Nonconformance Training in Best Practices

U

uhohraggy

#11
Part of the issue is within our NC process we have a root cause, and corrective action section, where a corrective action can be required within the NC process, or it can be escalated to a formal CAPA. If we have an NC and lets say a technician didn't follow the process, we would note that retraining is required, attach a copy of a training form documenting the retraining and close out the NC. Or if it was a minor update to a document, say, there was no check for a process step, we'd update the form to include the check. In either case there would be no need for a CAPA, but we hold the NC open until there is evidence of the CA. If the root cause appears to be systemic (recurrences, creating a new process or updating multiple documents) we'd open a CAPA close the NC and allow the CAPA to take over.

This is a process I inherited and have multiple people debating 1) CA's are in CAPA's and therefore the NC process should just deal with the NC disposition, all CA's are done in CAPA's, vs 2) NC's have to be evaluated for the possibility of CA's, which have to be done when possible, and CAPA's are for systemic issues only, so where do you capture a simple corrective action like a retraining of a single technician or a line item update to a document...opening a CAPA seems excessive for that, vs just addressing it with the NC. I've seen it both ways...and think both work depending on the organization. But thought I'd see what other Quality people think.

Thanks for the input
 
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John Broomfield

Staff member
Super Moderator
#12
uhohraggy,

Separate the process for controlling nonconforming product from the process for removing the root causes of nonconforming product from the system.

This allows space for considering the value of corrective action and for grouping similar types of nonconformity for actions to stop their recurrence.

John
 
U

uhohraggy

#13
Thanks John,

What about a simple CA...for example retraining a technician, or adding a check box to a DHR?

We've been hit in audits before for not documenting a simple CA like the above, but they aren't worth creating a CAPA for?
 

John Broomfield

Staff member
Super Moderator
#14
Thanks John,

What about a simple CA...for example retraining a technician, or adding a check box to a DHR?

We've been hit in audits before for not documenting a simple CA like the above, but they aren't worth creating a CAPA for?
uhohraggy,

If we look at the definition of corrective action we can see that correction does not become corrective action until we are removing root causes from our system.

And, in the two examples you have given, you will have records of the corrections.

Do not run your management system to keep your auditors happy. Be prepared to defend your organization's reasons for not investing in corrective at that time. You may want to record those reasons or the results of your evaluation of the need for corrective action.

Hardwiring corrective action to every product nonconformity makes corrective action ineffective due to insufficient resources. Instead, pause, evaluate and invest in stopping recurrence of the most costly (vital few) nonconformities.

John
 
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