CAPA (Corrective Action and Preventive Action) after Correction always?

Bev D

Heretical Statistician
Staff member
Super Moderator
#11
Chrissie - I don't undertand your response. perhaps I wasn't clear. My organization doesn't issue corrective actions for every nonconforming incident. (nor does the standard require it). We DO perform correction. For each single failure this isn't just a 'bandaid' - that particular product will work fine in the customers hands.

We are fully aware that some proportion of future product will have the same problem. SO as I explained, we issue corrective actions on the major problems. 'Major' is assessed by severity of the effect - just like the standard describes.

For example, lets say we have 1000 nonconforming units identified* in a year. If we were to issue a CA for each and every NC event we'd be swamped in paperwork, focused on teh trivial and paralyzed from making permanent fixes. Of these 1000, 50% are failure mode 1, 25% are failure mode 2, 10% are failure mode 3 and the remaining are from over 25 different failure modes. ONE is for a serious safety failure. We issue 4 corrective actions: the top 3 quantity problems and the single safety event. We get to root cause of each of these, implement the solutions to prevent recurrence. Then we move to the remaining problems. Of course this isn't a once ayear evetn but a continual process.

What is wrong with that? why do you mention PA? *I* didn't mention PA at all in my response.

*this is NOT the number of NCs we have in a year - it is for illustrative purposes only.
 
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