal line in both lists. This arrangement offers the
possibility of a horizontal reading across the audit grids and the conduct of a combined physical
and documentary inspection or audit.
We suggest a five-point rating scale for each criterion for evaluation that appears on the audit
grid:
• satisfactory (sa): when the criterion for evaluation in question completely respects the
hygienic or regulatory requirements or those established by use
• acceptable (ac): when respect for hygienic or regulatory requirements or those established
by use is incomplete and must be reinforced before attaining compliance
• non-satisfactory (ns): when hygienic or regulatory requirements or those established by
use have not been correctly taken into account with respect to the criterion for evaluation
in question
• absent (ab): when the requirements for hygienic or regulatory requirements or those
established by use have in no way been taken into account with respect to the criterion for
evaluation in question
• not applicable (n/a): when the criterion for evaluation suggested by the audit grid does
not apply to the type of FB under consideration. This would be the case, for instance, for
the evaluation of compliance with standard heat treatment in the context of a meat cutting
establishment where this type of technology does not apply.
Practically speaking, the scale can be converted to numeric values, allowing a “ranked average”
to be given to the FB that covers all evaluated criteria, with the exception of those that are “not
applicable.” By using this conversion, the manager of an FB may easily obtain a comprehensive
positive or negative evaluation of his establishment by applying the following equivalencies:
• satisfactory = +3
127
• acceptable = +1
• non-satisfactory = -1
• absent = -3
The values +2 and -2 have been discarded in favor of values +3 and -3 to avoid introducing a
double interval on the scale above and below zero, which would concentrate the averages
obtained toward that interval, making them statistically less indicative for professional.
The audit grids in the guide are preceded by explanatory sheets that specify the significance of
each point included in the management procedure. In fact, each point on these grids must be
understood and documented in the same way by different users in order for the observations
made by different inspectors/auditors to be compared and used statistically.
To respect the concept of consecutive phases in designing and implementing a FSMS for an FB,
the audit system we suggest in the guide to application includes several grids:
- grid 1/4: “Assessment of the implementation of the prerequisites”
- grid 2/4: “Assessment of the phase of preliminary HACCP study”
- grid 3/4: “Evaluation of the implemented HACCP plan”
- grid 4/4: Routine evaluation of the real and effective implementation of an HACCP
plan in the company
•
This set of grids may also be used by FB management as an overarching plan for setting up their
FSMS. To do so, we do not recommend checking and implementing the requirements of a grid
until at least 80% of the relevant points on the previous grid have yet been satisfied
It is also possible to calculate an average of the total point values that are applicable to a business
by using one or several audit grids to estimate if the 80% conformity level has been reached.
This level has been attained when there is an average calculated value of at least 1.8.
This value of 1.8% equivalent to a conformity level of 80%is obtained through the following
formula (6 x 0,8)-3 = 1,8
It must be remembered that this value of 80% is also taken as the criterion for certification
granting relative to the “Reference framework for harmonization of the management the food
hygiene in Africa” presented in chapter 4 of this thesis. The FB compliance with the
requirements of this reference framework must be evaluated using the audit grids in the
“Guidelines on the application of GMP, and HACCP”, as the two documents represent the two
parts of a comprehensive documentary set.
128
Grid 4/4 relative to the routine evaluation of the FSMS can only be utilized after a few weeks of
effective operation of this control plan in a food business. This grid only takes into account a
limited number of criteria essential to the evaluation of the effectiveness and efficiency of the
FSMS that has been implemented. Consequently, it can be used periodically and frequently
(weekly, monthly, quarterly), since it only entails a relatively short period of time. Because the
first part of this grid is devoted to the pre-requisites of the HACCP (or GHP/GMP), it can also be
used by businesses where the FSMS is limited to the implementation of these good practices.
If the routine evaluation based on grid 4/4 yields satisfactory results, the verification process can
be interrupted. If, on the contrary, the results are not satisfactory, the audit must be conducted
more completely in several subsequent stages.
•
Step 1: verification of the effectiveness of implementing the FSMS.
•
Step 2: if the implementation of the FSMS has proven effective but
inefficient, the relevance of the preventive measures implemented by
means of the HACCP evaluation grid ¾ and of the pre-requisites
(GHP/GMP) evaluation grid ¼ must be reviewed. If the FSMS is based
only on the implementation of pre-requisites, their relevance must be
reviewed using only the evaluation grid ¼ for the implementation of
prerequisites.
•
Step 3: if evaluation grid ¾ of the HACCP plan does not yield
satisfactory results, it is necessary to go back to grid 2/4 for evaluating the
preliminary phase of the HACCP study and refine or correct the
conclusion of the preliminary study.
This retroactive feedback makes it possible for FBs to maintain a cycle of permanent evaluation and
improvement of the FSMS.
Conclusions:
By helping to draft, implement and evaluate FSMS in SMEs, the guide of implementation “Guidelines on
HACCP, GMP and GHP for ASEAN Food SMEs” is a handbook for use by FB managers as well as
inspectors or auditors. For greater efficiency, after presenting the HACCP method in a practical light, and
pursuant to the pre-requisites indispensable to its implementation, this guide offers a set of audit grids that
enable FB managers to evaluate FSMS in their workplace, and inspectors or auditors to successfully carry
out their inspection or audit assignments.
129
130
Overall conclusion
131
The overarching objective of this thesis paper is to describe and explain two innovative methods
for facilitating the implementation of the Codex Alimentarius prerequisites: the “Comprehensive
Hygiene Management Method for FBs” and the “Alternative Method to the Codex Alimentarius
Decision Tree for determining CCPs.”
Faced with the complicated organization and difficulty of applying the Codex Alimentarius’
standards, professionals involved in managing FBs or assigned to inspect or audit these
businesses, especially in developing countries, are constantly expressing the need for ways to
simplify and facilitate the application of these standards. These two innovative methods, aimed
not only at conceiving but also at evaluating food safety management systems (GMP/GHP
associated or not with HACCP) have been designed with that goal in mind. With the knowledge
that our methods are being used optimally in different parts of the world (by the ASEAN, in the
African Union and some EU countries), we are now fully confident that our original goal has
been met.
These favorable results are directly related to the choice of applying different way of thinking to
resolve the problems confronting the FBs. We are deeply convinced that the effort to think
“differently,” as we have done in establishing these two methods is one of the most productive
approaches possible to solving a problem, even if this is usually not the easiest road to success.
To design and develop these new methods, we have adopted an original approach that uses an
innovative but validated scheme as the basis for describing the mechanisms through which foodrelated accidents appear, with relevance to either health or economic issues. This new way of
apprehending food safety enabled us to develop a concept to the benefit of food sector
professionals through which the same set of preventive measures allows different types of food
accidents, (related either to health or economic issues) to be avoided.
These two innovative methods facilitating the implementation of the Codex prerequisites are
based on the rationale of this scheme describing the occurrence mechanism of food accidents.
The transposition of these two methods is reflected in the publication of practical handbooks for
their use by professionals involved in either production or inspection/audits.
Two of these documents are presented in this thesis paper as practical examples of how these
method for facilitation may be easily transposed: the application guide ”Guidelines on HACCP,
GMP and GHP for ASEAN Food SMEs” originally intended for use by ASEAN food SMEs and the
“Reference framework for harmonization of the management the food hygiene in Africa.”
As concrete examples, we then present three field mission reports, all conducted using the
“alternative method to the Codex decision tree:” the study and improvement of the
microbiological quality of “Espelette chili powder;” the evaluation and improvement of an
FSMS used by an African SME producing cooked, dried, and smoked fish; and the study and
prevention of the transmission of cholera by food consumption in rural areas of Haiti. The
mission in Haiti allowed us to demonstrate that the “Alternative Method,” originally intended for
use by food businesses, could also be successfully applied to the analysis of risks and the
identification of provisions for controlling a contagious epidemic disease transmitted by food
consumption.
132
Among recent success stories that validate our work, the African Union Organization officially
adopted (January 2011) the “Reference framework for harmonization of the management the
food hygiene in Africa” for use as a general food safety standard for the exchange of foodstuffs
between its member states. Since then, as a further step in the approach to integrating food safety
measures, eight of the Member States of the African Union representing the ECOWAS
(Economic Community Of West African States) have decided to upgrade the Reference
framework from a voluntary standard for use to the status of a uniform regulation applicable to
exchanges of all types of foodstuffs.
These two facilitation methods have now proven their multifaceted utility through the variety of
problematics (technological, sanitary, medical emergency) to which they have been successfully
juxtaposed in many countries (Europe, Asia, Africa, and the Caribbean): in each and every
situation in the field, their applicability was proven possible. With new opportunities to
collaborate with other partners, the future will tell if their range of application can be expanded
even farther.
133
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138
APPENDICES
Appendix 1
The “Reference Framework for Harmonization of the
Management of Food Hygiene in Africa”
for Rural
RuralEconomy
Economy
AUCDepartment
Department for
Department for Rural Economy
& Agriculture
& Agriculture
& Agriculture
ORGANISATION AND IMPLEMENTATION OF FOOD SECURITY TRAINING ACTIVITIES IN AFRICA
ORGANISATION AND IMPLEMENTATION OF FOOD SECURITY TRAINING ACTIVITIES IN AFRICA
SANCO/D3/2008/SI2.514845
SANCO/D3/2008/SI2.514845
Better Training for Safer Food in Africa (BTSF)
REFERENCE FRAMEWORK
FOR HARMONIZATION OF THE MANAGEMENT
OF THE FOOD HYGIENE IN AFRICA:
Meilleure
Meilleure Formation
Formation Pour
Pour Des
Des Aliments
Aliments Plus
Plus Sains
Sains (BTSF)
(BTSF) Afrique
Afrique
27 August 2010
L’Harmonisation
L’Harmonisation de
de l’Inspection
l’Inspection en
en
Hygiène
Hygiène Alimentaire
Alimentaire en
en Afrique
Afrique
25
25 janvier
janvier 2010
2010
Reference Le
Le Référentiel
Référentiel
framework
Ce document
est le reflet
opinions
et ne peut être
comme reflétant les
This document
represents
of thedes
opinions
ofdu
theConsultant
stakeholders/authors
andconsidéré
not
Ce document
est le reflet
des
opinions
du
Consultant
et ne peut être
considéré
comme reflétant les
vues de la Commission Européenne ou celle de la Commission de l’Union Africaine
de la Commission
ou of
celle
la Commission
of the Europeanvues
Commission
or of theEuropéenne
Commission
thedeAfrican
Union. de l’Union Africaine
AGRICONSULTING EUROPE S.A.
AGRICONSULTING EUROPE
AGRICONSULTING
EUROPE S.A.
S.A.
REFERENCE FRAMEWORK FOR HARMONIZATION OF THE MANAGEMENT OF THE FOOD HYGIENE IN AFRICA
A
CONTENTS
1. Context
7
2. Development of the reference framework 7
3. Objectives
8
4. Field of application of the reference framework 8
4.1.
4.2.
4.3.
Hygiene of production
Controls
Establishments
8
9
9
5. Definitions 10
6. General principles of hygiene of the foodstuffs
11
6.1.
Supply water and energy
11
6.2.Requirements relating to the establishment, the general organization, 11
the construction and the maintenance of an establishment, its buildings and
equipment
6.3.
Operations and personnel 11
6.4
Climatic conditions 11
6.5.
Water
11
6.6.
Packaging
11
6.7.
Traceability and eligibility of the raw materials and intermediate products 12
6.8.
Processes of preservation
12
6.9.Checking of the efficiency and the effectiveness of measurements 12
of control/management of hygiene and risks
6.10.
Staff training 12
6.11.Control of the application of the reference framework, granting 12
approval, application of the health mark and issuing of certifications
6.12.Hygienic control of the importation of the foodstuffs originating or 12
coming from countries outside africa (and intended for the approved
establishments)
6.13.
Internal and external information systems
13
6.14.
Guide to application of the reference framwork 13
6.15.Monitoring of the application of the reference framework and 13
resolution of conflicts
BTSF AFRICA
| 3
REFERENCE FRAMEWORK FOR HARMONIZATION OF THE MANAGEMENT OF THE FOOD HYGIENE IN AFRICA
6.16.
Revision
13
7. Particular provisions 13
Appendix 1: r equirements relating to the establishments
and the operators of the food sector
14
8. Identification and recording of the establishments
14
9. Conformity of the buildings 14
9.1.
9.1.1.
9.1.2.
9.1.3.
9.1.4.
General principles.
14
Environment, location of establishment.
Supply of water and energy
Structure of the establishment Supply potable water
14
14
14
15
9.2.
Rules of construction 9.3.
Conformity of the material and the equipment
9.4.
Sanitary facilities. 9.5.
Maintenance (preventive and corrective)
9.6.
Storage of the chemical substances
9.7.
Pest control plan 9.8.Passive controls, maintenance of the accesses and the additional buildings
9.9.
Active controls 9.9.1
9.9.2
9.9.3.
9.9.4.
Detection of the vermin
Plan for vermin extermination Plan for insect control Chemical substances used in the control of the vermin:
10. Suppliers and controls a reception
10.1.
10.1.1.
10.1.2.
10.1.3.
10.2.
15
16
17
17
17
18
18
18
18
18
19
19
19
Suppliers
19
Raw materials specifications Preferential choice of suppliers
Preferential choice of the suppliers following a visit to their production facilities 19
20
20
Implimentation of controls at reception
20
10.2.1. Control sheets atreception
10.2.2. Organoleptic criteria
10.2.3. Control temperature of the products at reception
10.2.4. Other essential criteria
10.2.5.Recieving (into storage) procedures for raw materials following delivery checks and initial decontamination operations
10.2.6. Procedures for rejection
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20
20
20
21
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11. Personnel hygiene policy 21
12. Hand hygiene
22
12.1.
12.2.
12.3.
12.4.
12.5.
12.6.
12.7.
12.8.
12.8.1.
12.8.2.
Wash-hand basins
22
Hand washing procedures
22
Frequency of hand washing 22
Complete washing of the hands after the operations or dirty situations 23
Quick washing of the hands before the clean operations
23
Hygiene of the points of contact
23
Additional rules
23
Work clothes hygiene
23
Rules for work clothes
The hygiene of the boots and/or the shoes
23
24
13. Premises hygiene cleaning plan
24
13.1.
13.2.
General principles
Cleanliness of the tools during production
24
25
14. Hot and cold technologies and product formulation. 25
14.1.
14.1.1.
14.1.2.
14.1.3.
14.1.4.
14.1.5.
14.2.
14.2.1.
14.2.2.
14.3.
14.4.
14.4.1
14.4.2.
14.4.3
Cold technologies 25
Refrigeration
Refrigerated transport vehicles Rapid cooling and chilling Freezing
Defrosting.. 25
26
26
26
27
Hot technologies
27
Rules suitable for cooking
Rules common to pasteurization and canning
27
28
Product formulation Labelling, traceability, procedures for withdrawal (or of recall) 28
29
Labelling Traceability Procedures for withdrawal (or of recall)
29
29
29
15. Self-checking auto controls 15.1.
15.2.
15.3.
15.4.
General principles
Self-checking of the products
Self-checkings of surfaces
Staff training BTSF AFRICA
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30
30
30
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REFERENCE FRAMEWORK FOR HARMONIZATION OF THE MANAGEMENT OF THE FOOD HYGIENE IN AFRICA
16.Requirements for “the evaluation of routine” of 30
the implementation of the good hhygienic practices
(ghp) and of good manufacturing practice (gmp)
17. Requirements relating to the functional check of 32
the procedures of traceability and withdrawal (or recall)
of food products which can present a risk for the
consumer 17.1.
17.2.
17.3.
Traceability
Withdrawal/recall Labelling requirements 32
32
32
18. The food safety management plan (fsmp) and the implementation of the haccp system
32
Appendix 2: requirements for the identification and 32
approval of establishments by the competent authority
19. General principles 32
19.1. Obligations applicable to the officials responsible for controls
32
19.2.
Obligations relating to the implimentation of the tasks of official control33
19.3.
Information systems 33
19.3.1
19.3.2.
Internal External
33
34
20. Rules for the granting of certification 34
21. Use of the fund generated by certification (fees)
34
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1. Context
Food safety is one of the components of the policy of regional integration in Africa. To facilitate the
exchange of safe foodstuffs between African states will contribute to the achievement of this objective.
However, to reach that point it is advisable to define and harmonise a food safety reference framework
(together with the obligations applicable to the manufacturers/producers of foodstuffs), as well as a set
of procedures allowing for mutual recognition between African states of the food safety guarantees
offered by the establishments engaged in trade in foodstuffs.
This initiative for a Reference Framework is registered as one of the actions of the joint partnership
between Africa and Europe concluded at the Summit of Heads of State and governments of the African
Union and the European Union in December 2007 in Lisbon.
It was conducted jointly by the European Union (Directorate-General Health and Consumers - DG
SANCO) and the Commission of the African Union (Department of the Rural Economy and Agriculture
- DREA) in close cooperation with the Regional Economic Communities, the African states and the
technical Organizations concerned.
It is intended to promote a public-private partnership as regards safety of food, making it possible to
reaffirm the central role of the Central Competent Authorities, and to encourage the operators to
increase their level of compliance with the international standards on the safety of food in Africa.
2. Development of the reference framework.
this reference framework, developed within the framework of the program “Better Training For
Safer Food - BTSF- Africa “ financed by the European Union, was inspired by original similar work
of Dr. Richard Bonne and Mr. Franck Boccas, carried out within the framework of a program CEN/
ASEAN (European Committee for Standardization/ Association of the States of the South East Asian)
financed by the European Union. This work, based on the requirements of the Joint FAO/WHO Codex
Alimentarius Recommended International Code of Practice, General Principles of Food Hygiene, allows
for recognition of this reference framework for the purpose of compliance with the SPS Agreement and
international recommendations and facilitates the teaching and application of the International standards.
It was elaborated in the process of 10 subregional work-shops [1] which included all the African States
and the Regional Economic Communities (RECs) under the joint coordination of the Commission of
the African Union and the Commission of the European Union. These workshops closely associated
representatives of the Competent Authorities of the African States, the RECs, leaders/managers of
food processing enterprises and representatives of Consumer Organisations of African countries.
Representatives of the international organizations such as the WHO, the FAO, Codex Alimentarius,
UNIDO, ARSO, AVA, etc, also took part in the workshops and actively contributed to the development
of the Framework. This broad participation was aimed at a Pan-African consultation and the support of
the relevant international organizations in order to take into account specific regional issues, contribute
to the process in so far as they did not contradict the objectives of protection of the health of the
consumer, and to take into account their views on the developments necessary.
The practical application of this reference framework was tested through use of a guide
especially developed for this purpose and other original tools (grid of inspection and
an alternative to the decision tree method of the Codex HACCP System) during the 5
regional workshops.
1A
ccra (Ghana, July 6, 2009), Brazzaville (Congo, 21 September 25, 2009), Cairo (Egypt, 18-22 October 2009), Johannesburg (South
Africa, 23 November 27 2009), Lusaka (Zambia, 7-11 December 2009).
2D
ouala (Cameroun, 22 February 26, 2010), Casablanca (Morocco, 15 March 19, 2010), Kampala (Uganda, 19 April 23, 2010), Bamako
(Mali, 24 May 28, 2010) and Lilongwe (Malawi, 14 June 18, 2010).
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3. Objectives
In a more general way the objectives of these workshops were:
To train trainers in the understanding of The Recommended International Code Of Practice,General
Principles Of Food Hygiene (CAC/RCP 1-1969, rev. 4-2003) Alimentarius Codex and the application of
the related HACCP system;
b) To develop a harmonized understanding of the standard and methods of inspection by the Central
Competent Authorities and the operators in Africa;
c) To train trainers in the application of the harmonized methods of inspection/audit of application of
this reference framework;
D) To promote this reference framework throughout Africa for the development of an official system
of certification, intended for all the food industry on the continent;
E) To initiate mechanisms of official harmonised certification of food hygiene, as a first step towards the
integration of safety systems for food on the continent.
In order to achieve these goals, the participants were invited:
a) To reach an agreement on a technical reference framework to be used by the Competent Authorities
of the African States and agri-food business operators for the inspection of food hygiene and the
certification of the food companies respecting the Good Hygienic Practices (GHP) and Good
Manufacturing Practice (GMP) insofar as they are relevant to food hygiene.
b) To participate in simulation exercises and visits to establishments to practice the application of this
reference framework, to strengthen their understanding of the methods of inspection and to learn
the lessons necessary to modify the reference framework with a view to its future application and to
improve the safety of food and the protection of the consumer.
c) To reach an agreement on the rules that the Competent Authorities of the African States would use
for the propsosed system of certification as a starting point for a mechanism of mutual recognition.
4. Field of application of the reference framework
On the one hand this reference framework harmonizes the hygienic conditions for the production of
foodstuffs to apply in agri-food establishments. On the other hand it harmonizes the controls of these
conditions by the Competent Authorities. It is aimed primarily at establishments in the food sector
which market their food products (partially or totally) in one or more African states, provided the
countries concerned have adopted this reference framework in their legislation.
4.1. The conditions of hygienic production
This reference framework concentrates on the application of the Good Hygienic Practice (GHP) in the
production of the foodstuffs. It is however recommended to supplement the GHP by the implementation
of control plans based on principles of HACCP when the control of the critical points can be identified
and controlled. In addition it is useful to supplement the reference framework by the use of the the
guide to its application (Guidelines to the Application of GMP, GHP and HACCP) and the use of the
guide by the operators and by Competent Authorities during official controls is strongly recommended.
This very technical guide presents an alternative approach to the decision tree of the HACCP system
which allows a fast evaluation (in particular by the controlling authorities) of the relevance of the food
hygiene control plans in the agro-food sector. It does not apply to the other aspects which contribute to
the quality of these food products. However, concerning the quality of food (other than the food safety
component), it is obvious that food products of bad quality or badly preserved or with a very short shelf
life will be unsaleable or inedible thus leading to malnutrition or insufficient daily rations. It thus rests
with the governments of the African states, if they do not already do so, to implement other compulsory
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legal systems to promote the quality of the foodstuffs, their labelling, their nutritional composition, the
standards to which they must correspond, the definitions of “niche” products, or organic agriculture
etc, and with the professional organizations to structure the market, to segment it if need be, and to
enact guides to Good Manufacturing Practice (GMP). So this reference framework, based on GHP will
refer to the GMP only in measures which contribute, accompany, support, and supplement the Good
Hygienic Practices (GHP).
4.2. Controls
Although voluntary (indeed no company is obliged to market its products in a foreign country), the step
suggested is politically and economically very important in the context of food safety, regional integration,
the development of the trade between African states and the fight against poverty. Consequently the
control of the application of the reference framework will be carried out under the authority of the
competent official services. The establishment in conformity with this reference framework will be
certified for the exchanges of foodstuffs between African States. The removal of hygiene checks at
borders will reduce the customs formalities at border controls and thus improve the export trade. The
competent authorities will carry out controls in these establishments to ensure their compliance, using
methods such as audit, or inspection or any other means (evaluation, monitoring, taking of samples etc)
necessary to make their judgement. This approval will be demonstrates by a health mark affixed to
the packaging or wrapping of the food products and in the case of unwrapped meat (carcasses) by a
stamp with food grade ink. The characteristics of the Competent Authority as defined in this reference
framework, and in particular the necessary absence of conflict of interest between the officers in
charge of controls and the establishments controlled and certified, make it possible to consider, if it is
the wish of the governments of the African States, that certain tasks of controls may be delegated by
the Competent authority to third party organisations properly accredited to carry out such functions.
In addition, African countries and their food businesses are still often dependent on the importation
of certain raw materials, ingredients and materials used in wrapping/packing. The reference framework
allows for the future harmonisation of the sanitary arrangements for the importation of the foodstuffs
into Africa and control of such imported food products.
The objective of this harmonization is to make more fluid/simplify the exchanges of safe foodstuffs
within Africa, the reference framework allows for systems of mutual assistance and exchanges of
information between African states.
The Reference Framework also provides for the implementation of electronic systems of rapid alerts
and traceability for traded products. Finally the upstream and downstream traceability systems are
compulsory in the certified establishments to ensure the reliability of the system and rapid investigation
in the event of problems encountered in the traded products.
As this step of certification of the establishments is a conduit for the opening of market and reductions
of border controls as well as customs duties, [3] provided that such establoishments are in compliance
with other applicable regulations in the country of origin. (including national requirements as regards
hygienic safety of food higher than those of this reference framework, for example, official plans for the
monitoring chemical contaminants). These other provisions are in particular the rules concerning the
labour laws, laws relating to taxation, of consumption, the social right, the quality of food, the health and
welfare of animals. The persons in charge for these establishments must obviously pay to the National
Authority the fees necessary for the financing of the implementation of the system of control and
certification.
4.3. Establishments
This reference framework is not intended, initially, to be applied:
(1) to establishments whose products are destined exclusively for national market, except where they
provide their products wholly or in part to an establishment certified in accordance with this reference
framework, and
3 For certain countries, the social or religious obligations will have also to be taken into account to avoid certain
difficulties of application of the reference frame by the employees (for example the separation of the toilets men/women)
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(2) To retail establishments
(Including the private restaurants or private or public institutions catering for the public. However each
African state which regards this reference framework (wholly or partly, or even only its principles) as
necessary and relevant for any stage of the food production in its country can apply it to other areas of
the food business other than that to which it directly applies. Gradually this reference framework should
apply to all the establishments in the food sector not supplying directly to the final consumer (i.e. wholesale
trade, private restaurants). However it shall apply “mutatis mutandis” to large catering establishment and
to cutting/ processing operations attached to large supermarkets. Thus the establishments producing
only for the national market will be gradually targeted by this reference framework, for the purpose of
regional integration and to ensure an identical level of consumer protection and of fair competition in
trade on all the African territory.
It is important to note that the adoption of food legislation applicable to all the types of establishments
of the food sector without consideration of the means and the needs can encounter insurmountable
difficulties in implementation. This is likely to put at risk all credibility in the legislation and the ability
of the authority to implement it and ensure controls. Indeed, the fact that certain establishments
provide foodstuffs directly to the consumer for immediate consumption thus reducing the risks of food
poisoning due to the multiplication of pathogenic microorganisms potentially present (provided the such
establishments respect good hygienic practices and control specific risks) may allow them to be subjected
to less strict obligations. Strictly speaking in the Agri-food sector basic rules of hygiene contained within
this reference framework and adapted to the specific activity should be applied to avoid the inherent
risk of contamination and multiplication of microorganisms. The progressive application of this reference
framework to the operators in the Agri food industry is strongly recommended.
5. Definitions
For purposes of this reference frame, the definitions below apply.
Establishment: any building or area in which food is handled and the surroundings under the same
management.
Competent Authority: Means the Central authority of an African State competent to organise official
controls or any other Authority to which that central authority has delegated the aforementioned
competence. This definition includes, where appropriate, the corresponding authority of a third country.
Audit: The systematic and independent examition to determine whether activities and related results
comply with the planned arrangementsand whether these arrangements are implemented effectively
and are suitable to achieve the objectives.
Inspection: means the examination of any aspect of food, feed, or animal health and welfare in order
to verify that such aspect(s) comply with the legal requirements of food and feed law and animal
health and welfare rule .It includes the examination of establishments, their systems of management and
production, including the documentation, analysis of finished product, as well as origin of raw materials
and destination of finished products.
Traceability: capacity to trace and follow, through all the stages of the production, processing and the
distribution, a food, feed, or food producing animal or substance intended to be or expected to be
incorporated into a food or feed
Wrapping: the action to place a foodstuff in a wrapper or a container in direct contact with the food
product concerned and the wrapper or container itself.
Packing: the action of placing one or more wrapped foodstuffs in a second container and the latter the
container itself.
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Official control: any form of control that the competent authority for the verification of compliance with
food or feed lawand animal health and welfare rules.
Official certification: means the procedure by which competent authority or the control bodies
authorised to act in that capacity provide written or electronic or equivalen assurance concerning
compliance.
6. Principles general of hygiene of foodstuffs
6.1. Water and energy supply
The establishments must have a continuous supply of potable water and energy (gas, electricity, etc) and
if possible should be be located in zones of activity specific to food production.
6.2. Requirements relating to the establishment, the general organization, the construction and the
maintenance of the establishment the buildings and equipment
The location, the design of new facilities or buildings or the improvement of the facilities or buildings and
new or existing equipment must attempt to respect the principles relating to food hygiene and have as
the objective to prevent in an optimal way the contamination of the foodstuffs produced at all the stages
of their preparation from the raw material until the finished product, wrapped or unwrapped. Within
the framework of this prevention of the contaminantion and risks of the multiplication of undesirable
microorganisms, the following points cannot be ignored: the control of vermin, the implementation of a
pre-established cleaning plan and the verification of the cleanliness using appropriate techniques.
6.3. Operations and personnel
The operations of production, including the movements of the personnel, must be planned and carried
out, in time or space, with the objectives of protecting the foodstuffs, and in particular the foodstuffs most
exposed to contamination, (for example, unwrapped food products,) from any contamination during
each stage of production and to avoid recontamination of finished products. Within the framework
of this prevention of the contaminants and risks related to their multiplication the following points
are impossible to ignore: the implementation of Good Hygienic Practices (GHP) in the production
operations and a programme for the control of the contamination and/or multiplication by pathogenic
agents; the implementation of a personnel health policy and the control of the hygiene of the personnel.
6.4. Climatic Conditions
The influence of the climatic conditions (temperature, humidity), in particular for the countries in tropical
zones, must be taken into account in terms of risks of multiplication of the biological agents or conditions
supporting this multiplication. 6.5 Water
Water other than drinking water as defined in section 4.4.1 of the standard CAC/RCP 1-1969, REV, 4
(2003) may be used provided it will not represent a risk of direct contamination, immediate or deferred,
or contribute to the development of contaminating agents.
6.6. Packing
The Design of the packing/wrapping materials (first container of the food product) and the products
used in their manufacture must ensure an optimal protection of the products in order to effectively
reduce the possibility of contamination, to effectively prevent damage to the food and allow for labelling,
in particular that which is legally required, and information to inform operators and consumers on
preservation measures.
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6.7. Food Safety traceability and eligibility of the raw materials and intermediate products.
To achieve certification under this reference framework, the companies must set up a documented
food safey traceability system making it possible to identify without ambiguity suppliers of the various
foodstuffs, including the primary production sector, the ingredients, and the packaging material used in
the establishment. This documented system of food safety traceability must make it possible to identify
without ambiguity the destination of product dispatched from the establishment
Raw materials and intermediate products entering an establishment certified under this Reference
Framework should also be from an establishment certified in accordance with the Framwork and must
meet the conditions of the Reference Framework. Imported products must satisfy the same conditions
and offer the equivalent guarantees of compliance recognised by the Competent Authority and have
undergone veterinary and sanitary controls (national, regional, and subregional) as described in item 6.12
6.8. Processes of conservation.
The processes of conservation of the food (salting, fermentation, maturing, heat treatment /pasteurization,
sterilization, refrigeration,freezing) should not be included/understood as a means of stabilisation
or consolidation against biological contaminants their toxins or chemicals and are not intended to
compensate for failure to implement GHP or to remedy contamination already affecting the product.
However the Competent Authorities within the framework of official programs of control/eradication
of certain zoonotic diseases may accept certain processes/ treatments. (for example cold treatment of
horse/pig meat to prevent trichinose, heat treatment of eggs coming from farms infected with Salmonella,
pasteurization of cow’ s milk from herds contaminated by Mycobacterium Tuberculosis, etc.
6.9. V
erification of the effectiveness and efficiency of control measures and the management of hygiene
and hazards.
The measurement of the effectiveness of the good hygienic practices and the
contamination and multiplication of pathogens is a routine evaluation
measures to control
The measurement of the effectiveness of the good hygienic practice in the control of contamination and
multiplication by pathogens will be verified by sampling and analysis.
6.10. Staff training
Staff training must be carried out in order to control in an optimal way the risk of contamination and
multiplication of pathogens. Training should be carried out according to a plan and each operator and
supervisor should be trained in food hygiene to a level appropriate to the duties to which the operator
is assigned.
6.11. Control of the implementation of reference framework, of approval, (certification) application of
the health mark and issuing of health certificates.
The activities associated with the official controls of the implementation of the reference framework, the
granting of certification, application of the health mark and the issuing of the certification shall be carried
out by the Competent Authority of the African state on whose territory the establishment is suituated.
However some or all of these duties may be delegated by the Central Competent Authority to a third
party accredited by an accreditation agency recognised to the standard of EN 45011.
6.12 Control of foodstuffs imported from another African country or from countries outside Africa and
intended for use in a Certified establishment.
Foodstuffs coming from counties and/or establishments not applying the reference framework will have
to be subjected to a harmonized system of hygiene control defined by the Competent Authorities. This
control will be carried out at border inspection post or at the point of destination, under a customs
procedure approved by the Competent Authorities.
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6.13 Information systems internal and external
The Central Competent Authority, in charge of the control of the application of this reference framework,
must, by the introduction of an internal system of information management, have the capacity to identify
the establishment in a unique unequivocal and unambiguous way. This system will contain in addition to
relevant information concerning the establishments, the reports of the control activities carried out by
the competent authorities, the actions to be carried out and follow-up actions.
The Central Competent Authority in charge of monitoring the application of the Framework for
each country taking part in the process will provide to its partners (under a harmonized, defined, and
approved format) the information necessary for the identification and registration of the establishments
approved under the terms of the Framework.
Each Central Competent Authority will commit to participate in a network of mutual co-operation and
exchange of information with the Central Competent Authorities of the other African states, in particular
at the time of food safety problems encountered in an establishment certified under this reference
framework whose products have been or could be dispatched to other countries. This participation will
be done through systems of rapid exchange of information, food safety alerts and product traceability,
and in particular by the use of electronic certification of the foodstuffs exchanged and/or imported into
Africa, where such systems are available.
6.14. Guide application of the reference framework.
It is strongly recommended that this Framework together with the Guidelines to its application,
(Guidelines on the application of GMP, GHP, and HACCP) as approved by the African States, be used
by the management of Agri-food establishments and the official authorities in charge of the controls. It
is obligatory that the particular provisions described in the appendix to this Framework be respected.
6.15. Monitoring of the application of the reference frame and resolution of the conflicts.
The Regional Authority and/or Subregional Authorities are responsible for the supervision of the proper
and uniform application of this reference framework, mainly by the evaluation of the organization of the
competent authorities and their enforcement activities.
It is also the responsibility of the Regional Authorities or the Subregional Authorities to establish the
rules for the resolution of the conflicts between African states concerning the application of this
framework. This is particularly important in the event of a risk to public health, suspected or proven, so
that the protection measures taken by the African states in reaction to these threats are appropriate
and proportionate to the risks.
6.16. Revision
This reference framework and its appendices can be revised, in particular following an evaluation of its
application or to take account of the administrative changes and scientific and/or technological advances.
In particular the references to the Codex standards referred to in the reference framework should be
updated if these references are modified by the Codex procedure.
7. Particular provisions
The following provisions are applicable to this reference framework.
- Appendix 1 relating to the establishments and the operators in the food sector; and
- Appendix 2 relating to the recording and the certification of the establishments by the Competent
Authority.
The practical application of the provisions will be facilitated by the use of the guide developed to assist
in its application (Guidelines on the application of GHP, GMP and HACCP)
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Appendix 1: r equirements relating to the establishments
and the operators of the food sector
8. Identification and recording of the establishments
In order to satisfy the conditions necessary for a traceability system as well as the needs of the
Competent Authority in the management of its control function, the following details will be necessary
for the identification of the establishment.
g Name of the establishment. (And trade mark if it is different).
g Name of the legal person in charge.
g Name of the manager responsible for the ”food safety control plan”.
g Legal status of establishment (SA, limited liability company, etc).
g Complete address (postal or physical): n°, road, locality, city, administrative subdivision of location
(area, district, department, etc), country.
g Telephone, telefax, Internet address.
g Branch of activity in the Agri-food sector.
g Volume of activity (defined by: the volume of production, staff numbers, and other criteria retained
by the Competent Authority…).
g Current volume of export and countries of destination (for exporting establishments).
g Official registration no. (Trade register, national register of the companies, licence, etc).
9. Conformity of the buildings
The design of new buildings or the improvement of the existing buildings and equipment should the
respect of the following principles.
9.1. General principles.
9.1.1. Environment and site location.
The location of the establishment should not present sources of contamination constituting a threat
for the safety of food. It must in particular be free from:
g zones which are polluted or with industrial activities representing a potential sources of
contamination of food;
g Zones presenting a risk of air pollution;
g Zones prone to flooding;
g Zones which constiture a potential source of infestation by vermin;
g Zones where solids or liquid waste cannot be effectively removed;
Where the environmental conditions allow, a protection fence should be erected around the
establishment.
9.1.2. Supply of water and energy
The establishment must be provided with water and energy and the supply must be guaranteed by
the providers. Where possible, substitute sources (such as storage tanks and electrical generators) to
be used as necessary should be provided.
9.1.3. Structure of the establishment [4]
The structure of the establishment must respect of the following requirements.
The establishment should have at least four doors.
g A door for the entry of the raw materials.
g A door for the entry of the production personnel.
If the general organization of the establishment does not make it possible to satisfy both preceding principles,
separation in time rather than in space, of incompatible activities, constitute an acceptable alternative.. 4
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A door for the dispatch of the finished products.
A door for the disposal of waste.
A fifth door may be necessary in some establishment for the reception of wrapping and packaging
materials.
The onward flow ptinciple:
g The production operations should ensure a forward progression of the product, without back
return, from the lowest level of development to the highest, from the least hygienic condition to
the most hygienic, and from the least susceptible condition to the most susceptible. In order to
comply with this rule, the operators should not move around the production area but should
remain at the work station to which they are assigned.
