FAA Regulatory Requirements Promote Quality Products for Aviation Safety

1. FAA Regulatory Requirements Promote Quality Products for Aviation Safety National Academy of Engineers Angelia Collier April 11, 2017

2. OVERVIEW • FAA Statutory/Regulatory Authority • FAA Establishes Requirements to Promote Aviation Safety • Regulations, Orders & Advisory Circulars • Requirements To Promote Aviation Safety • Design & Production Approvals • Quality System • Supplier Control • Certificate Management • Supplier Control Audit • CM/Point of Manufacturer • Risk Assessment • Defective Standard Fastener Parts in Aviation • Standard parts

3. FAA Statutory Authority U.S. Code Title 49 (49 U.S.C.),(Section 44701(a)… The Administrator “shall promote safe flight of civil aircraft in air commerce by prescribing minimum standards required in the interest of safety for appliances and for the design, material, construction, quality of work, and performance of aircraft, aircraft engines, and propellers.” • Section 44702 of Title 49 provides authority for the FAA to issue specific certificates: Type (e.g., design approvals), production, and airworthiness certificates.

4. FAA Regulations, Orders & Advisory Circulars • Title 14 CFR contains FAA regulations including those related to design and production approvals. • FAA Orders contain internal guidance for FAA personnel. • Order 8120.22A, Production Approval Procedures, • FAA Order 8120.22A • Industry also refer to this guidance when establishing procedures and controls. • Advisory Circulars are issued by FAA. • AC 21-43, Production Under 14 CFR Part 21,Subparts, F, G, K & O, details the manufacturing and production requirements of part 21,AC 21-43A • Provides detailed guidance to industry on methods to meet regulatory requirements.

5. FAA Establishes Requirements to Promote Aviation Safety FAA establishes minimum requirements for: • Design of aviation products and articles • Quality systems for manufacturing, maintenance and operating organizations. FAA issues certificates and approvals for: • Initial design and major changes to design • Production and manufacturing • Maintenance • Operations

6. Design and Production Approvals • Title 14 Code of Federal Regulations • Products (aircraft, engines, propellers) • Design Approval: Type Certificate (TC), Part 21, subpart B, Type Certificates (sections 21.11 through 21.53) • Supplemental Type Certificate (STC), Part 21 , subpart E, STCs (sections 21.111-21.120) • Production Approval: Production Certificate (PC), Part 21, subpart G, PC(sections 21.131-21.156) • Production under TC is permitted under part 21 for 6 months, Part 21, subpart F (sections 21.121-21.130) • Articles (parts, appliances, materials, and processes) • Dual approval for design and production: • Parts Manufacture Approval (PMA), Part 21, subpart K (sections 21.301-21.320) • Technical Standard Order Approval (TSOA), Part 21, subpart O (sections 21.601-21.621)

7. Quality System for Manufacturers FAA production approvals are based on the ability of the quality system to ensure production of conforming products and articles. Section §21.137 requires each production approval holder (PAH) to establish and describe in writing, a quality system that ensures that each product and article conforms to its approved design and is in a condition for safe operation. The intent is for each PAH to develop a quality system that meets both the needs of the PAH and the rule. As such, PAH quality systems are scalable to the size and complexity of the product or article being produced. Fifteen elements are required in the quality system.

8. 15 Elements of the 21.137 Quality System

9. Supplier Control System One of the 15 elements (§21.137(c) requires the PAH to have a quality system that ensures all products or articles provided by its suppliers, including sub-tier suppliers, conform to the PAH’s requirements. A PAH is responsible for ensuring that each product or article conforms to the FAA-approved design data, and is in a condition for safe operation. This responsibility remains the same whether the PAH produces the entire product or article at its facility, or uses suppliers to furnish related articles. The supplier control program is required by the rule to be FAA-approved and defined in a manual. Implementation and maintenance of the supplier control; system is subject to evaluation by the FAA.

10. FAA’s Authority to Perform CM. Title 49 of the United States Code (49 U.S.C.) subtitle VII provides the statutory authority for the AIR CM program and allows the FAA to perform oversight of PAHs at any time and take appropriate actions in the interest of safety. Title 14 of the Code of Federal Regulations (14 CFR) part 21 includes specific requirements for PAHs to produce duplicates. FAA Order 8120.23, Certificate Management of Production Approval Holders provides guidance for surveillance of PAHs.

