Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions

Mortalis

Involved In Discussions
@Mortalis Without knowing the details of the eQMS or its built-in process flow, I would think that "Investigation" is synonymous with "evaluate" (as in: detect, segregate, evaluate, and disposition non-conforming material). It's not a detailed investigation of the cause of the nonconforming material, but rather an investigation/evaluation of the material itself, in order to determine how to disposition it (rework, scrap, accept with concession, return to vendor, etc).

Similarly, depending on where "verification" is at in the built-in workflow, the software designer likely meant for it to be mean "verifying that the nonconforming material is indeed nonconforming," or it could mean "verifying that the material was dispositioned appropriately."

Your Nonconforming Material SOP should specify what information is to be captured in these fields.

I do not believe that this verification process-gate should be interpreted as "verifying that the actions taken to address the nonconforming material have been effective." This type of Verification activity should be reserved for your corrective action system.

Your Nonconforming Material SOP should also give guidance on when a detailed analysis of the cause(s) of nonconforming material is warranted, and when actions should be taken to address those causes. THAT is when verification of the effectiveness of actions comes into play.

You are absolutely correct in each of your interpretations. I have written our NC SOP as well as the WI for how to use the software in just those words. But, I think you can see where I was going with the post and how the software can get the user confused between the semantics of two processes of NC and CA.
 
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