Criss crossing of the products lines:
g Production lines should not cross each other. They can be connected (assembly of ingredients, in
a previously washed package) or split (lines of by-products obtained during the preparation of
the principal product)
The separation warm and cold zones:
g The zones where warm food products are treated and the zones where the cold food products,
(chilled or frozen) are treated must be clearly differentiated and separated to avoid thermal
pollution and to maintain the cold chain.
The separation of the clean areas from the dirty areas:
g The waste produced at each stage of manufacture must be removed from the production area
as directly as possible and conveyed to the treatment facility or the designated storage. (Local
dustbin).
g
g
g
9.1.4. Supply drinking water [5]:
To properly carry out its activities the establishment must be supplied with sufficient quantities of
cold and hot potable water.
g The potable water pipework and non potable water pipework (for firefighting, steam production,
cooling circuits) must be clearly separated and identified (colour coding of the pipes).
g The potability of water used in the production of food or is used for washing food or washing the
establishment, must be assured. This potability must be certified by the supplier when supplied by
a local authority. In the case where a well, a spring, or an intermediate tank of storage tank is used
the testing must be carried out by an officially recognised laboratory.
g Ice or steam, intended to be in direct contact of food, must be produced from potable water.
9.2. Rules of construction
The floors must be:
g Smooth.
g Impermeable.
g Non-slippery.
g Resistant.
g Easy to wash and disinfect.
g Not subject to rot.
g Have adequate slope in order to allow the natural flow of waste water towards the drainage system.
The walls must be:
Smooth.
Light coloured.
Easy to wash and disinfect.
Made from non toxic material.
g
g
g
g
5 F or the products of the sea, the principle of use “of clean sea water” for cleaning of products and of the material can be
retained.
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g
g
Shock resistant up to a height of 2 meters.
Bonded to the floor with semi-circular joints to facilitate cleaning and disinfection.
The doors must be:
g Made from smooth material resistant to impact.
g Easy to clean and disinfect.
g Tight fitting to prevent the entry of pests.
The windows must be:
Easy to clean.
equipped with fly screens which can be dismantled for cleaning.
Tight fitting to prevent the entry of vermin.
g
g
g
The ceilings must be:
g Light coloured.
g Smooth.
g Easy to clean and disinfect.
Passive or active ventilation must:
g Ensure the extraction of the vapors and the fume.
g Reduce the risk of condensation and contamination of the foodstuffs.
g Contribute efficiently to regulating the temperature in the food preparation area.
Lighting must be:
g Bright.
g Not modifying the colors of the foodstuffs.
g Protected from the impact, and designed so as to avoid glass falling into the food during preparation.
The system of drainage must be equipped with grids and Ubends to avoid [6] :
g Obstruction of drains by the accumulation of waste,
g The entry of rodents in the buildings.
g The reflux of waste water.
9.3. Conformity of the material and the equipment
Furniture must be:
Smooth.
Easy to clean and disinfect.
Durable/non corrosive
Stainless.
Compliance with these rules prohibits the use of the paperboard or adhesive tape for manufacture of
furniture (or to carry out temporary installations or repairs) or in general the use of untreated wood.
The use of undressed wood of good quality, can be accepted (or officially authorized) in certain sectors
of agri -food production where it traditionally used. (Bakery, repening of cheeses, etc).
g
g
g
g
The materials used for the manufacture of tables shall be:
Smooth.
Light coloured.
Easy to clean and disinfect.
Durable/non corrosive.
Non toxic.
Impermeable
g
g
g
g
g
g
Various devices for treatment (or pretreatment) of waste water must be installed if necessary (legal obligation, protection
of the rivers, etc).
6
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Compliance with these rules prohibits the use of undressed wood or cardboard, or porous or rough
materials like concrete. The materials most often used are stainless steel, plastics, or earthenware tiles.
The use of the wood undressed wood of good quality, can be accepted (or officially authorized) in
certain sectors of agri-food production where it is traditionally used (bakery, etc).
The small equipment (hand tools) must be:
g Inalterable in all its parts.
g Easy to clean and disinfect.
Compliance with this principle generally prohibits the use of wood even for the handles of tools. The
materials most often used are the stainless steel, aluminium, plastics.
However, in some sectors of the agri-food production, the use of small tools made from of wood can
be accepted (bakery, etc).
The machines must be:
g Manufactured in inalterable materials.
g Easily dismantled.
g Easily cleaned.
Where possible (and when new equipment is being installed) equipment should not be placed close to
walls to allow for proper inspection and cleaning and to facilitate rodent control.
The vehicles used for handling, in the areas where food is manufactured or stored should not emit fumes
which could constitute a danger to the food or to the health of the operators.
9.4. Sanitary facilities
Sanitary facilities must be provided at the establishment, (suitably suituated so as not to be a source of
contamination of areas of production or storage) in sufficient numbers for the operators to maintain a
level of personal hygiene compatible with the handling of the foodstuffs.
These installations must include in particular:
g Operational toilets designed in accordance with the rules of hygiene;
g Adequate changing facilities (separate for men/women), equipped with showers with hot and cold
water, where the personnel can change;
g A locker with two compartments (or two lockers) per operator in order to provide separate storage
space for personal clothing and work clothing;
g Cloakrooms and toilets should be physically separated;
9.5. Maintenance (preventive and corrective)
The state of conformity of an establishment and its equipment depends on a maintainance plan based
on the following.
g The implementation of a plan of preventive maintenance, based on routine maintainance carried out,
in particular, on the refrigeration, mechanical, hydraulic, and electric equipment;
g Notification by operators to maintainance personnel of damages to installation as soon as they
appear;
g An up to date register of preventive and corrective maintainance which were carried out;
g Periodic calibration of the measuring instruments used in the establishment;
9.6. Storage of the chemical substances
All chemical substances and in particular those which are used in vermin control and those used for
cleaning and disinfection must:
g be stored in a locked room (or storage press) specific to the purpose;
g be stored and handled under conditions designed to reduce cross contaminations, caused by errors
of handling or by accidents;
g be labelled, indicating the active substances and information on the safe use of the substances.
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9.7. Pest contol plan
The pests generally considered are rodents and the insects. In certain sectors (Hypermarkets or other
large spaces) birds which settle in the superstructures of the buildings, or cats (slaughter-houses) which
soil the environment while attacking the stored food products are considered pests. In subtropical zones,
small amphibians and chéiroptères infesting the buildings are also regarded as pests.
Stray domestic animals, can like the vermin soil the environment and attack the stored food products.
They must also be taken into account (if possible they should be excluded by a perimeter fence)
9.8. Passive control, maintenance of surroundings and outbuildings
In order to prevent the settlement of pests in the surroundings of the establishment, i.e. not to
provide them places of refuge or sources of food it is necessary to have correct management of the
environment which includes:
g Isolated storage of unutilised materials, pallets and machines away from contact with the walls;
g Design and the maintenance of external spaces including:
 The elimination of holes and spaces in waste land with high vegetation;
 The elimination of the stagnant water pools;
 The regular cutting of lawns;
 The absence of rags, papers, plastic films and other detritis on the ground (constituting a source
of materials for construction of nests for rodents).
g Maintaining the interior surfaces (racks, tops of pieces of furniture) clean so as not to leave food
sources for insects and rodents.
g Tidying and cleaning of buildings (machine shop, boiler room, refrigeration room, power station, and
electrical equipment boxes, etc) to avoid rodent settlements.
g The installation of mosquito nets on the windows.
g The rigorous management of the waste containers which must be:
 maintained clean so as not to attract insects;
stored on a clean surface and easily cleaned area (with a source of cleaning water and drainage
for waste water);
 kept closed (so as not to be used as food resource for all types of pests);
 Not filled to overflowing (so that there is no food waste on the ground);
 manufactured from a waterproof material, easy to clean and disinfect;
 frequently removed from the production area;
9.9. Active Control
9.9.1. Detection
Rodents:
g Search for rodent droppings or traces of urine.
g Search for attacks on the food products (teeth marks) or their packaging (torn bags).
g Presence of traces of grease of rodents on the regular passages.
g Search for rodent nests.
Insects:
g Search for dead insects.
g Search for live insects in places of refuge (drawers).
g Search for and carefully remove dead insects from electic insects traps/collectors.
9.9.2. Rodent control plan
This plan consists of a complete set of documents, defining actions to be implemented, and
including:
g Technical cards for the rodent poison used;
g Procedure and scheduling of control operations, including the checking and renewal of bait points;
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The frequency and procedure of the inspection, search, and evaluation of possible infestation, in
particular by counting dead rodents when opening the traps;
g Details of additional treatment in the event of a residual infestation;
g A factory plan on which the location of the poison baits is identified;
g Indicators on the wall of the premises indicating bait points;
9.93. Insect Control Plan
This plan is composed of a complete set of documents defining actions and procedures to be
implemented and includes;
g Technical cards for the insecticide used.
g The procedure and frequency of insect control operations (walls, insecticidal paint application and
renewal, and spraying of the premises with insecticide).
g The procedure and frequency for emptying traps and trapped insect and monitoring in order to
evaluate the level of infestation.
g A factory plan on which the location of poison baits for crawling insect and electric insect traps
are identified.
9.9.4. Chemical substances used in pest control:
These substances must be approved for the purpose.Their delivery and storage must be accompanied
by clear documentation indicating the proper use, the storage conditions, and safety precautions, and
actions to be taken in the case of an accident.
10. Suppliers and controls at reception
10.1. Suppliers
The raw materials or intermediate products must come from establishments presenting the same
guarantees in terms of food safety as the establishment intending to export to other African states, or
equivalent guarantees for imported products. This equivalence shall be determined by the Competent
Authority of the importing country.
10.1.1. Specifications for raw materials
In order to have a sound bases for controls at delivery, the characteristics of the raw materials must
be specified precisely.
The conditions of acceptance or rejection of the batches must also be clearly defined, and using
specifications for each raw material, a chart will be drawn up which should include:
g Labelling, in particular, food safety official marks and elements of traceability;
g Type of packaging defined by its nature, its volume, its shape;
g Integrity of packing and wrapping
g For the imported foodstuffs, health certificate and import documentation in good order;
g Storage temperature for perishable goods;
g Microbiological standards and the formulation defining: the physicochemical composition,
presentation, particle /chunk size and variability, physicochemical constants, (pH, Aw, salt or sugar
concentration, viscosity of the liquids);
Purity criteria, applying to the raw materials and to packaging:
g Absence of residues (heavy metals, pesticides, hydrocarbons, solvents);
g Absence of certain foreign bodies (plastic, wood, glass, metals, mineral particles, body of insects,
feathers, hairs, etc);
g Particular specifications relating to the conditions under which the raw materials are produced,
may be included insofar as these can influence the safety of the food (general hygiene or specific
risk of contamination).
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10.1.2. Preferential choice of suppliers:
Preferential choice will relate to suppliers complying with:
g Certification (ISO 9000 or ISO 22000 or YEWS for example);
g Other type of certification (Halal, Kosher, vegetarian, without GMO);
g Any other international approval (the EU, the USA, Japan for example);
g An accreditation or a reference from a recognized customer (National Defense or large
supermarket chain).
10.1.3. Preferential choice of suppliers following a visit to the production facility
10.2. Controls at reception
The effective implimentation of the reception control checks is achieved by the use of control /recording
cards completed at the time of delivery and filed.
10.2.1. Control sheets at reception
These cards must make it possible to at least control the criteria according to:
official food safety approval number of the establishment or the health certificate for the
imported products from countries outside Africa,
g The health certificate accompanying the products exchanged between African states having
adopted the reference framework.
g The temperature of the product at reception (refer to appendix 3 of the guide to application of
this reference framework concerning the calibration of the measuring instruments);
g The Expiry date or the Best Before date.
g The presence of a batch number necessary to operate the system of traceability upstream and
downstream.
g The integrity of the wrapping and packaging material;
g The cleanliness of the delivery vehicle, which must be spefically designed for the transport of
foodstuff (food grade material for containers, thermal insulation, or refridgeration).
Other criteria can be checked according to their importance. In all the cases, the number of checks
must be limited, in order to make possible effective and efficient control.
Details of the parameter checked/inspected can be recorded in a variety of ways, perhaps either on
check cards or by use of an inspection grid printed from by a stamp on the reverse of the delivery
orders.
g The
10.2.2. Organoleptic criteria
The criteria given in the “specifications raw materials” must be confirmed and must be recorded.
Products which are not fit for human consumption must never be used in the process.
10.2.3. Temperature controls at reception
This measurement is necessary when the temperature is essential to ensure food safety (food of
animal origin). The temperature must be measured in the products themselves, or at their contact, in
the delivery vehicle or immediately after delivery.
After the doors have been opened the temperature in the delivery vehicle shall not be considered
to be significant.
The values of the temperatures defined in the appendix to the guide to the application of this
reference framework are to be respected with a tolerance of +/- 4°C at the time of the delivery.
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10.2.4. Other essential criteria
Other essential criteria may be taken into account and can be integrated into the delivery recording
documents:
g If necessary, the date of production or packaging (canned or frozen products) in plain or coded
form;
g The conformity of the labelling (of the packaged products) in particular the official food safety
marks, the composition of the product and the listing of the additives used.
10.2.5 R
ecieving (into storage) procedures for raw materials following delivery checks and initial
decontamination operations
The Some care must be taken during the introductionof raw materials into storage:
g The maximum time between the arrival of the raw materials and their storage under specified
conditions (chilled rooms, cold storage, etc) must be defined and respected.
g Soiled packing (cardboard wodden pallets, etc) shall be removed before placing the raw materials
in clean storage.
g If plant products (vegetables, fruits, etc) undego a decontamination treatment by steeping in
disinfectant solution (chlorination, ozonisation, etc) the concentration of disinfectant and holding
time (max an/or min) must be defined and respected.
10.2.6. Procedures of rejection
The application of a rejection procedure must correspond to the conditions for rejection established
in contract with the supplier. The following must be recorded on the card of rejection:
g Reference identifying the rejected batch (identification, composition);
g The reason for the rejection by referring to the conditions contained in the supply contract;
g Signatures of the conveyor and the receiver.
11. Personnel hygiene policy
The enforcement of this policy depends on the food factory occupational health care management
system. It is nevertheless necessary to recommend the following provisions:
The presentation of an certificate of fitness to handle food at the time of initial recruitment and then at
least annually (or more frequent in certain countries) or after any prolonged period of sickness, for each
operator engaged in the handling or manufacturing process
g A systematic monitoring of the staff by clinical examination of the arms hands face throat and other
exposed skin carried out by a medical practioner with appropriate experience of food handling
requirements.
g A systematic monitoring, for potential Samonella carriers (probably subject to frequent bouts of
diarrhoea) by consultation with a medical practitioner for industrial medicine.
g Enforcement of detection procedures for employees likely to carry Staphylococcus or Salmonellas,
by way of bacteriological analysis.
g Medical treatment for those diagnosed positive with any of the above micro-organisms and temporary
exclusion from process areas, without penalty, so as to ensure staff confidence in and cooperation
with the scheme.
g Temporary exclusion when justified from process areas and medical treatment for employees with
complex or purulent hand wounds or other clinical sign (coughing, diarrhoea, fever, etc) (without
penalty so as to ensure staff confidence in and cooperation with the scheme).
g Availability of first aid kits, regularly resupplied, to allow the treatment of wounds and their protection
with protective bandage.
g Employees shall be aware of the need to report to management any health incident presenting a
potential risk to the consumer.
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12. Hand hygiene
Hands, which are frequently in direct contact with foodstuffs, need to be considered as the first
operational tool. For this reason, detailed attention must be given to their cleanliness (just as with any
equipment placed at the operator’s disposal) and to the hand washing regime. If not subjected to strict
hygiene rules, hands constitute the first vector of contamination of foodstuff by microorganisms passed
on by the operator, (potentially pathogenic).
In order to reduce the risk of contamination of the hands, in all areas where foodstuffs are being handled,
waste bins must be equipped with opening mechanisms which are not hand operated (pedals etc).
12.1. Wash hand basins
Wash hand basins shall be installed in a sufficient number, at the working stations or near these stations,
as well as the exit from the staff rooms (toilets, cloakrooms, rest rooms, refectory, etc)
Wash hand basins shall conform to the following principles:
Water flow shall not be operated by hand, but by foot or knee or by an automatic presence detector
and shall be supplied, where appropriate, with hot and cold water and a mixing valve.
Liquid (or foam) soap shall be bacteriocidal but not a skin irritant (this excludes toilet soaps without
bacteriocidal effect).
Soap dispensers shall be placed in a position adjacent to the hand basins.
A second dispenser reserved for a disinfecting solution (e.g. of alcohol solution) can be associated with
the liquid soap dispenser.
g The
device for drying the hands must be of single use (paper towels being in practice, the only
possible onsolution)
g Pictorial notices demonstrating the hand washing procedures shall be posted close to the hand wash
basins.
g For the majority of the agri-food industry nail brushes should be placed at the disposal of the
operators. Nail brushes must be entirely of synthetic material (handles and bristles) and shall be kept
in a clean disinfectant solution which should be renewed after each work period.
12.2. Hand washing procedure
g It must be the subject of part of the continuous training scheme of the personnel;
g T
he wet hands coated with cleaning product must be rubbed for a period 20 seconds
(the operator
counts in his head: 101… 102… 103… up to 120);
rinsing of the hands, which are rubbed under running water, must last for a period 10 seconds at
least (using the same method of calculation of time);
g The drying of hands is not always necessary, being unnecessary for certain types of activities;
g If a disinfecting solution is used, the operators must let it dry spontaneously on the hands without
wiping it;
g Control of hand cleanliness can be achieved by visual inspection and /or microbiological tests, if
necessary carried out under the supervision of the workplace doctor.
g the
12.3. Frequency of washing of the hands
Since ffective hand washing takes a long time, strict definition of the frequency and circumstances of this
procedure is needed. Hands must be effectively washed whenever and wherever their contamination
is practically certain. The washing must be carried out immediately after dirty operations. This will
restore hands to satisfactory cleanliness and will prevent anything in contact with hands from gross
contamination. If contact points are themselves grossly contaminated, hand hygiene is not possible
because, as work continues, they are immediately re-contaminated.
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12.4. Complete hand washing after the operations or dirty situations
These operations are practically the same in all the branches of industry:
Arrival at the work station.
Passing through and/or using toilets or changing rooms.
After blowing the nose.
After handling dustbins.
After handling cardboard boxes at delivery (cardboard box bases are often very dirty).
After handling eggs shells (frequently contaminated by salmonellae).
After handling vegetables direct from the soil.
After handling game or poultry ‘in fur or feather’.
While passing from raw food production areas to cooked food product areas (i.e. from low risk to high
risk areas).
In this case materials used (cutting boards, knives, etc…) must similarly be changed or correctly cleaned.
12.5. Quick hand washing before conducting clean operations.
There are various clean operation specific to each branch of industry (cooked meat cutting, assembly
of pastry ingredients,…) and do not require a thorough washing of hands, if the operators have
systematically taken the precaution to wash their hands after the dirty operations, and if the hygiene of
the points of contact is controlled.
12.6. Hygiene contact points
g The
points of contact must be listed (handles of door of refrigerator, handles of machines, handles of
ustensils, electric switches, etc),
g These points of contacts must be the object of a meticulous cleaning, daily, or at each time work is
resumed at the work station or with each change of operator.
12.7. Additional rules
No smoking, taking of snuff, eating or chewing at the work station, in the work place or whenever
wearing work clothes.
No tasting of food involving hand-to-mouth action.
No rings, jewellery or watches to be worn (even if wearing work gloves).
Maintain neat short finger nails.
No nail varnish or perfume,
The washing of gloved hands must be carried out using the same procedure as for bare hands.
No reuse of disposable gloves after removal.
Never use perfume on hands in order to avoid transmitting smell or abnormal taste to foodstuffs.
1.2.8 Work clothing hygiene
12.8.1 Clothing behaviour
In agro-food industries, clothing can be a major vector in food contamination. Unclean work clothing
can be a source of contamination for hands, whenever it is used to wipe them. In certain sectors,
such as butchery, clothing is in direct contact with handled carcasses, (e.g. in shouldering carcasses
when loading/unloading delivery vehicles).
The Work clothing design and its management must respect specific principles.
g It must of a standard type, preferably light colour and provided by the company, and adapted to
the different activities of the company.
g It must put in a locker (or a compartment of cupboard) physically separated from personal
clothing.
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g The locker shall be maintained clean, shall not contain unprotected food and be design to prevent
access by pests.
colour, or the colour of one of its elements (cap, overall), may be specific to a work station
or a zone of assignment of operators (for example “clean” and “dirty” areas).
g It includes a cap or net which covers all hair – this includes snoods for moustaches and beards
(head covering may also be worn for other purposes, such as shock proof helmets).
g A net must also (if necessary) cover the beard; the moustache may be covered by the nazal/
mouth mask,
g It must include shoes (crush proof and non-skid) which are only worn in the factory (foot wear
shall not contaminate work wear in a locker)
g It must be laundered by the company or under its control (e.g. by contract with an industrial
laundry).
g in all the cases, the washing procedure must guarantee against any cross contamination by linen
intended for another use or of another source,
g It must be resistant to:
Mechanical actions (tears).
Fire.
Must be capable of withstanding frequent washings.
The obligation to wear compulsory work attire (or protective clothing for visitors) shall be
notified by notices at entry points to food processing areas.
Operators shall never arrive at or leave the establishment wearing their work attire.
g The
12.8.2 The hygiene of the boots and/or the shoes
The control of the hygiene of the boots and the shoes requires should respect the following
requirements:
g Permanennt devices (boots or shoes wshstands) or moveable devices (trays on the ground),
containing a disinfecting solution, must provide for cleaning/disinfection of the shoes or the boots
before entering the production zones.
g Equipment for the washing of footwear may not be manually operated;
g They must be supplied with water, detergent, disinfecting, a suitable brushing system;
g The concentration of disinfecting must be controlled and maintained at an effective level during
the whole of the processing period.
13: Premises hygiene-cleaning plan
13.1 General principles
At least two copies to the cleaning plan should be available:
g A complete version of the document held and updated by the quality management department and
to which are annexed the charts for the products used in cleaning/disinfection as well as directions
for the use of the machines used in the cleaning process.
g An abridged version allowing each cleaning operator to have only that part of the plan relating to
the operators particular duty.
In the cleaning plan file, task checklists should be included included as well as the target results of
microbiological test on surfaces after cleaning.
The cleaning task must be followed up by checks to monitor its effectiveness and the results of such
checks must be recorded. Conducting microbiological analyses of surfaces makes it possible to check
the effectiveness of the cleaning plan.
Good hygiene of the buildings envolves the creation of a cleaning plan. The use of the method known
as of the “WWWWWH” makes it possible to draft a suitable plan of cleaning. The nature of the first
question put during the application of the method of the “wwwwwh” guides the principle of the general
organisation.
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“When”? Cleaning tasks will be will be organized per day, week or month;
g “Which? The tasks of cleanings will be organized by an individual or a team;
g “What”? The tasks of cleaning will be organized according to the buildings the department or the
equipment.*
*See guidelines on the application ofGMP, GHP and HACCP
13.2 Cleanliness of tools during Production
During use, the manual tools must be the subject frequent cleaning/disinfection, by rinsing and placing
in a sterilizer with hot water at least 82°C:
Or several tools may be used and placed alternatively in the sterilizer;
g Or all the tools are changed periodically to be replaced by clean and disinfected tools (every hour,
every 30 minutes, etc);
g Any other equivalent method, allowing a frequent cleaning/disinfection of the manual tools, can
replace the use of sterilizers with hot water.
These operations of “cleaning/disinfection” of the manual tools must be carried out:
g After work on a soiled product (eg hide cutting in slaughter-house)
g Before passing from work on raw foodstuff to work on cooked products.
g In some operations, such as hide removal in an abattoir, operators are required to pass the tool from
one hand to the other. In this case the secondary hand, already soiled, becomes the operating hand
which holds the tool. Care needs to be taken to ensure effective cleaning of both tools and hands.
14 Hot and cold texhnologies an the formulation of
foodstuffs
14.1 Cold Chain Technology
The application of cold chain technology allows for a routine control of physical parameters (time and
temperatures), their monitoring and their recording. The monitoring of these parameters (and their
recording), for each batch stored or processed, allows the introduction of CCPs, if a hazard risk analysis
indicates that it is necessary and in the context of the food safety management plan established by the
business.
In general, cold storage (frozen or chilled) is reserved for high quality products. Cold application
(freezing or chilling) needs to be conducted as quickly as possible and the appropriate low temperatures
maintained continuously until further processing or consumption.This continuous application shall when
feasible, be monitored by temperature measuring and recording either manually or by automatic devices.
If necessary, food establishments in the primary production sectors (fishery or dairy products) must
be equipped so as to ensure cold storage of collected products and maintenance of an appropriate
temperature during storage.
14.1.1 Chilling
Chilling is the application of non-freezing cold temperature conditions to preserve foodstuffs. This
technique causes the slowing down (not cessation) of deterioration. Consequently, it can be applied
to foodstuffs only for relatively short periods according to food type, e.g. 2 or 3 days only for minced
meat, or perhaps a few weeks for some pasteurized products.
Temperature of refridgerated foodstuff:
g The temperature of storage is an important parameter for the safety of the cooled perishable
goods (food products of animal origin in particular). It must be measured in the products
themselves, or at their contact.
g The values of temperature defined in the appendix n° 4 of the guide to the application of this
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reference framework are to be respected with a tolerance of + 2°C during storage;
the doors of a cold room are open, the temperature of the ambient air should not be
regarded as a significant value.
Additional rules for the management of the storage of the cooled food products:
g These additional rules are detailed in the guide to the application of this reference framework.
g After
14.1.2 Refrigerated vehicles of transport
The refrigerated vehicles must be regarded as mobile cold rooms and for this reason their
performances and their use must be regarded as being identical to those of the fixed cold rooms.
14.1.3 Quick Chilling.
This technique relates to mainly the products cooked in advance as well as pasteurized products, after
they have undergone a treatment of partial decontamination by heat. It makes it possible, in practice
to reduce the microbial activity (mainly multiplication) by a quick reduction of the temperature, but
also by reducing the water activity at the surface of the product This second aspect is most useful in
abbatoirs.
The implementation of this quick chilling technique must comply with certain principles:
g the internal temperature of the cooked products must go down from 63°C (or more) to 10°C
(or less) in less than 2 hours.
g The method of reheating of refridgerated foodstuffs prepared in advance must allow the core
temperature ≤ 3°C of the product to rise to a core temperature of ≥ 63°C in a maximum of 1
hour;
g Quick chilling cells or any other method giving similar performance may be used (such as a bath
made up of water + ice)
g Dividing the mass of the product into smaller quantities makes the achievement of good rapid
chilling possible.
g to ensure the attainment of the required performance for each batch identified the product core
temperature and the time shall be systematically measured and recorded from chill start to finish.
g These measurements and recordings can possibly be used as a basis for setting-up of CCP, if the
business has decided to use the HACCP system.
14.1.4 Freezing
Freezing is the application of negative temperature for the preservation of food. Freezing inhibits any
microbial activityl (through the withdrawal of available water and low temperature) and it strongly
retards deterioration of biochemical origin (such as rancidity). Consequently the frozen products
can be preserved for several months (some for possibly 12 months, although some products can be
preserved for longer periods subject to strict control and possibly testing before use).
Temperature of preservation of frozen products
g The temperature of storage is an important parameter for the safety of the frozen food products.
It must be measured in contact with the product or possibly in the products themselves (dairy
ice creams);
g The temperature values set down for foods chilled or frozen in appendix 4 of the guide to the use
of this refrence framework are the higher limit values to be respected but better preservation
can be achieved using of temperatures which are colder especially over longer periods of storage.
Additional rules for freezing/deep freezing of the food products:
g These are detailed in the guide of application of this reference framework.
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14.1.5 Defrosting
Frozen foodstuffs generally not usable in that state are frequently subjected to a defrosting phase
prior to use.This process can be the source of a hazard if not carried out properly so the process
must obey certain rules.
Defrosting must be carried out using appropriate methods in conditions of controlled temperature
so as to ensure that all parts of the product undergoing defrosting do not rise above normal positive
cold storage temperatures, or it is carried out quickly enough not to compromise the safety of the
food.
Defrosting can be carried out:
g By placing the large parts frozen pieces in a chilled room in advance,
g By using microwave technology.
g By direct cooking of the frozen product,
g For the small pieces of product frozen in a protective packagea hot wate bath actively kept to
the boil can be used.
Defrosting should not be carried out:
g At ambient temperature;
g In a tepid water bath.
14.2 Heat technologies
The principal techniques based on the use of heat are four:
g Direct heating;
g Cooking;
g Pasteurization;
g Canning (or sterilization in can, bottles, or other pack.
The three last techniques of this list, present similarities:
g They have a reducing effect (more or less thorough) on the microbial flora of the food products
g Their effect can be quantified by a reference value:
Cooking value
Pasteurisation value
Sterilisation value
g This quantified value results from the combined effect of time and the temperature.
The application of these techniques can thus lend itself to the routine inspection of the physical
parameters (time and the temperature) and to the recording of the results obtained. The monitoring of
these values, for each batch manufactured or stored by the business, will allow the introduction of CPC,
if a risk analysis so indicates in the context of the application of a HACCP.
The application of these technologies is subject to common rules and some particular rules.
14.2.1 Rules suitable for cooking
g The
temperature and the duration of cooking must be subject to measurement and recording
(time and temperature).
g Cooked products meant for immediate consumption should not be kept for more than 2 hours
at a temperature of ≥ 63°C.
g Constant unit volumes of food batches make it possible to reproduce identical cooking conditions
for all manufactured batches.
g For products cooked in advance quick cooling is essential. (Fast cooling should be carried out by
a method discussed in the earler paragraphs).
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14.2.2 Rules common to pasteurization and canning
The reducing effect of these two methods on the microbialflora of food can be quantified by a
reference value
g Pasteurisation value or;
g Sterilisation value;
g A series of preliminary tests makes it possible to establish a reference scale for sterilization (or
pasteurization) for each type of product.
g The evolution of the time/temperature combinations for effective processing must be checked
and recorded;
 By measurements carried out with regular intervals,
 By the plotting of a graph plotted by automated devices.
g Canned foods must undergo a sterilisation process guaranteeing their stability under their usual
storage conditions.
g The shelf life of the pasteurized products is established by the manufacturer (his responsibility),
on the basis:
 Pasteurisation value obtained by the treatment applied, time/temperature;
 Stability tests by incubation or ageing test and prolonged storage of the product.
g The complete sealing of the packages into which products for processing are place must be
controlled and ensured (cans, bottles, jars, sachets…)
g Damage to the seals or accidental opening of the containers or accidental damage, compromises
the long term preservation of the product.
g Any accidental damage to the containers, must systematically involve the rejection of the product.
g Each batch treated must be composed of identical products:
 Of the same physico-chemical composition (formula, acidity, Aw, viscosity, granulometry, etc)
 Of the same size
 Of the same shape
 In the same packaging material.
14.3 Formulation of foodstuffs
For foodstuffs (products salted, dried, acidified, etc) which are preserved by
physicochemical
characteristics (acidity, water activity, etc) that are predefined it is essential to apply the formulation
carefully and to check it strictly.
The formulation of food depending on their physicochemical characteristics:
g pH (acidity) The control of the standard value of the pH (acidity/alkalinity) for these products, must
becontrolled, either by the direct measurement of this parameter (pH meter), or by the quantitative
measurement of the raw materials entering its formulation.
g Aw or water activity corresponding to the water available for microbial activity
The control of the standard Aw value for products for which the control of this is essential (salted,
dried or sweetened product) must be guaranteed either by direct measurement of this parameter
or by measuring the raw materials entering into the formulation
g Viscosity:
The efficiency of sterilisation or pasteurisation applied to a food product in the liquid phase depends
on its viscosity.The lower the viscosity the faster the heat transfer to all parts of the product will be.
The faster the heat transfer the more efficient the sterilisation (or pasteurisation) will be.
g Nutrient content
 Proteins
 Sugars
 Microbial growth ingredients
g Content of inhibiting elements:
 Fatty Acids
 Salt with strong concentration
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 Sugar with strong concentration
 Nitrites
Some of these parameters, fluctuations of which have a direct effect on the stability of the products, are
easily and quickly quantifiable and can thus be exploited for the introduction of CCP.
To ensure the consistancy the formulation, measurements of the component ingredients are needed.
g The weight
g Volume
g The number of units (containers) of a raw material introduced into the preparation
On the finished products or on work in progress some measurements may also be carried out:
g PH
g Viscosity
g Density of the solutions (measurement of sugar concentration for example)
g The refractive index of the solutions (measurement of concentration)
g The temperature
14.4 Labelling, traceability, procedures of withdrawal (or of recall)
14.4.1 Labelling
The labelling of the products must be in compliance with the requirements of the General Standard
for the Labelling of the Pre -Packaged Foods, intended to be given in the state to the consumer (Stan
Codex. 1-1985) and with the legislation of the country in which the food is marketed. It shall in particular
comply with the following mandatory requirements
g Name of the product;
g The composition of the product which must be in descending order on a percentage basis of
importance of various components, and which must specifically mention the recognized allergens if
the products contains allergens;
g The temperature of storage for the perishable goods
g Country of origin and the “health mark” if the if the production establishment has been allocated a
such a mark, or the identification of the manufacturer by name, address, and the registration number
allocated by the National Authority
g The “EXPIRY DATE” or date of optimal use “BEST BEFORE DATE”.
g Date of production, in clear or in code, and if necessary conditions for the preservation and storage
(If required by National legislation).
g The manufacturing batch number.
The labelling of the products can also include additional optional information (directions for use etc)
within the limits of the regulation in force in the country where the food is marketed.
14.4.2 Traceability
Food processors are undertaking two processes simultaneously and this must be bourn in mind when
considering traceability.
g A flow of foodstuffs processed to obtain a finished product starting from raw material
g A flow of information relating to the raw materials collected from the suppliers, then recorded to
meet the needs for the company, and finally transmitted to the products in the form of information
allowing traceability.
This management of the flow of information is essential for the establishment of procedures of
withdrawal (or of recall), but also for the designof a Food Safety Management System which may be
based on the HACCP system.
14.4.3 Procedures of withdrawal (or of recall)
Procedures for withdrawal (or recall) to be applied in emergency suituations must be prepared in
advance and available in the establishment, in the event that a batch of foodstuffs would be likely to
present a risk to the consumer.
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15 Self-checking (autocontrols)
15.1 General principles
A sampling plan, for purposes of microbiological and physicochemical analyses must be prepared base
on the basis of a risk analysis, and must:
g Relate to the finished products (and possibly to the raw materials and/or the products in the course
of manufacture) as well as the work environment (surface of the equipment, the tools and the work
surfaces, etc);
g refer to the standard method of analysis to be used which must be at least equivalent to those
prescribed in national legislation.
g refer to the standards for qualitative microbiological criteria (list of the generic flora or required
microbial species to be detected), and quantitative microbiological criteria (maximum limit of
presence of these microbial contaminants).
15.2 Self-checking of the products
The bacteriological testing carried out on the finished products is generally carachterised by a relatively
long response time. As a result it is not possible to await the receipt of the results to affect production
control or to even await them before releasing the products.
Consequently, the tests of finished products have a value in assessment function of the effectiveness of
the implementation of the GMP as well as the operation of the HACCP plan. Unfavourable results do
not make it possible to employ corrective actions on the products, but must lead to a re-evaluation and
improvement in the GMP as well as thre implementation of the HACCP plan.
Within the framework of the risk analysis carried out in carried out in the HACCP study bacteriological
analysis carried out on products at different stages of production makes it possible to to evaluate the
impact of each processing activity/step.
The results of analysis must be interpreted in accordance with certain rules based on the relative
importance of the microorganisms and their numbers in the product.
15.3 Self-checking of surfaces
The bacteriological tests carried out on surfaces are characterized by a relatively long response time.
Under these conditions, it is not possible to await the receipt of the results to continue manufacturing
or even to wait for them to release the products.
Consequently, the testing carried out on surfaces have a value in checking on the effectiveness of the
cleaning plan. Unfavourable results do not make it possible to take corrective actions on the products
which were in course of manufacture at the time at the time of testing, but must be used to review and
improve the cleaning plan.
15.4 Staff training
A training plan on the general principles of food hygiene must be set up in each food processing
establishment. Each member of the staff must receive training to a level appropriate to the tasks which
the member of staff is required to carry out.
The following simple principles can be followed to design and impliment a staff training programme.
g analyze the training needs, taking account of the specific work of the enterprise and the different
staff needs to be addressed.
g establish a training plan with clearly definited objectives and indicators, for example:
The objective “to train all the personnel, including the seasonal workers, before introducing them
into the production area «,
 The programme of training for the next months
 Indicators in this case are the number of people who followed this module and the competences
which they will have aquired,
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Design and organise the training sessions including the content and the training method to be
followed. (Teaching aids, material, logistic).
 The creation of a system of individual record sheets, recording for each member of the staff, the
various training cources which they have received.
g To carry out the training,
g To evaluate the results.
16 Requirements for the routine evaluation of the implimentation of good hygienic practices (ghp) and good
manufacturing practices (gmp)
A simplified periodic procedure, known as the “evaluation of routine” of the efficiency and the
effectiveness of the FSMS (Food Safety Management System), must be set up.
