Transcript Acceptable Means of Compliance & Alternative Means of Compliance

Acceptable Means of
Compliance
&
Alternative Means of
Compliance
Margit Markus Moossen
Legal 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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AltMOC: Principles
AMC
=
Non-binding
Alternative
means may
be used
Compliance
with rules
demonstrated
Process established to ensure:
No negative effect on safety
Transparency
•
EASA Conference Authority & Organisation Requirements
Harmonisation
ORA.GEN.115
Organisations may
use AltMOC to
establish
compliance with
rules
Implementation is
subject to prior
approval by CA:


Full description of
AltMOC
 Revisions to
manuals or
procedures
Demonstration
that rules are
complied with
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ARA.GEN.115 - 1
CA needs to have a system in place
to consistently evaluate the
compliance of AltMOC with the
rules
 For AltMOC proposed by
organisations
 For AltMOC it proposes itself
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ARA.GEN.115 - 2
CA evaluates AltMOC
proposed:
When AltMOC
complies with the
rule, CA:
Analysis of
documentation
provided & if needed
inspection
Notify applicant &
change of certificate, if
needed
Notify the Agency of
the content, including
copies of relevant docs
Inform other MS
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ARA.GEN.115 - 3
CA proposes AltMOC
itself
Makes them available
to all organisations and
persons under its
oversight
Notifies the Agency
Full description of
the AltMOC,
including any
revisions to
procedures
Demonstration that
AltMOC complies with
rules
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The Agency process - 1
Agency receives notification from CA
Standardisation

Risk based
approach
Rulemaking


Recurrent
task
Simplified
procedure
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The Agency process - 2
Information
included in
database


Quarterly
review by S &
R FP
Identification of significant AltMOC,
requiring further assessment
Statistical report to S & R management
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The Agency process - 3
Significant
AltMOC
reviewed by
internal
experts:


Compliance
with rules
Regularity of
procedure
Input to S, for
use in
Standardisation
Input to R, for
possible RM
task
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Actions

Creation of a dedicated mailbox
[email protected]

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 notification
A 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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Questions?
Suggestions?
Contact [email protected]