European Aviation Safety Agency

Transcription

Luftfahrt-Bundesamt
Inhalt
Begrüßung
Einführung
Was ……..?
Wie …….. ?
Wann……?
Ausblick
6.10.2011
Folie 1
Luftfahrt-Bundesamt
WAS?
1.Regelungsumfang-allgemein
Vorschläge der EASA:
Erwartet Nov. 2011
Annex I Part-FCL (EASA Opinion 04/2010)
Pilot licensing rules (ersetzen JAR-FCL 1 und 2)
Annex IV Part- MED (EASA Opinion 07/2010)
medical rules for flight and cabin crew (ersetzt JAR-FCL 3)
Annex V Part CC (EASA Opinion 02/2011)
Requirements for cabin crew in CAT
„und 1.Stufe der Cover Regulation“
Erwartet Frühjahr 2012
Annex VI Part-ARA (EASA Opinion 03/2011)
Annex VII Part-ORA
Authority and organisation req for air crew , Training Org, AMC,FSTD
(ersetzen Anforderungen aus JAR-FCL und aus JAA GM)
„und 2.Stufe der Cover Regulation“
mündet alles in Regulation on civil aviation „aircrew“
(AMC durch EASA frühestens zum Zeitpunkt des Inkrafttretens der IR, Frühjahr 2012 )
6.10.2011
Folie 2
Luftfahrt-Bundesamt
WAS?
2.Regelungsumfang-konkreter
Insbesondere Vorschriften zur Ausübung der Pilotenrechte
auf EASA Luftfahrzeugen
EASA Lfz:
Non EASA Lfz:
EASA CofA or permit
Annex II ( u.a. historische, militärische, Selbstbau etc.)
Allgemeine Anforderungen und spezifische für Luftfahrzeugkategorie ( z.B. vertikale
Start und Landefähigkeit, zurückgestellt, später evtl. TR für Flugzeug oder Hubschrauber))
Flugzeuge LAPL, PPL,CPL,ATPL,MPL
Hubschrauber LAPL,PPL,CPL,ATPL,
Segelflugzeuge LAPL, SPL
Ballone LAPL, BPL
Luftschiffe PPL,CPL
d.h. neue Lizenztatbestände (nach ICAO oder LAPL nur europäisch)
Neue Berechtigungen „Bergflugberechtigung, Testflugberechtigung“
Lizenz unbefristet (Datum Medical und TR)
6.10.2011
Folie 3
Luftfahrt-Bundesamt
Wie?:
1.Einführung EU Vorschriften (1)
BASIC Regulation
Verordnung (EG) Nr. 216/2008 des Europäischen Parlaments und des
Rates vom 20. Februar 2008
zur Festlegung gemeinsamer Vorschriften für die Zivilluftfahrt und zur Errichtung
einer Europäischen Agentur für Flugsicherheit, zur Aufhebung der Richtlinie
91/670/EWG des Rates, der Verordnung (EG) Nr. 1592/2002 und der Richtlinie
2004/36/EG
6.10.2011
Folie 4
Luftfahrt-Bundesamt
Basic Regulation (EC) 216/2008
(ersetzt Verordnung Nr. 1592/2002)
Kap I. Grundsätze
Art. 1 Geltungsbereich
Art. 2 Ziele
Art. 3 Begriffsbestimmungen
Kap II. Grundlegende Forderungen
Art. 7 Piloten „Verweis auf Anhang III Piloten müssen grundlegenden Anforderungen
Art. 8 Flugbetrieb
Art. 10 Aufsicht und Durchsetzung
Art. 14 Flexibilitätsbestimmungen
genügen“
Kap III. Europäische Agentur für Flugsicherheit
Abschnitt I Aufgaben
Abschnitt II Innerer Aufbau
Abschnitt III Arbeitsweise
Abschnitt IV Finanzvorschriften
Kap IV.Schlussbestimmungen
„Die Art. 5, 6, 7, 8, 9 und 10 gelten ab dem in den jeweiligen
Durchführungsbestimmungen vorgesehenen Zeitpunkten, spätestens ab
8. April 2012“
„(IR)“
6.10.2011
Folie 5
Luftfahrt-Bundesamt
Wie?
1.Einführung der EU Regelungen (2)
Einführungsvorschriften= Implementing Rules=IR
sind Verordnungen der EU-Kommission = Commission Regulations
Erlassen als sogenannte Rahmenverordnungen „Cover Regulations“
mit Annexes, die technische Details zur Einführung beinhalten.
Inhalt der Cover Regulation:
Erklärung der Beweggründe
Regelungsumfang
Definitionen
Anwendbarkeitsdatum
Übergangsbestimmungen
Implementing Rules werden in alle Nationalsprachen der Mitgliedsländer übersetzt und im
Official Journal of the European Union veröffentlicht und elektronisch in EUR-LEX verfügbar
AMC,GM und CS sind nur in englisch auf der EASA website verfügbar.
