Commission Regulation (EU) No 748/2012Show full title

SUBPART G — PRODUCTION ORGANISATION APPROVAL U.K.

21.A.131 Scope U.K.

This Subpart establishes:

(a)

the procedure for the issuance of a production organisation approval for a production organisation showing conformity of products, parts and appliances with the applicable design data;

(b)

the rules governing the rights and obligations of the applicant for, and holders of, such approvals.

21.A.133 Eligibility U.K.

Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart. The applicant shall:

(a)

justify that, for a defined scope of work, an approval under this Subpart is appropriate for the purpose of showing conformity with a specific design; and

(b)

hold or have applied for an approval of that specific design; or

(c)

have 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 U.K.

Each application for a production organisation approval shall be made to the competent authority in a form and manner established by that authority, and shall include 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 U.K.

An organisation shall be entitled to have a production organisation approval issued by the competent authority when it has demonstrated compliance with the applicable requirements under this Subpart.

21.A.139 Quality System U.K.

(a) The production organisation shall demonstrate that it has established and is able to maintain a quality system. The quality system shall be documented. This quality system shall be such as to enable the organisation to ensure 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. U.K.

(b) The quality system shall contain: U.K.

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.

The control procedures need to include specific provisions for any critical parts.

2.

An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall 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 U.K.

(a) The organisation shall submit to the competent authority a production organisation exposition providing the following information: U.K.

1.

a statement signed by the accountable manager confirming that the production organisation exposition 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)[F1 ;]

13.

[F2 if flight tests are to be conducted, a flight test operations manual defining the organisation's policies and procedures in relation to flight test. The flight test operations manual shall include:

(i)

a description of the organisation's processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;

(ii)

crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;

(iii)

procedures for the carriage of persons other than crew members and for flight test training, when applicable;

(iv)

a policy for risk and safety management and associated methodologies;

(v)

procedures to identify the instruments and equipment to be carried;

(vi)

a list of documents that need to be produced for flight test.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2015/1039 of 30 June 2015 amending Regulation (EU) No 748/2012 as regards flight testing (Text with EEA relevance).

F2 Inserted by Commission Regulation (EU) 2015/1039 of 30 June 2015 amending Regulation (EU) No 748/2012 as regards flight testing (Text with EEA relevance).

(b) The production organisation exposition shall be amended as necessary to remain an up-to-date description of the organisation, and copies of any amendments shall be supplied to the competent authority. U.K.

21.A.145 Approval requirements U.K.

The production organisation shall demonstrate, on the basis of the information submitted in accordance with point 21.A.143 that:

(a)

with regard to general approval requirements, facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and general organisation are adequate to discharge obligations under point 21.A.165;

(b)

[F3 with regard to all necessary airworthiness and environmental 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, including any exemption granted against the CO ₂ production cut-off requirements, to determine conformity with the applicable design data;

2.

the production organisation has established a procedure to ensure that airworthiness and environmental data are correctly incorporated in its production data and,

3.

such data are kept up to date and made available to all personnel who need access to such data to perform their duties;

(c)

with regard to management and staff:

1.

a manager has been nominated by the production organisation, and is accountable to the competent authority. His or her responsibilities within the organisation shall 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 (Part 21), and are identified, together with the extent of their authority. Such person(s) shall act under the direct authority of the accountable manager referred to in point (1). The person(s) nominated shall be 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 and environmental data matters;]

(d)

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 shall include details of the scope of their authorisation;

3.

certifying staff are provided with evidence of the scope of their authorisation.

Textual Amendments

F3 Substituted by Commission Delegated Regulation (EU) 2019/897 of 12 March 2019 amending Regulation (EU) No 748/2012 as regards the inclusion of risk-based compliance verification in Annex I and the implementation of requirements for environmental protection (Text with EEA relevance).

21.A.147 Changes to the approved production organisation U.K.

