U.S. Department

of Transportation Federal Aviation Administration 

# Advisory

Circular

Subject: Production Under 14 CFR Part 21, Subparts F, G, K, and O Date: 10 / 01 / 15 Initiated By: AIR

- 112 AC No: 21

- 43A

This advisory circular (AC) provides information for production approval holders (PAH) pursuant to Title 14 of the Code of Federal Regulations (14 CFR) part 21, Certification Procedures for Products and Articles. This AC provides PAHs and applicants for a production approval with guidance for developing and maintaining a production system that is approp riate to the PAH’s operations and complies with the regulations.

Susan J. M. Cabler Acting Manager, Design, Manufacturing, & Airworthiness Division Aircraft Certification Service1 0/01/ 15 AC 21

- 43A

CONTENTS Paragraph Page

ii CHAPTER 1. General Information.

................................ ................................ ........................... 1

- 1

1.1 Purpose of This Advisory Circular.

................................ ................................ .............. 1

- 1

1.2 Audience.

................................ ................................ ................................ ...................... 1

- 1

1.3 Effective Date.

................................ ................................ ................................ .............. 1

- 1

1.4 Cancellation.

................................ ................................ ................................ ................. 1

- 1

1.5 Explan ation of Changes.

................................ ................................ ............................... 1

- 1

1.6 Where to Find This AC.

................................ ................................ ................................ 1

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1.7 Applicability.

................................ ................................ ................................ ................ 1

- 2

1.8 Elig ibility.

................................ ................................ ................................ ..................... 1

- 2

1.9 Application.

................................ ................................ ................................ ................... 1

- 2

1.10 Organization Requirements.

................................ ................................ ......................... 1

- 3

CHAPTER 2. Quality System.

................................ ................................ ................................ ... 2

- 1

2.1 Purpose.

................................ ................................ ................................ ......................... 2

- 1

2.2 Background.

................................ ................................ ................................ .................. 2

- 1

2.3 Design Data Control.

................................ ................................ ................................ .... 2

- 1

2.4 Document Control.

................................ ................................ ................................ ........ 2

- 1

2.5 Supplier Control.

................................ ................................ ................................ ........... 2

- 2

2.6 Manufacturing Process Control.

................................ ................................ ................... 2

- 2

2.7 Inspection and Testing.

................................ ................................ ................................ . 2

- 4

2.8 Inspection, Measuring, and Test Equipment Control.

................................ .................. 2

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2.9 Inspection and Test Status.

................................ ................................ ........................... 2

- 6

2.10 Nonconforming Product and Article Control.

................................ .............................. 2

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2.11 Corrective and Preventive Actions.

................................ ................................ .............. 2

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2.12 Handling and Storage.

................................ ................................ ................................ ... 2

- 8

2.13 Control of Quality Records.

................................ ................................ .......................... 2

- 8

2.14 Internal Audits.

................................ ................................ ................................ ............. 2

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2.15 In

- Service Feedback.

................................ ................................ ................................ ..... 2

- 9

2.16 Quality Escapes.

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2.17 Issuing Authorized Release Documents.

................................ ................................ .... 2

- 101 0/01/ 15 AC 21

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CONTENTS (CONTINUED) Paragraph Page

iii CHAPTER 3. Supplier Control Program.

................................ ................................ .................. 3

- 1

3.1 Purpose.

................................ ................................ ................................ ......................... 3

- 1

3.2 Background

. ................................ ................................ ................................ .................. 3

- 1

3.3 Supplier Control.

................................ ................................ ................................ ........... 3

- 1

3.4 Use of Suppliers in Other Countries.

................................ ................................ ............ 3

- 1

3.5 FAA Surveillance of Supplier Control Systems.

................................ .......................... 3

- 1

3.6 Elements of a Supplier Control System.

................................ ................................ ....... 3

- 2

CHAPTER 4. Electronic Records.

................................ ................................ ............................. 4

- 1

4.1 Purpose.

................................ ................................ ................................ ......................... 4

- 1

4.2 Background.

................................ ................................ ................................ .................. 4

- 1

4.3 Electron ic Manufacturing and Quality System Records.

................................ .............. 4

- 1

4.4 Information Management System Facility Management.

................................ ............. 4

- 6

4.5 Training.

................................ ................................ ................................ ........................ 4

- 6

CHAPTER 5. Internal Audit Program.

................................ ................................ ...................... 5

- 1

5.1 Purpose.

................................ ................................ ................................ ......................... 5

- 1

5.2 Background.

................................ ................................ ................................ .................. 5

- 1

5.3 Types of Internal Audit Programs.

................................ ................................ ................ 5

- 1

5.4 Elements of an Internal Audit Program.

................................ ................................ ....... 5

- 1

CHAPTER 6. Additional PAH Requirements.

................................ ................................ .......... 6

- 1

6.1 Quality Manual.

................................ ................................ ................................ ............ 6

- 1

6.2 Location of or Change to Manufacturing Facilities.

................................ ..................... 6

- 1

6.3 Inspections and Tests.

................................ ................................ ................................ ... 6

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6.4 Issuance of a Production Approval.

................................ ................................ .............. 6

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6.5 Production Limitation Record.

................................ ................................ ...................... 6

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6.6 Duration.

................................ ................................ ................................ ....................... 6

- 2

6.7 Transferability.

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6.8 Pr ivileges.

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6.9 Responsibility of Holder.

................................ ................................ .............................. 6

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6.10 Amendment of Production Certificates.

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6.11 Approval for Deviation.

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- 51 0/01/ 15 AC 21

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CONTENTS (CONTINUED) Paragraph Page

iv 6.12 Design Changes.

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6.13 Changes in Quality System.

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6.14 Issuance of Letters of TSO Design Approval: Import Articles.

................................ ... 6

- 6

Appendix A. Related Publications.

................................ ................................ ............................. A

- 1

Appendix B. Definitions.

................................ ................................ ................................ ............. B

- 1

Ap pendix C. Production Under Type Certificate.

................................ ................................ ....... C

- 1

Appendix D. Scrap or Salvageable Aircraft Products and Articles.

................................ ........... D

- 1

Appendix E. Issuing Authorized Release Documents for Aircraft Engines, Propellers, and Articles.

................................ ................................ ................................ ................................ .. E

- 1

Appendix F. Production Approval Holder/Supplier Arrangement.

................................ ............. F

- 1

Appendix G. Production Certification: Multinational/Multicorporate Consortia.

..................... G

- 1

Appendix H. Advisory Circular Feedback Form

................................ ................................ ........ H

- 11 0/01/ 15 AC 21

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1

- 1 CHAPTER 1. GENERAL INFORMATION

.

1.1 Purpose of T his 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; s ubpart G, Production Certificates; subpart K, Parts Manufacturer Approvals; and subpar t 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 system s (for this AC, an applicant for a production approval, and a production approval holder are b oth collectively referred to as a PAH)

. This AC also provides guidance to PAHs on the develop ment and maint enance 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 doe s not constitute a r egulation. This AC describes an acceptable means, but not the only means, to c omply 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 1 0 / 01 / 2015

.

1.4 Cancellation. This AC cancels, as of its effective da te, 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 2 1

- 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.1 0/01/ 15 AC 21

- 43A

1

- 2  Require a PAH to ensure supplier

- provided prod ucts, 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.
Sec tions 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 ho lders of those production approvals. Section 21.601 also includes procedural requirem ents 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 Eligib ility. Section 21.132 , Eligibility, prescribes eligib ility requir e ments for a production certificate. Applicants for a p roduction 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 F ederal Aviation Administration ( FAA )

. Sections 21.303 and 21.603 contain additional requirements that require the applicant
to provide additional information with th e application. Applicants should refer to the applicable section for requirements pertainin g to the t ype 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 Suppl emental Type Certificate. This form is submitted to the Manager, Manufacturing Inspectio n Office (MIO), in the directorate in which the applicant’s principal manufacturing facility is located. A n applicant for an amendment to a production limitation record ( PLR ) should also submit its application to1 0/01/ 15 AC 21

- 43A

1

- 3 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 wil l 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 prin cipal manufactu ring 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 provis ions of the applicable subpart. This documen t must describe assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality with management and ot her organizational components. T he 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 provision s of the applicable sub part 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

 Descri be how the PAH will report failures, malfunct ions, 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 ha s authority over, all production operations conducted under part 21

. In addition, an accountable manager confirm s that all quality manual procedures are in place and that the PAH satisfies the requirements of s ubchapter C, Aircraft . The accountable manager may delegate functions and identify alternate points of contact

. Any such delegations should be noted in a n applicant’s or PAH’s organization document.1 0/01/ 15 AC 21

- 43A

2

- 1 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 t o 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 prod uct or article being produced. The quality system requirements contain the following 1 5 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 proce dures for design data control. These procedures should ensure proper storage, maintenance, and protection of design data. In addition, PAHs should ensure design data is id entified, controlled, and made available to t hose persons who require them. There should also be procedures for approving, documenting, and co ntrolling 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 proce dures 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 d ocuments 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.1 0/01/ 15 AC 21

- 43A

2

- 2 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 R esponsibilities. 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, appro ved suppliers, risk and revenue sharing partners, co

- producers

, or other service or manufacturing providers

.

2.6 Manufacturing P rocess C ontrol. Section 21.137(d) requires procedures for controlling manufacturing processes to ensure each product and article co nforms to its approved design.

2.6.1 Manufacturing P rocesses. PAHs should have procedures for ensuring all manufacturing processes (including special processes) that have bee n identified and defined by FAA

- approved design data are accounted for in the manufacturing process

.
2.6.2 Work Instructions and R evisions.
PAHs should ensure work instructions

, and revisions to work instructions

, are reviewed, approved, controlled, documented, and made available to t hose persons who require them.1 0/01/ 15 AC 21

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2

- 3 2.6.3 Changed Processes

. App ropriate personnel should substantiate and approve a ny 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 be fore 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 additi onal 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 calibrat ion o f a deliverable product or article may obtain additional guidance from SAE, Aerospace Recommended Practice (ARP) 9 005, Aerospace Guidance for Non

- Deliverable Software.

2.6.5.3 Procedures may allow for emergency

, non

- routine use of non

- released

softw are in the acce ptance process. These procedures should provide a means of locating and recalling the product that was manufactured, inspected, or tested by non

- rel eased software when necessary.

2.6.5.4 If non

- released software is used for product or article acceptance, the

produ ct 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 shi pment of products or articles.

2.6.6 Software Q uality A ssurance. The functional responsibilities for software quality as surance should be part of the quality assuranc e system submitted to the FAA. The organization responsible for software quality assurance should have functional independence t o allow objective evaluations. The organization responsible for software quality assurance should have authority and responsibility to identify and evaluate problems and ensure completion of

corr ective action on deficiencies. In addition, this organizati on should

—

 Ensure all software tasks are clearly and adequately described in documented procedures.1 0/01/ 15 AC 21

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2

- 4  Verify suppliers that use computer

- aide d

- 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 co nforms 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 h ave procedures documenting insp ection methods for each product or article to ensure they conform to t heir FAA

- approved design data. Procedures should include methods that ensure identification of inspection status throughout the

manu facturing process and s torage. In addition, procedures should ensure inspection

marking 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 sh ould ensure the appropriate organizations participate in reviewing te st 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 P rocesses.

2.7.3.1 PAHs should document the use of statistical processes in the qualit y

manual. Statistical processes will ensure that criteria for acceptance or rejection prevent the acceptan ce of nonconforming products or articles.

2.7.3.2 Statistical sampling should include sampling plans appropriate for the

type of product or article being a ccepted. Personnel should be trained in statistical sampling techniques.

