(File 3 of 5)
Presenter: Barbara Capron, Production and Airworthiness Division, AIR-200
Narration text: This segment covers major changes to subparts F, G, K, and O as they relate to production and airworthiness requirements. What I will present are those areas of the rule which are common across subparts G, K, and O. In addition, I will identify the common items present in subpart F.
Narration text: The common requirements fall into 10 main areas
- Quality system
- Quality system documentation
- Location of manufacturing facilities
- Inspections and tests
- Responsibility of the holder, and
- Changes to the quality system
Narration text: Organization - The rule requires that each applicant or current PAH provide the FAA with a document describing how the applicant’s organization will ensure compliance with the provisions of the applicable subpart. At a minimum, the document must describe assigned responsibilities and delegated authority, and the functional relationship of those responsible for quality to management and other organizational components. The FAA understands the need for various business models and organizational structures. The intent of this requirement is to obtain a commitment from the top management to 1) establish a quality system that complies with the applicable subchapter and ensures that each product and article conforms to its approved design and is in a condition for safe operation and 2) continually improve that quality system.
Narration text: Quality System - This is the most complex change to the rule. Previously, the quality system requirements for PMAs were different from quality system requirements for PCs and TSO authorizations. The new rule standardizes the quality system requirements for all PAHs. Section 21.137, .307, and .607 requires that each applicant or current PAH establish and describe in writing a quality system which addresses as a minimum the 14 elements as defined in § 21.137(a) through (n).
It is imperative that the ASI understand that these 14 basic elements are scalable. By this we mean that the scope and complexity of the quality system should be directly related to the size, complexity and criticality of the product or article being manufactured by the PAH.
We have produced AC 21-43 “Production Under 14 CFR Part 21 Subparts F, G, K, and O” to provide guidance to the industry. This AC discusses in greater detail the expectations of the FAA from the PAHs in relation to meeting their regulatory requirements.
Location of or change to manufacturing facilities
Narration text: Quality Manual - Sections 21.138, 21.308, and 21.608 require that each applicant or current PAH 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.
(a) If the quality manual is stored digitally through a computer-based medium, it should be easily available to PAH and FAA personnel who need to use the documentation for performing their duties.
(b) Applicants for a production approval or current PAHs are reminded that the manual must, as a minimum, address each of the requirements listed under the quality system above.
Location of or change to manufacturing facilities - The final rule standardizes the language of former §§ 21.137, 21.303(g), and 21.601(c) pertaining to the location of manufacturing facilities for a holder of a PC, PMA, and TSO authorization. The rule adds a requirement that PAHs, including those manufacturing under TC only, obtain prior approval from us for changes to the location of any of their manufacturing facilities. This rule adds a requirement that PAHs immediately notify the FAA, in writing, of any change to their manufacturing facilities that may affect the inspection, conformity, or airworthiness of its products or articles.
The intent of this rule is to standardize the requirements governing changes in manufacturing facilities for all PAHs. Manufacturing facilities are those that are listed on the PC and operate under the PAH’s quality system. A change in a manufacturing facility may be addressed by an approval process instead of a certificate termination and re-application process previously required by §§ 21.159 and 21.143. This approval process enhances safety by ensuring that we have an appropriate level of oversight to changes for all PAHs manufacturing facilities.
This requirement does not apply to suppliers. With respect to suppliers, the FAA approves the supplier control procedures a PAH uses in selecting and controlling its suppliers. A change in the supply base would not require our approval unless we would incur an undue burden in performing surveillance at the supplier facility (i.e., international suppliers).
Inspections and tests
Narration text: Inspections and tests - Sections 21.140, 21.310, and 21.610 require that each applicant or current PAH 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 the applicable subchapter.
