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 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 A, Production Approval Procedures,
FAA Order A 
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 through 21.53)
Supplemental Type Certificate (STC), Part 21 , subpart E, STCs (sections )
Production Approval: Production Certificate (PC), Part 21, subpart G, PC(sections )
Production under TC is permitted under part 21 for 6 months, Part 21, subpart F (sections )
Articles (parts, appliances, materials, and processes)
Dual approval for design and production:
Parts Manufacture Approval (PMA), Part 21, subpart K (sections )
Technical Standard Order Approval (TSOA), Part 21, subpart O (sections )

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 § 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 , 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 §
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 MS 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  
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?