Do nonconformances always result in corrective action

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harry

Super Moderator
#12
Yes, in one of the previous threads or discussion, we identified that it either need a 'corrective action' or just a 'correction'.
 

6thsense

Involved In Discussions
#14
Yes, in one of the previous threads or discussion, we identified that it either need a 'corrective action' or just a 'correction'.
im with harry on this one. not all nonconformances require Corrective action. in our audit system we have the probable outcomes. corrective actions, correction and Opportunities for improvement
 

Doug Tropf

Quite Involved in Discussions
#15
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:
I would agree with some of the other posters that all nonconformities do not require a corrective action. Your procedures should be detailed enough to provide guidance. TR 14969 offers the following on the subject:

The organization's corrective action procedures should clearly establish
- who is responsible for taking corrective action
- when and how this corrective action will be carried out, and
- how the effectiveness of the corrective action will be verified

also

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.
 
B

Bob Bonville

#16
I agree completely with Geoff. I would take it one step farther however and say that in all cases when a nonconformance is documented, the Corrective Action block of the document should not be left blank. There should be some statement written into it that states why corrective action is not required in this particular case. Unless this is done, it is a flag for an auditor.

Bob
 
J

JaneB

#17
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.
Interesting, isn't it, that in the various posts, there is such a diversity of opinion on the subject, with strong opinions for and against? No wonder you are having a debate with your management, Maxwell. :)

We all know it's possible for Quality Nazis (or whoever) to retreat to their Quality Corner and issue a blanket 'Thou Shalt Issue a Corrective Action in every instance of Nonconformity'... even if that were decided to be the rule for your organisation or wherever, I'd like to suggest that we consider the outcomes we presumably want and call to mind some of the underlying principles of quality.

I have certainly seen the results of such a black and white insistence on a 100% rule. And one of the problems is that if people think something is stupid or overkill, they will almost certainly work to subvert or bypass the system, actively or passively.

I want good outcomes and I want to have people 'involved at all levels'. I want improvement - which means I try to bring people in & have them buy in. Then there's an infinitely better likelihood that they'll work with the system, because they had a say in it and they understand the why.

One way of perhaps moving the debate along, or opening it up in a positive way, might be to collect a number of reasonably representative examples of NCs in your particular organisation, plus perhaps a few that are a bit 'outside the norm'. These could be used to have a really interesting discussion with management (presuming they are involved and interested), to see who believes for which example that a CA should be raised - and why - and who doesn't, and why.

If you can get from there to a reasonable consensus on when one does and when one might not, or that one always would because of X and Y and Z, then you've got a much better chance of getting to where you want to get to - ie, improving.
 
B

BobA5835 - 2009

#18
Mr. Geoff:

I was reading through this thread and following the info flow right up until you threw in the comment about the 'economics'. I'm now confused. "Somebody" may be considering the 'economics' at some future point after I complete my audit, but it certainly isn't going to be me while I'm doing the audit.

What am I missing here?:(

Thanks for any additional enlightenment.

Bob
 
#19
I'm going to step in here and offer some thoughts, I've no doubt Geoff will too.

When doing an audit (the whole of the audit, that is, including planning and preparation) it's always important to keep 'economics' in mind. One of the best reasons for doing an audit is to diagnose why there's a problem (read lost $$) with a process - non-conforming output or such like. Being able to go to management with an audit report which states, "we're losing this money due to 'x' in the process" is a very powerful statement. I've had internal auditors find as much as $8M in savings, because they 'got past' the simple 'Are we following procedures?' mentality to focus on what it cost to have an issue.

In another way, internal auditors who have a clear grasp of the Toyota Manufacturing Principles (or Lean) tend to be aware of the economics of the process they're auditing and often find opportunities to reduce waste.

Geoff, I believe, is also looking at the results of audits as needing the auditor to be aware of the likely cost/benefit ratio of any corrective action - which is often overlooked. It's a bit like a manager saying, "O.K, I know we've got a (strict) NC here, but it costs us this much 'Y' $$ to tolerate it, but 10x 'Y' to fix it......." Therefore it's unlikely to be addressed with any real enthusiasm!
 
T

treesei

#20
Please read 21 CFR 820. I cannot remember which section exactly but the FDA has some explanation.
 
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