CHAPTER 1. GENERAL INFORMATION.
1.1 Purpose of This Advisory Circular.
1.1.1 This advisory circular (AC) provides information for PAHs pursuant to 14 CFR part 21, Certification Procedures for Products and Articles. This AC addresses the manufacturing and production requirements pursuant to part 21, subpart F, Production Under Type Certificate; subpart G, Production Certificates; subpart K, Parts Manufacturer Approvals; and subpart O, Technical Standard Order Approvals.
1.1.2 This AC provides information on how an applicant for a production approval should develop and maintain its quality systems (for this AC, an applicant for a production approval, and a production approval holder are both collectively referred to as a PAH).
This AC also provides guidance to PAHs on the development and maintenance of a production system that meets the needs of the PAH and complies with FAA regulations.
1.1.3 This AC is not mandatory and does not constitute a regulation. This AC describes an acceptable means, but not the only means, to comply with these requirements. However, if you use the means described in the AC, you must follow it in all important respects.
1.2 Audience.
This AC affects applicants for a production approval or current PAH developing and maintaining a production system pursuant to the provisions of 14 CFR, part 21, subparts F, G, K and O.
1.3 Effective Date.
This AC is effective 10/01/2015.
1.4 Cancellation.
This AC cancels, as of its effective date, AC 21-43, dated 10/16/2009.
1.5 Explanation of Changes.
This revision supersedes AC 21-43, dated 10/16/2009 and has been updated to reflect amendment 21-98 to 14 CFR part 21. This revision explains recent regulatory changes that:
Require a PAH to identify an accountable manager.
Allow a PAH to issue authorized release documents for aircraft engines, propellers, and articles.
Permit a production certificate holder to manufacture and install interface components.
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Require a PAH to ensure supplier-provided products, articles, or services conform to the PAH’s requirements and establish a supplier-reporting process for nonconforming products, articles, or services released from or provided by a supplier.
1.6 Where to Find This AC.
You may find this AC and other related documents at http://www.faa.gov/regulations_policies/orders_notices/.
If you have any suggestions for improvements or changes to this AC, you may use the template provided in Appendix H of this AC.
1.7 Applicability.
Sections 21.131, 21.301, and 21.601 prescribe the procedural requirements for issuing production approvals (that is, production certificates (PC), parts manufacturer approvals (PMA), and technical standard order (TSO) approvals) and the rules governing the holders of those production approvals. Section 21.601 also includes procedural requirements for issuing letters of TSO design approval.
Note: Type certificate holders producing under subpart F should review appendix C to this AC for additional information.
1.8 Eligibility.
Section 21.132, Eligibility, prescribes eligibility requirements for a production certificate. Applicants for a production certificate are required by the rule to hold the following for the product concerned:
A current type certificate (TC), A supplemental type certificate (STC), or Rights to the benefits of that TC or STC under a licensing agreement.
1.9 Application.
Sections 21.133, 21.303, and 21.603 require an applicant for a production approval to apply in a form and manner prescribed by the Federal Aviation Administration (FAA).
Sections 21.303 and 21.603 contain additional requirements that require the applicant to provide additional information with the application. Applicants should refer to the applicable section for requirements pertaining to the type of production approval they seek.
1.9.1 For a PC, an applicant will submit FAA Form 8110-12, Application for Type Certificate, Production Certificate, or Supplemental Type Certificate. This form is submitted to the Manager, Manufacturing Inspection Office (MIO), in the directorate in which the applicant’s principal manufacturing facility is located. An applicant for an amendment to a production limitation record (PLR) should also submit its application to 1-2
a MIO, unless the applicant has been previously notified to submit the application to their Manufacturing Inspection District Office (MIDO) or Certificate Management Office (CMO).
1.9.2 For a PMA:
If an applicant is applying based on identicality or test and computation, the applicant will submit a letter of application to the Aircraft Certification Office (ACO) in the geographical area in which the applicant’s manufacturing facility is located.
If the applicant is applying based on a licensing agreement, the applicant will submit a letter of application to the MIDO in the geographical area in which the applicant’s manufacturing facility is located.
1.9.3 For a TSO authorization, an applicant will submit a letter of application to the ACO in the region in which the applicant’s principal manufacturing facility is located.
