Retrospective process verification / FAI (EN9100)

TinaS

Registered
Hi All

I never started any threats so far, but now it is time to...

We are assembling unmanned drones and need to fulfill EN9100, chapter 8.5.1.3 Production process verification. In fact the external auditor asked for a FAI.
So far it all mostly was development, meanwhile our drones are in use and we need to create one assembled reference as a base retrospectively. How would you perform this in a pragmatic easy way? Unfortunately there are no documented specifications, requirements, material certificates etc. As well tests are incomplete, not really traceable. So we have to start from scratch based on the running drone. What is the minimum we need to do in this case and do you think following steps will do it

1. Riskbased approach to define the most critical parts of the drone
2. Define the requirements they need to meet
3. Fulfill tests to show that the requirements are met
4. Additionally collect data from maintenance, failure analysis etc if existing to show no incidents happened

So far so good, but how can we handle material requirements to show that the components are made out of specific compositions. We cannot test this internally and are not willing to proof it externally. Can we retrospectively request a material certificate of the previous supplier if still existing, to proof this?
And how other we handle other tests we cannot fulfill neither in-house no externally? Can we proof this with the product in use?

Hopefully this is somewhat understandable, but I am totally new to this industry.
Thank you for your suggestions.
I am happy about any comments.
KS ;-)
 
Elsmar Forum Sponsor
Hi Tina,
Looks to me you need a good consultant to review your requirements and approach. What is your drones' category? It looks to me it may need a type certificate. Have you checked Part 21 or customers requirements in detail?
 
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