Problematik Terminologie - Definitionen
6.10.2011
Folie 6
Luftfahrt-Bundesamt
Wie?:
1.Einführung der EU Regelungen (3)
Regulation Air Crew
(Cover Regulation)
DRAFT
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Subject matter
Definitions
Pilot licensing and medical certification
Existing national pilots licences (Bestehende einzelstaatliche Pilotenlizenzen)
Existing national pilot medical certificates and aero-medical examiners certificates
Conversion of flight test qualifications
Existing national flight engineers licences
Conditions for the acceptance of licences from third countries
Credit for training commenced prior to the application of this regulation
Credit for pilot licences obtained during military service
Cabin crew
Entry into force and application
Annex I-VII
6.10.2011
Folie 7
Luftfahrt-Bundesamt
Basic Regulation
Regulation
Air crew
Annex I
Part-FCL
Annex II
Conversion of national
licences
Annex III
Licences of non-EU states
Annex IV
Part-MED
Annex V
Part-CC
Annex VI
Part-ARA
Annex VII
Part-ORA
Luftfahrt-Bundesamt
Anhang I zur Durchführung der Verordnung
Teil-FCL
(Übersetzungsstand Sept. 2011)
A. Allgemeine Bestimmungen
B. Leichtflugzeug-Pilotenlizenz-LAPL
C. Privatpilotenlizenz(PPL), Segelflugzeugpilotenlizenz(SPL) und
Ballonpilotenlizenz(BPL)
D. Lizenz für Berufspiloten-CPL
E. Lizenz für Verkehrsflugzeugführer in mehrköpfigen
Flugbesatzungen-MPL
F. Lizenz für Verkehrspiloten-ATPL
G. Instrumentenflugberechtigung-IR
H. Klassen- und Musterberechtigungen
I Weitere Erlaubnisse
J. Lehrberechtigte
K. Prüfer
6.10.2011
Folie 9
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Annex VII
Part-ARA
GEN
FCL
CC
ATO
FSTD
AeMC
MED
6.10.2011
Annex VII
Part-ORA
GEN
ATO
FSTD
AeMC
Folie 10
Luftfahrt-Bundesamt
Wie?:
2. Auswirkungen - Lizenzen
1.
Gültige JAR-FCL Lizenzen, med. Tauglichkeitszeugnisse ausgegeben bis 8.4.2013 werden automatisch als EASA
Zertifikate angesehen, (”grandfather”)
Umtausch in neues Format erfolgt bis spätestens 8.4.2018 (gestaffelt oder z.B. mit Lizenz- Kalenderablaufdatum)
Ab 8.4.2012 dürfen bei gewähltem “step approach” noch JAR-compliant Lizenzen nach JAR-FCL dt. oder bereits neue
Zertifikate (Lizenz, Medical) nach neuen Vorschriften Part FCLerteilt werden bzw. ab 8.4.2013 müssen neue Lizenzen nach
Part FCL ^spätestens erstmalig ausgegeben werden
nur eine Lizenz je Lfzkategorie, med. Berichte und Lizenz bei ausstellender Behörde FCL.015, Übertragung mit/ohne ?
Einwilligung des Betroffenen
Eintrag nat.Berechtigungen (z.B. Musterberechtigung für Annex 2 Luftfahrtgerät) nur TR für Annex II in CAT erlaubt (App I zu Annex VI PartARA (Lizenzformat) , sonst Beiblatt, sonstige nat. Besonderheiten)??
2.
Nicht JAR Lizenzen und Berechtigungen (“Einzelstaatliche Pilotenlizenzen, s. Artikel 4 Rahmenverordnung”)
müssen in Teil FCL Lizenzen überführt werden, im Grundsatz spätestens bis 8.4.2014
(Ausnahmen Übergangsfristen für Ballone, Luftschiffe etc.)
a) Umwandlungstabelle
vergleiche neu
Anhang II zur Durchführungsverordnung der Bestimmungen für die Umwandlung nationaler Lizenzen und Erlaubnisse für
Flugzeuge und Hubschrauber
mit alt
Übergang von nationalen (ICAO Lizenzen) mittels Anhang 1 zu JAR FCL 1.005 (2.005) “Mindestanforderungen für die Erteilung
von Lizenzen/Anerkennungen gemäß JAR-FCL auf der Grundlage nationaler Lizenzen/Anerkennungen”
b) Umwandlungsbericht (conversion report)
Vergleichsbetrachtungen evtl. ergänzende Anforderungen in“ Konsultation“ mit der EASA
6.10.2011
Folie 11
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Wann?
Übergangsfristen (1)
In Erwägung nachstehender Gründe:
(5) Es ist notwendig, einen reibungslosen Übergang zum neuen
Rechtsrahmen der Agentur zu ermöglichen, der die Aufrechterhaltung
eines hohen und einheitlichen Sicherheitsniveaus der Zivilluftfahrt
innerhalb der Gemeinschaft sicherstellt; die Luffahrtindustrie und die
Behörden der Mitgliedstaaten müssen genügend Zeit erhalten, sich an
diesen neuen Rahmen anzupassen und die weitere Gültigkeit der vor
dem Inkrafttreten der vorliegenden Verordnung erteilten Lizenzen und
Zertifizierungsbescheinigungen im Einklang mit Artikel 69 der
Grundverordnung anzuerkennen.
6.10.2011
Folie 13
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Wann?
