Product NCRs- Quality Review

FRA 2 FDA

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#1
I have been gradually taking more and more responsibility in my role as my competence allows. The newest thing that I have started signing off as the quality approval is product NCRs. We are about to revise our report form and this will expand my responsibility so I'm trying to get ahead of the game and make sure I can confidently take this on. Obviously I can handle ensuring that any rework plan or disposition of NCR product or decisions on CAPAs, etc makes sense and complies with our internal processes. However, the part where I have to ensure that regulatory and customer requirements must be met is where I'm lost. Short of either having very comprehensive knowledge of both or going through and looking up every possible part of an NCR report in all applicable regulations and customer agreements, I'm not sure how to do this and either of those seems like an insurmountable task. Is there a smart, efficient way to check these requirements and confidently approve an NCR report?
 
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FRA 2 FDA

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#2
Now that I've come back to this issue in my research (I started looking into this yesterday, my apologies for picking up in the middle of something without regaining my bearings), I can rephrase my question. I was concerned about use-as-is dispositions specifically. Our SOP says "before the Quality Manager signs that the disposition is acceptable, they must check that regulatory and customer requirements will be met". So that's my real question. How would I go about verifying that, as each instance of UAI is different?
 
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Sidney Vianna

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#3
Dispositioning nonconforming products for UAI, rework and repair should typically be a consensus decision of a multi-disciplinary team, involving personnel with profound knowledge of the product engineering side, including regulatory approvals.
 

MRBMP

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#4
Hello,
I agree with Sidneys point and would like to add some info from my experience. When it comes to UAI dispositions, this was collectively decided by a team of people (MRB) who should understand the product, specifications, etc. From a Quality perspective, it's always good to ask yourself, what are the potential risks of using the product? Is the documentation trail sufficient and justifies why the product can be UAI?
 

Bev D

Heretical Statistician
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#5
Two inputs:

I don’t think we are looking for consensus so much as we are looking for agreement of all of the facts involved in the effect of the NC. Consensus can be that everyone agrees on the wrong thing. I have seen many UAI dispositions pass failing material that later created functional failures because the disposition era used their feelings and opinions rather than facts and data. Occasionally facts and data can not be generated by functionally testing the parts.

UAI is appropriate when the NC Characteristic is not critical to the function or use of the product. And/Or the specifications are too tight to begin with. This second condition can occur when engineering decides to have an ‘internal’ specification that is tighter than the ‘regulatory’ specifications. This is done to provide a guard band against failures to the real spec and serves as a ‘warning’ that the process output is ‘dangerously’ close to being out of spec but the part will still function properly (a misguided type of process control).
The role of the disposition lead should be to discern the truth (with data and facts) regarding the specification and the amount of nonconformance.
 

FRA 2 FDA

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#6
Ah, ok. Now this doesn't seem nearly so daunting. Our procedure does also require engineering to approve UAI. So my role is to ensure the paper trail can be followed on their decision and that it all makes sense. Thanks for the input everyone!!
 
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