First Article Inspection - Is FAI Design Verification?

T

tomnmiami

#1
I am writing out Design Output procedure for ouro medical device firm, and am wondering it First Article Inspection Reports are commonly considered a design verification?

I assume its a form of design output, is that correct?

How are sample sizes usually selected for a FAI?

Thanks in advance,
T
 
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Jen Kirley

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#2
Re: First Article Inspection - is it Design Verification?

Design verification is done with a prototype, which could be subject to testing. If destructive testing is needed, then your design might need to be verified with more than one prototype sample...

The first piece refers to the production setup when commencing a run of product to sell.

First Article Inspection isn't a sample. It's verifying setup to prepare for production run. Inspecting ___ out of a batch/lot of ___ in a production run is a sample.

To summarize:

Design
Produce one or more prototypes
Inspect and test the by-golly out of it; diligently record results - maintain the record.
When ready, set up for production run
Do a 1st Article inspection; record the results - maintain the record
Commence run once the setup is verified satisfactory
Do sampling inspections according to Sampling Plan. Record results, maintain the records and respond as per the Plan.
 
T

tomnmiami

#3
Thanks Jennifer,

Great explanation!

Do you think it would be improper to have successful FAI as the conclusion of Design Transfer (evidence that manufacturing can produce the designed product), with ongoing recieveing inspections as means of monitoring process control from suppliers.?

BTW, we procure all finished product via contract manufacturers.

Thanks,
T
 
A

andygr

#4
The submitial of a FAI report with the first shipment is a common practice to ensure that the supplier has the capability of making the part to design requirements. As you mention this does not mean that they will always do so in the future and so based on risk and analysis you will have RI verify future shipments accordingly.
The FAI is a good tool to uncover many oppertunities early on with a supliers ability to meet design.
:2cents:
 
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