Grundsätzlich:
Entry into force on twentieth day following that of its
publication in OJEU
Applicable as from 8 April 2012
This Regulation ((Air crew) shall be binding in its entirety and
directly applicable in all Member States.
transitional period= opt out period,
allerdings Benachrichtigung der EASA und Kommission mit Begründung und Einführungsplan
mit Handlungen und Zeitschiene, STEP APPROACH
6.10.2011
Folie 14
Luftfahrt-Bundesamt
Wann?
Horizontales Opt out für alle Annexes I to VII d.h. Part- FCL,-MED,-CC,-ARA/ORA bis 8.4.2013 (Artikel 12 )
Mitgliedstaaten, Personen und Organisationen sollen sich in diesem Jahr vorbereiten auf neue Anforderungen,
d.h.
a) ihre jeweiligen Verfahren anpassen
b) Zertifizierung der Ausbildungseinrichtungen nach Part FCL beginnen mit dem Ziel Part FCL Training und
Part FCL Lizenzerteilung
c) Gleichzeitig den Mitgliedstaaten zu erlauben noch Erteilung und Verlängerung von JAR compliant und nat.
Lizenzen nach aktuellen Recht fortzusetzen
Dennoch bereits ab 8.4.2012 bis max 8.4.2018 Ersatzstellung für JAR-FCL Pilotenlizenzen und med.
Tauglichkeitszeugnisse
3 Jahre bis 8.4.2015 für neue Tatbestände
Pilot licences of powered-lift aircraft, airships, ballons, sailplanes
Light Aircraft Pilot Licence
Helicopters, multi-crew co-operation instructor (MCCI)
Mountain istructor, flight test instructor
Arobatic rating, sailplane and banner towing ratings, mountain
ratings and flight test rating
2 Jahre bis 8.4.2014 für Conversion non JAR-compliant aeroplane and helicopter licences
(trotz evtl. ICAO Gültigkeit)
and for provisions concerning third country pilots licence (z.B. FAA Lizenz)
non commercial operation
6.10.2011
Folie 15
Luftfahrt-Bundesamt
Wann?
und einige andere siehe entsprechenden Artikel der Rahmenverordnungen
z. B. von Part-CC und Part ARA/ORA,
z.B. Article 11a,11c Cover Reg.
ATO,AMC - 2 Jahre bis 8.4.2014 Management System,
Trainingsprogramme, Verfahren, Handbücher …aber….
LBA –bis 8.4.2017 Zertifikate ersetzen (ATO,AMC,FSTD)
(Referenz: Staff working paper „Transitional periods stemming from the Regulation on aircrew“
Brussels,13.07.2011
6.10.2011
Folie 16
Luftfahrt-Bundesamt
Wann?
Anwendungsbeispiele zu Übergangsfristen (5)
Pilot training organisations
JAR-FCL Anerkennungen für Ausbildungseinrichtungen gelten im bisherigen Umfang zunächst weiterhin
(„grandfather“), müssen aber bis spätestens 8.4.2017 in neue „Certificates“ überführt werden
(Antragsverfahren notwendig)
Erweiterung des Ausbildungsumfangs ist möglich, sobald nachgewiesen ist, dass die
Unterschiedsforderungen zwischen bisherigen und neuen Anforderungen erfüllt sind.
JAR compliant Ausbildungseinrichtungen einschließlich RF dürfen daher weiterhin für JAR compliant
Lizenzen (z.B. PPL,CPL,ATPL) ausbilden. Ausbildung für Part FCL Lizenzen dürfen sie auch betreiben
sogar während der Übergangsperiode bis zum 8.4.2014. Zu diesem Zeitpunkt müssen management
system, Trainingsprogramme, Verfahren und Handbücher angepasst sein.
(Für die Ausbildung neuer Part FCL Tatbestände müssen natürlich die Grundvoraussetzungen vorliegen.)
Ausbildungseinrichtungen einschließlich RF, die nur LAPL, PPL, BPL oder SPL ausbilden könnten eine
opt-out Phase für die Anforderungen zu Part ARA und ORA bis 8.4.2015 nutzen.
Flight simulation training
FSTD Zulassungen analog akzeptiert, aber neue Anerkennungen bis spätestens 8.4.2017 erforderlich
Aero-medical centres
JAR-FCL Anerkennungen gelten zunächst weiterhin („grandfather“), müssen aber bis spätestens 8.4.2017
in neue „Certificates“ überführt werden (Antragsverfahren notwendig)
In jedem Fall müssen management system, Trainingsprogramme, Verfahren und Handbücher bis
spätestens 8.4.2014 angepasst haben.
Anmerkung: Ausführungen ohne Gewähr, es gelten die Originalverordnungstexte
6.10.2011
Folie 17
Luftfahrt-Bundesamt
Wann?
Allgemeine Ausnahmemöglichkeit der Grundverordnung
in Artikel 14 „Flexibilitätsbestimmungen“
..im Fall unvorhergesehener und dringlicher betrieblicher Umstände oder
betrieblicher Bedürfnisse von beschränkter Dauer Freistellungen von
den grundlegenden Anforderungen dieser Verordnung und ihrer
Durchführungsbestimmungen erteilen, sofern keine Beeinträchtigung
des Sicherheitsniveaus eintritt.
