Acceptable Means of Compliance & Alternative Means of Compliance Margit Markus Moossen Legal...
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Acceptable Means of Compliance & Alternative Means of Compliance Margit Markus Moossen Legal department 31 January 2013
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Transcript of Acceptable Means of Compliance & Alternative Means of Compliance Margit Markus Moossen Legal...
Acceptable Means of Compliance
&Alternative Means of
Compliance
Margit Markus MoossenLegal department
31 January 2013
Overview
Introduction of AMC;Introduction of AltMoC; AltMoC process:
From the CA perspective;The Agency’s procedures;
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Acceptable Means of Compliance
Legal basis: Article 18(c) of Regulation 216/2008;
Article 10 (1) of Regulation 748/2012;Article 8(1) of Regulation 2042/2003;ARA.GEN.120(a) of Annex VI to Regulation 1178/2011;ARO.GEN.120(a) of Annex II to Regulation 965/2012;Recital 7 of Regulation 805/2011;
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Art 18(c) of Basic Regulation
The Agency shall, where appropriate issue certification specifications and acceptable means of compliance […] for the application of this Regulation and its implementing rules.
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AMC- ARO.GEN.120(a)
The Agency shall develop acceptable means of compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and ist Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met.
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AMC
‚soft law‘- adopted by the ED;non-binding;not mandatory to use;not to introduce new requirements or alleviate the requirements;presumed compliance when following the AMC issued by the Agency;
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Alternative Means of Compliance
ARA.GEN.120(b):Alternative means of compliance may be used to establish compliance with the Impementing Rules.
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ARA.GEN.105:“Alternative means of compliance” are those that propose an alternative to an existing AMC or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency;
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•EASA Conference Authority & Organisation Requirements
AltMOC: Principles
AMC=
Non-binding
Alternative means may
be used
Compliance with rules
demonstrated
Process established to ensure:
No negative effect on safetyTransparency Harmonisation
ORA.GEN.115
Organisations may use AltMOC to establish compliance with rulesImplementation is subject to prior approval by CA:
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Full description of AltMOC Revisions to
manuals or procedures
Demonstration that rules are complied with
ARA.GEN.115 - 1
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CA needs to have a system in place to consistently evaluate the compliance of AltMOC with the rulesFor AltMOC proposed by organisationsFor AltMOC it proposes itself
CA needs to have a system in place to consistently evaluate the compliance of AltMOC with the rulesFor AltMOC proposed by organisationsFor AltMOC it proposes itself
ARA.GEN.115 - 2
Analysis of documentation provided & if needed inspection
Notify applicant & change of certificate, if neededNotify the Agency of the content, including copies of relevant docsInform other MS
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CA evaluates AltMOC proposed:
When AltMOC complies with the
rule, CA:
ARA.GEN.115 - 3
Makes them available to all organisations and persons under its oversightNotifies the Agency
Full description of the AltMOC, including any revisions to procedures
Demonstration that AltMOC complies with rules
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CA proposes AltMOC
itself
The Agency process - 1
Agency receives notification from CA
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Standardisation
Risk based approach
Rulemaking
Recurrent taskSimplified procedure
The Agency process - 2
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Information included in database
Quarterly review by S &
R FP
Identification of significant AltMOC, requiring further assessment
Statistical report to S & R management
The Agency process - 3
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Significant AltMOC
reviewed by internal experts:
Compliance with rulesRegularity of procedure
Input to S, for use in
Standardisation
Input to R, for possible RM
task
Actions
Creation of a dedicated mailbox
Dedicated page on EASA website, with relevant information under development
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We would like your input
Any specific information you would like to see on the website?
The RAG has already indicated they would like to have:
A form for the notificationA list of contacts in the different CA, where you could send your notifications and queries
Do you have any further suggestions that would facilitate your work and our cooperation?
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