Several criteria will have to be taken into account for this “Evaluation of Routine”, and will be particular
to the individual establishment:
g Routine inspection of the raw materials at reception, demonstrated by the correct management of
the documentation at the receiving point;
g The checking of the efficiency and effectiveness of traceability system applied to the raw materials,
and to the finished products;
g The documentation attesting to the potability of the water used in the manufacturing process or
used for cleaning;
g The evidence of the implementation of the cleaning plan demonstrated by the recording of the tasks
including bacteriological analysis carried out on surfaces of equipment;
g The control of vermin in the production premises as well as the documentation relating to the pest
control plan;
g The presence of medical certificates indicating the suitability of the workers for working with
foodstuffs;
g Summary of individual record sheets and certificates of continuous training for each member of the
personnel;
g The physical control of the state of conformity of the eqipment, as well as the records relating the
preventive and corrective maintenance;
g The checking of the system of compliance with the temperatures relating to hot and cold technologies
attested to by the documentation;
g The checking at the production premises, that the water, soap and towels are correctly provided at
the wash hand basins as provided for in the plan;
g The checking on the production premises that the correct supplies of water detergent brushes for
cleaning footwear are provided; and the correct provisioning of the boot wash or the foot baths: the
supply of water and detergent;
g Checks are carried out for the presence of valid calibration certificates for all measureing equipment;
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17 Requirements relating to the functional checks of the
procedures of traceability and withdrawal (or recall)
of food products which can present a risk for
the consumer
17.1 Traceability
A simplified procedure must be periodically applied to check the effectiveness and efficiency of the
traceability system set up pursuant to item 14.4.2 of this appendix.
g By a simulation exercise of downstream traceability carried out on batches of finished products
marketed during recent days;
g By a simulation exercise of upstream traceabilitycarried out on raw materials stored in the
establishment.
17.2 Withdrawal/recall
A simplified procedure must be periodically applied to check the efficiency and effectiveness of the
withdrawal/recall procedure set up pursuant to the principles stated at 14.4.3 of this appendix:
17.3 Requirements relating to labelling
A simplified procedure must be periodically applied to check the efficiency and effectiveness of labelling
system set up pursuant to the principles stated at 14.4.1 of this appendix:
18The food safety managemet system (fsms) and the implementation of the haccp system
For the companies having chosen to implement a FSMS (FOOD SAFETY MANAGEMENT SYSTEM)
integrating HACCP, additional checks will have to take into account, the monitoring of CCP,s and the
management of the documentation which is a requirement for the implementation of a HACCP system
in accordance with Codex Recommended Intenational Code Of Practice -General Principles of Food
Hygiene - CAC/RCP 1-1969, REV, 4 (2003). The implementation is greatly facilitated by the use of the
simplified method appearing in the guide to the application of this reference framework.
Appendix 2: R
equirements relating to registration and approval (certification) of the establishments by
the competent authority
19 General principles
The official control activities for the implimentation (inspection, audit, etc) of this reference framework
may be delegated by the Central Competent Authority of the State to a third party accredited to carry
out the work in accordance with the standard.
19.1 Obligations applicable to officials responsible for controls
The Central Competent Authority (CCA) of the state must ensure that the officials responsible for
controls (public bodies or those to whom the task has been delegated):
g have the qualifications and the necessary experience to properly carry out the control tasks
(inspection, auditing, sampling and documentation checks).
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g are sworn in officials and free of any conflict of interest (material, financial, moral or social).
g H
ave or have access to the equipment, facilities and funds necessary to carry out their duties.
(In
particular the financial needs and personal health and safety of the officials).
g receive appropriate training and regular updating of the skill necessary to carry out the control tasks.
19.2 Obligations applicable to the organisation of official control
When carrying out an official control the representative of the Competent Authority must carry out
the controls in accordance with three steps.
g Preliminary preparation /programming of the inspection,
g Carry out the inspection in two phases:
g Physical inspection
g Documentary checks
g Issue a report of the outcome of the controls carried out and the corrective actions required (carry
out checks on the effective implementation of corrective action) and the sanctions applied where
appropriate.
19.3 Information systems
19.3.1 Internal
The Central Competent Authority under the authority of Government (central/national, regional
or local) is in charge of implimenting an information management system must be of identifying
the establishment in a formal way without ambiguity. The information management system should
include;
Identification and the recording of the establishments, taking into account the following:
Identification and registration of the food business
Identification of the person legally responsible for the establishment
(Certification will be granted to the establishment and the legally responsible person at the time
of certification. Under these circumstances the certification shall not be transferrable and/or
exchangeable)
Geographic location
In case of accidental pollution (chemical pollution of a river) or seasonal biological events (toxicity of
molluscs at the time of a red tide phenomena, etc), geographical location information will allow the
withdrawal of possibly contaminated products from the market.
Type of foodstuffs
This information is essential to evaluate the sensitivity of the processed products and consequently
the specific level of risk associated with the production establishment.
The volume of activity
The larger the volumes of products processed the more difficult it is to respect the requirement of
the cold chain and the heat treatments. Consequently large volumes of production are available to
a bigger number of consumers and represent a greater risk of a food safety accident than smaller
volumes of production.
The official registration number
Information relating to the geographical location of the establishment, and the registration number
kept by the local authority will have to correspond with the records maintained by the Central
Comprtent Authority so the records of inspection and possible certification can be maintained. g Establishing for each registered establishment a correlation link with the central competent
authority subdivision in charge of the inspection.
g Recording in the central information system of the Central Competent Authority the identy of
each officer in charge of control tasks, the location of officers and the establishments for which
each officer has responsibility.
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g After
each inspection recording in the central information system the outcome of the inspection.
This report should be available (on a consultation basis) to officers in other geographical regions
carrying out inspections on behalf of the Central Competent Authority.
g The records of certification granted.
19.3.2 External
The Central Competent Authority of each participating country shall provide to other participating
countries (using a harmomised system) the information described above for all establishment
certified in accordance with this system.
It is considered useful to have mutual cooperation and information sharing by Central Competent
Authorities of African states particularly at a time when there is a food safety problem identified in
an establishment whose products may have been exported across borders. This cooperation will
be done through a traceability and “Rapid Alert System” managed by the Regional or Subregional
Central Competent Authorities when the system is in place.
20. Rules for the granting of certification
Only establishment in good regulatory standing with their national authorities may be considered for
certification.
Only those establishments complying with at least 80% of the requirements of this reference framework
can be certified provided that they do not show any non compliance with the following essential
requirements.
g Establishment identification and registration (Section 8);
g Potable water supply and the conditions for its use in the manufacturing processes. (Sections 9.1.4);
g The control of the raw materials (Section 10);
g The respect of the cold chain (Section 14.1);
g Control of the heat treatments (Section 14.2);
g The labelling of the finished products and the installation of a food safety traceability system upstream/
downstream (Section 14.4) in compliance with the general principles (Sections 6.6 and 6.7).
One audit aimed at the renewal of the approval shall take place at least every two years.
However if at any time an official audit/inspection of an establishment which has been certified shows
that there are non conformances the Competent will have to consider suspension/withdrawal of
certification if;
g Less than 80% of the requirements defined in this reference framework are respected or
g The essential requirements of this reference framework are not respected.
21. Use of the fund generated by certification (fees)
The income generated by the collection of fees within the framework of certification must be used to
finance the development of the system of certification and contribute to the training of the officers
carrying out the official controls and the development of the infrastructures necessary.
The procedure for the collection of fees must be transparent and must be independent of the officers
carrying out the controls and should not be considered part of the income of the local competent
authority.
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Appendix 2
The “Guidelines on HACCP, GMP and GHP,
for ASEAN Food SMEs”
A comprehensive
hand-book
to assess your
hygiene practices
and HACCP system.
EC-ASEAN Economic
Cooperation Programme
on Standards, Quality and
Conformity Assessment
Project co-financed by the EU
Food Sub-Programme
Project co-financed by the
ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs
A GUIDE OF GOOD PRACTICES FOR THE PRODUCTION
OF FOOD THAT IS SAFE FOR HUMAN CONSUMPTION
Experts :
Mr. Dr. Richard Bonne (Team leader on this activity)
Mr. Nigel Wright (Lead Expert for Indonesia)
Mr. Laurent Camberou (Lead Expert for the Philippines)
Mr. Franck Boccas (Programme Manager)
Implementing
Agency
European Committee for Standardisation
Comité Européen de Normalisation
The information contained in this document reflects the views of the Implementing Agency and
Experts, but does not necessarily reflect the position of the European Commission.
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
FOREWORD
These guidelines have been developed in the framework of the Food Sub-programme of the
EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity
Assessment, 2003-2005. This programme funded by the European Commission was
implemented by the European Committee for Standardisation (CEN).
The guidelines propose an innovative method towards food hygiene and HACCP for Small
and Medium Enterprises of the food sector, entitled Comprehensive Hygiene Management.
This method has been elaborated by Dr. Richard Bonne; a French veterinary inspector and
teacher with more than 20 years of professional experience in inspection in the food industry
in Europe, Asia and Mediterranean countries.
The methodology which is proposed in these guidelines is the result of a long observation of
the problems which SMEs are facing when developing control systems to comply with
European and international requirements for Food Hygiene and HACCP. It has been applied
and taught in Europe for ten years, prior to being brought to this programme.
For the purpose of this programme, the method was tested through a pilot approach
combining on-the-job training for young professionals and technical assistance to food SMEs
in Indonesia, Philippines and Thailand in 2004-2005. Thirty food SMEs of different nature and
more than 70 trainees have participated in this pilot experiment. Dr. Richard Bonne (in
Thailand), Mr. Nigel Wright (in Indonesia) and Mr. Laurent Camberou (in the Philippines)
have implemented the method with the assistance of 11 local experts and the trainees in the
food SMEs. Each trainee was assigned a specific project to help one of the SMEs to apply
the recommendations of the experts.
They have achieved remarkable progress in the participating SMEs in a period of only one
year. Some companies have reduced their quality rejection rates (one of them by 9%) and
increased their market opportunities (one of them by more than 50%). Others have
significantly improved their audit scores with their international clients (world-wide pizza
restaurants chain), or have been able to pass audits to become suppliers of international
retail companies (French-owned hypermarket chain) operating locally.
These ASEAN food SMEs have demonstrated that with a strong commitment from their
management, they could apply the Comprehensive Hygiene Management Method with
success to gain competitiveness, through meeting the European and International
requirements for food hygiene and HACCP.
These guidelines provide directions on how to apply the method, with examples taken from
the pilot programme which took place in Indonesia, Philippines and Thailand. The guidelines
also contain an Audit Guide to assess the situation in food SMEs and guide them towards
GMP, GHP and HACCP through a practical and systematic approach. They can be used in
combination with the EC-ASEAN HACCP training manual available at CEN-PCU.
To all users of these guidelines, we wish success in the application of the method and a most
prosperous future for their enterprise.
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
ACKNOWLEDGMENTS
CEN-PCU would like to express its gratitude to Dr. Richard Bonne who has been providing the
technical leadership in this activity and has allowed his method – the Comprehensive Hygiene
Management - to be applied for the benefit of the participating food SMEs and ASEAN. We
hereby express our thanks for his sustained efforts in the preparation of the teaching and
application tools, as well as his technical guidance which has benefited to all the actors and
beneficiaries of this programme.
Our deep appreciation also goes to Mr. Laurent Camberou and Mr. Nigel Wright who have been
accompanying the participating food SMEs in Indonesia and the Philippines, throughout the
process since 2004, and have directly contributed to the preparation of these guidelines,
enriching them with their experience and knowledge.
Warm thanks are also extended to the group of Indonesian, Filipino and Thai experts who have
been relaying the EU experts in the participating SMEs, and have made this project a success
story, namely: Mr. Visith Chavasit, Mrs. Ratih Dewanti, Mrs. May Gatchalian, Mr. Tenku A.R.
Hanafiah, Mr. Somchai Komolyingcharoen, Mrs. Lilis Nuraida, Mr. Pisit Rangsaritwukul, Mrs.
Puangpetch Silkarn, Mrs. Katchaporn Temyord, Mrs. Lusiani Tjokronegoro, and Mr. Priyo
Waspodo.
Our appreciation goes to the institutions which have been providing logistical support and
technical back-up to make the field activities possible, have managed the recruitment of trainees
and the identification of participating food SMEs in Indonesia, Philippines and Thailand, namely:
the National Standards Agency of Indonesia (BSN), the Bureau of Product Standards of the
Philippines (BPS), the Thai Industrial Standards Institute (TISI), The Indonesian Food &
Beverage Association (GAPMI), the Department of Food Technology & Human Nutrition of the
Bogor Agriculture University (IPB - Indonesia) and the Institute of Nutrition of Mahidol University
(INMU – Thailand).
Lastly, we would like to thank all the participating food SMEs which have voluntarily participated
in the pilot programme and allowed the team to use examples taken from their operation to
illustrate key aspects of these guidelines, namely:
•
In Indonesia : PT. Macroprima Panganutma, Tangerang, PT. Ciptayasa Putra Mandiri,
(Goldfrance Jakarta Timur), PT. Niramas Utama (Bekasi), PT. Nutrifood Indonesia
(Bogor), PT. Bina Mentari Tunggal (Fiva Food Subang), PT. Madusari Nusa Perdana
(Cikarang), PT. Morindo International (Cikarang), PT. Trias Sukses Dinamika (Bogor), PT.
Japfa Santori Indonesia (Tangerang),
•
In the Philippines : DGS (Metro Manila), Mura Sarap (Manila), Lety's Buko Pie Factory
(Manila), TSB (Manila), Gracious Food Dried Mangoes (Manila), Anjo Farms (Pangasinan),
Castillejos Farms (Manila), Cabalen (Manila), Le Chef International (Manila), Prime Fruit
Company,
•
In Thailand: PC. Farm Hydroponics (Bangkok),
Rimping Foodland Products Ltd
(Nonthaburi), P. Bangkok Meat Ball Ltd (Pathumthani), S. Khon kaen (Bangkok), Nongmon
SMJ Products co Ltd (Chonburi), Nakornthai Edible Oils (Suratthani), Namprik Maesri Ltd
(Nakorn Pathom), Chokpethsamut 1999 (Bangkok), Foodland Supermarket (Bangkok)
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
TABLE OF CONTENTS
PREAMBLE .................................................................................................................... 1
INTRODUCTION............................................................................................................. 3
CHAPTER 1 : GUIDE TO GOOD PRACTICE ................................................................ 6
1.1.
Construction of the Guide to Good Practice..................................................................6
1.2.
Building Standards, Suppliers Control, Pest Control Plan...........................................10
Buildings and Environment Conformity ..............................................................................................10
Pest Control Plan................................................................................................................................16
Contractual Relationship with Suppliers and Deliveries Control ........................................................19
1.3.
Personnel Health Policy ..............................................................................................23
1.4.
Hand Washing Rules and Cleaning Plan ....................................................................24
Hand Hygiene.....................................................................................................................................24
Work Clothing Hygiene.......................................................................................................................26
Premise Hygiene – The Cleaning Plan ..............................................................................................27
1.5.
Hot & Cold Technologies and Foodstuffs Formulation................................................32
Cold Chain Technology ......................................................................................................................32
Heat Processing Technology..............................................................................................................35
Control by Foodstuff Formulation (composition) ................................................................................36
1.6.
Finish Products Analysis – Bacteriological Tests ........................................................37
Products..............................................................................................................................................37
Surfaces..............................................................................................................................................37
Interpretation of the Flora ...................................................................................................................38
1.7.
Staff Training ...............................................................................................................39
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
CHAPTER 2 : HACCP Study ....................................................................................... 40
2.1
Transition to HACCP ...................................................................................................40
2.2
The HACCP Method....................................................................................................42
2.3
The HACCP 12 Tasks .................................................................................................43
Task 1: Select the HACCP Team.......................................................................................................43
Task 2: Describe the Product .............................................................................................................44
Task 3: Identify Intended Use.............................................................................................................45
Task 4: Construct a Flow Diagram .....................................................................................................45
Task 5: On-Site Verification of the Flow Diagram ..............................................................................46
Task 6: List all Potential Hazards Associated with Each Step, Conduct a Hazard Analysis, and
Consider any Measures to Control Identified Hazards.......................................................................46
Task 7: Determine Critical Control Points ..........................................................................................48
Task 8: Establish Critical Limits for each CCP ...................................................................................53
CHAPTER 3 : HACCP Plan ......................................................................................... 54
The HACCP 12 Tasks (continued)..........................................................................................54
Task 9: Establish a Monitoring System for each CCP .......................................................................54
Task 10: Establish Corrective Actions................................................................................................54
Task 11: Establish Verification Procedures........................................................................................55
Task 12: Establish Documentation and Record Keeping...................................................................56
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
CHAPTER 4 : GMP, GHP & HACCP AUDIT GUIDE ................................................... 57
4.1
Presentation of the Audit Guide ..................................................................................57
4.2
Grid 1/4 : Assessment of the Implementation of Pre-requisites ..................................57
2. Supplies..........................................................................................................................................58
3. Implementation of a system of traceability .....................................................................................59
5. Control of human sources of contamination...................................................................................60
6. Hands cleaning and material cleaning ...........................................................................................61
4.3
Grid 2/4 : Assessment of preliminary HACCP study step ...........................................62
Task n° 1 ............................................................................................................................................62
Task n° 2 ............................................................................................................................................62
Task n° 3 ............................................................................................................................................63
Task n° 4 ............................................................................................................................................63
Task n° 5 ............................................................................................................................................63
Task n° 6 ............................................................................................................................................63
Task n° 7 ............................................................................................................................................64
Task n° 8 ............................................................................................................................................64
4.4
Grid 3/4: Assessment of the drafted HACCP plan ......................................................65
Task n° 9 ............................................................................................................................................65
Task n° 10 ..........................................................................................................................................65
Task n° 11 ..........................................................................................................................................66
4.5
Grid 4/4: Routine evaluation of the real and effective implementation of an HACCP plan
in the company........................................................................................................................67
13. Implementation of the GHP ..........................................................................................................67
14. HACCP plan , CCP monitoring.....................................................................................................68
Grid n° 1/4 : Assessment of the implementation of pre-requisites ......................... 70
Grid n° 2/4: Assessment of the phase of preliminary HACCP study ...................... 74
Grid n° 3/4 : Evaluation of implemented HACCP plan.............................................. 77
Grid n° 4/4: Routine evaluation of the real and effective implementation of an
HACCP plan in the company ...................................................................................... 79
A project co-financed by the European Union
A project co-financed by ASEAN
Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
Ed1, 2005
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
APPENDICES ............................................................................................................... 81
APPENDIX 1 – AUDIT REPORT TEMPLATE ........................................................................82
APPENDIX 2 - HAZARDS.......................................................................................................83
APPENDIX 3 - CALIBRATION................................................................................................84
APPENDIX 4 – HACCP CERTIFICATION..............................................................................86
APPENDIX 5 – CORRELATION WITH OTHER STANDARDS ..............................................88
A project co-financed by the European Union
A project co-financed by ASEAN
-1Preamble
PREAMBLE
This guide has been designed to take food producers through practices that may be adopted in
order to assure the production of safe food. It has been devised by a team of European food
specialists in a one year EC-ASEAN cooperation project.
It is designed to provide practical advice to food SMEs towards the application of the ASEAN
Common Principles and requirements for Food Hygiene1.
Control for safe food should not be viewed only as a tool for the preservation of health and life. It
maintains financial economy by enforcing good visible practices, reducing waste, assuring
customers and other parties (including insurance companies) of good management, and
minimising the risk of food recalls (which can be almost impossible in an export context).
Businesses using this approach will also find improvements in the competence of management
and staff because this methodology involves such people in exercises that require discipline,
self-critique, analysis and the implementation of resulting controls in a systematic way.
In essence, this guide covers the important stages of establishing :
a. good practices throughout the food production process (nowadays, often described as
‘Prerequisites’)2 ; and
b. a risk analysis process called HACCP (Hazard Analysis Critical Control Point) that has been
adopted worldwide because of its success in controlling identified hazards.
The intent is a practical route for identifying gaps in safe-food control systems. It involves the
use of four audit grids (matrices) (numbers 1/4, 2/4, 3/4 and 4/4) that direct the user along a path
to a complete safe-food system.
Figure 1 : Practical Route for identifying gaps in safe-food control systems
Grid 1/4
Implementation of
pre-requisites
Grid 2/4
HACCP study
Grid 3/4
HACCP plan
Grid 4/4
Routine evaluation
of the HACCP
system
Safe food
system
1
Harmonised ASEAN requirements for food hygiene based on Codex standard, 2006.
The term ‘prerequisite’ has been adopted since HACCP methodology came into use because implementers of safefood programmes have found that basic good practices need to be in place before HACCP is introduced in order to
keep the HACCP analysis and resulting control methods within a manageable scale – in fact, HACCP is impossible
without effective prerequisite establishment.
2
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
-2Preamble
Note
It is recognised that, in the supply chain (particularly when applied to sourcing ingredients from
primary agricultural sources, such as small market gardeners or from local markets) that food
manufacturers face difficulties in applying complete control on such supplies (e.g. for pesticide
residue and other chemicals control etc.).
This must not be used as an excuse to not address these issues.
Co-operation between agencies (e.g. food producer associations, government health / agriculture
ministries, test businesses), must be taken to promote hazard control by the adoption of agreed
protocols or chemical application schemes. By taking a lead in this matter, food manufacturers
will be well placed if there is ever any dispute following a safety incident.
Critical Note
All safe-food programmes lead to systems that need to be REVIEWED (as times, people,
processes and regulations change). No system is perfect. There is a tendency for businesses to
assume that, once a system is in place, all is O.K….
THIS SIMPLY IS NOT THE CASE.
A system is only as good as its worst failure. Use, re-use and re-use again the audit grids.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
-3Introduction
INTRODUCTION
This guide involves a practical four stage approach to the introduction of Prerequisite and
HACCP programmes:
1.
Good practices: Assessment and Implementation of Prerequisites
•
Compare the situation of the company with a scheme of Comprehensive Hygiene
Management for SMEs.
•
Identify the items of the scheme which have not, or have only been partially satisfied
amongst those which have been fully implemented, by answering the following questions:
item 1
o are the buildings and equipment in compliance with regulations and
standards?
o does a contractual relationship with raw material suppliers exist?
o does an effective pest control plan exist?
item 2
o is a policy of staff health control defined and applied?
item 3
o are the rules of hands washing and personal hygiene defined and
applied?
o does a cleaning plan of the buildings and equipment exist and is it
effectively applied ?
item 4
o do control procedures of the different "time/temperature" couples
implemented in the company exist?
o is there a control of the products formulation constancy?
item 5
o does a sampling and analysis plan of the finish products exist?
training
o is staff training ensured and regularly updated?
•
The first part of this guide is devoted to good practices and to the search for provisions
that need to be implemented in order to comply with any practices that have not, or have
only partially been, implemented;
•
Using audit grid 1/4 (developed for this guide), an initial assessment phase is completed
by an evaluation of the prerequisites implementation stage
•
With the help of the explanatory booklet, assurance is provided that criteria of the audit
(grid 1/4) are entirely fulfilled before starting to carry out HACCP implementation (first
phase) that is devoted to a preliminary study of the food manufacturing process.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
-4Introduction
Figure 2 : Detail of the first stage of the approach
Grid 1/4 : Implementation of pre-requisites
2
3
4
5
1
Comprehensive
Hygiene
Management
2.
3.
Grid 2/4
HACCP
First phase of the HACCP method (tasks 1 to 8)3: the HACCP Study
•
HACCP method analysis, task-by-task, without being allowed to pass to the next task until
the preceding one is entirely carried out;
•
Audit by the use of grid 2 /4 (relating to the preliminary analysis phase of HACCP method)
to check that each task carried out is completely and correctly fulfilled;
•
With the help of the explanatory booklet, assurance that the criteria of audit grid 2/4 are
entirely fulfilled, before being allowed to proceed to implementation of HACCP method
second phase (devoted to HACCP plan design).
Second phase of the HACCP method (tasks 9 to 12) : design of the HACCP plan
•
HACCP method implementation, task-by-task, without being allowed to pass to the next
task until the preceding one is entirely carried out;
•
Audit by the use of grid 3/4 (relating to HACCP plan design) to check that each task has
been carried out is completely and correctly fulfilled;
•
With the help of the explanatory booklet, assurance that the criteria of audit grid 3/4 are
entirely fulfilled, before being allowed to start operating the HACCP plan.
3
HACCP is based on seven principles, but these are utilised through a process involving a number of activities or
Tasks. There is a variety of systems devised for HACCP implementation, each defining a different number of such
Tasks. This guide uses the 12 tasks recommended in the joint FAO/WHO Codex Alimentarius General Principles of
Food Hygiene (CAC/RCP 1-1969, Rev.4-2003).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
-5Introduction
4.
Third phase: Routine evaluation of the operating HACCP plan
•
With the help of the explanatory booklet, make sure that the criteria of the audit grid 4/4
(relating to the real and effective operation of the HACCP plan) are entirely fulfilled;
•
If all of the criteria of audit grid 4/4 are not fulfilled, return to stages 3, 2 or even 1 (above).
The methodology described in this guide has been designed to deliver an
effective safe food system for all food producers.
There will be circumstances where producers use or develop, under their
responsibility, other methods of management.
This is, of course, perfectly acceptable so long as the method delivers:
•
EFFECTIVE CONTROL;
•
ANY EVIDENCE OF EFFECTIVENESS REQUIRED.
REMARK
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
-6-
3
4
Guide to Comprehensive Hygiene Management
CHAPTER 1 : GUIDE TO GOOD PRACTICE
1.1.
Construction of the Guide to Good Practice
This guide follows a logical route to defining the organisation of good practice, which can be
illustrated by the following diagrams:
Lack of health control
at recruitment
(and later)
OPERATORS
Lack of hygiene
control in
handling
CONTAMINATION
ENVIRONMENT GERMS
Premises, tools,
Pests, raw materials
Lack of control of
physico-chemical
parameters: time, T°
pH, Aw
Over population of
common flora and/
or disease bearing
germs
DEVELOPMENT
LOSS
TOXI-INFECTION
PRINCIPLE OF ROUTE
OF MICROBIOLOGICAL
OUTBREAK CAUSING
ECONOMIC LOSS OR
FOOD-BORNE POISONING
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
-7-
3
4
Guide to Comprehensive Hygiene Management
K E Y D EDU CT ION S FR OM T HE D IAG R AM O F O U TB R E AK
O F E C O N OM IC AL LO S S O R
FO O D - B O RN E P O IS ON IN G
•
The concom itant intervention of the contam ination and the
m ultiplication is essential to the appearance of a food
accident
•
This diagram explains the m echanism of action of all the
preservation m ethods, w hich reciprocally establishes its
validity
– total control of contam ination or m ultiplication induces a long
lasting preservation (canning, freezing)
– partial control of only one factor or of the both , induces a
short lasting preservation (refrigeration, pasteurization)
Dr Richard BO NNE 2006
ACTION MODE & DURATION OF PRESERVATION METHODS
Methods
Cold
Heat
Modified
atmosphere
Stabilization
Irradiation
Dehydratation
Pressure
Mode & duration (long lasting or limited)
Refrigeration
Freezing
Canning
Pasteurization
Limitation of bacterial growth
Inhibition of growth
Total elimination of contamination
Reduction of contamination (followed by
refrigeration)
Hot chain
Inhibition of growth
Vacuum package Inhibition of adulteration aerobic flora
Gas (CO²,N²)
Inhibition of adulteration aerobic flora
By sugar
By salt
By vinegar
Ionisation
Growth inhibition through lowering of Aw
Growth inhibition through lowering of Aw
Growth inhibition through lowering of pH
Total elimination of contamination
Drying
Freeze-drying
Ultra high
pressure
Growth inhibition through lowering of Aw
Growth inhibition through lowering of Aw
Total elimination of contamination
Dr Richard BONNE 2006
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
-8-
3
4
Guide to Comprehensive Hygiene Management
This flow can be used to define and organise the food safety policy of the
company. All elements of the above schematic will be addressed by 5 sets of
control provisions to organise the Comprehensive Hygiene Management©
scheme.
Each set of control provisions is explained in chapter one of this guide.
Each set of control provisions is referred to by a specific colour code: Cian,
Green, Red, Bleu or Grey.
IMPORTANT
Figure 3: Five sets of control provisions
2
3
PERSONNEL
HEALTH
POLICY
4
HANDS
WASHING
RULES &
CLEANING
PLAN
Lack of health
control at
recruitment
(and later)
OPERATORS
Lack of hygiene
control in
handling
CONTAMINATION
5
HOT & COLD
TECHNOLOGIES
+
FOODSTUFFS
FORMULATION
Lack of control of
physico-chemical
parameters: time, T°
pH, Aw
MULTIPLICATION
FINISH
PRODUCTS
ANALYSIS
Over population of
common flora and/
or disease bearing
germs
LOSS
TOXI-INFECTION
1
BUILDING STANDARDS
SUPPLIERS CONTROL
PEST CONTROL PLAN
ENVIRONMENT GERMS
Premises, tools, pests,
raw materials
STAFF TRAINING
COMPREHENSIVE
HYGIENE
MANAGEMENT©
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
-9-
3
4
Guide to Comprehensive Hygiene Management
And hence:
The General Organization of the Guide of Good Practice or Comprehensive Hygiene
Management© scheme:
1
Building Standards, Suppliers Control, Pest Control Plan
2
Personnel Health Policy
3
Hand Washing Rules & Cleaning Plan
4
Hot & Cold Technologies + Foodstuffs Formulation
5
Finish Products Analysis
2
PERSONNEL
HEALTH
POLICY
3
4
HAND
WASHING
RULES &
CLEANING
PLAN
5
HOT & COLD
TECHNOLOGIES
+
FOODSTUFFS
FORMULATION
FINISHED
PRODUCT
ANALYSIS
1
BUILDING STANDARDS
SUPPLIERS CONTROL
PEST CONTROL PLAN
STAFF TRAINING
COMPREHENSIVE HYGIENE
MANAGEMENT©
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
- 10 -
Building Standards, Suppliers Control, Pest Control Plan
1.2.
Building Standards, Suppliers Control, Pest Control Plan
Buildings and Environment Conformity
The design of new buildings, or the improvement of the existing buildings and equipment, should
respect the following principles:
¾ General principles
•
The plant should have at least four doors:
one door for the entry of raw materials
one door for the entry of production staff
one door for the shipment of finished products
one door for waste disposal
•
The onward flow principle.
Successive production operations should ensure a forward progression of products, without
back return, from the lowest level of development towards the highest one, from the least
healthy condition towards the healthiest one, from the least susceptible condition towards the
most susceptible one.
In order not to flout this rule, operators should not move from place to place - they should
maintain work at the station at which they are placed.
•
No production line criss-cross.
Two (or more) production lines should not crisscross. They can be connected (e.g. assembly
of composed products put into a previously washed package) or split (e.g. manufacturing
lines of by-products obtained during the preparation of the main product).
•
Separation of cool and warm zones.
Zones where hot foodstuffs are treated shall be clearly differentiated from those where cold
ones are treated in order to avoid their thermal pollution.
•
Separation of clean and dirty areas.
Waste produced with each stage of manufacture should be removed in the most direct way
possible towards its treatment location(s) (e.g. dishwashing) or storage (e.g. waste handling).
¾ Construction Regulation and Standards
•
Floors shall be:
smooth and impermeable
non-skid
hard-wearing
washable
not subject to rot
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 11 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
- 12 -
Building Standards, Suppliers Control, Pest Control Plan
•
Walls shall be:
smooth
light coloured
washable
not subject to rot
‘shock-resistant’ (up to 2 metres high)
bonded to the floor by semicircular joints, with no nooks or crannies, to
allow easy cleaning and drainage of wash and rinse water (see diagram
below)
Figure 4: Semicircular joints between walls and floors
...suggested 6 cm…
.radius of curvature.
wall
Not
OK
OK
Not
OK
floor
•
Ceilings shall be:
light coloured
washable
smooth
•
Passive or mechanical ventilation devices must ensure the elimination of steam and
smoke
•
Lighting shall be:
bright
neutral in colour (so as not to modify the foodstuff colours)
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 13 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
- 14 -
Building Standards, Suppliers Control, Pest Control Plan
¾ Equipment conformity
•
Equipment shall be:
smooth
not subject to rot
stainless
washable (without nooks and crannies that are inaccessible for cleaning)
Compliance with these rules prohibits the use of undressed wood, cardboard or tape for the
manufacture of furniture (or their use in temporary repairs)
Equipment should not be placed adjacent to walls so as to allow for proper cleaning and for
proper pest and cleaning inspection.
•
Materials used to manufacture tables shall be:
smooth
light coloured
washable
not subject to rot
hard-wearing
impermeable
The compliance with these rules prohibits the use of undressed wood or cardboard, and
porous or rough materials like undressed concrete. The materials most often used are
stainless steel, plastics and glazed earthenware tiles.
•
Tools shall be:
inalterable in all parts.
The compliance with this principle prohibits the use of wood even for the handles of tools.
The materials most often used are stainless steel, aluminium (which may not be allowed by
some food control authorities, in the US for example) and plastics.
•
Machines shall be:
not subject to deterioration, preferably stainless, definitely non-corrosive.
easily dismantled.
washable (without nooks and crannies that are inaccessible for cleaning).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 15 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 16 -
1
Building Standards, Suppliers Control, Pest Control Plan
Pest Control Plan
Pests generally taken into account are rodents and insects (and, in S.E. Asia, some small
amphibians). In certain sectors (e.g. hypermarkets or other large spaces) birds may settle in the
superstructures of the buildings or cats (e.g. in slaughter-houses) can soil the environment whilst
attacking stored foodstuffs.
¾ Passive control, surroundings and outbuildings keeping
In order not to allow the settlement of pests on the plant surroundings, (i.e. not to provide
them places of refuge and feed resources) it is necessary to maintain a non-attractive
environment which includes:
•
Isolated storage of unutilised materials, pallets and machines, without contact with the
walls of the buildings.
•
Design and maintenance of external spaces, including:
-
The elimination of holes and spaces in waste land with high vegetation.
The regular short shearing of grass lawns.
The absence of rags, papers, plastic films and other detritus abandoned on the
ground (sources of materials for the construction of rodent nests).
•
Keeping of interior surfaces (racks, tops of furniture pieces) clean so as not to leave feed
sources for rodents and insects.
•
Tidying and cleaning of technical buildings (machine shop, boiler room) so as not to
support rodent settlement.
•
Installation of mosquito nets at windows and suitable screens on access doors.
•
Rigorous management of waste containers which shall include:
-
Frequent washing so as not to attract insects.
Storing on a clean and easily washable surface (water tap and floor drainage of
waste water).
Kept closed (to prevent use as a feed source by all types of pests).
Filling without overflowing (not to drop food waste on the ground).
¾ Active control
Pests detection
•
Insects:
-
•
Search for dead insects.
Search for alive insects in places of refuge (drawers).
Search and careful removal of bodies in electric insects trap collectors.
Rodents:
-
Search for rodents dropping or traces of urine.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 17 -
1
Building Standards, Suppliers Control, Pest Control Plan
-
Search for attacks on foodstuffs (biting traces) or attractive conditions (torn open
bags).
Presence of traces of grease of rodents on the usual passing through points.
Search for nests of rodents.
Rodents control plan
This plan is composed of a complete (set of) document(s), defining actions to be
implemented, and including:
•
Technical cards of rodent poisons utilised.
•
Procedure and time tabling of rodent control operations, including the checking and
renewal of distributed poison baits.
•
Time tabling and procedure for identification, evaluation and elimination of possible rodent
infestation.
•
Implementation procedure of additional treatment in the event of a residual infestation.
•
Factory plan on which the locations of poison baits are identified.
•
Identification on walls of the premises in order to locate poison baits.
Insect control plan.
This plan is composed of a complete (set of) document(s), defining actions to be
implemented, and including:
•
Technical cards of insecticides utilised.
•
Time tabling and procedure of insect control operations (walls insecticides, paint
application and renewal, premise insecticide spraying).
•
Factory plan on which are localized the poison baits devoted to crawling insects.
•
Factory plan on which the locations of electric insect traps are identified.
•
Timetabling and procedure for traps emptying and trapped insects monitoring in order to
evaluate infestation levels.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 18 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 19 -
1
Building Standards, Suppliers Control, Pest Control Plan
Contractual Relationship with Suppliers and Deliveries Control
¾ Raw materials specification.
In order to have a sound basis for deliveries’ control, the characteristics of ordered raw
materials need to be specified precisely with suppliers. The conditions of acceptance /
rejection of batches also need to be clearly defined. Raw materials specifications should
include:
•
Cards of specification of raw materials.
•
Formulation defining physico-chemical composition, presentation, particle or chunk size
and variability, constants (e.g. pH, Aw, salt or sugar concentration, viscosity of the
liquids).
•
Condition defined by type, volume, shape.
•
Labelling (in particular with food safety official marks and elements of traceability).
•
Bacteriological standards (lawful or contractual) (possibly including contractual access to
results of bacteriological control plans set up by suppliers).
•
Purity criteria, including absence of, or allowed levels of, foreign bodies (plastic, glass,
metals) or residues (heavy metals, pesticides,…).
•
Condition for and responsibilities in case of inspection failure (removal, replacement etc).
¾ Preferential choice of suppliers benefiting from:
•
Certification (e.g. ISO 9001, ISO 22000) ,
•
or of a national or international approval (e.g. EEC and USA approvals),
•
or of other approvals (Halal, Kosher, vegetarian, GM free, retailer promoted assurance
schemes, etc),
•
or of an accreditation or a referencing by a recognized customer.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 20 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 21 -
1
Building Standards, Suppliers Control, Pest Control Plan
¾ Preferential choice of suppliers accepting customer visits of their production site.
¾ Recording cards of deliveries check.
These cards shall allow for minimum control of the following criteria:
•
Delivery temperature of the product (see Appendix – Calibration).
•
Use-by date or deadline of optimal use.
•
Labelling conformity and, in particular, official food safety marks.