2.7.3.3 Engineering and manufacturing orga nizations 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 implement ing any of the following statistical product acceptance methods:1 0/01/ 15 AC 21

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2

- 5  SAE ARP9013/1, Statistical Product Acceptance Requirements Using Isolated Lot Sampling Methods;

 SAE ARP9013/2, Statistical Product Acceptance Requirements Using Attribute or Variable Lot Acc eptance 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. Thi s 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 cri teria. Adequate test pieces with known defects should be available to nondestructive inspection (NDI) personn el. PAHs should also have procedures addressing the certification, recertification, and decertification of nondestructive testing personnel. PAHs m ay 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 submitt ed 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

a rticle 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, periodica lly inspected, and calibrated. Standards used for calibration sho uld have adequate accuracy and be traceable to a s tandard acceptable to the FAA. Any equipment required for special processing, such as tools, gages, instruments, and timers shoul d be available and calibrated. Calibration of thread ga ges presents unique ch allenges. The Industrial F asteners Institute standard IFI

- 301, Gage Calibration Requirements and Procedures for Thread Gages

, is an industry standard that has been reviewed by the1 0/01/ 15 AC 21

- 43A

2

- 6 FAA and found acceptable to provide guidance for initia l and subsequent cali bration 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 use d in an acceptable environment. Proced ures should ensure PAHs conduct an evaluation and take necessary corrective action when a product or article has been accepted by an

o ut

- 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 orde r 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 th e manufacturing cycle including any storage f acility 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 Contr ol

. Section 21.137(h) requires procedures to ensure only products or articles that conform to their approved design are installed o n a type

- certificated product. These procedures are required by the rule to provide for the identification, documentation, e valuation, segregation, and disposition of noncon forming products and articles. Only authorized individuals may make disp osition determinations. Section 21.137(h) also requires procedures to ensure discarded articles are rendered unusable.

2.10.1 Procedures.
PAH s 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 nonconf orming material to determine if acceptance of the nonconformance constitutes a major or min or change to FAA

- approved data. The FAA, through the design approval process, will approve any MRB dispo sition identified as a major change.1 0/01/ 15 AC 21

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2

- 7 2.10.3 Data Analysis

. Senior management should review and analyze nonconforming materi al data to detect adverse trends and determine appropriate levels of corrective and preventive actions.

2.10.4 Disposition of Scrap and Salvageab le 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 Co rrective 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 sys tem.

2.11.1 Corrective Action.
PAHs are required by the rule to have procedures to eliminate the cause(s) of known nonconformities or noncom pliances 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 supp lier is responsible for the nonconformities or noncompliances

.
2.11.2 Preventive Action

. PAHs are required by the rule to have procedur es to eliminate the cause(s) of potential nonconformities or noncompliance s to prevent their occurrence. Preventive actions sho uld 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/noncomplia nces;

 Identification and implementation of action(s) needed;1 0/01/ 15 AC 21

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2

- 8  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 m onitor 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 o r 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, manufactu ring, 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. T he 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 subpart s G, K, and O , including records generate d 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 record s

.1 0/01/ 15 AC 21

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2

- 9 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 le gible, complete, and accurate. Any storage media used

for record retention should exhibit legible data, acceptance st amps, 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 r ecords will be dispositioned or destroyed.

2.14 Internal Audits

. Section 2 1.137(l) requires procedures for planning, conducting, and documenting internal audits to ensure compliance wit h the approved quality system. The procedures are required by the rule to include reporting results of internal audits to the manager responsible for implementing corr ective and preventive actions. Chapter 5 of this AC provides additional information on internal audit programs.

2.14.1 Procedures.
PAHs should have procedures that establ ish an internal audit program. The internal audit program should verif y 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

- S ervice Feedback

. Section 21.137(m) requires procedures for receivin g and processing feedback on in

- service failur es, 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
tra cking of in

- service failures, including how records are generated and maintained.1 0/01/ 15 AC 21

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2

- 10 2.15.2 Corrective Actions

. PAHs should ensure that service problems, unairworthy conditions, unsafe features, and unsafe characteristics reported by the FAA

, or users , are investi gated and receive prompt corrective action.

2.15.3 Service Bulletins and Maintenance Manuals

. PAHs 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 nonco nforming products or articles. These procedures should include actions to correct deficiencies in the quality system th at 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 ru le 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 t hese 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 mus t comply w ith 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

, spec ified in § 21.335. Additional g uidance on exports can be found in AC 21

- 2, Complying with the Requirements of Importing Countries or Jurisdictions When Export ing U.S. Products, Articles, or Parts

, and AC 21

- 44, Issuance of Export Airworthiness Approvals Under 14 CFR Part 21 Subpart L

.1 0/01/ 15 AC 21

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2

- 11 2.17.1 Procedures.
P rocedures established under § 21.137(o) must ensure that only qualified personnel issue authorized release documents

. A PAH ’s evaluat ion of these individuals’ qualifications should include an assessment of the ir knowledge, background,

e xperience, and training. Qualifications should be commens urate 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 guid ance 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 F orm 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.1 0/01/ 15 AC 21

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3

- 1 CHAPTER 3. SUPPLIER CONTROL PRO GRAM

.

3.1 Purpose. This chapter provides information on, and describes criteria for

, establishing and maintaini ng 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 exam ple, 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 ensure s 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 approva l 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

- d own 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 ap prove suppliers, but may conduct surveillance of the supplier control system at both PAH and supplier facilities in accordance with FAA Order 8120.2 3

, 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.1 0/01/ 15 AC 21

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3

- 2 3.6 Elements of a Supplier Control System

. A PAH is responsible for ensuring that each pro duct or a rticle conforms to the FAA

- approved design data

, and is in a condition for safe operation. This responsibility remains the same whether the PAH produces the entire product or article at its facility, or uses supplier s to furnish related articles. The suppl ier control program is required by the rule to be FAA

- ap proved and defined in a manual. Implementation and maintenance of the supplier control system is sub ject to evaluation by the FAA. FAA production approvals are based on the ability of the quality system to ensure production of

c onforming products or articles. Therefore, the supplier control system should contain procedures that include the following:

3.6.1 Organizational S tructure. Establishment of an organizational structure that ensures appropriate au thority, sufficient resources, and adequate expertise to control supplier activities.

3.6.2 Supplier Arrangement

. Documentation of the supplier arrangement, generally through a contract, that defines all necessary elements and procedures between the PAH and a s upplier. Appendix F to this AC contains elements that should be defined in the arrangement between the PAH and the supplier.

3.6.3 Supplier Evaluation and Selection

. A process that evaluates and selects suppliers based on their capability to perform all manufa cturing activities, inspections, and tests necessary to determine conformity of articles to the applicable design data

. Additionally, the supplier evaluation and selection process should determine the supplier ’ s ability to meet other PAH specified requirem ents. The process should include criteria for the initial evaluation, selection, periodic or ongoing evaluation s , and disapproval of suppliers. These should include the following:

3.6.3.1 Initial evaluation of suppliers to determine their ca pability to meet

requir ements. The PAH should make this determination before permitting the supplier to furnish any articles. The need for the PAH to conduct onsite evaluations should be based on a supplier control process as described in paragraph 3.6.5 of this AC

. The FAA strongly encourages PAHs to conduct initial onsite evaluations based on risk factors such as:

 Category of the part as listed on the FAA’s Aircraft Certification Service Category Parts List (available on the FAA website);

 Number of supplier tiers, and number of suppliers within each tier, used by the supplier (including, if necessary, onsite evaluations of subtier suppliers);

 Design and manufacturing complexity of the article ;

 Ability of the PAH to inspect the article on receipt; and

 Other risk factors as discussed in paragraph 3.6.5.1 of this A C

.1 0/01/ 15 AC 21

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3

- 3 3.6.3.2 Periodic or ongoing evaluations of suppliers to ensure their continued

adherence to the requirements.

3.6.3.3 Methods for determining the extent and type of evaluations (for example,

onsite evaluations, proces s reviews, document reviews, or in dependent product evaluations). The extent and type of evaluations should be b ased

on the type, complexity, method of control, and criticality of the articles procured. The need for the PAH to conduct onsite evaluations should be based on a supplier control process and verification of s upplier product as described in paragraph s 3.6.5 and 3.6.6 of this AC

. The FAA strongly encourages PAHs to conduct periodic/ongoing onsite evaluations.

3.6.4 Approved Supplier List

. Suppliers under the PAH quality system are included in

, or referenced in

, a controlled list, along with each supplier’s associated scope. Procedures ensure purchase documentation is issued only to suppliers on this list.

3.6.5 Supplier Control P rocess. A process that describes the means of supplier control, based on the criticality and complexity of the article or service provided to ensure conformity. The techniques described below are not all

- inclusive but are provided to assist the PAH in developing supplier control procedures applicable to the or ganization.

3.6.5.1 Risk assessment includes both supplier and product risk factors. Product

risk factors include safety classification from the design approval process, special process, and design and manufacturing complexity. SAE ARP9134, Supply Chain Risk Manag ement Guidelines (dated 3/3/2004), is an industry guideline that the FAA has reviewed and found acceptable to provide guidance for the identification of supplier risk factors.

3.6.5.2 Qualification and auditing of a supplier’s quality system.

3.6.5.3 Monitoring continued capability, throughout the supply chain, to perform

all manufacturing activities, inspections, and tests to determine conformity of articles to applicable design data. The PAH will determine and apply acceptance standards for the physical condition, confi guration status, and conformity of articles (including customer/ buyer

- furnished equip ment). This determination will be made whether the articles are to be used in production

, or as replacement or spare articles

.
3.6.5.4 First article inspection to verify the article conforms to the approved data

,

and any additional contract requirements, includ ing destructive testing. A first article inspection should be conducted for a new production line, changes to the manufacturing or quality processes, or a new supplier. SAE AS9102A, Aerospace First Article Inspection Requirement ( revision A, dated 1/13/2004) , is an industry standard that has been1 0/01/ 15 AC 21

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3

- 4 reviewed and found acceptable by the FAA to provide guidance in establishing first article processes and procedures.

3.6.6 Verificati on of Supplier P roduct.
Methods used to verify that articles conform to specified requirements, including
customer

- supplied materials an d customer

- designated sources. These methods include, but are not limited to, the following:

3.6.6.1 For articles accepted at t he PAH’s facility, inspection may be accomplished

on receipt

, or when characteristics remain accessible, at any time before the fin al acceptance of the end item. The procedures should encompass a complete inspection (for example, all dimensional characteri stics, nondestructive testing, hardness checks, spectrographic analysis, and funct ional tests). When the PAH has established that the supplier’s production or process methods will consistently produce articles that conform to its requirements , use of stati stical quality cont rol methods may be acceptable. The inspection plan used is re quired by the rule to preclude the acceptance of any nonconforming articles. Additionally , when it is necessary to determine material integrity, the following methods should be considered:

 Laboratory analysis to verify an article’s complete chemical and physical properties when tests can be performed without destroying the article (for example, by test coupon or small section of the article).

 When laboratory analysis cannot be performed without destroying the article, a sample of such articles should be subject to a qualitative and quantitative analysis (for example, by test coupon or small section of the article)

. This analysis will verify the article’s complete chemical and p hysical properties.

3.6.6.2 For articles that cannot or will not be inspected on receipt, the PAH’s

procedures should include, as a minimum, inspection and testing of first articles to verify the articles conform to the PAH’s requirements and
p eriodic inspection t hereafter. Inspections and tests completed for the purpose of showing conformity to contract requirements may be accomplished a t a supplier’s facility. These inspections and tests are required by the rule to be conducted according to a documented process

w ithin the PAH’ s FAA

- approved quality system. More than one article may require such inspection or testing until the production repeatability of the supplier has been established. These procedures should include methods to control, identify, and segregate a rticles waiting for testing or inspection from those already approved.

3.6.6.3 The PAH may allow a supplier to perform an appropriate or major

inspection when it has established that the supplier is capable of performin g such an inspection function. However, the PAH should approve any1 0/01/ 15 AC 21

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3

- 5 delegation of inspection or use of statistical techniques b eyond the first tier supplier. Such delegation includes the following:

 Major i nspections. These include properties classified as critical by the approved design holder’s engi neering drawings, process specifications, test specifications, and quality control procedures; or properties that cannot be verified except by destructive test of each article or extensive disassembly.