Einbindung EASA, Prüfung, Entscheidung Kommission,
evtl.Widerruf
6.10.2011
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Luftfahrt-Bundesamt
Ausblick
Mit nationaler (nicht FCL) Lizenz wird es grundsätzlich ab einem zukünftigen
Zeitpunkt(8.4.2014, bzw. Übergangsfristen) nicht mehr möglich sein, diese Rechte auf EU
registrierten Luftfahrzeugen auszuüben. (Ausnahme Grundverordnung Artikel 4(5) für Annex
II Luftfahrzeuge, sofern nicht im gewerblichen Verkehr)
Rollenverteilung
- Antragsteller
- Behörde
(demonstrate compliance)
so früh, vollständig und korrekt wie möglich
(implement regulations, Prioritäten)
- EASA
(opinion for rulemaking, Standardization)
In Erwägung nachstehender Gründe:
(4) Die Notwendigkeit zur Gewährleistung einer einheitlichen Anwendung gemeinsamer
Anforderungen für die Erteilung von Pilotenlizenzen erfordert es, dass die zuständigen
Behörden der Mitgliedstaaten gemeinsame Verfahren einhalten und die Agentur
gegebenenfalls die Einhaltung dieser Vorschrifte beurteilt; die Agentur sollte zur Ermöglichung
der Einheitlichkeit in den Rechtsvorschriften annehmbare Nachweisverfahren und Leitlinien
erarbeiten
Empfehlung:
vorheriger Übergang ins FCL System, da dann automatische Akzeptanz dieser Lizenz
auch Einführung der neuen Vorschriften
6.10.2011
Folie 19
Regulation Aircrew
Medical
Workshop Luftfahrt-Bundesamt
30 September 2011
Dr Annette Ruge
Chief Medical Officer - EASA
Tagesordnung
Regulation Aircrew
Member States
AMEs & Pilots
AeMCs
Transition
2008 © European Aviation Safety Agency
European Agencies
Agencies located in 17 Countries
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
1
7
1
1
3 (Railway)
1 (Aviation)
3
1
Italy
2
Lithuania
1
Luxembourg
2
Netherlands
2
Poland
1
Portugal
2 (Maritime)
Spain
5 (OCH)
Sweden
1 (ECDC)
United Kingdom 2 (Medicines)
EASA Roles
Executive Role
Certification of Aircraft
Approval of Organisations in Third Countries
Appeal Board
Legislative Role
Right of initiative
Draft Opinions
Publish Decisions (AMC and GM Material)
Monitoring Role
Standardisation
EASA: Governing Bodies
Management Board
Member States and the European Commission
Responsible for:
definition of the Agency’s priorities
establishment of the budget
monitoring the Agency’s operation
appoints the Executive Director and Directors
Advisory Board
Members from Industry
assists Management Board
EASA: Governing Bodies
AGNA
Advisory Group of National Authorities
involves NAAs in the rulemaking process
SSCC
Safety Standards Consultative Committee
involves Industry in the rulemaking
process
Political Level
EASA Committee
Organised by the European Commission
Chair: Commission
Members: Member States
EASA participates on invitation
Rulemaking Programme
The Rulemaking Programme
is established for a period of 4 years
EASA proposes programme
AGNA and SSCC are consulted on priority
setting
Management Board and Executive Director
determine the final RM programme
Rulemaking Programme
Rulemaking Programme Medical:
2010 – 2012
Develop Opinion ATCO.MED
2010 – 2013
Develop Decision ATCO.MED
2011 – 2013
Update Part-MED
2012 – 2013
Update medical kits
2012 – 2014
Develop guidance for Part-MED
Rulemaking Process
Draft pre-RIA
Add task to RM programme
Determine whether group or Agency task
Consultation of RM programme
Initiate task
ToRs – consulted with AGNA and SSCC
Group composition – consulted with AGNA and SSCC
Draft Opinion and/or Decision as appropriate
Rulemaking Process
Draft Explanatory Note and RIA
Publish Opinion and/or Decision
Public Consultation (3 months)
Publish Comment-Response Document + EN
Public Consultation (3 months)
Publish Opinion + EN
Commission and EASA Committee take
over
The EU Regulatory Procedures
Co-Decision Procedure
Parliament
Commission
Council
Working Groups
REGULATION (EC) No 216/2008 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
The Regulatory Procedures
Commitology Procedure
Parliament
Council
Commission
EASA Committee
Veto right 3 months
Implementing Rules defining technical details of (EC) No 216/2008 OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
Rule Structure
Essential Requirements
binding rules
Council and
Parliament
Implementing Rules (IR)
further define essential requirements
binding rules
Commission
Parliament
Acceptable Means of Compliance (AMC)
further define Implementing Rules
non-binding but
justification is needed in case of non compliance
Guidance Material (GM)
non-binding material for further clarification
EASA publication
EASA Decision
EASA Opinion
Basic Regulation
Regulation Aircrew
Cover Regulation
Annex I
Part FCL
Annex IV
Part Medical
Annex VI
Part ARA
Annex II
Conversion of
national licences
Annex V
Part Cabin Crew
Annex VII
Part ORA
Annex III
Acceptance of TC
licences
Summary
Regulation 216/2008 (BR) determines
the scope of EASA
the shared responsibilities of EASA, Member
States and European Commission
the basic technical rules within the scope of
EASA (in Annexes)
Summary
EASA and it‘s Governing Bodies
Management Board & Advisory Board
Overall management issues (e.g. budget)
Adopts working methods
…..
