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CAPA effectiveness check

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.

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Bev D

Heretical Statistician
Staff member
Super Moderator
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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