 Material review. This includes the identification and maintenance of relevant MRB procedures that define the scope and authority of the supplier MRB. Material review also includes the process for submitting, to the PAH, supplier nonconformances that are required by the rule
to be approved before they can be c onsidered as changes to the FAA

- approved type design.

 Statistical te chniques.

3.6.6.4 The PAH is required by the rule to have supplier, including subtier supplier,

information a vailable to the FAA on request. This information should include

, but is not limited to

, the following:

 The name and address of each supplier.

 The name and address of each supplier that performs major inspection or material review for the PAH.

 The name and address of each supplier that furnishes articles when conformance to PAH requirements cannot, or will not, be made on receipt at the PAH’s receiving facility.

 Where, and by whom, the article will undergo inspection.

 The title and telephone number of the person to contact at the supplier facility that can furnish the purchase order(s), quali ty control data, technical data, and other pertinent data or information to the FAA.

 Identification of each supplier with direct ship authorization.

 Results of the PAH’s supplier evaluations, audits, or other surveillance activities.

3.6.6.5 The PAH is required by the rule to have a method for generating and

maintaining inspection records. These procedures should include the following:

 Contents of each record u sed for the article inspected. This should include, as a minimum, the name, part or article number, serial number (if applicable), sample size, type and number of inspections made, conformance or nonconformance, number and description of nonconformances found, and action taken.1 0/01/ 15 AC 21

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3

- 6  Requirements for record legibility, completeness, accuracy, and retention periods.

 Requirements that tools used for reco rd retention (for example, tape files and microfilm) exhibit legibl e data and acceptance stamps

or signatures.

3.6.7 Supplier Rating

. A system that exhibits the performance, capability, and reliability of suppliers.

3.6.8 Notifica tion to the FAA. A procedure to ensure advance notification to the FAA of any significant change in the scope of any supplier arrangements

.
3.6.9 Reporting of Supplier N onconformances. A supplier

- reporting p rocess 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.

3.6.10 Change Control

. A system that ensures changes in requirements are properly controlled and incorpo rated as agreed bet ween the supplier and the PAH. These include

, but are not limited to

—

 Submittal to the PAH for approval of supplier designs and changes before incorporation, when required;

 Submittal to the PAH of changes to a supplie r’s manufacturing pr ocess, when required;

 Submittal to the PAH of changes to a supplier’s quality system that may affect inspection, conformity, or the airworthiness of the article; and

 Methods used to act on notifications of nonconforming articles, and ensuring proper invest igation and corrective action is taken.

3.6.11 Direct Ship

. Methods for controlling direct shipments from a PAH’s supplier to a customer for articles manufactured under the PAH’s production approval. The customer may order articles from e ither the PAH or the sup plier. SAE ARP9114, Direct Ship Guidance for Aerospace Companies (dated 9/9/2005), is an industry guideline that has been reviewed by the FAA and found acceptable to provide guidance in establishing direct ship ment processes and procedures. There may be re strictions on the direct shipment of articles from suppliers not located in the United States

. The FAA Manufacturing Inspection District Office ( MIDO ) may be contacted for more specific information. Direct shipment may only be used when the PAH

—

3.6.11.1 Has approved quality procedures that will compensate for the absence of

inspections normally co nducted at the PAH’s facility. Compensating factors1 0/01/ 15 AC 21

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3

- 7 should include onsite evaluations of the supplier and the inspection of the article as either

—

 A source inspectio n performed by the PAH, or

 An inspection by the supplier under a delegated inspection authority from the PAH.

3.6.11.2 Provides direct ship authorization to a supplier.

3.6.11.3 Issues and maintains records of direct ship authorization and makes them

available to regulatory authorities on request.

3.6.11.4 Ensures the requirements of the importing country will be met before

authorizing direct shipment to a customer located outside the United States.

3.6.11.5 Obligates the supplier to

—

 Direct ship the article.

 Meet any special customer requir ements accepted by the PAH.

 Maintain evidence that the supplier has direct ship authorization from the PAH.

 Maintain evidence of direct shipments made on behalf of the PAH.

 Provide a signed direct ship declaration with the shipment.

 Provide a signed or stamped statement of conformance certifying that the article conforms to approved data with the shipment.

 Provide traceability of the shipment to the customer purchase request.

 Provide evidence with the shipment that acceptance or inspe ction has been accomplished by the PAH or through a delegated inspection authority.

 Provide a statement with the shipment that delegation of inspection authority has been granted by the PAH, and that the inspection was performed on behalf of the PAH when d elegated inspection is used.

3.6.12 Other

- Party S upplier S urveillance.
Methods for the use of other

- party supplier surveillance may be used by a PAH provided the processes used meet the requirements identified in FAA Order 8120.12

, Production Approval Holder Use Of Other

- Parties To Supplement Their Supplier Control Program

, and are documented in the PAH’s quality manual.

3.6.13 Suppliers Holding a P roduction A pproval.
Methods used to address suppliers that hold a production approval f or the article to be supplied. A PAH’s surveillance of individual suppliers may be reduced, but not eliminated, provided that

—1 0/01/ 15 AC 21

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3

- 8  Satisfactory interface between the two quality sys tems can be demonstrated
to the FAA;

 The articles to be supplied are included in the scope of their production

a pproval ; and

 If the supplier is located outside the United States, a bilateral agreement for airworthiness is in effect between the United States and the country of the supplier. The bilateral agreement will include provisions for United States ’ acceptance of the types of articles or products produced under the supplier’s production approval

.
3.6.14 Use of Suppliers Located Outside the United States. Methods for the use of suppliers (including subtier suppliers) outside the United States. These should include provisions for the following:

 The PAH provid ing early notification to the FAA of the proposed use of a supplier in another country or jurisdiction.

 The PAH is required by the rule to make available to the FAA information on non

U.S. suppliers when request ed.

 The PAH should ensure the FAA has access within the country where its supplier (including subti er suppliers) is manufacturing. It should also ensure all necessary processes, agreements, or procedures are in place to mitigat e any undue burden on the FAA

. Such burdens could inhibit the FAA from performing its regulatory functions and certificate management responsibilities.

 The PAH is required by the rule to ensure access to its supplier s

. Assurance of

access should be provided by the supplier, or when no regulatory agreements are in place, the government of the country or jurisdiction in which the supplier is located. This assurance of access will be made available to the FAA. If access is at any time obstructed or denied, the FAA may instruct the PAH to cease using the supplier.

3.6.15 FAA Certificate Management in Other Countries

. When a PAH uses a supplier in a country or jurisdiction that has a bilateral agreement with the United States, the FAA may use a bilateral partner CAA to perform surveillance activit ies and/or conduct inspections on behalf of the FAA. The following procedures should be used:

 The PAH will afford the FAA or CAA any necessary support in its surveillance activity.

 When specifically requested by the FAA/CAA to facilitate surveillance activities, suppliers located outside the United States will make appropriate data available to the FAA through the PAH for certificate manag ement purposes. This data should be in the En glish language.1 0/01/ 15 AC 21

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3

- 9 Note 1: FAA Order 8100.11, Decision Paper Requirements for Undue Burden and No Undue Burden Determinations Under 14 CFR part 21 for Production and Export Airworthiness Approvals

, is used by FAA personnel when notified by the PAH of its intent to u s e a supplier outside the United States.

Note 2: When the FAA requests a bilateral partner CAA to conduct surveillance activities or conformity inspection(s) at a supplier facility, the PAH will be responsible for any charges imposed by the CAA to accomplish the r equest(s).1 0/01/ 15 AC 21

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4

- 1 CHAPTER 4. ELECTRONIC RECORDS

.

4.1 Purpose. This chapter provides information and guidance to PAHs on managing and controlling information systems that generate and store records used in the manufacture of products and articles.

4.2 Background. Several CFR sections require PAHs to maintain manufacturi ng and quality records as evidence that products and articles were produced in accordance with approved design requirements. As the aerospace industry has grown, many PAHs have developed or purchased information systems to generate and store manufacturing and quality records. This chapter does not discuss what manufacturing and quality records should contain. Rather, it describes the control mechanisms that a PAH should use for an information system that generates or stores records of products and articles manufactured to CFR requirements.

4.3 Electronic Manufacturing and Q uality S ystem R ecords. The record system should detect and deter unauthorized disclosure, mo dification, or

use of records. Record systems require protection to ensure an accurate history of the manufacturing process of a product or article. An information management system shoul d be protected from intruders. The system should also be protected from employees with authorized access privileges who attempt t o perform unauthorized actions. Protec tion is achieved not only by technical, physical, and personnel safeguards, but also by clearly articulating to all employees the organizational procedures regarding authorized system use.

4.3.1 Security Principles of Electronic Record Systems

. Although inform ation management systems are diverse, common security attributes should be present in all record systems. An acceptable electronic record system should include the following:

4.3.1.1 User Identification

.

Each system user should be uniquely identified in the system with an account number or other identification code. This code identifies who has logged onto the system and is the prim ary means of verifying access. The information management system should retain the user identification codes entered to verify th e requests made on the system. This information should be available for review by the system manager.

4.3.1.2 Authentication of User

.

There should be a means of verifying that the person entering the user identification code is the authorized individual. Typical ly, this1 0/01/ 15 AC 21

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4

- 2 authentication is through a password know n only to the authorized user. This password would allow access to the system only when used together with the user identification code. Passwords should be updated periodically.

4.3.1.3 Principle of Least Possibl e Privilege

.

The authorization capability of the record system should follow the principle that each person is limited to only the information and transaction authority required by their job responsibilities. Privacy locks may be used to

ensu re this princ iple is followed. The level of access at which information is guarded within the system will depend on the design of the system. Based on the design of the information management system, privacy locks and keys may control single data elements or any combin ation of data elements. Levels of protection may include the following:

 Data items,

 Data aggregates,

 Sets,

 Fields,

 Files, or

 The complete system.

4.3.1.4 Relation to Q uality D ata R esponsibilities.

The system should ensure authorization privileges coincide with the responsibilities outlined in the organization’s quality system. For example,

a manufacturing individual should not normally have write capability to an inspection acceptance field within a manufacturing record. Additionally, an inspector should not have access to a material review engineer disposition field w ithin a material review record. The system should be capable of assigning each user the spe cific access authority needed. The various types of authorization may include the following:

 Read

- O nly A ccess. Allows the user to read all or specific fields of information but does not allow any write or data manipulation capability.

 Insert or W rite A ccess A uthorizations. Allows the user to enter data into specified fields or series of fields.

 Change A ccess Authorizations

. Allows the user to change entries in specified fields, but does not allow removal of the original entry. Changes may be accomplished by adding informati on to a restricted field (which is only used when the information in a field will be retained) but the information is not correct. For example, when a n article has been rejected by inspection, th e rejection history may need to be retained even after the ar ticle is repaired. Change access authorization may be given to allow a senior inspector the authority to1 0/01/ 15 AC 21

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4

- 3 change the inspection status of a reworked article; however, the record retains the original rejection indication and the user identification of the in dividual making the change.

 Delete Access Authorizations

. Allows the user to remove entri es and leave the fields blank. While authorizati on to delete information by the user making the entry may be unrestricted, subsequent delete authorization should be c losely controlled. Delete access authorization may be issued only to supervisors for deleting incorrect ent ries by subordinate employees. Subsequent to final approval of a product or article, inf

ormation should not be deleted. After approval, incorrect dat a should be changed rather than deleted.

 Security Access Authorizations

. The system manager should retain the

s ecurity access authorizations. These authorizations should only be exercised when properly executed documents allow their use, such as an
approv al letter signed by the director of quality.

4.3.2 Auditing Mechanisms

. The information management system should include mechanisms that detect security breaches. These breaches should include any attempt to circumvent security or modi fy data without authoriza tion. When such a security breach is detected, the system should alert the security manager and note any f ields that have been accessed. The security breach information should be retained within the system until r eviewed by the system
manager. Security breach logs should be available only to select individuals and be protected from modification o r data alteration at all times. Normally the system operator will be warned of u nauthorized activity. Serious events, such as repeated unauthorized access attemp ts, may generate alarms at the system level.

