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CHAPTER 2.— PRODUCTION APPROVALS/CERTIFICATION
2.1 Production certificate/approvals
2.1.1 General
2.1.1.1 An applicant (manufacturer) may be eligible for a production certificate or production organization approval from the CAA, subject to determination by the CAA based on its examination of supporting data and inspection of the production facilities, processes and organization, that the applicant has complied with the relevant requirements.
2.1.1.2 An applicant for a production certificate/approval should hold, for the product or part concerned:
a) a current Type Certificate or other approved design (or, in the case of a production organization approval, should have applied for a Type Certificate/Design Approval); or
b) a Supplemental Type Certificate (or, in the case of a production organization approval, should have applied for a Supplemental Type Certificate/Design Approval); or
c) the right of access to the applicable design data of a Type Certificate/Supplemental Type Certificate for production purposes under an agreement.
2.1.2 Quality system
2.1.2.1 The applicant should show that it has established and can maintain a quality system for any product or part for which he requests a production certificate/approval, so that each article will meet the design provisions of the pertinent design approval. The quality system should include the following:
a) an organization chart indicating the chain of authority, including any delegations of that authority, and documentation of the assigned responsibility and authority of the management representative who ensures implementation and compliance with the quality system, and the interrelation of key personnel affecting the quality system;
b) procedures for the control of design data. The procedures shall ensure that documents and data are reviewed for adequacy, by authorized personnel, prior to design data changes;
c) procedures to control documents and data that form the quality system and any subsequent changes. The procedures shall ensure that documents and data are reviewed for adequacy, by authorized personnel, prior to inclusion in the quality system;
d) procedures to ensure conformance of supplier furnished products, parts, materials, and services to the approved design prior to release for installation in the product or part, including, but not limited to:
1) methods for initial supplier evaluation and selection;
2) methods for controlling suppliers at all tiers, including procedures for corrective actions;
3) methods for the monitoring/surveillance of suppliers, based on techniques such as risk assessment; qualification and auditing of supplier’s quality system; monitoring continued capability throughout the supply chain; first article inspection; incoming inspections and tests of supplied parts; identification of incoming documentation and data relevant to the showing of conformity; and a supplier rating system, which gives visibility of the performance, capability and reliability of the suppliers;
4) an arrangement which defines all necessary elements and procedures between the manufacturer and the supplier, including items such as design data and configuration control, incoming inspections, identification and traceability, non-conformities, sub-tier suppliers, access for the CAA, and significant changes to the quality system; and
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