AGNA & SSCC
Advises on priority setting regarding the RM
Programme
….
Summary
Remit of EASA Rulemaking
draft Opinions (IRs) and Decisions (AMCs)
consult draft rules and AMCs with all
stakeholders
Publish Decisions
Provide support to the Commission
Commission and EASA Committee
Adopt IRs (with involvement of EU-Parliament)
Workshop Medical – 30 September 2011 – Luftfahrt-Bundesamt
END OF SESSION 1
Regulation Air Crew
Mitgliedsstaaten
30 September 2011
Dr Annette Ruge
Tagesordnung
Regulation Aircrew
Member States
AMEs & Pilots
AeMCs
Transition
Implementation
Cover Regulation
Annex IV
Part Medical
Annex VI
Part ARA
Annex VII
Part ORA
Subpart A
General Rules
ARA GEN
ORA.GEN
ARA.AeMC
ORA.AeMC
Subpart B
Flexibility Clause
Medical Rules
Subpart C
Medical Rules
Cabin Crew
Subpart D
AMEs and GMPs
ARA.MED
Appendices
Part-MED
MED.A.001
Subpart A
Competent Authority
Designated by Member State
MED.A.010
Definitions
–
‘Licensing authority’ means the competent
authority of the Member State that issued the
licence, or to which a person applies for the
issue of a licence, or, when a person has not
yet applied for the issue of a licence, the
competent authority in accordance with this
Part;
Competent & Licensing Authority
Application for medical certificate
Pilot
Country A
AME or AeMC or (GMP)
Country A
Ap
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Competent Authority
=
Licensing Authority
Country A
t
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AME or AeMC
Country B
Me
Licensing Authority
Country A
a
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Competent Authority
Country B
Application for AME-certificate
Application for Licence
Pilot
Country A
ARA.GEN.105 Definitions
Acceptable Means of Compliance (AMC)
adopted by the Agency
non-binding standards
means to establish compliance with the BR and IR
Alternative means of compliance propose
adopted by Member State
an alternative to an existing AMC or
new means to establish compliance with BR
and IR for rules for which no associated AMC have
been adopted by the Agency
Guidance Material (GM)
non-binding material
developed by the Agency
illustrates the meaning of a requirement or
specification
supports interpretation of BR, its IRs and AMC
AMC and GM undergo the normal RM Process
Principal place of business
the head office or registered office of the
organisation
Responsible for the principal financial functions and
operational control
ARA.GEN.120 Means of compliance
AMCs developed by the Agency
Compliance with these AMCs implies that the
related requirements of the IRs are met
Alternative AMCs – Competent Authority
responsible that alternative AMCs lead to
compliance with IRs
notify the Agency without undue delay
inform other Member States
ARA.GEN.200 Management system
The competent authority shall,
(b)
for each field of activity … appoint one or more
persons with the overall responsibility for the
management of the relevant task(s).
(c)
establish procedures for participation in a
mutual exchange of all necessary information and
assistance with other competent authorities concerned
including on all findings raised and follow-up actions
taken as a result of oversight of persons .....
.... and organisations exercising activities in the territory
of a Member State, but certified by the competent
authority of another Member State or the Agency.
ARA.GEN.220 Record-keeping
(a)
The competent authority shall establish
a system of record-keeping providing for
adequate storage, accessibility and reliable
traceability of records….
(5) processes for issuing personnel
licences, ratings, certificates and attestations
and for the continuing oversight of the
holders of those licences, ratings, certificates
and attestations;
(12) the use of flexibility provisions in
accordance with Article 14 of Regulation (EC)
No 216/2008
ARA.GEN.300 Oversight
(a)
The competent authority shall verify:
(1)
compliance with the requirements applicable to
organisations or persons prior to the issue of an
organisation certificate, …… personnel licence, certificate, …
or attestation ..
(b)
This verification shall:
……
(3)
be based on audits and inspections, including ramp
and unannounced inspections; and …
ARA.GEN.305 Oversight programme
Oversight programme for organisations
oversight planning cycle of 24 months
cycle may be reduced if there is evidence that the
safety performance has decreased
cycle may be extended to a maximum of 36 months
and, under certain conditions, to 48 months
Oversight programme for persons
shall include inspections, including unannounced
inspections, as appropriate.
No oversight planning cycle established in Part-ARA.
ARA.GEN – certification and findings
ARA.GEN.310 - Initial certification procedure – organisations
ARA.GEN.315 - Procedure for issue, revalidation, renewal or
change of licences, ratings, certificates or attestations –
persons
ARA.GEN.330 - Changes – organisations
ARA.GEN.350 - Findings and corrective actions – organisations
ARA.GEN.355 - Findings and enforcement measures - persons
Authority Requirements ARA.MED
Section I - General
Medical Assessor
ARA.MED.120 - Medical assessors
The competent authority shall appoint one or more
medical assessor(s) to undertake the tasks described
in this Section.