4.3.3 Protection Against Software and Hardware Destruction

. Information system records should be protected from destructive computer programs (that is, computer viruses) that a ttack or degrade the software. Informat ion management systems should include virus detection programs that ensure viruses are not introduced into the environment through contaminated software or hardware.

4.3.3.1 Inventories.

Inventories of all software and hardware configurations and locations shoul d be used to ensure unauthorized hardware/software does not enter the information management system’s environment.

4.3.3.2 Portable Equipment

.

Portable computer equipment

, such as laptops

, represent special risks from destructive software ; therefore, procedures should address their use in the information management system’s environment.1 0/01/ 15 AC 21

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4

- 4 4.3.3.3 Network Security

.

Many PAHs use large information management system networks with several interact ing workstations or terminals. If a large interactive system is used, procedure s should address additional protection nec essary to control the network. The PAH should define the degree of protection, based on the complexity and application of the system.

4.3.3.4 System Backup

.

Provisions should be developed for loss of data resulting from s ystem failure. In all cases, lost data will be regenerated. The amount of time between backups will depend on the degree of risk the approval holder wishes to accept to reestablish lost information.

4.3.4 Media Control

. The media on which information is stored should be caref ully controlled and protected. Transportable media such as tapes, disks, and cartridges should be stored in secure locations. Media from external sources should be subject to validation to ensure the y are from authorized sources. The listin g below provides some examples of the types of media available.

4.3.4.1 Floppy disks and computer hard drives should not be used for long

- term

storage of quality and m anufacturing records. Information that will be retained for more than 3 months should be transfe rred to optical disks or magnetic storage media such as chromium di oxide or metal particle tapes. An external or electronic labeling system should be used that ensures retrieval of individual records.

4.3.4.2 Magnetic tapes should be tested within 6 months of use to verify the tape is

free of errors and complies with the standards of the National Institut e of Standards and Technology. Optimally, new tapes that have been maintained in a cool

, dry environment should be chosen for storing records. Specific storage cr iteria for magnetic tapes include the following:

 Environmental temperatures between 62 and 68 degrees Fahrenheit.

 Relative humidity between 35 percent and 45 percent.

 All tapes should be rewound under controlled tension every 3 1⁄2 years.

 All information that will be retained for more than 10 years should be transferred to new tapes before reaching 10 years.

 Annually, a statistically valid sample of all tapes should be tested to identify any loss of data. Tapes with 10 or more errors due t o storage conditions should have all data transferred to new tapes. If the sample contains defective tapes, all other tapes that might have been affected by the same cause (that is, poor quality tape, high usage, poor environment, or improper handling) sho uld be tested and corrected.1 0/01/ 15 AC 21

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4

- 5  Smoking, eating, or drinking in the magnetic tape storage or test areas should be prohibited.

4.3.4.3 Chromium dioxide tapes should be handled like magnetic tapes except for

pe riodic rewinding and cleaning. Although unproven, some in dustry experts believe rewinding and cleaning can be destructive to these tapes.

4.3.4.4 Before use of any metal particle tapes for long

- term storage, the PAH

should ensure the tapes can maintain the integrity of the data stored.

4.3.4.5 Additional information regarding long

- term storage of electronic

media can be found in the National Institute of Standards and Technology ’s Special Publication 500

- 101, Care and Handling of Computer Ma gnetic Storage Media. This publication is available from the Superintendent of Document s, U.S. Government Printing Office, Washington, DC 20402.

4.3.4.6 Optical disks are recommended for their greater durability over older media

such as magnetic tapes or disks.

4.3.4.6.1 Gold compact disks or digital versatile disks are preferred over similar

med ia for long

- term data storage. This is preferred over aluminum and silver writing surfaces, which are susceptible to corrosion or oxidation.

4.3.4.6.2 The PAH should maintain data transferred to storage, and provide access

and ensure integrity of information for the long term. This may require migrating data from one media to the nex t to avoid media obsolescence. The devices necessary to read the discs should also be kept and maintained.

4.3.4.6.3 When obtaining archival grade discs, the PAH should consider the

following: dye failure, bon ding failure, scra tches, and production quality. Testing is a highly recommended step in the process as conditions vary from machine to machine and among dis k s. It is recommended tha t the PAH keep multiple copies. Ideally one master copy should be stored u nder optimal conditions; one in

- use copy should be stored for access purposes; and one safety copy should be stored at a different location.

4.3.4.6.4 Rewritable disk formats are not recommended as their use can lead to

accidental, but permanent, loss of data.

4.3.4.6.5 Optic al disks, for all their resilience, are still suscep tible to environmental

factors. Optical dis k s should not be exposed to extreme temperatures or direct sunlight that may cause heat buildup in the dis k or damage the dat a layer with ultraviolet rays. The environment should optimally be maintained between 65 and 75 degrees Fahrenheit, and between 30 and 50 percent humidity.1 0/01/ 15 AC 21

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4

- 6 4.3.5 Documentation. The information management system should be properly documented.

4.3.5.1 All software programs within the system, including pr ogram changes,

should be fully documented.

4.3.5.2 Procedures should be developed that control all data entered into the

system. The procedures should address all information management system and human interface activities.

4.3.6 Availability.
The information manage ment system industry is extremely dynamic concerning the systems that ar e available for recordkeeping. If the PAH changes from one system to another, the records produced by the old system will remain accessible to the FAA in a usable format. The PAH’s doc umented quality control system should indicate how this accessibility is accomplished.

4.4 Information Management System Facility Management

. The information management system cannot be properly protected unless the facilities that house the equipment are pr operly protected from physical threats and hazards. Areas that should be considered include the following:

4.4.1 Physical Security

. Each area where electronic records will be used should be surveyed f or potential physical hazards. Fire and water are two of the most damaging forces reg arding electronic information. Although not all hazards can be eliminated, opportunities for loss can be minimized by careful planning.

4.4.2 Environmental Conditions

. Procedures should address the environmental conditions (for example, temperature, humidity, static) of the areas where the record system computer s and stored media are located. Manufacturer specifications provide a useful guide for developing procedures.

4.4.3 Disaster Recovery

. A contingency plan should be developed that will allow recovery of critical system information in case of a disaster, such as a fire. One acceptable method is to have a remote backup system to which data is regularly transferred.

4.5 Train ing. Organizations that have elected to use electronic record systems should train each employee who is involved wi th any portion of that system. The subject matter and objectives should vary depending on the employee’s level within the organiz ation and j ob responsibilities. Training should include security awareness, organizational policy, system operation, and record storage requirements. Training should be documented and those documents made available for review by the FAA.1 0/01/ 15 AC 21

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5

- 1 CHAPTER 5. INTERNAL AUDIT PROGR AM

.

5.1 Purpose. This chapter provides information and describes criteria for establishing an internal audit program. This chapter may be used by PAHs and their suppliers to show compliance with § 21.137 regard ing internal audits.

5.2 Background. An internal audit program is a comprehensive, contin uous monitoring process that is initiated and usually managed by top company and quality assurance (QA) management. The personnel conducting the various audits in support of the internal audit program may be internal or external to the process. The objective of this process is to promote attitudes and procedures that focus on controlling processes, rather than depending on corrections of deficiencies, to meet quality goals.

5.3 T ypes of Internal Audit Programs

. An internal audit program should be part of the overall quality system, be approved by top company and QA management, and have a detailed written description of the key elements of the program. Each PAH is unique regarding size, facilities, personnel, resources, and methods of operation. Therefore, different types of programs may be appropriate for individual organizations. The three basic audit programs commonly used are (1) a dedicated internal quality audit department, ( 2) a dedicated individual manager with part

- time auditors provided from through out the organization, and (3) a combination of internal and external resources.

5.4 Elements of an Internal Audit Program

. An internal audit program is required by the rule to pro vide an adequate level of independence, a reporting process that ensures an accountable manager is aware of the audit results, and an effective corrective action process. The corrective action process should determine the root causes of deficiencies, corre ct these deficiencies, and prevent the recurrence of deficiencies. The program should have a structure and process designed to improve all system elements and processes that affect product quality. The key elements of an internal audit program are as follo ws:

5.4.1 Audit P lanning.

5.4.1.1 Audit S chedules.

Specific audit schedules should identify areas or activities subject to audit and ensure they are audited in a predetermined frequency and defined timeframe. Audit schedules should be based on the criticality of the activity being audited and should consider factors such as audit result history, production volume, process performance, high

- risk areas, and management concerns.1 0/01/ 15 AC 21

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5

- 2 5.4.1.2 Auditor Selection

.

The internal q uality audit program should specify that auditors receive training in auditing, audit principles, and systems analysis techniques. When full

- time dedicated audit resources are not practical, developed procedures should show that persons perform ing audits o r supervising audit teams are not directly responsible for the areas being audited.

5.4.1.3 Audit Preparation

.

The auditor needs to be cognizant of internal and external requirements and other factors that may impact the process.

5.4.1.4 Checklist Development

.

A thorough audit program should determine and evaluate how an organization’s quality manual, operating procedures, process controls, methods, and practices account for and incorporate all internal and external requirements. The questions contained in a check list, in effect, transpose standards, regulations, or procedural requirements into a series of questions. The checklist denotes points to be checked and helps the auditor determine the correct order in which to proceed with an audit.

5.4.2 Conducting the Audit

. The auditor should use the audit checklist to gather evidence to determine compliance or noncompliance to the quality system or standard being evaluated. Evidence is gathered via review of products or articles, documents, observation of activities, recor d checks, and interviews with key individuals in the area(s) under review. Evidence gathered during the audit should be documented as the audit is conducted.

5.4.3 Reporting the Results

. A report should be prepared documenting the results of the audit. Procedu res should be in place allowing straight

- line reporting from the a udit team to top company and QA management. The audit report should , at a minimum, include the following:

 Date the audit was conducted,

 Auditor performing the audit,

 Standard or procedure the audit was conducted against (for example, part 21 requirements or the PAH Quality Manual),

 Summary of findings. This should include a brief description of the findings and supporting documents (for example, PAH procedures or recor ds),

 Evaluation and relative importance of a finding (major or minor), and

 Summary of observations, both positive and negative.

5.4.4 Root Cause / C orrective and P reventive A ction. The PAH should determine root cause and develop a c orrective and preventive action plan.1 0/01/ 15 AC 21

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5

- 3 5.4.5 Close the Audit F indings. After the process owner indicates completion of the corrective action, QA management should verify that process changes effectively corrected the existing deficiency and prevented recurrence. If the verification process in dicates that the corrective action was not effective, top company management should be notified. QA management should then request additional corrective action and revalidation from the process owner.

5.4.6 File Report

. Audit reports, including corrective actio n and closure data, should be maintained.1 0/01/ 15 AC 21

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6

- 1 CHAPTER 6. ADDITIONAL PAH REQUI REMENTS

.

6.1 Quality Manual

. Sections 21.138, 21.308, and 21.608 state that each applicant or current PAH provide a manual describing its quality system to the FAA for approval. The manual is required by the rule to be in the English language and retrievable in a form acceptable t o the FAA.

6.1.1 If the quality manual is stored digitally through a comp uter

- based medium, it should be easily available to P AH s and FAA personnel who need to use the manual for performing their duties.

6.1.2 PAHs are reminded that the manual is required by the rule to address all of the quality system requirements in 21.137.

6.2 Location of or Change to Manufacturing Facilities

. Sections 21.139, 21.309, and 21.609 state that a PAH may obtain a production approval for manufacturing facilities located outside the United States, if the FAA finds no undue burden in administering the applicable requirements of Title 49 of the United St ates Code and this subchapter.

6.2.1 The PAH is required by the rule to obtain FAA approval before making any changes to the location of any of its manufacturing facilities.

6.2.2 The PAH is required by the rule to immediately notify the FAA, in writing, of any change to the manufacturing facilities affecting the inspection, conformity, or airworthiness of its product or article.

