Production Approval Procedures

8120.22B Chapter 1. Introduction 1-1. Purpose of This Order. This order references part 5 and establishes the prepositioning policy for aircraft engines, propellers and articles pending FAA-approved design. In addition, this order describes the policies and procedures for the issuance of production approvals in accordance with part 21, subparts, G, K, and O. The following chapters provide specific guidance for the FAA to process the application and issue a production approval.

Note: This order is available to the public for information purposes only. Its content is not legally binding on the public in its own right and will not be relied upon by the Department as a separate basis for affirmative enforcement action or other administrative penalty. Public conformity with the guidance document is voluntary only; nonconformity will not affect rights and obligations under existing statutes and regulations.

1-2. Audience. All FAA employees who provide oversight of the production approval process.

1-3. Where to Find This Order. You can find this order on the MyFAA website at Regulations and Policies and on the Dynamic Regulatory System (DRS) website at DRS.

1-4. What This Order Cancels. This revision cancels the following order, deviation, and policy memorandums.

• FAA Order 8120.22A, CHG 1, Production Approval Procedures , dated October 27, 2023.

• AIR100-16-110-DM10, Deviation to FAA Order 8120.22A Production Approval Procedures , dated May 10, 2016.

• AIR100-16-110-DM12, Deviation to FAA Order 8130.21 Regarding Prepositioned Products and Articles , dated June 28, 2016.

• AIR100-16-110-PM05, Shipment of Prototype Products and Articles with the Authorized Release Certificate, FAA Form 8130-3, Airworthiness Approval Tag , dated June 28, 2016.

1-5. Explanation of Policy Changes.

a. Identifies part 5 requirements for type certificate (TC) and production certificate (PC) holders to submit an implementation plan and provides the PMA and TSOA holders, who desire, the means to participate in the Voluntary SMS Program.

b. Incorporates prepositioning products and articles guidance from FAA Order 8130.21H, CHG 1, Procedures for Completion and Use of the Authorized Release Certificate, FAA Form 8130-3, Airworthiness Approval Tag.

c. Incorporates memorandums AIR100-16-110-DM12, Deviation to FAA Order 8130.21 Regarding Prepositioned Products and Articles , and AIR100-16-110-PM05, 1-1 8120.22B Shipment of Prototype Products and Articles with the Authorized Release Certificate, FAA Form 8130-3, Airworthiness Approval Tag.

d. Adds chapter 9 to establish policy for prepositioning products and articles pending FAA design approval.

e. Adds a hyperlink to the System Oversight Division (AIR-800) Division-Approved Templates located on AIR-800 Templates for all notification, acknowledgement, hand-off, and PMA letters and supplements referenced throughout this order.

f. Updates FAA Form 1320-19, Directives Feedback Form, in appendix E.

1-6. Effective Dates .The provisions of this revision become effective sixty days from the date of signature.

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8120.22B Chapter 2. Production Under a Type Certificate (Part 21, Subpart F) Section 1. General Information 2-1. Applicability. Part 21, subpart F, applies to a manufacturer of a product or article produced under a TC with no other production approval in place.

2-2. Privileges. A manufacturer of a product or article in accordance with part 21, subpart F, is not granted any privileges. However, a manufacturer of a product or article produced under a TC may be authorized by 14 CFR part 183, Representatives of the Administrator , to apply for and obtain an organization designation authorization (ODA). FAA Order 8000.95, Designee Management Policy and FAA Order 8100.15, Organization Designation Authorization Procedures , contain procedures for the administration of ODAs.

2-3. Advising the Applicant. When production under part 21, subpart F is indicated, a TC applicant should be advised (during the preliminary TC board) of the following: a. Advisory circular (AC) 21-43, Production Under 14 CFR Part 21, Subparts F, G, K, and O , describes an acceptable means of complying with part 21, subpart F. The FAA may approve alternative methods and procedures when the applicant can show that the proposed methods or procedures will achieve compliance with part 21, subpart F.

b. The applicant should establish and submit a plan to the FAA to schedule inspections and evaluations. The applicant must allow the FAA to inspect or test, including at a supplier facility, to show compliance with § 21.123(d).

c. FAA inspectors or authorized designees will conduct inspections and issue all the necessary airworthiness certificates and approvals for a maximum period of six months, except as otherwise authorized, after the date of issue of the TC. The applicant should also be advised that FAA personnel resources are limited and that delays may occur during the six-month period, depending on the number of inspections and hours that may be necessary.

d. For continued manufacturing of a product or article, the applicant must obtain a PC, in accordance with part 21, subpart G, within six months after the date the TC is issued.

Application for a PC is made on FAA Form 8110-12, Application for Type Certificate, Production Certificate, or Supplemental Type Certificate.

e. For any products or articles that are manufactured and made available for use after the deadline date without FAA authorization, enforcement actions may result as defined in FAA Order 2150.3, FAA Compliance and Enforcement Program.

f. The TC holder or licensee who produces a completed product under part 21, subpart F, must flight test or functional test that product in accordance with the requirements of §§ 21.127 and 21.128, or § 21.129, as applicable.

2-1 8120.22B (1) Aircraft. Each aircraft, both prior to and after the issuance of a PC, must be flight tested in accordance with an approved production flight test procedure and flight checklist form as required by § 21.127.

(2) Aircraft Engines and Propellers. Each aircraft engine or propeller, both prior to and after the issuance of a PC, must be subjected to an acceptable test run or functional test in accordance with the requirements of § 21.128 or § 21.129, as appropriate.

g. SMS Requirements.

(1) Section 21.135(c) requires PC applicants, except those applying for a PC based on a supplemental type certificate (STC), to meet the applicable requirements in 14 CFR part 5. The part 5 requirements for a PC applicant during the production approval process are defined in § 5.13.

(2) PC applicants should submit their SMS implementation plan for FAA approval following the guidance in AC 21-58, Safety Management Systems for Part 21 Type and Production Certificate Holders.

(3) Part 5 is applicable to PC applicants that desire to manufacture a complete product (aircraft, aircraft engine, or propeller). PC applicants desiring to manufacture less than a complete product, e.g., applicants to manufacture “article(s) or parts only,” are not required to meet part 5. These applicants do not need to submit an SMS implementation plan.

h. The applicant cannot use manufacturing facilities located outside the United States unless the FAA has determined that the location of the facilities places no undue burden on the FAA, as specified in § 21.122(a).

(1) Prior to the issuance of a PC, a TC holder, or licensee who produces a product is responsible for complying with part 21, subpart F, as appropriate for the particular product or article involved.

(2) Aircraft, aircraft engines, and propellers must be marked in accordance with the requirements of 14 CFR 45.11 and 45.13(a) through (c), as applicable.

Note: The holder of a Dealer’s Aircraft Registration Certificate is responsible for complying with the requirements of 14 CFR part 47, Aircraft Registration , regarding the use of temporary registration numbers. Specifically, the temporary registration number must be removed from the aircraft no later than the date on which either title or possession passes to another person as required by § 47.16.

(3) A TC holder or licensee is also responsible for reporting any failures, malfunctions, and defects as required by § 21.3.

(4) Section 21.135 requires a PC applicant producing under a TC to provide to the FAA a document describing how its organization will ensure compliance to part 21, subpart G and describes the requirements for this document. The document must identify a single point of contact who is knowledgeable of, and accountable for, maintaining the organization’s FAA- 2-2 8120.22B approved operations. In addition, the document must describe the accountable manager’s assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality.

2-4. Reserved.

Section 2. FAA Actions During the Six-Month Period 2-5. FAA Conformity Determinations. After the TC is issued and prior to the issuance of a PC, the Certificate Management (CM) section is responsible for determining whether the product or articles conform to the type design and are in a condition for safe operation. The CM section is responsible for performing inspections of incoming materials (at the source, if necessary), installations, and the completed products. The CM section is responsible for documenting each inspection on FAA Form 8100-1, Conformity Inspection Record , so that each product or article inspected has a complete inspection record.

2-6. Assessing the Applicant’s Progress. The CM section should periodically assess the applicant’s progress in complying with the regulations for obtaining approval of a PC. If it appears that the applicant is delaying this action or may not be eligible for a PC by the deadline date, the applicant should be advised in writing of all known deficiencies. Also, the applicant should be cautioned that after the deadline date, the FAA will not issue any airworthiness certificates or any other approvals unless the certification branch manager authorizes an extension of time. The CM section should keep the certification branch manager apprised of the applicant’s progress.

2-7. Extension of Six-Month Period. The FAA may grant an extension when there are unusual or extenuating circumstances that preclude the establishment of a PC within the six- month limitation. The FAA should not grant an extension of the six-month period without giving due consideration to the impact the extension would have on FAA personnel resources and safety. In all instances, the FAA should consider an extension only when the applicant can substantiate the reasons for requesting such an extension. The authorization for extension must be issued to the applicant in writing.

2-8. PC Not Established Within Six-Month Period. When an applicant fails to establish a PC by the end of the six-month period (except when extended), the FAA will no longer make conformity determinations and will discontinue the issuance of all airworthiness certifications and approvals. However, the FAA should continue to counsel and advise the applicant to the extent necessary to assist in obtaining a PC as soon as practicable.

2-9. Review of Production Quality System Data. When a PC applicant producing under a TC submits quality system data as evidence of compliance with part 21, subpart F, the cognizant CM section will evaluate this data in accordance with the criteria contained in appendix A to this order. Upon completion of its evaluation of the quality system data, the CM section will submit any inadequacies to the applicant for corrective action, using the appropriate template at AIR- 800 Division-Approved Templates. After the data has been reviewed and any applicable corrective actions are taken, the CM section will approve the quality system data submitted by the applicant.

2-3 8120.22B 2-10. Provisional Approval Procedures. The CM section should accomplish evaluation of the applicant’s quality system, concurrent with conducting conformity inspections and making those airworthiness determinations required of the FAA prior to the issuance of a PC. It is, therefore, to the advantage of the FAA to evaluate and provisionally approve the quality system on a progressive basis. As portions of the quality system are determined to meet the regulatory requirements, the CM section should do as follows: a. Maintain a record of those portions of the system considered satisfactory.

b. Reduce conformity inspections to a spot-check basis for articles covered by the provisionally approved portion of the quality system.

c. Place increased emphasis on securing corrective actions on the portions of the quality system where procedural discrepancies have been found or where the quality system has been found to be inadequate.

2-11. Preliminary Certificate Management (PCM) Audit. When the CM section has determined that the PC applicant can comply with § 21.137, the CM section will conduct a PCM audit as follows: a. PCM Audit. The PCM audit evaluates the applicant’s production facilities in accordance with the pertinent 14 CFR regulation, the FAA-approved design data, and the quality system data referenced in paragraph 2-9 of this order. The cognizant CM section manager will select a team to conduct this audit. The team may consist of the cognizant principal inspector (PI) and at least one other manufacturing inspector or the CM section manager. It is also recommended that an engineer be selected for the team when deemed necessary by the type and complexity of processes and procedures being used at the facility. The standardized evaluation criteria may be used as an aid to evaluate compliance. Team members should be advised that some of the evaluation criteria contained therein may not be related to 14 CFR part 21 and therefore may only be evaluated as a best practice. This audit is not considered a quality system audit (QSA). Noncompliance’s will be documented on FAA Form 8100-6, Noncompliance Record.

b. Notifying the Applicant. Upon completion of the PCM audit, the CM section will formally notify the applicant of any corrective actions necessary to comply with § 21.137 using the appropriate template at AIR-800 Division-Approved Templates. The CM section should advise the applicant that a production certification board (PCB) will be scheduled that could result in a request for additional actions.

c. Reporting. The CM section will prepare FAA Form 8120-14, Production Approval/Certificate Management Activity Report , upon completion of the PCM audit, and provisional approval of the applicant’s quality system, when applicable. The CM section will provide notification to the applicable certification branch manager that the FAA Form 8120-14 may be viewed in the Aircraft Certification Audit Information System (ACAIS). In addition, the CM section will provide information to the applicable division director concerning the applicant’s ability to comply with § 21.137.

2-4 8120.22B 2-12. PCB. Upon receipt of FAA Form 8120-14 and notification by the CM section that the applicant can comply with § 21.137, the applicable certification branch manager should schedule a PCB in accordance with chapter 3, section 3 of this order.

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8120.22B Chapter 3. Production Certificate (Part 21, Subpart G) Section 1. General Information 3-1. Applicability.

a. Part 21, subpart G, applies to any of the following persons who desire to manufacture a complete product and article(s) with the benefit of a PC: (1) The holder/licensee of a § 21.21 TC.

(2) The United States holder/licensee of a § 21.29 TC, if the licensing agreement clearly provides for the TC holder’s and its Civil Aviation Authority’s (CAA) control over any design changes by the licensee. A working arrangement, associated with the respective bilateral agreement, must also be in place between the CAA and the FAA defining their respective responsibilities as State of Design and State of Manufacture.

(3) The holder of a STC, when the STC will be incorporated as follows: (a) Prior to the issuance of an original airworthiness certificate (OAC) to the aircraft; or (b) After the issuance of an OAC to the aircraft. In this case, the PC would authorize the manufacturing of associated STC articles in accordance with part 21. However, installation of the STC and return to service of the product is accomplished under the provisions of 14 CFR part 43, Maintenance, Preventive, Maintenance, Rebuilding, and Alteration.

(4) The holder/licensee of a § 21.25 TC, provided the TC was issued based on FAA approval of the type design data. The data must have been submitted by the applicant or the licensor and must meet the requirements of § 21.31.

(5) The holder/licensee of a § 21.27 TC, provided the duplicates produced always originate as an aircraft that was designed and constructed in the United States, accepted for operational use, and declared surplus by the military.

(6) The holder/licensee of a § 21.27 TC must demonstrate their quality system meets the requirements of §§ 21.137 and 21.138 at the product level.

b. A PC may not be issued to the holder of a TC issued under part 21, subpart C, Provisional Type Certificate.

c. A PC may not be issued if the manufacturing facilities are located outside the United States, unless it has been determined, in accordance with § 21.139, that such location(s) would place no undue burden on the FAA.

d. PCs are intended to be issued for the manufacturing of duplicate products (aircraft, aircraft engine, and propeller) only. There may be instances when it is appropriate to issue a PC 3-1 8120.22B for something less than a “product.” In those instances, the CM branches must coordinate with the Policy and Standards Division (AIR-600) to determine if a PC is acceptable prior to the issuance of the PC.

3-2. Privileges. A PC holder has the privileges specified in § 21.145. In addition, a PC holder can designate a qualified employee(s) as a designated manufacturing inspection representative (DMIR) in accordance with the provisions of 14 CFR part 183. The PC holder may also be authorized by part 183 to apply for and obtain an ODA. FAA Order 8000.95, Designee Management Policy , and FAA Order 8100.15 contain procedures for the administration of DMIRs and ODAs, respectively.

3-3. Advising the Applicant. The applicant should be advised as follows: a. AC 21-43 describes an acceptable means of complying with part 21, subpart G.