1.10 Organization Requirements.
Sections 21.135, 21.305, and 21.605 require each PAH to provide the FAA with a document describing how its organization will ensure compliance with the provisions of the applicable subpart. This document must describe assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality with management and other organizational components. The document must also identify the applicant’s or PAH’s accountable manager.
1.10.1 The FAA recognizes that businesses have varying business models and organizational structures. The intent of the organization requirement is to obtain a commitment from top management to— Establish a quality system that complies with the provisions of the applicable subpart and ensures each product and article conforms to its approved design and is in a condition for safe operation, Continually improve that quality system, Establish a primary point of contact between a PAH and the FAA, and Describe how the PAH will report failures, malfunctions, or defects to the FAA, in accordance with § 21.3.
1.10.2 Accountable Manager.
In addition to serving as a PAH’s primary contact with the FAA, the accountable manager is responsible within an applicant’s or PAH’s organization for, and has authority over, all production operations conducted under part 21. In addition, an accountable manager confirms that all quality manual procedures are in place and that the PAH satisfies the requirements of subchapter C, Aircraft. The accountable manager may delegate functions and identify alternate points of contact. Any such delegations should be noted in an applicant’s or PAH’s organization document.
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CHAPTER 2. QUALITY SYSTEM.
2.1 Purpose.
This chapter provides information and describes criteria for establishing and maintaining a quality system. PAHs may use this document in support of their responsibilities pursuant to §§ 21.137, 21.307, and 21.607.
2.2 Background.
Section 21.137 requires each PAH to establish and describe, in writing, a quality system that ensures each product and article conforms to its approved design and is in a condition for safe operation. The intent is for each PAH to develop a quality system that meets both the needs of the PAH and the rule. As such, PAH quality systems are scalable to the size and complexity of the product or article being produced. The quality system requirements contain the following 15 elements outlined in paragraphs 2.3 through 2.17 below.
2.3 Design Data Control.
Section 21.137(a) requires procedures for controlling design data, and subsequent changes, to ensure only current, correct, and approved data are used.
2.3.1 Procedures.
PAHs are required by the rule to have procedures for design data control. These procedures should ensure proper storage, maintenance, and protection of design data.
In addition, PAHs should ensure design data is identified, controlled, and made available to those persons who require them. There should also be procedures for approving, documenting, and controlling changes to the design data.
2.3.2 Design Changes.
Design, manufacturing, and special process changes should be approved in a manner acceptable to the FAA. Design changes necessary to correct unsafe conditions should be incorporated into the FAA-approved design. In accordance with § 21.50(b), Instructions for Continued Airworthiness (ICA) should be kept current with the design changes.
2.4 Document Control.
Section 21.137(b) requires procedures for controlling quality system documents and data, and subsequent changes, to ensure only current, correct, and approved documents and data are used.
2.4.1 Procedures.
PAHs should have procedures to ensure proper storage, maintenance, and protection of documents and data, as required by § 21.137(k). Additionally, PAHs should ensure quality system documents and data, including all tags and forms, are identified, controlled, and made available to those persons who require them.
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2.4.2 Document and Data Changes.
There should be procedures for documenting, approving, and controlling changes to the quality system documents and data.
2.4.3 Electronic Storage.
PAHs may choose to store documents electronically, as long as printed copies are made available on FAA request.
2.5 Supplier Control.
Section 21.1(b)(10) defines a supplier as a person at any tier in the supply chain who provides a product, article, or service that is used or consumed in the design or manufacture of, or installed on, a product or article. Section 21.137(c) requires procedures for ensuring each supplier-provided product, article, or service conforms to the PAH’s requirements. This section also requires a PAH to establish a supplier reporting process for products, articles, or services that have been released from or provided by a supplier and subsequently found not to conform to the PAH’s requirements.
2.5.1 Procedures.
Refer to chapter 3 of this AC for additional information on what procedures a typical supplier control program should contain.
2.5.2 PAH Responsibilities.
The PAH is ultimately responsible for determining that all products and articles conform to their approved type design and are in a condition for safe operation. This responsibility cannot be delegated to, or relieved by the use of, approved suppliers, risk and revenue sharing partners, co-producers, or other service or manufacturing providers.
2.6 Manufacturing Process Control.
Section 21.137(d) requires procedures for controlling manufacturing processes to ensure each product and article conforms to its approved design.
