Regulatory Requirements for Approved Parts

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suthek
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Regulatory Requirements for Approved Parts

#1 Post by suthek » Wed Nov 02, 2016 1:40 pm

Ultimate question:
Can design holders issue Form One for any part within the design? (including commercial parts.)

Background:
I'm reading through the standards are regulations and I see mention of commercial and standard parts.
I'm trying to understand where it's stated that these parts can't have a statement of conformity and can only have a CofC/release.

From my understanding, the design holder (lets say bombardier) can issue a Form One for anything within their design... Even commercial parts they didn't make.
However, it appears to be unclear. Quite a few people tell me that commercial parts can't have a Form One.

Where this stems from appears to be CAR561.10 (Statement of Conformity.)
And ultimately "Appendix A" "Authorized Release Certificate".

In "Appendix A" I see: "Purpose and Use"
Holders of Transport Canada approved manufacturer certificates may issue Authorized Release Certificates for new items produced under their own manufacturer certificate, including items produced by their suppliers that are subject to the manufacturer’s Quality Assurance Program oversight. They may also issue certificates for previously certified items (i.e., items received with a prior Authorized Release Certificate issued by an appropriately approved supplier) provided the component concerned is part of a higher assembly whose production is within the prime manufacturer certificate holder’s scope of approval.

This then brings me to the confusion of "what is Quality Assurance Program oversight"?
A large design holder like Bombardier has 4000+ approved suppliers. Even Distributors of commercial parts.
If the supplier is approved, isn't that "Quality Assurance Program oversight"?

Hoping some veterans can provide insight. Maybe "Quality Assurance Program oversight" is defined somewhere and I'm missing it?
Or maybe you have other regulations quotes that would help provide guidance?
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PilotDAR
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Re: Regulatory Requirements for Approved Parts

#2 Post by PilotDAR » Thu Nov 03, 2016 6:22 pm

In Canada, a manufacturer of aeronautical products will have a Transport Canada Manufacturing Approval. This approval will contain the conditions of issuance, will certainly include a quality control system. There will also be an "approval limitation record" associated with the manufacturing approval, which will list the products for which the manufacturer may issue Form 1 approval. The fact that a company is approved to manufacture, does not mean they can issue Form 1 for anything. If standard and/or commercial parts are included in their design (on the approval limitation record), and their quality control system and distribution system permits, they could sell and issue Form 1 for those too, even though they were sourced, rather than manufactured.

In a previous life, I managed several of these systems. In one case, a Transport Canada approved manufacturer sold us a quantity of a specific part, along with a certificate of conformity. I was asked by my employer to issue a Form 1 from our company, for those parts. Before I did, I contacted the source company, and asked for a copy of their approval limitation record. It was provided with resistance. When I read it, the parts we had received, for which a C of C had been issued, were not included in the list of parts for which they were the design holder, or otherwise were authorized to present as "manufactured". I declined to issue the form 1, citing inadequate incoming certification. It turned out that those parts had been manufactured "outside the approved system" and were not entitled to be certified with a Form 1. The company employing me at that time ceased business not too long after (by which I mean to convey that it is not the other very successful, and honourable Canadian manufacturer for whom I also worked, who have an enviable record of compliance).

If you have a Form 1 which you doubt, follow it up, the path of compliance must be straight forward, and unambiguous.
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