CAR not closed off by the time next Audit rolls around

S

sfriendship - 2007

#1
I've been looking after our QMS for 3 years but I have never come across this situation until now...

During an internal audit held 6 months ago I raised a Corrective Action Request. Despite many attempts to follow it up and encourage the manager to do what needs to be done to close it off, he has been "too busy" and it's still open.

And so the next audit has rolled around and I have found the same problem again.

Our Internal Audit Report Form has an option under Audit Summary which states "The audit revealed deficiencies that were perviously detected during the last audit".

So I've ticked this, but do I raise a new CAR recording the same deficiency or refer back to the previous CAR?

And how badly will this be viewed when we come up to our next Surveillence Audit?

I'd love to hear from anyone has has any ideas or similar experiences - thanks :)
 
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V

vanputten

#2
I think you have a new problem. The new problem that you have is that management responsible for the area being audited has NOT ensured that actions were taken without undue delay. See the last paragrpah of 8.2.2 of ISO 9001:2000.

Keep the other request for corrective action in the system. Write a new request.

I guess "undue delay" could be argued. Was a realistic and reasonable justification given for the 6 month delay? If so, I would like to see what could possibly justfy this delay.

If the answer is too busy, then what they are telling you is that they are too busy to maintain the QMS. If that is the case, your organization has much bigger problems. Too busy to maintian the QMS is a nonconformance with 4.1, the very essential requirement to maintain the QMS.

You should also ask the very top management the following, "By what authority do I audit?" Meaning, you and others should know by what given authroity are you performing audits and asking for corrective action. This is important so when you escalate an issue like this, top management backs you up since they have concioulsy given you the audit authority.

By the way, how do I get the opportunity to look after a QMS in Australia? You're lucky.

Regards,

Dirk
 
#3
During an internal audit held 6 months ago I raised a Corrective Action Request. Despite many attempts to follow it up and encourage the manager to do what needs to be done to close it off, he has been "too busy" and it's still open.

And so the next audit has rolled around and I have found the same problem again.
I have a question. Is the audit finding 'interesting' to the manager? Does it affect his process effectiveness, affect his customers (internal or external), affect a regulatory requirement which is risky to the business?? If the answer is 'none of the above', then why would you expect any thing different?
I'm not saying that the audit finding shouldn't have been closed, but often auditors expect corrective actions when all that's needed is just correction. Are you forcing some heavy weight action to a situation which simply needs a fix?

Another thing you might want to take a look at is the frequency of your Management Review. If a good nc can go unanswered for so long, maybe your Management Review needs increasing in frequency (even on a 'special' basis) to escalate this - but make sure your nc is value added.........

The significance of what the issue is, in the eyes of an external auditor is debatable - one in how many?
:2cents:
Andy
 

Miner

Forum Moderator
Staff member
Admin
#4
Keep the original CAR open. Do not duplicate it. Do not close the old and open a new one because this clouds the real issue.

The new finding could be against the Corrective Action system, or provision of resource. If this has been through a Management Review cycle with no action taken, there could be an additional finding against Management Review.
 
S

sfriendship - 2007

#5
Thank you - these are all good points. This has certainly uncovered a few problems we need to address.

On reflection I don't think the audit finding was "interesting" to the manager, and maybe this particular procedure isn't needed. We'll have some discussion about that.

It makes sense that the new finding be against the Corrective Action system or provision of resource - thanks for that suggestion.

Cheers
Sarah

PS Yes Dirk, Australia is not a bad place to live and work, especially on a beautiful day like this :)
 
M

M Greenaway

#6
Why should we necessarily think that an issue raised during an audit has priority over the many issues raised daily from many sources ?
 

SteelMaiden

Super Moderator
Super Moderator
#7
Keep the original CAR open. Do not duplicate it. Do not close the old and open a new one because this clouds the real issue.

The new finding could be against the Corrective Action system, or provision of resource. If this has been through a Management Review cycle with no action taken, there could be an additional finding against Management Review.
or management commitment or responsibility and authority

Why should we necessarily think that an issue raised during an audit has priority over the many issues raised daily from many sources ?
M, I guess we'd have to ask if the manager ever asked for an extension because of the relevant impact of the CAR vs. everyday issues. And if the everyday issues were more important, I guess I would expect to see internal CARS to show that fact. IMHO, in six months time this manager could have at least completed an investigation, even if the action items were not all completed.