2.6.1 Manufacturing Processes.
PAHs should have procedures for ensuring all manufacturing processes (including special processes) that have been identified and defined by FAA-approved design data are accounted for in the manufacturing process.
2.6.2 Work Instructions and Revisions.
PAHs should ensure work instructions, and revisions to work instructions, are reviewed, approved, controlled, documented, and made available to those persons who require them.
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2.6.3 Changed Processes.
Appropriate personnel should substantiate and approve any new or changed processes.
2.6.4 Traceability.
Traceability should be maintained throughout the manufacturing process from raw material to completed product or article. Articles introduced into production before full acceptance should have a process for identifying, controlling, and segregating them.
2.6.5 Software Use.
2.6.5.1 Airborne and production software present unique challenges in manufacturing process control. PAHs that develop airborne software may obtain additional guidance from the Society of Automotive Engineers (SAE), Aerospace Standard (AS) 9006, Deliverable Aerospace Software Supplement for AS9100A.
2.6.5.2 PAHs that use production software for the design, manufacture, inspection, test, acceptance, or calibration of a deliverable product or article may obtain additional guidance from SAE, Aerospace Recommended Practice (ARP) 9005, Aerospace Guidance for Non-Deliverable Software.
2.6.5.3 Procedures may allow for emergency, non-routine use of non-released software in the acceptance process. These procedures should provide a means of locating and recalling the product that was manufactured, inspected, or tested by non-released software when necessary.
2.6.5.4 If non-released software is used for product or article acceptance, the product or article should be identified as nonconforming until the software used is approved and released. Each product or article affected should be identified by an individually unique serial number to ensure recall if necessary. The product or article should not be shipped until all acceptance software has been released, unless an FAA-approved alternate means of acceptance is used. A recall system is not considered an acceptable alternate means of product acceptance for shipment of products or articles.
2.6.6 Software Quality Assurance.
The functional responsibilities for software quality assurance should be part of the quality assurance system submitted to the FAA. The organization responsible for software quality assurance should have functional independence to allow objective evaluations. The organization responsible for software quality assurance should have authority and responsibility to identify and evaluate problems and ensure completion of corrective action on deficiencies. In addition, this organization should— Ensure all software tasks are clearly and adequately described in documented procedures.
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Verify suppliers that use computer-aided-manufacturing (CAM), computer-aided inspection (CAI), or computer-aided-testing (CAT) software and related digital input/output data for product or article acceptance implement appropriate controls.
Have final authority for formally releasing software and related digital input/output data used for product or article acceptance.
Ensure corrective action has been taken on any deficiencies previously discovered.
2.7 Inspection and Testing.
Section 21.137(e) requires procedures for inspections and tests used to ensure each product and article conforms to its approved design. These procedures are required by the rule to include the following, as applicable, a flight test of each aircraft produced unless that aircraft will be exported as an unassembled aircraft, and a functional test of each aircraft engine and each propeller produced.
2.7.1 Inspection Procedures.
PAHs should have procedures documenting inspection methods for each product or article to ensure they conform to their FAA-approved design data. Procedures should include methods that ensure identification of inspection status throughout the manufacturing process and storage. In addition, procedures should ensure inspectionmarking devices are controlled and only issued to authorized persons.
2.7.2 Testing Procedures.
PAHs should establish, maintain, and control test procedures, instructions, and subsequent changes. PAHs should ensure the appropriate organizations participate in reviewing test instructions or procedures. Products or articles that have been adjusted or reworked after test acceptance (such that the results of that testing could be affected) should be retested using approved processes.
2.7.3 Statistical Processes.
2.7.3.1 PAHs should document the use of statistical processes in the quality manual. Statistical processes will ensure that criteria for acceptance or rejection prevent the acceptance of nonconforming products or articles.
2.7.3.2 Statistical sampling should include sampling plans appropriate for the type of product or article being accepted. Personnel should be trained in statistical sampling techniques.
2.7.3.3 Engineering and manufacturing organizations should participate in the review, implementation, and maintenance of statistical quality/process control techniques used for product or article acceptance. PAHs may use SAE ARP9013, Statistical Product Acceptance Requirements, which sets forth general requirements for implementing any of the following statistical product acceptance methods:
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SAE ARP9013/1, Statistical Product Acceptance Requirements Using Isolated Lot Sampling Methods;
SAE ARP9013/2, Statistical Product Acceptance Requirements Using Attribute or Variable Lot Acceptance Sampling Plans;
SAE ARP9013/3, Statistical Product Acceptance Requirements Using Process Control Methods; or SAE ARP9013/4, Statistical Product Acceptance Requirements Using Continuous Sampling, Skip-Lot Sampling, or Methods for Special Cases.
