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CAPA effectiveness check

#1
I have a CAPA open that involves an attribute test resulting in P/F. The root cause was identified and corrective action applied. During the effectiveness check of this CAPA, 504 parts were tested to result in a 99% confidence that the population of non-defective is at least 99.0904%. When the testing was performed it was identified that 2 units failed due to an issue outside the scope of the initial CAPA.

So the parts are passing but due to another issue, that has since been eliminated, 2 failed. Would this change the results to 2 failures out of 504 units? Or can it be written as 502 units with 2 removed. I am asking because the corrective action is clearly effective yet it seems there was another root cause that resulted in failure.

Thoughts?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
exactly Tagin. The two units that failed for an unrelated cause did not fail for the cause in question so they still belong in the calculation...
 
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