Alternative methods and procedures may be approved when the applicant can show that the proposed methods and procedures will achieve compliance with part 21, subpart G.

b. The applicant must establish a quality system in accordance with § 21.137 and provide a quality manual describing its quality system to the FAA in accordance with § 21.138.

The manual must include descriptive material that adequately covers each applicable paragraph of § 21.137. The manual may vary in length depending upon the scale of the quality system, size of the manufacturing facilities, and complexity of the product. For further guidance, refer to AC 21- 43.

c. The PC holder who produces a completed product under part 21, subpart G, must flight test or functional test that product in accordance with the requirements of § 21.137(e).

(1) Aircraft. All aircraft must pass an approved production flight test as part of the inspection procedure required for issuance of an airworthiness certificate. FAA Form 8130-7, Special Airworthiness Certificate, issued for such purposes provides authorization for production flight testing (reference FAA Order 8130.2, Airworthiness Certification of Aircraft ). The exception is an aircraft manufactured under a PC and being exported without assembly or flight test under the provisions of § 21.137(e). The intent of this rule is to permit shipment of aircraft without assembly or flight test when the extent of disassembly is the same as an aircraft that has been disassembled for shipment purposes. In these instances, the manufacturer must provide FAA-approved assembly and flight test procedures as a condition of shipment.

(2) Periodic FAA Production Flight Tests. FAA production flight tests will be conducted periodically at the PC holder’s facility to ensure continued compliance with all parameters as specified in pertinent TC data with respect to performance, flight characteristics, operation qualities, equipment operations, etc. The PI, in coordination with the FAA flight test personnel from the appropriate certification branch, may arrange these flight tests. In addition, a determination should be made in coordination with the flight test personnel that the manufacturer’s approved production test pilots are using approved procedures and that the approved procedures remain adequate.

3-2 8120.22B (3) Aircraft Engines and Propellers. Aircraft engines and propellers must pass a functional test in accordance with type design requirements as part of the quality system required by § 21.137(e)(2).

d. PC Holder’s Responsibility.

(1) Organization. Section 21.135 requires a PC holder to provide the FAA a document describing how its organization will ensure compliance to § 21.135 and sets out the requirements for this document. The document must identify a single point of contact who is knowledgeable of, and accountable for, maintaining the organization’s FAA-approved operations. In addition, the document must describe the accountable manager’s assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality. The accountable manager serves as the PAH’s primary contact with the FAA, and is responsible for, and has authority over, a PAH’s production operations.

(2) Reporting Failures, Malfunctions, and Defects. The PC holder must report any failure, malfunction, or defect in any product or article as required by § 21.3. The PC holder should establish a procedure for such reporting as a part of its quality system. This reporting requirement applies to failures, malfunctions, or defects that may result in or have resulted in one of the occurrences listed in § 21.3(c).

(3) Quality System. The PC holder must establish and describe in writing a quality system that complies with § 21.137. The PC holder is responsible for maintaining the quality system in conformity with the data and procedures approved for the PC. The PC holder is also responsible for determining that each completed product and article submitted for airworthiness certification or approval conforms to the TC or STC and is in a condition for safe operation.

(4) Supplier Control. A supplier is 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-furnished product, article, or service conforms to the PAH’s requirements. This section also requires the PAH to establish a supplier-reporting process for products, articles, or services that have been released from the supplier and subsequently found not to conform to the PAH’s requirements.

(5) Issuing Authorized Release Documents for Aircraft Engines, Propellers, and Articles. Section 21.137(o) requires procedures for issuing authorized release documents, using FAA Form 8130-3, if the PAH intends to issue those documents. These procedures must provide for the selection, appointment, training, management, and removal of individuals authorized by the PAH to issue authorized release documents (refer to AC 21-43).

3-3 8120.22B (a) Procedures established pursuant to § 21.137(o) should ensure that only qualified personnel issue authorized release documents. A PAH’s evaluation of these individuals’ qualifications should include an assessment of their knowledge, background, experience, and training. Qualifications should be commensurate with the complexity and type of product or article for which the PAH issues an authorized release document. These procedures should also include requirements for completing FAA Form 8130-3 that meet the requirements of FAA Order 8130.21, Completion of FAA Form 8130-3 under Part 21.

(b) These documents may be issued for new aircraft engines, propellers, and articles manufactured by the PAH, and for used aircraft engines, propellers, and articles rebuilt or altered pursuant to § 43.3(j). When an authorized release document is used for export, § 21.137(o) requires a PAH to comply with the applicable § 21.335 requirements for the export of new and used aircraft engines, propellers, and articles. Refer to FAA Order 8130.21 to ensure the PAH is in compliance with § 21.335.

(6) Change to the Quality System. Each change to a quality system is subject to review by the FAA pursuant to § 21.150(a). A PC holder must immediately notify the appropriate CM section in writing of any changes that may affect the inspection, conformity, or airworthiness of its product or article pursuant to § 21.150(b). These changes would include, but are not limited to, the following: (a) Resumption of production after being discontinued for an extended period for other than normal periods of time, such as vacation periods, (b) Significant curtailment or resumption of production operations, (c) Significant reduction or reassignment of quality system personnel, and (d) Changes or revisions to quality system data and related procedures.

(7) Changes to Manufacturing Facilities. The PC holder must immediately notify the CM section in writing of any changes to its manufacturing facilities that may affect the inspection, conformity, or airworthiness of its product or article in accordance with § 21.139(c).

The PC holder must obtain FAA approval before making any changes to the location of its manufacturing facilities in accordance with § 21.139(b).

(a) A PC holder’s manufacturing complex would normally consist of a principal facility and all associate facilities using the same quality system approved by the FAA, for the particular type certificated product(s). Associate facilities are discussed in chapter 6 of this order.

(b) The PC is issued to the principal manufacturing facility that controls the design and quality of the product(s) for which the approval was granted. The principal facility address will be listed under the “business address” and all associate facility addresses will be listed under “manufacturing facilities” on FAA Form 8120-4, Production Certificate . A postal address is not acceptable for a facility since the actual location must be identified. Such 3-4 8120.22B addresses, however, may be used as supplemental to the actual address when desired for such uses as corresponding to and from FAA offices.

(c) A PC holder may not transfer a PC, refer to § 21.144. If the PC holder wants a PC for a new location, the PC holder must reapply in accordance with § 21.133.

(d) When the PC holder seeks FAA approval to move an associate facility or add a new production facility, the FAA may, if deemed necessary, conduct a preliminary PCM audit at the new production facility or moved facility. If a PCM audit is deemed necessary, a satisfactory audit result must be obtained before the facility can be approved for production. The PC also must be amended to reflect this change.

(8) A PC holder must ensure that each article and completed product presented for airworthiness certification or approval conforms to its approved design and is in condition for safe operation. This includes primary category aircraft assembled under a PC by another person from a kit provided by the PC holder.

(9) A PC holder must obtain an airworthiness certificate or approval for each aircraft, aircraft engine, and propeller produced under that PC that conforms to its approved design and is in a condition for safe operation. If the PC holder issued the original airworthiness certificate or approval as an export airworthiness approval under part 21, subpart L, that export airworthiness approval would also satisfy the requirement for an airworthiness approval under this subpart.

(10) A PC holder must maintain complete and current design data for each product and article produced under its production approval.

(11) A PC holder must retain its PC and make it available to the FAA upon request.

(12) A PC holder must make available to the FAA information regarding all delegation of authority to suppliers.

(13) Aircraft, aircraft engines, and propellers, except for a fixed-pitch wooden propeller, must be marked using an approved fireproof method pursuant to the requirements of § 45.11 and 45.13(a), as applicable.

Note: The holder of a Dealer’s Aircraft Registration Certificate is responsible for complying with the requirements of part 47 regarding the use of temporary registration numbers. Specifically, the temporary registration number must be removed from the aircraft no later than the date on which either title or possession passes to another person.

See § 47.16.

3-5 8120.22B (14) Identification plate requirements for aircraft, aircraft engines, or propellers produced under a design data licensing agreement program.

(a) Pursuant to § 45.13, an identification plate for an aircraft, aircraft engine, or propeller produced under a design data licensing program must include the following information (as applicable): 1. The builder’s name is the specific name of the licensee as shown on the licensee’s PC.

2. The model designation is that model identified on the associated type certificate data sheet (TCDS).

3. The builder’s serial number is the serial number(s) dedicated for the use of the licensee as assigned by the TC holder on the associated TCDS.

4. The TC number is the number identified on the associated TCDS and upon which conformity to type design requirements is determined.

5. The PC number is the number that is listed on the licensee’s PC.

6. For aircraft engines, the established rating as shown on the TCDS.

7. For aircraft engines manufactured after January 1, 1984, the following information must also be included: i. The date of manufacture as defined in 14 CFR 34.1.

ii. The status of compliance to applicable exhaust emission provisions, as approved by the FAA (for example, COMPLY, EXEMPT NEW, EXCEPTED SPARE, or NON-U.S., as appropriate).

(b) As prescribed under the provisions of § 45.13(a)(8), the FAA will normally deem it appropriate and necessary to include the following information on the identification plates of products manufactured under a design data licensing agreement between an FAA TC and PC holder: “Manufactured by (insert the PC holder’s name) under a licensing agreement with (insert the TC holder’s name).” (c) The FAA requires that only the information in paragraph 3-3.d.(14)(a) and (b) of this order be included on the identification plates for all products manufactured under a licensing agreement program. However, the FAA would permit a company/corporate logo or registered trademark to be included (after review and approval by the FAA) on the identification plates, if desired by the manufacturer. Aircraft, aircraft engine, and propeller identification plates should be included as part of the product’s approved design data and are usually defined in an engineering drawing describing material, size, required information entries, mounting location, etc.

3-6 8120.22B (15) Marking and Identification of Articles Produced by a PC Holder.

(a) Section 21.146(d) requires that articles produced by a PC holder for which a certificate or approval has been issued must be marked in accordance with part 45.

However, part 45 does not address specific marking requirements for articles produced by a PC holder that appear on its production limitation record (PLR). In such cases, those articles must be marked in accordance with the approved design. As a minimum, the article must be identified with the PC holder’s part number and name, trademark, symbol, or other FAA approved PC holder’s identification.

(b) Subassemblies and component parts of products or articles do not have to be identified unless they leave the PC holder’s facility as a separate article. In such cases, in accordance with § 21.146(e), they must be identified with the manufacturer’s part number and name, trademark, symbol, or other FAA-approved PC holder’s identification. The PC holder may choose any method to meet this requirement. Methods include, but are not limited to, the following: 1. Marking the article, 2. Attaching a tag to the article with the required information, 3. Placing the article in a container with the required information, or 4. Providing a document with the article with the required information.

(c) If the article is too small or otherwise impractical to mark with the required information, the PC holder must attach that information to an article, or its container.

(d) Suppliers to PC holders may mark or identify articles, provided that then PC holder adequately controls those suppliers as part of its quality system. Suppliers that mark or identify articles should be treated the same as any other supplier furnishing articles or services, using supplier control procedures as part of the quality system. The CM section may require that specific article marking controls be included in these procedures, along with any additional conditions that may be necessary for suppliers with direct ship authorization.

(e) Each PC holder who manufactures an article for which a replacement time, inspection interval, or related procedure is specified in the airworthiness limitations section of the PC holder’s maintenance manual or instructions for continued airworthiness must permanently and legibly mark that article. Those markings must include a serial number (or equivalent) unique to that article, in addition to other required markings.

e. SMS Requirements.

(1) Section 21.135(c) requires PC applicants, except those applying for a PC based on a STC, to meet the applicable requirements in part 5. The applicable part 5 requirements for a PC applicant during the production approval process are defined in § 5.13.

Section 5.13(b)(2) requires a PC applicant to submit an SMS implementation plan to the FAA for approval during the certification process.

3-7 8120.22B (2) PC applicants should submit their SMS implementation plan for FAA approval following the guidance in AC 21-58, Safety Management Systems for Part 21 Type and Production Certificate Holders.

(3) Part 5 is applicable to PC applicants that desire to manufacture a complete product (aircraft, aircraft engine, or propeller). PC applicants desiring to manufacture less than a complete product, e.g., applicants to manufacture “articles or parts only”, are not required to meet part 5. These applicants do not need to submit an SMS implementation plan.

Note: PC holders and applicants not required to comply with part 5 may choose to participate in the FAA’s Voluntary SMS Program and should notify the CM section manager of their intentions. Applicants or holders desiring to participate in the Voluntary SMS Program may contact the FAA through the following email for further information: 9-AVS-AIR-SMS@faa.gov 3-4. Reserved.

Section 2. Processing an Application for a PC 3-5. Application. Application for a PC is made on FAA Form 8110-12. See § 21.133. The applicant must submit the application, accompanied by a document describing the organization in accordance with § 21.135 and one copy of the quality manual showing compliance with § 21.137. These documents must be submitted to the CM branch manager where the applicant’s principal manufacturing facility is located. Upon receipt of a properly executed FAA Form 8110- 12, the CM branch manager will forward a copy to the CM section. The CM section will prepare a letter of acknowledgement advising the applicant that the CM section has been authorized to initiate a PCM audit to determine compliance with applicable regulations. A copy of the letter should be forwarded to the CM branch.

Note: The CM branch may delegate the application for, or amendment to, a PC to the CM section. If this occurs, PC holders will be notified that when submitting FAA Form 8110-12 for an amendment to a PLR, they should send the form directly to the PC holder’s geographic CM section instead of their CM branch.

3-6. PCM Audit. The CM section should plan to conduct an audit within 30 days after acknowledging the PC application. This audit will be conducted as follows: a. Evaluate the applicant’s quality manual for compliance with § 21.137. Additional guidance is provided in AC 21-43. Any inadequacies in the quality manual submitted must be identified to the applicant for corrective action. After the quality manual has been reviewed, and any applicable corrective actions taken, the CM section will approve the quality manual submitted by the applicant. The approved quality manual may be retained in the CM section files.

b. Evaluate the applicant’s production facilities in accordance with the pertinent 14 CFR, the FAA-approved design data, and the quality manual approved in paragraph 3-6.a. of this order. The CM section manager will select a team to conduct this audit. The team may 3-8 8120.22B consist of the cognizant PI and at least one other manufacturing inspector or the CM section manager. It is also recommended that an engineer be selected for the team when deemed necessary by the type and complexity of processes and procedures being used at the facility. The standardized evaluation criteria may be used as an aid to evaluate compliance. Team members should be advised, however, that some of the evaluation criteria contained therein may not be related to 14 CFR and therefore may only be evaluated as a best practice. This audit is not considered to be a QSA. Noncompliance’s will be documented on FAA Form 8100-6, Noncompliance Record.

c. Confirm that the applicant has submitted an SMS implementation plan to the FAA for approval in compliance with §§ 21.135(c) and 5.13(b)(2).