Definition ICAO Annex 1
Medical assessor. A physician qualified and
experienced in the practice of aviation medicine who
evaluates medical reports submitted to the Licensing
Authority by medical examiners.
ARA.MED.125- Referral to the licensing authority
When an AeMC, or aero-medical examiner (AME) has
referred the decision on the fitness of an applicant to the
licensing authority:
(a)
the medical assessor or medical staff designated
by the competent authority shall evaluate the relevant
medical documentation and request further medical
documentation, examinations and tests where
necessary; and
(b)
the medical assessor shall determine the
applicant’s fitness for the issue of a medical certificate
with one or more limitation(s) as necessary
ICAO Annex 1
6.1.3 The medical examiner shall report to the Licensing
Authority any individual case where, in the examiner’s
judgement, an applicant’s failure to meet any
requirement, whether numerical or otherwise, is such
that exercise of the privileges of the licence being applied
for, or held, is not likely to jeopardize flight safety
(1.2.4.8)
ARA.MED.150 Record-keeping
System of record-keeping shall contain
details of aero-medical examinations and assessments
submitted by AMEs, AeMCs or GMPs
Rules to determine to whom medical records
can be released
Medical data can only be released after written
consent of the applicant
Lists of AMEs and AeMCs to be maintained
Section II – Aero-Medical Examiners
ARA.MED.200 - 255
Procedure for the issue, revalidation,
renewal or change of an AME certificate
Continuing oversight of AMEs and GMPs
Limitation, suspension or revocation of an
AME certificate
Enforcement measures
Section III – Medical Certification
ARA.MED.315
Review of examination reports
The licensing authority shall have a process in
place to:
(a)
review examination and assessment reports
received from the AeMCs, AMEs and GMPs and inform
them of any inconsistencies, mistakes or errors made
in the assessment process; and
(b)
assist AMEs and AeMCs on their request
regarding their decision on aero-medical fitness in
contentious cases.
ARA.MED.325 Secondary review procedure
The competent authority shall establish a
procedure for the review of borderline and
contentious cases with independent medical
advisors, experienced in the practice of aviation
medicine, to consider and advise on an
applicant’s fitness for medical certification.
Summary
Part Authority Requirements Aircrew contains
two main building blocks:
Subpart GEN
Individual Subparts for specific privileges
Subparts ARA.AeMC and ARA.MED have to be
considered together with Subpart GEN
The Appendices to Part-ARA contain the
necessary documentation
Summary
Concerning Medical: Part ARA contains the rules
for the processes that the competent authority
has to have in place:
Management System
Oversight Programme
Issue, revalidation, renewal, limitation and
revocation of certificates
Enforcement measures
Record Keeping including data protection
Handling of medical files
Obligations of Medical Assessor
END OF SESSION 2
Regulation Aircrew
Fliegerärzte & Piloten
30 September 2011
Dr Annette Ruge
Tagesordnung
Regulation Aircrew
Member States
AMEs & Pilots
AeMCs
Transition
Implementation
Cover Regulation
Annex IV
Part Medical
Annex VI
Part ARA
Annex VII
Part ORA
Subpart A
General Rules
ARA GEN
ORA.GEN
ARA.AeMC
ORA.AeMC
Subpart B
Flexibility Clause
Medical Rules
Subpart C
Medical Rules
Cabin Crew
Subpart D
AMEs and GMPs
ARA.MED
Appendices
Part-MED:
Subpart A
Changes compared to JAR-FCL 3 (original version)
Section 1 of Part-MED applies to pilots and cabin crew
General & Occupational Health Medical Practitioner
Medical certificates for sailplanes and balloons
Class 2 medical certificate for commercial ballooning
Medical for Light Aircraft Pilot Licence (LAPL)
AeMCs shall issue initial class 1 medical certificates
Licensing authority may issue medical certificates
Part-MED:
Subpart A
Changes compared to JAR-FCL 3 (original version)
New definitions
Accredited medical conclusion
Assessment
Examination
Investigation
Licensing authority
Limitation
AME or AeMC
Country B
RP
RP
RP
RP
BL
RP
BL
RP
BL
BL
Competent Authority
BL
BL
Country B
BL
Licensing Authority BL
BL
Country DE
BL
BL
BL
BL
BLAviation Safety Agency
2008 © European
Application for AME-certificate
Application for Licence
Pilot
Country DE
MED.A.025
Obligations of AeMC, AME, GMP and OHMP
Ensure that communication is possible without
language barriers
make the person aware of the consequences of
providing incomplete, inaccurate or false
statements on their medical history
if the person has been assessed as unfit, inform
him/her of his/her right of a secondary review
„Secondary review‟ means „appeal“ in this case
After completion of the aero-medical
examinations and/or assessment the AME or
AeMC shall
advise the person whether fit, unfit or
referred to the licensing authority, AeMC or
AME as applicable
submit without delay a signed, or
electronically authenticated, full report to
include the assessment result and a copy of
the medical certificate to the licensing
authority
MED.A.050 – Referral
AeMC or AME shall transfer the relevant
medical documentation to the licensing
authority
In consultation with the licensing authority
No rule to specify whether or not „relevant
medical documentation“ has to be sent to the
licensing authority
Obligations of applicants
MED.A.035 (c)
Prior to the aero-medical examination, the pilot
shall provide the AME with
proof of their identity;
Present/last medical certificate
A signed declaration on:
Correctness of medical history
Any previous aero-medical examination: result and
done by whom
Any previous unfit assessment or revocation/
suspension of a medical certificate
LAPL
Validity period of medical certificate
60 months until age 40
24 months thereafter
Medical IRs in MED.B.095
Review of contentious cases by AME or AeMC
GMP only if permitted under national law of the
Member State where the licence is issued
Part-MED
Subpart B
Flexibility
MED.B.001 implements the ICAO Standard
1.2.4.8 (flexibility clause)
Class 1 – refer to the licensing authority as
indicated in Subpart B
Class 2 – AME or AeMC to decide upon fitness
in consultation with the licensing authority
Medical certificates with a limitation can be
revalidated or renewed by the AME or AeMC
without involvement of the licensing authority
Class 1: Flexibility
A pilot has a condition that, according to the
IRs, leads to a referral to the licensing authority
Does the AME or AeMC issue an unfit
assessment?