•
Appending of batch identification marks necessary to operate any upstream and
downstream traceability system.
•
Free from packaging damage.
•
Cleanliness of delivery vehicles.
Details of parameters checked / inspected on deliveries may be recorded in a variety of ways,
perhaps either on check cards or by use of an inspection grid, printed from ink pad, on the
reverse of delivery orders.
¾ Receiving (into storage) procedures for raw materials following delivery checks, and
any initial decontamination operations.
Some care must be taken during introduction of raw materials into storage:
•
Maximum time duration following arrival of raw materials into temperature controlled
storage (chill rooms and cold rooms) shall be defined and respected.
•
Soiled packaging (outer cardboard boxes, wooden pallets or supports, etc) shall be
eliminated before placing raw materials in clean stores.
•
If fruits or vegetables undergo a decontamination treatment by steeping in disinfectant
solution (chlorination, ozonisation, …) the concentration of disinfectant and process time
(max and / or min) shall be defined and controlled for each batch.
¾ Rejection. Procedures.
The application of a rejection procedure must correspond to the clauses drawn up by contract
with the supplier. The following needs to be recorded on rejection cards:
•
Reference(s) of the rejected batch (identification, constitution).
•
The reason for rejection by reference to conditions defined in the supply contract.
•
Signatures of the conveyer and the receiver.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 22 -
1
Building Standards, Suppliers Control, Pest Control Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
2
- 23 Personnel Health Policy
1.3.
Personnel Health Policy
Enforcement of staff (and management) health policy depends theoretically on food factory
occupational health care. It is nevertheless necessary to recommend the following provisions:
•
An annual medical consultation of every operator concerned in handling or manufacturing
of foodstuffs.
•
The systematic monitoring of staff for lesions caused by staphylococcus through clinical
examinations of arms, hands, face, throat and other exposed skin, to be carried out by a
medical practitioner of appropriate food handling experience.
•
The systematic monitoring of staff for potential Salmonella carriers (probably subject to
frequent bouts of diarrhoea) by conversing with a medical practitioner from industrial
medicine.
•
Enforcement of detection procedures for operators likely to carry Staphylococcus or
Salmonellas, by way of bacteriological analysis.
•
Medical treatment for those diagnosed positive with one of these two micro-organisms
(without penalty so as to ensure staff confidence in the scheme).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 24 Hand Washing Rules & Cleaning Plan
1.4.
Hand Washing Rules and Cleaning Plan
Hand Hygiene
The hands, frequently in direct contact with foodstuffs, need to be considered as the first
operational tool. For this reason, detailed attention must be given to their cleanliness (just as with
any equipment placed at the operator’s disposal) and to their washing regime. It should be noted
that the hands, if not subjected to strict hygiene rules, constitute the first vector of contamination
of food stuffs, by germs (pathogens) passed on from the operator.
The implementation of training to demonstrate the proper technique for hand washing and drying
is recommended.
¾ Hand wash sinks
Hand wash sinks shall conform to the following principles:
•
Water flow shall not be operated by hand, but by foot or knee or by an automatic
presence detector.
•
Liquid (or foam) soap shall be bactericidal but not a skin irritant (thereby excluding toilet
soaps without bactericidal effect).
•
Soap dispensers shall be placed in a position adjacent to the wash sinks.
•
A second dispenser reserved for a disinfecting solution (e.g. of alcohol solution) can be
associated with the liquid soap dispenser.
•
The device devoted to hand drying must be of single use (paper towels being practically
the only possible solution).
•
Nailbrushes complete the wash-stand equipment. They should be made entirely from
synthetic matter (handle and bristles) and need to be kept in a dilute clean disinfectant
solution, renewed for each work period.
¾ Hand washing procedure
•
Wetted, liquid soap-smeared hands must be rubbed for 20 seconds (the operator
counting: 101 . . . 102 . . . 103 . . . up to 120).
•
The rinsing of hands, which are rubbed under running water, must last a minimum of 10
seconds (counting…).
•
Wiping of the hands is not systematic, not being necessary for certain types of activities.
•
If a disinfectant solution is used, it shall be allowed to dry naturally on the hands.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 25 Hand Washing Rules & Cleaning Plan
¾ Hand washing frequency
With effective hand washing taking a long time, strict definition of the frequency and
circumstances of this procedure is needed. Hands must be effectively washed whenever and
wherever their contamination is practically certain. This washing, carried out immediately
after dirty operations, will restore hands to satisfactory cleanliness and will prevent any points
in contact with hands from gross contamination. If these contact points are themselves
grossly contaminated, hand hygiene is not possible because, as work continues, they are
immediately recontaminated.
¾ Complete hand washing after dirty operations (or dirty situations)
(practically the same in all branches of the food industry4:
•
Arrival at the work station.
•
Passing through and / or using toilets or changing rooms.
•
After nose blowing.
•
After dustbin handling.
•
After handling cardboard boxes from delivery (cardboard box bases are often very dirty).
•
After handling shell eggs (frequent contaminated by salmonellae).
•
After handling non-cleaned vegetables direct from the soil.
•
After handling game or poultry ‘in fur or feather’.
•
while passing from raw food production areas to cooked food product areas (i.e. from low
risk to high risk areas).
•
In this case materials used (cutting boards, knives, etc…) must similarly be changed or
correctly cleaned.
¾ Quick hand washing before conducting clean operations
There is a multiplicity of clean operations, each specific to a branch of the food industry (e.g.
cooked meat cutting, assembly of pastry making...). Whilst remaining at work within the
confines of an appointed process, only a quick hand wash procedure is necessary, so long
as operators systematically care about washing their hands after previous dirty operations
and if contact point hygiene control is maintained.
¾ Hands contact points hygiene
•
Hands contact points shall be listed (handles of refrigerators or doors, kitchen utensil
handles, machines, electric switches, etc).
•
These contact points must be the object of meticulous daily cleaning (or even at each
restart at the work station or with a change of operator).
4
This list is not limitative and sometimes must be completed according to the specific situation of each food
establishment.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 26 Hand Washing Rules & Cleaning Plan
¾ Additional rules
•
No smoking at the work station, in the work place or whenever wearing work clothes.
•
No food tasting involving hand-to-mouth.
•
No nail varnish (or perfume - this is not a hygiene concern, but is one of potential food
taint).
•
Maintaining neat short finger nails.
•
No rings, jewellery or watches to be worn (even if wearing work gloves).
•
The washing of gloved hands must be carried out with the same régime as for bare
hands.
•
No reuse of disposable gloves after removal.
Work Clothing Hygiene
In agro-food industries, clothing can be a major vector involved in food contamination. Work
clothing, when not clean, can be a source of contamination for hands, whenever it is used to
wipe them. In certain sectors, such as butchery, clothing is in direct contact with handled
carcasses, (e.g. in shouldering carcasses when loading delivery vehicles).
Work clothing management must respect some specific principles:
•
It is of a standard type and is provided by the company.
•
It is put in a locker (or a compartment of cupboard), physically separated from personal
clothing (the locker shall be maintained in a clean manner).
•
Its colour, or the colour of one of its elements (cap, overall), may be specific to a work
station or a zone of assignment of operators.
•
It includes a cap or net which covers all hair – this includes snoods for moustaches and
beards (head covering may also be devoted to other purposes, such as shock proof
helmets).
•
It includes shoes (crush proof and non-skid) which are only worn in the factory (foot wear
shall not contaminate work wear in a locker).
•
It is laundered by the company or under its responsibility (e.g. by contract with an
industrial laundry – in this case the wash method shall be defined to ensure that laundry
is not cross contaminated from dirty clothing from other sources).
•
It is :
•
hard-wearing to mechanical actions (tear) and frequent washing,
ignition proof.
permanent devices (boots/shoes washstands) or movable ones (trays), containing a
disinfecting solution, must allow cleaning/disinfection of shoes or boots before getting
into the production zone
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 27 Hand Washing Rules & Cleaning Plan
Premise Hygiene – The Cleaning Plan
Good hygiene of buildings and equipment involves the enforcement of a cleaning plan.
¾ There are at least two copies of the cleaning plan in the factory:
•
A complete version of the document, held and updated by the
department of quality management, and to which technical cards
of cleaning and disinfection products used are attached, as well as
directions for use of machines used in cleaning processes;
•
A divided version, allowing each cleaning operative of the cleaning
plan to have the part(s) which relates to her/his duty.
IMPORTANT
¾ In the cleaning plan file, tasks checklists are included, as well as
expected results of surface bacteriological tests.
¾ The execution of cleaning tasks must be followed up by recorded
checks by the operative, immediately monitoring its effectiveness.
¾ Conducting microbiological analyses of surfaces makes it possible to
check the effectiveness of the cleaning plan.
The method known as ‘W.W.W.W.W.H.’ (mnemonic - five Wives and one Husband) makes it
possible to draft a suitable cleaning plan. These letters stand for six questions (when? who?
what? where? why? and how?)5 that direct the development of the plan.
The choice of the first question (asked from When? or Who? or What?) defines the process of
organising tasks in the cleaning plan:
•
‘When?’
–
cleaning tasks will be organised by day, by week, by month (by schedule)
•
‘Who?’
–
cleaning tasks will be assigned by operator, by team…
•
‘What?
–
cleaning tasks will be organised according to building, department
and equipment
5
Frequently referred to as ‘The Six Honest Serving Men’ – for the poetic minded, refer to ’Just So Stories’ by Rudyard Kipling.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 28 Hand Washing Rules & Cleaning Plan
¾ ‘W.W.W.W.W.H.’ method application
DRAFTING of the CLEANING PLAN:
WHAT ?
W.W.W.W.W.H.
Plant description analysis
Tables, shelves, furniture
Surfaces
Floors, ceilings, walls, doors
Groups
Rooms
Equipment
Machines
Tools, utensils
Answering to this question :
¾ ensures that all components of the establishment are included in cleaning operations.
¾ eliminates useless equipment and objects which get in the way of cleaning.
¾ identifies each mobile component of a group (trolleys, container . . . ) with a marked
number to ensure its regular cleaning and maintenance.
¾ constitutes component groups, for which cleaning responsibility is entrusted
to a defined operator.
W.W.W.W.H.
DRAFTING of the CLEANING PLAN: W.
WHO ?
Operations Entrusted to Cleaning Operatives
By workstation
Production staff
Assignments
Cleaning staff or
Cleaning supplier
By skill
responsibility
Answering this question must respect some principles:
¾ even if employing an internal cleaning team or a cleaning contractor, production staff
must never be completely detached from cleaning
¾ the cleaning plan must define the state in which production staff hands on materials
to the cleaning team (switched off, dismantled, rinsed, excess dirt removed . . . )
¾ the cleaning plan must define the state in which the cleaning team hands back
materials to the production staff (lubricated, reassembled, switched on . . .)
¾ if a contractor is responsible for cleaning, the cleaning plan provides the basis
for the customer / supplier relationship by defining tasks set out in the contract
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 29 Hand Washing Rules & Cleaning Plan
W.W.W.H.
DRAFTING of the CLEANING PLAN: W.W.
At work place or at cleaning site
WHERE ?
Cleaning Frequency
WHEN ?
¾ after each operational time (batch, shift . . . )
¾ in catering, after each service
¾ daily
Defining cleaning days is required for any longer time intervals demanded:
‰ in order to check if the frequency is really applied
‰ to be able to control the continued application of identified cleaning tasks
For example
Weekly
Monthly
Quarterly
Annually
every Monday
every first Tuesday of each month
every first Saturday of each quarter
during each annual shut down
DRAFTING of the CLEANING PLAN: W.W.W.W.W.H.
HOW ?
Physical
Dismantle
Brush off, scrape
Order of operations
Chemical
Cleaning solution concentration
Temperature
Required application time
Appropriate application method
¾ the drafting of this procedure must ensure that it is legible and comprehensible
for operators
¾ cleaning procedures must take account of the nature of the dirt (mineral or organic)
¾ cleaning procedures must take account of the nature of surfaces to be cleaned
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 30 Hand Washing Rules & Cleaning Plan
W.H.
DRAFTING of the CLEANING PLAN: W.W.W.W.
Required Results
WHY ?
Visual Cleanliness
Daily or Weekly defined check lists
Microbiological cleanliness (microbiological testing for surface contamination)
Required
• Standards:
• Methods:
microbial population tolerated per unit of surface
culture medium, Petri film, swabbing . . .
Providing information as a role in the implemented system of risk control
• Confirmation of the effectiveness of the cleaning plan (GHP).
• In the event of non-satisfactory results:
¾ any action needed on the products manufactured during the
control period – no action on products because such
testing is only a ‘snap shot’ validation of effectiveness of
cleaning operations and has no bearing on the potential
hazardous state of a product.
¾ is cleaning plan discipline being maintained ?
¾ is revision and modification of the cleaning plan required ?
¾ Tool cleanliness during production time
During use, manual tools need to be subject to cleaning and frequent disinfection practices
by rinsing and putting in a hot water sterilizer (82°C):
•
the same tool is regularly cleaned and decontaminated by putting in the sterilizer,
•
or several tools are used and placed in the sterilizer alternately,
•
or all tools are changed periodically to be replaced by clean and disinfected material
(every hour, every 30 minutes, etc…).
These operations of cleaning and disinfection of manual tools shall be carried out:
•
After work on a soiled product (e.g. hide cutting in slaughter-house).
•
Before passing from working on raw foodstuffs to cooked foodstuffs.
•
In some operations, such as hide removal in an abattoir, operators are required to pass
the tool from one hand to the other. In this case the secondary hand, already soiled,
becomes the operating hand which holds the tool. Care needs to be taken to ensure
effective cleaning of both tool and hand.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
3
- 31 Hand Washing Rules & Cleaning Plan
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
4
- 32 Hot & Cold Technologies and Foodstuffs Formulation
1.5.
Hot & Cold Technologies and Foodstuffs Formulation
Cold Chain Technology
The application of cold chain technology allows a routine control of physical parameters (time
and temperatures), their monitoring and their recording. The monitoring of these parameters, for
each batch stored or processed, allows the introduction of CCPs, if an HACCP risk analysis
indicates that this is necessary.
In general, cold storage (frozen or chill) is reserved for high quality products. Cold application
(freezing or chilling) needs to be conducted as quickly as possible and the appropriate low
temperatures maintained continuously until further processing or consumption.
¾ Chilling
Chilling is the application of non-freezing cold temperature conditions to preserve foodstuffs.
This technique only allows for the slowing down (not cessation) of deterioration.
Consequently, it can be applied to foodstuffs only for relatively short periods according to
food type, such as only 2 or 3 days for minced meat, to perhaps a few weeks for some
pasteurized products.
•
To avoid taint by other odours, or contamination from the cold storage ventilation, or
dehydration, chill stored products must be protected :
-
by food wrapping film;
by an entire packing wrap.
•
Any stacking of containers of unprotected foodstuffs must be avoided in order to prevent
contamination of foodstuffs in lower containers from dirty bases of upper containers.
•
Products of different food groups (meats, vegetables, fish...) need to be stored, if at all
possible, in separate cold rooms.
•
In the absence of separate chill storage rooms, it is necessary to store each type of
product on a specific rack so as to avoid cross contamination (especially vertically) by any
exuded liquids, with the most contaminated products on the lowest racks in order to
minimise contamination by gravity.
•
‘FIFO’ (first in/ first out) must be followed for each type of product. (The use of products
of the same type in order of expiry date is an alternative to FIFO).
•
‘FIFO’ is fulfilled by effective control of product turnover, made possible by enforcement of
a traceability system.
•
Expiry dates, on products’ packaging, must be rigorously respected.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
4
- 33 Hot & Cold Technologies and Foodstuffs Formulation
•
Storage of unprotected foodstuffs directly on the floor (as well as packed products), must
be rigorously prohibited, because it constitutes:
-
an obstacle to cleaning the floor;
subsequently, a source of contamination of work surfaces when products are
used;
a potential source of hands contamination during the handling of heavy or bulky
products.
•
Ventilations ducts of chill rooms, and air dispersal socks in chilled work rooms, must be
regularly cleared of dust and be washed, to avoid the spread of the spores of moulds
accumulated on grids, ventilators and sock materials.
•
The temperature of chill rooms must be regularly recorded for monitoring purposes, if at
all possible by the use of automatic devices (automatic graph or computerised) for
continuous recording.
•
Alternatively, by direct temperature measurement and recording, checked in the stored
product, at least once per day but preferably more frequently (based on the degree of
confidence in the refrigeration equipment involved and use patterns of the store).
¾ Quick chilling
This rapid cooling technique relates mainly to products cooked in advance, and to
pasteurized products, after partial microbial decontamination by the heating process. Its use
must respect particular principles :
•
The operation of a fast cooling chamber (or other suitable method) whereby the internal
temperature of products must go down from 63°C (or more) to 10°C (or less) in under 2
hours.
•
Dividing the mass of product into smaller quantities makes the achievement of good rapid
chilling performance possible.
•
To ensure the attainment of the required performances, for each batch of production
identified, core product temperature shall be monitored, from chill start to finish.
•
This monitoring, for each batch processed and then through storage, allows
implementation of CCPs, if an HACCP risk analysis indicates that this is necessary.
¾ Freezing
Freezing inhibits virtually all microbial activity (through low temperature and the effective
withdrawal of available water). It also strongly retards deterioration of biochemical origin
(such as rancidity). Consequently the frozen product can be successfully preserved for
several months (generally for up to 12 months, although longer periods can provide
acceptable product subject to strict control and possible testing).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
4
- 34 Hot & Cold Technologies and Foodstuffs Formulation
However certain principles must be respected in using this technique:
•
The core temperature must be reduced to below freezing point as quickly as possible.
•
Dividing the mass of product into smaller quantities makes the achievement of good rapid
freezing performance possible.
•
Maintaining air circulation around each product piece when divided.
•
Freezing in a frozen cold store does not produce foodstuffs of good organoleptic quality,
due to cell breakdown caused by a slow freezing rate. It is also prejudicial to the quality of
frozen products already within store.
•
Foodstuffs intended to be frozen should be placed in its protective package before the
freezing process, to avoid surface deterioration by cold burn.
•
FIFO (see chilling above) principles should be maintained.
•
The temperature of storage freezers must be regularly checked:
-
by using automatic devices (automatic graph or computerised) for continuous
recording; or
by direct measurement and recording of temperatures, checked between two
surfaces of the stored foodstuffs held tight together, at least once per day, by
using thermometer probes.
¾ Defrosting
Frozen foodstuffs, generally not usable in this state, are frequently subject to a defrosting
phase prior to use. Defrosting is a slower process than freezing and therefore product
undergoing treatment tends to be in a vulnerable state for longer than in freezing. This
process can be a source of hazard and must follow specific control methods.
Defrosting can be carried out:
•
By placing, well in advance, large frozen pieces in a chill room (without causing potential
contamination risks to other stored products).
•
By microwave technology.
•
By direct cooking of frozen products.
•
For small pieces, frozen in a protective package, a hot water bath actively kept to the boil
can be used.
Some methods of defrosting should absolutely not be applied:
-
at ambient temperature;
in a tepid water bath.
IMPORTANT
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
4
- 35 Hot & Cold Technologies and Foodstuffs Formulation
Heat Processing Technology
There are three main techniques based on the use of heat:
•
Cooking.
•
Pasteurization.
•
Sterilization in can, bottle or other pack.
They present similarities:
•
They reduce the microbial flora of the food products.
•
Their effect can be quantified by a reference rate:
-
cooking rate;
pasteurizing rate;
sterilizing rate.
•
This quantified rate results from the combined effect of time and temperatures.
•
The application of these technologies allows, for each manufactured or stored batch, a
routine control of physical parameters (time and temperatures) and their recording. This
monitoring, for each batch processed and then through storage, allows implementation of
CCPs, if an HACCP risk analysis indicates that this is necessary.
•
The application of these technologies is subject to common rules and some particular
rules.
¾ Rules suitable for cooking
•
The temperature and duration time of cooking must be the subject to measurement and
recording for monitoring purpose.
•
Constant unit volumes of food batches makes it possible to reproduce identical cooking
conditions of for all manufactured batches.
•
Cooking in advance shall never be followed by a slow cooling process.
¾ Suitable rules common to pasteurization and canning
•
Preliminary series of tests make it possible to establish a reference scale of sterilization
parameters for each type of product.
•
The evolution of the ‘time / temperature’ combination for effective processing must be
checked and recorded:
-
•
by measurements carried out at regular intervals;
by the layout of a graph plotted by automated devices.
The full complete sealing of the packages (cans, jars) in to which products for processing
are placed must be ensured and controlled.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
4
- 36 Hot & Cold Technologies and Foodstuffs Formulation
•
Each manufactured batch shall be composed of identical products:
-
of the same chemical and physical composition (formula, viscosity…);
of the same size;
of the same shape;
enclosed in the same packaging.
Control by Foodstuff Formulation (composition)
Foodstuff formulation dictates physico-chemical characteristics of the product, used in food
preservation, including:
•
pH (acidity).
•
Aw (water activity) corresponding to water availability for microbial activity.
•
Viscosity.
•
nutrient content:
-
•
proteins;
carbohydrates and other microbial growth factors.
content of inhibiting elements:
-
nitrites;
fatty acids;
high salt levels;
high sugar levels.
•
Some of these parameters, fluctuations of which have a direct effect on microbial activity,
are easily and quickly quantifiable and can thus be exploited for the implementation of
control at CCPs.
•
To guarantee the precision of formulation, measurements of component ingredients are
needed:
-
•
Weight;
Volume.
For finished products, or for work-in-progress, some measurements are also taken, such
as:
-
acidity (pH);
water availability (Aw);
viscosity;
liquid density (as a measure of dissolved solutes);
temperature (T°).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
5
- 37 Finish Products Analysis
1.6.
Finish Products Analysis – Bacteriological Tests
Products
Bacteriological testing carried out on finished products is generally characterised by a relatively
long response time. As a result, it is not possible to await the receipt of tests results to affect
production control, nor even to wait for them for product release.
Consequently, tests on finished products have an assessment function on GHP, as well as on
the operating HACCP plan. Unfavourable results do not make it possible to employ corrective
actions on finished product, but must lead to re-evaluation and improvement of GHP
implementation, as well as of the HACCP plan.
Within the framework of risk analysis, carried out in an HACCP study, bacteriological tests on
product at different production stages, makes it possible to evaluate the impact of each process
activity/step, in terms of risk reduction or increase.
For analysis results to be interpretable, they must be compliant with specific rules of coherence
based on the relative weighting of total bacterial populations and component populations.
Surfaces
Bacteriological tests carried out on tools or equipment surfaces are characterised by a relatively
long response time. As a result, it is not possible to await the receipt of tests results to affect
production control, nor even to wait for them for product release.
Consequently, tests on tool or equipment surfaces have an assessment function on GHP, as well
as on operating HACCP plan. Unfavourable results do not make it possible to employ corrective
actions on finished product, but must lead to re-evaluation and improvement of the factory
cleaning plan.
Figure 5: Consistency criteria for bacteriological analysis of foodstuffs
BACTERIOLOGICAL ANALYSIS
COHERENCE RULES
total aerobic mesophilic flora
for validity,
bacterial counts,
for any sample,
must fit within
the boundaries
indicated
total coliforms
fæcal coliforms
staphylococci
salmonellae
anaerobic
sulphite
reducing
bacteria
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
5
- 38 Finish Products Analysis
Interpretation of the Flora
•
Total aerobic mesophilic flora:
-
•
Total coliforms:
-
•
is responsible for food poisoning incidents;
is particularly of human origin, often in partnership with fæcal coliforms;
to correct such a variance, it is necessary to seek out and control the sources of
human origin contamination (e.g. dirty operators' hands…).
Clostridium perfringens (anaerobic sulphite reducing bacteria):
-
•
are witness to definite fæcal contamination;
to correct such a variance, it is necessary to seek out and control the sources of
fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground
spread manure contaminating green vegetables, egg shells…).
Staphylococcus aureus:
-
•
are witness to a possible fæcal contamination;
to correct such a variance, it is necessary to seek out and control the sources of
fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground
spread manure contaminating green vegetables, egg shells…).
Fæcal coliforms:
-
•
is a reflection of total contamination;
reaches high values in any case of failure of the hot or cold thermal process
chains (refrigeration, delayed hot distribution, cooling, …);
the return to normal values will be obtained by reinforcement of thermal storage
chain control.
is responsible for food poisonings incidents;
is of fæcal or ground origin and is frequently in spore form;
to correct such a variance, it is necessary to seek out and control the sources of
fæcal contamination (e.g. dirty operators' hands, animal gut contents, ground
spread manure contaminating green vegetables, egg shells…).
Salmonellae:
-
are responsible for serious food poisoning incidents;
are of fæcal origin and most of the times associated to poultry/egg and related
products;
to correct this anomaly it is necessary to seek and control the sources of fæcal
contamination (dirty operators' hands, animal gut contents, ground manure
contaminating green vegetables, egg shells…).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
- 39 Staff training
1.7.
Staff Training
The following simple principles can be followed to plan, design and implement staff training.
¾ Sequence to be followed
•
Analyse the training needs, taking into account the specific context of the enterprise and
the different public to be addressed.
•
Establish a training plan with clearly defined objectives and indicators.
For example: “Train all the seasonal personnel in hygiene before they are sent to
production”. The indicator in this case is the number of persons who have followed
the session and the different skills to be acquired.Design and organise the
session. This is where the training tools and materials are prepared and the logistical
arrangements made.
•
Carry-out the training.
•
Assess the effects.
¾ A few tips for trainers
•
2 weeks before the session: confirm the implementation conditions,i.e. : dates, list of
•
participants, room…1 week before : is the equipment and material to be distributed
available ?
•
1 day before:
-
is the equipment in place ?
is the room ready to receive the trainees ?
is the material to be distributed ready ?
•
15 minutes before the training: verify that the equipment is working and the materials
available for the trainees.
•
In the beginning of the training:
-
welcome the trainees;
present the programme and schedule of the day.
•
Every morning (if the session lasts several days): make a synthesis of the previous day,
answer questions, present the programme of the day.
•
During the session: alternate the functions (producer, regulator, facilitator), explain difficult
points, have exercises done by the trainees, listen carefully to the trainees, answer all
questions.
¾ Assessment of the training
•
Evaluate if the trainees have acquired the necessary skills and/or competences.
•
Mesure deviations using the indicators defined in the beginning.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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HACCP study
CHAPTER 2 : HACCP Study
2.1
Transition to HACCP
The version of the HACCP method to which this guide refers is the official version published in
the ‘Codex Alimentarius’6. In the following lines of this guide, HACCP tasks are described in a
summarised form, limited to some words or to short sentences. It is accepted that use of this
guide cannot be considered without reference to the Codex version. Particular tasks will be
studied from the practical point of view, in order to facilitate the implementation of the method
under field conditions.
¾ Prerequisites
Enforcement of Good Hygiene Practice (GHP) and
Good Manufacturing Practice (GMP) constitute
essential prerequisites for the transition to the
implementation of HACCP methodology.
IMPORTANT
In order to make sure of real and effective implementation of these good practices, it is
necessary to refer to the audit grid 1/4 ‘Assessment of implementation of prerequisites’
attached to this document. (To use all audit grids, it is necessary to refer to the explanatory
booklet which is attached to them).
Success in implementing this HACCP process will depend on a thorough application of each
task in sequence and of the real and effective application of its requirements. Jumping one
or more task, or being satisfied with incomplete implementation, may well lead to a situation
of failure, with potential dangerous conditions within an apparently safe system.
¾ Procedures of implementation of HACCP – via each product or via manufacturing
operations
A HACCP scheme can be easily approached product by product in companies which
manufacture only one product or a restricted range of products. On the other hand, for
companies which offer a larger range of products (often small firms in canning or in
delicatessen product manufacture), specific application of HACCP to each product will
constitute an insurmountable obstacle.
It should be noted, in this second case, that the large variety of products is obtained by the
use of a limited number of basic technologies of manufacture (cooking, cooling, etc...),
always the same ones, but combined in different ways. Under these conditions, all that is
required is to choose a proper application of HACCP methodology to each one of these basic
operations. For any complete product, association of each basic operation involved, properly
managed by HACCP application, allows risk control to be established on the production line.
6
Codex Alimentarius Food Hygiene Basic Texts – Food and Agriculture Organization of the United Nations – General
Principles of Food Hygiene (CAC/RCP, 1-1969, Rev.4 2003).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
- 41 -
2
3
4
HACCP study
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
- 42 -
3
4
HACCP study
2.2
The HACCP Method
•
The HACCP process sets out two missions (two main processes to be carried out,
each with definable results).
•
The HACCP method is the application of seven defined principles.
•
The HACCP method defines twelve tasks for analysis, effective control
implementation and system review.
¾ HACCP – The 2 missions
1.
Hazard analysis
(Objective – determination of CCPs – Critical Control Points).
2.
Control of CCPs (Objective – effective implementation of food safety control at
CCPs).
¾ HACCP – The 7 principles
1.
Conduct a Hazard Analysis.
a - Identify the hazards associated with food production at all the stages of this
process
b - Evaluate the probability of appearance of these hazards
c - Identify the necessary preventive measures
2.
Determine the Critical Control Points (CCPs) of these hazards.
3.
Establish critical limit(s). (which must be met to ensure that each CCP is under
control) Establish operational criteria (limiting values, target levels, tolerances).
4.
Establish a system to monitor control of the CCPs.
Establish a monitoring system to affirm real and effective control of the CCPs
5.
Establish the corrective action to be taken when monitoring indicates that a
particular CCP is not under control.
6.
Establish procedures for verification to confirm that the HACCP system is
working effectively.
7.
Establish documentation concerning all procedures and records appropriate to
these principles and their application.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
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HACCP study
The HACCP 12 Tasks7
2.3
Task 1: Select the HACCP Team
•
Constitution of the team: internal and external competences, flow chart;
•
Training of the team in HACCP;
•
Organisation of the team;
-
•
Definition of the necessary resources;
-
•
Data: historical, causes of food borne disease, epidemiologic, clinical
Normative and lawful data
Technological data
Planning of activities;
-
•
Office devices (computer, photocopier,…)
Budget
Collection of information;
-
•
Functional mode
Organiser, secretary, team leader
Time table and duration of team work sessions
Programme of the implementation of successive HACCP stages
Definition of the field of study (e.g. product, group of products, hazards under study, full
product process or part(s) of process, etc.) Full food safety control for any product will
only be complete when every process that goes towards its manufacture has been
included, but practical and time restraints frequently lead to a division into realistic parts).
PRACTICAL
ADVICE
In order to prevent the HACCP programme taking too long:
•
Draw up agreed, documented, unambiguous management commitment to
effectively implement HACCP for the purpose of providing safe food
for the consumer (and for the economic security of the business). See
Notice regarding commitment in explanations about Task 10 of the
HACCP method)
•
Ensure that any delays are justified compared to the time table.
•
Respect frequency and duration of planned HACCP team meetings (e.g.:
once by fortnight, one hour duration) (management commitment will
ensure that HACCP team members have time allocated, as well as
adequate other resources).
7
A detailed training manual for the application of the HACCP method has been prepared in the framework of
the EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity Assessment. Copies can be
obtained from the Standards Unit in ASEAN Secretariat.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
4
HACCP study
In order to prevent the HACCP programme taking too long (cont’d):
•
Begin each meeting with a reiteration of the tasks which were to be
completed, and finish by assignment of tasks to be achieved for the
following meeting.
PRACTICAL
ADVICE
Task 2: Describe the Product
•
Collect data on the finished product (and possibly in-process product)
-
•
General characteristics: denomination, composition, volume, structure...,
Physical-chemical characteristics: pH, Aw, redox potential (Eh), preservatives,
Modified atmosphere,
Packing,
Labelling,
Conditions of storage and lifespan,
Storage and distribution network conditions.
Collect data on raw materials
-
Definitions,
Presentation: volume, type of packaging,
Formulation (% of each raw material used),
Physicochemical characteristics : pH, Aw, Eh, viscosity, …,
Concentration rate of the solutions and additives rate ,
Temperature of storage,
Lifespan,
Treatment, preparation, manufactured, use/purpose.
For all raw materials, it is important that their condition at delivery is constant
because control of their means of processing depends on it.
PRACTICAL
ADVICE
For example, for the same frozen raw material, defrosting time is
tripled if the smallest package dimension is doubled. The defrosting
step must therefore be adapted. If not, subsequent processing steps
(cooking, etc.) must be adapted in order to avoid hazards and / or
economic loss, because their efficacy will not be the same. If not taken
into account, the tripled defrost time may lead to incompletely cooked
meat in a subsequent stage.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
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HACCP study
Task 3: Identify Intended Use
•
Identification of the intended methods of use:
-
•
Lifespan,
Methods of preparation,
Instructions of use,
Foreseeable deviations,
Storage,
Intended target groups of consumers.
Examination of the adequacy between product and its instructions of use.
PRACTICAL
ADVICE
Foreseeable deviations from normal product use should be identified so that they
can be avoided. This helps demonstrate company responsibility.
Task 4: Construct a Flow Diagram
•
Identification of elementary operations/steps
operation A
operation B
operation A + 1
operation B + 1
operation A + 2
•
Collection of additional information on each elementary operation/step
-
Nature, function,
Process, method, parameters,
Inputs (raw materials and packaging),
Buildings, equipment, environment,
Flow,
Operators,
GHP (cleaning, disinfection, maintenance),
Instructions.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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3
4
HACCP study
If a flow diagram is drafted by observing work on site, the best and most
convenient method is by vocal recording, transcribed afterwards.
PRACTICAL
ADVICE
This allows a precise and continuous operations statement, produced
without having to look away to write.
Task 5: On-Site Verification of the Flow Diagram
•
On-site checking of flow diagram for different periods of production:
-
•
Regular.
High production rate.
Low production rate.
Different shifts.
Modification of the flow diagram, or drafting of several versions of the diagram:
-
according to real conditions observed on production site;
or according to specific organisation during different production rates.
It is necessary to give a close attention to the low rate production periods as
for those of high rate. The reduction of the number of operators like its
increase, often makes important changes to the organisation of work: only one
operator ensures the tasks of two work stations or two operators occupy only
one work station. These significant changes are often generating hazards
which do not exist under normal operation.
IMPORTANT
Task 6: List all Potential Hazards Associated with Each Step, Conduct a Hazard Analysis,
and Consider any Measures to Control Identified Hazards
•
Analyse causes of hazards to each operation/step.
•
List causes of hazards (physical, chemical, microbiological) (see Text Box below).
•
For microbiological hazards, causes are of three types:
-
contamination by germs of spoilage or pathogenic flora
multiplication of the germs/pathogens
survival of the germs/pathogens to a decontaminating treatment (heat,
ionization, …)
•
Qualitative and quantitative hazard evaluation: Calculation of hazard criticality,
subsequently used in risk evaluation, Hazard grading.
•
Definition of the preventive measures.
•
Formalise preventive measures (control means, procedures, instructions, records).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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HACCP study
Physical and Chemical hazards are characterised by imparting danger only by
contamination and not by multiplication / survival.
As such, most of these hazards are controlled by Good Practices or other
prerequisites (see next page) and will generally found to be not subject to
HACCP control, although there are exceptions.
PRACTICAL
ADVICE
The HACCP analysis process is valid and should include physical and
chemical hazards, in order to confirm where they fit into control mechanisms.
For the purpose of this guide, most attention is paid to microbiological hazards,
but the process demonstrated is identical for these hazard types (see
APPENDIX 2)
Figure 6: Hazard analysis process
hazard analysis
Hazard - definition
A biological chemical or physical agent in, or condition of, food with the potential to cause an
adverse health effect
Note – there are families of hazards: microbiological, parasitic, physical, chemical
Microbiological hazard analysis
Contamination
controlled by GHP and GMP
not appropriate to CCP implementation
3 components
Multiplication
Survival
depending on physical-chemical
parameters (time, temperature, acidity, water
availability)
suitable to CCP implementation
Hazards analysis (transition from the concept of danger to that of hazard)
application of the index of criticality to identified dangers: Ic = S x F x P
* S = seriousness
* F = frequency
* P = probability of no detection
notation scale from 0 to N
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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3
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HACCP study
Task 7: Determine Critical Control Points
DEFINITION Critical Control Point (CCPs):
A step at which control can be applied and is essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level.
For each elementary operation, determine if it constitutes a CCP.
You can use 3 different approaches to do so:
1. by use of a decision tree, or
2. by the application of INTUITIVE REASONING (using common sense), or
3. by carrying out Hazard Analysis on the Flow Diagram by an alternative method.
1 – by use of a DECISION TREE – each question MUST be considered and answered
VERY CAREFULLY8.
Q1
Do control preventive measure(s) exist ?
Yes
Modify step, process or product
No
Is Control at this step necessary for safety ?
No
Q2
Yes
Stop (*)
Not a CCP
Is the step specifically designed to eliminate or reduce the likely
occurrence of a hazard to an acceptable level ? (**)
Yes
No
Q3
Could contamination with identified hazard(s) occur in excess of
acceptable level(s) or could these increase to unacceptable levels ? (**)
Yes
Q4
No
Stop (*)
Will a subsequent step eliminate identified hazard(s) or reduce likely
occurrence to an acceptable level ? (**)
Yes
Not a CCP
8
Not a CCP
No
CRITICAL CONTROL POINT
Stop (*)
For the interpretation of the questions please refer to the EC-ASEAN Training Manual pages 40-43.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
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HACCP study
2 - by the application of INTUITIVE REASONING (using common sense).
IN PRACTICE . . . for each ingredient or activity, answer two questions:
•
If control is lost at this point, will the remaining hazard kill people or cause them
harm?
If no, not a CCP. If yes, continue:
•
Is there any subsequent manageable step before consumption that will remove
the hazard or reduce its effect to an acceptable degree?