(1) Confirmation that the applicant has submitted an SMS implementation plan is the only SMS related requirement necessary for the issuance of a PC.

(2) All further SMS related approval activities are provided in Order 8120.24, Implementation Plan Approval, Verification, and Evaluation of Safety Management Systems for Design and Production Approval Holders.

d. Upon completion of the audit, the CM section will formally notify the applicant of any corrective actions needed to comply with § 21.137 using the appropriate template at AIR- 800 Division-Approved Templates. The applicant should be further advised that these items represent only the result of the FAA’s preliminary audit. Additional requests for corrective actions can be anticipated because of subsequent noncompliance’s, which may be noted during the PCB evaluation activity, as detailed in paragraph 3-6. of this chapter.

e. The CM section will provide notification to the CM branch that FAA Form(s) 8100-6 may be viewed in ACAIS. FAA Form(s) 8100-6 should identify any unresolved items requiring corrective action. In addition, letters issued to the applicant requesting corrective action also may be viewed in the ACAIS project folder.

3-7. Reserved.

Section 3. Production Certification Board 3-8. General PCB Information. The PCB is a high-level FAA evaluation function based directly upon the responsibilities established in title 49 of the United States Code (49 U.S.C.)

44701, 44702, 44704, and 44709.

a. Purpose. The purpose of the PCB is to evaluate the eligibility of the applicant for issuance of a PC based upon the preliminary findings and recommendations of the CM section and the PCB’s review of the applicant’s facilities and quality system.

b. Applicability. The PCB should be convened only for initial production approvals, or when entire facilities have been relocated or are added to the PC. The PCB should not be convened for the addition of new models to the PLR or relocation of a portion of the facility. In these instances, the procedures are contained in paragraph 3-15. of this order should be followed.

3-9 8120.22B c. PCB Members. PCB members should consist of a group of qualified specialists from airframe, systems and equipment, propulsion, manufacturing, and flight test functions, as appropriate. These members will assist in evaluating the applicant’s production, engineering, flight test procedures, and other related functions. Representatives from AIR-600, and applicable certification branches may also participate in a PCB when deemed desirable or necessary.

d. PCB Chairman. The CM branch manager serving the geographic area where the manufacturing facility is located will act as the chairman of the board. When necessary, the CM branch manager may delegate the chairmanship to the CM section manager or other qualified CM branch personnel.

3-9. PCB Member Responsibilities. Specific PCB member responsibilities are as follows: a. PCB Chairman. The PCB chairman is responsible for: (1) Selecting and assigning PCB members, as deemed appropriate for the particular product, and notifying the members of the PCB in sufficient time to permit adequate planning and preparation.

(2) Notifying the applicant of the PCB schedule and identifying members and their assignments.

(3) Selecting a representative number of the applicant’s supplier facilities for evaluation to determine whether the applicant’s quality system provides for satisfactory supplier control.

(4) Conducting pre/post PCB meetings with the PCB or the applicant.

(5) Reviewing and analyzing the PCB findings and ensuring that appropriate corrective actions have or will be taken.

(6) Completing, signing, and distributing the PCB minutes.

b. Principal Inspector. The PI, in coordination with the CM section having certificate management responsibility, and the PCB chairman, is primarily responsible for establishing schedules, making arrangements for meeting rooms, obtaining sufficient copies of the quality manual, and making all other arrangements necessary for convening and conducting the PCB in the most expeditious manner. The PI is further responsible for ensuring that the applicant has taken all agreed upon corrective actions, for preparing the minutes of the PCB, and for initiating and completing any enforcement actions, when applicable.

c. Propulsion Section/Branch. The propulsion section/branch or its equivalent is responsible for the evaluation and approval of the applicant’s production engine/propeller test procedures, as required by § 21.137(e). This effort will be coordinated with the responsible CM section. After determining that the procedures are acceptable, a letter of approval will be prepared and forwarded to the applicant when a PC is issued. A copy of this approval letter will be included in the PCB minutes.

3-10 8120.22B d. Flight Test Section/Branch. The flight test section/branch or its equivalent is responsible for the evaluation and approval of the applicant’s flight test procedures and checklists as required by § 21.137(e). This effort will be coordinated with the responsible CM section. Upon determining that the procedures and checklists are acceptable, a letter of approval will be prepared and forwarded to the applicant when a PC is issued. The letter will also include the names of those company pilots designated and authorized by the applicant to conduct production flight tests. A copy of this letter will be included in the PCB minutes.

e. Other PCB Members. Airframe and equipment engineering representatives and all other PCB members are responsible for ensuring that the applicant is in compliance with § 21.137, as appropriate to their particular assignment. Representatives from AIR-600 and the applicable certification branch are responsible for acting in an advisory capacity or for the completion of any PCB activity assigned by the PCB chairman.

3-10. Conduct of the PCB. A PCB is generally conducted in the following basic phases: a. Initial FAA Personnel Meeting. Prior to arranging a pre-production board meeting, FAA personnel will hold a meeting to review the results of the PCM audit, CM section recommendations, and related correspondence between the FAA and the applicant. This meeting will also serve to plan the PCB audit, schedule subsequent meetings, and establish agenda items for the pre-production board meetings.

b. Pre-Production Board. A pre-production board meeting with the applicant’s representatives should be considered upon receipt of the PC application. This meeting should include the PCB chairman, CM section manager, the PI, and others as necessary. The purpose of this meeting is to advise the applicant as to the purpose of the PCB and of the FAA’s evaluation plans. It should be made clear to the applicant that the PCB is a fact-finding body convened to determine whether the applicant is following §§ 21.135 and 21.137. The applicant should also be advised that the PCB is responsible for making a thorough evaluation of the applicant’s quality system, quality manual, organization, production facilities, and if deemed necessary, supplier facilities. Also, a determination should be made at this time that the location of the applicant’s facilities will pose no undue burden on the FAA as specified in § 21.139.

c. PCB Audit. Following the pre-production board meeting with the applicant, the PCB should evaluate the applicant’s quality manual and perform an on-site evaluation of the applicant’s quality system, organization, production facility, and any suppliers, as deemed appropriate. In addition, the PCB should confirm that the applicant for a PC to produce a complete product has submitted an SMS implementation plan to the FAA for approval. Refer to paragraph 3-6. of this order for audit procedures.

d. Internal FAA PCB Meetings. PCB meetings, attended by all PCB participants, will be conducted as needed to discuss and evaluate each unsatisfactory condition submitted by each member.

e. Reporting. The PCB will prepare FAA Form 8120-14, Production Approval/Certificate Management Activity Report , upon completion of the PCB. All unsatisfactory conditions will be recorded on FAA Form(s) 8100-6 and 8120-14.

3-11 8120.22B f. Final PCB Meeting. A final meeting, attended by all PCB members and representatives of the applicant, will be held to advise the applicant of the PCB findings. Each unsatisfactory condition should be presented and discussed briefly.

(1) Corrective Action. In those instances where a product is being produced under a TC, prior to the issuance of any production approval, the PC applicant must be requested to commence immediate corrective action on those items that directly involve the product and related quality system practices. A reasonable time may be allowed for correcting deficiencies in the quality manual. However, the applicant must be advised that the PCB cannot recommend that a PC be issued unless all applicable regulations are complied with and until the CM section has evaluated all corrective actions and found them to be satisfactory.

(2) Formal Confirmation. The applicant must also be advised that an official letter will be sent confirming the verbal presentation of the list of unsatisfactory conditions. This formal notification letter should be prepared by the PI for the signature of the chairman of the board, within ten working days following the final meeting with the manufacturer. The notification letter template is located at AIR-800 Division-Approved Templates.

(3) Violations. If the PC applicant is manufacturing a product/article under a TC, and any of the unsatisfactory conditions are determined to be violations to part 21, subpart F, appropriate enforcement actions should be initiated by the CM section in accordance with FAA Order 2150.3.

g. Final Phase of PCB. The final phase of a PCB is the evaluation by the CM section of the corrective action taken by the applicant. The results of the re-inspection should be reported to the chairman of the board using FAA Form 8120-14.

h. PCB Conclusion. The CM section will formally advise the applicant in writing, as soon as practical, that a PC will be issued based on a showing of compliance to §§ 21.135 and 21.137, or that a PC will not be issued if there is failure to show compliance with §§ 21.135 and 21.137. The CM section will provide notification to the CM branch that the letter has been issued. It may be viewed in the ACAIS project folder.

3-11. PCB Minutes. The CM section will prepare the PCB minutes for the signature of the chairman. The minutes should encompass a concise record of the entire PCB proceedings, including the names and titles of all participants.

a. All correspondence relating to the PCB, including letters to the applicant, replies, etc., are part of the minutes and should be attached as appendices.

b. All FAA Form(s) 8100-6 and 8120-14, or printed copy of electronic equivalent, should also be attached to the PCB minutes as a separate appendix.

3-12. Distribution of PCB Minutes. The PCB minutes should be distributed as follows: a. Original to the CM branch involved. Destruction of the original is prohibited.

b. One copy to the cognizant CM section that participated in the PCB.

3-12 8120.22B 3-13. PCB Adjournment. The PCB will be adjourned when the PCB minutes are accepted by the chairman and distributed to the PCB members.

3-14. Reserved.

Section 4. Issuance of Production Certificate and Production Limitation Record 3-15. Preparation and Delivery of PC and PLR. Upon a finding by the PCB that the PC applicant’s quality manual, quality system, organization, and facilities comply with §§ 21.135, 21.137, and 21.138, the CM section will prepare FAA Form 8120-4, Production Certificate , and FAA Form 8120-3, Production Limitation Record , for the signature of the CM branch manager or delegate. Signature authority for the PC and PLR may be delegated to the PCB chairman.

Electronic signatures are permitted. Delivery of production approvals may be accomplished using email or sent via certified mail. Whichever method of delivery is used, it is essential that the PC holder be advised of its requirement to retain its PC and make it available to the FAA upon request.

a. PC. Each PC will be assigned a unique, consecutive number using a four-digit format beginning with 1000 (e.g., PC No. 1000). The FAA will create and maintain a summary of all issued PCs along with a record of any subsequent changes.

Note: When a PC is issued based on a licensing agreement that is for a specific period of time, it must be indicated on FAA Form 8120-4 under “Duration”.

b. PLR. The FAA issues a PLR as part of a PC. A PLR will include the TC, model number, and production authorization date for each product, and identify each Interface Component (IC) the PC holder is authorized to manufacture and install. After the FAA issues a PLR, a PAH should ensure the PLR accurately reflects each product and IC the PAH intends to manufacture.

Note: When a PC is issued for an STC, the PLR will include the STC number, the model number of each product on which the STC is eligible, and the date that production was authorized.

(1) Amendment of PCs/PLR. Section 21.147 requires a PC holder to apply for an amendment to a PC in a form and manner prescribed by the FAA. A PC holder should apply by submitting to the FAA a properly executed FAA Form 8110-12. It is not normally necessary to establish a PCB. Instead, the CM section should conduct an audit using the guidelines in paragraph 3-6. of this order, as appropriate, to determine whether the quality system is adequate or has been appropriately changed to ensure positive control of the product to be added to the PLR. When changes to the quality system are substantial, the PI may elect to request a nonscheduled QSA to make this determination. The CM section with certificate management responsibility may issue revisions to the PLR to include new products or models, when authorized. The amendment of PCs requires the following: (a) The applicant for an amendment to a PC to add a TC, model, or both must comply with the applicable §§ 21.137, 21.138, and 21.150 requirements.

3-13 8120.22B (b) The applicant for an amendment to a PC may have its PLR amended to allow the manufacture and installation of an IC, provided: 1. The design and installation data for the IC is owned by, or licensed to, the applicant and made available to the FAA on request, 2. The applicant manufactures the IC, 3. The applicant’s product conforms to its approved type design, and the IC conforms to its approved type design data, 4. The assembled product, with the installed IC, is in a condition for safe operation, and 5. The applicant complies with any other conditions and limitations the FAA considers necessary.

(c) The applicant for an amendment to a PC must comply with §§ 21.147(b), 21.135(c), 5.11(b), and 5.11(d) requirements. These sections require the following: 1. No action is required for the first six months after the part 5 effective date.

2. Have submitted an SMS implementation plan to the FAA for approval within six months of the part 5 effective date.

3. Complete SMS implementation within thirty-six months of the part 5 effective date.

(2) IC Amendment to the PLR. Section 21.147 authorizes a PC holder to apply to amend its PLR to permit the manufacture and installation of ICs. An IC is an article that serves as a functional interface between an aircraft and aircraft engine, an aircraft engine and a propeller, or an aircraft and a propeller. The PLR identifies each IC that the PC holder is authorized to manufacture and install. The following process must be followed before a PC holder may manufacture and install ICs: (a) PC holder submits a request to the CM section to add ICs (previously identified by the certification branch) to the PLR.

(b) CM section coordinates with the certification branch for applications to add ICs to the PLR when no prior conformation is available to prove the articles meet the requirements to be identified as ICs.

(c) CM section evaluates whether the PAH has the capability to manufacture and install the ICs.

(d) If the CM section determines the PAH is capable, the ICs will be added to the PLR.

(e) CM section communicates its decision to the PC holder.

3-14 8120.22B Note: Refer to appendix B to this order for more detailed information on adding ICs to the PLR.

(3) Other Additions to the PLR. If a PC holder desires to add a new TC or new model under an existing TC to the PLR, the PC holder must make application in the same manner as for the original issuance. In this instance, it is not normally necessary to establish a PCB. In place of the PCB, the CM section should conduct an audit using the guidelines in paragraph 3-6. of this order, as appropriate, to determine whether the quality system is adequate or has been appropriately changed to ensure positive control of the product to be added to the PLR. When changes to the quality system are substantial, the PI may elect to request a nonscheduled QSA to make this determination. The CM section having certificate management responsibility may issue revisions to the PLR to include new products or models, when authorized.

(4) Deletions from the PLR. Where production of a type-certificated product has been discontinued, and more than one TC is listed on the PLR, the following applies: (a) If neither the complete product nor spare articles are being produced, the discontinued product or model should be deleted from the PLR. Upon issuance of the revised PLR, the CM section will request that the PC holder return the superseded PLR, which will be marked “Superseded” and retained in the files. If no other products, models, or spare articles are covered by the PC, the PC holder will be requested to return both the PC and PLR for cancellation. The CM section will retain the canceled PC and PLR.

(b) If production of the complete product has ceased, but spare articles are still being produced, the PLR should be revised to reflect this. The CM section should ensure that the PC holder remains in compliance with part 21, subpart G, and will continue to advise the FAA of any changes in its organization, systems, procedures, or processes.

(5) STC Modifications Incorporated by a TC/PC Holder.

(a) When the holder of the TC seeks and obtains its own STC, or is licensed to use another person’s STC data, the TC holder may amend the TC to incorporate the STC approval by reference. Another party’s STC that is incorporated during production and is referenced in and becomes a part of the TC need not be shown on the PLR. When a TC is amended to incorporate data approved under an STC, only the TC should continue to be shown on the PLR.