So, are you unable to close this because not all of the actions items are completed, or because the CAR was never investigated? I have several CARs, internal and audit issues that are nearing on a year old that we are still working on. No biggy. We had to order things with a long lead time, we had to tender a CEA request to corporate, whatever. Don't get hung up on the time it takes, focus on the quality of the investigations and actions taken.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
All good responses.

If you deal with this matter as has been described, the fact that there was an open CAR when the next audit rolled around shouldn't become a surveillance audit problem.

That is, having an open CAR is not a problem in the surveillance audit context. Failing to notice that or respond to it is a problem.

I agree it's worthwhile to do a 5-why analysis for this, starting with the CAR owner.

If the analysis concludes it's a behavioral matter--that is, he/she didn't get around to it, and management is serious about such things, perhaps an escalation or Management Action Notice is a good step.

Caution is wise, though. It's easy to blame a deeper problem on behavior or attitude of one person. It's harder to address the thing as lack of commitment or resources--which comes back to commitment.

It's not an enviable problem, but again I stress it needs addressing.

We don't know much about your subject manager here, but I have to remind myself at times that people generally understand the need for quality okay, but their focus is different. The complexities and sense of urgency for maintaining a tightly-running QMS may be quite outside a CAR owner's frame of thinking.

If the difficulty arises in large part because it's an unusually complex problem, then a different approach to corrective action may be needed to accomodate a long or involved project tied to a CAR.

Toward such a purpose I have adapted a nice form that was posted in a different thread. I've attached it. Feel free to tinker with it if you like, but if you do major improvements to it please post your end result for sharing.

Meanwhile, I will also direct you to the Reading Room, where I have attached a paper titled "When Employees Don't Follow Procedures". It might provide a tad bit of insight on why people (sometimes) don't behave in expected ways.

I've started a paper titled "Correcting Corrective Action" and hope to post it in The Reading Room soon.

I hope this helps!
 

Attachments

F

fuzzy

#9
I've been looking after our QMS for 3 years but I have never come across this situation until now...

During an internal audit held 6 months ago I raised a Corrective Action Request. Despite many attempts to follow it up and encourage the manager to do what needs to be done to close it off, he has been "too busy" and it's still open.

And so the next audit has rolled around and I have found the same problem again....

And how badly will this be viewed when we come up to our next Surveillence Audit?

I'd love to hear from anyone has has any ideas or similar experiences - thanks :)
I've had a fairly similar situation occur with CA from IA which rang my 3rd Party Auditor's bell hard enough for him to blurt out "you know that's a Major", after seeing one CAR for No Training Records open for 6+ mos. without any reply from the HR Manager. We didn't get the Major, but we have been put on notice :mad: that for the coming re-registration audit we best get it done, or we will get the hook:( . There are other problems with previous 3rd party minors that I wouldn't close out internally, which got a similar warning.

While the above narrative may raise a ruckus with ISO purists:notme: , I believe that my registrar is dead serious; no empty threat as part of the certification "game".

And I respect him for the approach...
 
V

vanputten

#10
"but often auditors expect corrective actions when all that's needed is just correction. Are you forcing some heavy weight action to a situation which simply needs a fix?"

A correction only eliminates the nonconformity, not the casue. I would have a hard time calling a correction a "fix." Also, how does one meet the requirements of the last paragraph of 8.2.2 of ISO 9001 by only implementing corrections? "actions are taken without undue delay to eliminate detected nonconformities and their causes."

Only doing corrections is most often a short term response that does nothing more than eliminate the nonconformity and does nothing to improve the oganization.

"Why should we necessarily think that an issue raised during an audit has priority over the many issues raised daily from many sources ?" Why should we think that issues raised during an audit do NOT have priority? I ask the opposite question.

Part of this aspect of the discussion gets back to audit authority, employee understanding and competence as to why internal auditing is performed, and competence of the internal auditors. For the most part, internal audits and the results are always perceived as less important even if the auditors are very competent, and the results are meaningful and important. This is a symptom of the illness in the industrialized work (or at least the USA) related to system thinking, corrections, corrective actions, continual improvement, target settings, objectives, priorities, mechanistic thinking, emphasis on short term goals, etc.

Regards,

Dirk
 
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