Note: SAE ARP9013 does not apply to statistical methods that are separate from product acceptance. Many companies use statistical methods solely to monitor and improve their product quality, and those methods are not subject to the requirements of this document. This document series applies only to those statistical methods used for product acceptance.
2.7.4 Nondestructive Testing.
PAHs using nondestructive testing to verify conformity of products or articles should have procedures addressing acceptance and rejection criteria. Adequate test pieces with known defects should be available to nondestructive inspection (NDI) personnel.
PAHs should also have procedures addressing the certification, recertification, and decertification of nondestructive testing personnel. PAHs may choose to use National Aerospace Standard (NAS) 410, NAS Certification and Qualification of Nondestructive Test Personnel (issued February 2003).
2.7.5 Flight Test Procedures.
PAHs that manufacture a complete aircraft should ensure flight test procedures and subsequent changes are submitted to and approved by the FAA. Flight test pilots should be fully qualified, and flight check-off lists should be properly completed.
2.8 Inspection, Measuring, and Test Equipment Control.
Section 21.137(f) requires 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 is required by the rule to be traceable to a standard acceptable to the FAA.
2.8.1 Approval, Inspection, and Calibration Procedures.
PAHs should have procedures ensuring tools, gages, and equipment are approved, periodically inspected, and calibrated. Standards used for calibration should have adequate accuracy and be traceable to a standard acceptable to the FAA. Any equipment required for special processing, such as tools, gages, instruments, and timers should be available and calibrated. Calibration of thread gages presents unique challenges. The Industrial Fasteners Institute standard IFI-301, Gage Calibration Requirements and Procedures for Thread Gages, is an industry standard that has been reviewed by the 2-5
FAA and found acceptable to provide guidance for initial and subsequent calibration of thread gages.
2.8.2 Tool Control Procedures.
PAHs should have a tool control procedure ensuring tools and gages used for product or article acceptance (including NDI equipment) are protected, maintained, and used in an acceptable environment. Procedures should ensure PAHs conduct an evaluation and take necessary corrective action when a product or article has been accepted by an out-of-tolerance gage.
2.9 Inspection and Test Status.
Section 21.137(g) requires procedures for documenting the inspection and test status of products and articles supplied or manufactured to the approved design.
2.9.1 Procedures.
PAHs should have procedures that define how inspection and test records are generated and maintained. PAHs should ensure supplier-furnished articles or services conform to the purchase order requirements, as applicable. Records of this verification should be generated and maintained.
2.9.2 Inspection.
The PAH should ensure the inspection status of production products or articles are identifiable throughout the manufacturing cycle including any storage facility controlled by the PAH. In addition, the PAH is responsible for generating and maintaining records of completed tests for aircraft, aircraft engines, or propellers.
2.10 Nonconforming Product and Article Control.
Section 21.137(h) requires procedures to ensure only products or articles that conform to their approved design are installed on a type-certificated product. These procedures are required by the rule to provide for the identification, documentation, evaluation, segregation, and disposition of nonconforming products and articles. Only authorized individuals may make disposition determinations. Section 21.137(h) also requires procedures to ensure discarded articles are rendered unusable.
2.10.1 Procedures.
PAHs should have procedures that ensure a material review board (MRB) is established, documented, and operational. PAHs should have procedures that include how nonconforming products or articles are identified, controlled, and dispositioned.
2.10.2 Disposition Determinations.
Authorized individuals should review nonconforming material to determine if acceptance of the nonconformance constitutes a major or minor change to FAA-approved data. The FAA, through the design approval process, will approve any MRB disposition identified as a major change.
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2.10.3 Data Analysis.
Senior management should review and analyze nonconforming material data to detect adverse trends and determine appropriate levels of corrective and preventive actions.
2.10.4 Disposition of Scrap and Salvageable Aircraft Products and Articles.
These products and articles should be disposed of in an acceptable manner. Appendix D to this AC provides additional information on controlling and dispositioning scrap and salvageable aircraft products and articles.