(b) When the PC holder of a TC obtains an STC, or related licensing agreement, but does not make the STC an integral part of the TC, the PC holder may incorporate the STC in production products prior to OAC approval, provided that: 1. The PC holder makes application to the FAA to add the STC to its PLR, 2. The quality system data are revised as necessary, and 3-15 8120.22B 3. The engineering data submitted for the STC approval provide all the details necessary for manufacture and for making conformity determinations.

(c) When a PC holder elects to use neither of the foregoing methods, the TC holder may incorporate an STC modification into production products only after OAC, in accordance with the provisions of part 43.

3-16. Initial Risk-Based Resource Targeting Assessment. After the issuance of the PC, the CM section will conduct a risk-based resource targeting (RBRT) assessment of the PC holder.

The results will determine the initial basis for conducting ongoing certificate management responsibilities, as summarized in FAA Order 8120.23, Certificate Management of Production Approval Holder.

3-16

8120.22B Chapter 4. Parts Manufacturer Approval (Part 21, Subpart K) Section 1. General Information 4-1. Applicability.

a. Part 21, subpart K, is applicable to any person who desires to manufacture an article under a PMA. The PMA is both a design and production approval issued to an applicant who has demonstrated the capability to design and manufacture to specific FAA requirements. The FAA does not separate the State of Design from the State of Manufacture.

b. A PMA may be obtained for replacement articles for technical standard order (TSO) article(s) that are approved as part of a product type design, provided that installation eligibility to that product can be shown. However, approval of an article that would constitute a major design change to the TSO article cannot be done under a PMA and would require a new TSOA. An applicant’s design that could meet the identical provisions of § 21.303 would normally not be considered a major design change.

c. A PMA may not be issued if the manufacturing facilities for the article are located outside the United States, unless it has been determined, in accordance with § 21.309, that such location(s) would place no undue burden on the FAA.

d. Exceptions. A PMA is required except as described below: (1) Manufacturing inspection procedures, materials, or special processes, such as hardening, plating, or shot-peening are not in and of themselves eligible for PMA. However, if a person participates in controlling the design, manufacture, or quality of an article by performing such procedures or processes and does so with the intent that the article be sold for installation on a type-certificated product, that person must do so as an approved supplier to another’s FAA- approved quality system.

(2) A PMA cannot be issued based on a “one-time-only” STC or FAA Form 337, Major Repair and Alteration , approval. The applicant would have to reapply for a new STC, which constitutes a “multiple approval,” before a PMA could be considered.

(3) Other PAHs (TC, PC, or TSOA) may produce replacement article(s) for their products or article(s) under their existing design and production approvals. A supplier to a PAH may not produce replacement or modification article(s) for sale for installation on a type- certificated product, unless that supplier has a PMA for the replacement or modification article(s). However, a PAH may authorize a major inspection and grant direct-ship authority (with FAA approval) to a supplier.

(4) An aircraft owner or operator may produce article(s) for installation on their own product without a PMA. The installation of those article(s) must comply with part 43 and other applicable airworthiness standards.

4-1 8120.22B (5) An air carrier, operating under 14 CFR part 121, Operating Requirements: Domestic, Flag, and Supplemental Operations , or 14 CFR part 135, Operating Requirements: Commuter and On Demand Operations and Rules Governing Persons On Board Such Aircraft , may produce article(s) for installation on its own product without a PMA, provided the installation of those article(s) is approved in accordance with part 43 and complies with the air carrier’s accepted maintenance procedures manual and instructions.

(6) An FAA-certificated repair station may produce an article for installation on a type-certificated product for current and anticipated in-house repairs or modifications. Further guidance may be found in AC 43-18, Fabrication of Aircraft Parts by Maintenance Personnel.

(7) The FAA does not require a PMA for production of commercial or standard parts produced for sale for installation on a type-certificated product. A PAH may purchase commercial or standard parts and subject them to more restrictive inspection criteria prior to approval for installation. When a question arises as to whether a part is a commercial or standard part, the certificating CM section should be contacted to determine whether the design of the part meets the criteria for a commercial or standard part.

(8) In accordance with § 21.502, replacement or modification article(s) produced and imported to the United States under the provisions of an agreement with a foreign country do not require a PMA. The scope of the agreement must specifically include acceptance of replacement and modification article(s). Acceptable replacement and modification article(s) may include: (a) Article(s) produced under the provisions of a bilateral agreement by the foreign holder of an FAA TC issued in accordance with § 21.21 or § 21.29, an STC, or a letter of TSO design approval; or (b) Articles produced by a foreign manufacturer and approved by their local CAA as specified in a bilateral agreement. Depending on the scope of the bilateral agreement, such articles may include those designed as replacements for United States State of Design products.

Note: In both cases, the article(s) are accepted for import under § 21.502, only when accompanied by a proper export airworthiness approval.

4-2. Privileges. A PMA holder has the privileges specified within the PMA letter and supplement. In addition, a PMA holder is eligible to have a qualified employee(s) designated as a DMIR in accordance with the provisions of part 183. The PMA holder may also be authorized by part 183 to apply for and obtain an ODA. FAA Orders 8000.95 and 8100.15 contain procedures for the administration of DMIRs and ODAs, respectively.

4-3. Advising the Applicant. The applicant should be advised that: a. AC 21-43 sets forth an acceptable means of complying with part 21, subpart K.

Alternative methods and procedures may be approved when the applicant can show that the proposed methods and procedures will achieve compliance with part 21, subpart K.

4-2 8120.22B b. The applicant must establish a quality system in accordance with § 21.307 and provide a quality manual describing its quality system to the FAA in accordance with § 21.308.

The manual must include descriptive material that adequately covers each applicable paragraph of § 21.137. The manual may vary in length depending on the scale of the quality system, size of the manufacturing facilities, and complexity of the article. For further guidance, refer to AC 21- 43.

c. Approval of an application for PMA requires an approval of the design by the certification branch and a quality system approval by the CM section.

d. PMA Holder’s Responsibility.

(1) Organization. Section 21.305 requires a PMA holder to provide to the FAA a document describing how its organization will ensure compliance to subpart K and sets out the requirements for this document. The document must identify a single point of contact who is knowledgeable of, and accountable for, maintaining the organization’s FAA-approved operations. In addition, the document must describe the accountable manager’s assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality. The PMA holder must amend the document as necessary to reflect changes in the organization required by §§ 21.305 and 21.316(a).

(2) Reporting Failures, Malfunctions, and Defects. The PMA holder must report any failure, malfunction, or defect in any article as required by § 21.3. The PMA holder must establish a procedure for such reporting as a part of its quality system. This reporting requirement applies to failures, malfunctions, or defects that may result in or have resulted in one of the occurrences listed in § 21.3(c).

(3) Quality System. The PMA holder must establish and describe in writing a quality system that complies with § 21.307. The PMA holder is responsible for maintaining the quality system in compliance with the data and procedures approved for the PMA, and for determining that each completed article produced conforms to the PMA and any terms or conditions prescribed in the approval.

(4) Supplier Control. A supplier is 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-furnished product, article, or service conforms to the PAH’s requirements. This section also requires the PAH to establish a supplier-reporting process for products, articles, or services that have been released from the supplier and subsequently found not to conform to the PAH’s requirements.

(5) Issuing Authorized Release Documents for Articles. Section 21.137(o) requires procedures for issuing authorized release documents, using FAA Form 8130-3, if the PAH intends to issue those documents. These procedures must provide for the selection, appointment, training, management, and removal of individuals authorized by the PAH to issue authorized release documents, refer to AC 21-43.

4-3 8120.22B (a) Procedures established pursuant to § 21.137(o) should ensure that only qualified personnel issue authorized release documents. A PAH’s evaluation of these individuals’ qualifications should include an assessment of their knowledge, background, experience, and training. Qualifications should be commensurate with the complexity and type of product or article for which the PAH issues an authorized release document. These procedures should also include requirements for completing FAA Form 8130-3 that is outlined in FAA Order 8130.21.

(b) These documents may be issued for new aircraft engines, propellers, and articles manufactured by the PAH, and for used aircraft engines, propellers, and articles rebuilt or altered pursuant to § 43.3(j). When an authorized release document used for export, § 21.137(o) requires a PAH to comply with the applicable § 21.335 requirements for the export of new and used aircraft engines, propellers, and articles. Refer to FAA Order 8130.21 to ensure the PAH is in compliance with § 21.335.

(6) Change to the Quality System. Each change to a quality system is subject to review by the FAA in accordance with § 21.320(a). A PMA holder must immediately notify the appropriate CM section in writing of any changes that may affect the inspection, conformity, or airworthiness of its article in accordance with § 21.309(c). These changes would include, but are not limited to, the following: (a) Resumption of production after being discontinued for an extended period of time for other than normal periods of time, such as vacation periods.

(b) Significant curtailment or resumption of production operations.

(c) Significant reduction or reassignment of quality system personnel; and (d) Changes or revisions to quality system data and related procedures.

(7) Changes to Manufacturing Facilities. The PMA holder must immediately notify the CM section in writing of any changes to its manufacturing facilities that may affect the inspection, conformity, or airworthiness of its article in accordance with § 21.309(c). The PMA holder must obtain FAA approval prior to making any changes to the location of its facilities in accordance with § 21.309(b).

(a) When a PMA holder moves the principal manufacturing facility to a new location, the PMA is no longer effective since a PMA is not transferable. Refer to § 21.314 for further guidance. If the PMA holder wants a PMA for the new location, then the PMA holder must reapply in accordance with § 21.303.

(b) A PMA holder’s manufacturing complex would normally consist of a principal facility and all associate facilities using the same quality system approved by the FAA, for the particular article(s). Associate facilities are discussed in chapter 6 of this order.

(c) The PMA is issued to the principal manufacturing facility that controls the design and quality of the article(s) for which the approval was granted. A postal address is not acceptable for a facility since the actual location must be identified. Such addresses, however, 4-4 8120.22B may be used as supplemental to the actual address when desired for such uses as corresponding to and from FAA offices.

(d) When the PMA holder seeks FAA approval to move an associate facility or add a new production facility, the FAA may, if deemed necessary, conduct a PCM audit at the new production facility or moved facility. If a PCM audit is deemed necessary, a satisfactory audit result must be obtained before the facility can be approved for production.

(8) Additional Article Approvals. If a PMA holder wishes to produce additional articles under the existing approved quality system, an application must be made, and the holder must show compliance with § 21.307. The CM section will then issue a PMA supplement that adds the new articles to the original approval, using the PMA letter available on AIR-800 Division-Approved Templates. If the new articles’ production constitutes a significant change in the operation or capabilities of the PMA holder, the CM section will conduct a review of the holder’s production and quality systems.

(9) Relationship Changes. The PMA holder may not produce articles if any change in its relationship to the design approval holder (licensor) or otherwise prevents it from meeting its PMA responsibilities.

e. PMA Article Marking Requirements. Section 45.15 specifies the marking requirements for PMA articles produced for installation on TC products, STC products, and TSO articles. In accordance with § 45.15, article(s) produced under a PMA must be permanently and legibly marked with the PMA holders name, trademark, symbol, or FAA-approved identification and part number and the letters “FAA-PMA”. The issuance of the PMA letter authorizes and requires the PMA holder to mark articles as prescribed in § 45.15. The PMA letter is available on AIR-800 Division-Approved Templates.

(1) Marking Critical PMA Articles. In addition to the marking requirements of § 45.15(a), a PMA article with a critical characteristic(s), as described in § 45.15(c), must be permanently and legibly marked with a serial number (or equivalent) unique to that part. The FAA must confirm that the marking location and the associated process will not affect airworthiness.

(2) Marking Detail Parts of PMA Assemblies. PMA article markings required by § 45.15 are applied to the top-level assembly of the approved replacement or modification article. Marking subassemblies or individual detail parts is not required. For example, if the PMA were approved for a hydraulic pump, the PMA marking would be affixed to the completed assembly. It is not required that each individual subassembly or detail part within the assembly be marked with “FAA-PMA,” unless it is being produced under its own PMA. If a PMA is granted for an assembly, individual detail parts of the assembly sold separately, except those produced under their own PMA, must be accompanied by a shipping document containing the information required by § 45.15(a) and must identify the detail part as a subcomponent of a PMA assembly. The article marking requirements for detail parts that are sold by the original PMA holder for installation into its related PMA assemblies may be found within the applicable design data for the assembly. This provides traceability of the individual detail parts to their related PMA assemblies.

4-5 8120.22B Note: There is no need to reissue previously issued PMA letters that require detail parts of an assembly sold separately to be marked in accordance with § 45.15.

(3) Part Numbering. Except as provided in paragraph 4-3.e.(3)(a) and (b) of this order, the applicant’s article should be numbered such that it is distinguishable from the corresponding TC holder’s part number. The TC holder’s part number with a prefix or suffix is sufficient for this purpose, if use of such a prefix or suffix will not cause confusion with the part marking practices of the TC holder. The requirement of § 45.15(a)(1) (to mark with the name, trademark, or symbol of the applicant) may be satisfied using a prefix or suffix if the prefix or suffix is consistent across the applicant’s product line. Each article also must be marked with “FAA-PMA” to meet the requirement of § 45.15(a)(2).

(a) Supplier Part Number. Some applicants are suppliers to PAHs. Often these PAHs use the supplier part numbers in their approved designs. When these suppliers later apply for PMA, they may continue to use their original part numbers, provided they also meet the requirements of § 45.15.

Note: PAHs and suppliers should be advised that when articles are marked only with PAH part numbers, the PAH is responsible for the design and quality of the article and any compliance and enforcement actions. Likewise, when the supplier is manufacturing under its PMA and has marked its article in accordance with § 45.15, they are responsible for the design and quality of the article(s) and any compliance and enforcement actions.

(b) Articles Manufactured Under License. When the PMA is based on the applicant showing evidence of a licensing agreement, the PMA article may have the same number as the type-certificated article, provided the applicant also meets the requirements of § 45.15.

(4) Articles Impractical to Mark. If the FAA finds the article too small or impractical (because of characteristics) to mark all (or any) of the information on the article, the information not marked on the article must be attached to the article or its container in accordance with § 45.15(d).

(5) Supplier Marking of PMA Articles. Suppliers to PMA holders may identify articles with PMA markings provided the PMA approval holder adequately controls those suppliers as part of its quality system. Suppliers that mark articles should be treated the same as any other supplier furnishing articles or services, using supplier control procedures as part of the quality system. The CM section may require that specific article marking controls be included in these procedures, along with any additional conditions that may be necessary for suppliers with direct-ship authorization.

(6) Identification Marking of Replacement and Modification Articles. The PAH must identify any portion of the PMA article (e.g., sub-assemblies, component parts, or replacement articles) that leave the manufacturer's facility as FAA-approved with the manufacturer's part number and name, trademark, symbol, or other FAA-approved manufacturer's identification.

