Collapse to view only § 21.138 - Quality manual.
- § 21.131 - Applicability.
- § 21.132 - Eligibility.
- § 21.133 - Application.
- § 21.135 - Organization.
- § 21.137 - Quality system.
- § 21.138 - Quality manual.
- § 21.139 - Location of or change to manufacturing facilities.
- § 21.140 - Inspections and tests.
- § 21.141 - Issuance.
- § 21.142 - Production limitation record.
- § 21.143 - Duration.
- § 21.144 - Transferability.
- § 21.145 - Privileges.
- § 21.146 - Responsibility of holder.
- § 21.147 - Amendment of production certificates.
- § 21.150 - Changes in quality system.
§ 21.131 - Applicability.
This subpart prescribes—
(a) Procedural requirements for issuing production certificates; and
(b) Rules governing holders of those certificates.
§ 21.132 - Eligibility.
Any person may apply for a production certificate if that person holds, for the product concerned—
(a) A current type certificate,
(b) A supplemental type certificate, or
(c) Rights to the benefits of that type certificate or supplemental type certificate under a licensing agreement.
§ 21.133 - Application.
Each applicant must apply for a production certificate in a form and manner prescribed by the FAA.
§ 21.135 - Organization.
(a) Each applicant for or holder of a production certificate must provide the FAA with a document—
(1) Describing how its organization will ensure compliance with the provisions of this subpart;
(2) Describing assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality to management and other organizational components; and
(3) Identifying an accountable manager.
(b) The accountable manager specified in paragraph (a) of this section must be responsible within the applicant's or production approval holder's organization for, and have authority over, all production operations conducted under this part. The accountable manager must confirm that the procedures described in the quality manual required by § 21.138 are in place and that the production approval holder satisfies the requirements of the applicable regulations of subchapter C, Aircraft. The accountable manager must serve as the primary contact with the FAA.
(c) Each applicant for or holder of a production certificate, except those based only on a supplemental type certificate or on the rights to the benefits of a supplemental type certificate under a licensing agreement, must meet the applicable requirements of part 5 of this chapter.
§ 21.137 - Quality system.
Each applicant for or holder of a production certificate must establish and describe in writing a quality system that ensures that each product and article conforms to its approved design and is in a condition for safe operation. This quality system must include:
(a) Design data control. Procedures for controlling design data and subsequent changes to ensure that only current, correct, and approved data is used.
(b) Document control. Procedures for controlling quality system documents and data and subsequent changes to ensure that only current, correct, and approved documents and data are used.
(c) Supplier control. Procedures that—
(1) Ensure that each supplier-provided product, article, or service conforms to the production approval holder's requirements; and
(2) Establish a supplier-reporting process for products, articles, or services that have been released from or provided by the supplier and subsequently found not to conform to the production approval holder's requirements.
(d) Manufacturing process control. Procedures for controlling manufacturing processes to ensure that each product and article conforms to its approved design.
(e) Inspecting and testing. Procedures for inspections and tests used to ensure that each product and article conforms to its approved design. These procedures must include the following, as applicable:
(1) A flight test of each aircraft produced unless that aircraft will be exported as an unassembled aircraft.
(2) A functional test of each aircraft engine and each propeller produced.
(f) Inspection, measuring, and test equipment control. Procedures to ensure calibration and control of all inspection, measuring, and test equipment used in determining conformity of each product and article to its approved design. Each calibration standard must be traceable to a standard acceptable to the FAA.
(g) Inspection and test status. Procedures for documenting the inspection and test status of products and articles supplied or manufactured to the approved design.
(h) Nonconforming product and article control. (1) Procedures to ensure that only products or articles that conform to their approved design are installed on a type-certificated product. These procedures must provide for the identification, documentation, evaluation, segregation, and disposition of nonconforming products and articles. Only authorized individuals may make disposition determinations.
(2) Procedures to ensure that discarded articles are rendered unusable.
(i) Corrective and preventive actions. Procedures for implementing corrective and preventive actions to eliminate the causes of an actual or potential nonconformity to the approved design or noncompliance with the approved quality system.
(j) Handling and storage. Procedures to prevent damage and deterioration of each product and article during handling, storage, preservation, and packaging.
(k) Control of quality records. Procedures for identifying, storing, protecting, retrieving, and retaining quality records. A production approval holder must retain these records for at least 5 years for the products and articles manufactured under the approval and at least 10 years for critical components identified under § 45.15(c) of this chapter.
(l) Internal audits. Procedures for planning, conducting, and documenting internal audits to ensure compliance with the approved quality system. The procedures must include reporting results of internal audits to the manager responsible for implementing corrective and preventive actions.
(m) In-service feedback. Procedures for receiving and processing feedback on in-service failures, malfunctions, and defects. These procedures must include a process for assisting the design approval holder to—
(1) Address any in-service problem involving design changes; and
(2) Determine if any changes to the Instructions for Continued Airworthiness are necessary.
(n) Quality escapes. Procedures for identifying, analyzing, and initiating appropriate corrective action for products or articles that have been released from the quality system and that do not conform to the applicable design data or quality system requirements.
