EASA Part-21 Subpart G Product Audit

Title Page

Document No.
Audit Title
Client / Site
Conducted on
Prepared by
Location
Personnel

21.A.133, 21.A.134 & 21.A.135

21.A.133 Eligibility

21.A.133(a). Has the applicant justified that, for a defined scope of work, an approval under this Subpart is appropriate for the purpose of showing conformity with a specfic design?
21.A.133(b) & (c). Does the organisation hold or have applied for an approval of that specific design; or has ensured, through an appropriate arrangement with the applicant for, or holder of, an approval of that specific design, satisfactory coordination between production and design?

21.A.134 Application

21.A.134. Has the organisation made an application to the competent authority in a form and manner established by that authority, and has included an outline of the information required by point 21.A.143 and the terms of approval requested to be issued under point 21.A.151?

21.A.135 Issue of production organisation approval

21.A.135. Has the organisation demonstrated compliance with the applicable requirements under this Subpart?

21.A.139 Quality System

21.A.139(a). Has the organisation demonstrated that it has established and is able to maintain a quality system, and the quality system has been documented, and the quality system ensures that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, and thus exercise the privileges set forth in point 21.A.163?
21.A.139(b). Does the quality system contain:
1. as applicable within the scope of approval, control procedures for:
(i) document issue, approval, or change;
(ii) vendor and subcontractor assessment audit and control;
(iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;
(iv) identification and traceability;
(v) manufacturing processes;
(vi) inspection and testing, including production flight tests;
(vii) calibration of tools, jigs, and test equipment;
(viii) non conforming item control;
(ix) airworthiness coordination with the applicant for, or holder of, the design approval;
(x) records completion and retention;
(xi) personnel competence and qualification;
(xii) issue of airworthiness release documents;
(xiii) handling, storage and packing;
(xiv) internal quality audits and resulting corrective actions;
(xv) work within the terms of approval performed at any location other than the approved facilities;
(xvi) work carried out after completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;
(xvii) issue of permit to fly and approval of associated flight conditions.
Do the control procedures include provisions for any critical parts?
21.A.139(2). Does the independent quality assurance function monitor compliance with, and adequacy of, the documented procedures of the quality system, and does this monitoring include a feedback system to the person or group of persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as necessary, corrective action?

21.A.143 Exposition

21.A.143(a). Has the organisation submitted to the competent authority a POE providing the following information:
1. a statement signed by the manager confirming that the POE and any associated manuals which define the approved organisation's compliance with this Subpart will be complied with at all times;
2. the title(s) and names of managers accepted by the competent authority in accordance with point 21.A.145(c)(2);
3. the duties and responsibilities of the manager(s) as required by point 21.A.145(c)(2) including matters on which they may deal directly with the competent authority on behalf of the organisation;
4. an organisational chart showing associated chains of responsibility of the managers as required by point 21.A.145(c)(1) and (2);
5. a list of certifying staff as referred to in point 21.A.145(d);
6. a general description of man-power resources;
7. a general description of the facilities located at each address specified in the production organisation's certificate of approval;
8. a general description of the production organisation's scope of work relevant to the terms of approval;
9. the procedure for the notification of organisational changes to the competent authority;
10. the amendment procedure for the production organisation exposition;
11. a description of the quality system and the procedures as required by point 21.A.139(b)(1);
12. a list of those outside parties referred to in point 21.A.139(a).
.
21.A.143(b). Is the production organisation exposition amended as necessary to remain a up-to-date description of the organisation, and copies of any amendments supplied to the competent authority?

21.A.145 Approval requirements

21.A.145(a). Has the organisation demonstated, on a basis of the information submitted in accordance with point 21.A.143 that with regards to general approval requirements, facilities, working conditions, equipment and tools, processes and materials, number and competence of staff, and general organisation are adequate to be able to discharge its obligations under point 21.A.165?
21.A.145(b). Has the organisation demonstrated, on the basis of the information submitted in accordance with point 21.A.143 that with regards to all necessary airworthiness, noise, fuel venting and exhaust data: 1. the production organisation is in receipt of such data from the Agency, and from the holder of, or applicant for, the type certificate, restricted type- certificate or design approval, to determine conformity with the applicable design data; 2. the production organisation has established a procedure to ensure that airworthiness, noise, fuel venting and exhaust emissions data are correctly incorporated in its production data; 3. such data arte kept up to date and made available to all personnel who need access to such data to perform their duties?
21.A.145(c). Has the organisation demonstrated, on the basis of the information submitted in accordance with point 21.A.143 that with regard to management and staff; 1. a manager has been nominated by the production organisation, and is accountable to the competent authority, and his or her responsibilities within the organisation consist of ensuring that all production is performed to the required standards and that the production organisation is continuously in compliance with the data and procedures identified in the exposition referred to in point 21.A.143; 2. a person or group of persons have been nominated by the production organisation to ensure that the organisation is in compliance with the requirements of this Annex I (Part 21), and are identified, together with the extent of their authority, and also such person(s) act under the direct authority of the accountable manager referred to in point (1), and the persons nominated are able to show the appropriate knowledge, background and experience to discharge their responsibilities; 3. staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the production organisation in respect of airworthiness, noise, fuel venting and emission data matters?
21.A.145(d). Has the organisation demonstrated, on the basis of the information submitted in accordance with point 21.A.143 that with regard to certifying staff, authorised by the production organisation to sign the documents issued under point 21.A.163 under the scope or terms of approval; 1. the knowledge, background (including other functions in the organisation), and experience of the certifying staff are appropriate to discharge their allocated responsibilities; 2. the production organisation maintains a record of all certifying staff which includes details of the scope of their authorisation; 3. certifying staff are provided with evidence of the scope of their authorisation?

