Attribute Test Method Validation

J

jdm2008

#1
We are doing attribute test method validation, which involves making good and bad samples and making sure operators can recognize the difference between the two. We have come across a particular weld defect that we cannot reproduce under any condition we generate during manufacturing(there was a process change that eliminated this defect).
Logic would dictate in reality this is not much of an issue, however given the harsh regulatory environment we are in, I am a little hesitant on what to do.
The options are to me
1. Remove this defect from the test procedure, with a justification.
2. Complete the test method validation with an image.
3. Generate the defect with the previous process before the improvement(this will be difficult, and take more time than we have to complete the test method validation), and is illogical.

The logical option seems to be number #2, however will the FDA accept this?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

I suggest you document a risk evaluation on that defect being present but not detected, and decide on the mitigation based on that.

You could also contact the FDA and ask upfront.

Cheers,
Ronen.
 
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