If yes, not a CCP. If no, this is a CCP
3 - by carrying out Hazard Analysis on the Flow Diagram by an alternative method
Experience of regular use of the decision tree sometimes ends in a mind block – the tool
seems inappropriate in some particular situations. At this point of failure, some HACCP
specialists have recommended the use of intuition for CCP identification. In effect, this
amounts to passing from one extreme (of complete logical thinking) to the other (of no logic)
– from the mind-numbing objectivity of the decision tree to the utter subjectivity of intuition may be a dangerous move.
As an alternative, it is suggested to apply the following method :
Firstly : identify in the process what are the sources of hazard : Contamination, Multiplication
or Survival (failure of decontamination treatments like sterilisation or pasteurisation); and
Secondly : apply the following reasoning:
A) As it is not possible to immediately quantify Contamination levels at any one point of
process, it may be concluded that control of Contamination depends on GHP and
GMP implementation rather than on CCP establishment;
B) Germ Multiplication and Survival of germs present in the product, depends on
measurable parameters (time, temperature, acidity, water activity…). When these
parameters can be monitored, compared to critical values in the course of the process
and be exploited to eventually take action when there is a loss of control, then a CCP
can be defined at this process step.
In short, the restraint of contamination depends on good practice, while that of the
multiplication and survival is based on CCP establishment, made possible by the control of
specific physical-chemical factors when effectively/practically possible.
This alternative method is illustrated in the next schematic.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
- 50 -
2
3
4
HACCP study
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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HACCP study
Inputs
Contacts
Physico-chemical
parameters
Raw materials
operators
formulation
conditionings
N operation
(or N Step)
tools
Risks
duration
Control means
C
GHP
M
GMP
To
equipment
S
pH
Tables…
CCP
Aw
N+1 operation
(or N+1 Step)
C = contamination
M = multiplication
S = survival
N+2 operation
(or N+2 Step)
Drafting contacts topography can help to index the sources of contamination.
Contacts topography
Any contact can generate a contamination
1st example:meat cutting
K
P
O
P : product (meat)
K: knife
C: cutting board
O: operator (hands)
C
2nd example :meat mincing
M
O
P
P : product (meat)
S : hand scrapper
M : mincer
O: operator (hands)
S
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
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Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
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HACCP study
Task 8: Establish Critical Limits for each CCP
DEFINITION Critical Limit (CL):
A criterion (target value + tolerance) which separates acceptability from unacceptability.
•
For any CCP, the critical limit represents the value beyond which the control of the
identified hazard is no longer guaranteed. It makes sense to bring the process back to
tight control before this value is reached or breached. Therefore, for safety (and
economic) reasons, a target value more rigorous than the critical limit needs to be
enforced.
•
A target value needs a tolerance which ensures that, when intervention occurs, the critical
limit is not exceeded.
•
Identification for each CPP, based of the identified hazards, leads to characteristics to be
controlled and appropriate preventive measures.
•
For each characteristic, defined critical limits have to be respected in order to ensure CCP
control.
When this task is completed, the first phase of implementation of the HACCP
method has been completed. This phase constitutes the preliminary study:
product defining, hazard analysis, good practice drafting, CCP
determination. This phase also includes the determination of target values
specific to each CCP.
IMPORTANT
The valid and effective carrying out of these first eight tasks of the HACCP
method can be evaluated via the audit grid 2/4 ‘Assessment of the phase of
preliminary HACCP study’ (see annexe attached), also referring to its
explanatory booklet. Attaining successful evaluation is essential to go through
the final four tasks devoted to HACCP plan designing.
A meticulous and thorough application of the first eight tasks makes it possible
to have a precise hazard analysis. Analysis precision, applied to each
manufactured product, makes it possible to devise a HACCP plan, both simple
and effective. Any uncertainties in an incomplete hazard analysis will lead to
doubt and hence to an oversized HACCP plan, devised to ensure a satisfactory
level of safety covering such doubt.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
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Implementation of the HACCP Plan
CHAPTER 3 : HACCP Plan
The HACCP 12 Tasks9 (continued)
Task 9: Establish a Monitoring System for each CCP
DEFINITION Monitoring:
A planned sequence of observations or measurements of CCP control measures. The
records of monitoring provide evidence for future use in verification that the CCP is under
control.
•
Monitoring provision: plan, method, device necessary to carry out the observations, tests
or measurements employed to ensure that the critical limits of each CCP are respected.
•
Define the monitoring provisions for each CCP.
•
Formalise the monitoring provisions (responsibilities, procedures, instructions, records...).
Observations, tests or measurements taken within the monitoring scheme for
CCPs, will have to produce results identifiable to a particular batch or product
phase in the process.
PRACTICAL
ADVICE
This condition is essential for implementing predefined corrective actions,
applied in manufacture to batches for which the observations, tests or
measurements indicated a loss of hazard control. CCP monitoring results
shall be such that they are delivered immediately, or with only a short delay,
to ensure that any corrective action takes place fast enough to maintain
process control.
Task 10: Establish Corrective Actions
DEFINITION Corrective Action:
Any action to be taken when the results of monitoring at the CCP indicates a loss of control
or trend towards loss of control.
Corrective actions include:
•
provisions to ensure the return to CCP control, and
•
the management of any affected products.
9
A detailed training manual for the application of the HACCP method has been prepared in the framework of
the EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity Assessment. Copies can be
obtained from the Standards Unit in ASEAN Secretariat.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
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Implementation of the HACCP Plan
Define corrective actions to be implemented if the monitoring system shows
unacceptable deviation.
Formalise clear corrective actions (responsibilities, procedures, instructions,
recordings…).
Management of the deviation and the following up of actions on product
batches, to be subject to corrective action, are made possible by the
effective operation of a system of upstream and downstream traceability.
PRACTICAL
ADVICE
Notice:
The commitment of Top Management to an effective HACCP system is most evident when
monitoring indicates that control has been lost.
Decisions on actions to be employed in the event of control deviation have already been
made and documented within the HACCP plan, so interference (crisis management ?)
from Top Management is not needed, (especially when economic losses are becoming
evident due to corrective action).
This is principally important if monitoring indicates that a health issue has become evident
due to loss of control. The business needs to swing into immediate emergency action
without delay whilst Top Management looks at the situation to make decisions.
Task 11: Establish Verification Procedures
DEFINITION Verification:
The application of methods, procedures, tests and other evaluations, in addition to
monitoring, to determine compliance with the HACCP plan.
Definition of all provisions for confirming an effective HACCP operating plan is needed.
These provisions may include:
•
Tests on products.
•
Monitoring of target values.
•
Implementation and concerned batches follow up.
•
Simulation of incidents.
•
Auditing of the HACCP system.
•
Review of records – deviation review – trend analysis.
All checking provisions shall be formalised into the HACCP system.
verification of all parts of the HACCP system, including its records
It shall include
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
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2
3
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Implementation of the HACCP Plan
Task 12: Establish Documentation and Record Keeping
Documentation:
Collection of documents which describes the provisions of the HACCP system, including
records that prove its real and effective implementation.
•
Report of HACCP study (stages 1 to 8)
•
Design of HACCP plan (stags 9 to 12)
-
HACCP plan elements,
Specifications,
preventive measures,
critical limits and CCP monitoring system,
corrective actions,
document management,
verification methods,
checks,
reviews of the system,
records.
Task No12 completes the second of the two phases of the HACCP method
implementation and accomplishes HACCP plan development. Before being
able to evaluate the effectiveness of the plan it will be necessary to make it
operate for a few weeks or months.
The valid, effective establishment of these last four tasks can be evaluated
using the audit grid 3/4 ‘Evaluation off implemented HACCP plan’ (see
annexe attached), also referring to its explanatory booklet. It is essential to
go through a phase of practical operation of the HACCP plan.
IMPORTANT
After a few weeks or months of operation, valid, effective implementation can
be evaluated using the audit grid 4/4 ‘Routine evaluation of the valid and
effective implementation of an HACCP plan, (see annexe attached), also
referring to its explanatory booklet.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
1
2
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CHAPTER 4 : GMP, GHP & HACCP AUDIT GUIDE
4.1
Presentation of the Audit Guide
The complete audit document consists of four evaluation grids.
The first one is devoted to pre-requisites and the following three to the HACCP method,
(preliminary study, HACCP plan implementation, validity and effectiveness of the plan).
Two columns in each grid are reserved for noting observations taken at the time of audit:
4.2
•
as appropriate, the observation will give a satisfactory (sa), acceptable (ac) or not
satisfactory (ns) result;
•
in other cases the observation makes it possible to note an absence (ab), good practice
not implemented or documentation not appearing in the file;
•
finally, an audit grid item available for observation may not be applicable in the context of
the particular food process (na).
Grid 1/4 : Assessment of the Implementation of Pre-requisites
1.1 Conformity of the buildings: general organisation
Examination of the plans of premises makes it possible to examine matters of the fundamental
principles of organization, often better than on the field, such as • observance of the ‘onward
flow’ principle on production lines • separation of clean and unclean sectors • no criss-cross of
production lines • separation of hot and cold zones.
Immediate surroundings must contain no source of contamination, such as a garbage dump or
wet unhygienic zones. Passageways and parking areas must be paved or cemented. Lawns
must be cut regularly to avoid high vegetation constituting a refuge for pests.
The plans provided in the file shall make it possible to identify each room and to locate each
work station, each significant material, as well as water mains (or other supplies) and hand
washing points.
Waste water and clean water circulations are also to take into account.
Finally, the plans make it possible to locate entrances and exits of various flows (production,
waste, operators . . .) as well as their circulation within the physical plant.
The various points noted here must be acceptable so as to meet requirements regulation.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
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Audit of GMP and HACCP system
1.2 Conformity of the buildings: construction and materials
The descriptive booklet, either within the framework of a project, or associated with observations
on the ground (at the time of the visit to the premises), makes it possible to control the
conformity of materials and methods implemented in building the plant. The covering of the
floor and the walls, the way in which they are joined, the devices used to collect water for floor
washing, (the principles of which are stated in #1.2 of the guide), must conform to regulation.
Passive or mechanical ventilation devices must ensure the elimination of steam and smoke.
Lighting must be bright and neutral in colour (so as not to modify the foodstuff colours)
1.3 Conformity of the premises: equipment, materials and furniture
The technical documentation of these elements, associated to ground observations carried out
at the time of the visit to the premises, make it possible to check their conformity with the
regulation (point 1.3).
1.4 Lawful or normative conformity
The elements of conformity of the buildings presented under the former points (1.1, 1.2, and
1.3) can be controlled and confirmed within the framework of an official approval or a
certification.
1.5 Upholding the condition of buildings, maintenance
Ageing and decay, by continued use of the establishments, can cause the loss of condition of
the buildings. The implementation of regular maintenance, together with appropriate immediate
remedial action for sudden breakage, confirmed by the keeping of a maintenance daybook
(register of requests with records of repair), helps uphold the condition of buildings and
equipment.
2. Supplies
2.1 Contractual relationship with suppliers
The criteria of acceptance for delivered consignments, with corrective actions required
according to the significance of any noted variance, must be defined in advance and included in
a contractual document drawn up between the producer and his suppliers.
2.2 Specification of raw materials
•
of composition: this plays a significant role in the tendency of the product to deteriorate
(water content) or in its stability (sugar or salt content). Also it guarantees the accuracy of
the composition of the finished product as defined on final product labelling.
•
of microbiological standards guarantees the safety of food by limiting the presence of
pathogenic germs and of toxic metabolites (microbial toxins, histamine . . .).
•
of the maximum allowed content of residues, covering such substances as heavy metals,
antibiotics, pesticides.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
•
of packaging: ensuring by its characteristics protection of delivered raw material. By its
volume it influences parameters such as duration of defrosting time or the utilisation period
after opening.
•
the condition of preservation is generally related to temperature and shelf life . These two
measurable parameters can be the subject to monitoring for each consignment and are
thus favourable to the introduction of CCPs.
•
organization of stock turnover: it should comply with FIFO principles (First In / First Out).
2.3 Control of deliveries
Inspection of delivery check-lists makes it possible to control the conformity of certain major
specifications of raw materials. Observation of variations in these specifications indicate a loss
of hazards control and will result in the use of pre-established corrective actions.
Observations and measurements must be carried out at the time of delivery, and the check-lists
must be checked at the same time. When a variance is noted, the ‘customer/supplier’
agreement must include the signature of a type-approval certificate or a card of anomaly
specifically drafted for this purpose, by the supplier or his representative (delivery person).
If immediate inspection is not possible, (such as for large mixed palletised loads, or if a long
term check is involved, such as for microbiological counts), then the customer / supplier
agreement must be clear on the procedure adopted for inspection and on actions to be taken in
the light of failure.
2.4 Potability of water
Water is a nutritious raw material and also a cleaning agent. Considering this double use,
confidence in its microbiological quality, as well as its chemical quality, is of prime importance.
Analysis reports can be easily obtained from water suppliers. However, manufacturers using
private water sources (well, borehole .) will have to employ their own water quality control plan.
3. Implementation of a system of traceability
A system of traceability makes it possible to manage any food safety crisis by going back to the
origin of the products implicated. It also makes it possible to identify all the outlets where they
have been sold.
A traceability system also allows, using the HACCP flow charts, to find those production batches
that will be subject to corrective action, i.e. all batches that have been produced since CCP
monitoring indicates the last time that the system was known to be still in control.
Frequently, (and particularly when computerized systems of traceability are implemented by
specialist providers), those responsible for food product traceability do not know the
configuration of the traceability system; they are simply trained how to use it. Under these
conditions, it is good practice to submit this system to a simulation trial, rather than rely on a
system audit. Simulation results allow the auditor to judge the efficacy of the traceability system
and the capability of staff in its use.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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3
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Audit of GMP and HACCP system
3.1 System of upstream traceability
A simulation of upstream traceability needs to be able, for any real substance chosen randomly
from within raw materials stocks, to divulge all information on its source, origin, batch, delivery
date. The system of traceability must be able to provide an answer to these questions.
Examination of delivery check-lists, supplier invoices and records of raw material stocks, can all
help to understand the system of traceability.
3.2 System of downstream traceability
A simulation of downstream traceability needs to be able, for a product chosen randomly in
finished products stocks, to divulge all information on recipients of any other parts of this batch,
as well as batches of raw materials which were used for its manufacture. The system of
traceability must be able to provide an answer to these questions. The examination of purchase
orders, copies of clients’ invoices and registers of finished product stocks, can also help
understand the system of traceability.
4. Pest control
4.1 Implementation of a pest control plan
The presence of pests in a factory can be noted during a visit to the premises by the presence
of dead insects or droppings / urine of rodents.
A plan of rodent extermination must be implemented. The file must include a plan of the factory
where the poison baits are located, and the technical cards of rodent poisons being used.
Storage outside the buildings (equipments and materials) must not be placed next to the walls
but kept as far from them as possible and must allow a minimum space of at least two meters.
This arrangement makes it possible to avoid the settling of pests directly against the walls, their
penetration and their establishment inside the plant.
Management of waste materials must prevent their overflow and the presence of any food
waste on the ground which could attract pests.
A plan of insects control must also be implemented. The file must include the schedule of
operations and technical information cards of insecticides.
The implementation of the programme of pests control operations must be recorded on
appropriate checklists.
5. Control of human sources of contamination
5.1 Medical monitoring of the operators
Monitoring is proven by the delivery of an annual medical certificate of fitness for foodstuffs
handling to each operator. In the event of a stoppage caused by a severe infectious condition,
or presenting a significant risk of transmission via food, such a certificate may well be required
for a return to work.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
5.2 Staff training to the principles of hygiene and good manufacturing practices
The company must implement a plan of staff training. As with medical monitoring, appropriate
certificates of training shall be delivered for each successfully trained member of staff.
5.3 Professional clothing hygiene
•
The documents relating to the internal system of management of professional
clothing (clean or soiled) must makes it possible to check that it is provided and
cleaned by the company (or under its responsibility). Moreover each member of the
staff must use two cupboards in the cloakroom (or one single cupboard with two
compartments), to ensure the separate storage of working garments and everyday
wear. Permanent devices (boots/shoes washstands) or movable ones (trays),
containing a disinfecting solution, must allow cleaning/disinfection of shoes or boots
before getting into the production zone
5.4 Respect of the good hygiene practices and good manufacturing practice
Due to training and to the provision of guides of good hygiene practices and guides of good
manufacturing practices, staff are able and are obliged to respect these good practices.
6. Hands cleaning and material cleaning
6.1 Hands
Visits to premises makes it possible to check that conforming washstands (non-manual taps,
disinfectant liquid soap dispenser, disposable hands wiping system) are made available to
operators in sufficient numbers. These washstands must be located near working stations,
cloakrooms and toilets.
Contamination by hands, regarded as the ‘first tool of the operators’, is controlled by the training
received and by the posting of hand-washing instructions near the washstands.
6.2 Material and buildings
The control of contamination of equipment and buildings requires the introduction of a cleaning
plan, drafted by applying the problems resolution method known as ‘the W.W.W.W.H.W method‘
(Who? What? Where? When? How? Why?)
Written procedures of cleaning, together with technical cards of cleaning products, are gathered
in this cleaning plan. Each operator (production operator or member of the cleaning team) has a
copy of the part which corresponds to his cleaning tasks. The good execution of this cleaning
plan can be assured by checking with appropriate records.
•
control of good execution of tasks using a check-grid completed as the work progresses
•
control of visual cleanliness of surfaces using a weekly (or higher frequency) check-grid
•
microbiological control plan of surfaces, valuable for validation of the cleaning plan, and
resulting in analysis reports for appropriate action.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
4.3
Grid 2/4 : Assessment of preliminary HACCP study step
After evaluation of the implementation of pre-requisites in the former grid, this second grid
approaches HACCP itself. This method is structured in twelve Tasks which are taken in order,
one after the other. Grid 2/4 takes into account steps 1 to 8 inclusive.
Task n° 1
Management commitment
This commitment testifies to the sincere resolve of the management to apply HACCP
methodology involves a letter addressed individually to each member of the staff of the
company.
Set up of the HACCP team
The HACCP team organisation chart (organogram) should be the basis for specifying functions
and responsibilities for each member. These functions and responsibilities need to be
described on individual job specifications for the HACCP programme.
Resources
The resources available to the HACCP team (computer, photocopier, budget etc.) shall be
clearly defined and recorded in the HACCP file.
HACCP team management
Organisation is planned around the scheduling of activities, setting out the frequency and
duration of team working sessions. The plan defines time limits for the implementation of
HACCP stages. With objectives being predicted for completion by specific dates, any delay
needs to be justified.
Each working session starts with a statement of work completed since the former meeting and
ends in the allocation of the tasks to be realised for the following meeting. Each working session
must be recorded in a report.
Task n° 2
2.1 Description of the product
The product description file, completed by the execution of stage n° 2, collates all relevant
information on the product including (but not restricted to):
•
composition (ingredients, nutrition)
•
volume, nature, storage, packaging, labelling,
•
raw materials specifications (composition, proportion in the product, physicochemical
characteristics, conservation, pre-processing, microbiological standards).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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2
3
4
Audit of GMP and HACCP system
Task n° 3
3.1 Identification of expected use
This stage results in the drafting of documented instructions for use. The information provided
by labelling of the product (storage temperature, shelf life . . .) also depends on the conclusions
of this step.
This study on expected use needs to take into account the expected groups of consumers
involved (e.g. children, older people). It also needs to include a study on potential foreseeable
deviations of use and on any dangers which could result from these.
Task n° 4
4.1 Draft the flow diagram
Task n° 5
5.1 Verify the flow diagram
The flow diagram is the base for hazards analysis, so it must closely correspond to the real field
conditions for all products or all families of products (as appropriate to the study), for all the
production periods.
In certain sectors of production (catering, pastry baking), flow diagrams will relate to basic
operations (oven cooking, fast cooling . . .). Combinations of these flow diagrams then make it
possible to carry out study of all types of production schemes. When each one of these basic
operations is controlled, the whole of the production can then be regarded as controlled.
It should be noted that the same product can present conditions for more than one flow diagram
if the conditions of production change, for example between slack and busy periods. In this
example, the number of operators, and hence also work organization, may change.
During inspection or audit, some sequences of production need to be compared with the flow
diagram appearing in the file in order to assess its validity.
Task n° 6
6.1 Hazards analysis
Using the flow diagram and the list of potential hazards already in the file, the analyst now
needs to evaluate the significance of hazards:
•
by checking that no hazard has been overlooked;
•
by checking that all hazards identified by using the flow diagram are collated in a
summary (table, list . . .);
•
by checking that the calculation of the criticality index (specified on a separate
document) provides a valid evaluation and hence a correct rating of risks;
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
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Audit of GMP and HACCP system
•
by checking through the calculation of the criticality index, that identified risks are real
(and thus excluding any risks with a zero index value)
A list of preventive measures, each specific to each identified hazard as applied in the particular
establishment, with procedures for implementation, must appear in the file.
Task n° 7
7.1 Determine critical points
The use of the HACCP flow diagram, together with a CCP decision method (CODEX decision
tree, or the intuitive method), allows for identification of CCPs, which are gathered into a
summary (table, list, etc…)
The identification of a parameter, indicating maintained safety control or otherwise of each CCP,
that can be monitored, allows differentiation from standard production operation control. This
measurement needs to be timely so as to maintain production∗, and at low cost.
Auditors need to verify that a measurable parameter is associated with each identified CCP.
Task n° 8
8.1 Establish critical limits for each CCP
By examination of the file documents, the limits of the criteria which separate acceptability from
non acceptability need to be the assessed.
Each criterion, together with its possible justifications, are evaluated using:
∗
•
limits of performances of the available equipment . . .
•
quantified data (from data sources) on the microbial flora (temperature, pH and Aw,
growth limits . . .);
•
results of ageing tests;
•
lawful or normative obligations.
If results take too long to come back, production will be held up awaiting them, or expensive large stores of workin-process or final product will be required
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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2
3
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Audit of GMP and HACCP system
4.4
Grid 3/4: Assessment of the drafted HACCP plan
This third grid relates to the evaluation of the last four tasks of HACCP method. These are
devoted to the drafting of the hazard control plan.
Task n° 9
9.1 Establish a monitoring system for each CCP
Initially, the significance and appropriateness of all monitoring procedures need to be evaluated.
Then the framework of parameters for monitoring, (T°, Temps, Aw, pH, weight, volumes) and
their recording, needs to be established and validated to ensure that any loss of control is
immediately identified
9.2 Calibration plan of measuring instruments
Any instruments involved in monitoring of CCPs need to be included in calibration plans and the
calibration plans need to be implemented.
(If an instrument is found to be out of calibration, an action plan needs to be in place, particularly
indicating actions for all product that has been produced since the last time that the instrument
can be confirmed as being correctly calibrated).
Task n° 10
10.1 Establishment of corrective actions
The HACCP plan needs to define the corrective actions implemented in the event of loss of
control (i.e. observation of a deviation of values being monitored for control). To this aim the
documentary system must fulfil certain constraints:
•
to establish appropriate levels of corrective action to be implemented corresponding to
the gravity of observed CCP deviation
•
to define application of operational procedures of for the various corrective actions
selected
10.2 Ensuring the follow-up of batches of products for corrective action(s)
The company must set up a system of monitoring sheets, based on traceability, to follow up the
batches which need to be subject to corrective actions.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
Task n° 11
11.1 Establish verification procedures
The inspector (or the auditor) controls the implementation of validation methods and documents
for HACCP plan or for the implementation of GHP and GMP. The details of implementation
means may include (but not be restricted to):
An analytical control plan (microbiological and chemical) of the finished product, (defining the
finished product standards) including:
•
sampling plan (number, size, frequency of samples)
•
microbiological standards for different (types, groups of) products
•
residue standards for such as: growth factors, pesticides, antibiotics, heavy metals
•
standard analysis model report
•
keys for interpretation of analyses
Analytical control plan of surface cleanliness:
•
sampling plan (number and frequency of samples)
•
microbiological standards for surfaces
•
standard analysis model report
•
keys for interpretation of analyses
11.2 Field verification
Confirmation of the verity rests on the execution of a documentary review or audits (by external
or internal people) of the risks control system (GHP/GMP and / or HACCP).
If this step does not allow for satisfactory observation of results, it will lead to revising the set-up
of the hazard control system.
Task n° 12
12.1 Establish documentation and record keeping
The inspector (or the auditor) needs to check that the HACCP system documentation effectively
includes all documents (commitment, objectives and system establishment, procedures,
analysis reports, outside technical data, checklists, etc . . .) as defined in the eleven steps of the
HACCP outlined above or in the Pre-requisites section (- and for the control of this twelfth step)
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
4.5
Grid 4/4: Routine evaluation of the real and effective implementation of an
HACCP plan in the company
This last grid is intended to be employed at the time of routine visits carried out in companies
whose complete HACCP system has already been inspected (or audited), and has already
received an official approval or a certification
13. Implementation of the GHP
13.1 Supplies control
The inspector (or the auditor) needs to confirm that raw material delivery check-lists are
correctly kept. He needs to ensure, by examining preceding weeks’ checklists, that corrective
actions are actually implemented based on documented delivery controls, such as:
•
documented warnings to the suppliers
•
rejection of raw materials batches
Available analysis reports also enable him to check that water used for production (as an
ingredient or as a cleaning medium) is potable.
13.2 Validation of the cleaning plan
The inspector (or the auditor) needs to confirm that checklists of task implementation are
correctly and immediately completed at the time of cleaning completion
He must also check the validity of results of microbiological cleanliness analyses for equipment
and surfaces. In the event of nonconformity of the results, he must make sure that the company
has taken appropriate action, such as bolstering its cleaning procedures or changing its
cleaning / disinfection products (if contaminating microbiological flora have become resistant).
13.3 Validation of the pest control plan
The inspector (or the auditor) needs to confirm that any intervention forms of the pest control
company, are correctly filled out for each visit.
During the visit of the premises, he must also seek out signs of pests:
•
droppings and urine of rodents
•
damage to foodstuffs bags (rice, pasta, beans…) caused by rodents
•
insects bodies
•
droppings of birds nesting / nests in the superstructures of buildings
13.4 Medical follow-up of the staff
This medical follow-up is validated by the presence of a medical certificate of aptitude to
foodstuffs work, in the personal file of each operator employed by the company.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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Audit of GMP and HACCP system
13.5 Staff training
The implementation of the continual training plan is confirmed by the presence of certificates
delivered for each training course, in the personal file of each staff member.
The inspector (or the auditor) can also have informal conversations, (without breaking principles
of hygiene), with operators posted on the lines of production, in order to evaluate their level of
awareness and competence.
13.6 Maintenance of buildings and equipment
In addition to the visual observations that can be made during the visit to evaluate premises
maintenance, the inspector (or the auditor) must check on the upkeep of the maintenance
daybook
13.7 Upholding of the conformity and provisioning of the washstands
This part of the audit mainly depends on visual observations carried out during the visit to the
production premises.
13.8 Upholding of the conformity and provisioning of the boots/shoes washstands
This part of the audit mainly depends on visual observations carried out during the visit to the
production premises
14. HACCP plan , CCP monitoring
14.1 CCP monitoring
The implementation of this step (n° 9) of the method is validated by the records relating to the
CCP monitoring. Assurance in the discipline in their keeping and their use is an essential point
of the audit of any implemented HACCP plan. Without such rigour being applied to the keeping
and use of these records, no real and effective HACCP plan can be implemented.
Any loss of control indicated by a deviation of the measured values, needs to be checked and
coupled with necessary corrective action.
Recordings need to be dated and signed after reading and before archiving.
A (non exhaustive) list of records relating to the monitoring of CCPs
•
records of cold store temperatures (chill and frozen) and of air-conditioned production
areas
•
records of inventory control (in respect of deadlines for use)
•
records of the heat treatment pair of parameters ‘duration / temperature’
•
schedules of sterilisation, pasteurisation, cooking
•
monitoring recordings of pH (dairy products, dry salted meats . . .)
•
measurement recordings of water activity values (Aw)
•
weighing, volume measurement of product ingredients, during recipe build
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
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2
3
4
Audit of GMP and HACCP system
14.2 Follow-up of the corrective actions
The inspector (or the auditor) needs to confirm that monitoring sheets of corrective actions are
correctly and progressively filled, until the effective reworking, removal or destruction of any
affected batches
14.3 Conformity of the finished products
Conformity of finished products to microbiological and toxicological standards must be validated
by analysis reports held by the company. Any observation of analysis reports not in accordance
with standards, must lead to reconsideration, and subsequently to, improvement of the entire
current system of hazard control. (GHP, GMP and HACCP plan)
14.4 Traceability
The inspector (or the auditor) needs to check simulations of upstream and downstream
traceability at the time he is visiting the establishment – either on raw materials, or in production,
or finished products randomly taken.
14.5 Simulations of incidents
The simulation of incidents is a method which can be used to check the validity and
effectiveness of monitoring systems.
Losses of control are signalled by warning lights or hooters (cold stores, metal detectors . . .)
Such simulations of incidents can be periodic recorded events which the auditor will be able t
reports o trace from records.
They may also be carried out at the request of the inspector (or the auditor) at the time of visit.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality &
Conformity Assessment (Asia/2003/069-236)
A project cofinanced by ASEAN
1
GMP, GHP & HACCP Audit Guide
Grid n° 1: Assessment of the implementation of pre-requisites
2
3
4
Grid n° 1/4 : Assessment of the implementation of pre-requisites
Inspection (audit) n°: ……………………
HACCP Audit Grid (n° ¼)
sa = satisfactory
ac = acceptable
ns = non satisfactory
ab = absence
na = not applicable
Control of contamination sources
Considered criteria
1 Buildings
1.1 Conformity of the premises: general organization:
- Conformity of the establishment immediate surroundings ........................
- compliance with the onward flow principle .............................................
- separation of clean sector and unclean sector ..........................................
- no crisscross of the production lines .........................................................
- separation of hot zone and cold zone .......................................................
1.2 Conformity of the premises: construction :
- wall coverings: smooth, light coloured, washable, resistant......................
- floor covering: smooth, light coloured, washable, resistant ......................
- floor and walls joined by round gorge assemblages ..................................
- floor grids and U-bends to collect waste water .........................................
- ventilation devices ensuring steam and smoke elimination ……………...
- lighting bright and neutral in colour ……………………………………...
1.3 Conformity of the premises : equipment and furniture
- materials: inalterable and easy to clean ....................................................
- furniture: smooth, washable, resistant ......................................................
- work surfaces: smooth, washable, resistant ..............................................
Documents associated to these criteria
Plan of the establishment (1/500 to 1/1000) showing:
- drinking water supply .............................................................................
- waste water drain off ...............................................................................
Plan of the establishment (1/100 to 1/300)showing: .......................................
- identification of rooms.............................................................................
- position of workstations and the equipment ............................................
- position of cloakroom and toilets.............................................................
- location of inputs/outputs of flows (staff, products, …) ..........................
- flowchart of flows (staff, products, raw materials, waste,…) ..................
Explanatory leaflet of materials used and techniques of constructions employed
..............................................................................................................................
Explanatory leaflet of the equipment (machines )...............................................
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HACCP Grid 1 - Page1/4
Considered criteria
Documents associated to these criteria
1.4 Lawful or normative conformity …..…………………………….
Documents attesting of:
national approval ……………………………………………...............................
foreign country importation approval ………………………................................
certification of voluntary setting in conformity with specific food safety standards
…………………………………………
Daybook of technical mending of buildings and equipment.................................
1.5 Maintenance of buildings and equipment…………………………
2 Supplies
2.1 Contractual relationship with the suppliers ………………………
2.2 Raw materials specifications …………………………………….
2.3 Checking of deliveries ……………………………………………
2.4 Water portability………………………………………………….
Contracts past with suppliers
criteria of acceptance of batches
planed corrective actions for any case of loss of control ......................................
Cards of specifications of raw materials . ............................................................
Composition .........................................................................................................
Microbiological standards ....................................................................................
Residues limit content ..........................................................................................
conditioning (type, volume, weight…) ................................................................
Preserving conditions ...........................................................................................
lifespan .................................................................................................................
Organization of stock turnover ...........................................................................
Recording cards of control of deliveries ..............................................................
temperature of delivered products .......................................................................
intact conditionings ...............................................................................................
compliance with consumption deadlines...............................................................
labelling compliance with official food safety marking rules ...............................
cleanliness of the delivery vehicle ........................................................................
..............................................................................................................................
Analysis or certificate of water potability ............................................................
HACCP Grid 1 – Page2/4
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Grid n° 1: Assessment of the implementation of pre-requisites
Considered criteria
3 Implementation of a system of traceability
3.1 System of upstream traceability........................................................................
3.2 System of downstream traceability..................................................................
4 Pest control
4.1 Implementation of a pest control plan ..............................................................
- management of the outdoor dustbins, absence of waste on the ground..............
- management of materials and equipment outdoor storage .................................
2
3
4
Documents associated to these criteria
Specimen of simulation test of upstream traceability
Recordings relating to upstream traceability: .....................................................
delivery control cards ...........................................................................................
listing of raw materials stock ..............................................................................
Specimen of simulation test of downstream traceability
Recordings relating to downstream traceability ..................................................
customers purchase orders ...................................................................................
listing of finished product stocks ..........................................................................
customers invoices ...............................................................................................
Pest control plan …………………………………………………………………
Insect control plan ………………………………………………………………..
Intervention forms of the pest control company (department) …………………...
HACCP Grid 1 – Page 3/4
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Grid n° 1: Assessment of the implementation of pre-requisites
Considered criteria
5 Control of staff originated contaminations
5.1 Medical follow-up of the staff members...........................................................
5.2 Plan of staff training .........................................................................................
5.3 Clothing hygiene :
standard work clothing supplied by the company...................................................
washing of clothing by the company or under its responsibility ...........................
management of clean and dirty clothing................................................................
lockers with 2 compartments ..................................................................................
boots/shoes washstands in conformity with standards ……………………………
5.4 Compliance with GHP and GMP......................................................................
6 Hands and premises cleaning
6.1 Hands
washstands in conformity with standards or regulations ........................................
washing hands procedures ......................................................................................
6.2 Premises
enforcement of a cleaning plan ..............................................................................
microbiological Control of effectiveness of cleaning .............................................
2
3
4
Documents associated to these criteria
Individual health certificates of food handling ability ...........................................
Time table and contents of training activities ........................................................
Staff members vocational training certificate ........................................................
In house management procedure of clothing , or washing supplier contract .........
Specific approved GHP and GMP guide of the production sector or ..................
in house manual of the GHP and GMP of the company ........................................
Posting of washing hands instruction near the washstands ...................................
Sum of written cleaning procedures comprised in "cleaning plan".......................
Check-grids of good execution of cleaning tasks...................................................
Weekly check-grid of visual cleanliness of equipment surfaces............................
Reports of microbiological controls of surfaces.....................................................
HACCP Grid 1 – Page 4/4
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Grid n° 2: Assessment of the phase of preliminary HACCP study
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3
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Grid n° 2/4: Assessment of the phase of preliminary HACCP study
Assessment carried out following the chronological continuation of the method tasks
Considered criteria
Documents associated to these criteria
Task n°1
1.1 Management engagement .................................................................................
Management engagement declaration letter.........................................................
1.2 HACCP team founding
members of the staff involved in the HACCP team................................................
assignment of technical tasks and responsibilities .................................................
training of the team to HACCP method..................................................................
calling in external experts.......................................................................................
Organisation chart of the HACCP team ...............................................................
Individual post sheets ...........................................................................................
Individual vocational training certificates ............................................................
1.3 Means put at the disposal (computer, photocopy, budget…)............................
Listing of the HACCP team functioning means....................................................
1.4 Activities management
organization, programming.....................................................................................
dissemination, updating of successive versions of HACCP documents .................
field of study and compiling of specific data..........................................................
Planning of activities.............................................................................................
Time table, deadlines file .....................................................................................
Working sessions reports ......................................................................................
Flow chart of dissemination of HACCP documents .............................................
Bibliographical collection: technical and lawful data relating to the sector of
production and the type of analysed hazards.........................................................
HACCP Grid 2 – Page 1/3
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Grid n° 2: Assessment of the phase of preliminary HACCP study
Considered criteria
Task n°2
2.1 Description of the product ................................................................................
composition, volume, conditioning ........................................................................
raw materials specifications: composition, proportion in the finished product,
physicochemical parameters, lifespan, preservation, pre treatment........................
Task n°3
3.1 Identification of the expected use
lifespan ..................................................................................................................
expected groups of consumers................................................................................
conditions of use.....................................................................................................
foreseeable deviations of use ..................................................................................
Task n°4
4.1 Draft of the flow diagram
................................................................................................................................
................................................................................................................................
Task n°5
5.1 Verify the flow diagram
flow diagram in accordance with real field conditions ...........................................
taking into account of all the productions rates (high and low)..............................
contents of the diagram: nature of the stages, inputs, contacts, physicochemical
parameters (T°, time, Aw, pH) ...............................................................................
2
3
4
Documents associated to these criteria
Descriptive file of the product..............................................................................
User instructions manual.......................................................................................
Labelling
Mandatory ...................................................................................................
Informative ..................................................................................................
Flow diagram(s)
for each product or each family of products ........................................................
or by current elementary operations usually associated to carry out the products
(cookery)...............................................................................................................
or by work periods ................................................................................................
HACCP Grid 2 – Page 2/3
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Grid n° 2: Assessment of the phase of preliminary HACCP study
Considered criteria
2
3
4
Documents associated to these criteria
Task n°6
6.1 Hazards analysis
analysis of the considered field hazards (biological, physical, chemical) based on the
flow diagram .............................................................................................................
risk assessment by calculation of index of criticality ................................................
