Reviewing Issues related to DOA – POA Interface within an EASA Environment
What do the Regulations Require?
AMC No 1 to 21.A.133(b) and (c) Eligibility – Link between design and production organisations.
An arrangement is considered appropriate if it is documented and satisfies the competent authority that co-ordination is satisfactory.
To achieve satisfactory coordination the documented arrangements must at least define the following aspects irrespective of whether the two organisations are separate legal entities or not:
a) The responsibilities of a design organisation which assure correct and timely transfer of up-to-date airworthiness data (e.g., drawings, material specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.);
b) The responsibilities and procedures of a POA holder/applicant for developing, where applicable, its own manufacturing data in compliance with the airworthiness data package;
c) The responsibilities of a POA holder/applicant to assist the design organisation in dealing with continuing airworthiness matters and for required actions (e.g., traceability of parts in case of direct delivery to users, retrofitting of modifications, traceability of processes’ outputs and approved deviations for individual parts as applicable, technical information and assistance, etc.);
d) The scope.
What Must the Scope Cover?
The scope of the arrangements must cover Part 21 Subpart G requirements and associated AMC and GM, in particular: 21.A.145(b), 21.A.165(c), (f) and (g);
a) The responsibilities of a POA holder/applicant, in case of products prior to type certification, to assist a design organisation in demonstrating compliance with CS (access and suitability of production and test facilities for manufacturing and testing of prototype models and test specimen);
b) The procedures to deal adequately with production deviations and non-conforming parts;
c) The procedures and associated responsibilities to achieve adequate configuration control of manufactured parts, to enable the production organisation to make the final determination and identification for conformity or airworthiness release and eligibility status;
d) The identification of the responsible persons/offices who control the above;
e) The acknowledgment by the holder of the TC/STC/repair or change approval/ETSO authorisation that the approved design data provided, controlled and modified in accordance with the arrangement are recognised as approved;
f) In many cases the production organisation may receive the approved design data through an intermediate production organisation. This is acceptable provided an effective link between the design approval holder and the production organisation can be maintained to satisfy the intent of 21.A.133.
Note – When the design and production organisations are two separate legal entities a Direct Delivery Authorisation must be available for direct delivery to end users in order to guarantee continued airworthiness control of the released parts and appliances.
Where there is no general agreement for Direct Delivery Authorisation, specific permissions may be granted (refer to AMC 21.A.4).
POA Holder Obligations
AMC No 2 to 21.A.133(b) and (c) Eligibility – Link between design and production organisations
a) In accordance with AMC No 1 to 21.A.133(b) and (c) the POA holder must demonstrate to the competent authority that it has entered into an arrangement with the design organisation.
b) The arrangement must be documented irrespective of whether the two organisations are separate legal entities or not.
c) The documented arrangement must facilitate the POA holder to demonstrate compliance with the requirement of 21.A.133(b) and (c) by means of written documents agreed.
Note – In the case where the design organisation and POA holder are part of the same legal entity these interfaces may be demonstrated by company procedures accepted by the competent authority.
Feedback from Competent Authority POA Oversight
The following issues have been documented over a period of time to serve as an indicator as to where the issues and shortfalls may exist.
a) 20 findings of POAs unable to demonstrate manufacture to Approved Data
b) 19 findings of lack of effective control of Concessions
c) Taken together, Link with Design is the subject generating the highest level of non-conformance across POA
d) The organisation cannot demonstrate that an item is in conformity with approved design data and is safe to fly
e) Design data not available
f) Manufacturing processes not i.a.w. approved data
g) Incorrect/damaged tooling not i.a.w. approved data
h) The organisation is not adequate to support the approval or part thereof due to:
i) Lack of Accountable Manager/nominated personnel
j) Competence of staff
k) Escalation of level 2 findings
l) Falsification of records
m) Failure to respond to high safety severity findings within the agreed timescales
n) Negative implications of the systemic breakdown of the quality system
Aspects to Review During Audit
a) Does the Applicant have suitably documented arrangements including the timely transfer of all airworthiness and design data? (Specifications, Drawings, Service Bulletins etc.)
b) Have all the responsibilities & procedures of the applicant for developing and validating manufacturing data against design & airworthiness data supplied been validated?
c) Is there an adequate and effective procedure to define traceability of such data to each product, part & appliance for the purpose of certifying safe operation and conformity?
d) Design data is rarely sufficient to actually manufacture without generating and validating further data. -Who has approved the new/changed process/document? Are they authorised in the Company procedures? Is there evidence of validation of the change to the Design Data? & To what extent does the design organisation (i.e. the DOA) expect to be involved in this process?
e) Concerning the involvement of Intermediate Production Organisation. Is there Evidence that the Design Holder has visibility of the lower-tier arrangement either directly or via flow-down? Is there POA awareness and access to the associated procedures? (Otherwise, how does the organisation know how to work and where to report problems?)
f) In case of FAA PMA, the PMA Holder may not own the design date – ‘licensing’. Has the ability to accept changes been delegated to the IPO or not?
g) Escapes, Concessions and Occurrences – Change to include need to advise NAAs on Occurrence Reports as well as the DOA/EASA.
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Tags:
Design Organisation Approval (DOA), DOA, POA, Production Organisation Approval (POA)