6.2.3 Each applicant for a production approval or current PAH should check with its local MI DO to determine approval and notification methods.

6.3 Inspections and Tests

.

6.3.1 Sections 21.140, 21.310, and 21.610 state that each applicant or current PAH allow the FAA to

—

 Inspect its quality system, facilities, technical data, and manufactured products or

a rticles

.

 Witness any tests including any inspections or tests at any supplier facility (within the PAH’s supply chain) necessary to determine compliance with the applicable subchapter.

 The PAH should ensure FAA access to, and cooperation of, all involved facilities in the supply chain

. The PAH should also ensure access to

, and cooperation of

, all involved facilities in the supply chain for it sel f or its representatives.1 0/01/ 15 AC 21

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6

- 2 6.3.2 Section 21.310 also prescribes prohibitions unique to that section. PAHs operating und er s ubpart K should refer to the applicable section to ensure they are not in violation of those prohibitions.

6.4 Issuance of a Production A pproval. Sections 21.141, 21.311, and 21.611 states that the FAA issues a production approval after finding that the a pplicant complies with the requirements of the applicable subpart.

6.4.1 Applicants for a production approval should ensure they have reviewed and documented how they have met the applicable requirements so the FAA may complete a timely review.

6.4.2 Applicants for a production approval that are part of a multinational and/or multicorporate consortium may refer to appendix G to this AC for further guidance on how to comply with § 21.137.

6.5 Production Limitation R ecord. Section 21.142 , Production limitat ion record, states that the FAA will issue a PLR as part of a PC

. A PLR lists the TC number and model of every product the PC holder is authorized to manufacture , as well as every interface component a PC holder is authorized to manufacture and install und er part 21

. PC holders should ensure the PLR accurately reflects any product it intends to manufacture and any interface component it intend s to manufacture and install

.

6.6 Duration.

6.6.1 Sections 21.143, 21.313, and 21.613 state that a production approval be con sidered effective until it is surrendered, suspended, revoked, o r terminated by the FAA. There are minor differences between the duration of a PC and that of a PM A or TSO authorization. Applicants receiving a production approval should refer to the applicable section for information on the duration of a particular production approval.

6.6.2 Section 21.613 also sets forth the requirements for revised or canceled TSOs. The holder of an affected FAA letter of acceptance of a statement of conformance, TSO
aut horization, or letter of TSO design approval, may continue to manufacture articles that meet the original TSO without obtaining a new acceptance, authorization, or approval. However, the holder is required by the rule to comply with the requirements of thi s chapter

.

6.7 Transferability. Sections 21.144, 21.314, and 21.614 state that a PAH may not transfer the production approval or letter of TSO design approval.1 0/01/ 15 AC 21

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6

- 3 6.7.1 T he FAA prohibits th at transfer of a production approval, but the FAA recognizes that companies do change ownership. In many cases, design data, quality systems, and manufacturing processes are all transferred as part of the change in ownership, and in these instances the FAA will support the establishment of a new production approval.

6.7.2 Applicants for new production approvals based on previously issued production approvals should consult their local ACO and MIO for assistance.

6.8 Privileges.
Section 21.145 , Privileges, identifies privileges associated with a production certificate. PAHs should refer to th e applicable section to ensure that they know these privileges.

6.9 Responsibility of Holder

. Sections 21.146, 21.316, and 21.616 prescribe a PAH ’ s responsibilities. PAHs should refer to the appropriate rule section for the type of production approval they wish to obtain or maintain to ensure they understand all of the applicable requirements.

6.9.1 The PAH is responsible 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 revenue sharing partners, or co

- producers.

6.9.2 Although this res ponsibility never changes, the PAH may be relieved of some of the burden of inspection and testing duties when it uses type

- certificated products or articles manufactured under another person’s production approval. This relief may be extended to include pr oducts or articles manufactured in a foreign country and imported into the United States under the provisions of a bilateral agreement pursuant to part 21, subpart N, Approval of Engines, Propellers, Materials, Parts, and Appliances: Import.

6.9.3 All types of PAHs now have substantially similar responsibilities, as described below.

6.9.3.1 Paragraph (a) of each section requires the PAH to document any

organizational changes. Such documentation 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 the respective subpart. The PAH is required by the rule to provide these amendments to the FAA. This requirement ensures the FAA remains informed of changes in a PAH’s organization as well as its continued compliance with the respective subpart

.
6.9.3.2 Paragraph (b) of each section requires a PAH to maintain its quality system

in compliance with the data and procedures approved for its production approval.1 0/01/ 15 AC 21

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6

- 4 6.9.3.3 Paragraph (c) of e ach section requires a PAH to ensure each product

or article conforms to its approved design and is in a condition for safe operation.

6.9.3.4 Paragraph (d) of each section requires a PAH to mark its product or article

in accordance with part 45, including critical parts.

6.9.3.5 Paragraph (e) of each section requires a PAH to identify any parts of the

product or article that leave the manufacturer’s facility as FAA

- approved. This includes the manufacturer’s part number and name, trademark, symbol, or other FAA

- appr oved PAH identification. (Examples of other FAA

- approved PAH identification are production approval number, cage code, or a federal supply code for manufacturers (FSCM).) The information may be conveyed in the form of stickers, tags, shipping documents, sh ipping containers, or by other means. This information may also be applied directly to the subassemblies or component parts in accordance with approved data.

6.9.3.6 Paragraph (f) of each section requires a PAH to have access to type design

data necessary to deter mine conformity and airworthiness for each product and article produced under its production approval. TSO authorization holders have the additional requirement of retaining this data until they no longer manufacture the article. At that time, copies of th e data are required by the rule to be sent to the FAA.

6.9.3.7 Paragraph (g) of each section requires a PAH to retain the document(s)

granting production approval and make it available to the FAA on request.

6.9.3.8 Paragraph (h) of each section requires a PAH to make ava ilable to the FAA

information regarding all delegation of authority to suppliers. This includes delegations for the purpose of performing major inspections, delegations related to direct ship authorization, and delegations related to the disposition of non conforming material.

6.10 Amendment of Production Certificates.
Section 21.147 , Amendment of production certificates, requires :

6.10.1 Any applicant for an amendment to a PC seeking to add a type certificate

, model, or both must comply with §§ 21.137, 21.138, and 21. 150.

6.10.2 Any applicant for an amendment to a PC , under § 21.147, must apply in a form and manner prescribed by the FAA. Currently, the FAA expects an applicant to submit a properly executed FAA Form 8110

- 12, Application For Type Certificate, Production Certificate, Or Supplemental Type Certificate

. An y applica tion for an interface component should clearly note that in block 5.a.1 0/01/ 15 AC 21

- 43A

6

- 5 6.10.3 Under § 21.147(c), a ny applicant may apply to amend its PLR to allow the manufacture and installat ion of an interface component

, provided

—

 The applicant owns or has a license to use the design and installation data for the interface component

, and ma k e s that data available to the FAA on request.

 The interface component is manufactured by the applicant.

 The applicant’s product conforms to its approved type design

, and the interface component conforms to its approved type design.

 The assembled product with the installed interface component is in a condition for safe operation unless otherwise noted

.

 The a pplicant complies with any other conditions and limitations the FAA considers
necessary.

6.11 Approval for Deviation

. Section 21.618 , Approval for deviation, requires a manufacturer requesting approval to deviate from a performance standard of a TSO to show that factors or design features provide an equivalent level of safety and compensate for the standards from which a deviation is requested. The manufacture r will send requests for approval to deviate to the appropriate ACO, along with all pertinent data. If the article is manufactured under the authority of a foreign country or jurisdiction, the manufacturer will send requests for approval to deviate, along with all pertinent data, through the CAA of that country or jurisdiction to the FAA.

6.12 Design Changes

. Sections 21.319 and 21.619 prescribe what constitutes a major or minor design change, as well as who may make those changes. Minor changes will be approved under a method acceptable to the FAA. Major changes are required by the rule to be approved by the FAA before they can be included in the design of the product or article. PAHs that are uncertain if a design change is major or minor should consult with the FAA before implementing the changes.

6.13 Changes in Quality System

. Sections 21.150, 21.320, and 21.620 establish that each change to the quality system is subject to FAA review. Additionally , the PAH is required by the rule to immediately notify t he FAA, in writing, of any change that may affect the inspection, conformity, or airworthiness of its product or article. PAHs that wish to initiate changes to the quality system should submit the proposed changes to the MIO, MIDO, or Manufacturing Inspect ion Satellite Office (MISO) with certificate management responsibilities.1 0/01/ 15 AC 21

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6

- 6 6.14 Issuance of Letters of TSO Design Approval : Import Articles

. Section 21.621 , Issue of letters of TSO design approval: Import articles, prescribes under what conditions a letter of TSO design approval may be issued for imported articles.1 0/01/ 15 AC 21

- 43A Appendix A

A

- 1 APPENDIX A. RELATED PUBLICATIONS

.

A.1 Federal Aviation Administration (FAA) Orders

.

 FAA Order 8000.95

, Designee Managemen t Policy

.

 FAA Order 8100.8, Designee Management Handbook

.

 FAA Order 8100.11, Decision Paper Requirements for Undue Burden and No Undue Burden Determinations Under 14 CFR p art 21 for Production and Export Airworthiness Approval s

.

 FAA Order 8100.15

, Organization Designation Authorization Procedures

.

 FAA Order 8110.4, Type Certification

.

 FAA Order 8110.42, Parts Manufacturer Approval Procedures

.

 FAA Order 8120.22, Production Approval Procedures

.

 FAA Order 8120.23, Certificate Management of Production A pproval Holders

.

 FAA Order 8120.12, Production Approval Holder Use Of Other

- Parties To Supplement Their Supplier Control Program

.

 FAA Order 8120.13, International Cooperative Supplier Surveillance Program Procedures

.

 FAA Order 8130.21, Procedures for Compl etion and Use of the Authorized Release Certificate, FAA Form 8130

- 3, Airworthiness Approval Tag

.

A.2 FAA Advisory Circulars (AC).

 AC 20

- 115, Airborne Software Assurance

.

 AC 21

- 2, Complying with the Requirements of Importing Countries or Jurisdictions when Exporting U.S. Products, Articles, or Parts

.

 AC 21

- 18, Bilateral Airworthiness Agreements

.

 AC 21

- 23, Airworthiness Certification of Civil Aircraft, Engines, Propellers, and Related Products Imported to the United States

.

 AC 21

- 24, Extending a Production Certificate to a Facility Located in a Bilateral Airworthiness Agreement Country

.

 AC 21

- 44, Issuance of Export Airworthiness Approvals Under 14 CFR Part 21 Subpart L

.1 0/01/ 15 AC 21

- 43A Appendix A

A

- 2 A.3 Society of Automotive Engineers ( SAE ) Documents. Copies may be pu rchased from the SAE.

 SAE Aerospace Recommended Practice (ARP) 9005, Aerospace Guidance for Non

- Deliverable Software

.

 SAE ARP9013, Statistical Product Acceptance Requirements

.

 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

.

 SAE ARP9013/4, Statistical Pro duct Acceptance Requirements Using Continuous Sampling, Skip

- Lot Sampling, or Methods for Special Cases

.

 SAE ARP9114, Direct Ship Guidance for Aerospace Companies

.

 SAE ARP9134, Supply Chain Risk Management Guidelines

.

 SAE Aerospace Standard (AS) 9006, Deliverable Aerospace Software Supplement for AS9100A

.

 SAE AS9100 C

, Quality Management Systems

- Aerospace Requirements

.

 SAE AS9102A, Aerospace First Article Inspection Requirement

.

A.4 Other Documents

.

 National Aerospace Standard (NAS) 410, NAS Certificati on and Qualification of Nondestructive Test Personnel

.

 Industrial Fasteners Institute Standard IFI

- 301, Gage Calibration Requirements and Procedures for Thread Gages

.1 0/01/ 15 AC 21

- 43A Appendix B

B

- 1 APPENDIX B. DEFINITIONS

.

For the purposes of this document, the following definitions apply.

