AMC-ELA No 2 to 21.B.220(c) Procedures for investigation – General

1. General

The CAA needs to investigate the applicant’s production organisation for its ability to produce products within the scope of work and that conform to the type in a repeatable way, so that they conform to the type design. It should establish procedures that include the following aspects:

2. Preparation and planning for an investigation

    2.1. The POA team leader (POATL) should initiate the investigation of a new applicant by arranging a meeting with the applicant, in which the applicant should provide a general presentation of its organisation and products, parts or appliances, and in which the POATL should describe the investigation process to the applicant.

    2.2. The POA team (POAT) should study the information gathered in the initiation phase, including information from other teams of the CAAr CAA on the functioning of the applicant’s organisation, especially when the production organisation and the design organisation form one consolidated team.

    2.3. The POAT should establish an investigation plan that:

      — takes account of the location of the POA applicant’s facilities;

      — defines the subject matter that will be covered by the team members;

      — identifies any areas of expertise that the team may be lacking in, and how to seek external advice;

      — includes a comprehensive plan for auditing a representative set of products while work is in progress or following its completion, and by direct product assessment, or assessment of product-related production records; and

      — includes liaison with the applicant in order to plan mutually suitable dates and times for visits, to determine the necessary size of the investigation team on both sides, and to agree on the investigation plan and the approximate timescales.

3. Investigation

    3.1. Evaluation of the documentation (production organisation exposition (POE), procedures, etc.)

    The POAT should:

      — assess the POE for compliance with point 21.A.143, e.g. by using AMC-ELA No 1 to 21.A.143;

      — evaluate (as applicable) the use of ISO 9001 or AS/EN 9100 in accordance with AMC-ELA No 1 to 21.B.220(b).

    3.2. Auditing

    The POAT should:

      — audit the product and its associated documentation for conformity with the 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 CAA Form 4 (refer to AMC-ELA 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 subject-matter 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 follow-up 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.