Issuance - Sections 21.141, 21.311, and 21.611 require the FAA to issue a production approval after finding that the applicant complies with their applicable requirements. The rule change also removes the implication that a production certificate is an entitlement and to clarify that the issuance of a production certificate is contingent on the applicant meeting other requirements
Duration - Sections 21.143, 21.313, and 21.613 prescribe that a production approval is effective until surrendered, suspended, revoked, or terminated by the FAA. Minor differences exist between the duration of a PC and that of a PMA or TSO authorization. Applicants receiving a production approval should refer to the applicable section for information on the duration of a particular production approval. Section 21.613 also requires that, if a TSO is revised or canceled, the holder of an affected FAA letter of acceptance of a statement of conformance, TSO authorization, or letter of TSO design approval may continue to manufacture articles that meet the original TSO without obtaining a new acceptance, authorization or approval, but must comply with the requirements of §§ 21.3, 21.137(m), 21.610, 21.613 through 21.619, and 45.15(b).
Transferability - Sections 21.144, 21.314, and 21.614 states that the holder of a production approval may not transfer the production approval or letter of TSO design approval.
While there are no provisions for transferring a production approval, the FAA recognizes that companies change hands frequently. In many cases, design data, quality systems, and manufacturing processes are all transferred as part of the sale. Therefore, the FAA does support efforts to expedite and establish a new production approval.
Responsibility of the holder
Narration text: Responsibility of the holder - While this area of the rule has slight differences between G, K, & O they are substantially the same. It is again highly recommended that you read the appropriate section for the type of production approval you are working with.
The holder of a production approval has the responsibility for controlling the manufacture of completed products and articles in conformity with the FAA-approved type design data and quality system requirements. This responsibility cannot be delegated to or relieved by the use of approved suppliers, risk and/or revenue sharing partners, co-producers, etc
This section of the rule adds two new requirements. The first, under paragraph (d), requires PAHs to mark the product or article, including any critical parts, for which they have been granted a certificate or approval, in accordance with Part 45.
The second, under paragraph (e), requires PAH to identify any parts of that product or article (e.g., sub-assemblies or component parts) 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.
These two requirements also apply to Subpart F, Production under type certificates, §21.123.
Responsibility of the holder (cont.)
Narration text: The other responsibilities are:
Paragraph (a) of each section requires the PAH to document changes in its organization. This is accomplished by amending the document required by §§ 21.135, 21.305, and 21.605 respectively, detailing how the organization will comply with the provisions of this subpart. The PAH must provide these amendments to the FAA. This requirement ensures that we remain informed of changes in a PAH’s organization as well as its continued compliance with this part.
Paragraph (b) of each section requires the PAH to maintain its quality system in compliance with the data and procedures approved for its production approval.
Paragraph (c) of each section requires a PAH to ensure that each product or article conforms to its approved design and is in a condition for safe operation.
Paragraph (f) of each section requires PAHs to have access to type design data necessary to determine conformity and airworthiness for each product and article produced under its production approval. TSO authorization holders have the additional requirement to retain this data until it no longer manufactures the article. At that time, copies of the data must be sent to the FAA.
Paragraph (g) of each section requires a PAH to retain the documents granting the production approval and make them available to the FAA upon request.
Paragraph (h) of each section requires a PAH to make available to the FAA information regarding all delegation of authority to suppliers. These delegations include, for example, delegations for the purpose of performing major inspections, delegations related to direct ship authorization, and those delegations related to the disposition of nonconforming material.
Changes to the quality system
Narration text: Changes to the quality system - Previously § 21.147, required all PC holders, to notify the FAA of any change that may affect the inspection, conformity, or airworthiness of its product. This rule retains that requirement and now, in addition to products, extends it to “articles”.
Sections 21.150, 21.320, and 21.620 establishes that each change to the quality system is subject to review by the FAA; and that the PAH must immediately notify the FAA, in writing, of any change that may affect the inspection, conformity, or airworthiness of its product or article. PAHs who wish to initiate changes to the quality system should submit the proposed changes to the office with certificate management responsibilities.
Summary - While I have covered most of the changes to Subpart F, G, K and O, as the relate to production and production approvals, there are still many more changes. As has been stated before, and will probably be stated again, it is imperative that each of you read and understand the rule change, the preamble to the rule and the policy and guidance being produced as a result of this change.
Nathan Leonard, Part 21 Course Manager, FAA Academy and Barbara Capron, Production and Airworthiness Division, AIR-200