No, the pilot undergoes a secondary review
based on the AMCs
The decision on fitness (or not) is taken only
after this secondary review
Class 1 - Flexibility
A pilot has been referred to the licensing
authority and has been considered as fit to fly
according to the provisions in the AMCs
Special authorisation / waiver ?
or
Fit to fly
?
Flexibility
A pilot does not meet the requirements in
Subpart B but accredited medical conclusion
results in a decision by the licensing authority
that a fit assessment may be given.
Special authorisation / waiver
or
Fit to fly
?
?
MED.B.001 - Limitations
OML: When the holder of a CPL, ATPL or MPL
does not fully meet the requirements for a class
1 medical certificate and has been referred to
the licensing authority, it shall be assessed
whether the medical certificate may be issued
with an OML „valid only as or with qualified copilot‟. This assessment shall be performed by
the licensing authority
OSL: may be imposed or removed by an AeMC
or AME in consultation with the licensing
authority.
Exemptions
Exemptions are a general change to an
Implementing Rule
Rules how to deviate from IRs are in Article 14
“Flexibility Provisions” of the Basic Regulation.
The process is carried our through diplomatic
channels
EASA provides advice to the Commission
The Commission decides and MS are informed
Medical Rules LAPL – MED.B.095
An applicant for a LAPL medical certificate shall be
assessed based on aero-medical best practice.
Clinical examination to be undertaken
For the issue of an initial medical certificate
All assessments after age 50
No medical standards, e.g. visual acuity, in
implementing rules
Part-MED
Subpart C
Cabin Crew
Cabin Crew Medical
MED.C.005
Aero-medical assessments
Initial assessment
Re-assessments at intervals not exceeding 60 months
Aero-medical assessments shall be conducted by an
AME, AeMC, or by an OHMP
The AME, AEMC or OHMP will issue a medical report
No medical details to be sent to authorities
Limitations are possible and decided by the examiner
Part-MED
Subpart D
AME – GMP - OHMP
Aero-medical Examiners
Amendments to JAR-FCL 3 and JIP
The competent authority cannot determine the number
of AMEs
An AME can work in several Member States
Medical degree and specialist training (without further
specification)
AME certificate in Appendix VII, EASA form 148
AME working in several MS
MED.D.001
In order to work in another MS, the AME must
have:
(1)
been granted access by the host Member State
to exercise their professional activities as a specialised
doctor;
(2)
informed the competent authority of the host
Member State; and
(3)
received a briefing from the competent
authority of the host Member State.
