Risk-Based PMA. Process. Federal Aviation Administration. Presented to: AEA Technology Incubator By:

Transcription

1 Risk-Based PMA Process Presented to: AEA Technology Incubator By: Daniel J. Elgas, Certification Procedures Branch, AIR-6C0 Date: August 16, 2018

2 Project Background AIR evaluated the level of FAA resources expended on projects where the criticality or potential safety impact of the article is low Set out to balance those resources with the right size of production certification rigor needed to approve the manufacturing of low-risk articles AIR is focused on Employing risk-based decision making Modernizing the existing general aviation fleet Engaging applicants who are new to the certified market 2

3 Quality System Requirements Applicants must establish a quality system that ensures that each product and article conforms to its approved design and is in a condition for safe operation. A quality system must include: (a) Design data control (b) Document control (c) Supplier control (d) Manufacturing process control (e) Inspecting and testing (f) Inspection, measuring, and test equipment control (g) Inspection and test status (h) Nonconforming product and article control (i) Corrective and preventive actions (j) Handling and storage (k) Control of quality records (l) Internal audits (m) In-service feedback (n) Quality escapes (o) Issuing authorized release documents 3

4 Risk-Based PMA Process The FAA accepted the company s existing quality system (with minor revisions) and waived the MIDO audit traditionally performed prior to issuance of a PMA Quality system would expand in complexity if the risk level of their article (or future articles) increases That expansion would be scaled to meet the increased risk in the same fashion as is done today for PMA applicants 4

5 Quality System Description Applicant provides an explanation as to how they meet the requirements of the regulation (or they provide a reference to an existing procedure). 5

6 Quality System Description Guidance 6

7 Initial Feedback on Risk-Based PMA Feedback has been overwhelmingly positive Reduced the cost and time spent on a traditional production approval The detail and size of a quality system can be scaled to fit the complexity and safety requirements of the specific product being manufactured 7

8 Next Steps AIR plans to institutionalize the changes made to streamline the PMA process in the next revision to the Order , Production Approval Procedures The final policy will positively impact a broader group of companies and projects In the interim, new applicants may take advantage of this process 8

9 Policy and Guidance References Title 14 Code of Federal Regulations Part 21, subpart K, Parts Manufacturing Approval Part 21, subpart L, Export Airworthiness Approvals Part 45, Identification and Registration Marking Advisory Circulars 21-43, Production Under Title 14, Code of Federal Regulations, Part 21, subparts F, G, K, and O 45-2, Identification and Registration Marking Orders , Parts Manufacturer Approval Procedures , Production Approval Procedures , Certificate Management of Production Approval Holders Forms , Application for Type Certificate, Production Certificate, or Supplemental Type Certificate 9