4-6 8120.22B c. SMS. PMA applicants and holders are not required to comply with part 5 but may choose to participate in the FAA’s Voluntary SMS Program and should notify the CM Section of their intentions. Applicants or holders desiring to participate in the Voluntary SMS Program may contact the FAA through the following email for further information: 9-AVS-AIR- SMS@faa.gov.

4-4. Reserved.

Section 2. Processing an Application for a PMA.

4-5. Applicant Responsibilities.

a. Application Letter. The applicant must submit a letter of application to a certification branch or CM section, depending on the design approval basis. See 14 CFR 21.303.

If the applicant is applying based on an STC or identicality by licensing agreement, the application will be submitted to the CM section having geographical responsibility for the area in which the applicant’s manufacturing facility is located. If the design approval basis is other than an STC or identicality by licensing agreement, the application will be submitted to the certification branch having geographical responsibility for the area in which the applicant’s manufacturing facility is located. The application must include the following information: (1) The names and addresses of the manufacturing facilities where the articles will be manufactured.

(2) The identity of the article for which PMA application is being made, including: (a) The type certificated product identified by make, model, series, and if appropriate, serial number, on which the article is to be installed.

(b) The TC holder’s part number and if known, the drawing number and revision level that the PMA article would replace or modify.

(3) A description of the quality system in detail specified in § 21.307.

(4) A brief description of the method by which design approval will be sought: (a) Identicality by Showing Evidence of a Licensing Agreement. The applicant should submit an appropriate document from the TC, STC, or TSOA holder authorizing use of its FAA-approved data. Evidence of a licensing agreement is not a separate approval method, but merely a way to show identicality. The evidence of a licensing agreement is used by the applicant to show that the data submitted are FAA-approved and are therefore identical. For FAA purposes, the licensing agreement, in whatever form it takes, need only to authorize the applicant to use the type design data specified. The current industry practice of TC holders preparing “assist letters” for applicants to submit to the FAA sufficiently meets the requirements of showing evidence of a licensing agreement under § 21.303(a)(4). The CM section should 4-7 8120.22B ensure the “PMA assist letter” includes the information specified in paragraph 4-6.f .(1) of this order.

(b) Identicality Without a Licensing Agreement. The applicant should submit a statement certifying that the design is identical in all respects to the design of the article covered under an approved design (for example, TC, STC, or TSOA). In addition, the applicant should summarize the data that support the identicality assertion. Identicality to another PMA is unacceptable.

(c) Test and Computation. The applicant should submit a data package that includes a statement that all design, materials, processes, test specifications, system compatibility, and interchangeability are supported by an appropriate test and substantiation plan for FAA review and approval.

(d) STC. The applicant should stipulate use of the approved data from the STC and reference the STC number.

b. Unnumbered PMA Supplement. The applicant must prepare an unnumbered PMA supplement located on the AIR-800 Division-Approved Templates website. PMA supplements may be emailed to expedite processing.

4-6. CM Section Responsibility. The CM section confirms that the applicant has the capability to produce the proposed article in accordance with the approved design. The CM section will conduct the production approval process upon receipt of the PMA supplement evidencing approval of the design by the certification branch, or upon receipt of an application based on identicality by licensing agreement or STC. The production approval process includes the following: a. Conformity Inspections. The CM section will perform or delegate conformity inspections at the request of the certification branch or other CM sections.

b. Quality System Description. The CM section will ensure that the applicant has submitted a description of the quality system in the detail specified in § 21.307. Data submitted as evidence of compliance with part 21, subpart K should be evaluated in accordance with the criteria contained in appendix A to this order. The certification branch should be involved in evaluating technical data such as design data control, software control, and material review board (MRB). When the data have been found to be acceptable, an additional statement, like the following, must be included in the initial PMA letter: “(applicant name) must produce all articles in accordance with (applicant name), quality manual, revision (manual’s revision), dated (manual’s date) or a later FAA-approved revision.” c. PCM Audit. Prior to the original issuance of a PMA, the CM section will conduct the audit of the applicant’s facility, including supplier facilities, as appropriate, to determine whether the applicant is in compliance with part 21, subpart K. The CM section should decide whether to perform a conformity inspection within 30 days of receiving the PMA supplement from the certification branch or prior to issuing a PMA based on an STC or identicality by licensing agreement. This determination should be made based on article criticality, the history of the applicant, article complexity, supplier control issues, etc. When applicable, the CM section 4-8 8120.22B will verify the applicant’s manufacturing critical processes required to achieve the approved design characteristics.

d. Principal Inspector. When deemed necessary, the PI should conduct or plan for an article conformity when additional articles are approved by a supplement to the original PMA approval letter, or when the manufacturer expands or relocates its facility.

e. Design Change Issues. The CM section should ensure that the applicant has the proper authority or quality system processes to implement minor design changes and MRB dispositions. The CM section should coordinate with the certification branch to evaluate the quality system controls that detail the design change and MRB disposition processes.

f. PMA Assist Letter. The evidence of a licensing agreement from the TC, STC, or TSOA holder must include written permission for the applicant to use the design data to apply for a PMA. See 14 CFR 21.303 (a)(4). A “PMA assist letter” or similar evidence authorized by the TC, STC, or TSOA holder is sufficient for showing evidence of a licensing agreement. A licensing agreement alone is insufficient to issue a PMA. The applicant must meet all the requirements of § 21.303.

(1) The “PMA assist letter” must include the following information: (a) Product model, name, and TC/STC/TSO number.

(b) A statement that the PMA applicant is authorized to use the design data as identified by article name and drawing number. If the PMA Assist Letter does not contain the article drawing number, then the PMA application package must provide evidence of Design Holder acceptance of the design data.

(c) Information describing the authority of the PMA applicant to use the TC or STC holder’s part number and other article marking information, if applicable.

(d) Information on the article’s eligibility for installation (product make, series, model, and if appropriate, the serial number per the TCDS).

(2) Applicants must provide sufficient data to support discretionary conformity inspections in their application letters. Holders of the TC, STC, or TSOA may add this information to their assist letters. These data include: (a) The revision level of the article’s drawing to baseline the design for future approved changes.

(b) A statement as to whether design changes to the article and disposition of nonconforming articles will be controlled through the TC, STC, or TSOA holder’s quality system. The statement also should describe how design change information will flow to the applicant, and consequently, to the FAA.

(c) Information that establishes the life limits or airworthiness limitations of the article.

4-9 8120.22B g. Identicality Finding. Based on the review of the “PMA assist letter” that contains the information specified in paragraph 4-5.a.(4)(a) of this order, the CM section will make a finding of identicality by showing evidence of a licensing agreement. The CM section also will review the PMA supplement prepared by the applicant.

h. Life-Limited Articles. The CM section will forward PMA applications for life- limited articles to the certification branch to verify completeness of design data. The CM section should ensure that the application includes a continued operational safety plan.

4-7. Reserved.

Section 3. Issuance of a PMA 4-8. Assignment of the PMA Number. The CM section will assign a PMA number to each original PMA letter in accordance with the existing project assignment number procedures. The PMA number should be unique to each PMA holder and be carried forth on subsequent approved supplements to that PMA. The CM section will sign the PMA supplements affirming production approval after completing validation of the quality system.

4-9. PMA Letter.

a. The CM section will prepare the following PMA documents: (1) A PMA letter for the initial issuance of a PMA.

(2) A transmittal letter for all subsequent issuances of PMA, including all supplements is available on AIR-800 Division-Approved Templates.

b. When an applicant or approval holder asks to use electronic technology to satisfy information requirements for part 21 activities or asks to use an alternative method of storing certification, production, and related information, the applicant or approval holder establishes a procedure to do so and shares the required information with the CM section. The CM section decides whether it will maintain a hard or electronic copy of the required information. For additional information, refer to FAA Order 8000.79, Use of Electronic Technology and Storage of Data , and FAA Order 1350.14, Records Management , which allow for electronic records.

c. The original(s) PMA letter should be presented to the manufacturer, and the CM section will retain one copy for filing. The PMA supplement information will be uploaded into DRS by the CM section.

4-10. Initial Risk-Based Resource Targeting Assessment. After the issuance of the PMA, the CM section will conduct an RBRT assessment of the PMA holder. The results will determine the initial basis for conducting ongoing certificate management responsibilities, as summarized in FAA Order 8120.23.

4-11. Reserved.

4-10 8120.22B Section 4. Post-PMA Activities 4-12. Transferability.

a. A PMA is not transferable to another person, company, or location per § 21.314.

The regulations do not preclude revising approval letters to show a change in name only if the holder provides evidence there is no change in the quality system, management, ownership, or location of the principal facility. However, the design portion of a PMA based on an STC may be sold, licensed, or otherwise transferred. If the STC holder or a licensee intends to manufacture articles, it must apply for a new PMA.

b. In the event a PMA holder is acquired by another company, with no resulting change in the legal status of the PMA holder, the acquiring company will not be required to apply for a new PMA. However, the PMA holder must: (1) Retain possession of the production approval, (2) Retain the same quality system, and (3) Continue to operate at the same location with the same core management officials.

c. The PI should conduct an on-site visit to ensure that the PMA holder has complied with the requirements in paragraph 4-12.b. of this order. In addition, the acquiring company should provide a letter to the CM section indicating its status as the new owner of the PMA holder and any future plans affecting the status of the PMA holder. The PI should update the project files to include documentation indicating the acquisition.

d. If the status of the PMA changes (for example, the PMA holder is disbanded or absorbed into the acquiring company) or the PMA holder transfers or relinquishes its production approval, the CM section will ensure that a new application for PMA is submitted for processing by the FAA.

4-13. Reuse of PMA Design Data. Though a PMA itself is not transferable, the design and substantiating data approved under a PMA may be used by another person to apply for a new PMA. The applicant must show compliance with the regulations and may submit previously approved substantiating data to meet (partially or fully) this requirement.

4-14. Changes to the Quality System. Whenever a PMA applicant has submitted data as evidence of compliance with part 21, subpart K, and the CM section has approved the data, any subsequent revisions to these data should be approved by the PI prior to implementation.

Revisions that affect the design (for example, MRB, design data control, service difficulty reporting) should be coordinated with the certification branch. The CM section should notify the PMA holder of the approval in writing using the Quality System Changes Acceptance Letter at AIR-800 Division-Approved Templates.

4-11 8120.22B 4-15. Revising/Amending the PMA Supplement. When a PMA approval letter is reissued, the first paragraph in the letter should be revised to include the previous supplement numbers.

This will eliminate the practice of attaching additional pages of PMA supplements. Often an existing supplement needs correcting for typographical errors or to update contacts. While each certification branch or CM section sets an appropriate method to correct or update the supplement, they must maintain original signatures from each office on all altered supplements in the event of a revision. Some offices issue a revised supplement with corrections. The revised supplement is sent to the PMA holder along with a request to return the original incorrect supplement. An applicant may send an amended supplement request and supporting data to expand installation eligibility. However, while this is an acceptable practice, it is preferred that the applicant generate a new supplement instead. The applicant will submit to the certification branch an updated supplement in Microsoft Word table format with a note stating the specific certification branch or CM section action requested (for example, correction, revision, amendment, superseding, cancellation, or change of address).

4-16. Export Considerations. Many countries have additional requirements regarding their acceptance of PMA articles. In particular, the European Union member states require special statements on FAA Form 8130-3 regarding whether an article is critical or non-critical. Any required statements would be entered in block 12 of FAA Form 8130-3.

4-12

8120.22B Chapter 5. Technical Standard Order Authorization (Part 21, Subpart O) Section 1. General Information 5-1. Applicability. Part 21, subpart O, is applicable to a person who desires to manufacture an article that meets a specific TSO. The TSOA system does not apply to articles produced under a PMA, TC, or PC. The TSOA is both an FAA design and production approval issued to an applicant who has demonstrated the capability to design and manufacture a specific TSO. The FAA does not separate the State of Design from the State of Manufacture.

5-2. Privileges. A TSOA holder has the privileges specified in subpart O and within the letter of TSOA. In addition, a TSOA holder is eligible to have a qualified employee(s) designated as a DMIR in accordance with the provisions of part 183. The TSOA holder may also be authorized by part 183 to apply for and obtain an ODA. FAA Orders 8000.95 and 8100.15 contain procedures for the administration of DMIRs and ODAs, respectively.

5-3. Advising the Applicant. The applicant will be advised that: a. AC 21-43 sets forth an acceptable means of complying with part 21, subpart O.

Alternative methods and procedures may be approved when the applicant can show that the proposed methods and procedures will achieve compliance with part 21, subpart O.

b. The applicant must establish a quality system in accordance with § 21.607 and provide a quality manual describing its quality system to the FAA in accordance with § 21.608.

The manual must include descriptive material that adequately covers each applicable paragraph of § 21.137. The manual may vary in length depending upon the scale of the quality system, size of the manufacturing facilities, and complexity of the article. For further guidance, refer to AC 21-43.

c. A TSOA holder is a manufacturer who controls the design and quality of an article produced under the TSO system. The TSOA holder’s control extends to all related articles, processes, or services, including all related articles, processes, or services procured from outside sources.

d. A TSO design approval can be obtained only for the applicable TSO that is in effect on the date of application for that article.

e. A TSOA does not imply installation eligibility on a type-certificated product.

5-1 8120.22B f. TSOA Holder’s Responsibility.

(1) Organization. Section 21.605 requires a TSOA holder to provide the FAA a document describing how its organization will ensure compliance to subpart O and sets out the requirements for this document. The document must identify a single point of contact who is knowledgeable of, and accountable for, maintaining the organization’s FAA-approved operations. In addition, the document must describe the accountable manager’s assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality. The TSOA holder must amend the document as necessary to reflect changes in the organization required by §§ 21.605 and 21.616(a).

(2) Reporting Failures, Malfunctions, and Defects. The TSOA holder must report any failure, malfunction, or defect in any article as required by § 21.3. The TSOA holder should be encouraged to establish a procedure for such reporting as a part of its quality system. This reporting requirement applies to failures, malfunctions, or defects that may result in or have resulted in one of the occurrences listed in § 21.3(c).

(3) Quality System. The TSOA holder must establish and describe in writing a quality system that complies with § 21.607. The TSOA holder is responsible for maintaining the quality system in conformity with the data and procedures approved for the TSOA and for determining that each article conforms to the TSO and any terms or conditions prescribed in the TSO letter of authorization. The TSOA holder must provide to the FAA a document describing how its organization will ensure compliance to § 21.607. This document must identify a single point of contact who is knowledgeable of, and accountable for, maintaining the organization’s FAA-approved operations. In addition, the document must describe the accountable manager’s assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality.

(4) Supplier Control. A supplier is a person at any tier of 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-furnished product, article, or service conforms to the PAH’s requirements. Section 21.137(c) also requires the PAH to establish a supplier-reporting process for products, articles, or services that have been released from the supplier and subsequently found not to conform to the PAH’s requirements.

