Sofema Aviation Services (SAS) www.sassofia.com considers issues that have been reported by regulatory authorities related to the interface and functioning of an EASA Design Organisation Approval (DOA) and Production Organisation Approval (POA) relationship.
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.
- 20 findings of POAs unable to demonstrate manufacture to Approved Data
- 19 findings of lack of effective control of Concessions
- Taken together, Link with Design is the subject generating the highest level of non-conformance across POA
- The organisation cannot demonstrate that an item is in conformity with approved design data and is therefore safe to fly
- Design data not available
- Manufacturing processes not i.a.w. approved data
- Incorrect/damaged tooling not i.a.w. approved data
- The organisation is not adequate to support the approval or part thereof due to:
o Lack of Accountable Manager/nominated personnel
o Competence of staff
o Escalation of level 2 findings
o Falsification of records
o Failure to respond to high safety severity findings within the agreed timescales
o Negative implications of the systemic breakdown of the quality system
Aspects to Review During Audit
- Does the Applicant have suitably documented arrangements including the timely transfer of all airworthiness and design data? (Specifications, Drawings, Service Bulletins, etc.)
- Have all the responsibilities & procedures of the applicant for developing and validating manufacturing data against design & airworthiness data supplied been validated?
- 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?
- Design data is rarely sufficient to actually manufacture without generating and validating further data.
o Who has approved the new/changed process/document?
oĀ Are they authorised in the Company procedures?
o Is there evidence of validation of the change to the Design Data? &
o To what extent does the design organisation (i.e. the DOA) expect to be involved in this process?
- Concerning the involvement of Intermediate Production Organisation.
o Is there Evidence that the Design Holder has visibility of the lower-tier arrangement either directly or via flow-down?
o Is there POA awareness and access to the associated procedures? (Otherwise, how does the organisation know how to work and where to report problems?)
- In case of FAA PMA, the PMA Holder may not own the design date ā ālicensingā.
o Has the ability to accept changes been delegated to the IPO or not?
- Escapes, Concessions, and Occurrences ā Change to include the need to advise NAAs on Occurrence Reports as well as the DOA/EASA.
Next Steps
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Sofema Aviation ServicesĀ www.sassofia.comĀ and Sofema OnlineĀ www.sofemaonline.com provide classroom and online EASA Part 21 Training. For details please see our websites or email us at team@sassofia.com
Tags:
EASA Specifications, Competence of staff, Regulatrions, IPO, Design Holder, Design Data, Manufacturing processes, Approved Data, Authority POA, EASA, Aviation Regulations, POA, Production Organisation Approval (POA), Design Organisation Approval (DOA), DOA, FAA, Audit, Accountable Manager