(o) Issuing authorized release documents. Procedures for issuing authorized release documents for aircraft engines, propellers, and articles if the production approval holder intends to issue those documents. These procedures must provide for the selection, appointment, training, management, and removal of individuals authorized by the production approval holder to issue authorized release documents. Authorized release documents may be issued for new aircraft engines, propellers, and articles manufactured by the production approval holder; and for used aircraft engines, propellers, and articles when rebuilt, or altered, in accordance with § 43.3(j) of this chapter. When a production approval holder issues an authorized release document for the purpose of export, the production approval holder must comply with the procedures applicable to the export of new and used aircraft engines, propellers, and articles specified in § 21.331 and the responsibilities of exporters specified in § 21.335.
§ 21.138 - Quality manual.
Each applicant for or holder of a production certificate must provide a manual describing its quality system to the FAA for approval. The manual must be in the English language and retrievable in a form acceptable to the FAA.
§ 21.139 - Location of or change to manufacturing facilities.
(a) An applicant may obtain a production certificate for manufacturing facilities located outside of the United States if the FAA finds no undue burden in administering the applicable requirements of Title 49 U.S.C. and this subchapter.
(b) The production certificate holder must obtain FAA approval before making any changes to the location of any of its manufacturing facilities.
(c) The production certificate holder must immediately notify the FAA, in writing, of any change to the manufacturing facilities that may affect the inspection, conformity, or airworthiness of its product or article.
§ 21.140 - Inspections and tests.
Each applicant for or holder of a production certificate must allow the FAA to inspect its quality system, facilities, technical data, and any manufactured products or articles and witness any tests, including any inspections or tests at a supplier facility, necessary to determine compliance with this subchapter.
§ 21.141 - Issuance.
The FAA issues a production certificate after finding that the applicant complies with the requirements of this subpart.
§ 21.142 - Production limitation record.
The FAA issues a production limitation record as part of a production certificate. The record lists the type certificate number and model of every product that the production certificate holder is authorized to manufacture, and identifies every interface component that the production certificate holder is authorized to manufacture and install under this part.
§ 21.143 - Duration.
A production certificate is effective until surrendered, suspended, revoked, or the FAA otherwise establishes a termination date.
§ 21.144 - Transferability.
The holder of a production certificate may not transfer the production certificate.
§ 21.145 - Privileges.
(a) The holder of a production certificate may—
(1) Obtain an aircraft airworthiness certificate without further showing, except that the FAA may inspect the aircraft for conformity with the type design; or
(2) In the case of other products, obtain approval from the FAA for installation on type-certificated aircraft.
(b) Notwithstanding the provisions of § 147.3 of this chapter, the holder of a production certificate for a primary category aircraft, or for a normal, utility, or acrobatic category aircraft of a type design that is eligible for a special airworthiness certificate in the primary category under § 21.184(c), may—
(1) Conduct training for persons in the performance of a special inspection and preventive maintenance program approved as a part of the aircraft's type design under § 21.24(b), provided a person holding a mechanic certificate with appropriate airframe and powerplant ratings issued under part 65 of this chapter gives the training; and
(2) Issue a certificate of competency to persons successfully completing the approved training program, provided the certificate specifies the aircraft make and model to which the certificate applies.
§ 21.146 - Responsibility of holder.
The holder of a production certificate must—
(a) Amend the document required by § 21.135 as necessary to reflect changes in the organization and provide these amendments to the FAA.
(b) Maintain the quality system in compliance with the data and procedures approved for the production certificate;
(c) Ensure that each completed product or article for which a production certificate has been issued, including primary category aircraft assembled under a production certificate by another person from a kit provided by the holder of the production certificate, presented for airworthiness certification or approval conforms to its approved design and is in a condition for safe operation;
(d) Mark the product or article for which a certificate or approval has been issued. Marking must be in accordance with part 45 of this chapter, including any critical parts;
(e) Identify any portion of the product or article (e.g., sub-assemblies, component parts, or replacement articles) that leave the manufacturer's facility as FAA approved with the manufacturer's part number and name, trademark, symbol, or other FAA approved manufacturer's identification;
(f) Have access to type design data necessary to determine conformity and airworthiness for each product and article produced under the production certificate;
(g) Retain its production certificate and make it available to the FAA upon request; and
(h) Make available to the FAA information regarding all delegation of authority to suppliers.
§ 21.147 - Amendment of production certificates.
(a) A holder of a production certificate must apply for an amendment to a production certificate in a form and manner prescribed by the FAA.
(b) An applicant for an amendment to a production certificate to add a type certificate or model, or both, must comply with §§ 21.135(c), 21.137, 21.138, and 21.150.
(c) An applicant may apply to amend its production limitation record to allow the manufacture and installation of an interface component, provided—
(1) The applicant owns or has a license to use the design and installation data for the interface component and makes that data available to the FAA upon request;
(2) The applicant manufactures the interface component;
(3) The applicant's product conforms to its approved type design and the interface component conforms to its approved type design;
(4) The assembled product with the installed interface component is in a condition for safe operation; and
(5) The applicant complies with any other conditions and limitations the FAA considers necessary.
§ 21.150 - Changes in quality system.
After the issuance of a production certificate—
(a) Each change to the quality system is subject to review by the FAA; and
(b) The holder of a production certificate must immediately notify the FAA, in writing, of any change that may affect the inspection, conformity, or airworthiness of its product or article.