AS9100D FAI requirements needed?

#1
I am quite new to the quality world compared to most. However, 4.3

8.5.1.3 Production Process Verification The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements. NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans. Downloaded from SAE International by Sandra Geiger, Monday, September 26, 2016 SAE INTERNATIONAL AS9100™D Page 34 of 54 The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes). NOTE: This activity can be referred to as First Article Inspection (FAI). The organization shall retain documented information on the results of production process verification.

also from 4.3
(the organization shall )provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

So, the purpose of an FAI is to mitigate the risk of escapees and undesired outputs from a process. This make tons of sense when an organization produces medium to high volume production. However, we are a low production facility (in the sense that our largest production we have done was 7 units over the past 6 months) and as a result, we perform 100% inspection and testing of all product. Hence the only way that we have to identify espcapes is if the design personnel realize that a test activity didn't really test the full functionality of a board, or we run into issues with 1 circuit board talking to another and realize that our test didn't weed out these so we retest all of them.

So whats the purpose of the FAI if you are still doing 100% inspection and testing as the risk we currently run is the same whether we perform a FAI or not.
Someone please sanity check me on this.
 
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#2
So whats the purpose of the FAI if you are still doing 100% inspection and testing as the risk we currently run is the same whether we perform a FAI or not.
Firstly, it is very important to make sure everybody understands that First Article is NOT the same as First Piece. First piece verification is to ensure the production parameters set up for a given characteristic are adequate; typically done in automated and semi-automated machine processes.

As for the First Article Inspection, that's an assurance to your customers that you are capable of producing the part 100% in conformity with the requirements, BEFORE THEY PLACE "large orders" for the parts. Also, please keep in mind that the FAI records are required for the P/N, not each lot. In commercial aerospace, it is very common for customers to demand FAI via quality clauses in their contracts and/or PO's.

So, if you are already performing 100% verification of ALL parts characteristics, then your only additional work will be to create an FAI Record for the FIRST TIME you produce a part. Seems like it is "minimal additional work" and most aerospace customers mandate FAI to their suppliers; actually many require FAI to be done in conformance with AS9102.

But AS9100 applies not only to (commercial/military) aviation, but also defense and space applications. So, it is possible that a supplier in the space hardware chain (where most hardware is produced in small quantities) might not see any benefit in FAI and be able to justify it's non applicability in their QMS.
 
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John Predmore

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#3
I explain that FAI is a risk-reduction activity. You are already 100% testing so what risk am I talking about? The risk that a single dimension or note on the engineering drawing was overlooked, or misinterpreted due to clerical error, or there was a miscommunication somewhere in the supply chain during the product roll-out. Many times, product validation was done on prototype parts off prototype tooling, so the error in final production tooling could be missed. This mistake could happen with a mundane dimension that no one views as critical, no one ever checks. You could make a lot of non-conforming product at the beginning of a product launch before an insidious error might be discovered. Performing a one-time full inspection of every dimension and attribute is cheap insurance against such a risk.
 

Big Jim

Super Moderator
#4
Theoretically you may be able to exclude it if you can come up with an appropriate justification (what you originally posted probably wouldn't fly as you show a lack of understanding of the purpose) but I would not recommend it. It has a valid reason for being in the standard for AS9100, that is to make sure the equipment and documentation can produce parts that meet spec. 100% inspection could fall short if you are not inspecting the right things.
 
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