21.A.147 Changes to the approved production organisation

21.A.147(a). Has, after the issue of a production organisation approval, each change to the approved production organisation that is significant to the showing of conformity or to the airworthiness and characteristics of noise, fuel venting and exhaust emissions of the product, part or appliance, particularly changes to the quality system, been approved by the competent authority, and also has the application for approval been submitted in writing to the competent authority and the organisation can demonstrate to the competent authority before implementation of the change that it will continue to comply with this Subpart?
21.A.147(b). The competent authority shall establish the conditions under which a production organisation approved under this Subpart may operate during such changes unless the competent authority determines that the approval should be suspended.

21.A.148, 21.A.149, 21.A.151, 21.A.153 & 21.A.157

21.A.148 Changes of location

21.A.148. Has any change of location of the manufacturing facilities of the approved production organisation been deemed as significant and point 21.A.147 been complied with?

21.A.149 Transferability

21.A.149. Except as a result of a change in ownership, which is deemed significant for the purpose of point 21.A.147, a production organisation is not transferable.

21.A.151 Terms of approval

21.A.151. Do the terms of approval identify the scope of work, the products or the categories of parts and appliances, or both, for which the holder is entitled to exercise the privileges under point 21.A.163?

21.A.153 Changes to the terms of approval

21.A.153. Has each change to the terms of approval been approved by the competent authority, and has the application for change to the terms of approval been made in a form and manner established by the competent authority?

21.A.157 Investigation

21.A.157. Has the production organisation made arrangements that allow the competent authority to make any investigations, including investigations of partners and subcontractors, that are necessary to determine compliance and continued compliance with the applicable requirements of this Subpart?

21.A.158 Findings

21.A.158(a). When objective evidence is found showing non-compliance of the production organisation approval with the applicable requirements of this Annex I (Part 21), are the findings classified as follows;
1. a level one finding is any noncompliance with this Annex I (Part 21) which could lead to uncontrolled noncompliance's with applicable design data and which could affect the safety of the aircraft;
2. a level two finding is any noncompliance with this Annex I (Part 21) which is not classified as level one.
21.A.158(b). Are items identified, by objective evidence, to contain potential problems that could lead to a noncompliance under point (a), classified as a level three finding?
21.A.158(c). After receipt of notification of findings according to point 21.B.225,
1. in the case of a level one finding, has the production organisation demonstrated corrective action to the satisfaction of the competent authority within a period of no more than 21 working days after written confirmation of the finding?
2. in the case of a level two finding, has the production organisation complied with the corrective action period granted by the competent authority which initially shall not be more than three months?
3. a level three finding shall not require immediate action by the holder of the production organisation approval.
21.A.158(d). In the case of a level one or level two finding has been issued to the production organisation, and it is subject to a partial or full limitation, suspension or revocation under point 21.B.245, has the organisation provided a confirmation of receipt of the notice of limitation, suspension or revocation of the organisation in a timely manner?

21.A.159 Duration and continued validity, 21.A.163 Privileges

21.A.159 Duration and continued validity

21.A.159(a). A production organisation approval shall be issued for an unlimited duration. It shall remain valid unless:
1. the production organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or
2. the competent authority is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with point 21.A.157; or
3. there is evidence that the production organisation cannot maintain satisfactory control of the manufacture of products, parts or appliances under the approval; or
4. the production organisation no longer meets the requirements of point 21.A.133; or
5. the certificate has been surrendered or revoked under point 21.B.245.
21.A.159(b). Upon surrender or revocation, the certificate shall be returned to the competent authority.
Notes

21.A.163 Privileges

21.A.163. Pursuant to the terms of approval issued under point 21.A.135, does the holder of a production organisation approval:
(a) perform production activities under this Annex I (Part 21);
(b) in the case of complete aircraft and upon presentation of a statement of conformity (EASA Form 52) under point 21.A.174, obtain an aircraft certificate of airworthiness and a noise certificate without further showing;
(c) in the case of other products, parts or appliances, issue authorised release certificates (EASA Form 1) without further showing;
(d) maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form 53) in respect of that maintenance;
(e) under procedures agreed with its competent authority for production, for an aircraft it has produced and when the production organisation itself is controlling under its POA the configuration of the aircraft and is attesting conformity with the design conditions approved for the flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight conditions in accordance with point 21.A.710(b).
Notes