General Medical Practitioner
GMPs shall act as AMEs for issuing LAPL medical
certificates only if they exercise their activity in
a Member State where GMPs have appropriate
access to the full medical records of applicants
Occupational Health Medical Practitioners
OHMPs shall only conduct aero-medical
assessments of cabin crew if:
(a)
the competent authority is satisfied that the
relevant national occupational health system can ensure
compliance with the applicable requirements of this Part;
(b)
they are licensed in the practice of medicine and
qualified in occupational medicine in accordance with
national law; and
(c)
have acquired knowledge in aviation medicine
as relevant to the operating environment of cabin crew
Documentation
Appendices to Part-ARA
All certificate templates: Appendices I – VII
The format of these forms is obligatory
Appendix V – Aero-medical Centre Certificate
Appendix VI – Medical Certificate
Appendix VII – AME Certificate
AMCs
Forms in AMCs should be used to facilitate cross
border activities
Application form for medical certificate
Examination forms
EASA AMCs will be published shortly
Summary
Part-MED is directed to AMEs, GMPs, OHMPs,
pilots and cabin crew and contains
General rules for medical certificates and cabin crew
reports
Medical standards for pilots including the new LAPL
and for cabin crew
Flexibility clause
Certification of AMEs
The medical standards reflect JAR-FCL 3
Summary
The flexibility clause in MED.B.001 allows an
individual assessment of pilots, also considering
their skill and experience
The documentation for certificates is in
Appendices to Part-ARA and the format is
binding
The medical application and examination forms
are in AMCs to Part-ARA and should be
implemented
Workshop Medical – 30 September 2011 – Luftfahrt-Bundesamt
End of Session 3
Regulation Aircrew
Aero-Medical Centres
Transition
30 September 2011
Dr Annette Ruge
Regulation Aircrew
Cover Regulation
Annex IV
Part Medical
Annex VI
Part ARA
Annex VII
Part ORA
Subpart A
General Rules
ARA GEN
ORA.GEN
ARA.AeMC
ORA.AeMC
Subpart B
Flexibility Clause
Medical Rules
Subpart C
Medical Rules
Cabin Crew
Subpart D
AMEs and GMPs
ARA.MED
Appendices
ORA.GEN
All requirements of ORA.GEN
apply to aero-medical centres
ARA/ORA.GEN
ORA.GEN.115: The certification procedure will
be according to ARA.GEN 310
ARA.GEN.310 Initial certification procedure –
organisations
Verification of compliance with the requirements
The certificate shall be issued for an unlimited duration
The privileges and scope of the activities shall be specified
in the terms of approval attached to the certificate(s)
ORA.GEN.135 - Continued Validity
The Organisation approval certificate shall
remain valid subject to:
the organisation remaining in compliance with the
relevant requirements
Is in compliance with provisions related to the
handling of findings
the competent authority being granted access to the
organisation to determine continued compliance
ARA.AeMC.150 - Findings
Level 1 findings include, but are not limited to,
the following:
(a)
failure to nominate a head of the AeMC;
(b)
failure to ensure medical confidentiality of aero-
medical records; and
(c)
failure to provide the competent authority with the
medical and statistical data for oversight purposes
ORA.GEN.150 - Findings
After receipt of notification of findings, the
organisation shall:
(a) identify the root cause of the non-compliance;
(b) define a corrective action plan; and
(c) demonstrate corrective action implementation to the
satisfaction of the competent authority
within a period agreed with that authority as defined in
ARA.GEN.350 (d).
ARA.GEN.350 (d)
In the case of level 1 findings the competent
authority shall take immediate and appropriate
action to prohibit or limit activities, and if
appropriate, it shall take action to revoke the
certificate or specific approval or to limit or
suspend it in whole or in part, depending upon
the extent of the level 1 finding, until successful
corrective action has been taken by the
organisation.
ORA.GEN.200
Organisations have to implement a
Management System
Responsibility and accountability throughout the
organisation
Description of the overall philosophies and principles
Identification of aviation safety hazards entailed by the
activities
Maintaining personnel trained and competent to
perform their tasks
Documentation of all management system key
processes
Compliance monitoring shall include a feedback
system of findings to the accountable manager
More in ORA.GEN
ORA.GEN.205 Contracted activities
E.g. specialist examinations
ORA.GEN.210 Personnel requirements
E.g. nomination of an accountable manager
ORA.GEN.215 Facility requirements
ORA.GEN.220 Record-keeping
More on ORA.GEN
ORA.GEN.120 Means of compliance
An organisation may propose alternative AMCs
Alternative AMCs have to be approved by the
competent authority prior to implementation
The proposal must contain a justification
ORA.AeMC
ORA.AeMC 105 – Scope
Issue medical certificates including initial
class 1 medical certificates
Specific requirements in addition to ORA.GEN
Management system
Personnel requirements
Facility requirements
Record keeping
Cover Regulation
Transition
Regulation Aircrew
Cover Regulation
Annex IV
Part Medical
Annex VI
Part ARA
Annex VII
Part ORA
Transitional Periods
The Cover Regulations contains the provisions
for transition to the new system
The Aircrew Regulation is applicable as from
8 April 2012
However ……
Horizontal opt-out
Prepare for implementation until 7 April 2013 …
….. to implement on 8
April 2013 at the latest
….. however …..
Grandfathering
JAR-compliant medical certificates and aeromedical examiner certificates shall be deemed
to have been issued in accordance with
Regulation Aircrew
Non-JAR-compliant certificates shall remain
valid until the date of their next revalidation or
until 8 April 2017, whichever is earlier
Revalidation of these certificates shall comply
with Annex IV to Regulation Aircrew (Part-MED)
Opt-outs other than horizontal
By 8 April
2014 – AeMCs shall have adapted their
management systems, training programmes,
procedures and manuals to be compliant with
Part-ORA
2015 – LAPL Medical (and licence) shall be
introduced
2017 – AME and AeMC approvals and pilot
medical certificates shall have been replaced
by the format in Part-ARA
Transition
End of horizontal
opt-out
LAPL
medical
Regulation
Aircrew is
applicable
Replace NonJAR certificates
JAR certificates
and approvals
AeMCs to
adapt
8 Apr
2012
2013
2014
2015
2017
2018
End of the day
European
Aviation
Safety
Agency

European Aviation Safety Agency

Transcription

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