6.2 Preventive measures drafting...............................................................................
Task n°7
7.1 Determination of CCPs
by the use of the Codex decision tree ........................................................................
or by the intuitive method ......................................................................................
plus identification of a related quantifiable and manageable parameter(s) ...............
Task n°8
8.1 Determination of critical limits for each CCP
selected criteria ..........................................................................................................
required justifications ...............................................................................................
bibliographical data on the microbial flora................................................................
results of ageing tests.................................................................................................
lawful obligations ......................................................................................................
List of identified hazards......................................................................................
Transposition of the identified hazards on the flow diagram then on a table related
to the stages of production ....................................................................................
Risks assessment report (calculation of index of criticality)................................
Identification and collection of the preventive measures relating to each risk......
..............................................................................................................................
..............................................................................................................................
Operational procedures of implementation of these measures..............................
List of CCPs .........................................................................................................
List of the selected criteria and their required justifications .................................
HACCP Grid 2 – Page 3/3
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Grid n° 3: Evaluation of implemented HACCP plan
3
4
Grid n° 3/4 : Evaluation of implemented HACCP plan
Assessment carried out following the chronological continuation of the method steps
Considered criteria
Task n°9
9.1Implementation of a monitoring system for each CCp ......................................
Documents associated to these criteria
Manual of operational procedures.........................................................................
Models of recording documents of the measured values, used within the
framework of the monitoring procedures..............................................................
Duration.......................................................................................................
Temperature.................................................................................................
pH ................................................................................................................
Aw ...............................................................................................................
measurement of quantities: volume, weight, formulation ...........................
Plan of calibration of the measuring instruments..................................................
Measuring instruments calibration..........................................................................
Task n°10
10.1 Draft of corrective actions to implement in the event of loss of control
(deviation of the monitored values) ........................................................................
Table of correspondence between the observed deviations and the corrective
action type that must be implemented...................................................................
Operational procedures manual of corrective actions ..........................................
10.2 Ensure the follow-up of the batches subjected to corrective actions ..............
................................................................................................................................
Model of monitoring sheet of batches subjected to corrective action (traceability of
these batches) ........................................................................................................
HACCP Grid 3 – Page 1/2
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Grid n° 3: Evaluation of implemented HACCP plan
Considered criteria
Documents associated tothese criteria
Task n°11
11.1 Establish verification procedures
microbiological analysis of the finished products...................................................
simulations of deviations or losses of control.........................................................
recordings audit ......................................................................................................
checking of compliance with the implemented corrective actions .........................
validation of good cleaning practices .....................................................................
Plan of analysis of products (raw materials, in production or finished products) :
..............................................................................................................................
sampling plan (number and frequency of samples)...............................................
types and standards of the microbial flora of the products....................................
report of bacteriological analysis of products .......................................................
2
3
4
Microbiological analysis plan of equipment surfaces ...........................................
sampling plan (number and frequency of samples)...............................................
types and standards of equipment surfaces microbial flora..................................
report of bacteriological analysis of equipment surfaces ......................................
11 .2 Define practical methods of checking............................................................
Task n°12
12.1 Establish documentation and records keeping ................................................
Audit reports (in house or external) ......................................................................
The whole of the documents taken into account at the preceding steps................
HACCP Grid 3 – Page 2/2
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Grid n° 4: Routine evaluation of the real and effective implementation of an HACCP plan in the company
2
3
4
Grid n° 4/4: Routine evaluation of the real and effective implementation of an HACCP plan in the company
This fourth part is a documentary review. The documents relating to the good practices of hygiene are examined first. Then those relating to HACCP method are examined (in particular
those which refer to the control of the CCP)
Considered criteria
13 Implementation of GHP and GMP: real and effective
13.1 Supplies monitoring........................................................................................
Documents associated to these criteria
Raw material delivery checklists correctly and immediately kept ........................
Satisfactory water analyses reports .......................................................................
13.2 Cleaning plan validation .................................................................................
Checklists of cleaning tasks execution correctly and immediately completed......
..............................................................................................................................
13.3 Pests control plan............................................................................................
Satisfactory results of microbiological analysis of surfaces..................................
Intervention forms of pest control service correctly filled ...................................
13.4 Medical follow-up of the staff ........................................................................
Staff medical certificates correctly updated ..........................................................
13.5 Staff training ...................................................................................................
Individual staff training certificates ......................................................................
13.6 Maintenance of buildings and equipment .......................................................
Maintenance daybook correctly kept ....................................................................
13.7 Upholding of the conformity and provisioning of the washstands (observation
in the course of visit) ..............................................................................................
13.8 Upholding of the conformity and provisioning of the boots/shoe washstands
(observation in the course of visit) ………………………………………………..
HACCP Grid 4 – Page 1/2
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Considered criteria
14 HACCP plan , CCPs control
14.1 CCP monitoring ..............................................................................................
2
3
4
Documents associated to these criteria
Recording relating to CCPs monitoring :
temperature recordings of the cold stores .............................................................
records of inventory control (respect of consumption deadlines) ........................
records of heat treatment couple "duration / temperature", schedules of
sterilisation, pasteurisation, cooking .....................................................................
measurement records of pH (dairy products, dry salted meats) ............................
measurement records of water activity (Aw) ........................................................
measurement records of weights, volumes, formulation rates ..........................
reports of calibration (in house or official way) of measuring instruments (scales,
thermometers…) ...................................................................................................
Monitoring sheets of corrective actions correctly and progressively filled until the
departure of concerned batches............................................................................
14.2 Corrective action follow-up ............................................................................
Analysis reports of raw materials or in production or finished products .............
..............................................................................................................................
14.3 Finished products conformity .........................................................................
Simulations of upstream and downstream traceability realized randomly at the
time of the visit .....................................................................................................
14.4 Traceability.....................................................................................................
Recordings of simulations of incidents / or simulation of incident during the audit
session...................................................................................................................
14.5 Simulations of incidents .................................................................................
HACCP Grid 4 – Page 2/2
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Page 80
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-APPENDICES
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3
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Guidelines on HACCP, GMP and GHP for ASEAN Food SMEs
APPENDICES
1 - Audit Report Template
2 - Hazards
3 - Calibration
4 - HACCP Certification
5 - Correlation with other Standards
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 81
1
APPENDICES
2
3
4
Audit Report Template
APPENDIX 1 – AUDIT REPORT TEMPLATE
Name of the establishment....................................................................................................
Adress ..................................................................................................................................
Phone n°................................................................................................................................
Fax n° ...................................................................................................................................
e-mail ...................................................................................................................................
Branch of industry : .....................................................................................................
Staff member met: ........................................................................................................
Number of employees ...................................................................................................
Volume of production ...................................................................................................
Inspection (audit) n°: ……………………
Page n°: …………….
Grid
ref
Obs
Doc
Shortcomings
Possible solutions
Conclusions:
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 82
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1
APPENDICES
2
3
4
APPENDIX 2 - HAZARDS
(HAZARD EXAMPLES)
¾ Chemical Hazards
Raw Materials
pesticides
growth regulators
antibiotics
heavy metals
natural toxins
microbial toxins
allergens
During process
cleaning agents
incorrect ingredient concentrations
hydrocarbon lubricants
refrigerants
pest control agents
microbial toxins
allergens
fumes / dust
Packaging
plasticizers
ink / adhesive
metals
¾ Physical Hazards
The list is endless, including foreign objects of all kinds. The food industry tends to take special
care over some types that easily cause damage if eaten by people, such as glass (prerequisite –
a glass management policy and management system) and metals (prerequisite – good
maintenance management). However, in this latter case, metal detection also in use and is
normally treated as a CCP. This, of course, means that the correct term is metal rejection –
simply to detect metal is clearly not the object of the activity.
¾ Microbiological Hazards
Pathogenic bacteria
Parasites and protozoa
Viruses and algae
Moulds
–
presence
contamination
survival
growth
the organism or its toxic products
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 83
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APPENDICES
2
3
4
APPENDIX 3 - CALIBRATION
Measuring equipment used to monitor Critical Control Points (CCPs) (and also product legality
factors, such as fill volumes or average weights) shall be calibrated and, where possible,
traceable to a recognised national standard. Where a national standard is not applicable, the
nature of the basis of the calibration shall be described.
All too often, companies establish calibration methods involving routine use of subcontractors, or
regular internal systems whereby instruments are calibrated very frequently with a very accurate
method. This is not always necessary – calibration is required to keep systems in control, but
this can be maintained with simpler methods that are referred back to a national standard on a
less frequent basis. What matters is that the frequency and accuracy of calibration is appropriate
to ensure that instrument variations are identified before they take the instrument out of allowed
tolerance. Weight scales, for example, can be calibrated against a reference set of brass weights
preserved by the company in good condition, (perhaps normally locked away in the Quality
Manager’s office). This reference set need calibration to national standards only, for example,
every five years or so, unless damaged.
Thermocouple probe thermometers are notorious for going out of calibration. A frequent rapid
method of checking is required to maintain good measurement systems, coupled with a less
frequent reference back to a national standard.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 84
1
APPENDICES
2
3
4
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 85
1
APPENDICES
2
3
4
APPENDIX 4 – HACCP CERTIFICATION
HACCP Certification - Warnings
A frequently defined objective for developing an HACCP system is to obtain recognition by an ‘expert’ body
in the form of certification from a third party audit body (perhaps required due to customer pressure).
This practice has value in providing extra verification of validity and effectiveness of the system, but it does
present a risk.
The award of a certificate does not mean that the system is faultless.
No auditor is perfect – the illusion of excellence provided by a certificate can lead to situations where a
business may believe that it operates a flawless HACCP system. It may well then not maintain
effectiveness of its own verification (auditing) processes.
actual observed example (from other sources)
product – smoked cooked chicken sausages, to be eaten either after home cooking OR
DIRECTLY FROM THE PACKAGE (perhaps as a part of a salad, or other garnish)
process – filled sausages were smoked / cooked in a chamber and then cooled by water before
packing in plastic pouches. Some of the cooling water was drawn from a well and was subject to
a disinfection procedure.
There was a potential hazard of microbiological contamination from the water that would not
have been removed by any subsequent process, so the disinfection point is ■ a CCP, and ■
should have been subject to a proper monitoring programme.
Neither of these points had been identified and yet the company had been awarded an HACCP
certificate by a well known accredited certification body, which was even prepared to argue that
this was not a CCP.
The award of the certificate had brought about a complacent attitude that meant that the
company was satisfied with its HACCP system and had not subjected it to effective review.
THE OBJECTIVE OF DEVELOPING A HACCP SYSTEM IS SAFE FOOD –
– NOT CERTIFICATION
Companies should beware of HACCP certification that is offered as a route to enable a company to export
into (for example) the European Union.
In all cases, the authorisation for exports to EU will be delivered only by the National Competent Authority
(recognised by the EU) which approves the food establishments involved.
Demonstration of good practice with an HACCP certificate will only provide part of any evidence required
and is a good route to demonstrating committed management, but other approvals are also needed at
national level, such as:
▪ Residues plan
▪ Use of accredited laboratories
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 86
1
APPENDICES
2
3
4
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 87
1
APPENDICES
2
3
4
APPENDIX 5 – CORRELATION WITH OTHER STANDARDS
A concern expressed by participating companies has been a desire to understand the
requirements of standards, or protocols, which may be needed for export to Europe and how far
completion of an HACCP – GHP – GMP system will go to fulfil these requirements.
Of consideration here are two standards, one the result of worldwide co-operation in the field of
formal international standards, ISO, the International Organization for Standardization, the other
an approach adopted for harmonization of retailer requirements called the Global Food Safety
Initiative. These provide different sets of requirements that reflect the objectives of the cooperating organisations. They are:
ISO 22000:2005 – Food safety management systems – requirements
As its title suggests, this standard sets out a systematic approach to food safety, combining two
approaches into an effective tool for management. These approaches are:
•
the management system approach, as normally understood in ISO 9001:2000, except
that ISO 22000 looks at the customer requirement of food safety ONLY and not at all the
other requirements that are expressed as ‘customer requirements’. For companies that
use management systems, this means that an ISO 22000 approach can fit food safety
very easily into this pattern.
•
HACCP, is broadly described in this EC-ASEAN guide. ISO 22000 is almost exclusively
based on HACCP, with less attention to GHP, GMP, or other prerequisites (which it terms
as ‘supportive safety measures’). With this attention to HACCP, it provides a flow
diagram demonstrating linkages between the twelve tasks of HACCP and its own
sections.
Users of this guide will have attended to most, or all, of the HACCP requirements of ISO 22000
but may need manage their system in a more systematic fashion if they are looking for ISO
22000 certification.
The use of ISO 22000 is yet to be proved because its objective was never identified by a
particular user group (such as retailers or importers / exporters). Its main use will probably come
if an international trade organisation (such as the World Trade Organization), was to decide that
a harmonised standard on food products was required for food trade.
For the moment the only standard recognised by WTO in the frame of the application of the SPS
agreement are: i) Codex Alimentarius for Food Safety, ii) OIE for animal health and iii) IPPC for
plant health (phytosanitary issues).
The Global Food Safety Initiative (GFSI)
This is a comprehensive private initiative for food safety resulting from co-operation between
major European food retail super and hyper market chains. Because of their need to
demonstrate ‘due diligence’, this protocole is comprehensive. Its specifications go beyond, but
include, those of this GHP, GMP, HACCP guide. It is much more prescriptive in setting its
requirements.
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 88
1
APPENDICES
2
3
4
Those organisations who have established food safety management through this guide will find
that they have addressed many GFSI needs. They will not have to alter their work, but will have
to add in extra sections on:
•
Quality Management System
•
Particular requirements on
-
Factory Environment Standards
Product Control
Process Control and
Personnel
GFSI is not, in itself, a standard. Its objective is to set out common needs for other audit
protocols, awarding such protocols GFSI status. Four such protocols have, so far, been
approved, these being ▪ The British Retail Consortium Technical Standard ▪ The Dutch HACCP
Code ▪ EFSIS Standard ▪ International Standard for Auditing Food Suppliers (International Food
Standard).
Guidelines on HACCP, GMP and GHP
for ASEAN Food SMEs (2005)
A project co-financed by
the European Union
EC-ASEAN Economic Cooperation Programme on Standards, Quality & Conformity
Assessment (Asia/2003/069-236)
A project co-financed
by ASEAN
Page 89
This hand-book
will help ASEAN
Food SMEs, from
any food sector, to
self-assess their
hygiene practices
and HACCP system
against the
requirements of the
European Union.
It contains a
full set of self-assessment
matrices designed by food
specialists and inspectors
from the EU, together with
guidelines on how to
fill in the gap(s) identified
through the assessment(s).
European Committee for
Standardisation / Comité
Européen de Normalisation
This report reflects the view of the
Implementing Agency and Experts and
in any case can be considered as the
view of the European Commission.
Appendix 3
“Report of Technical mission on food safety, agriculture
and cholera mission in Haiti”
Dr. Md. Sirajul Islam
Consultant. FAO, Haiti.
Report of Technical mission on food safety, agriculture and cholera mission in Haiti:
Dr. Md. Sirajul Islam
Consultant. FAO, Haiti.
A survey was conducted to test and analyse water samples collected from a cholera affected
area in Haiti. Five water samples were collected from Artibonite river, an irrigation canal,
paddy field, lake and sea. The samples were tested in the National Public Health Laboratory
of Haiti following Standard procedures. In brief, 100 ml water samples were collected from
the above mentioned sites and transported in the laboratory on the same day. Then 50 ml of
the water sample was inoculated into 25 ml of triple strength alkaline bile peptone water.
Then the inoculated APW was incubated at 370 C overnight. After overnight incubation, a
loopful of the APW was inoculated onto TCBS and TTGA media. Then the media are
incubated overnight at 37oC for 18-24 hours. The suspected Vibrio cholerae colonies from
the TCBS and TTGA media were subcultured on to gelatin agar (GA) media. The GA media
were again incubated overnight at 37oC. Then slide agglutination was done with the
suspected Vibrio colonies with Vibrio cholerae O1 polyvalent antiserum. However, not a
single colony from any of the sample yielded any Vibrio cholerae O1.These results may
suggest that the area from where these samples were collected are not heavily contaminated
with V. cholerae. Therefore there should not be any impact of cholera in the agriculture
inputs, irrigation water and fisheries.
These results also may suggest that there should not be any effect on rice production, river
and coastal fisheries and there should not be any risk of aquiring cholera by working in these
environments. Even if this environment is slightly contaminated, it will not have any effect as
these bacterium is very prone to desiccation. Those people who will be working in the rice
field or involved in fishery related work if their feet or hands are contaminated but if the
hands or feet are dried up, all these bacteria will be dead. So if the people are aware of how to
take precautionary measures then it will not pose any risk if contracting cholera.
FAO should arrange training activities with its stake holders to remove the unnecessary fear
about cholera from the mind of the people.
The laboratory staff of the National Public Health Laboratory has been shown how to isolate
and identify Vibrio cholerae from the environmental water samples using enrichment
technique.
The findings have been discussed in a meeting with various stake holders like representative
from WHO, UNICEF and other UN bodies.
Due to the limitation of the time, a through study could not be undertaken, however the
preliminary data clearly suggests that there is no wide spread contamination of the aquatic
environment and as such it will not create any problem in agriculture and fisheries. However,
FAO should organize meetings, workshops, etc. with its various stakeholders routinely to
educate them about the findings and its role in transmission of cholera. A rigorous attempts
should be made to create awareness among the people to remove the unnecessary fear from
the mind of the people about cholera.
Appendix 4
Examples of risks analysis applying
the "Alternative Method to the Decision Tree"
on other Haitian culinary preparations
Appendix 4, product n°1
Rice
Appendix 4, product n°2
Corn
Appendix 4, product n°3
Vegetables
Appendix 4, product n°4
Pea puree
Appendix 5
Emergency assistance to the activation of communication
networks for the prevention of cholera in remote areas of
rural farming communities affected by the epidemic
FOOD AND
AGRICULTURE
ORGANIZATION
OF THE
UNITED NATIONS
ORGANISATION
DES NATIONS
UNIES POUR
L’ALIMENTATION
ET L’AGRICULTURE
ORGANIZACION
DE LAS NACIONES
UNIDAS PARA
LA AGRICULTURA
Y LA ALIMENTACION
REPRESENTATION EN HAITI
16, angle rues Armand Holly et Débussy
Port-au-Prince, Haïti
B.P. 13225 (Delmas)
Téléphones:
Facsimilé:
E-Mail:
FAO website:
2452899/2453008/2457866/2459062
2453010
[email protected]
http://www.fao.org
Aide d'urgence à l'activation des réseaux de communication pour la prévention du choléra dans
les régions isolées des communautés rurales agricoles touchées par l'épidémie
Dr Richard Bonne
Projet : OSRO/HAI/101/CHA
Remerciements
Qu’il me soit permis, en introduction de ce rapport de remercier chaleureusement toute l’équipe de la
FAO implantée en Haïti : Philippe, Carlo, Volny, Carmen, Maria, Bakary, Webster, Roodly et tous les
autres, qui ont fait tout leur possible pour me faciliter les choses au cours de ma mission, sans oublier
Messieurs Lafrance, Caze, Leosthène et tous leurs collègues chauffeurs, pour leur disponibilité, leur
gentillesse, leur patience et leur efficacité dans les embouteillages de Port-au-Prince. Mes excuses à
tous ceux dont les noms ne figurent pas ici, qu’ils sachent que je n’oublie pas pour autant l’aide qu’ils
m’ont apportée et dont je les remercie.
Considérations d’ordre général
Après son irruption brutale en Haïti en octobre 2010, l’épidémie de choléra a marqué le pas, sous
l’effet des mesures sanitaires qui ont été prises pour traiter les malades, pour améliorer la situation
sanitaire de l’environnement par la mise en place de latrines, et pour initier la population au respect de
bonnes pratiques d’hygiène, de nature à la protéger de la contagion.
La saison sèche a certainement favorisé la régression de l’épidémie de choléra, mais l’arrivée prochaine
de la saison des pluies fait craindre à juste titre sa reprise, ce que semble confirmer l’apparition, ces
derniers jours, de quelques nouveaux foyers sporadiques de la maladie.
Alors que l’épidémie sévit depuis sept mois, il est temps de revoir et d’affiner les messages de
prévention adressés à la population, et aussi de tirer profit, en termes d’efficacité, des observations
faites depuis l’apparition du choléra en Haïti.
Pour ce qui concerne les messages, il est incontestable qu’ils ont été transmis et retenus par la
population, sauf peut-être dans les zones rurales reculées, qui vont de ce fait faire l’objet d’une
attention particulière dans les mois à venir. Il est également indubitable, que ces messages portant sur
l’application par la population de bonnes pratiques d’hygiène, ont eu un effet très positif dans la
régression de l’épidémie de choléra.
Néanmoins, l’expérience montre que les bénéficiaires de ce type de messages généraux, ont souvent du
mal, dans leur « vie de tous les jours », à appliquer ces bonnes pratiques, au bon moment et dans la
bonne situation. Partant de cette constatation, une nouvelle étape pourrait être franchie dans cette
campagne de prévention, en gardant les mêmes messages et en les associant à des contextes pratiques.
Les contextes pratiques retenus pourraient être en premier lieu, celui du travail aux champs avec en
particulier l’objectif de pouvoir s’y nourrir et s’y abreuver en toute sécurité, et en second lieu d’intégrer
ces messages d’hygiène aux pratiques usuelles de préparation des repas dans le cadre familial.
Les observations recueillies depuis le début de l’épidémie, ont permis également de mettre en évidence
des facteurs qui semblent favorables de façon cruciale, à l’apparition de cas cliniques sévères de
choléra. De fait, l’on sait que pour une forte proportion de personnes (environ 90% (3)) se trouvant en
contact avec le vibrion cholérique, la contamination ne se traduit pas par l’apparition de signes
cliniques. Bien entendu la résistance propre à chaque individu joue certainement un rôle, mais la dose
infectante ingérée en joue certainement également un.
En effet, il ressort des cas cliniques observés, que la grande majorité des malades, avaient consommé
des produits préparés à l’avance ou refroidis lentement ou conservés à température ambiante, dans les
heures précédant l’apparition des troubles. Ces conditions très particulières, appliquées à des aliments
cuits qui auraient été recontaminés par le vibrion, pourraient être très favorables à sa multiplication
rapide et peut-être également à la production concomitante de toxine dans l’aliment. Kolvin et Roberts
ont montré que le vibrion pouvait pousser activement à 22°, 30° et 37°C, dans une grande variété
d’aliments cuits tels que le riz ou les lentilles, et plus particulièrement dans ceux qui présentent un pH
élevé comme les crevettes et le moules cuites ou bien encore les œufs durs (2).
Les produits cuits semblent donc particulièrement favorables à sa multiplication, car non seulement la
cuisson a éliminé les autres flores qui pourraient gêner son développement par compétition, mais de
plus, elle a supprimé certains facteurs inhibiteurs du vibrion présents dans les aliments à l’état cru (1), et
a produit par dégradation des protéines, des nutriments qui lui sont très favorables (4).
En conséquence ces personnes auraient possiblement ingéré avec leur aliment, une dose infectante
massive. La question de savoir si cette multiplication se serait accompagnée ou non de la production de
toxine, qui pourrait expliquer, si elle a eu lieu, l’apparition rapide d’une forme sévère de choléra chez
ces malades. La brutalité d’apparition des troubles et la sévérité des symptômes, serait peut-être dans ce
cas due à l’intoxination massive accompagnant la forte population de vibrions présente dans l’aliment.
Compte tenu de ces observations, il convient d’optimiser les messages d’hygiène diffusés depuis le
début de l’épidémie, en mettant l’accent sur le risque majeur engendré par la consommation différée
des aliments cuits et sur le nécessaire abandon de cette pratique.
La contamination par des doses plus faibles (par l’eau, ou par la mise à la bouche de mains
modérément souillées, …) qui peut entrainer un portage asymptomatique temporaire, pose
probablement aussi un important problème en termes de propagation de l’épidémie. En effet bien que
ne présentant pas de troubles, ces porteurs excrètent des vibrions avec leurs selles pendant plusieurs
jours. L’absence de troubles ou l’apparition de symptômes bénins, font qu’ils sont ignorants de leur
situation, et qu’en conséquence, ils n’appliquent pas les règles d’hygiène préconisées (en particulier
celles qui concernent les mains), de façon renforcée pendant cette période.
Un plan d’analyse de l’eau, portant sur un échantillonnage probablement trop restreint, appliqué au
moment même du pic épidémique, n’a cependant pas permis la mise en évidence du vibrion dans l’eau
des rivières, ni dans celle des rizières. Cela ne signifie pas pour autant que l’agent infectieux soit
absent, et ne soit pas à l’origine d’affections asymptomatiques chez les ouvriers agricoles qui sont en
contact avec cette eau ou même la consomment. Le rôle de ces porteurs asymptomatiques serait alors
majeur dans la propagation de l’épidémie. L’apparition de symptômes nécessite pour sa part
l’intervention d’une dose infectante minimum (de 103 UFC pour les estimations les plus basses à 1011
UFC pour les estimations les plus hautes (1), ou > 108 UFC (3)), qui pourrait être obtenue grâce à
l’intervention d’un facteur favorisant, comme la multiplication du vibrion cholérique dans les aliments
cuits puis contaminés ensuite.
Comme il est habituel de l’observer en présence d’une épidémie, la population a adopté une attitude de
défense consistant à éliminer de sa consommation des aliments qu’elle suspecte, à tort ou à raison, de
transmettre l’agent infectieux. Cette attitude de défense consiste également à stigmatiser, à partir
d’arguments rationnels ou irrationnels, certaines catégories sociales suspectées d’avoir une
responsabilité particulière dans la propagation de la maladie.
Une meilleure connaissance des mécanismes responsables de l’épidémique, basée sur les observations
de terrain faites depuis son apparition, ainsi qu’une optimisation des messages d’hygiène émis à
l’intention de la population, devraient permettre de rétablir la consommation des aliments délaissés et
de mettre fin aux campagnes de stigmatisation.
Sur un plan beaucoup général, la catastrophe sanitaire que constitue le choléra, peut permettre d’initier
à moyen et long terme, une politique générale de sécurité sanitaire des aliments, dont les effets se
feront sentir, tant sur la qualité et la salubrité des denrées alimentaires remises aux consommateurs, que
sur la maîtrise des affections transmises par voie alimentaire, qu’elle soient d’origine microbiologique
(toxi-infections alimentaires) , virale (hépatite A) ou parasitaire (cysticercose, protozooses). Certaines
similitudes observées dans les conditions d’apparition du choléra clinique et des toxi-infections
alimentaires classiques, favorisées par la possibilité offerte aux germes de se multiplier dans l’aliment,
donne à espérer que les règles d’hygiène appliquées dans la lutte contre le choléra, auront une influence
significative sur la réduction du nombre de ces affections.
Calendrier des activités
La journée du 27 avril a été consacrée á la rencontre de différentes personnes impliquées comme
partenaires du programme :
- Mr Francesco DEL RE. Coordinateur du cluster agricole du PAM
- Mme Marie ORMEUS, représentante d’OCHA qui est l’organisme financeur du
programme.
- Mme Marta GOMEZ DENAMPS, représentante de l’OMS
La journée du 28 avril a été consacrée á la rencontre de :
- Mme Gaëlle FOHR et Mme Bérangère ANTOINE, représentantes de l’UNICEF
(programme WASH/HP)
Ces rencontres ont été l’occasion de présenter á ces partenaires, les actions dont la mise en œuvre est
envisageable pendant notre mission en Haïti, et qui peuvent se résumer aux deux volets qui seront
développés plus loin :
- Optimisation de la mise en œuvre des bonnes pratiques d’hygiène alimentaire, mises en
place dans le cadre des programmes précédents.
- Etude de faisabilité de la mise en place de la stérilisation solaire de l’eau de boisson.
Du 30 avril au 3 mai déplacement dans la région de l’Artibonite
Ce déplacement malheureusement trop bref a cependant permis de recueillir des informations auprès:
- Du représentant de la FAO pour la région de l’Artibonite, Mr Léo KORTEKAAS
- De Mme Colette EUGENE (DSA), Coordinatrice Départementale du FNLS
- De Mme FAUSTIN, employée localement comme chauffeur par la FAO, qui a décrit et
permis d’observer les modes traditionnels de préparation des aliments dans l’Artibonite
Au cours de la journée du 4 mai, une réunion a été organisée avec les représentants des trois ministères
impliqués dans la lutte contre le choléra :
-
Mme Michèle B. PAULTRE. Directeur, Direction Contrôle Qualité & Protection du
Consommateur. Ministère du Commerce et de l’Industrie
Dr Paule-Andrée Louise BYRON, Chef de Service de Promotion de la santé, au Ministère
de la Santé
Dr Max MILLIEN, représentant la Direction de Production et Santé Animale, du Ministère
de l’Agriculture, des Ressources Naturelles et du Développement Rural
Cette réunion a été l’occasion, avec l’assentiment des représentants des trois ministères concernés, de
rappeler l’incontestable « leadership » que doit avoir le Ministère de la Santé dans la politique mise en
place pour lutter contre le choléra.
L’accent a été également mis sur la nécessité de reconstituer et de remotiver les services de l’Etat
haïtien, en charge de la promotion et du contrôle de la sécurité sanitaire des aliments. La situation qui
avait cours dans les années 90 et qui permettait à Haïti d’être exportateur de viande, a été évoquée
comme un niveau sanitaire qu’il serait souhaitable de retrouver à l’avenir.
Le Dr Max MILLIEN, a insisté sur la nécessité qu’il voyait à impliquer les autorités locales dans la
diffusion et l’amplification des messages relatifs aux bonnes pratiques d’hygiène, visant à juguler
l’épidémie de choléra.
L’ancienneté du corpus réglementaire haïtien, qui n’a fait l’objet d’aucune réactualisation, a été
également évoquée (loi de 1934, sur les produits animaux et végétaux et Code Rural de 1963) comme
un frein aux exportations et à la mise en place au niveau du marché national, d’une politique de sécurité
sanitaire des aliments.
La possibilité de transposition en Haïti (ou dans le cadre plus large des accords d’échanges
commerciaux passés entre les Etats de la Caraïbe) des méthodes et des outils de promotion de l’hygiène
des aliments, développés en Asie du Sud Est et plus récemment en Afrique, dans le cadre du
programme « Une Meilleure Formation pour Des Aliments Plus Sains» (BTSF : Better Training for
Safer Food) de la Commission Européenne, a été évoquée au cours de la réunion.
Il a été convenu au cours de cette réunion, que des contacts seraient pris dans ce sens avec la DGSANCO de la Commission Européenne, par la FAO et les Autorités Haïtiennes, après la fin de cette
mission.
Le matin du lundi 09 mai a été l’occasion d’assister à une réunion de surveillance post-séisme,
organisée à la Direction d’Epidémiologie, de Recherche et de Laboratoire (DELR) du Ministère de la
Santé Publique et de la Population, présidée par le Dr Donald LAFONTAN.
Cette réunion a été l’occasion d’exposer aux participants, nos premières impressions sur le mode de
transmission du choléra intervenant probablement dans certaines formes sévères, ainsi que sur les
mesures de prévention qui pourraient en découler. L’épidémiologiste du « Center for Desease Control
and Prevention », présent à cette réunion Mr Nick SCHAAD, s’est montré particulièrement intéressé
par ces nouvelles perspectives.
La matinée du 11 mai à été consacrée à un déplacement dans la commune de Croix-des-Bouquets ayant
permis des échanges avec les personnes qui suivent :
- Mme Marie Norgla JEAN coordonnatrice de l’UCS/CSF
- Le Dr Timothée CLIFORD (Deputy Health Coodinator) du centre local « Merlin » de
traitement du choléra.
-
Mr Alfred WALTIER (Messager du Bureau Sanitaire Communal de Croix-des-Bouquets
Rapport d’activités techniques
A) Orientations principales
1) Optimisation de la mise en œuvre des bonnes pratiques d’hygiène alimentaire mises en
place dans le cadre des programmes précédents.
La campagne de lutte contre le Cholera, ayant permis d’endiguer l’épidémie de fin 2010 et début 2011,
s’est traduite en pratique par la diffusion très large, parmi la population haïtienne, de bonnes pratiques
d’hygiène à appliquer au quotidien afin d’éviter de se contaminer. Afin de potentialiser l’effet de ces
notions, qui sont maintenant acquises par la plus grande partie de la population, il nous semble qu’il
serait maintenant intéressant de les corréler avec les modes culinaires usuels utilisés en Haïti.
Dans un premier temps, il convient d’identifier et de décrire les grandes familles de produits et les
modes de préparation culinaire, les plus souvent appliqués dans le cadre familial. Le procédé culinaire,
spécifique à chaque famille d’aliments identifiée, sera schématisé sous la forme d’un diagramme de
préparation, qui servira de support á l’analyse des risques. Cette analyse sera réalisée á chacune des
étapes de fabrication figurant sur ce diagramme.
Le but de cette analyse des risques, est d’identifier les moyens de maitrise (en fait les bonnes pratiques
d’hygiène), qu’il est nécessaire d’appliquer á chacune de ces étapes. Ces bonnes pratiques, comme
nous l’avons vu plus haut, ont déjà été enseignées sous forme de messages, à la population lorsque
l’épidémie a éclaté.
L’objectif final de ce travail est de fournir á la population des documents (affiches, fascicules,
vidéos…) associant la recette (sous forme illustrée) de chaque famille de produits, sur laquelle, pour
chaque étape de préparation, les bonnes pratiques d’hygiène pertinentes soient mentionnées. L’accent
sera mis sur les étapes de fabrication jouant un rôle crucial et au niveau desquelles les précautions
d’hygiène devront être mises en œuvre avec une attention particulière.
Cette démarche doit permettre de combler le vide qui existe souvent, entre des connaissances reçues et
leur application aux situations pratiques de la vie de tous les jours.
2) Etude de faisabilité de la mise en place de la stérilisation solaire de l’eau de boisson.
D’un autre point de vue, il serait intéressant d’étudier la possibilité d’appliquer le procédé SODIS de
décontamination de l’eau de boisson, par le rayonnement solaire. Ce procédé pourrait, dans un premier
temps, être introduit à petite échelle, pour résoudre des cas spécifiques de fourniture d’eau potable à
des activités pratiquées dans des lieux isolés, comme les travaux des champs.
Ces propositions ont été accueillies avec intérêt par les différents interlocuteurs rencontrés.
B) action de formation aux principe de l’évaluation et de la gestion des risques alimentaires
La journée du jeudi 12 mai à été consacrée à un programme de formation destiné a donner aux
participants des outils pour réaliser l’évaluation des risques alimentaires, mais aussi déterminer les
modes de prévention à mettre en œuvre pour leur maîtrise, particulièrement au cours des étapes de
préparation présentant le niveau de risque le plus élevé. Les différentes méthodes exposées et les outils
nécessaires à leur mise en œuvre, sont présentés sous forme de documents pédagogiques annexés du
présent rapport.
Cette formation ainsi que les méthodes d’investigation utilisées pour étudier le « risque choléra » au
cours de cette mission, constituent une tentative pour appliquer, en situation d’urgence et dans le cadre
de la préparation familiale traditionnelle d’aliments, des méthodes qui ont déjà fait largement leurs
preuves dans le cadre des PME d’autres pays en voie de développement.
Ces méthodes ont été d’abord présentées, dans leur format d’origine propre aux PME, aux participants
à la formation qui auront ensuite la charge de diffuser ces savoirs. Puis une version adaptée à la
problématique de prévention du choléra en milieu familial, accompagnée d’exemples et d’exercices à
faire, par les participants a été proposée.
C) Eléments relatifs á la maitrise de la sécurité sanitaire des aliments
1) Salubrité des matières premières utilisées pour cuisiner
Les matières premières utilisées pour cuisiner dans le cadre familial, sont de différents types et de
différentes origines. Si de très rares produits, comme par exemple le concentré de tomate en boite
ou le bouillon-cube, ne peuvent pas constituer une source de contamination, l’immense majorité des
matières premières utilisées, constituent de ce point de vue un risque potentiel maximum. Que l’on
prenne en compte les conditions de production des produits de la pêche ou des légumes ou des
viandes abattues, aussi bien que celles de leur exposition á la vente sur les marchés, le niveau
d’hygiène observé est déplorable de tous les points de vue : environnement très sale et absence de
chaine du froid.
En conséquence, compte tenu de la multiplicité des acteurs impliqués dans la fourniture des
matières premières, mais aussi du nombre très élevé de situations où les règles élémentaires
d’hygiène ne sont pas respectées, il est illusoire d’espérer á court terme, une amélioration notable
de la qualité sanitaire des matières premières proposées aux familles pour cuisiner.
Une telle amélioration, de la qualité des matières premières, ne pourra être obtenue á terme qu’en
renforçant la maitrise de l’hygiène dans les différentes filières de production ainsi qu’au niveau de
leurs réseaux de mise sur le marché (secteurs des produits de la pêche, des légumes, des céréales,
des viandes, …). Dans le cadre des procédures adoptées en urgence pour lutter contre l’épidémie de
cholera, toute démarche visant á obtenir une amélioration rapide, même minime, mais cependant
significative, de la qualité sanitaire de ces matières premières, serait illusoire.
2) Conditions d’apparition des cas cliniques de cholera dans la population.
La collecte d’information sur le terrain, nous a permis de recueillir auprès de Mme Colette
EUGENE, Coordonnatrice départementale du PNLS de l’Artibonite, une donnée qui doit être
considérée comme étant de la première importance. A la question volontairement ouverte : avezvous relevé une caractéristique commune aux personnes atteintes du cholera ? Sa réponse a été la
suivante : les malades avaient acheté auprès des marchands de rues des produits préparés a l’avance
et refroidis. Ou bien leur repas avait été préparé à l’avance par une servante ou bien encore le repas
leur avait été apporté d’ailleurs, sur une longue distance. Elle a également observé que la
consommation directe de fruits de mer, n’avait pas rendu les gens malades du cholera.
