Do nonconformances always result in corrective action

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#61
Greetings

I am having a debate with management, the question being do nonconformities ALWAYS result in corrective action or are there cases where a nonconformity DOES NOT result in a corrective action. Any examples you might have would be greatly appreciated.

Thank You

:lmao:
:confused: With all of the comments I am a little confused because I am not sure which standard we are talking about. Some comments address ISO9001:200x and others talk about ISO 13485.

Which one are we talking about here: ISO 9001:200x or ISO 13485. Can you please enlighten me?
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#62
NNoooooooooooo!

Never 'step over' an audit finding! - put it in the summary report. It may not warrant any action at the time it was found (in isolation) but if it goes unrecorded, you may be missing an opportunity to 'see' it occuring in other places, each time as 'isolated' situations. Hence, the audit manager won't be able to detect a trend and, say after 3, 4, 5 or 6 audits, focus attention on the system which is causing these not so isolated findings.......

The wording of ISO is a moot point since the 08 version allows, specifically, for corrections. I'd be very wary of jumping to the conclusion that the root cause is the procedure being too specific! That, itself, has a root cause........
AndyN - reread my post - I believe I clearly differentiated between audit findings and product NCs. I clearly said that audit NCs must have corrective action and they would therefore be documented in a corrective action. IF and when ISO 08 is released I would advocate for documenting trivial findings that are 'corrective action worthy' in the audit report...

I do not jump to the conclusion that a procedure is too specific. I would have to have proof. I am especially sensititive to people going around procedures because they feel the procedure is too 'restrictive'. However in the example of the shipping company given earlier that procedure was clearly too proscriptive - everybody did the right thing for the right reasons but were still in violation of a self imposed procedure. Should we go after the root case of overly proscriptive procedures? well maybe - if there are enough of them to warrant such action - remember too that the current released version of ISO says that for audit findings "actions are taken without undue delay to eliminate detected nonconformities and their causes". It does not say action must be taken against ROOT or SYSTEMIC causes. And if we have an overly proscriptive procedure and we change it to allow for actions that are perfectly acceptable yet are 'nonconformances' to the proscriptive version of the procedure we have in fact eliminated the nonconformance and it's cause without undue delay...

we MUST prioritize our work. not all problems are of equal effect on the organization. and no organization that I know ahs the manpower to deal with every little thing that isn't perfect. (that's not to say that I am opposed to continual improvement - I'm not - but it's a continual process not one big giant leap)
 
#63
Bev, I did re-read your post and now I'm even more confused! Non-conformities, whether for internal audits or products, should not be 'stepped over'!

What people 'feel' about a procedure being too restrictive is not what the auditor is there to report. It may be a symptom, not the reason. There's a lot of information an auditor can gather to discover why the people aren't doning what the documentation says......

To assign a corrective action each and every time there's an internal quality system audit finding is an old fashioned, external audit based technique, which shouldn't be emulated internally........IMHO
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#64
Bev, I did re-read your post and now I'm even more confused! Non-conformities, whether for internal audits or products, should not be 'stepped over'!

What people 'feel' about a procedure being too restrictive is not what the auditor is there to report. It may be a symptom, not the reason. There's a lot of information an auditor can gather to discover why the people aren't doning what the documentation says......

To assign a corrective action each and every time there's an internal quality system audit finding is an old fashioned, external audit based technique, which shouldn't be emulated internally........IMHO
OK I really think you are misinterpreting waht I've written so let's take a different approach: what is your definition of "stepping over" and specifically why do you think I'm advocating it?

(I agree with you on issuing a CA for every internal audit NC - but the current released version of ISO9000 does require it...)
 

Stijloor

Staff member
Super Moderator
#65
:confused: With all of the comments I am a little confused because I am not sure which standard we are talking about. Some comments address ISO9001:200x and others talk about ISO 13485.

Which one are we talking about here: ISO 9001:200x or ISO 13485. Can you please enlighten me?
I have the same question...

Please help.

Stijloor.
 
A

Allan66

#66
Going back to the original question, I would use the guidance of "The degree of corrective action taken should be dependent upon and
related to the risk, size and nature of the problem and its effect(s) on product quality" to state that all NC's should have Corrective Action considered.

If there is an action - no matter how trivial (eg enter a missing but recorded-elsewhere piece of information on a form) or complex (Re-engineeded the business) then by definition you have taken Corrective Action. If in your considerations you and the management team decided to do nothing then I would strongly recommend documenting this (briefly) and why.

There is whole lot of difference between not impementing a Corrective Action and making a decision not to implement a Corrective Action.
 

jkuil

Quite Involved in Discussions
#68
I have the same question...

Please help.

Stijloor.
ISO 13485:2003 is the quality mangement system standard for the medical device industry. It basically has the same requirements (text) as ISO 9001:2000 with a few adaptations specifically for the medical device industry. Interestingly for corrective action it adds the requirement of recording of the results of any investigation.:cool:
 
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