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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2.15.2 Corrective Actions.
PAHs should ensure that service problems, unairworthy conditions, unsafe features, and unsafe characteristics reported by the FAA, or users, a re investigated and receive prompt corrective action.
2.15.3 Service Bulletins and Maintenance Manuals.
P AHs should ensure service bulletins and changes to maintenance manuals are approved by authorized personnel and coordinated with FAA engineering.
2.16 Quality Escapes.
Section 21.137(n) requires 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.
2.16.1 Procedures.
PAHs should have procedures that document how they will track, evaluate, categorize, and disposition all nonconforming products or articles. These procedures should include actions to correct deficiencies in the quality system that allowed the quality escape.
2.16.2 Analytical Tools.
PAHs should use trend analysis and risk assessment tools to determine the severity of, and long-term effects of, nonconformances.
2.16.3 Recalls.
A PAH should notify users of products or articles when those products or articles are recalled for suspected or known nonconformance.
2.17 Issuing Authorized Release Documents.
Any PAH that intends to issue authorized release documents must have procedures for doing so that meet the requirements of § 21.137(o). This rule requires a PAH to have procedures providing for the selection, appointment, training, management, and removal of individuals authorized by the PAH to issue authorized release documents.
A PAH may issue these documents for new aircraft engines, propellers, and articles it manufactures, and for used aircraft engines, propellers, and articles rebuilt or altered pursuant to § 43.3(j). When a PAH uses an authorized release document for export purposes, the PAH must comply with any applicable bilateral agreement. Furthermore, under § 21.137(o), a PAH must comply with the rules 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. Additional guidance on exports can be found in AC 21-2, Complying with the Requirements of Importing Countries or Jurisdictions When Exporting U.S. Products, Articles, or Parts, and AC 21-44, Issuance of Export Airworthiness Approvals Under 14 CFR Part 21 Subpart L.
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2.17.1 Procedures.
Procedures established under § 21.137(o) must ensure that only qualified personnel issue authorized release documents. A PAH’s evaluation of these individuals’ qualifications should include an assessment of their knowledge, background, experience, and training. Qualifications should be commensurate with the complexity and type of product or article for which the PAH issues an authorized release document.
These procedures should also include requirements for completing FAA Form 8130-3 that meet chapters 1, 2, and 4 of FAA Order 8130.21, Procedures for Completion and Use of the Authorized Release Certificate, Airworthiness Approval Tag. Refer to appendix E to this AC for additional guidance on issuing authorized release documents for aircraft engines, propellers, and articles.
2.17.2 FAA Form 8130-3.
A PAH’s authorized personnel should issue authorized release documents using FAA Form 8130-3.
2.17.3 Conditional Requirement.
Section 21.137(o) is only applicable to a PAH that wants to issue an authorized release document. Any PAH not issuing an authorized release document may continue to obtain airworthiness approvals from the FAA.
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CHAPTER 3. SUPPLIER CONTROL PROGRAM.
3.1 Purpose.
This chapter provides information on, and describes criteria for, establishing and maintaining a supplier control program. PAHs may use this document in support of their responsibilities under §§ 21.137, 21.307, and 21.607.
3.2 Background.
Part 21 requires PAHs to establish and maintain a quality system. Part 21 also requires that this quality system ensure supplier-produced components (for example, software, articles, and subassemblies), services (for example, special processes and calibration), and customer or buyer-furnished equipment or material conform to the PAH’s requirements.
3.3 Supplier Control.
3.3.1 Contract Requirements.
A PAH is required by § 21.137(c) to have a quality system that ensures all products or articles provided by its suppliers, including subtier suppliers, conform to the PAH’s requirements. The PAH’s requirements will depend on the complexity of supplied products or articles and whether or not the supplier holds a production approval for similar products or articles.
3.3.2 PAH Responsibilities.
The PAH should ensure access to, and cooperation of, all involved facilities in the supply chain for the PAH and the FAA. The PAH is responsible for supplier adherence to the requirements flowed-down through the supply chain. A PAH does not delegate responsibility under its production approval to a supplier.
3.4 Use of Suppliers in Other Countries.
A PAH may use suppliers in other countries when the PAH has established and implemented a supplier control system acceptable to the FAA. A PAH that plans to use a supplier in another country should notify the FAA as soon as possible to determine the FAA’s ability to perform surveillance.
3.5 FAA Surveillance of Supplier Control Systems.
The FAA does not approve suppliers, but may conduct surveillance of the supplier control system at both PAH and supplier facilities in accordance with FAA Order 8120.23, Certificate Management of Production Approval Holders. The FAA may also request technical assistance from a bilateral partner civil aviation authority (CAA) to act on behalf of the FAA. The PAH cannot rely on FAA or CAA surveillance as a means of supplier control.
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