B.1 Accountable Manager. A representative of the applicant for

, or holder of

, a production approval

. An accountable manager serves as a PAH’s primary contact with the FAA office responsible for issuance of the production approval or certificate management of the PAH

. The accountable manager is responsible within the applicant’s or PAH’s organization for, and has the authority over, all pr oduction operations conducted pursuant to 14 CFR part 21 , Certification Procedures for Products and Articles

. The accountable manager confirms that the procedures described in the quality manual required by § § 21. 138, 21. 308

, or 21. 608 are in place and that the production approval holder satisfies the requirements of subchapter C, Aircraft

.

B.2 Airworthiness Approval. A document issued by the FAA for an aircraft, aircraft engine, propeller, or article that certifies the aircraft, aircraft engine, propeller, or article conforms to its approved design and is in a condition for safe operation , unless otherwise specified

.

B.3 Applicable Design Data. All necessary drawings, specifications, and other techni cal information provided by the applicant for, or the holder of, a design orga nization approval, TC, STC, TSO authorization, PMA , or equivalent, and released in a controlled manner for production purposes.

B.4 Approved. Unless used with reference to another person, means approved by the FAA or any
pe rson to whom the FAA has delegated its authority in the matter concerned, or approved under the provisions of a bilateral agreement between the United States and

= a foreign country or jurisdiction.

B.5 Approved Design Data. Applicable design data that has be en granted an appr oval (for example, TC, STC, TSO authorization, PMA, or equivalent) by the relevant CAA.

B.6 Article. A material, part, component, process, or appliance.1 0/01/ 15 AC 21

- 43A Appendix B

B

- 2 B.7 Authorizations. Permission granted by management to individuals authorized with full or partial admission to restricted access information management systems.

B.8 Authorized Release Document. A document issued by a PAH for an aircraft engine, propeller, or article that certifies the aircraft engine, propeller, or article conforms to its approved design and is in a condition for safe operation, unless otherwise specified.

B.9 Data. A set of alphanumeric and/or graphic characters organized to represent facts or instructions suitable for communicating, interpreting, or processing by a compute r.

B.10 Direct Ship Authorization. The written authorization granted by a PAH with responsibility for the airworthiness of an article, to a supplier to ship articles produced in accordance with the PAH’s quality system, directly to end users without the parts being processed through the PAH’s own facility.

B.11 Field. An element of a computer file that may contain data and whose size is controlled by the
program.

B.12 Information Systems. A computer system designed to automate a specific function, such as records management.

B.13 Interface Component. An article that serves as a functional interface between an aircraft and an aircraft engine, an aircraft engine and a propeller, or an aircraft and a propeller. An interface component is designated by the holder of the type certificate or the supplemental type certificate who controls the approved design data for that article.

B.14 Licensing Agreement. A commercial agreement between a TC or STC holder and a PAH (or applicant) formalizing the rights and duties of both partner s to use the design data for the purpose of manufacturing the product or article.1 0/01/ 15 AC 21

- 43A Appendix B

B

- 3 B.15 Privacy Keys. A password or procedure that allows full or partial access to a restricted information management system.

B.16 Privacy Locks. A procedure that restricts access to a portion of an information system.

B.17 Production Approval. A document issued by the FAA to a person that allows the production of a product or article in accordance with its approved design and approved quality system and can take the form of a production certificate, a PMA, or a TSO authorization.

B.18 Quality Escape. A product or article that has been released from the quality system and does not conform to the applicable design data or quality system requirements.

B.19 Quality System. A documented organizationa l structure containing responsibilities, procedures, processes, and resources that implement a management function to determine and enforce quality principles

.

B.20 Read

- O nly Capability. The authority given to an individual, allowing that person to access or r ead data in a field without being able to change or enter data.

B.21 Salvageable. Aviation parts that are unserviceable (or of unknown status) that may have a potential aviation use. Salvageable parts may be considered in different categories:

 Non

- airworthy p arts which may be worth storing until restored to an airworthy condition, or until they are shown to be airworthy with adequate documentation and/or testing; and

 Parts that cannot be found airworthy at the time they are stored; but, there is reason to beli eve that they are likely to have future aviation value. For example, a part that has reached its present life limit may be stored in an area in anticipation of an increase in that limit based on in

- service experience and analysis, or a part that requires r epair for which there is currently no approved process may be stored in anticipation of a new approved process.1 0/01/ 15 AC 21

- 43A Appendix B

B

- 4 B.22 Scrap. Products and articles an owner has disposed of because they are beyond economical repair, considered to be of little value, or unusable for any other aviation reason. Scrap products and articles are placed into four categories:

 Products and articles that have no value except for the base material.

 Products and articles whose misuse in aviation poses an insignificant safety risk.

 Products and articles that were used in low

- risk

, safety aviation applications and may have future use in non

- aviation applications.

 Products and articles that were used in safety

- critical aviation applications and may have future use in non

- aviation applications.

B.23 Standard Part. A part manufactured in complete compliance with an established g overnment or industry

- accepted specification that contains design, manufacturing, and uniform identification requirements. The specification must inclu de all information necess ary to produce and conform the part, and must be published so any person/organization
may manufacture the part

.

B.24 Supplier. Any person

, as defined by 14 CFR 1. 1, 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.

B.25 Write Capability. The authority given to a user that allows that person to enter or change data in a field.1 0/01/ 15 AC 21

- 43A A ppendix C

C

- 1 APPENDIX C. PRODUCTION UNDER TYP E CERTIFICATE

.

C.1 Purpose. This appendix covers only those sections of 14 CFR part 21, subpart F, Production Under Type Certificate, where further discussion, information, or examples would b e helpful. The headings of each of the following main paragraphs refer to the applicable section of subpart F. A manufacturer producing a product under subpart F is allowed to produce and sell articles associated with its product as spares for that product only.

C.2 Discussion.

C.2.1 Section 21.121, Applicability. The term “production under a type certificate” refers to production by a TC holder or its licensee without benefit of a production approval for that product or article thereof.

C.2.2 Section 21.122, Location of or change to manufacturing facilities.

C.2.2.1 If the FAA finds no undue burden in administering the applicable

requirements of Title 49 of the United States Code and 14 CFR chapter I,

s ubchapter C

, Aircraft, the manufacturer may use manufacturing facilities loca ted outside of the United States.

C.2.2.2 The TC holder is required by the rule to obtain FAA approval before

making any changes to the location of any of its manufacturing facilities.

C.2.2.3 The TC holder is required by the rule to immediately notify the FAA, in

writi ng, of any change to the manufacturing facilities that may affect the inspection, conformity, or airworthiness of its product or article thereof.

C.2.2.4 Each TC holder should check with its local MIDO to determine approval

and notification methods.

C.2.3 Section 21.12 3, Production under type certificate.

C.2.3.1 Paragraph (c) requires each manufacturer of a product or article thereof

under a TC to maintain completed inspection and test records for 5 years. For critical parts identified pursuant to 14 CFR part 45, Identificatio n and Registration Marking, s ection 45.15(c), the record retention requirement is 10 years. The beginning of the 5

- year or 10

- year record retention for a given product or article thereof corresponds to the manufacturing completion date of that product or a rticle. These records will enable the TC holder to prove to the FAA that it has properly completed and documented all inspections and tests required to ensure compliance with subpart F. Manufacturers are required by the rule to maintain evidence that indicates conformance or nonconformance of the product or article thereof regarding required inspections and tests.1 0/01/ 15 AC 21

- 43A A ppendix C

C

- 2 C.2.3.2 Paragraph (d) requires each manufacturer of a product or article thereof

m anufactured under a TC to allow the FAA to make any inspection or test (including any inspection or test at a supplier facility) necessary to determine compliance. “Allowing” means the manufacturer will

—

 Give free and full access to facilities, information , and relevant data to show compliance with this subchapter, and

 Provide appropriate assistance to the FAA to enable the FAA to perform these inspections and tests. Inspections and tests include audits, inquiries, questions, discussions, monitoring, witnes sing, checks, flight and ground tests, and inspections of in

- process and completed products or articles thereof, and all relegated design data.

C.2.3.3 Paragraph (f) requires a TC holder to identify any parts of the product that

leave the TC holder’s manufacturing facility as FAA

- approved. This includes the manufacturer’s part number and name, trademark, symbol, or other FAA

- approved identification (for example, a cage code or a n FSCM). The information may be conveyed in the form of stickers, tags, shipping documen ts, shipping containers, or by other means. This information may also be applied directly to the subassemblies or component parts in accordance with approved data.

C.2.3.4 Paragraph (g) requires the manufacturer producing under subpart F to

obtain a production ap proval under subpart G, Production Certificates, within 6 months of the TC’s issuance. The following requirements apply:

 During the 6

- month period from the TC’s issue date, each completed product or article thereof is subject to FAA inspection before the i ssuance of airworthiness certificates or approvals. Because of limited FAA monetary and manpower resources, these inspections may be delayed or be very time

- consuming, and would normally allow a very low production rate by the TC holder. It is, therefore, to the TC holder’s advantage to develop and implement an approved system in accordance with subpart G as quickly as possible.

 If the TC holder does not establish and implement an approved system in accordance with subpart G at the end of the 6

- month perio d, and there are no extenuating circumstances to preclude such establishment and implementation, the FAA may discontinue inspections until an approvable system has been established.

C.2.4 Section 21.127, Tests: aircraft.

C.2.4.1 Before the production flight test of airc raft, any items coming under the

provisions of § 21.127(b)(5) should be checked. For example, it is important that

—1 0/01/ 15 AC 21

- 43A A ppendix C

C

- 3  The means provided to level the aircraft are accurate and in conformity with type design data.

 Each aircraft is weighed to determine the emp ty weight and center of gravity is in conformity with the type design data.

C.2.4.2 The flight test procedure and flight check

- off form, required to be

established and approved under § 21.127, should be submitted to the FAA ACO for approval.

C.2.5 Section 21.128, Tests: aircraft engines.

C.2.5.1 The test equipment used for test runs should be capable of accurate output

determinations sufficient to ensure the engine output delivered complies with official ratings and operating limitations.

C.2.5.2 Following the tests prescribed by § 21.1 28, each engine is subject to

FAA inspection to determine the engine is in condition for safe operation. Such inspection may also include internal inspection and examination to ensure no unsafe condition exists. The degree of internal inspection will

norma lly be determined by the cumulative results of such inspections conducted on the first production engines, and by service experience. The FAA may consider a statistical plan for intern al engine inspections if the TC holder submits a proposal based on produ ct uniformity, a satisfactory history of previous internal inspections, and service experience.

C.2.6 Section 21.129, Tests: propellers.

C.2.6.1 An acceptable functional test for variable pitch propellers would include

25 complete cycles of the control throughout the propeller pitch and rotational speed ranges. Additionally, for feathering or reversing propellers, there should be five cycles of feathering operation and five cycles of reversing operation from the lowest normal pitch to the maximum reverse pitch.

C.2.6.2 Followi ng the functional test, each propeller is subject to inspection by the

FAA in a similar manner as that described for engines in paragraph C.2.3 of this appendix.

C.2.7 Section 21.130, Statement of conformity.
O n receipt of the statement of conformity, the FAA will inspect the completed product to determine it conforms to the type design and is in a condition for safe operation. If so, an airworthiness certificate will be issued for aircraft, or an airworthiness approval tag will be issued for an engine, propeller, or articles thereof.1 0/01/ 15 AC 21

- 43A A ppendix D

D

- 1 APPENDIX D. SCRAP OR SALVAGEABLE AIRCRAFT PRODUCTS AN D ARTICLES

.

D.1 Purpose. The information provided in this appendix may be used by production approval holders and their suppliers. This information may be

—

 Applied to manufacturers involved in the cont rol, distribution, sale, main tenance,

or disposition of scrap or salvageable aircraft engines, aircraft propellers, and aircraft articles

.

 Used to identify, segregate, and control rejected products and articles to preclude their use in a finished product.