(5) Issuing Authorized Release Documents for Articles. Section 21.137(o) requires procedures for issuing authorized release documents (using FAA Form 8130-3) if the PAH intends to issue those documents. These procedures must provide for the selection, appointment, training, management, and removal of individuals authorized by the PAH to issue authorized release documents (refer to AC 21-43).

5-2 8120.22B (a) Procedures established pursuant to § 21.137(o) should ensure that only qualified personnel issue authorized release documents. A PAH’s evaluation of these individuals’ qualifications should include an assessment of their knowledge, background, experience, and training. Qualifications should be commensurate with the complexity and type of product or article for which the PAH issues an authorized release document. These procedures should also include requirements for completing FAA Form 8130-3 that meets of FAA Order 8130.21.

(b) These documents may be issued for new aircraft engines, propellers, and articles manufactured by the PAH, and for used aircraft engines, propellers, and articles rebuilt or altered pursuant to § 43.3(j). When an authorized release document is used for export, § 21.137(o) requires a PAH to comply with the applicable § 21.335 requirements for the export of new and used aircraft engines, propellers, and articles. Refer to FAA Order 8130.21 to ensure the PAH is in compliance with § 21.335.

(6) Change to the Quality System. Each change to a quality system is subject to review by the FAA in accordance with § 21.620(a). A holder of a TSOA must notify the appropriate CM section in writing prior to any changes that may affect the inspection, conformity, or airworthiness of the article. These changes would include, but are not limited to, the following: (a) Resumption of production after being discontinued for an extended period of time for other than normal periods of time, such as vacation periods, (b) Significant curtailment or resumption of production operations, (c) Significant reduction or reassignment of quality system personnel, and (d) Changes or revisions to quality system data and related procedures.

(7) Changes to Manufacturing Facilities. The TSOA holder must immediately notify the CM section in writing of any changes to its manufacturing facilities that may affect the inspection, conformity, or airworthiness of its article in accordance with § 21.609(c). The TSOA holder must obtain FAA approval prior to making any changes to the location of its manufacturing facilities in accordance with § 21.609(b).

(a) A TSOA holder’s manufacturing complex would normally consist of a principal facility and all associate facilities using the same quality system approved by the FAA, for the particular TSO article(s). Associate facilities are discussed in chapter 6 of this order.

(b) The TSOA is issued to the principal manufacturing facility that controls the design and quality of the article(s) for which the approval was granted. A postal address is not acceptable for a facility since the actual location must be identified. Such addresses, however, may be used as supplemental to the actual address when desired for such uses as corresponding to and from FAA offices.

5-3 8120.22B (c) When a TSOA holder moves the principal manufacturing facility to a new location, the TSOA is no longer effective. In accordance with FAA Order 8150.1, Technical Standard Order Procedures , the responsible CM section will evaluate the TSO holder’s quality system to determine the TSO holder’s ability to comply with § 21.607. If the CM section finds no change to the TSO holder’s ability to comply with § 21.607, the TSO holder may be eligible for the reissuance of its TSOA(s). The certification branch must notify the TSO holder that no new articles may be shipped from its new facility until the TSOA has been reissued. When the TSOA holder seeks FAA approval to move an associate facility or add a new production facility, the FAA may, if deemed necessary, conduct a PCM at the new production facility or moved facility. If an audit is deemed necessary, a satisfactory audit result must be obtained before the facility can be approved for production.

(8) Identification Marking. A TSOA holder is responsible for ensuring that only those articles that meet the applicable TSO performance standards are identified as required by § 45.15.

(a) Supplier Marking. Suppliers to TSOA holders can identify articles with TSO markings provided the TSO approval holder adequately controls those suppliers as part of its quality system. Suppliers that mark articles should be treated the same as any other supplier furnishing articles or services, using supplier control procedures as part of the quality system.

The CM section may require that specific article marking controls be included in these procedures, along with any additional conditions that may be necessary for suppliers with direct- ship authorization.

(b) Detail Parts and Invoice Identification. When detail parts are produced for installation in a TSO article, individual detail parts of the TSO article sold separately must be accompanied by a shipping document containing the information required by § 45.15(d) and must identify the detail part as a subcomponent of a TSO article.

(c) Detail Parts and Design Data Identification. TSO article markings required by § 45.15 are applied to the top-level assembly for which the original TSOA was granted, not subassemblies or individual detail parts. It is not required that each individual subassembly or detail part within the TSO article be marked. The TSO marking requirements for detail parts, which are sold by the original TSOA holder for installation into its related TSO articles, may be found within the applicable design data for the TSO article. This provides traceability of the individual detail parts to their related TSO articles.

(9) Reidentifying Marking. Sections 21.616(d) and 21.616(e) do not prohibit a certificated person, authorized under § 43.3, from modifying or replacing the original TSO identification marking in accordance with the TSOA holder’s instructions (for example, service letters, service bulletins, or airworthiness directives) resulting from an FAA-approved design change. The following guidance applies to the incorporation of design changes to TSO articles that have left the manufacturer’s quality system that require the reidentification of the TSO articles.

5-4 8120.22B (a) There are instances when the holder of a TSOA, or a letter of TSO design approval, changes a design and provides data so that these changes may be incorporated into articles in service, through alteration. Service bulletins, service letters, and airworthiness directives are common nomenclature for these types of data, but the data may be transmitted in any appropriate form. Regardless of whether the change is major or minor, as defined in § 21.619, it may be necessary or appropriate to reidentify the article.

(b) The reidentification procedure indicated in paragraph 5-3.f.(9) of this order must be part of the FAA-approved data for the entire alteration. The identification markings must comply with the requirements of § 21.616 and the applicable TSO. Some of the reidentification methods expected include the following: making additional marks; making new marks and obliterating the old; installing a new data plate or label provided by the TSOA holder; or a combination these methods. Consideration should be given to minimizing confusion as to the status of the article and maximizing traceability to the maintenance and alteration records.

(c) Design changes introduced by persons other than the TSOA holder are permissible under § 21.619(c). FAA Order 8150.1 addresses the identification/marking requirements of TSO articles that are modified by persons other than the TSO manufacturer.

(10) Identification Marking of Replacement and Modification Articles. The PAH must identify any portion of the TSO article (e.g., sub-assemblies, component parts, or replacement articles) that leave the manufacturer's facility as FAA-approved with the manufacturer's part number and name, trademark, symbol, or other FAA-approved manufacturer's identification.

g. Safety Management Systems. TSOA applicants and holders are not required to comply with part 5 but may choose to participate in the FAA’s Voluntary SMS Program and should notify the CM section manager of their intentions. Applicants or holders desiring to participate in the Voluntary SMS Program may contact the FAA through the following email for further information: 9-AVS-AIR-SMS@faa.gov.

5-4. Reserved.

Section 2. Processing an Application for a TSOA 5-5. Application. A U.S. applicant (or an applicant’s authorized agent) must submit an application for a TSOA by letter to the appropriate certification branch manager having geographical responsibility for the area in which the applicant’s principal manufacturing facility is located. The applicant must submit, along with the application, those documents required by § 21.603, which include a: a. Statement of conformance.

b. Copy of the technical data.

c. Manual describing the quality system in the detail specified in § 21.607.

5-5 8120.22B 5-6. Design Approval. The regulations and requirements concerning TSO design approval methods are contained in part 21, subpart O, and the applicable TSO. Policy covering TSO design approval methods is contained in FAA Order 8150.1.

5-7. PCM. At the request of the certification branch, the CM section should conduct an audit, within the deadline established by the certification branch. This audit will be conducted as follows: a. Evaluate the applicant’s quality manual for compliance with § 21.607. Additional guidance is provided in AC 21-43. The manual must include an acceptable test procedure to which each production article will be tested. Any inadequacies in the quality manual submitted must be identified to the applicant for corrective action. After the quality manual has been reviewed, and any applicable corrective actions taken, the CM section will approve the quality manual submitted by the applicant. The approved quality manual may be retained in the CM section files.

b. Evaluate the applicant’s production facilities in accordance with the pertinent 14 CFR, the FAA-approved design data, and the quality manual approved in paragraph 5-7.a. of this order. The CM section manager will select either an individual or a team to conduct this audit. The team may consist of the cognizant PI and at least one other manufacturing inspector or the CM section manager. It is also recommended that an engineer be selected for the team when deemed necessary by the type and complexity of processes and procedures being used at the facility. The standardized evaluation criteria may be used as an aid to evaluate compliance, as discussed in FAA Order 8120.23. Team members should be advised, however, that some of the evaluation criteria contained therein may not be related to 14 CFR and therefore may only be evaluated as a best practice. This audit is not considered to be a QSA. Record all noncompliance’s on FAA Form(s) 8100-6 and 8120-14.

c. The CM section will advise the certification branch concerning the results of the PCM audit. Any unresolved items requiring corrective action should be identified and copies of letters to the applicant requesting corrective action will be provided.

5-8. Reserved.

Section 3. Issuance of a TSOA or Letter of TSO Design Approval 5-9. TSO Letter of Authorization. After showing compliance with part 21, subpart O, the certification branch will issue a letter in accordance with established procedures. Electronic signature is permitted. This letter should be amended, as appropriate, to reflect subsequent additions to a manufacturer’s original TSOA, after appropriate coordination between the certification branch and CM section in determining the need for a PCM audit (refer to FAA Order 8150.1).

5-6 8120.22B 5-10. Transferability.

a. A TSOA is not transferable. However, a TSOA holder undergoing a name change is not considered a transfer. A sale of ownership resulting in a change in the legal status of the TSOA holder, or the sale of TSO design rights is considered a transfer and will require the new owners to submit an application for exemption to retain the TSOA.

b. If a TSOA holder is acquired by another company, with no resulting change in the legal status of the TSOA holder, the acquiring company will not be required to apply for a new TSOA. However, the TSOA holder must: (1) Retain possession of the production approval, (2) Retain the same quality system, and (3) Continue to operate at the same location with the same core management officials.

c. The PI should conduct an on-site visit to ensure that the TSOA holder has complied with the requirements in paragraph 5-11.b. of this order. In addition, the acquiring company should provide a letter to the CM section indicating its status as the new owner of the TSOA holder and any plans affecting the status of the TSOA holder. The PI should update the project files to include documentation indicating the acquisition.

d. If the status of the TSOA changes (for example, the TSOA holder is disbanded or absorbed into the acquiring company) or the TSOA holder transfers or relinquishes its production approval, the certification branch will ensure that a new application for TSOA is submitted for processing by the FAA.

5-11. Processes TSOA/LODA Transfers. Transfers may not be made by the TSOA holder but can be requested and approved by the FAA. All requests for transfers must be submitted to the holder’s geographic certification branch and include the appropriate justification. Refer to FAA Order 8150.1 for additional information.

5-12. Initial Risk-Based Resource Targeting Assessment. After the issuance of the TSOA, the CM section will conduct an RBRT assessment of the TSOA holder. The results will determine the initial basis for conducting ongoing certificate management responsibilities, as summarized in FAA Order 8120.23.

5-7

8120.22B Chapter 6. Extension of a Production Approval (Domestic Only) Section 1. General Information 6-1. Applicability. The procedures in this chapter are applicable to a PAH who desires to extend its production approval to another facility, referred to herein as an associate facility.

6-2. Privileges. An associate facility has the same privileges as the original PAH, unless the original PAH or the FAA withholds specific privileges. If authorized by the original PAH, the associate facility can request from its CM section the appointment of DMIRs. In addition, if authorized by the original PAH, the associate facility may apply for and obtain an ODA. FAA Orders 8000.95 and 8100.15 contain procedures for the administration of DMIRs and ODAs, respectively.

6-3. Advising the Original PAH and the Associate Facility.

a. A PAH can request the FAA to extend its production approval to an associate facility. To be approved, the associate facility must: (1) Be located within the United States, (2) Be owned and controlled by the original PAH that controls the design and quality of the product or article(s), except for companies participating in joint-production or co- production business agreements, (3) Use a quality system that has been approved by the original PAH, and (4) For a PMA or TSOA holder, produce the same article to the same extent as the original PAH. See § 21.139, 21.309, and 21.609.

b. When the associate facility produces the complete product or article(s) and meets 14 CFR eligibility requirements for the type of production approval, it should be encouraged to obtain a separate production approval. The PAH would benefit from a separate approval because the FAA offices would not need to coordinate production approval extensions.

c. All FAA correspondence intended for the original PAH will be from or routed through the CM section that has certificate management responsibilities of the original PAH.

d. Original PAH’s Responsibilities.

(1) The original PAH must implement its quality system at the associate facility or approve the quality system used by the associate facility. See § 21.137.

(2) If the original PAH retains the approval or acceptance of changes, the associate facility should be required to submit all proposed changes to the originally approved quality manual to the PAH for acceptance or approval. The FAA must be immediately notified of 6-1 8120.22B all changes that may affect the inspection, conformity, or airworthiness of its product or articles.

See § 21.139 e. Associate Facility’s Responsibilities.

(1) The associate facility will communicate with the CM section having geographical responsibility of the area in which the associate facility is located.

(2) The associate facility will comply with the quality system of the original PAH, or the quality system approved by the original PAH.

(3) If the approval of changes to the quality manual is retained by the original PAH, the associate facility will submit proposed changes to the original PAH for approval.

(4) If the approval of changes to the quality system data is delegated to the associate facility, the associate facility should submit changes to its geographic CM section.

(5) The quality manual should identify an accountable manager for the associate facility.

6-4. Reserved.

Section 2. Processing a Request for Extension of a Production Approval 6-5. Request for Extension of a Production Approval. The original PAH can request an extension of its production approval to an associate facility. The extension application will be submitted to the original PAH’s CM section. The request must contain the following information: a. The location of the associate facility.

b. The type and extent of activities to be performed at the associate facility.

c. Any special conditions of the request, such as the delegation or withholding of delegation of MRB authority or designee privileges.

d. A point of contact at the associate facility. See 14 CFR part 21, subparts G, K, and O.

6-6. Evaluating the Request. The CM section of the original PAH will evaluate the request for an extension and determine if: a. The location of the associate facility is adequately described.

b. The PAH’s quality system is adequate to control the design and quality of the products and articles produced at the associate facility, or the original PAH has reviewed and approved the associate facility’s quality system.

6-2 8120.22B c. The request states explicitly the type and extent of production to be accomplished at the associate facility.

d. Any special conditions of the extension apply (for example, delegation or nondelegation of MRB authority).

6-7. Coordination with the Geographic CM Section. Following the evaluation of the request from the original PAH, the CM section will contact the CM section having geographical responsibility of the area in which the associate facility is located. The CM section will: a. Submit a hand-off memorandum to the geographic CM section informing it of the request, a copy of the extension request, and the evaluation results, using the hand-off request template located on AIR-800 Division-Approved Templates.

b. Request the geographic CM section to perform a PCM audit.

c. At a minimum, arrange for the following to be addressed: (1) Reporting of PCM audit findings.

(2) Reviewing changes to quality manual.

(3) Compliance and enforcement actions.

(4) Submittal of correspondence.