[F3 (a) 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 environmental characteristics of the product, part or appliance, particularly changes to the quality system, shall be approved by the competent authority. An application for approval shall be submitted in writing to the competent authority and the organisation shall demonstrate to the competent authority, before implementing the change, that it complies with this Subpart.] U.K.

(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. U.K.

21.A.148 Changes of location U.K.

A change of the location of the manufacturing facilities of the approved production organisation shall be deemed of significance and therefore shall comply with point 21.A.147.

21.A.149 Transferability U.K.

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

21.A.151 Terms of approval U.K.

The terms of approval shall 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.

Those terms shall be issued as part of a production organisation approval.

21.A.153 Changes to the terms of approval U.K.

Each change to the terms of approval shall be approved by the competent authority. An application for a change to the terms of approval shall be made in a form and manner established by the competent authority. The applicant shall comply with the applicable requirements of this Subpart.

21.A.157 Investigations U.K.

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

21.A.158 Findings U.K.

(a) When objective evidence is found showing non-compliance of the holder of a production organisation approval with the applicable requirements of this Annex I (Part 21), the finding shall be classified as follows: U.K.

1.

a level one finding is any non-compliance with this Annex I (Part 21) which could lead to uncontrolled non-compliances with applicable design data and which could affect the safety of the aircraft;

2.

a level two finding is any non-compliance with this Annex I (Part 21) which is not classified as level one.

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under point (a). U.K.

(c) After receipt of notification of findings according to point 21.B.225, U.K.

1.

in case of a level one finding, the holder of the production organisation approval shall demonstrate 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 case of level two findings, the corrective action period granted by the competent authority shall be appropriate to the nature of the finding but in any case initially shall not be more than three months. In certain circumstances and subject to the nature of the finding the competent authority may extend the three months period subject to the provision of a satisfactory corrective action plan agreed by the competent authority;

3.

a level three finding shall not require immediate action by the holder of the production organisation approval.

(d) In case of level one or level two findings, the production organisation approval may be subject to a partial or full limitation, suspension or revocation under point 21.B.245. The holder of the production organisation approval shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the production organisation approval in a timely manner. U.K.

21.A.159 Duration and continued validity U.K.

(a) A production organisation approval shall be issued for an unlimited duration. It shall remain valid unless: U.K.

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.

(b) Upon surrender or revocation, the certificate shall be returned to the competent authority. U.K.

21.A.163 Privileges U.K.

Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation approval may:

(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).

21.A.165 Obligations of the holder U.K.

The holder of a production organisation approval shall:

(a)

ensure that the production organisation exposition furnished in accordance with point 21.A.143 and the documents to which it refers, are used as basic working documents within the organisation;

(b)

maintain the production organisation in conformity with the data and procedures approved for the production organisation approval;

(c)

1.

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; or

2.

[F4 determine that other products, parts or appliances are complete and conform to the approved design 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;

3.

additionally, in the case of engines, determine that the completed engine is in compliance with the applicable emissions requirements on the date of manufacture of the engine;

4.

determine that other products, parts or appliances conform to the applicable data before issuing an EASA Form 1 as a conformity certificate;]

(d)

record all details of work carried out;

(e)

establish and maintain 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. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information;

(f)

1.

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 to have possible 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;

2.

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). Such reports shall be 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;

3.

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;

(g)

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;

(h)

establish an archiving system incorporating requirements imposed on its partners, suppliers and subcontractors, ensuring conservation of the data used to justify conformity of the products, parts or appliances. Such data shall be held at the disposal of the competent authority and be retained in order to provide the information necessary to ensure the continuing airworthiness of the products, parts or appliances;

(i)

where, under its terms of approval, the holder issues a certificate of release to service, determine that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation, prior to issuing the certificate;

(j)

where applicable, under the privilege of point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

(k)

where applicable, under the privilege of point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing a permit to fly to an aircraft.

Textual Amendments

F4 Substituted by Commission Regulation (EU) No 7/2013 of 8 January 2013 amending Regulation (EU) No 748/2012 laying down Implementing Rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (Text with EEA relevance).