D.2 Background. Products and articles may be deemed scrap or salvageable once they are determined as unserviceable or ineligible for installation on an aircraft, aircraft engine, or aircraft propeller. In some cases, it has been common practice to dispose of scrapped products and articles by selling, discarding, or transferring the articles. A lack of proper industry controls may result in an article being copied or repaired, reintroduced into the market, and being falsely identified as an approved article. Us e of such products and articles can have serious safety implications and liabilities for the manu facturer, aircraft operator,

or repair facility. Using an effective system to control sc rap or salvageable products and articles will reduce the chances that these articles will be distributed or sold

as serviceable.

D.3 Documenting the Process. Maintaining a well

- defined quality program is fundamental to controlling rejected products and articles. One element to be addressed within this program is the control and disposal of scrap and salvageable products and articles. Quality systems without this element could allow products and articles to migrate back into active inventories.

D.4 Preventing Misrepresentation of Scrap Products and Articles.

D.4.1 Manufacturers should disp ose of scrap products and articles through mutilation, when appropriate. Proper and thorough mutilation of products and articles will ensure they are unusable for their original application and render them incapable of being reworked or camouflaged to prov ide the appearance of being serviceable.

D.4.2 Effective mutilation may be accomplished by one or a combination of the following methods: grinding, burning, removal of a major integral feature, permanent distortion of products and articles, cutting a significan t size hole with a cutting torch or saw, melting, sawing into many small pieces, and removing manufacturer identification, part, lot, batch, and serial number.1 0/01/ 15 AC 21

- 43A A ppendix D

D

- 2 D.5 Disposing of Scrap Products and Articles. Manufacturers disposing of scrap products and article s may choose to release them for legitimate

non

- flight use. This non

- flight use may include training, education, research and development, tool set up, or non

- aviation applications. In such instances, mutilation may not be appropriate. The following method s may be used to prevent future misrepresentation:

D.5.1 Permanently and clearly mark the products and articles as “Not for Aviation Use” and “Not Serviceable.” Ink stamping is not normally considered an acceptable method unless indelible ink is used and the products and articles are checked to ensure the ink cannot be removed.

D.5.2 Remove part number identification.

D.5.3 Remove identification plate and marking.

D.5.4 Maintain a tracking or accountability system, by serial number or other individualized data, to record transf

erred scrap products and articles.

D.5.5 In any agreement or contract transferring scrap products and articles, develop written procedures identifying disposition and disposal requirements.

D.5.6 Secure a signed certification statement from the purchaser indicating “t he purchaser will not use or convey these products and articles for use in aviation products.”

D.5.7 For those articles determined to be scrap and having no further aviation use, manufacturers should

—

 Establish and maintain procedures requiring documentation (f or example, a written contract) from scrap dealers indicating their intent to properly dispose of all products and articles received.

 Establish and maintain procedures to audit scrap dealers to their
contract requirements.

 Maintain records of serial numb ers for scrapped life

- limited or other critical products and articles. In such cases, the owner who mutilates applicable products and articles is encouraged to provide the original manu facturer with the data plate

or serial number and final disposition of the product or article.

D.6 Preventing Misrepresentation of Salvageable Products and Articles.

D.6.1 Manufacturers handling salvageable products and articles should

—

 Establish secure areas to segregate such articles from active serviceable inventories and to prevent unauthorized access.

 Develop procedures to address the retention of records for products and articles exceeding current repair criteria and life limits and that are being held in anticipation of future repair methods or extension to life limits. Caution should1 0/01/ 15 AC 21

- 43A A ppendix D

D

- 3 be exercised to ensure these products and article s receive the appropriate final disposition.

D.6.2 Aviation safety is best served with sound processes that control scrap and salvageable products and articles. Using the practices identified i n this docume nt will reduce the potential that these articles will be distributed and sold as serviceable products. With aviation safety in mind, the aviation community is responsible for preventing misrepresentation of aviation products and articles. The FAA encourage s manufacturers to establish a program that controls scrap and salvageable products and articles as an integral part of their quality management systems.

D.6.3 M isrepresented products and articles that are offered for sale, or have been furnished for aviation us e, should be reported to the FAA. This may be accomplished by submitting FAA Form 8120

- 11, Suspected Unapproved Parts Notification, or by calling the Aviation Safety Hotline toll free number, 800

- 255

- 1111.1 0/01/ 15 AC 21

- 43A Appendix E

E

- 1 APPENDIX E. ISSUING AUTHORIZED R ELEASE DOCUMENTS FOR AIRCRAFT ENGINES, PROPELLERS, AND ARTI CLES

.

E.1 Purpose. This appendix provides guidance to any PAH o n developing procedures to comply with 14 CFR 21.137(o)

. These procedures are required before a PAH may issue authorized release documents, using FAA Form 8130

- 3, for new aircraft engines, propellers, and articles manufactured by the production approval holder , or for used aircraft engines, propellers, and artic les when rebuilt or altered pursuant to § 43.3(j).

E.1.1 A PAH may choose to either issue its own authorized release documents or rely on FAA personnel or designees. A PAH is required to have procedures under § 21.137(o) only if th e PAH seeks to issue its own authorized release documents

. However, after the FAA has approved a PAH’s procedures to allow the PAH to issue authorized release documents

, the FAA expect s the PAH to u se its own approved system , rather than relying on the FAA for Form 8130

- 3 approval

.
E.1.2 Section 21.137(o) requires any PAH issu ing authorized release documents to establish quality system procedures provid ing for the selection, appointment, training, management, and removal of individuals authorized by the PAH to issue authorized release documents. These procedures should ensure that individuals selected to issue authorized release documents meet the qualifica tion requirements for an FAA DMIR with function code 03, as described in FAA Order 8000.95, Designee Management Policy

.

E.2 Background, Knowledge, and Experience. In selecting and appointing individuals authorized to issue authorized release documents, a PAH should ensure those selected individuals possess knowledge of the applicable FAA regulations, policies, guidance, and procedures

, and have the technical experience and skills appropriate for the complexity of the product or article for which an authorized release document is to be issued. In addition, a PAH’s selection and appointment records should show that each selected individual’s background, knowledge, and experience demonstrate his or her integrity and ability to apply sound judgment. The FAA strongl y suggest s any PAH review the knowledge, experience, skill, and training standards described in FAA Order 8000.95 and used by the FAA to select and appoint designees pursuan t to 14 CFR part 183

, Representatives of the Administrator

.

E.3 Authorized Personnel.
A PAH’s FAA

- approved procedures should include a current list of all personnel authorized to issue authorized release documents. This list should include each authorized individual member by name, function(s), scope or limitations, and the location at whi ch each authorized individual’s functions are to be conducted. The1 0/01/ 15 AC 21

- 43A Appendix E

E

- 2 PAH’s authorized procedures should conform to current FAA policy and, a t a minimum, address the following:

E.3.1 A process for determining the number of individuals needed to support the company’ s workload.

E.3.2 The specific functions, product s , or article s for which the authorized individual will issue authorized release documents

, and any locations where th os e services will be needed. This should include both PAH facilities and approved supplier loca tions.

E.3.3 The general knowledge, type and length of experience, and technical qualification requirements needed for a specific function, product, or article.

E.3.4 The PAH’s t raining and testing requirements, including initial, ongoing, and recurrent testing and tr aining , and the required frequencies. Training topics should include:

 Initial Engines, Propellers, and Articles Training, recurring every 36 months ;

 Procedures for completing FAA Form 8130

- 3 Authorized Release Document ;

 Complying with requirements of impor ting countries or jurisdictions when exporting U.S. products, articles, or parts ; and

 Understanding and complying with regulations pursuant to 14 CFR p art 21

, s ubparts H and L

.
E.3.5 The continuous oversight and monitoring of all authorized individuals and their activities, regardless of location. This includes, for example, the scope of the oversight and its frequency.

E.3.6 Methods for maintaining adequate records for each authorized individual. This includes establishing a record retention period. The records should , a t a minimum, contain the following information for each selected individual:

 Name
,

 Date of birth

,

 Experience

,

 Verifiable references (technical and character)

,

 Training status

,

 Scope of the authorization

,

 Location(s) at which functions are to be conducte d

,

 Date of authorization

,

 Appointment status

,

 Expiration date of authorization ( as appropriate ), and

 Identification number of authorization ( as appropriate ).1 0/01/ 15 AC 21

- 43A Appendix E

E

- 3 E.3.7 A method for withdrawing an authorization from a supplier location

.
E.3.8 Evidence of authorization. The method used should make it very clear to the PAH, the authorized individual, and the FAA who is authorized and the overall scope and limitations of their authorization.

E.3.9 A m ethod for auditing the effectiveness of the overall authorized release document pro gram.

E.3.10 A p rocess for removing or revising the scope of an individual’s authorization

.
E.3.11 The r etention period for records related to the issuance of each authorized release document (that is, FAA Form 8130

- 3).

E.4 Completing FAA Form 8130

- 3. Section 21.137(o) requires any PAH who choose s to issue authorized release documents, to have an established quality system procedure for completing authorized release documents.

E.4.1 These procedures should include requirements for completing FAA Form 8130

- 3 that meet FAA Orde r 8130.21 Chapters 1, 2, and 4

. When establishing a procedure for completing the authorized release documents, a PAH should incorporate by reference
any applicable procedures from FAA Order 8130.21

. The latest revision of FAA Order 8130.21 will always have the most up

- to

- date instruction s applicable to a ny person with authority to complete authorized release documents

. Blocks 13b., 13c., 13d., 14b., 14c., and 14d. require information that is specific to each PAH. The following instructions should be included in the procedures for completing the authorized release documents:

E.4.1.1 Block 13.b. Authorized Signature.

This space should be signed by an authorized person. Only a perso n authorized under a PAH’s approved quality system that includes the procedures pursuant to § 21.137(o) may sign this block.

E.4.1.2 Block 13.c. Approval/Authorization No.

Enter the approval or authorization number of the authorized representative

or organization identified in Block 13b. Also, for a PAH, e nter the applicable production approval number (for example, PT1234CE or PQ1234NM).

E.4.1.3 Block 13

. d. Name (Typed or Printed).

Enter the typed or printed name of the authorized representative or organization whose sig nature appears in Block 13b.1 0/01/ 15 AC 21

- 43A Appendix E

E

- 4 E.4.1.4 Block 14.b. Authorized Signature.

This space should be signed by an authorized person. Only a person authorized under a PAH’s approved quality system that includes the procedures pursuant to § 21.137(o) may sign this block.

E.4.1.5 Bl ock 14.c. Approval/Authorization No.

Enter the approval/authorization number of the authorized representative/organization identified in Block 13b. Enter the applicable production approval number (for example, PT1234CE or PQ1234NM).

E.4.1.6 Block 14.d. Name (Type d or Printed).

Enter the typed or printed name of the authorized representative or organization whose signature appears in Block 14b.

E.4.2 If a PAH manufactures a product or article for export, the PAH is responsible for ensuring that it complies with applicab le bilateral agreements and with §§ 21 .331 and 21.335

. AC 21

- 2, Complying with the Requirements of Importing Countries or Jurisdictions When Exporting U.S. Products, Articles, or Parts , provides information and guidance regarding the requirements of import ing countries or jurisdictions.

E.4.2.1 If an exporter cannot comply with § 21.331(a) and (c), it must notify the

FAA before issuance of FAA Form 8130

- 3

. T he FAA will request a written statement from the importing CAA indicating the CAA’s acceptance of the aircraft engine, propeller, or article. Governmental authorities will transmit and receive requests for acceptance before export. The FAA will notify the exporter of the CAA’s written response , at which point t he PAH can issue the export documentation.

E.4.2.2 As provided in § 21.331(b) and (d), if the CAA of an importing country or

jurisdiction accepts any deviations from § 21.331(a) and (c), the PAH must list as exceptions any differences between the aircraft engine, propeller, or article on the approval or authorized release document. All deviations as exceptions should be noted in the form’s “Remarks” block, referencing the importing CAA’s written statement of acceptance. The form also should be accompanied by a copy of the importing CAA’s statement of acceptance.1 0/01/ 15 AC 21

- 43A Appendix F

F

- 1 APPENDIX F. PRODUCTION APPROVAL HOLDER / SUPPLIER ARRANGEMENT

.

