Non Conformance Closure by including it on another Corrective Action

Q

Quality Priest

#1
Just wanted to gauge how you guys would feel about the closure of NCR's under the following circumstances.
If you raise and NCR and not all actions for that NCR are closed, then further issues are picked up which incorporate the outstanding issues from the original NCR– Would you deem it acceptable to close the previous NCR referencing the new NCR which is more detailed?
 
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J

JaneB

#2
Just wanted to gauge how you guys would feel about the closure of NCR's under the following circumstances.
If you raise and NCR and not all actions for that NCR are closed, then further issues are picked up which incorporate the outstanding issues from the original NCR– Would you deem it acceptable to close the previous NCR referencing the new NCR which is more detailed?
This is a broad question (or hypothetical). It would very much depend on the particular situation and circumstances.

Ultimately, the key issue vis a vis corrective action/nonconformity is: has effective corrective action been taken to prevent the cause(s) of the NC from recurring? and thus on the face of it, if that means referencing across to a 'more detailed' NCR, and IF this means that the answer to the question then becomes Yes, then OK, so be it.

But this query and the whole scenario raises a lot of questions in my mind, such as why were 'not all actions' for the original NCR addressed and closed? Why are they 'outstanding'? Why and how have 'further issues' been 'picked up'? Why is a 'more detailed' NCR a better option than properly actioning the original one? Was the original one not adequate, not suitably written, etc? Does the organisation not know how to do corrective action appropriately? Does it not take action in a suitable time frame? If not, why not? etc etc

See what I mean about it depends on the circumstances?
 

Marcelo

Inactive Registered Visitor
#3
Why would a NC have corrective "actions" instead of "action"? The theory of a NC is that you need to correct the root cause to prevent it's recurrence, so in principle it would have only ione corrective action.

If you have "actions" you are problably viewing the NC from a too ample an angle. This usually happens if you do not make a good analysis of the problem (it may be the case that the NC you raised is in fact multiple NCs).
 
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Q

Quality Priest

#4
Thank you for your quick reply, and appreciate the points you make.
Wish this was hypothetical!
Following on from a Supplier (who is a customer and Business partner) audit, under previous management actions were taken to rectify audit NCR’s – these actions were not all successful however they were closed out internally. Since I have taken over we have received another visit where I have re-opened the actions as new NCR’s but cross referenced the old. The auditor in an email to all and sundry has stated that this is not acceptable company practice.
My stance is that we have traceability to the old NCR’s so there should be no problem, going forward.
As for the BUT……….. I can only ponder why and answer with a NO to all!!
 

Marcelo

Inactive Registered Visitor
#5
Hum, so maybe you were saying actions for different NCs, sorry.

Anyway, I would close the old ones BUT open another NC to verify why previous NCs were not closed, as these were required to be closed.
 
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G

Geoff Withnell

#6
Why would a NC have corrective "actions" instead of "action"? The theory of a NC is that you need to correct the root cause to prevent it's recurrence, so in principle it would have only ione corrective action.

If you have "actions" you are problably viewing the NC from a too ample an angle. This usually happens if you do not make a good analysis of the problem (it may be the case that the NC you raised is in fact multiple NCs).
There can be multiple root causes for a nonconformance. An example might be weld failure, with joint design, part preparation and equipment maintenance could all be root causes of the same failure. In complex system failures (airline crashes, etc) there are often long "chains" of problems, that lead to the failure. They are all "root causes" in that fixing any one of them would have prevented the failure, not just the earliest one in the chain.

Geoff Withnell
 

Marcelo

Inactive Registered Visitor
#7
There can be multiple root causes for a nonconformance. An example might be weld failure, with joint design, part preparation and equipment maintenance could all be root causes of the same failure. In complex system failures (airline crashes, etc) there are often long "chains" of problems, that lead to the failure. They are all "root causes" in that fixing any one of them would have prevented the failure, not just the earliest one in the chain.
Totally agree with you, however I was thinking NCs in terms of the standards.

They expect that you define "one" root cause and "one" action to try and fix it. If it´s not effective, you need to change the root cause (as you said) or the action, or both.
 
J

JaneB

#8
I see. Difficult situation (and can be one of the problems with a supplier doing audits!) I gather by 'all and sundry' that the auditor cc'd lots of people, thus escalating the issue, which isn't great practice on his part. At all. :nope: You have my sympathy.

Given that the previous actions did not successfully rectify the NCRs although they were closed, I would tend to agree that opening new actions (even with cross-referencing) probably isn't the best way to do it. Any QM or auditor is going to wonder: are they trying to avoid taking proper action, or failing to recognise that the closure was not justified?

Proably better to 'bite the bullet' and admit previous closure was premature or unwarranted, and re-open the original. Especially if your customer/ partner/ auditor is jumping up and down and raising a great hoo-hah about it.

But it isn't true that this is never or should never be done. :nope: I do occasionally close one or even more than 1 NCRs and transfer action to a new one (with cross-reference to the old), but only when it's sensible, logical and there's good reason for doing it, such as consolidating a few minor ones into one, or perhaps a big subsequent change in circumstances. Because otherwise the CA trail of what was actually done on what can get rather convoluted or muddy.

Marcelo, I do not agree that there is always and only ever One Single Root Cause for an NC. At all. Indeed, good root cause analysis may often find more than one cause. But if that is the way it 'must' be done for medical devices (is it? ), I guess one is stuck with it.
 

Marcelo

Inactive Registered Visitor
#9
Hello Jane

Marcelo, I do not agree that there is always and only ever One Single Root Cause for an NC. At all. Indeed, good root cause analysis may often find more than one cause. But if that is the way it 'must' be done for medical devices (is it? ), I guess one is stuck with it.
Yeah, I agree with you, as I agreed with Geoff. What I said is that the standard expect that you act on only one at a time, not several - if so, you would risk getting a worse problem.

I was talking about 13485 here because the thread is related to ISO 13485, however this is also true to ISO 9001 as the text on corrective actions is almost the same (13485 only adds the need to update documentation id needed).
 
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