Cette même question a été posée à Mme Marie Norgla JEAN, coordonnatrice de l’UCS/CSF,
(visite à La Croix-des-Bouquets), et sa réponse a été du même ordre « les malades avaient, dans
leur grande majorité, consommé de la nourriture achetée à des marchands de rues ». Pour ce qui
concerne les ouvriers agricoles, elle nous a déclaré qu’elle avait l’impression, sans pouvoir en
donner la confirmation formelle, que les malades qu’elle avait rencontrés, avaient apporté leur
repas le matin aux champs pour le consommer au cours de la journée.
Elle nous a cependant recommandé, pour obtenir une meilleure information, de nous adresser
directement aux Agents de Santé en Milieu Rural, responsables des Centres de Réhydratation Orale
qui traitent la majorité des ouvriers agricoles atteints. Afin de leur faciliter la collecte des
informations qui nous semblent importantes, nous allons rédiger à leur intention, un questionnaire
simple à remplir chaque fois qu’un nouveau malade du choléra se présente dans un de ces centres.
Enfin le Dr Timothée CLIFORD, Deputy Health Coodinator (visite au CTC Merlin), nous a
apporté une information complémentaire de celle recueillie auprès de Mmes EUGENE et JEAN. A
la fin de la visite ayant eu lieu un mardi, la question lui a été posée de savoir « combien il avait
actuellement de malade hospitalisés au centre Merlin ». Il a répondu : « nous en avons 31, ce qui est
un nombre important, en rapport avec la recrudescence de cas de choléra que nous observons
chaque weekend». Il faut interpréter cette observation par le fait que le weekend end est l’occasion
de célébrations (noces, baptêmes, repas de groupes) pour lesquelles sont préparés à l’avance des
repas de fort volume, destinés à un nombre important de convives.
Au cours de ces repas interviennent de nombreuses sources de contamination liées au nombre
important d’opérateurs impliqués dans la préparation. En outre, les repas ainsi préparés font
souvent l’objet de refroidissements lents et d’attentes prolongées à température ambiante, qui sont
favorables à la multiplication rapide des germes de contamination en général et éventuellement à
celle du vibrion cholérique.
Le fait que ces repas de groupes soient en général, dans différentes régions du monde, responsables
d’une forte proportion des accidents alimentaires observés (en particulier en France), est un facteur
de risque qui n’est plus remis en cause à l’heure actuelle, par les spécialistes de la sécurité sanitaire
des aliments.
Sur la base de ces observations, il semble que la possibilité donnée au vibrion cholérique de se
multiplier dans un aliment cuit, qu’il a recontaminé, pourrait être un facteur favorisant majeur, si ce
n’est indispensable, à l’apparition de la forme clinique sévère de la maladie chez le consommateur.
3) Rôle possible des mères de famille dans la prévention de la transmission par les aliments, du
cholera (en particulier), et des toxi-infections alimentaires (en général).
Compte tenu de ce qui vient d’être développé dans le paragraphe précédent, toute matière première
entrant dans une cuisine familiale, doit être par principe considérée comme massivement
contaminée, ce qui correspond d’ailleurs á la réalité dans l’immense majorité des cas.
Heureusement la plupart des procédés de préparation appliqués dans la tradition culinaire
Haïtienne, font intervenir des phases de cuisson prolongées, qui ont la capacité de détruire
totalement les flores bactériennes non sporulées de contamination, apportées par les matières
premières, et dont fait partie le vibrion cholérique.
Par ailleurs la mère de famille étant le seul acteur intervenant dans la préparation des repas, ce sera
sur elle, et sur elle seule, que devront reposer la responsabilité et l’application des bonnes pratiques
d’hygiène. Cette situation instaure un contexte très favorable à l’hygiène, qui n’intervient
malheureusement pas dans les repas de groupes à la préparation desquels participent de nombreux
opérateurs difficiles à contrôler.
Dans ces conditions, il est d’une importance cruciale d’éviter par des manipulations très propres, la
recontamination de ces denrées dans l’espace de temps compris entre la fin de la cuisson et la
consommation. Les composants ajoutés au dernier moment de la préparation, comme les oignons,
et qui ne subissent pas une cuisson prolongée, propre à garantir l’élimination d’une éventuelle
contamination bactérienne, doivent être d’une salubrité irréprochable.
En complément de ces manipulations très propres, la consommation de ces aliments devra
intervenir rapidement après la cuisson, pour éviter toute multiplication d’une éventuelle flore de
recontamination, pouvant comprendre le vibrion cholérique. Par le respect scrupuleux de ces deux
conditions, la salubrité de ces produits aura de bonnes chances d’être préservée.
De ce point de vue, et surtout au plan du cholera, la salubrité de l’eau utilisée, qu’elle entre dans la
composition des aliments ou qu’elle serve aux opérations de lavage des denrées alimentaires ou au
nettoyage des matériels, doit être irréprochable.
Pour garantir le plus possible, des conditions d’hygiène optimales pour la manipulation finale des
préparations culinaires prêtes à être consommées, il convient, á notre avis, d’appliquer la
chronologie de précautions, qui suit.
1* Appliquer des bonnes conditions d’hygiène aux premières opérations de lavage, de parage,
d’épluchage et de découpe des denrées crues ou brutes. Même à ce premier stade, il est essentiel
d’utiliser de l’eau dont la salubrité est avérée. D’ailleurs d’un point de vue général, toute
introduction ou utilisation d’eau dont la salubrité n’est pas garantie, dans les zones où sont préparés
des aliments, pour quelque raison que ce soit, doit être strictement prohibée.
Compte tenu des observations faites sur le terrain, il semble que la procédure de chloration de l’eau
ne s’accompagne pas de toute la rigueur souhaitable, qui permettrait de garantir systématiquement
la présence d’un taux de chlore efficace. Il semble indispensable que cette chloration de l’eau se
fasse á l’aide de mesurettes, ou que l’on utilise des comprimés de chloration dont le nombre soit
fixe, par unité de volume d’eau traitée.
Il faut insister sur le fait qu’une eau insuffisamment traitée, peut devenir un vecteur de
contamination entre les aliments, les ustensiles de cuisine et les mains, alors que la chloration de
l’eau a justement pour but de désinfecter et d’éviter ce type de contaminations croisées.
2* Lorsque tous les composants de la préparation sont engagés dans une première opération de
cuisson, les mains ainsi que les ustensiles, les récipients et l’environnement de travail devront faire
l’objet d’une procédure de nettoyage/décontamination soignée. En effet, à partir du moment où les
produits ont commencé à être cuits, ils doivent être considérés comme plus sains mais aussi plus
vulnérables. Il est donc indispensable, qu’ils soient manipulés dans un environnement également
sain.
3* Ensuite, tout au long de la préparation, les bonnes pratiques d’hygiène recommandées à la
population, depuis le début de l’épidémie de choléra, devront être appliquées, étape par étape.
4* Puis, des précautions d’hygiène particulièrement strictes devront être associées à toutes les
manipulations des aliments, intervenant postérieurement à leur dernière phase de cuisson
5* Enfin, il semble essentiel, sur la base de nos premières observations et bien qu’elles soient
limitées en nombre, de ne pas différer (dans le temps mais aussi dans l’espace) la consommation
des aliments qui viennent d’être préparés. Il faudra en particulier éviter absolument toute phase de
refroidissement lent ou de maintien prolongé á température ambiante, d’autant plus qu’Haïti se
trouve en zone tropicale.
De telles mauvaises conditions d’attente sont très favorables à la multiplication des germes
responsables des toxi-infections alimentaires classiques, mais peut être aussi à celle du vibrion
cholérique si l’opportunité lui a été donnée de recontaminer les aliments après cuisson, alors que les
produits cuits semblent particulièrement favorables à son développement.
4) Intégration de la politique de maitrise du cholera dans le cadre d’une politique plus large de
sécurité sanitaire des aliments.
1* Lutte contre les toxi-infections alimentaires.
Un certain nombre de germes, parmi lesquels on peut citer par exemple les Salmonelles
(responsables de la typhoïde et des paratyphoïdes pour certains sérotypes) mais aussi
staphylococcus aureus, bacillus cereus, yersinia enterocolitica, Listeria monocytogenes et
différentes clostridies (botulinum et perfringens) peuvent être responsables de troubles toxiinfectieux, lorsqu’ils sont ingérés en grand nombre avec l’alimentation.
La maitrise de la contamination des aliments, assurée par la propreté des opérations auxquelles
sont soumises les denrées alimentaires, ainsi que par l’application de procédures de désinfection
telles que la chloration de l’eau, représente le premier volet de cette lutte contre les toxiinfections alimentaires.
Le second volet consiste á empêcher la multiplication bactérienne en maitrisant les chaines
thermiques :
- toute attente à température ambiante ou tout refroidissement lent des denrées
alimentaires après cuisson doivent être prohibés.
- ce qui est chaud doit rester chaud (á plus de 65° C)
- ce qui est froid doit rester froid (entre 0 et 4° C)
- le passage du chaud au froid doit être le plus rapide possible (de 65° á 10° C en moins
de 2 heures)
- le passage du froid au chaud doit être le plus rapide possible (de 4° á 65° C en moins
de 1 heure)
Comme nous venons de le voir, ces mesures de lutte contre les toxi-infections alimentaires pourraient
certainement être aussi préconisées dans la lutte contre le cholera. En conséquence, leur respect devrait
se traduire par une baisse significative du nombre de toxi-infections alimentaires et peut-être aussi, du
moins faut-il l’espérer, par une réduction du nombre de cas de choléra clinique enregistrés.
2* Lutte contre les zoonoses parasitaires
La mise en place de latrines visant à éliminer toute défécation dans l’environnement, est une
des mesures majeures retenues dans la lutte contre le cholera, visant à empêcher la dissémination de
l’agent infectieux responsable (le vibrion cholérique) dans l’environnement.
Compte tenu de la divagation des animaux domestiques des espèces porcine et bovine, cette pratique,
contraire aux principes de l’hygiène, est favorable à la transmission de zoonoses parasitaires telles que
les cysticercoses du bœuf et du porc. Les animaux se contaminent en consommant des aliments souillés
par les déjections humaines, tandis que les consommateurs se contaminent en ingérant la viande de ces
animaux, insuffisamment cuite.
Par ailleurs la consommation par les porcs qui divaguent, de détritus d’origine carnée, pourrait être très
favorable à la dissémination de la trichinose qui est une parasitose gravissime, commune à l’espèce
humaine et aux porcins.
Ces dernières lignes laissent espérer que les règles d’hygiène, proposées pour lutter contre le cholera,
devraient permettent si elles sont largement respectées, d’observer une réduction sensible du nombre
des toxi-infections alimentaires ainsi que de diminuer la prévalence de certaine zoonoses parasitaires
transmises par les bovins et les porcins.
5) Synthèse des éléments qui devraient probablement être pris en compte au plan
microbiologique, pour expliquer l’apparition des cas cliniques de choléra
a) Un aliment cuit présentant les caractéristiques qui suivent :
- Cuisson longue et élimination de toute la flore non sporulée à la fin de la cuisson, dont
celles qui pourraient jouer le rôle de « flore de barrière »
- Elimination des inhibiteurs du vibrion présents dans certains aliments crus
- Production de nutriments à chaîne courte très favorables au développement rapide du
vibrion
b) des conditions de manipulation non maîtrisées après cuisson permettant une recontamination
de l’aliment par le vibrion :
- par les mains
- par les récipients et les ustensiles
- par l’environnement massivement souillé comme celui des marchés
- par l’eau
c) un refroidissement lent après cuisson suivi d’une attente prolongée à température ambiante
avant consommation
d) Synthèse
Ces conditions qui sont observées avec une très grande fréquence, dans les heures qui précédent
l’apparition des troubles (si l’on se réfère aux témoignages recueillis), évoquent l’intervention possible
des évènements suivants par ordre chronologique :
- cuisson assurant la décontamination des aliments et l’instauration de conditions
nutritionnelles favorables au développement du vibrion
- recontamination de l’aliment par des manipulations non maîtrisée au plan de l’hygiène
- prolifération intense du vibrion, possible dans certains aliments, provoquée par le
refroidissement lent et le maintien prolongé à température ambiante, et permettant
probablement d’atteindre la dose minimale infectante capable de provoquer un cas de
choléra clinique
- charge microbienne très importante, peut-être accompagnée d’une forte concentration de
toxine cholérique produite au cours de la multiplication du germe. Ce point relatif à la
production éventuelle de toxine dans certains aliments, reste vérifier par la mise en œuvre
d’un protocole expérimental.
- troubles apparaissant rapidement et violemment du fait de la forte dose infectante et peutêtre aussi, sous l’effet d’un choc toxinique si cette substance a été libérée dans la l’aliment
au cours de la multiplication du vibrion.
e) Interrogations
-
-
-
pour le moment aucun élément dans la bibliographie disponible ne rapporte le phénomène
de production de toxine dans l’aliment, associée à la prolifération du vibrion, qui elle est
avérée dans ces conditions pour certains aliments. Cependant cette production de toxine est
un phénomène établi pour ce qui concerne sa production dans les milieux de culture utilisés
au laboratoire pour la recherche du vibrion.
Une seconde interrogation consiste à savoir si la toxine est thermorésistante ou non.
L’obtention de cette information nous semble cruciale, car si cette toxine est
thermosensible, un réchauffement poussé de l’aliment avant consommation, lorsqu’elle est
différée, pourrait constituer une pratique majeure de prévention du choléra chez les
consommateurs
Une troisième interrogation concerne la sensibilité de la toxine aux valeurs de pH acides. En
effet, de cette résistance dépend sa capacité à traverser l’espace stomacal (pH=2) sans être
inactivée, et à agresser ensuite les cellules (épithéliales) de la paroi intestinales. Ce caractère
serait très important à connaître, quand on sait que le vibrion cholérique pour ce qui le
concerne est détruit quand il se trouve dans un environnement fortement acide.
f) Ebauche sur la base des informations recueillies, d’un scénario possible de contamination de
nature à provoquer l’apparition de cas cliniques sévères de choléra.
- à partir d’une source de vibrion cholérique, introduite dans un environnement géographique,
préalablement indemne, ce germe va se répandre préférentiellement par voie hydrique : eaux
usées ou de ruissellements, contaminés par les défécations d’un porteur du vibrion cholérique,
puis propagation le long du réseau hydrographique naturel
- contamination de nombreux individus par voie hydrique : consommation d’eau, baignade,
lavage des aliments, arrosage des jardins, etc …
- constitution d’une importante population de porteurs, dont la majorité présente un portage
asymptomatique. Ce portage asymptomatique est particulièrement favorable à la propagation du
vibrion, car ces porteurs n’étant pas conscients de leur état, ne prennent pas de précaution
particulière, comme par exemple le renforcement de l’hygiène des mains.
- amplification de la contamination hydrique avec intervention concomitante de la
contamination directe d’individu à individu (poignée de mains) ou contamination des aliments
par manipulation souillée.
- du fait de la très forte présence du germe dans l’environnement de préparation, contamination
d’aliments après cuisson suivie d’un refroidissement lent et conservation prolongée à
température ambiante
- apparition de cas cliniques sévères de choléra chez certains consommateurs ingérant ces
aliments massivement contaminés, et présentant peut-être (mais ceci doit faire l’objet d’un
protocole expérimental pour être évalué) une forte concentration de toxine cholérique.
Conclusion :
Dans l’état actuel des investigations une forte présomption, dans l’apparition de formes sévères de
choléra clinique, porte sur la séquence de préparation des aliments qui suit: intervention de la cuisson,
puis de la recontamination des aliments, suivies enfin par un refroidissement lent et une conservation
prolongée à température ambiante.
Par application du principe de précaution, qui doit logiquement découler de cette présomption
raisonnablement fondée, il semble indispensable d’inciter la population à manipuler les aliments cuits
en appliquant de la façon la plus rigoureuse possible, les bonnes pratiques d’hygiène qui leur ont été
recommandées depuis l’apparition de l’épidémie de choléra. En outre, la consommation de ces aliments
devra survenir le plus rapidement possible, après la fin de leur préparation. Le délai de 30 minutes à ne
pas dépasser, devra être présenté comme un objectif à atteindre, revêtant une importance cruciale.
La production de toxine dans l’aliment, comme ses capacités de résistance à la chaleur et à l’acidité,
faisant l’objet d’interrogations cruciales, il est trop tôt pour recommander un réchauffage prolongé des
aliments dont la consommation doit être différée, comme une précaution de nature à éviter l’apparition
d’une forme de choléra clinique. Que ce réchauffage détruise les vibrions, même en forte
concentration, ne fait aucun doute. En revanche, il est encore crucial de trancher sur le point de savoir
si un réchauffage poussé est de nature à inactiver la toxine cholérique au cas non encore élucidé, où elle
serait effectivement présente, dans l’aliment.
Afin d’acquérir ces connaissance indispensables, sur la capacité du vibrion cholérique à produire de la
toxine dans l’aliment comme sur la résistance à la chaleur et à l’acidité de cette substance, la mise en
œuvre du programme de recherche nécessaire à lever ces doutes, pourrait être confiée par contrat avec
la FAO, à un laboratoire implanté en Haïti même.
Annexes :
1°) CODE D'USAGES INTERNATIONAL RECOMMANDÉ -PRINCIPES GÉNÉRAUX D'HYGIÈNE ALIMENTAIRE
CAC/RCP 1-1969, RÉV. 4 (2003)
2°) Guide d’application Bonnes Pratiques de Fabrication Bonnes Pratiques d’Hygiène et
HACCP
3°) Gestion globale de l’hygiène (document Pdf)
4°) Méthode alternative (document Pdf)
5°) Exemples, exercices, corrigés (documents Pdf)
Références bibliographiques
1) L.Sutra, M.Federighi, J-L Jouve, Manuel de bactériologie alimentaire, édit
Polytechnica, 1998
2) Kolvin, JL & Roberts, D (1982) Studies on the growth of Rio cholerae biotype classical
in food. J.Hygiene, 89, 243-252).
3) BEH (bulletin Epidémiologique Hebdomadaire), n°10/1999, mars 1999
4) Food Microbiology Fondamental & frontiers, edit Michael.P.Doyle, Larry.R.Beuchat &
Thomas.J.Montville, chapt Vibrio species by James.D.Oliver & James.B.Kaper, 1997
Appendix 6
GENERAL PRINCIPLES OF FOOD HYGIENE
CAC/RCP 1-1969
GENERAL PRINCIPLES OF FOOD HYGIENE
CAC/RCP 1-1969
TABLE OF CONTENTS
INTRODUCTION.............................................................................................................................................................3
SECTION I - OBJECTIVES............................................................................................................................................3
THE CODEX GENERAL PRINCIPLES OF FOOD HYGIENE:...................................................................................................3
SECTION II - SCOPE, USE AND DEFINITION..........................................................................................................3
2.1
2.2
2.3
SCOPE ....................................................................................................................................................................3
USE........................................................................................................................................................................4
DEFINITIONS ..........................................................................................................................................................5
SECTION III - PRIMARY PRODUCTION ..................................................................................................................5
3.1
3.2
3.3
3.4
ENVIRONMENTAL HYGIENE ...................................................................................................................................6
HYGIENIC PRODUCTION OF FOOD SOURCES............................................................................................................6
HANDLING, STORAGE AND TRANSPORT .................................................................................................................6
CLEANING, MAINTENANCE AND PERSONNEL HYGIENE AT PRIMARY PRODUCTION .................................................6
SECTION IV - ESTABLISHMENT: DESIGN AND FACILITIES ............................................................................7
4.1
4.2
4.3
4.4
LOCATION .............................................................................................................................................................7
PREMISES AND ROOMS ...........................................................................................................................................8
EQUIPMENT ...........................................................................................................................................................8
FACILITIES .............................................................................................................................................................9
SECTION V - CONTROL OF OPERATION..............................................................................................................11
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
CONTROL OF FOOD HAZARDS ..............................................................................................................................11
KEY ASPECTS OF HYGIENE CONTROL SYSTEMS ....................................................................................................11
INCOMING MATERIAL REQUIREMENTS .................................................................................................................13
PACKAGING .........................................................................................................................................................13
WATER ................................................................................................................................................................13
MANAGEMENT AND SUPERVISION .......................................................................................................................13
DOCUMENTATION AND RECORDS.........................................................................................................................14
RECALL PROCEDURES ..........................................................................................................................................14
SECTION VI - ESTABLISHMENT: MAINTENANCE AND SANITATION .........................................................14
6.1
6.2
6.3
6.4
6.5
MAINTENANCE AND CLEANING ...........................................................................................................................14
CLEANING PROGRAMMES ....................................................................................................................................15
PEST CONTROL SYSTEMS .....................................................................................................................................15
WASTE MANAGEMENT .........................................................................................................................................16
MONITORING EFFECTIVENESS..............................................................................................................................16
SECTION VII - ESTABLISHMENT: PERSONAL HYGIENE ................................................................................16
7.1
7.2
7.3
7.4
7.5
HEALTH STATUS ..................................................................................................................................................17
ILLNESS AND INJURIES .........................................................................................................................................17
PERSONAL CLEANLINESS .....................................................................................................................................17
PERSONAL BEHAVIOUR ........................................................................................................................................17
VISITORS .............................................................................................................................................................18
SECTION VIII - TRANSPORTATION .......................................................................................................................18
8.1
8.2
8.3
GENERAL .............................................................................................................................................................18
REQUIREMENTS ...................................................................................................................................................18
USE AND MAINTENANCE ......................................................................................................................................18
SECTION IX - PRODUCT INFORMATION AND CONSUMER AWARENESS..................................................19
9.1
LOT IDENTIFICATION ...........................................................................................................................................19
Adopted 1969. Amendment 1999. Revisions 1997 and 2003.
CAC/RCP 1-1969
9.2
9.3
9.4
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PRODUCT INFORMATION ......................................................................................................................................19
LABELLING ..........................................................................................................................................................19
CONSUMER EDUCATION .......................................................................................................................................19
SECTION X - TRAINING .............................................................................................................................................20
10.1
10.2
10.3
10.4
AWARENESS AND RESPONSIBILITIES ...............................................................................................................20
TRAINING PROGRAMMES ................................................................................................................................20
INSTRUCTION AND SUPERVISION .....................................................................................................................20
REFRESHER TRAINING .....................................................................................................................................20
HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES
FOR ITS APPLICATION..............................................................................................................................................21
PREAMBLE....................................................................................................................................................................21
DEFINITIONS ................................................................................................................................................................21
PRINCIPLES OF THE HACCP SYSTEM ..................................................................................................................22
GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM..................................................................24
INTRODUCTION...........................................................................................................................................................24
APPLICATION...............................................................................................................................................................24
TRAINING ......................................................................................................................................................................28
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INTRODUCTION
People have the right to expect the food they eat to be safe and suitable for consumption.
Foodborne illness and foodborne injury are at best unpleasant; at worst, they can be fatal. But
there are also other consequences. Outbreaks of foodborne illness can damage trade and tourism,
and lead to loss of earnings, unemployment and litigation. Food spoilage is wasteful, costly and
can adversely affect trade and consumer confidence.
International food trade, and foreign travel, are increasing, bringing important social and
economic benefits. But this also makes the spread of illness around the world easier. Eating
habits too, have undergone major change in many countries over the last two decades and new
food production, preparation and distribution techniques have developed to reflect this. Effective
hygiene control, therefore, is vital to avoid the adverse human health and economic consequences
of foodborne illness, foodborne injury, and food spoilage. Everyone, including farmers and
growers, manufacturers and processors, food handlers and consumers, has a responsibility to
assure that food is safe and suitable for consumption.
These General Principles lay a firm foundation for ensuring food hygiene and should be used in
conjunction with each specific code of hygienic practice, where appropriate, and the guidelines on
microbiological criteria. The document follows the food chain from primary production through
to final consumption, highlighting the key hygiene controls at each stage. It recommends a
HACCP-based approach wherever possible to enhance food safety as described in Hazard
Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex).
The controls described in this General Principles document are internationally recognized as
essential to ensure the safety and suitability of food for consumption. The General Principles are
commended to Governments, industry (including individual primary producers, manufacturers,
processors, food service operators and retailers) and consumers alike.
SECTION I - OBJECTIVES
1.1 THE CODEX GENERAL PRINCIPLES OF FOOD HYGIENE:
•
identify the essential principles of food hygiene applicable throughout the food chain
(including primary production through to the final consumer), to achieve the goal of ensuring
that food is safe and suitable for human consumption;
•
recommend a HACCP-based approach as a means to enhance food safety;
•
indicate how to implement those principles; and
•
provide a guidance for specific codes which may be needed for - sectors of the food chain;
processes; or commodities; to amplify the hygiene requirements specific to those areas.
SECTION II - SCOPE, USE AND DEFINITION
2.1 SCOPE
2.1.1
The food chain
This document follows the food chain from primary production to the final consumer, setting out
the necessary hygiene conditions for producing food which is safe and suitable for consumption.
The document provides a base-line structure for other, more specific, codes applicable to
particular sectors. Such specific codes and guidelines should be read in conjunction with this
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document and Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for
its Application (Annex).
2.1.2
Roles of Governments, industry, and consumers
Governments can consider the contents of this document and decide how best they should
encourage the implementation of these general principles to:
•
protect consumers adequately from illness or injury caused by food; policies need to consider
the vulnerability of the population, or of different groups within the population;
•
provide assurance that food is suitable for human consumption;
•
maintain confidence in internationally traded food; and
•
provide health education programmes which effectively communicate the principles of food
hygiene to industry and consumers.
Industry should apply the hygienic practices set out in this document to:
•
provide food which is safe and suitable for consumption;
•
ensure that consumers have clear and easily-understood information, by way of labelling and
other appropriate means, to enable them to protect their food from contamination and
growth/survival of foodborne pathogens by storing, handling and preparing it correctly; and
•
maintain confidence in internationally traded food.
Consumers should recognize their role by following relevant instructions and applying
appropriate food hygiene measures.
2.2 USE
Each section in this document states both the objectives to be achieved and the rationale behind
those objectives in terms of the safety and suitability of food.
Section III covers primary production and associated procedures. Although hygiene practices
may differ considerably for the various food commodities and specific codes should be applied
where appropriate, some general guidance is given in this section. Sections IV to X set down the
general hygiene principles which apply throughout the food chain to the point of sale. Section IX
also covers consumer information, recognizing the important role played by consumers in
maintaining the safety and suitability of food.
There will inevitably be situations where some of the specific requirements contained in this
document are not applicable. The fundamental question in every case is “what is necessary and
appropriate on the grounds of the safety and suitability of food for consumption?”
The text indicates where such questions are likely to arise by using the phrases “where necessary”
and “where appropriate”. In practice, this means that, although the requirement is generally
appropriate and reasonable, there will nevertheless be some situations where it is neither
necessary nor appropriate on the grounds of food safety and suitability. In deciding whether a
requirement is necessary or appropriate, an assessment of the risk should be made, preferably
within the framework of the HACCP approach. This approach allows the requirements in this
document to be flexibly and sensibly applied with a proper regard for the overall objectives of
producing food which is safe and suitable for consumption. In so doing it takes into account the
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wide diversity of activities and varying degrees of risk involved in producing food. Additional
guidance is available in specific food codes.
2.3 DEFINITIONS
For the purpose of this Code, the following expressions have the meaning stated:
Cleaning - the removal of soil, food residue, dirt, grease or other objectionable matter.
Contaminant - any biological or chemical agent, foreign matter, or other substances not
intentionally added to food which may compromise food safety or suitability.
Contamination - the introduction or occurrence of a contaminant in food or food environment.
Disinfection - the reduction, by means of chemical agents and/or physical methods, of the number
of micro-organisms in the environment, to a level that does not compromise food safety or
suitability.
Establishment - any building or area in which food is handled and the surroundings under the
control of the same management.
Food hygiene - all conditions and measures necessary to ensure the safety and suitability of food
at all stages of the food chain.
Hazard - a biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse health effect.
HACCP - a system which identifies, evaluates, and controls hazards which are significant for food
safety.
Food handler - any person who directly handles packaged or unpackaged food, food equipment
and utensils, or food contact surfaces and is therefore expected to comply with food hygiene
requirements
Food safety - assurance that food will not cause harm to the consumer when it is prepared and/or
eaten according to its intended use.
Food suitability - assurance that food is acceptable for human consumption according to its
intended use.
Primary production - those steps in the food chain up to and including, for example, harvesting,
slaughter, milking, fishing.
SECTION III - PRIMARY PRODUCTION
OBJECTIVES:
Primary production should be managed in a way that ensures that food is safe and suitable for its
intended use. Where necessary, this will include:
−
avoiding the use of areas where the environment poses a threat to the safety of food;
−
controlling contaminants, pests and diseases of animals and plants in such a way as not to
pose a threat to food safety;
−
adopting practices and measures to ensure food is produced under appropriately hygienic
conditions.
RATIONALE:
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To reduce the likelihood of introducing a hazard which may adversely affect the safety of food, or
its suitability for consumption, at later stages of the food chain.
3.1 ENVIRONMENTAL HYGIENE
Potential sources of contamination from the environment should be considered. In particular,
primary food production should not be carried on in areas where the presence of potentially
harmful substances would lead to an unacceptable level of such substances in food.
1.2 3.2
HYGIENIC PRODUCTION OF FOOD SOURCES
The potential effects of primary production activities on the safety and suitability of food should
be considered at all times. In particular, this includes identifying any specific points in such
activities where a high probability of contamination may exist and taking specific measures to
minimize that probability. The HACCP-based approach may assist in the taking of such measures
- see Hazard Analysis and Critical Control (HACCP) Point System and Guidelines for its
Application (Annex).
Producers should as far as practicable implement measures to:
•
control contamination from air, soil, water, feedstuffs, fertilizers (including natural fertilizers),
pesticides, veterinary drugs or any other agent used in primary production;
•
control plant and animal health so that it does not pose a threat to human health through food
consumption, or adversely affect the suitability of the product; and
•
protect food sources from faecal and other contamination.
In particular, care should be taken to manage wastes, and store harmful substances appropriately.
On-farm programmes which achieve specific food safety goals are becoming an important part of
primary production and should be encouraged.
3.3 HANDLING, STORAGE AND TRANSPORT
Procedures should be in place to:
•
sort food and food ingredients to segregate material which is evidently unfit for human
consumption;
•
dispose of any rejected material in a hygienic manner; and
•
Protect food and food ingredients from contamination by pests, or by chemical, physical or
microbiological contaminants or other objectionable substances during handling, storage and
transport.
Care should be taken to prevent, so far as reasonably practicable, deterioration and spoilage
through appropriate measures which may include controlling temperature, humidity, and/or other
controls.
3.4 CLEANING, MAINTENANCE AND PERSONNEL HYGIENE AT PRIMARY PRODUCTION
Appropriate facilities and procedures should be in place to ensure that:
•
any necessary cleaning and maintenance is carried out effectively; and
•
an appropriate degree of personal hygiene is maintained.
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SECTION IV - ESTABLISHMENT: DESIGN AND FACILITIES
OBJECTIVES:
Depending on the nature of the operations, and the risks associated with them, premises,
equipment and facilities should be located, designed and constructed to ensure that:
−
contamination is minimized;
−
design and layout permit appropriate maintenance, cleaning and disinfections and minimize
air-borne contamination;
−
surfaces and materials, in particular those in contact with food, are non-toxic in intended
use and, where necessary, suitably durable, and easy to maintain and clean;
−
where appropriate, suitable facilities are available for temperature, humidity and other
controls; and
−
there is effective protection against pest access and harbourage.
RATIONALE:
Attention to good hygienic design and construction, appropriate location, and the provision of
adequate facilities, is necessary to enable hazards to be effectively controlled.
4.1 LOCATION
4.1.1
Establishments
Potential sources of contamination need to be considered when deciding where to locate food
establishments, as well as the effectiveness of any reasonable measures that might be taken to
protect food. Establishments should not be located anywhere where, after considering such
protective measures, it is clear that there will remain a threat to food safety or suitability. In
particular, establishments should normally be located away from:
•
environmentally polluted areas and industrial activities which pose a serious threat of
contaminating food;
•
areas subject to flooding unless sufficient safeguards are provided;
•
areas prone to infestations of pests;
•
areas where wastes, either solid or liquid, cannot be removed effectively.
4.1.2
Equipment
Equipment should be located so that it:
•
permits adequate maintenance and cleaning;
•
functions in accordance with its intended use; and
•
facilitates good hygiene practices, including monitoring.
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4.2 PREMISES AND ROOMS
4.2.1
Design and layout
Where appropriate, the internal design and layout of food establishments should permit good food
hygiene practices, including protection against cross-contamination between and during
operations by foodstuffs.
4.2.2
Internal structures and fittings
Structures within food establishments should be soundly built of durable materials and be easy to
maintain, clean and where appropriate, able to be disinfected. In particular the following specific
conditions should be satisfied where necessary to protect the safety and suitability of food:
•
the surfaces of walls, partitions and floors should be made of impervious materials with no
toxic effect in intended use;
•
walls and partitions should have a smooth surface up to a height appropriate to the operation;
•
floors should be constructed to allow adequate drainage and cleaning;
•
ceilings and overhead fixtures should be constructed and finished to minimize the build up of
dirt and condensation, and the shedding of particles;
•
windows should be easy to clean, be constructed to minimize the build up of dirt and where
necessary, be fitted with removable and cleanable insect-proof screens. Where necessary,
windows should be fixed;
•
doors should have smooth, non-absorbent surfaces, and be easy to clean and, where necessary,
disinfect;
•
working surfaces that come into direct contact with food should be in sound condition, durable
and easy to clean, maintain and disinfect. They should be made of smooth, non-absorbent
materials, and inert to the food, to detergents and disinfectants under normal operating
conditions.
4.2.3
Temporary/mobile premises and vending machines
Premises and structures covered here include market stalls, mobile sales and street vending
vehicles, temporary premises in which food is handled such as tents and marquees.
Such premises and structures should be sited, designed and constructed to avoid, as far as
reasonably practicable, contaminating food and harbouring pests.
In applying these specific conditions and requirements, any food hygiene hazards associated with
such facilities should be adequately controlled to ensure the safety and suitability of food.
4.3 EQUIPMENT
4.3.1
General
Equipment and containers (other than once-only use containers and packaging) coming into
contact with food, should be designed and constructed to ensure that, where necessary, they can
be adequately cleaned, disinfected and maintained to avoid the contamination of food. Equipment
and containers should be made of materials with no toxic effect in intended use. Where
necessary, equipment should be durable and movable or capable of being disassembled to allow
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for maintenance, cleaning, disinfection, monitoring and, for example, to facilitate inspection for
pests.
4.3.2
Food control and monitoring equipment
In addition to the general requirements in paragraph 4.3.1, equipment used to cook, heat treat,
cool, store or freeze food should be designed to achieve the required food temperatures as rapidly
as necessary in the interests of food safety and suitability, and maintain them effectively. Such
equipment should also be designed to allow temperatures to be monitored and controlled. Where
necessary, such equipment should have effective means of controlling and monitoring humidity,
air-flow and any other characteristic likely to have a detrimental effect on the safety or suitability
of food. These requirements are intended to ensure that:
•
harmful or undesirable micro-organisms or their toxins are eliminated or reduced to safe levels
or their survival and growth are effectively controlled;
•
where appropriate, critical limits established in HACCP-based plans can be monitored; and
•
temperatures and other conditions necessary to food safety and suitability can be rapidly
achieved and maintained.
4.3.3
Containers for waste and inedible substances
Containers for waste, by-products and inedible or dangerous substances, should be specifically
identifiable, suitably constructed and, where appropriate, made of impervious material.
Containers used to hold dangerous substances should be identified and, where appropriate, be
lockable to prevent malicious or accidental contamination of food.
4.4 FACILITIES
4.4.1
Water supply
An adequate supply of potable water with appropriate facilities for its storage, distribution and
temperature control, should be available whenever necessary to ensure the safety and suitability of
food.
Potable water should be as specified in the latest edition of WHO Guidelines for Drinking Water
Quality, or water of a higher standard. Non-potable water (for use in, for example, fire control,
steam production, refrigeration and other similar purposes where it would not contaminate food),
shall have a separate system. Non-potable water systems shall be identified and shall not connect
with, or allow reflux into, potable water systems.
4.4.2
Drainage and waste disposal
Adequate drainage and waste disposal systems and facilities should be provided. They should be
designed and constructed so that the risk of contaminating food or the potable water supply is
avoided.
4.4.3
Cleaning
Adequate facilities, suitably designated, should be provided for cleaning food, utensils and
equipment. Such facilities should have an adequate supply of hot and cold potable water where
appropriate.
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4.4.4
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Personnel hygiene facilities and toilets
Personnel hygiene facilities should be available to ensure that an appropriate degree of personal
hygiene can be maintained and to avoid contaminating food. Where appropriate, facilities should
include:
•
adequate means of hygienically washing and drying hands, including wash basins and a
supply of hot and cold (or suitably temperature controlled) water;
•
lavatories of appropriate hygienic design; and
•
adequate changing facilities for personnel.
Such facilities should be suitably located and designated.
4.4.5
Temperature control
Depending on the nature of the food operations undertaken, adequate facilities should be available
for heating, cooling, cooking, refrigerating and freezing food, for storing refrigerated or frozen
foods, monitoring food temperatures, and when necessary, controlling ambient temperatures to
ensure the safety and suitability of food.
