Page 220 - UK Regulation Part 21 Initial Airworthiness Annex I (consolidated) March 2022

PART 21 - INITIAL AIRWORTHINESS (ANNEX I)

provisions of the relevant type design. If discrepancies are found on the
audited product, the POATL should assess whether the definitions of the
quality system have been adhered to, and whether those definitions may
have been misleading and may have contributed to the discrepancies, which
may indicate a need for a modification;
- review the acceptance of the key nominated personnel, confirmed by the
completed CAAForm 4 (refer to AMCELA No 1 to 21.A.145(c)), on the basis
of a review of the skills of each nominee, used as the basis for the
nomination;
- conduct sample audits at appropriate stages of production to verify that:
(i) the products, parts, appliances and material produced by the organisation are
in conformity with the applicable design data;
(ii) the level of product conformity achieved indicates that the facilities, working
conditions, equipment and tools are appropriate to allow the work to be
performed in a repeatable way;
(iii) the achieved production rate and the number of product non-conformities
indicate that the number of personnel and their competences are sufficient to
allow the work to be performed in a repeatable way; and
(iv) the identified responsibilities and examples show that there is satisfactory
and effective coordination between the production entity and the design entity.
The investigation team should be accompanied during the sample audits by
company representatives who are knowledgeable about the applicant’s
organisation and procedures. This will ensure that the organisation is aware
of the progress of the audit and of any problems as they arise. This will also
make it easier for the investigation team to gain access to the information of
the company;
- coordinate with the subjectmatter experts who provide external advice for any
areas of expertise that the team may be lacking in, and enable an efficient
investigation to take place, which will provide consistent and effective
investigations and reporting;
- meet the accountable manager at least once during the investigation
process, and preferably twice. The accountable manager should be briefed
on the investigation process and on the results of the investigation.
3.3 Follow-up of corrective actions
In order to draft the audit report, the POAT should hold a meeting with the applicant
to review any findings and observations.
The POAT, upon completion of the investigation, should hold a meeting with the
applicant to verbally present the report.
The POAT should present the findings, the corrective action plan, and the
preliminary arrangements for any followup that may be necessary.
The POATL should transmit the final report, together with the minutes of the final
meeting with the applicant, to the CAA of the applicant. The report should include
any recommendations for improvements and any significant findings, together with
appropriate conclusions and a corrective action plan. In particular, it should indicate
whether the POE is acceptable, or changes are required.
If the findings made during the investigation mean that a recommendation for
approval will not or cannot be issued, then the related findings should be provided to
the applicant in writing within 2 weeks’ time from the date of the visit.
3.4 Recommendation for the issuance, amendment, suspension or revocation of a
production organisation approval
The POATL should track the feedback obtained from the applicant, taking into
consideration the timelines specified in point 21.A.158(c). The POATL should
consider the means provided by AMC No 1 to 21.B.230. The recommendation
should be documented using CAA Form 56, Part 5.
3.5 Continued surveillance
Subsequent to an initial approval, the POATL should coordinate with the applicant
on a mutually agreed surveillance plan that is appropriate for the size, product
range and production rate of the company, taking into consideration the means
provided by AMC ELA No 1 to 21.B.235.
21.B.220(c) GM1 Procedures for investigation – Investigation preparation and planning
Following the acceptance of the application and before commencing an investigation, the CAA should,
for the preparation and planning of the investigation:
- identify the site locations needing investigation
- establish any necessary liaison arrangement with other competent authorities
- agree the size and composition of the POAT and any specialist tasks likely to be covered
and to select suitable team members
- liaise with the CAA of the other State where there is seen to be a need to visit a production
approval holder facility in that State for one of the following reasons:
1) where a manufacturer has subcontracted production to another organisation and
therefore a need arises to ensure that contract has the same meaning for all parties to the
contract, and the CAA of the State agrees
2) to inspect a product, part, appliance, or material under production for its own register.
21.B.220(c) GM2 Procedures for investigation – General
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