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Should Corrective Action be segregated from Preventive Action?

sagai

Quite Involved in Discussions
#1
Do we have to have a segregated record for corrective action and preventive action?
Is there any problem recording CAPA in general without saying This is CA, That is PA?
(I know the difference, I am wondering if we should distinguish them when recording.)
I tend to believe there is no such requirement in the standard, but curious about others opinion, Many thanks.
 
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Geoff Withnell

#2
Do we have to have a segregated record for corrective action and preventive action?
Is there any problem recording CAPA in general without saying This is CA, That is PA?
(I know the difference, I am wondering if we should distinguish them when recording.)
I tend to believe there is no such requirement in the standard, but curious about others opinion, Many thanks.
I can't think of any requirement to do so. Some flag on the PAs, to make it easier to pull them out as examples during audits, may be worthwhile, but required, no.
 

RA Guy

Involved In Discussions
#3
13485 has separate clauses for CA and PA, so I tend to think there is a requirement to identify actions as CA or PA. Otherwise how do you demonstrate complying with both clauses in an audit situation? At a minimum, the CAPA determination step would need to identify if a CA or PA.
 

sagai

Quite Involved in Discussions
#4
What if the PAs are those CAPAs having no registered NonConformities against to, while CAs are the ones having registered NonConformities to?
Many thanks.
 
G

Geoff Withnell

#6
The OP said he knew the difference. The question is "Do we have to have a segregated record for corrective action and preventive action?" No, the records do not need to be segregated. In an audit situation, if the auditor says "show me some corrective actions", show him some. The MR should be familar with the actions being taken, and can likewise ID PAs. If you want to flag them for your convenience, it is perfectly fine to do so, and I would even recommend it. But being the easiest, most convenient way to do it, in my opinion, your opinion, the OP's opinion or ewven the auditor's opinion does NOT make it "required".
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Do we have to have a segregated record for corrective action and preventive action?
Is there any problem recording CAPA in general without saying This is CA, That is PA?
(I know the difference, I am wondering if we should distinguish them when recording.)
I tend to believe there is no such requirement in the standard, but curious about others opinion, Many thanks.
When ISO 9001:2000 came about, 11[sup]1[/sup]/[sub]2[/sub] years ago, a well known CB set a policy that registrants certified by them were mandated to have SEPARATE procedures for corrective and preventive actions. They got a lot of backlash and have rescinded the policy. Actually one of the clarifications in the ISO 9001:2008 standard had to do with that aspect.

As for your question concerning segregating corrective action records from preventive action records, you should be able to distinguish which is which, even though there is a lot of non-sense, when it comes to preventive actions. We have some of the longest threads on that subject, here at The Cove. Also, don't forget the wisdom contained in the ISO TC 176 APG paper titled Auditing Preventive Action.
 
Last edited:

RA Guy

Involved In Discussions
#8
Hi Geoff:

Perhaps we are not reading "segregated" in the same way. I understand it as indicating (or distinguishing as SV states above) that a CA is a CA and a PA is a PA. As far as I am concerned one can use the same process, templates, logs, etc. for both CAs and PAs.

If there is no flag or other mechanism to "segregate" the CAs from the PAs, how is the "if its not documented, its not done" rule of thumb satisfied? It can't be by the memory or instiutional knowledge of the MR or anyone else. What if they leave the company?

In an audit, anything that comes out verbally, must be backed up by the record or other objective evidence. If the auditee is the only source verbally telling the auditor what's what, I'd suggest that the auditor is injecting his/her opinion by accepting that with no documented evidence.
 

sagai

Quite Involved in Discussions
#9
I know not I was the one was called, but sorry Sir, "objective evidence" is not necessary a document, a record or anything tangible. As far as I concern in the ISO world. Cheers!

---
3.8.1
objective evidence
data supporting the existence or verity
of something

NOTE Objective evidence may be ob-
tained through observation
, measure-
ment, test (3.8.3), or other means.
 

RA Guy

Involved In Discussions
#10
Sagai, I agree and that's why I said "by the record or other objective evidence."
I am not sure in your CAPA example what other type of evidence could be presented besides a document or record.
My original post stated 13485 has 2 separate requirements. Both requirements need to be demonstrated by objective evidence. The record is the best way in MHO.
I am open to other suggesteions on how this could be done without documentary evidence "segregating" the 2 types of action.
 
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