21A.122 Eligibility Any natural or legal person may apply to show conformity of individual products, parts or appliances under this Subpart, if; (a) it holds or has applied for an approval covering the design of that product, part or appliance, or (b) it has ensured satisfactory coordination between production and design, through an appropriate arrangement with the applicant for, or holder of, an approval of such a design. 21A.124 Application (a) Each application for an agreement to the showing of conformity of individual products, parts and appliances under this Subpart shall be made in a form and manner established by the Competent Authority. (b) Such application shall contain: 1. evidence which demonstrate, where applicable, that: (i) the issuance of a production organisation approval under Subpart G would be inappropriate; or (ii) the certification or approval of a product, part or appliance under this Subpart is needed pending the issuance of a production organisation approval under Subpart G. 2. An outline of the information required by 21A.125(b). 21A.125 Issue of a letter of agreement The applicant shall be entitled to have a letter of agreement issued by the Competent Authority agreeing to the showing of conformity of individual products, parts and appliances under this Subpart, after: (a) having established a production inspection system that ensures that each product, part or appliance conforms to the applicable design data and is in condition for safe operation. (b) providing a manual that contains: 1. a description of the production inspection system required under paragraph (a), 2. a description of the means for making the determinations of the production inspection system, 3. a description of the tests of 21A.127 and 21A.128, and the names of persons authorised for the purpose of 21A.130(a). (c) demonstrating that it is able to provide assistance in accordance with 21A.3 and 21A.129(d). L 243/28 EN Official Journal of the European Union 27.9.2003 21A.125B Findings (a) When objective evidence is found showing non-compliance of the holder of a letter of agreement with the applicable requirements of this Part, the finding shall be classified as follows: 1. A level one finding is any non-compliance with this Part 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 Part 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 paragraph (a). (c) After receipt of notification of findings according to 21B.143: 1. In case of a level one finding, the holder of the letter of agreement 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 six months. In certain circumstances and subject to the nature of the finding the Competent Authority may extend the six month period subject to 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 letter of agreement. (d) In case of level one or level two findings, the letter of agreement may be subject to a partial or full limitation, suspension and revocation under 21B.145. The holder of the letter of agreement shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the letter of agreement in a timely manner. 21A.125C Duration and continued validity (a) The letter of agreement shall be issued for a limited duration not exceeding one year. It shall remain valid unless: 1. The holder of the letter of agreement fails to demonstrate compliance with the applicable requirements of this Subpart; or 2. There is evidence that the manufacturer cannot maintain satisfactory control of the manufacture of products, parts, or appliances under the agreement; or 3. The manufacturer no longer meets the requirements of 21A.122; or 4. The letter of agreement has been surrendered, revoked under 21B.145, or has expired. (b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the Competent Authority. 21A.126 Production inspection system (a) The production inspection system required under 21A.125 shall provide a means for determining that: 1. Incoming materials, and bought or subcontracted parts, used in the finished product are as specified in the applicable design data. 2. Incoming materials, and bought or subcontracted parts, are properly identified. 3. Processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product are accomplished in accordance with specifications accepted by the Competent Authority. 4. Design changes, including material substitutions, have been approved under Subpart D or E and controlled before being incorporated in the finished product. (b) The production inspection system required by 21A.125(a), shall also be such as to ensure that: 1. Parts in process are inspected for conformity with the applicable design data at points in production where accurate determinations can be made. 2. Materials subject to damage and deterioration are suitably stored and adequately protected. 3. Current design drawings are readily available to manufacturing and inspection personnel, and used when necessary. 27.9.2003 EN Official Journal of the European Union L 243/29 4. Rejected materials and parts are segregated and identified in a manner that precludes installation in the finished product. 5. Materials and parts that are withheld because of departures from design data or specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts determined by this procedure to be serviceable shall be properly identified and reinspected if rework or repair is necessary. Materials and parts rejected by this procedure shall be marked and disposed of to ensure that they are not incorporated in the final product. 6. Records produced under the production inspection system are maintained, identified with the completed product or part where practicable, and retained by the manufacturer in order to provide the information necessary to ensure the continued airworthiness of the product. |