4.4.6
Air quality and ventilation
Adequate means of natural or mechanical ventilation should be provided, in particular to:
•
minimize air-borne contamination of food, for example, from aerosols and condensation
droplets;
•
control ambient temperatures;
•
control odours which might affect the suitability of food; and
•
control humidity, where necessary, to ensure the safety and suitability of food.
Ventilation systems should be designed and constructed so that air does not flow from
contaminated areas to clean areas and, where necessary, they can be adequately maintained and
cleaned.
4.4.7
Lighting
Adequate natural or artificial lighting should be provided to enable the undertaking to operate in a
hygienic manner. Where necessary, lighting should not be such that the resulting colour is
misleading. The intensity should be adequate to the nature of the operation. Lighting fixtures
should, where appropriate, be protected to ensure that food is not contaminated by breakages.
4.4.8
Storage
Where necessary, adequate facilities for the storage of food, ingredients and non-food chemicals
(e.g. cleaning materials, lubricants, fuels) should be provided.
Where appropriate, food storage facilities should be designed and constructed to:
•
permit adequate maintenance and cleaning;
•
avoid pest access and harbourage;
•
enable food to be effectively protected from contamination during storage; and
CAC/RCP 1-1969
•
Page 11 of 31
where necessary, provide an environment which minimizes the deterioration of food (e.g. by
temperature and humidity control).
The type of storage facilities required will depend on the nature of the food. Where necessary,
separate, secure storage facilities for cleaning materials and hazardous substances should be
provided.
SECTION V - CONTROL OF OPERATION
OBJECTIVE:
To produce food which is safe and suitable for human consumption by:
−
formulating design requirements with respect to raw materials, composition, processing,
distribution, and consumer use to be met in the manufacture and handling of specific food
items; and
−
designing, implementing, monitoring and reviewing effective control systems.
RATIONALE:
To reduce the risk of unsafe food by taking preventive measures to assure the safety and
suitability of food at an appropriate stage in the operation by controlling food hazards.
5.1 CONTROL OF FOOD HAZARDS
Food business operators should control food hazards through the use of systems such as HACCP.
They should:
•
identify any steps in their operations which are critical to the safety of food;
•
implement effective control procedures at those steps;
•
monitor control procedures to ensure their continuing effectiveness; and
•
review control procedures periodically, and whenever the operations change.
These systems should be applied throughout the food chain to control food hygiene throughout
the shelf-life of the product through proper product and process design.
Control procedures may be simple, such as checking stock rotation calibrating equipment, or
correctly loading refrigerated display units. In some cases a system based on expert advice, and
involving documentation, may be appropriate. A model of such a food safety system is described
in Hazard Analysis and Critical Control (HACCP) System and Guidelines for its Application
(Annex).
5.2 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS
5.2.1
Time and temperature control
Inadequate food temperature control is one of the most common causes of foodborne illness or
food spoilage. Such controls include time and temperature of cooking, cooling, processing and
storage. Systems should be in place to ensure that temperature is controlled effectively where it is
critical to the safety and suitability of food.
Temperature control systems should take into account:
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•
the nature of the food, e.g. its water activity, pH, and likely initial level and types of microorganisms;
•
the intended shelf-life of the product;
•
the method of packaging and processing; and
•
how the product is intended to be used, e.g. further cooking/processing or ready-to-eat.
Such systems should also specify tolerable limits for time and temperature variations.
Temperature recording devices should be checked at regular intervals and tested for accuracy.
5.2.2
Specific process steps
Other steps which contribute to food hygiene may include, for example:
•
chilling
•
thermal processing
•
irradiation
•
drying
•
chemical preservation
•
vacuum or modified atmospheric packaging
5.2.3
Microbiological and other specifications
Management systems described in paragraph 5.1 offer an effective way of ensuring the safety and
suitability of food. Where microbiological, chemical or physical specifications are used in any
food control system, such specifications should be based on sound scientific principles and state,
where appropriate, monitoring procedures, analytical methods and action limits.
5.2.4
Microbiological cross-contamination
Pathogens can be transferred from one food to another, either by direct contact or by food
handlers, contact surfaces or the air. Raw, unprocessed food should be effectively separated,
either physically or by time, from ready-to-eat foods, with effective intermediate cleaning and
where appropriate disinfection.
Access to processing areas may need to be restricted or controlled. Where risks are particularly
high, access to processing areas should be only via a changing facility. Personnel may need to be
required to put on clean protective clothing including footwear and wash their hands before
entering.
Surfaces, utensils, equipment, fixtures and fittings should be thoroughly cleaned and where
necessary disinfected after raw food, particularly meat and poultry, has been handled or
processed.
5.2.5
Physical and chemical contamination
Systems should be in place to prevent contamination of foods by foreign bodies such as glass or
metal shards from machinery, dust, harmful fumes and unwanted chemicals. In manufacturing
and processing, suitable detection or screening devices should be used where necessary.
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5.3 INCOMING MATERIAL REQUIREMENTS
No raw material or ingredient should be accepted by an establishment if it is known to contain
parasites, undesirable micro-organisms, pesticides, veterinary drugs or toxic, decomposed or
extraneous substances which would not be reduced to an acceptable level by normal sorting
and/or processing. Where appropriate, specifications for raw materials should be identified and
applied.
Raw materials or ingredients should, where appropriate, be inspected and sorted before
processing. Where necessary, laboratory tests should be made to establish fitness for use. Only
sound, suitable raw materials or ingredients should be used.
Stocks of raw materials and ingredients should be subject to effective stock rotation.
5.4 PACKAGING
Packaging design and materials should provide adequate protection for products to minimize
contamination, prevent damage, and accommodate proper labelling. Packaging materials or gases
where used must be non-toxic and not pose a threat to the safety and suitability of food under the
specified conditions of storage and use. Where appropriate, reusable packaging should be
suitably durable, easy to clean and, where necessary, disinfect.
5.5 WATER
5.5.1
In contact with food
Only potable water, should be used in food handling and processing, with the following
exceptions:
•
for steam production, fire control and other similar purposes not connected with food; and
•
in certain food processes, e.g. chilling, and in food handling areas, provided this does not
constitute a hazard to the safety and suitability of food (e.g. the use of clean sea water).
Water recirculated for reuse should be treated and maintained in such a condition that no risk to
the safety and suitability of food results from its use. The treatment process should be effectively
monitored. Recirculated water which has received no further treatment and water recovered from
processing of food by evaporation or drying may be used, provided its use does not constitute a
risk to the safety and suitability of food.
5.5.2
As an ingredient
Potable water should be used wherever necessary to avoid food contamination.
5.5.3
Ice and steam
Ice should be made from water that complies with section 4.4.1. Ice and steam should be
produced, handled and stored to protect them from contamination.
Steam used in direct contact with food or food contact surfaces should not constitute a threat to
the safety and suitability of food.
5.6 MANAGEMENT AND SUPERVISION
The type of control and supervision needed will depend on the size of the business, the nature of
its activities and the types of food involved. Managers and supervisors should have enough
knowledge of food hygiene principles and practices to be able to judge potential risks, take
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appropriate preventive and corrective action, and ensure that effective monitoring and supervision
takes place.
5.7 DOCUMENTATION AND RECORDS
Where necessary, appropriate records of processing, production and distribution should be kept
and retained for a period that exceeds the shelf-life of the product. Documentation can enhance
the credibility and effectiveness of the food safety control system.
5.8 RECALL PROCEDURES
Managers should ensure effective procedures are in place to deal with any food safety hazard and
to enable the complete, rapid recall of any implicated lot of the finished food from the market.
Where a product has been withdrawn because of an immediate health hazard, other products
which are produced under similar conditions, and which may present a similar hazard to public
health, should be evaluated for safety and may need to be withdrawn. The need for public
warnings should be considered.
Recalled products should be held under supervision until they are destroyed, used for purposes
other than human consumption, determined to be safe for human consumption, or reprocessed in a
manner to ensure their safety.
SECTION VI - ESTABLISHMENT: MAINTENANCE AND SANITATION
OBJECTIVE:
To establish effective systems to:
−
ensure adequate and appropriate maintenance and cleaning;
−
control pests;
−
manage waste; and
−
monitor effectiveness of maintenance and sanitation procedures.
RATIONALE:
To facilitate the continuing effective control of food hazards, pests, and other agents likely to
contaminate food.
6.1 MAINTENANCE AND CLEANING
6.1.1
General
Establishments and equipment should be kept in an appropriate state of repair and condition to:
•
facilitate all sanitation procedures;
•
function as intended, particularly at critical steps (see paragraph 5.1);
•
prevent contamination of food, e.g. from metal shards, flaking plaster, debris and chemicals.
Cleaning should remove food residues and dirt which may be a source of contamination. The
necessary cleaning methods and materials will depend on the nature of the food business.
Disinfection may be necessary after cleaning.
CAC/RCP 1-1969
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Cleaning chemicals should be handled and used carefully and in accordance with manufacturers’
instructions and stored, where necessary, separated from food, in clearly identified containers to
avoid the risk of contaminating food.
6.1.2
Cleaning procedures and methods
Cleaning can be carried out by the separate or the combined use of physical methods, such as
heat, scrubbing, turbulent flow, vacuum cleaning or other methods that avoid the use of water, and
chemical methods using detergents, alkalis or acids.
Cleaning procedures will involve, where appropriate:
•
removing gross debris from surfaces;
•
applying a detergent solution to loosen soil and bacterial film and hold them in solution or
suspension;
•
rinsing with water which complies with section 4, to remove loosened soil and residues of
detergent;
•
dry cleaning or other appropriate methods for removing and collecting residues and debris;
and
•
where necessary, disinfection with subsequent rinsing unless the manufacturers’ instructions
indicate on scientific basis that rinsing is not required.
6.2 CLEANING PROGRAMMES
Cleaning and disinfection programmes should ensure that all parts of the establishment are
appropriately clean, and should include the cleaning of cleaning equipment.
Cleaning and disinfection programmes should be continually and effectively monitored for their
suitability and effectiveness and where necessary, documented.
Where written cleaning programmes are used, they should specify:
•
areas, items of equipment and utensils to be cleaned;
•
responsibility for particular tasks;
•
method and frequency of cleaning; and
•
monitoring arrangements.
Where appropriate, programmes should be drawn up in consultation with relevant specialist
expert advisors.
6.3 PEST CONTROL SYSTEMS
6.3.1
General
Pests pose a major threat to the safety and suitability of food. Pest infestations can occur where
there are breeding sites and a supply of food. Good hygiene practices should be employed to
avoid creating an environment conducive to pests. Good sanitation, inspection of incoming
materials and good monitoring can minimize the likelihood of infestation and thereby limit the
need for pesticides.
CAC/RCP 1-1969
6.3.2
Page 16 of 31
Preventing access
Buildings should be kept in good repair and condition to prevent pest access and to eliminate
potential breeding sites. Holes, drains and other places where pests are likely to gain access
should be kept sealed. Wire mesh screens, for example on open windows, doors and ventilators,
will reduce the problem of pest entry. Animals should, wherever possible, be excluded from the
grounds of factories and food processing plants.
6.3.3
Harbourage and infestation
The availability of food and water encourages pest harbourage and infestation. Potential food
sources should be stored in pest-proof containers and/or stacked above the ground and away from
walls. Areas both inside and outside food premises should be kept clean. Where appropriate,
refuse should be stored in covered, pest-proof containers.
6.3.4
Monitoring and detection
Establishments and surrounding areas should be regularly examined for evidence of infestation.
6.3.5
Eradication
Pest infestations should be dealt with immediately and without adversely affecting food safety or
suitability. Treatment with chemical, physical or biological agents should be carried out without
posing a threat to the safety or suitability of food.
6.4 WASTE MANAGEMENT
Suitable provision must be made for the removal and storage of waste. Waste must not be
allowed to accumulate in food handling, food storage, and other working areas and the adjoining
environment except so far as is unavoidable for the proper functioning of the business.
Waste stores must be kept appropriately clean.
6.5 MONITORING EFFECTIVENESS
Sanitation systems should be monitored for effectiveness, periodically verified by means such as
audit pre-operational inspections or, where appropriate, microbiological sampling of environment
and food contact surfaces and regularly reviewed and adapted to reflect changed circumstances.
SECTION VII - ESTABLISHMENT: PERSONAL HYGIENE
OBJECTIVES:
To ensure that those who come directly or indirectly into contact with food are not likely to
contaminate food by:
−
maintaining an appropriate degree of personal cleanliness;
−
behaving and operating in an appropriate manner.
RATIONALE:
People who do not maintain an appropriate degree of personal cleanliness, who have certain
illnesses or conditions or who behave inappropriately, can contaminate food and transmit illness
to consumers.
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7.1 HEALTH STATUS
People known, or suspected, to be suffering from, or to be a carrier of a disease or illness likely to
be transmitted through food, should not be allowed to enter any food handling area if there is a
likelihood of their contaminating food. Any person so affected should immediately report illness
or symptoms of illness to the management.
Medical examination of a food handler should be carried out if clinically or epidemiologically
indicated.
7.2 ILLNESS AND INJURIES
Conditions which should be reported to management so that any need for medical examination
and/or possible exclusion from food handling can be considered, include:
•
jaundice;
•
diarrhoea;
•
vomiting;
•
fever;
•
sore throat with fever;
•
visibly infected skin lesions (boils, cuts, etc.);
•
discharges from the ear, eye or nose.
7.3 PERSONAL CLEANLINESS
Food handlers should maintain a high degree of personal cleanliness and, where appropriate, wear
suitable protective clothing, head covering, and footwear. Cuts and wounds, where personnel are
permitted to continue working, should be covered by suitable waterproof dressings.
Personnel should always wash their hands when personal cleanliness may affect food safety, for
example:
•
at the start of food handling activities;
•
immediately after using the toilet; and
•
after handling raw food or any contaminated material, where this could result in contamination
of other food items; they should avoid handling ready-to-eat food, where appropriate.
7.4 PERSONAL BEHAVIOUR
People engaged in food handling activities should refrain from behaviour which could result in
contamination of food, for example:
•
smoking;
•
spitting;
•
chewing or eating;
•
sneezing or coughing over unprotected food.
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Personal effects such as jewellery, watches, pins or other items should not be worn or brought into
food handling areas if they pose a threat to the safety and suitability of food.
7.5 VISITORS
Visitors to food manufacturing, processing or handling areas should, where appropriate, wear
protective clothing and adhere to the other personal hygiene provisions in this section.
SECTION VIII - TRANSPORTATION
OBJECTIVES:
Measures should be taken where necessary to:
−
protect food from potential sources of contamination;
−
protect food from damage likely to render the food unsuitable for consumption; and
− provide an environment which effectively controls the growth of pathogenic or spoilage
micro-organisms and the production of toxins in food.
RATIONALE:
Food may become contaminated, or may not reach its destination in a suitable condition for
consumption, unless effective control measures are taken during transport, even where adequate
hygiene control measures have been taken earlier in the food chain.
8.1 GENERAL
Food must be adequately protected during transport. The type of conveyances or containers
required depends on the nature of the food and the conditions under which it has to be transported.
8.2 REQUIREMENTS
Where necessary, conveyances and bulk containers should be designed and constructed so that
they:
•
do not contaminate foods or packaging;
•
can be effectively cleaned and, where necessary, disinfected;
•
permit effective separation of different foods or foods from non-food items where necessary
during transport;
•
provide effective protection from contamination, including dust and fumes;
•
can effectively maintain the temperature, humidity, atmosphere and other conditions necessary
to protect food from harmful or undesirable microbial growth and deterioration likely to
render it unsuitable for consumption; and
•
allow any necessary temperature, humidity and other conditions to be checked.
8.3 USE AND MAINTENANCE
Conveyances and containers for transporting food should be kept in an appropriate state of
cleanliness, repair and condition. Where the same conveyance or container is used for transporting
different foods, or non-foods, effective cleaning and, where necessary, disinfection should take
place between loads.
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Where appropriate, particularly in bulk transport, containers and conveyances should be
designated and marked for food use only and be used only for that purpose.
SECTION IX - PRODUCT INFORMATION AND CONSUMER AWARENESS
OBJECTIVES:
Products should bear appropriate information to ensure that:
− adequate and accessible information is available to the next person in the food chain to enable
them to handle, store, process, prepare and display the product safely and correctly;
−
the lot or batch can be easily identified and recalled if necessary.
Consumers should have enough knowledge of food hygiene to enable them to:
−
understand the importance of product information;
−
make informed choices appropriate to the individual; and
− prevent contamination and growth or survival of foodborne pathogens by storing, preparing
and using it correctly.
Information for industry or trade users should be clearly distinguishable from consumer
information, particularly on food labels.
RATIONALE:
Insufficient product information, and/or inadequate knowledge of general food hygiene, can lead
to products being mishandled at later stages in the food chain. Such mishandling can result in
illness, or products becoming unsuitable for consumption, even where adequate hygiene control
measures have been taken earlier in the food chain.
9.1 LOT IDENTIFICATION
Lot identification is essential in product recall and also helps effective stock rotation. Each
container of food should be permanently marked to identify the producer and the lot. Codex
General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985, Rev. 1(1991))
applies.
9.2 PRODUCT INFORMATION
All food products should be accompanied by or bear adequate information to enable the next
person in the food chain to handle, display, store and prepare and use the product safely and
correctly.
9.3 LABELLING
Prepackaged foods should be labelled with clear instructions to enable the next person in the food
chain to handle, display, store and use the product safely. Codex General Standard for the
Labelling of Prepackaged Foods (CODEX STAN 1-1985, Rev. (1991)) applies.
9.4 CONSUMER EDUCATION
Health education programmes should cover general food hygiene. Such programmes should
enable consumers to understand the importance of any product information and to follow any
instructions accompanying products, and make informed choices. In particular consumers should
be informed of the relationship between time/temperature control and foodborne illness.
CAC/RCP 1-1969
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SECTION X - TRAINING
OBJECTIVE:
Those engaged in food operations who come directly or indirectly into contact with food should
be trained, and/or instructed in food hygiene to a level appropriate to the operations they are to
perform.
RATIONALE:
Training is fundamentally important to any food hygiene system.
Inadequate hygiene training, and/or instruction and supervision of all people involved in food
related activities pose a potential threat to the safety of food and its suitability for consumption.
10.1
AWARENESS AND RESPONSIBILITIES
Food hygiene training is fundamentally important. All personnel should be aware of their role
and responsibility in protecting food from contamination or deterioration. Food handlers should
have the necessary knowledge and skills to enable them to handle food hygienically. Those who
handle strong cleaning chemicals or other potentially hazardous chemicals should be instructed in
safe handling techniques.
10.2
TRAINING PROGRAMMES
Factors to take into account in assessing the level of training required include:
•
the nature of the food, in particular its ability to sustain growth of pathogenic or spoilage
micro-organisms;
•
the manner in which the food is handled and packed, including the probability of
contamination;
•
the extent and nature of processing or further preparation before final consumption;
•
the conditions under which the food will be stored; and
•
the expected length of time before consumption.
10.3
INSTRUCTION AND SUPERVISION
Periodic assessments of the effectiveness of training and instruction programmes should be made,
as well as routine supervision and checks to ensure that procedures are being carried out
effectively.
Managers and supervisors of food processes should have the necessary knowledge of food
hygiene principles and practices to be able to judge potential risks and take the necessary action to
remedy deficiencies.
10.4
REFRESHER TRAINING
Training programmes should be routinely reviewed and updated where necessary. Systems
should be in place to ensure that food handlers remain aware of all procedures necessary to
maintain the safety and suitability of food.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 21
HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND
GUIDELINES FOR ITS APPLICATION
Annex to CAC/RCP 1-1969 (Rev. 4 - 2003)
PREAMBLE
The first section of this document sets out the principles of the Hazard Analysis and Critical Control
Point (HACCP) system adopted by the Codex Alimentarius Commission. The second section provides
general guidance for the application of the system while recognizing that the details of application may
vary depending on the circumstances of the food operation. 1
The HACCP system, which is science based and systematic, identifies specific hazards and measures for
their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control
systems that focus on prevention rather than relying mainly on end-product testing. Any HACCP
system is capable of accommodating change, such as advances in equipment design, processing
procedures or technological developments.
HACCP can be applied throughout the food chain from primary production to final consumption and its
implementation should be guided by scientific evidence of risks to human health. As well as enhancing
food safety, implementation of HACCP can provide other significant benefits. In addition, the
application of HACCP systems can aid inspection by regulatory authorities and promote international
trade by increasing confidence in food safety.
The successful application of HACCP requires the full commitment and involvement of management
and the work force. It also requires a multidisciplinary approach; this multidisciplinary approach should
include, when appropriate, expertise in agronomy, veterinary health, production, microbiology,
medicine, public health, food technology, environmental health, chemistry and engineering, according
to the particular study. The application of HACCP is compatible with the implementation of quality
management systems, such as the ISO 9000 series, and is the system of choice in the management of
food safety within such systems.
While the application of HACCP to food safety was considered here, the concept can be applied to other
aspects of food quality.
DEFINITIONS
Control (verb): To take all necessary actions to ensure and maintain compliance with criteria
established in the HACCP plan.
Control (noun): The state wherein correct procedures are being followed and criteria are being met.
Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard
or reduce it to an acceptable level.
Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of
control.
Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce it to an acceptable level.
Critical limit: A criterion which separates acceptability from unacceptability.
1
The Principles of the HACCP System set the basis for the requirements for the application of HACCP, while the
Guidelines for the Application provide general guidance for practical application.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 22
Deviation: Failure to meet a critical limit.
Flow diagram: A systematic representation of the sequence of steps or operations used in the
production or manufacture of a particular food item.
HACCP: A system which identifies, evaluates, and controls hazards which are significant for food
safety.
HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of
hazards which are significant for food safety in the segment of the food chain under consideration.
Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an
adverse health effect.
Hazard analysis: The process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for food safety and therefore should be
addressed in the HACCP plan.
Monitor: The act of conducting a planned sequence of observations or measurements of control
parameters to assess whether a CCP is under control.
Step: A point, procedure, operation or stage in the food chain including raw materials, from primary
production to final consumption.
Validation: Obtaining evidence that the elements of the HACCP plan are effective.
Verification: The application of methods, procedures, tests and other evaluations, in addition to
monitoring to determine compliance with the HACCP plan.
PRINCIPLES OF THE HACCP SYSTEM
The HACCP system consists of the following seven principles:
PRINCIPLE 1
Conduct a hazard analysis.
PRINCIPLE 2
Determine the Critical Control Points (CCPs).
PRINCIPLE 3
Establish critical limit(s).
PRINCIPLE 4
Establish a system to monitor control of the CCP.
PRINCIPLE 5
Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under
control.
PRINCIPLE 6
Establish procedures for verification to confirm that the HACCP system is working effectively.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 23
PRINCIPLE 7
Establish documentation concerning all procedures and records appropriate to these principles and their
application.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 24
GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM
INTRODUCTION
Prior to application of HACCP to any sector of the food chain, that sector should have in place
prerequisite programs such as good hygienic practices according to the Codex General Principles of
Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety requirements.
These prerequisite programs to HACCP, including training, should be well established, fully operational
and verified in order to facilitate the successful application and implementation of the HACCP system.
For all types of food business, management awareness and commitment is necessary for implementation
of an effective HACCP system. The effectiveness will also rely upon management and employees
having the appropriate HACCP knowledge and skills.
During hazard identification, evaluation, and subsequent operations in designing and applying HACCP
systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing
practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of
consumers of concern, and epidemiological evidence relative to food safety.
The intent of the HACCP system is to focus control at Critical Control Points (CCPs). Redesign of the
operation should be considered if a hazard which must be controlled is identified but no CCPs are
found.
HACCP should be applied to each specific operation separately. CCPs identified in any given example
in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application
or might be of a different nature. The HACCP application should be reviewed and necessary changes
made when any modification is made in the product, process, or any step.
The application of the HACCP principles should be the responsibility of each individual businesses.
However, it is recognised by governments and businesses that there may be obstacles that hinder the
effective application of the HACCP principles by individual business. This is particularly relevant in
small and/or less developed businesses. While it is recognized that when applying HACCP, flexibility
appropriate to the business is important, all seven principles must be applied in the HACCP system.
This flexibility should take into account the nature and size of the operation, including the human and
financial resources, infrastructure, processes, knowledge and practical constraints.
Small and/or less developed businesses do not always have the resources and the necessary expertise on
site for the development and implementation of an effective HACCP plan. In such situations, expert
advice should be obtained from other sources, which may include: trade and industry associations,
independent experts and regulatory authorities. HACCP literature and especially sector-specific HACCP
guides can be valuable. HACCP guidance developed by experts relevant to the process or type of
operation may provide a useful tool for businesses in designing and implementing the HACCP plan.
Where businesses are using expertly developed HACCP guidance, it is essential that it is specific to the
foods and/or processes under consideration. More detailed information on the obstacles in
implementing HACCP, particularly in reference to SLDBs, and recommendations in resolving these
obstacles, can be found in “Obstacles to the Application of HACCP, Particularly in Small and Less
Developed Businesses, and Approaches to Overcome Them” (document in preparation by FAO/WHO).
The efficacy of any HACCP system will nevertheless rely on management and employees having the
appropriate HACCP knowledge and skills, therefore ongoing training is necessary for all levels of
employees and managers, as appropriate.
APPLICATION
The application of HACCP principles consists of the following tasks as identified in the Logic Sequence
for Application of HACCP (Diagram 1).
CAC/RCP 1-1969, Rev. 4-2003 - Annex
1.
Page 25
Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and expertise is
available for the development of an effective HACCP plan. Optimally, this may be accomplished by
assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should
be obtained from other sources, such as, trade and industry associations, independent experts, regulatory
authorities, HACCP literature and HACCP guidance (including sector-specific HACCP guides). It may
be possible that a well-trained individual with access to such guidance is able to implement HACCP inhouse. The scope of the HACCP plan should be identified. The scope should describe which segment
of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all
classes of hazards or only selected classes).
2.
Describe product
A full description of the product should be drawn up, including relevant safety information such as:
composition, physical/chemical structure (including Aw, pH, etc), microcidal/static treatments (heattreatment, freezing, brining, smoking, etc), packaging, durability and storage conditions and method of
distribution. Within businesses with multiple products, for example, catering operations, it may be
effective to group products with similar characteristics or processing steps, for the purpose of
development of the HACCP plan.
3.
Identify intended use
The intended use should be based on the expected uses of the product by the end user or consumer. In
specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be considered.
4.
Construct flow diagram
The flow diagram should be constructed by the HACCP team (see also paragraph 1 above). The flow
diagram should cover all steps in the operation for a specific product. The same flow diagram may be
used for a number of products that are manufactured using similar processing steps. When applying
HACCP to a given operation, consideration should be given to steps preceding and following the
specified operation.
5.
On-site confirmation of flow diagram
Steps must be taken to confirm the processing operation against the flow diagram during all stages and
hours of operation and amend the flow diagram where appropriate. The confirmation of the flow
diagram should be performed by a person or persons with sufficient knowledge of the processing
operation.
6.
List all potential hazards associated with each step, conduct a hazard analysis, and consider
any measures to control identified hazards
(SEE PRINCIPLE 1)
The HACCP team (see “assemble HACCP team” above) should list all of the hazards that may be
reasonably expected to occur at each step according to the scope from primary production, processing,
manufacture, and distribution until the point of consumption.
The HACCP team (see “assemble HACCP team”) should next conduct a hazard analysis to identify for
the HACCP plan, which hazards are of such a nature that their elimination or reduction to acceptable
levels is essential to the production of a safe food.
In conducting the hazard analysis, wherever possible the following should be included:
•
the likely occurrence of hazards and severity of their adverse health effects;
•
the qualitative and/or quantitative evaluation of the presence of hazards;
CAC/RCP 1-1969, Rev. 4-2003 - Annex
•
survival or multiplication of micro-organisms of concern;
•
production or persistence in foods of toxins, chemicals or physical agents; and,
•
conditions leading to the above.
Page 26
Consideration should be given to what control measures, if any exist, can be applied to each hazard.
More than one control measure may be required to control a specific hazard(s) and more than one
hazard may be controlled by a specified control measure.
7.
Determine Critical Control Points
(SEE PRINCIPLE 2) 2
There may be more than one CCP at which control is applied to address the same hazard. The
determination of a CCP in the HACCP system can be facilitated by the application of a decision tree
(e.g., Diagram 2), which indicates a logic reasoning approach. Application of a decision tree should be
flexible, given whether the operation is for production, slaughter, processing, storage, distribution or
other. It should be used for guidance when determining CCPs. This example of a decision tree may not
be applicable to all situations. Other approaches may be used. Training in the application of the
decision tree is recommended.
If a hazard has been identified at a step where control is necessary for safety, and no control measure
exists at that step, or any other, then the product or process should be modified at that step, or at any
earlier or later stage, to include a control measure.
8.
Establish critical limits for each CCP
(SEE PRINCIPLE 3)
Critical limits must be specified and validated for each Critical Control Point. In some cases more than
one critical limit will be elaborated at a particular step. Criteria often used include measurements of
temperature, time, moisture level, pH, Aw, available chlorine, and sensory parameters such as visual
appearance and texture.
Where HACCP guidance developed by experts has been used to establish the critical limits, care should
be taken to ensure that these limits fully apply to the specific operation, product or groups of products
under consideration. These critical limits should be measurable.
9.
Establish a monitoring system for each CCP
(SEE PRINCIPLE 4)
Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The
monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should
ideally provide this information in time to make adjustments to ensure control of the process to prevent
violating the critical limits. Where possible, process adjustments should be made when monitoring
results indicate a trend towards loss of control at a CCP. The adjustments should be taken before a
deviation occurs. Data derived from monitoring must be evaluated by a designated person with
knowledge and authority to carry out corrective actions when indicated. If monitoring is not
continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in
2
Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes. In many
instances, while this tree has been useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific
to all food operations, e.g., slaughter, and therefore it should be used in conjunction with professional judgement, and modified in
some cases.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 27
control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to online processes and there will not be time for lengthy analytical testing. Physical and chemical
measurements are often preferred to microbiological testing because they may be done rapidly and can
often indicate the microbiological control of the product.
All records and documents associated with monitoring CCPs must be signed by the person(s) doing the
monitoring and by a responsible reviewing official(s) of the company.
10.
Establish corrective actions
(SEE PRINCIPLE 5)
Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with
deviations when they occur.
The actions must ensure that the CCP has been brought under control. Actions taken must also include
proper disposition of the affected product. Deviation and product disposition procedures must be
documented in the HACCP record keeping.
11.
Establish verification procedures
(SEE PRINCIPLE 6)
Establish procedures for verification. Verification and auditing methods, procedures and tests,
including random sampling and analysis, can be used to determine if the HACCP system is working
correctly. The frequency of verification should be sufficient to confirm that the HACCP system is
working effectively.
Verification should be carried out by someone other than the person who is responsible for performing
the monitoring and corrective actions. Where certain verification activities cannot be performed in
house, verification should be performed on behalf of the business by external experts or qualified third
parties.
Examples of verification activities include:
•
Review of the HACCP system and plan and its records;
•
Review of deviations and product dispositions;
•
Confirmation that CCPs are kept under control.
Where possible, validation activities should include actions to confirm the efficacy of all elements of the
HACCP system.
12.
Establish Documentation and Record Keeping
(SEE PRINCIPLE 7)
Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP
procedures should be documented. Documentation and record keeping should be appropriate to the
nature and size of the operation and sufficient to assist the business to verify that the HACCP controls
are in place and being maintained. Expertly developed HACCP guidance materials (e.g. sector-specific
HACCP guides) may be utilised as part of the documentation, provided that those materials reflect the
specific food operations of the business.
Documentation examples are:
Hazard analysis;
CCP determination;
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 28
Critical limit determination.
Record examples are:
•
CCP monitoring activities;
•
Deviations and associated corrective actions;
•
Verification procedures performed;
•
Modifications to the HACCP plan;
An example of a HACCP worksheet for the development of a HACCP plan is attached as Diagram 3.
A simple record-keeping system can be effective and easily communicated to employees. It may be
integrated into existing operations and may use existing paperwork, such as delivery invoices and
checklists to record, for example, product temperatures.
TRAINING
Training of personnel in industry, government and academia in HACCP principles and applications and
increasing awareness of consumers are essential elements for the effective implementation of HACCP.
As an aid in developing specific training to support a HACCP plan, working instructions and procedures
should be developed which define the tasks of the operating personnel to be stationed at each Critical
Control Point.
Cooperation between primary producer, industry, trade groups, consumer organisations, and responsible
authorities is of vital important. Opportunities should be provided for the joint training of industry and
control authorities to encourage and maintain a continuous dialogue and create a climate of
understanding in the practical application of HACCP.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 29
DIAGRAM 1
LOGIC SEQUENCE FOR APPLICATION OF HACCP
1.
Assemble HACCP Team
2.
Describe Product
3.
Identify Intended Use
4.
Construct Flow Diagram
5.
On-site Confirmation of Flow Diagram
6.
List all Potential Hazards
Conduct a Hazard Analysis
Consider Control Measures
7.
Determine CCPs
8.
Establish Critical Limits for each CCP
9.
Establish a Monitoring System for each CCP
10.
Establish Corrective Actions
11.
Establish Verification Procedures
12.
Establish Documentation and Record Keeping
See Diagram 2
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 30
DIAGRAM 2
EXAMPLE OF DECISION TREE TO IDENTIFY CCPs
(answer questions in sequence)
Q1
Do control preventative measure(s) exist?
Yes
No
Modify step, process
or product
Is control at this step
necessary for safety?
No
Q2
Not a CCP
Yes
Stop
(*)
Is
the
step
specifically
designed
to
eliminate or reduce the likely occurrence of
a hazard to an acceptable level? (**)
Yes
No
Q3
Could contamination with identified hazard(s)
occur in excess of acceptable level(s) or could
these increase to unacceptable levels? (**)
Yes
Q4
No
Not a CCP
Stop
(*)
Will a subsequent step eliminate identified
hazard(s) or reduce likely occurrence to an
acceptable level? (**)
Yes
Not a CCP
No
Stop
CRITICAL CONTROL POINT
(*)
(*)
Proceed to the next identified hazard in the described process.
(**)
Acceptable and unacceptable levels need to be defined within the overall objectives in identifying the CCPs of HACCP
plan.
CAC/RCP 1-1969, Rev. 4-2003 - Annex
Page 31 of 31
DIAGRAM 3
EXAMPLE OF A HACCP WORKSHEET
1.
Describe Product
2.
Diagram Process Flow
LIST
3.
Step
Hazard(s
)
Control
Measure(s)
4.
CCPs
Critical
Monitoring
Corrective
Limit(s)
Procedure(s)
Action(s)
Verification
Record(s)
Publications
Dans une revue à comité de lecture
-
2013 Bonne.R, « La gestion globale de l’hygiène dans les IAA» : une méthode de
facilitation pour la mise en œuvre des prescriptions d’hygiène du Codex
Alimentarius Bull. Acad. Vét. France — 2013 - Tome 166 - N°2
-
2011 Pairone.B, Bonne.R: Un esempio di metodo alternativo all’ ”albero delle
decisioni” del Codex alimentarius per la determinazione dei CCP.Medicina
veterinaria preventiva Numero 35 settembre 2011, 68-74
2011 « Référentiel d’Harmonisation de la Gestion de l’Hygiène Alimentaire en
Afrique », adopté par la Commission de l’Union Africaine (Direction de
l’Economie Rurale et de l’Agriculture) et par la Commission Européenne (DGSanco), Better Training for Safer Food (BTSF). Disponible sur le site « EC/DG
Sanco website » (Bruxelles 2011) (annexe 1 du mémoire de thèse)
2010 « Guide d’Application du Référentiel Hygiène et ses Règles d’Application »,
adopté par la Commission de l’Union Africaine (Direction de l’Economie Rurale
et de l’Agriculture) et par la Commission Européenne (DG-Sanco), Better Training
for Safer Food (BTSF). Disponible sur le site « EC/DG Sanco website » (Bruxelles
2011)
2006 Bonne.R, Camberou.L, Wright.N, Boccas.F : Guidelines on GMP, GHP and
HACCP for ASEAN Food SMEs (publication CEN/ASEAN Djakarta Indonésie)
disponible sur le site formation de la DG SANCO
(http://ec.europa.eu/food/training/good_hygiene_practice_en.htm) (annexe 2 du mémoire de
thèse)
1997 Bonne.R : « Maîtrise du risque bactériologique dans la filière viande
première partie : abattage et découpe » Le Biotechnologiste International- n° 15janvier 97
1995 Bonne.R : « Démarche de maîtrise globale de l’hygiène dans les entreprises
agro-alimentaires » - Le Biotechnologiste International - n° 8 – mars 95
1994 Contamination : le point dans votre restaurant » - L’hôtellerie- n° 2347 –
mars 94
1993 Bonne.R, Alteza.C, Guérin.D, Marestang.L : « Mesure de l’ABVT lors des
pollutions accidentelles des carcasses de viande par le gaz ammoniac » - Le Point
Vétérinaire – vol 24, n°50 d’avril 93
1989 Bonne.R : La promotion de la restauration hôtelière par l’hygiène : Bulletin
de la société vétérinaire pratique de France, juin 1989, T., n°6, 333-345
1989 Bonne.R, Daguin.A : La marque « H.R.H » pour une promotion de l’hygiène
dans le cadre de la restauration commerciale dans le Département du Gers, Bulletin
de l’académie vétérinaire de France, 1989, 62, 135-146
1987 Enregistrement à l’INPI (Institut National de la Propriété Industrielle) de la
marque collective « H.R.H » (Hygiène et Restauration Hôtelière)
1978 Bonne.R, : Contribution à l’étude épidémiologique de la fièvre Q, Thèse
doctorat vétérinaire, Toulouse 1978.
Autres
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