6-8. Reserved.

Section 3. Approval of the Request for Extension of a Production Approval 6-9. Approval of the Request. After satisfactory completion of the PCM audit and any applicable corrective actions taken, the CM section will approve the extension request. The CM section will request that the original PAH provide the CM section of the associate facility with a copy of the quality system data if it is not available at the associate facility. The CM section will issue the original PAH an amended PC or PMA approval letter, using the template located at AIR-800 Division-Approved Templates For a TSOA holder, the CM section will request that the certification branch issue a revised TSOA letter. The amended production approval authorization letter will list the associate facility as a manufacturing location. A copy of the amended production approval authorization letter will be sent to the CM section of the associate facility.

6-10. Geographic CM Section Responsibility After Extension Approval. The geographic CM section will perform certificate management at the associate facility.

6-11. Non-traditional Associate Facilities. Some PAH extensions do not fit within the traditional concept of an associate facility. For example, a corporation holding many production approvals in different locations throughout the United States may decide to consolidate its approvals and manage them from one location. These former PAHs may then be converted to 6-3 8120.22B associate facilities. In such cases, the FAA managing CM section of the PAH must coordinate a proposal for the nontraditional associate facility activity with both cognizant CM branch managers and AIR-600. The CM branch managers, cognizant division managers, and AIR-600 must concur with the proposal before proceeding with the non-traditional associate facility activity. The proposal must include a memorandum of understanding (MOU) between the affected CM branches to address the following issues: a. Rationale for use of a nontraditional certificate management plan, b. Certificate management roles and responsibilities, c. Handoff requirements, d. Control and maintenance of records, e. Transition activities, f. Use of additional certificate management tools, and g. Any other applicable issues.

6-4

8120.22B Chapter 7. Non-U.S. Manufacturing Facilities—Determination of Undue Burden and No Undue Burden 7-1. Undue Burden and No Undue Burden. The FAA does not issue TCs or production approvals if the manufacturing facilities are located outside the United States, unless the FAA finds the location of the manufacturer’s facilities places no undue burden on the FAA. See §§ 21.122, 21.139, 21.309, and 21.609.

a. For the FAA to ensure resources will be available to perform regulatory oversight of associate facilities and suppliers outside the United States, a determination of no undue burden will be made as early in the certification process as possible. Therefore, the certification project plan must include a list of proposed associate facilities and suppliers, including any known sub- tier suppliers of critical parts, processes, or materials, located outside the United States.

b. When an initial production approval application involving non-United States manufacturing facilities is reviewed by the FAA, an “undue burden or no undue burden” determination must be made. The FAA is required to prepare a decision paper in accordance with 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.

c. If a new or existing PAH proposes to use non-U.S. suppliers, the criteria for supplier selection must be applied to determine whether the supplier would likely be selected for a supplier control audit. If the supplier would not be selected, there is no burden. If the supplier could be selected, the FAA is required to prepare a decision paper in accordance with FAA Order 8100.11.

d. Any subsequent changes to an approval holder’s manufacturing programs involving non-U.S. facilities will cause the FAA to reevaluate the initial undue burden or no undue burden decision.

e. FAA Order 8100.11 provides general instructions on what to consider during decision paper development. It also contains the general content requirements of decision papers that include a specific list of required decision paper elements.

7-2. Reserved.

7-1

8120.22B Chapter 8. Work Performed on New Products or Articles After Leaving a U.S.

PAH/Supplier’s Quality System 8-1. New Products or Articles Remaining Within Part 21. New products or articles that have left the control of a U.S. PAH or their approved supplier’s quality system and are acquired by another PAH must have subsequent work performed in accordance with the part 21 quality system. See § 21.137.

a. The three options for new products or articles are as follows: (1) The product or article may be returned to original PAH and processed.

(2) The work may be performed by the original PAH personnel at the location of the receiving PAH.

(3) The work may be performed by the receiving PAH.

b. Conditions for accomplishing work under part 21 by the receiving PAH are as follows: (1) The receiving PAH must have the appropriate design data, approved procedures, and processes to determine conformity of the product or article, as well as qualified and authorized personnel to work on the product or article.

(2) The PAH has a defined process for accomplishing and documenting any work performed to ensure that the product or article continues to conform to the design data.

8-2. New Products or Articles No Longer Within Part 21. New products or articles that have left the United States PAH or their approved supplier’s quality system and are received by an airline, repair station, distributor, etc., are (1) completed aircraft with an airworthiness certificate, or (2) spare, replacement, or modification articles or products intended for installation on a higher-level product or article that has already met the applicability requirements of part 43.

Therefore, the receiving airline, repair station, or distributor is responsible for ensuring that any maintenance, preventive maintenance, rebuilding, altering, etc., on such products or articles will be performed by persons authorized under part 43.

8-1

8120.22B Chapter 9. Prepositioning Aircraft Engines, Propellers, or Articles.

9-1. Applicability. This chapter applies to any applicant who desires to ship or preposition aircraft engines, propellers, or articles that are pending FAA design approval.

9-2. Request to Preposition. Applicants or production approval holders (PAHs) may request to preposition aircraft engines, propellers, or articles for testing to another PAH or supplier participating in the certification project, air carriers, or certified repair stations, etc.

9-3. Requirements.

a. There should be an established certification project with the FAA containing a certification plan outlining procedures for prepositioning prototype aircraft engines, propellers, or articles. PAH’s quality system should reference these internal procedures. The FAA will review for acceptability. These procedures will describe how prototype aircraft engines, propellers, or articles will be controlled when prepositioned. At a minimum, these procedures should describe: (1) Justification for prepositioning.

(2) Quantity and description of aircraft engines, propellers, or articles to be prepositioned.

(3) Location(s) where products and articles will be shipped.

(4) How prototype items will be monitored, controlled, and segregated.

(5) How design changes will be implemented.

(6) How the configuration and revision status will be controlled and maintained.

(7) How notification will be conveyed, processed, and documented after the issuance of FAA design approval. This process will include all methods to verify those prepositioned aircraft engines, propellers, or articles conform to the final approved design and are in a condition for safe operation.

b. While prepositioning may reduce long lead times that impact manufacturing and configuration control, access to preposition articles and products must be strictly controlled to prevent the installation of unapproved parts on type certificated aircraft. The FAA may determine the need for additional requirements to be contained in the PAH’s procedures.

Note : For additional guidance, refer to the current version of AC 21-32, Control of Prepositioned Products and Articles Shipped Prior to Design Approval.

9-4. Conformity Inspection. The applicant or PAH may choose to preposition aircraft engines, propellers, or articles during conformity activities. FAA Form 8120-10, Request for 9-1 8120.22B Conformity (RFC) , or other acceptable means, will indicate shipping prototype aircraft engines, propellers, or articles when the “8130-3 Tags Required” block is checked.

9-5. Who May Issue FAA Form 8130-3. The following persons may issue FAA Form 8130- 3 for a prepositioned aircraft engines, propellers, or articles: a. Aviation safety inspectors, (ASI - Manufacturing).

b. Designated manufacturing inspection representatives- (DMIR).

c. Designated airworthiness representatives, (DAR-F - Manufacturing).

d. ODA unit members (UM) with the appropriate functions code of the following types: production certification (PC) ODA, technical standard order authorization holder (TSOA) ODA, parts manufacturer approval (PMA) ODA.

Note: PAHs with personnel who issue authorized release documents (ARD) using FAA Form 8130-3 in accordance with § 21.137(o) are not eligible to preposition aircraft engines, propellers, or articles.

9-6. Completion of FAA Form 8130-3 for Prepositioning Products and Articles.

Instructions on how to complete FAA Form 8130-3 are found in FAA Order 8130.21. The entries in this paragraph are specific to prepositioning prototype aircraft engines, propellers, or articles and should be annotated in the appropriate blocks of FAA Form 8130-3. Otherwise, follow the guidance in FAA Order 8130.21 for record retention and completion requirements of the form. Identify the data in block 12 (e.g., for conformity inspection, for test only, pending approved data, pending type-certificate).

a. Block 4. Organization Name and Address. Enter the full name and physical address (no post office box numbers) of the organization or facility for which the form is being issued, and project number (for example, Certificate No. LI1R 123K), as appropriate. A logo or other identification of the organization is permitted provided it can be contained within the block.

b. Block 11. Status/Work. Enter “PROTOTYPE” for a new item that is in conformity with non-approved design data.

c. Block 12. Remarks. When used for prepositioning, enter the following statement: “Prototype product(s)/article(s) pending certification under FAA project number [enter number] are not eligible for installation on in- service, type-certificated aircraft. Upon approval of the applicable design data and completion of an inspection to validate conformity to that approved design data and condition for safe operation, that product or article may be considered new.” d. Block 13a. Airworthiness Approval. Mark the “Non-approved design data specified in block 12” box.

9-2 8120.22B 9-7. Additional Considerations. Prototype aircraft engines, propellers, or articles are not eligible for export, because they have not yet conformed to an approved design. Under the technical assistance provisions of a bilateral agreement, the foreign civil aviation authority (CAA) may request certifying statements attesting to the conformity of prototype aircraft engines, propellers, or articles manufactured and prepositioned from the United States. When the FAA agrees to provide this statement, FAA Form 8130-3 may be used to ship a prototype aircraft engines, propellers, or articles. However, it must be used only as a conformity inspection document that lists all applicable data and details of any deviations noted.

9-8. Export Considerations. After issuance of the TC/STC, products and articles are eligible for export. If it is known that a product or article will be installed on an aircraft registered in a country where the CAA requires an export airworthiness approval, then refer to FAA Order 8130.21 to ensure compliance with § 21.331.

9-3

8120.22B Chapter 10. Administrative Information 10-1. Distribution. This order is distributed to AIR, the Flight Standards Service (FS), all engineering managing offices, all manufacturing offices, and the Workforce Development Branch (AIR-940).

10-2. Delegation of Authority. Policy and Standards Division AIR-600 is responsible for issuing, revising, or canceling the material in this order.

10-3. Forms. This order identifies several forms used for the evaluation, approval, and CM of production activities. These forms are available online at https://www.faa.gov/forms/index.cfm/go/document.list/.

10-4. Deviations. Adherence to the procedures in this order is necessary for uniform administration of this directive material. Any deviations from this guidance material must be coordinated and approved by AIR-600. If a deviation becomes necessary, the FAA employee involved should ensure the deviations are substantiated, documented, and concurred with by the appropriate supervisor. The deviation must be submitted to AIR-600 for review and approval.

The limits of federal protection for FAA employees are defined by title 28, U.S.C. 2679.

10-5. Related Publications. Orders referenced in this directive list only the basic order number.

It is the responsibility of the user to establish that the latest revision/amendments are being used.

See appendix E for a list of related publications mentioned in this order.

10-6. Requests for Information. All public requests for information regarding production approval or certificate management activities will be processed in accordance with the Freedom of Information Act. Refer to FAA Order 1270.1, Freedom of Information Act Program.

10-7. Electronic Signature. The use of an electronic signature for the issuance of a PC and a production limitation record, or a production approval letter for a PMA or TSOA is permitted.

10-8. Suggestions for Improvement. Your suggestions are welcome. FAA Form 1320-19, Directive Feedback Information , is located in appendix E of this order for your convenience.

Please forward all comments on deficiencies, clarifications, or improvements regarding the contents of this order to the AIR Directives Management Officer (DMO) at 9-avs-air-directives- management-officer@faa.gov .

10-9. Records Management. Refer to the current General Records Schedule or FAA Records Retention and Disposition Schedule or contact your respective service office records coordinator or file custodian for guidance regarding the retention/disposition of records.

10-1 8120.22B Appendix A Appendix A. Evaluation of a PAH’s Quality System A-1. Purpose. This appendix, in conjunction with the applicable 14 CFR requirements, provides guidance to review all data submitted by a PAH that describe the quality system required for the applicable production approval. This data will include a quality manual describing the PAH’s quality system in accordance with § 21.137. Any inadequacies in the PAH’s submitted data must be sent to the PAH for corrective action using the appropriate template on AIR-800 Division-Approved Templates. After the data has been reviewed, and any applicable corrective actions taken, the CM section will approve the data, using the Quality System Changes Acceptance Letter at AIR-800 Division-Approved Templates.

A-2. Data Review. All quality system data submitted to the cognizant CM section must be reviewed to ensure that: a. The described quality system will adequately provide for the consistent acceptance of only those products or articles which are in conformity with the approved design data and in a condition for safe operation.

b. The quality system is adequately described, meets the intent of the pertinent rules, and can be realistically implemented. Be cautious of data that are overly descriptive since such data may often be difficult to implement.

c. The data are identified by title, revision, and date, and contain the signature of the appropriately authorized person in the PAH’s organization.

d. The data are well organized, unambiguous, and not subject to misinterpretation.

e. Inspection procedures are well organized and easy to understand and implement.

f. The quality system adequately defines when a product or article has officially left the control of the quality system.

g. The quality system adequately describes the process of re-introducing, back into the quality system, new products or articles that have left a PAH’s quality system. The process must ensure the following criteria are met: (1) The products or articles are traceable to the PAH that manufactured them.

(2) The products or articles meet the type design and are in a condition for safe operation.

Note: Depending on their complexity, a visual inspection may be adequate for determining that the products or articles meet their type design. When a determination cannot be made by a visual inspection, the products or articles must be re-introduced to the quality system at a point where functional testing is possible.

A-1 8120.22B Appendix A h. New products and articles that leave the control of a PAH and fail on initial installation or testing are nonconforming. Those nonconforming products and articles that are returned to the PAH must be processed utilizing the PAH’s quality system.

i. Statistical sampling plans are clearing documented. The aviation safety inspector (ASI) must ensure that sampling plans based on valid consensus standards do in fact comply with those standards . Sampling plans that are not based on valid consensus standards should be closely examined to determine their statistical validity (Juran’s Quality Control Handbook may be used as an aid in determining this validity). Regardless of the basis of the sampling plans used, the PAH is responsible for ensuring that all products or articles conform to the approved design data. Therefore, the ASI should ensure that the acceptance/rejection criteria will not allow for acceptance of nonconforming product or articles. If specific experience or expertise is required to review sampling plans, the PI should advise the CM section manager. Additional information is available from AC 21-43, paragraph 2-7. The following should be considered when reviewing sampling plans: (1) Controlled process. Prior to implementing a sampling plan, objective evidence must exist that demonstrates and ensures that the process(es) used to manufacture sampled characteristics are documented, controlled, repeatable, and consistent.

(2) Characteristics classified. Each characteristic that will be part of the sample plan must be identified, evaluated, and properly classified. Characteristics are classified based upon the effect they may have on safety or usability of the product or article.

(3) Proper and reasonable sample sizes. Specific sample sizes should be chosen based upon the lot/batch size, the characteristic classification and criticality, the design tolerances being measured, and the probability of accepting nonconforming products or articles.