The following list comprises elements typically found in the arrangement between the PAH and the supplier, if applicable. Guidance on the content of each element is provided, but this is not intended to be comprehensive.
NOTE : The supplier arrangement may indicate whenever the PAH finds one or more of the elements to be inapplicable.

F.1 Scope.

F.1.1 Identify articles to be provided by the supplier and associated supplier facilities.

F.1.2 Identify any limitation(s) defined by the PAH.

F.2 PAH Evaluation. Stipulate that the supplier is acting under the PAH quality system and that all of the corrective actions requested by the PAH will be implemented.

F.3 Implementation Procedures. Attach a quality plan or equivalent documentation to the contract.

F.4 Internal Quality System.

F.4.1 Identify methods for the PAH to evaluate the internal quality system of the supplier.

F.4.2 Describe the interface between the PAH’s quality systems and the supplier in the quality plan.

F.5 Design Data and Configuration Control.

F.5.1 Identify the design data package provided by the PAH , including all pertinent data required for the supplied article(s) to be identified, manufactured, inspected, used, and maintained.

F.5.2 Establish procedures for managing design changes.

F.6 Manufacturing Data. Identify the manufacturing data developed by the sup plier, if any, based on the design data submitted by the PAH. (Refer to paragraph F. 5 of this appendix.)1 0/01/ 15 AC 21

- 43A Appendix F

F

- 2 F.7 Test and Inspections (Including Incoming).

F.7.1 Identify procedures to define the necessary test and inspection processes

—

 To ensure and determine the conformity of the supplied article(s) during the supplier’s manufacturing activities, and on receipt by the PAH.

 To be performed for qualification of the supplier (including first article inspection) and related documentation requirements.

F.7.2 The PAH may rely on inspections/tests performed by a supplier, provided:

 Personnel responsible for these tasks satis fy the quality standards of the PAH,

 Quality measurements are clearly identified, and

 The records or reports showing evidence of conformi ty are available for review and audit.

F.8 Identification and Traceability. Stipulate that the PAH flows

- down to the supplier and any subtier suppliers ’ identification and traceability requirements.

F.9 Supplier Personnel C ompetence. Identify the PAH’s requirements for the compe tence of supplier personnel ( that is

, production, inspection, and quality staff) based on qualifications, education, training, skills, and experience.

F.10 Calibration.

F.10.1 Ensure calibration is traceable to a national standard acceptable to the FAA.

F.10.2 Ensure certif

icates are submitted where suppliers perform calibration services for the PAH.

F.11 Handling, Storage (Segregation), and Packing.

F.11.1 Identify requirements from the PAH concerning handling, storage, packing, and shelf life to be followed by the supplier.

F.11.2 Address s egregation of approved and non

- approved articles as well as nonconforming articles.

F.12 Record Completion and Retention. Identify procedures for document management and retention by the supplier.1 0/01/ 15 AC 21

- 43A Appendix F

F

- 3 F.13 Nonconformities. Identify procedures for handling and document ing nonconformities between the PAH and the supplier, addressing

—

 The identification, documentation, and classification (major, minor) of nonconformities.

 The disposition of nonconformities and the subsequent segregation and control of the nonconforming ar ticles. This includes the secure disposition of scrap articles to avoid reuse (refer to paragraph F. 11 of this appendix).

Note: The disposition of nonconformities is generally the responsibility of the design approval holder. Nevertheless, it may be acceptable to the FAA for the design approval holder to delegate the approval of nonconformities to persons located in the organization of the PAH and its suppliers, thus acting as part of the design approval holder.

 The immediate notification to the PAH on nonconforming articles that have left the supplier’s quality system.

F.14 Conformity Document. Specify the document by which the supplier certifies conformity to the applicable design data to the PAH.

F.15 Provisions for Direct Delivery/Direct Shipment. Identify t he authorization and the requirements for direct delivery/direct shipment to end users from the supplier’s facilities, based on relevant regulatory requirements. (For direct shipment requirements

, refer to chapter 3, paragraph 3.6.11.5 of this AC.)

F.16 Assistance for Continued Airworthiness. Identify procedures for supplier assistance to the PAH for continued airworthiness, including methods to notify and act on notification o f already delivered nonconforming articles, ensuring proper investigation and implementation of corrective action.

F.17 Subtier Suppliers.

F.17.1 Specify the conditions under which the supplier may subcontract to or obtain supplies from a third party.

F.17.2 Specify procedu res for:

 A supplier to flow

- down the FAA and PAH requirements to subtier suppliers.

 Notification to the PAH in case of further subtier supplier activity and/or significant problems encountered during manufacturing.1 0/01/ 15 AC 21

- 43A Appendix F

F

- 4 F.18 Significant change to the Quality System. Require the PAH be notified, as soon as practical, of any changes to the supplier system (evaluated by the PAH) that may affect the quality of the supply.

F.19 Failures, Malfunctions, and Defects. Specify to the supplier the necessary requirements for report ing failures, malfunctions, and defects to ensure the PAH can comply with FAA requirements.

F.20 Access for the PAH and FAA. Ensure access to, and cooperation of, all involved facilities in the supply chain for the PAH and FAA. This will enable

—

 The PAH to ver ify compliance with the PAH

- supplier arrangement and to assess the quality of the contracted articles, and

 The FAA to investigate the PAH’s compliance with the applicable requirements at the supplier level.

F.21 Language. Identify the language to be used for t he exchange of information (including all working documents, such as technical and quality data) that is acceptable to the FAA.

F.22 Identification of Responsibilities. Identify responsible office/function/positions in cha rge for all elements of the PAH

- suppli er arrangement.

F.23 Duration of the Supplier Arrangement. Identify the duration of the supplier arrangement in terms of time and/or quantity of supply to be delivered to the PAH.1 0/01/ 15 AC 21

- 43A Appendix G

G

- 1 APPENDIX G. PRODUCTION CERTIFICA TION: MULTINATIONAL/MULTIC ORPORATE CONSORTIA

.

G.1 Purpose. This appendix provides information and criteria for evaluating and approving the quality system of a multinational or multicorporate consortium seeking a production certificate (P C). This appendix does not apply to a type certificate ( TC ) holder that enters into a licensing agreement with a manufacturer holding a PC at the time of license. The Federal Aviation Administration ( FAA ) does not consider such a licensing arrangement the formation of a PC. PC extensions are addressed in AC 21

- 24, Extending a Production Certificate to a Facility Located in a Bilateral Airworthiness Agreement Country

.

G.2 Discussion. A multinational/multicorporate consortium consists of a U nited S tates manufact urer(s) and a manufacturer(s) located outside the United States that have agreed to form a single company for production of a particular product. A consortium company usually exists in name only, in that it does not physically manufacture a product in one location. The consortium company retains responsibility for the design and quality of the product for which the PC has been issued. However, the consortium company may assign the manufacturing task to other partner companies or suppliers located domestical ly or in combination with manufacturers located outside the United States.

G.3 Requirements.

G.3.1 Section 21.135 requires any applicant for a PC to provide the FAA with a document describing how its organization will ensure compliance with subpart G, Production Certificates . The FAA considers a multinational or mul t i corporate consortium company seeking a PC to be the applicant. The applicant must comply with the organizational requirements outlined in section 1.10 of this AC. The accountable manager identified in the organization document serves as the consortium company’s primary contact with the FAA office responsible for issuance of the production approval, or for certificate management of the production approval holder.

G.3.2 Section 21.137

, Quality system

, requ ires a PAH to establish and describ e in writing a quality system that ensures each product or article conforms to its approved design and is in a condition for safe operation

. The FAA considers the consortium company to be the applicant, and the partner co mpanies to be suppliers.

G.3.3 The consortium company will be named on the PC, al ong with the consortium
company address (possibly a corporate office) and the address(es) of the principal and subordinate manufacturing facilities. Extension of a PC to facilities located outside the United States may be authorized when certain criteria are met, as listed in AC 21

- 24.1 0/01/ 15 AC 21

- 43A Appendix G

G

- 2 If a PC is extended to a facility located outside the United States, the FAA remains responsible for certificate management.

G.3.4 In the case of multinati onal/multicorporate consortia, if a partner company or supplier has an FAA

- approved quality system for its own product, the PC applicant is still required to have an independent system meeting the requirements of subpart G.

G.3.5 A PC applicant functioning as a corporate entity, distributor, or assembler will have a viable means of ensuring all articles, processes, procedures, and completed products are properly inspected for conformity to the approved type design.

G.4 Quality System Documentation.

G.4.1 The applicant for a PC is required by the rule to establish to the FAA’s satisfaction that its quality system and procedures meet the requirements of § 21.137 before a PC is issued.

G.4.2 The quality system data will clearly specify that all facilities (domestic and outside of th e United States) will be made accessible to the FAA and to the CAA acting on behalf of the FAA. If articles or services are provided by a supplier or manufacturer in a country outside the United States, accessibility includes review of the data (drawings, specifications, procedures, and inspection records) and equipment pertinent to the product or articles produced under the PC.

G.4.3 The quality system manual proposed by the applicant will contain sufficient details establishing the quality system organization a nd procedures as a separate and independent entity (rather than simply incorporating by r eference the quality systems of its partner companies). This does not preclude the use of, or reference to, applicable portions of a partner company’s quality system, but ensures the applicant’s system will be evaluated on its own merits. This also enables the FAA to conduct surveillance to ensure compliance with the regulations.

G.5 Quality Organization and Authority.

G.5.1 The applicant’s senior quality manager will have direct access to the consortium’s senior management.

G.5.2 The applicant’s quality system organization will have an independent management organization. This organization will establish departmental control over the partner companies regarding the quality of the joint ly produced product. The individuals chosen to fill these management positions will have a clearly defined and separate allegiance to the applicant’s top management, rather than to any company for which they have worked or for which they are currently work ing.

G.5.3 The responsibility and authority of the employees in the consortium’s management organization will be clearly defined in the quality system data. This includes the1 0/01/ 15 AC 21

- 43A Appendix G

G

- 3 consortium’s relationship to the quality and production organizations of the partner co mpanies.

G.5.4 The applicant may propose to assign inspection authority to a limited number of its employees to ensure the quality of products being produced. While no minimum number of employees can or should be specified by the FAA, the viability of the
propos ed quality system procedures will be assessed with respect to the number of employees available to implement the system.

G.5.5 It is particularly important to establish accountability for compliance with § 21.137 in the case of a multinational consortium. This is because the responsibilities of suppliers outside the United States, regarding their other products under their own CAAs, may be inconsistent with those required by § 21.137. Compliance responsibility for the consortium product will rest with the PC hol der. This direct responsibility will be understood by the applicant’s management and the management of the supplier, and be described in the quality manual.

G.5.6 The fact that the actual manufacture of the applicant’s product may take place in a country outsid e the United States does not affect the applicability of FAA regulations and orders regarding the management and surveillance of the PC holder.1 0/01/ 15 AC 21

- 43A Appendix H

H

- 1 APPENDIX H. ADVISORY CIRCULAR FE EDBACK FORM

If you find an error in this AC, have recommendations for improving it, or have suggestions for new items/subjects to be added, you may let us know by (1) emailing this form to 9

- AWA

- AVS

- AIR500

- Coord@faa.gov or (2) faxing it to the attention of the AIR Dir ectives Management Officer at 202

- 267

- 3983.

Subject: ____________________________ Date: ____________________

Please check all appropriate line items:

 An error (procedural or typographical) has been noted in paragraph __________________ on
page ___ _______________________.
 Recommend paragraph ____________ on page ______________ be changed as follows:

 In a future change to this AC, please cover the following subject: (Briefly describe what you want added.)

 Other comments:

 I would like to discuss the above. Please contact me.

Submitted by: __________________________________ Date: ________________________