Revised 14 CFR 21

The Federal Aviation Administration (FAA) recently published significant revisions to 14 CFR 21, the regulations that govern the design, production, and continued airworthiness of U.S. civil aircraft. These changes become effective April 14, 2010.

The FAA is amending its certification procedures and identification requirements for aeronautical products and articles. The amendments will update and standardize those requirements for Production Approval Holders (PAHs), revise export airworthiness approval requirements to facilitate global manufacturing, move all part marking requirements from part 21 to part 45, and amend the identification requirements for products and articles.

The changes also standardize the quality system requirements for PAHs so that all PAHs comply with the same set of quality system requirements, regardless of the product or article produced.

Quality System Requirement

This final rule prescribes a PAH’s requirements for controlling the quality of the product or article it manufactures. The FAA has imposed additional PAH quality system requirements designed to achieve overall improvement of the PAH’s quality system.

The quality system consists of fourteen specific quality system requirements. As described below, it is important to note that those fourteen quality system requirements are scalable, depending on the size and complexity of the PAH and of the product or article produced. Some of these requirements were already mandatory prior to this rulemaking and have been retained. The remaining requirements also have already been incorporated by industry for years and used voluntarily as ”best practices.”

Prior to this rulemaking, holders of different production approvals complied with, and were audited to, differing sets of requirements. For instance, if a manufacturer produced a Parts Manufacturing Approval (PMA) part and a Technical Standard Order (TSO) article, the manufacturer was subject to different quality and marking standards for each part it produced.

Today’s requirements are now applicable to Production Certificate (PC) and PMA holders and TSO authorizations alike. This final rule relieves PAHs from having to maintain, and the FAA from having to oversee, multiple PAH systems and procedures. Hence, this final rule will increase regulatory efficiency.

Two of the sections in 14 CFR 21 relating to the quality system are included below.

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-furnished product or article conforms to its approved design; and
(2) Require each supplier to report to the production approval holder if a product or article has been released from that supplier and subsequently found not to conform to the applicable design data.

(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. Procedures to ensure that:
(1) 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) 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.

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.

To see the full FAA Final Rule for 14 CFR 21, view this PDF document. http://edocket.access.gpo.gov/2009/pdf/E9-24821.pdf