21.A.165 Obligations of the holder

21.A.165(a). Does the production organisation ensure that the POE furnished in accordance with point 21.A.143 and the documents to which it refers, are used as basic working documents within the organisation?
21.A.165(b). Does the production organisation maintain the production organisation in conformity with the data and procedures approved for the production organisation approval?
21.A.165(c)1. Does the production organisation determine that each completed aircraft conforms to the type design and is in condition for safe operation prior to submitting statements of conformity to the competent authority?
21.A.165(c)2. Does the production organisation determine that other products, parts, or appliances are complete and conform to the approved data and are in a condition for safe operation before issuing an EASA Form 1 to certify conformity to approved design data and condition for safe operation, and additionally in case of engines, determine according to data provided by the engine type-certificate holder that each completed engine is in compliance with the applicable emissions requirements as defined in point 21.A.18(b), current at the date of manufacture of the engine, to certify emissions compliance?
21.A.165(c)3. Does the production organisation determine that other products, parts or appliances conform to the applicable data before issuing EASA Form 1 as a conformity certificate?
21.A.165(d). Does the production organisation record all details of work carried out?
21.A.165(e). Has the production organisation established and maintained an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences, and this system includes evaluation of relevant information relating to occurrences and the promulgation of related information?
21.A.165(f)1. Does the production organisation report to the holder of the type-certificate or design approval, all cases where products, parts or appliances have been released by the production organisation and subsequently identified as having deviations from the applicable design data, and investigate with the holder of the type-certificate or design approval in order to identify those deviations which could lead to an unsafe condition?
21.A.165(f)2. Does the organisation report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to point (1), and such reports are made in a form and manner established by the Agency under point 21.A.3A(b)(2) or accepted by the competent authority of the Member State?
21.A.165(f)(3). Does the production organisation where the holder of the production organisation approval is acting as a supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data?
21.A.165(g). Does the production organisation provide assistance to the holder of the type-certificate or design approval in dealing with any continuing airworthiness actions that are related to the products parts or appliances that have been produced?
21.A.165(h). Has the production organisation established an archiving system incorporating requirements imposed on its partners, suppliers and subcontractors, which ensure conservation of the data used to justify conformity of the products, parts or appliances, and such data is to be held at the disposal of the competent authority and be retained in order to provide the information necessary to ensure continuing airworthiness of the products, parts or appliances?
21.A.165(i). Has the production organisation where, under its terms of approval, the holder issues a certificate of release to service, determined that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation, prior to issuing the certificate?
21.A,165(j). Has the production organisation where applicable, under the privilege of point 21.A.163(e), determined the condition under which a permit to fly can be issued?
21.A.165(k). Has the production organisation where applicable, under the privilege of point 21.A.163(e), established compliance with points 21.A.711(c) and (e) before issuing a permit to fly to an aircraft?

21.A.3A Failures, malfunctions and defects

21.A.3A(a). Does the production organisation have a system for collecting, investigating and analysing reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation, and has information about this system been made available to all known operators of the product, part or appliance and, on request, to any person authorised under other associated implementing Regulation?
21.A.3A(b)1. Has the production organisation reported to the Agency any failure, malfunction, defect or other occurrence of which it is aware related to a product, part, or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation, and which has resulted in or may result in an unsafe condition?
21.A.3A(b)2. Has the production organisation made these reports in a form and manner established by the Agency, as soon as practicable and in any case dispatched not later than 72 hours after the identification of the possible unsafe condition, unless exceptional circumstances prevent this?
21.A.3A(c)1. Has the production organisation investigated the reason for the deficiency and reported to the Agency the results of its investigation and any action it is taking or proposes to take to correct that deficiency?
21.A.3A(c)2. Has the production organisation provided to the Agency any data the Agency requires?

Procedures reviewed

Procedures reviewed

Product(s) reviewed

Part number(s)
Description(s)
Work order(s)

Additional notes

Notes

EASA Part-21 Subpart G Product Audit

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21.A.133 Eligibility

21.A.134 Application

21.A.135 Issue of production organisation approval

21.A.139 Quality System

21.A.143 Exposition

21.A.145 Approval requirements

21.A.147 Changes to the approved production organisation

21.A.148 Changes of location

21.A.149 Transferability

21.A.151 Terms of approval

21.A.153 Changes to the terms of approval

21.A.157 Investigation

21.A.158 Findings

21.A.159 Duration and continued validity

21.A.163 Privileges

21.A.165 Obligations of the holder

21.A.3A Failures, malfunctions and defects

Procedures reviewed

Product(s) reviewed

Additional notes

Related checklists

EASA Part-21 Subpart G Product Audit

Free EASA Part-21 Subpart G Product Audit Checklist

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21.A.133 Eligibility

21.A.134 Application

21.A.135 Issue of production organisation approval

21.A.139 Quality System

21.A.143 Exposition

21.A.145 Approval requirements

21.A.147 Changes to the approved production organisation

21.A.148 Changes of location

21.A.149 Transferability

21.A.151 Terms of approval

21.A.153 Changes to the terms of approval

21.A.157 Investigation

21.A.158 Findings

21.A.159 Duration and continued validity

21.A.163 Privileges

21.A.165 Obligations of the holder

21.A.3A Failures, malfunctions and defects

Procedures reviewed

Product(s) reviewed

Additional notes

Related checklists