GM No 2 to 21.B.220(c) Procedures for investigation – General
1. Purpose of the Procedures
The purpose is to investigate the applicant production organisation for compliance with Part 21 Subpart G in relation to the requested terms of approval. When appropriate, this procedure should also be used to investigate significant changes or applications for variation of scope of approval.
The following procedure assumes that the application has been accepted and that an investigation team has been selected.
2. Initiation
The POA Team Leader initiates the procedure by:
2.1 arranging a meeting with the POAT members to review the information provided in accordance with 21.A.134 and to take account of any knowledge that the POAT members have regarding the production standards of the applicant
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2.3 arranging a meeting with the applicant in order to:
— enable the applicant to make a general presentation of its organisation and products, parts or appliances
— enable the POAT to describe the proposed investigation process
— enable the POAT to confirm to the applicant the identity of those managers nominated in accordance with Part 21 Subpart G who need to complete a CAA Form 4 (See CAA Form 4 for Production Organisations on CAA website) The applicant should provide a completed copy of CAA Form 4 for each of the key management staff identified by Part 21 Subpart G. The CAA Form 4 is a confidential document and will be treated as such.
3. Preparation The POAT:
3.1 studies the information gathered in the initiation phase
3.2 establishes an investigation plan which:
— takes account of the location of the POA applicants facility as identified per GM No 3 to 21.B.220(c)
— defines areas of coverage and work-sharing between POAT members taking account of their individual expertise
— defines areas where more detailed investigation is considered necessary
— establishes the need for external advice to POAT members where expertise ay be lacking within the team
— includes completion of a comprehensive plan for the investigation in order to present it to the applicant
— recognises the need to:
— review the documentation and procedures
— verify compliance and implementation
— audit a sample of products, parts, and appliance
3.3 co-ordinates with the appropriate Part 21 Section A Subpart J design organisation approval Teams sufficiently for both parties to have confidence in the applicants co- ordination links with the holder of the approval of the design (as required by 21.A.133)
3.4 establishes liaison with the applicant to plan mutually suitable dates and times for visits at each location needing investigation, and also to agree the investigation plan and approximate time scales with the applicant
4. Investigation The POAT:
4.1 makes a check of the POE for compliance with Part 21 Subpart G
4.2 audits the organisation, its organisational structure, and its procedures for compliance with Part 21 Subpart G, using CAA Form 56 as a guide during the investigation, and as a checklist at the end of it
4.3. generates compliance checklists for investigations of working processes and procedures on site as required
4.4 accepts or rejects each CAA Form 4 completed by the key nominated personnel in accordance with 21.A.145(c)(2)
4.5 checks that the production organisation exposition (POE) standard reflects the organisation, its procedures, practices and 21.A.143. Having checked and agreed a POE issue or subsequent amendment, the CAA should have a clear procedure to indicate its acceptance or rejection
4.6 makes sample audits at working level to verify that:-
(i) work is performed in accordance with the system described in the POE
(ii) products, parts, appliances or material produced by the organisation are in conformity with the applicable design data (see GM 21.B.235(b)(4)).
(iii) facilities, working conditions, equipment and tools are in accordance with the POE and appropriate for the work being performed
(iv) competence and numbers of personnel is appropriate for the work being performed
(v) co-ordination between production and design is satisfactory
4.7 at an advanced stage of the investigation, conducts an interim team review of audit results and matters arising, in order to determine any additional areas requiring investigation.
Each investigation team should be accompanied during the process by company representatives who are knowledgeable of the applicants organisation and procedures. This will ensure that the organisation is aware of audit progress and problems as they arise. Access to information will also be facilitated.
The POATL should co-ordinate the work of POAT members for an efficient investigation process, which will provide a consistent and effective investigation and reporting standards.
5. Conclusions
5.1 The POATL holds a team meeting to review findings and observations so as to produce a final agreed report of findings.
5.2 The POATL, on completion of the investigation, holds a meeting to verbally presents the report to the applicant.
The POATL should be the chairman of this meeting, but individual team members may present their own findings and observations.
5.3 The meeting should agree the findings, corrective action time scales, and preliminary arrangements for any follow up that may be necessary.
5.4 Some items may as a result of this meeting be withdrawn by the POATL but if the investigation has been correctly performed, at this stage there should be no disagreement over the facts presented.
5.5 Inevitably there will be occasions when the POAT member carrying out the audit may find situations in the applicant or POA holder where it is unsure about compliance. In this case, the organisation is informed about possible non-compliance at the time and advised that the situation will be reviewed within the CAA before a decision is made. The organisation should be informed of the decision without undue delay. Only if the decision results in a confirmation of non-compliance this is recorded in Part 4 of the CAA Form 56.
5.6 The POATL will transmit the final signed report on the CAA Form 56 together with notes of the final meeting with the applicant to the CAA where the applicant is located. The report will include recommendations and significant findings, together with appropriate conclusions and corrective actions. In particular, it should indicate if the POE is acceptable, or changes are required.
5.7 Completion of the CAA Form 56 includes the need to record in Part 4 comments, criticisms, etc., and this must reflect any problems found during the visit and must be the same as the comments, criticisms made to the organisation during the debrief. Under no circumstances should additional comments, criticisms, etc., be included in Part 4 of the report unless the applicant or POA holder has previously been made aware of such comments.
Many applicants may need to take corrective action and amend the proposed exposition before the CAA is able to conclude its investigation. Such corrective actions should be summarised in Part 4 of the the CAA Form 56 and a copy always given to the applicant, so that there is a common understanding of the actions necessary before approval can be granted.
The intention of the CAA Form 56 Part 4 is to provide a summary report of findings and outstanding items during initial investigation and major changes. The CAA will need to operate a supporting audit system to manage corrective action monitoring, closure etc. While the CAA Form 56 Part 4 format may be used for monitoring purposes, it is not adequate on its own to manage such system.
5.8 If the findings made during the investigation mean that approval recommendation will not or cannot be issued, then it is essential that such findings are confirmed in writing to the organisations within two weeks of the visit. The reason for confirmation in writing is that many organisations take a considerable time to establish compliance. As a result, it is too easy to establish a position of confusion where the organisation claims it was not aware of the findings that prevented issue of an approval.
6. Management Involvement
The accountable manager will be seen at least once during the investigation process and preferably twice, because he or she is ultimately responsible for ensuring compliance with the requirements for initial grant and subsequent maintenance of the production organisation approval. Twice is the preferred number of visits to the accountable manager, with one being conducted at the beginning of the audit to explain the investigation process and the second, at the end, to debrief on the results of the investigation.