Do nonconformances always result in corrective action

#41
I want to thank everyone who contributed to the discussion (Do non conformances always result in corrective action). I appreciate being able to get different so many different opinions from so many quality professionals (thank you cove). In the end I guess it is ultimately the organizations choice. :thanks:
Absolutely!
 
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eternal_atlas

Involved In Discussions
#42
If you dont have a source for corrective /preventive action, then it is not a non-conformance. In our QMS,every non-conformance will have some root cause and corrective/preventive action .
 
M

mseiedi

#44
Let's have a look at ISO 9001 standard!

8.5.2 states that "..organization shall take action to eliminate the cause of the nonconformity ..." . OK, up to this point it seems that we need to be very stringent about nonconformities !!

But wait ... going forward in 8.5.2, we see that there is a process-like steps for elimination of root causes.

if we get the hurt of requirement stated in subclause (c), there should not be any doubt about nonconformities and subsequent actions.

It says "...Evaluation the need for action to ensure that nonconformities do not recure..."

I think (personally) that ISO 9001, provides an opportunity to re-think about necessity to take further actions.

:cool:
 
S

szohar

#45
I've seen instances where minor non-conformances have occurred due to circumstances that are unique/isolated/unusual situations. The QA Manager decided that a CAPA was not needed. The non-conformance was simply documented, along with the root cause, the reason that the root cause was isolated and not likely to recur, and the resolution for the particular instance of non-conformance. The QA Manager signed off explicitly that a CAPA was not required for the situation.

Note: The QA Manager only did this for very minor non-conformances. However, you were looking for instances where CAPAs were not issued, so these are instances that I have seen.

IMNSHO, the best way to address this type of thing is before it happens, in your SOPs and reporting forms. The SOP should explicitly identify conditions where a CAPA may not be required, and should identify what explanations and sign-offs are needed when choosing not to issue a CAPA. Any forms used to document non-conformances should include a check-off for whether a CAPA was issued, and if not, should include a fillable field for the explanation for not issuing the CAPA.
 
S

szohar

#47
there is no non-conformance without corrective or preventive action. thats what i mean..

What if the root cause is an anomaly that cannot be prevented or mitigated, and if the result of the non-conformance is an anomalous deviation that is acceptable and that can be explained?

I grant that this is an unusual set of circumstances, but I've seen this happen, so it's not outside the realm of possibility.
 
C

curryassassin

#49
In our small organisation, sometimes a minor nonconformance is addressed via an explanation of the root cause and impact of the nonconformance which may include a risk assessment but no further action. I advocate the tracking and trending of nonconformances and taking further action if the trend indicates, rather than corrective active action for every nonconformance. We need to bear in mind the frequency, cost, impact on quality/regulations/business/customer etc when deciding to take further action.
 

eternal_atlas

Involved In Discussions
#50
In our small organisation, sometimes a minor nonconformance is addressed via an explanation of the root cause and impact of the nonconformance which may include a risk assessment but no further action. I advocate the tracking and trending of nonconformances and taking further action if the trend indicates, rather than corrective active action for every nonconformance. We need to bear in mind the frequency, cost, impact on quality/regulations/business/customer etc when deciding to take further action.
Risk Assessment is a preventive action. so non-conformance doesnt exist without any corrective or preventive actions.

though u tracking the small non-conformances, altast if u take a corrective action/preventive action which is a action taken common for all those small non-conformances..

Or else , cite one example of non-conformance without any corrective or preventive action in any field..
 
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