2.11 Corrective and Preventive Actions.
Section 21.137(i) requires 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.
2.11.1 Corrective Action.
PAHs are required by the rule to have procedures to eliminate the cause(s) of known nonconformities or noncompliances to prevent recurrence. Corrective actions should be appropriate to the effects of the nonconformities or noncompliances encountered and address the following:
Review of nonconformities or noncompliances;
Identification of the cause(s) of nonconformities or noncompliances;
Evaluation of the need for action to ensure that nonconformities or noncompliances do not reoccur;
Identification and implementation of action(s) needed;
Recording of the results of action(s) taken;
Review of corrective action(s) taken; and Flow-down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for the nonconformities or noncompliances.
2.11.2 Preventive Action.
PAHs are required by the rule to have procedures to eliminate the cause(s) of potential nonconformities or noncompliances to prevent their occurrence. Preventive actions should be appropriate to the effects of the potential problems and should address the following:
Identification of potential nonconformities/noncompliances and their causes;
Evaluation of the need for action to prevent occurrence of nonconformities/noncompliances;
Identification and implementation of action(s) needed;
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Recording of results of action(s) taken; and Review of preventive action(s) taken.
2.11.3 Monitoring of Actions.
When processes or procedures result in nonconforming products or articles, PAHs should monitor the response to, implementation of, and effectiveness of corrective and preventive actions.
2.12 Handling and Storage.
Section 21.137(j) requires procedures to prevent damage and deterioration of each product and article during handling, storage, preservation, and packaging.
2.12.1 Procedures.
PAHs should have procedures to ensure only conforming and properly identified products or articles are placed in storage. These procedures should also ensure traceability for split lots, and control of the removal or issuance of those products or articles.
2.12.2 Storage, Handling, Manufacturing, and Assembly.
PAHs are responsible for the following:
Having procedures to ensure compliance with any special environmental controls during material storage, handling, manufacturing, and assembly of products or articles.
Identifying and controlling shelf life or environmentally sensitive products or articles.
Properly separating and identifying products or articles in storage and manufacturing areas.
2.13 Control of Quality Records.
Section 21.137(k) requires the PAH’s quality system to have procedures for identifying, storing, protecting, retrieving, and retaining quality records. The same section also requires a PAH to 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 pursuant to § 45.15(c).
2.13.1 Procedures.
2.13.1.1 PAHs should have procedures that account for all records generated, or needed, to show compliance to the applicable requirement of subparts G, K, and O, including records generated throughout the supply chain.
Additionally, the PAH is responsible for controlling record storage facilities to ensure both against degradation of records and the availability of these records.
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2.13.1.2 Records to be retained should include, but are not limited to, inspection and test records, calibration records, supplier records, special process certifications, MRB records, and production travelers.
2.13.1.3 Records should be legible, complete, and accurate. Any storage media used for record retention should exhibit legible data, acceptance stamps, and required signatures. Refer to chapter 4 of this AC for additional guidance on computer-generated or stored records.
2.13.2 Record Retention Schedule.
PAHs should establish a record retention schedule for various types of process, test, and quality and inspection system data.
2.13.3 Record Disposition.
The procedures should define how obsolete records will be dispositioned or destroyed.
2.14 Internal Audits.
Section 21.137(l) requires procedures for planning, conducting, and documenting internal audits to ensure compliance with the approved quality system. The procedures are required by the rule to include reporting results of internal audits to the manager responsible for implementing corrective and preventive actions. Chapter 5 of this AC provides additional information on internal audit programs.
2.14.1 Procedures.
PAHs should have procedures that establish an internal audit program. The internal audit program should verify compliance with established policies, procedures, and approved data.
2.14.2 Reporting.
PAHs should ensure the results of internal audits are reported to the appropriate level of management, and that audits are used for improving the quality system or product.
2.15 In-Service Feedback.
Section 21.137(m) requires procedures for receiving and processing feedback on in-service failures, malfunctions, and defects. These procedures are required by the rule to include a process to assist design approval holders to address any in-service problem(s) involving design changes and determine if any changes to the Instructions for Continued Airworthiness (ICA) are necessary.
2.15.1 Procedures.
PAHs should have procedures that establish a system for receiving, processing, and tracking of in-service failures, including how records are generated and maintained.
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