For Internal Audit findings, would you open a CAPA for every observation?

Michael Malis

Quite Involved in Discussions
#1
Hi All,

For Internal Audit:

Would you open CAPA's for all observations (Major or Minor) or only Majors?
What is the benefit and why? Please clarify your position.

In my opinion, I would open a CAPA's for all observations, because regardless if this is a CAPA or not, you still need to do all the activities (investigation, root cause, action and effectiveness verification). So why not do it all in one system (CAPA) instead of multiple systems?
 
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Jim Wynne

Staff member
Admin
#2
Hi All,

For Internal Audit:

Would you open CAPA's for all observations (Major or Minor) or only Majors?
What is the benefit and why? Please clarify your position.

In my opinion, I would open a CAPA's for all observations, because regardless if this is a CAPA or not, you still need to do all the activities (investigation, root cause, action and effectiveness verification). So why not do it all in one system (CAPA) instead of multiple systems?
Without knowing what standard or requirements you're dealing with, I question the use of "major" and "minor" categories in internal audits. Something is either a nonconformity or it isn't, and the risk involved with each instance should govern the extent of actions taken, if any.

I think that in many instances it's not necessary to do all of the investigating and root cause analysis, but it should be considered necessary to create a record. This means that you might use your CA form to answer the finding, but use it only to explain that full-blown CA isn't necessary or prudent.
 
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Stijloor

Staff member
Super Moderator
#3
Without knowing what standard or requirements you're dealing with, I question the use of "major" and "minor" categories in internal audits. Something is either a nonconformity or it isn't, and the risk involved with each instance should govern the extent of actions taken, if any.

I think that in many instances it's not necessary to do all of the investigating and root cause analysis, but it should be considered necessary to create a record. This means that you might use your CA form to answer the finding, but use it only to explain that full-blown CA isn't necessary or prudent.
Very much so! The "risk assessment" piece in the CA and PA procedure is often missing (or ignored) resulting in overreaction and wasted effort.

Stijloor.
 
#4
Michael:

Pretty much as Jim and Jan say. The grading of nc statements is of little use to anyone if the content of said statement doesn't convey the seriousness of the issue. Frankly, it's an external audit technique and has no real value with internal audits.

Similarly, you could think of audit findings a bit like non conforming product. Management sometimes deal with that by replacing the bad ones and never go out of their way to find the cause - based on costs, where it was found etc. Internal audit findings can be treated similarly, IMHO. Some are just fixed, others which are more systemic in nature need a more widespread action.
 
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Michael Malis

Quite Involved in Discussions
#5
I am in agreement with all above.

Would you recommend anything else if FDA and ISO 13485 standards are applicable and risk assessment correlates to allocation of major and minor observations?
 

Big Jim

Super Moderator
#7
Hi All,

For Internal Audit:

Would you open CAPA's for all observations (Major or Minor) or only Majors?
What is the benefit and why? Please clarify your position.

In my opinion, I would open a CAPA's for all observations, because regardless if this is a CAPA or not, you still need to do all the activities (investigation, root cause, action and effectiveness verification). So why not do it all in one system (CAPA) instead of multiple systems?
It may help to define terms.

Where you said "observations" you may have meant "findings".

Findings include nonconformances (major, minor, or undistinguished), observations, and opportunities for improvement.

"CAPA" frequently means both corrective actions and preventive actions.

Corrective actions need to be performed on all audit nonconformances. Some observations and opportunities for improvement may become preventive actions if you wish to pursue them.

So, you need the corrective action portion of a CAPA for nonconformances, and you may find it beneficial to apply observations and opportunities for improvement as a preventive action portion of a CAPA.

By the way, I think it is beneficial to separate a CAPA system into CAR and PAR, using separate forms to keep from tangling the two.
 
J

JaneB

#8
As Randy has already said: What does your internal procedure say?

If it straps you into doing it, then you have to do it... or, if that's too cumbersome, then more sensibly, change the procedure.
 
P

prabhatchaddha

#9
Here i will like to brinig an attention toward one of the system used by P&G.
They use alert system.They issue an alert for a each non conformity then these alear can be catagoried.Depeding on these alert a CAPA is prepared.
They even rate their approved vendors on these aleart bases.
Analysising on basis of these alert is rather easy then issuing a CAPA for each non conformity.

Regards

Prabhat Chaddha
 

Michael Malis

Quite Involved in Discussions
#10
It may help to define terms.

Where you said "observations" you may have meant "findings".

Findings include nonconformances (major, minor, or undistinguished), observations, and opportunities for improvement.

"CAPA" frequently means both corrective actions and preventive actions.

Corrective actions need to be performed on all audit nonconformances. Some observations and opportunities for improvement may become preventive actions if you wish to pursue them.

So, you need the corrective action portion of a CAPA for nonconformances, and you may find it beneficial to apply observations and opportunities for improvement as a preventive action portion of a CAPA.

By the way, I think it is beneficial to separate a CAPA system into CAR and PAR, using separate forms to keep from tangling the two.
Hi Jim,

It is findings, not just observations.
Also procedure can be changed...if required.

And if we all agree that corrective actions must be performed for all nonconformances, why not to use one system? To me, the amount of work is the same...

Is it "easier" to have a separate system for minor nonconformances because you can get away with less work or because it is less visible?

Thanks to all for your feedback,
Mike
 
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