(4) Unbiased sample selection. The plan should fully describe how samples are selected. The sample method must be unbiased; that is, the sample selection method does not unfairly weight a particular timeframe, production sequence, tooling configuration, operator(s), batch, etc. To ensure an unbiased representative sample, the lot, batch, or group should be homogeneous (that is, consisting of the same characteristics, type, grade, class, composition, and manufactured under the same data and conditions, and manufactured at approximately the same time).

(5) Samples controlled. When sampling is used, the results of the selected sample apply to the entire lot, batch, or grouping. The lot, batch, or group should be clearly identified and segregated throughout the entire sampling, inspection, and possible disposition process. If any characteristics are found to be nonconforming in the sample, the entire lot, batch, or grouping must be withheld pending additional analysis, ensuring that there are no other For example, see Military Handbook—Statistical Process Control (SPC) Implementation and Evaluation Aid, MIL-HDBK-683 (see Quick Search Assist); Department of Defense Handbook—Companion Document to MIL- th STD-1916 (see Quick Search Assist); and Nicholas Squeglia, Zero Acceptance Number Sampling Plans, 6 Ed, 2023, (see ASQ).

2 th J.M. Juran and F.M. Gryna, Juran’s Quality Control Handbook. 4 Edition (New York: McGraw-Hill, 1988).

A-2 8120.22B Appendix A (6) nonconforming articles. Should this analysis indicate the possible existence of additional nonconforming articles, the entire lot, batch, or grouping must be dispositioned in accordance with the PAH’s approved material review procedures. In all cases, the PAH is responsible for ensuring that all products and articles conform to the approved design data.

A-3. Data Approval/Acceptance Standards for a PC, PMA, or TSOA Holder. The cognizant CM section will determine the adequacy of the data reviewed in accordance with paragraph 2 of this appendix. Any inadequacies in the data submitted must be identified to the PAH for corrective action. After the data have been reviewed, and any applicable corrective actions taken, the CM section will prepare a letter approving the PAH’s quality system data and forward it to the PAH. The appropriate template is located on AIR-800 Division-Approved Templates. The cognizant CM section should also send a copy of the approval letter to the cognizant certification branch. This data, the 14 CFR, and the FAA-approved design data comprise the standards with which the PAH must show continued compliance.

A-4. Supplier Control. A PAH should establish procedures allowing it to accept products, articles, or services from its suppliers that do not meet the approved design yet conform to the PAH’s requirements. Section 21.137(c) requires a PAH to: a. Ensure each supplier-provided product, article, or service conforms to the PAH’s requirements; and b. Establish a supplier-reporting process for products, articles, or services that have been released from the supplier and subsequently found not to conform to the PAH’s requirements.

A-3 8120.22B Appendix B Appendix B. Adding Interface Components to the PLR B-1. Purpose. This appendix provides guidance regarding the geographic certification branch responsibilities to designate an article as an IC. Before October 1, 2015, amendment 21-98 to 14 CFR part 21 authorized an amendment to a PC holder’s PLR only when the PC holder needed to add a type-certificated product or article. Today, pursuant to § 21.147, a PC holder may also apply to amend its PLR to permit the manufacture and installation of ICs. Certification branches are instructed to support the PLR amendment process to add ICs through the verification and documentation of articles identified by the TC or STC holder.

B-2. Process. A PC holder seeking to add an IC or ICs to its PLR should submit a request to its CM section. The CM section will contact the certification branch to confirm that the articles are eligible to be identified as ICs and determine whether the PAH has the capability to manufacture and install the ICs. If it is determined that the PAH is capable, the CM section will add the article to the PLR and inform the PC holder of its determination, using the appropriate template at AIR-800 Division-Approved Templates.

B-3. Designation Request. A geographic certification branch for a TC or STC holder seeking to designate an article as an IC should obtain the following: a. A list of the articles the TC/STC holder seeks to designate as ICs, b. A list of the approved type design data for the articles, including but not limited to the drawings and specifications, and c. Documentation describing the functional interface between the aircraft and the aircraftengine, the aircraft engine and the propeller, or the aircraft and the propeller.

B-4. Certification Branch Responsibilities. Upon review of the information, the certification branch should perform the following actions: a. Verify the interface functionality. Section 21.1 defines an IC as an article that is, among other things, designated by the TC or STC holder that controls the approved design data for that article. However, the certification branch responsible for oversight of the design approval holder should concur with the designation. The certification branch should also coordinate its interpretation with the product division to encourage standardization.

b. If an applicant proposes to produce ICs under a licensing agreement, verify that any listed type design data is sufficiently complete to allow manufacture or installation. Note that type design data is already approved. Further, the CM section overseeing the PAH that will add the ICs to the PLR performs analysis to determine if the PAH is capable of manufacturing and installing ICs. The certification branch is therefore not expected to conduct a technical evaluation of the data. However, FAA must substantiate and approve any changes to the approved type design that are proposed to facilitate manufacture of the ICs as required by part 21, subpart D.

B-1 8120.22B Appendix B c. Provide documentation to the TC or STC holder acknowledging the articles and type design data identified as ICs. The documentation should include the signature of the certification branch manager or appropriately delegated manager.

B-2 8120.22B Appendix C Appendix C. Acronyms AC Advisory Circular ACAIS Aircraft Certification Audit Information System ASI Aviation Safety Inspector CAA Civil Aviation Authority CM Certificate Management DMIR Designated Manufacturing Inspection Representative FAA Federal Aviation Administration IC Interface Component LODA Letter of Design Approval MOU Memorandum of Understanding MRB Material Review Board OAC Original Airworthiness Certificate ODA Organization Designation Authorization PAH Production Approval Holder PC Production Certificate PCB Production Certification Board PCM Preliminary Certificate Management PI Principal Inspector PLR Production Limitation Record PMA Parts Manufacturer Approval QSA Quality System Audit RBRT Risk-Based Resource Targeting SDR Service Difficulty Report SMS Safety Management Systems STC Supplemental Type Certificate SUP Suspected Unapproved Part TC Type Certificate TCDS Type Certificate Data Sheet TSO Technical Standard Order TSOA Technical Standard Order Authorization C-1 8120.22B Appendix D Appendix D. Definitions D-1. Definitions. For the purpose of this order, the following definitions apply.

a. Accountable Manager. A representative of the applicant, or the holder of a production approval, who serves as the primary contact with the FAA. The accountable manager is responsible for, and has the authority over, all production operations that are conducted pursuant to part 21.

b. Airworthiness Approval. See § 21.1(b).

c. Approved. See § 1.1.

d. Approved. See § 1.1.

e. Article. See § 21.1(b).

f. Associate Facility. A facility that has been approved as an extension to an original PAH. This facility is owned and operated by the same corporate management as the original PAH that controls the design and quality of the product or article(s), except for companies participating in joint-production or co-production business agreements. The associate facility must be listed as a manufacturing facility on the PC or the letter of authorization for other production approvals, for example, PMA or TSOA.

g. Authorized Release Document. A document issued by persons authorized in accordance with a PAH’s approved quality system that includes § 21.137(o) procedures using an FAA Form 8130-3.

h. Audit. A systematic and independent examination to determine compliance of an established supplier system, inspected product or article(s), or processes with purchase order requirements, technical data, or specifications.

i. Certificate. A document (that is, a certificate or approval) issued by the FAA that recognizes an applicant’s or PAH’s established quality system and allows for the production of products or articles in accordance with an FAA-approved design.

j. Certificate Management. The method by which the FAA ensures that a PAH remains in compliance with those pertinent regulations that govern the manufacturing of its particular products or articles.

k. Commercial Part. See § 21.1(b).

l. Corrective Action. The measures taken to resolve unsatisfactory conditions and to prevent reoccurrence.

m. Days. A reference to calendar days, unless otherwise specified.

D-1 8120.22B Appendix D n. Distributor. Any person engaged in the sale or transfer of products and articles for installation in type-certificated aircraft, aircraft engines, or propellers, and that conducts no manufacturing activities.

o. Foreign Manufacturer. A person other than an FAA PAH who causes a product or article(s) to be produced outside the United States.

p. Implementation Plan. A plan that includes a description of the means of compliance (including but not limited to new or existing policies, processes, or procedures) the approval holder has used, or plans to use, to meet the requirements of part 5.

q. Interface Component. See § 21.1(b).

r. Internal Procedure. A PAH’s or associate facility’s procedures that are not included as part of the FAA-approved data.

s. Licensing Agreement. A commercial agreement between a TC or STC holder and a PAH (or applicant) formalizing the rights and duties of both partners to use the design data for the purpose of manufacturing the product or article.

t. Manufacturer. See § 1.1 u. Noncompliance. A PAH’s or associate facility’s operating practice that is found to be inconsistent with 14 CFR, FAA-approved data, or internal procedures. A supplier’s operating practice found to be inconsistent with a PAH’s or associate facility’s purchase order requirements is considered to be a noncompliance by the PAH or associate facility.

v. Ongoing Certificate Management. The performance of certificate management requirements based on an RBRT assessment that may be accomplished on a continuing basis.

w. Principal Inspector. A manufacturing inspector who has been assigned certificate management responsibility of a particular PAH or associate facility.

x. Produce. To manufacture, or cause to be manufactured, a product or article(s).

y. Product. See § 21.1(b).

z. Production Approval. See § 21.1(b).

aa. Production Approval Holder. The holder of a PC, PMA, or TSOA who controls the design and quality of a product or article(s). A person who has been issued a production approval by the FAA.

D-2 8120.22B Appendix D bb. Production Certification Board. An FAA evaluation function consisting of a selected group of FAA specialists acting under the direction of the PCB chairperson for the purpose of determining eligibility of the holder of a TC or a STC, or a licensee, for the issuance of a PC.

cc. Quality System. A documented organizational structure containing responsibilities, procedures, processes, and resources that implement a management function to determine and enforce quality principles.

dd. Quality System Data. Data that provide a description of the quality system required by part 21 for a PAH. These data would encompass the methods, procedures, processes, inspections, tests, specifications, charts, lists, forms, etc., which the PAH employs to produce products or articles.

ee. Risk-Based Resource Targeting. A structured process designed to support AIR management in determining risk, assigning resources based on that risk, and prioritizing multiple projects.

ff. Safety Management System (SMS). See § 5.3.

gg. Specialist. As related to the facility audit function of PCBs, FAA manufacturing inspectors/supervisors or flight test, structures, systems, or equipment engineering personnel.

hh. Supplier. See § 1.1, that provides a product, article, or service, at any tier in the supply chain that is used or consumed in the design or manufacture of, or installed on, a product or article.

D-3 8120.22B Appendix E Appendix E. Related Publications and Forms E-1. Title 14, Code of Federal Regulations (14 CFR). You can download the full text of the 14 CFR regulations referenced in this order from the Federal Register website at eCFR and on the FAA Dynamic Regulatory System (DRS).

E-2. U. S. Department of Transportation, FAA Publications. The following documents are related to the guidance in this order; they are available on the FAA website at Regulations & Policies and on the FAA Dynamic Regulatory System (DRS).

a. FAA Advisory Circulars.

• AC 21-32, Control of Prepositioned Products and Articles shipped prior to Design Approval.

• AC 21-43, Production Under 14 CFR Part 21, Subparts F, G, K, and O.

• AC 21-58, Safety Management Systems for Part 21 Type and Production Certificate Holders.

• AC 43-18, Fabrication of Aircraft Parts by Maintenance Personnel.

b. FAA Orders.

• Order 1270.1, Freedom of Information Act Program.

• Order 1350.14, Records Management.

• Order 2150.3, FAA Compliance and Enforcement Program.

• Order 8000.79, Use of Electronic Technology and Storage of Data.

• Order 8000.95, Designee Management Policy and FAA Order 8100.15, Organization Designation Authorization Procedures.

• Order 8100.11, Decision Paper Requirements for Undue Burden and No Undue Burden Determinations Under 14 CFR Part 21 for Production and Export Airworthiness.

• Order 8100.15, Organization Designation Authorization Procedures.

• Order 8120.23, Certificate Management of Production Approval Holder.

• Order 8120.24, Implementation Plan Approval, Verification, and Evaluation of Safety Management Systems for Design and Production Approval Holders.

• Order 8130.2, Airworthiness Certification of Aircraft ).

• Order 8130.21H, CHG 1, Procedures for Completion and Use of the Authorized Release Certificate, FAA Form 8130-3, Airworthiness Approval Tag.

• Order 8150.1, Technical Standard Order Procedures.

E-1 8120.22B Appendix E c. FAA Policy Memorandums (PMs).

• PM AIR100-16-110-PM05, Shipment of Prototype Products and Articles with the Authorized Release Certificate , FAA Form 8130-3, Airworthiness Approval Tag.

• PM AIR100-16-110-DM12, Deviation to FAA Order 8130.21 Regarding Prepositioned Products and Articles.

E-3. Other Publications.

• Department of Defense Handbook, Companion Document to MIL-STD-1916 (Washington, D.C.: U.S. Department of Defense, Quick Search Assist, 1999).

th • Juran, J.M. and Gryna, F.M., Juran’s Quality Control Handbook, 4 Edition (New York: McGraw-Hill, 1988).

• Military Handbook, Statistical Process Control (SPC) Implementation and Evaluation Aid, MIL-HDBK-683, (Washington, D.C.: U.S. Department of Defense, Quick Search Assist, 1991).

th • Squeglia, Nicholas, Zero Acceptance Number Sampling Plans, 6 Edition (Milwaukee, WI: ASQ Quality Press, 2023).

E-4. FAA Forms The following FAA Forms are available on the FAA website at FAA Forms.

• FAA Form 337, Major Repair and Alteration.

• FAA Form 1320-19, Directives Feedback Form.

• FAA Form 8100-1, Conformity Inspection Record.

• FAA Form 8100-6, Noncompliance Record.

• FAA Form 8100-6, Noncompliance Record.

• FAA Form 8110-12, Application for Type Certificate, Production Certificate, or Supplemental Type Certificate.

• FAA Form 8120-3, Production Limitation Record.

• FAA Form 8120-4, Production Certificate.

• FAA Form 8120-10, Request for Conformity (RFC).

• FAA Form 8120-14, Production Approval/Certificate Management Activity Report.

• FAA Form 8130-7, Special Airworthiness Certificate.

E-2 8120.22B Appendix F Appendix F. Directive Feedback Information Please submit any written comments or recommendations for improving this directive or suggest new items or subjects to be added to it. Also, if you find an error, please tell us about it.

Subject: To: Directive Management Officer, 9-avs-air-directives-management-officer@faa.gov (Please mark all appropriate line items) ☐ An error (procedural or typographical) has been noted in paragraph on page .

be changed as follows: ☐ Recommend paragraph on page (attached separate sheet if necessary) ☐ In a future change to this order, please include coverage on the following subject: (briefly describe what you want added): ☐ Other comments: ☐ I would like to discuss the above. Please contact me.

Submitted by: Date: Telephone Number: Routing Symbol: FAA Form 1320-19 (11/23) Supersedes Previous Edition F-1