11. Certificate Management of Production Approval Holders Certificate management (CM) is the method by which the FAA ensures that a PAH remains in compliance with regulations that govern the manufacturing of its particular products or articles. CM is accomplished by the Manufacturing Inspection District Office (MIDO) or Certificate Management Office(CMO) that has responsibility for the geographical area in which the PAH is located. An aviation safety inspector (ASI) located at the MIDO or CMO performs both ongoing and special CM responsibilities.

12. Certificate Management • AIR oversees PAHs via CM to ensure that they comply with the regulations and that their products meet the approved design. There are two types of CM: • Ongoing • QSA • PI Evaluations • Product Audits • Supplier Control Audits • As Needed • Accident Investigation • Suspected Unapproved Parts (SUPs) • Quality Escapes

13. Supplier Control Audit (SCA) A SCA is conducted as part of our PAH Certificate Management, and is an audit of PAH Supplier Control System. The objective of SCA is to determine that PAH’s are meeting the requirements of Title 14 of the Code of Federal Regulations (14 CFR), and to evaluate supplier compliance to the PAH quality and design data. Audit takes place at supplier facilities Non-compliances are issued to and addressed by the PAH PAH is directly responsible for supplier control and compliance Suppliers are selected through a risk-based approach

14. CM/Audit At Point of Manufacturer An audit (PI evaluation, supplier control audit, or QSA) is a systematic product-based examination of an established PAH’s manufacturing system based on the quality system elements as defined in §21.137. Audits validate if the PAH is complying with regulations and to determine products and articles conform to FAA‑approved type design. Audits are conducted at a PAH or its suppliers. The audit should be conducted at the point of manufacturing, focusing on areas with the highest risk.

15. Risk Assessment PAH’s are subject to an initial and annual risk assessment. • Determines the level/types of oversight • Allows FAA resources to be efficiently used Risk Assessment is based on three pillars: • Exposure of their products to the National Airspace System • Organizational Assessment • Facility Assessment The output of the PAH’s risk assessment, specifically the risk level determination and the organizational RBRT designation, is used to define the managing office’s CM audit responsibilities.

16. DEFECTIVE FASTENERS PARTS IN AVIATION Aviation and Deep-Sea Offshore Drilling Industry share a commonality with defective fasteners. The Fastener Quality Act of 1990 focused on curtailing the large influx of counterfeit heavy bolts that were used in applications like pipelines. The Act imposed more stringent requirements on vendors, suppliers and users. It had impact on manufacturers of aerospace fasteners as well. Within the last 10 years there have been examples of defective fasteners in aviation due to improper manufacturing processes like heat treatment or passivation. FAA response was to initiate Suspected Unapproved Parts (SUPs) Investigations, launched Safety Alerts for Operators (SAFO), written Airworthiness Directives (ADs) and compiled data in response to defective hardware. EASA has found instances of defective MS21042-3 an -4 nuts and NAS 626 bolts in type design aircraft. They cited several rotorcraft and transport airplane accidents they contend may be attributed to defective fasteners used in “critical” applications. FAA, EASA, the Standards Groups and the aviation Industry are examining the problem and seeking harmonized solutions. .

17. Standard Parts in Type Design FAA allows for the use of “standard parts” (such as nuts and bolts) in Type Design under CFR Part 21.9(a)(3). Anyone can make a standard part as long as it is made to a Government or Industry Standard. Standard Parts are defined to conform to an established Government/Industry specs e.g., NAS & SAE. FAA acceptance of standard parts was based on it’s confidence with DOD system. In the 1990’s as a cost savings, DOD disbanded much of their quality infrastructure (DCAS and DCASMA, etc.) and oversight of standard parts companies; relinquished many fastener standards to the Standards Groups like AIA and SAE. The standards groups took ownership of the specifications but do not provide quality oversight of the Standard Parts manufacturers.

18. Standard Parts • Regulations, Policy, Guidance • 14 CFR Part 21, (21.9(a)(3) • AC 21-29C, Detecting and reporting SUPs • AC 20-62E, Eligibility, Quality, & ID of Aeronautical Replacement Parts • Federal Register, Volume 62, Number 43 of March 5, 1997, Docket No. AIR-100-9601  • Key Features • No FAA design approval required (acceptable) • Produced per published specs. & criteria (marking) • Responsibility lies with installers (FAA oversight) • Limitations • Industry defined outside of FAA input • Installation set by type design or part 43 • Not applicable for “critical” applications • Require enhanced quality control measures • Issues to resolve when standards originate from foreign sources • Different authorities have purview over what they identify as “standard”

19. Questions?