Do nonconformances always result in corrective action

Bev D

Heretical Statistician
Staff member
Super Moderator
#31
ah - but you're trying to apply logic and reason!

The difference between a nonconformance to the QMS or of the product to requirements is the key to the OP's question: the question being: "do nonconformities ALWAYS result in corrective action or are there cases where a nonconformity DOES NOT result in a corrective action".

If we accept that his use of the phrase of "Corrective Action" means the standard definition = "corrective action to prevent recurrence" then we must be aware that for ISO9000, section 8.2.2 internal audit (which addresses nonconformities to the QMS) states very clearly "The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Internal audit is focused on QMS compliance and not product conformance. In this case, corrective action is generally interpreted to be required.


internal auditors tend to fudge about with the definition of what constitutes a 'finding' of nonconformance. isolated instances of a signel clerical error or mistake may not be deemed a finding of nonconformance by some auditors so as to avoid corrective actions, but this approach is subject to intense debate...
 
Elsmar Forum Sponsor
#32
Bev D - you maybe right about what's generally interpreted - and that's where conventional wisdom is often incorrect!

A few years back, At the ASQ conference, a keynote address was given by Jack West which (basically) said that he external audit model was to balme for 'over interpreting' the need for corrective action (including root cause analysis) instead of allowing for correction.

I'd go further and say the whole internal audit model needs to change (away from current 'wisdom'), including ensuring that auditors only report non-conformities (and effectiveness is key, here) and allow management to decide on how to treat the actions. After all, it's their business.

If they fail to get serious about this, no internal auditor is going to change anything, no amount of threats about the CB auditor finding the same or grading nc's as major/minor will drive any actions! Indeed, treating all audit findings as needing (root cause) corrective actions, is IMHO, one of the fastest ways to bring the system down to simply keeping a certificate on the wall
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#33
Bev D - you maybe right about what's generally interpreted - and that's where conventional wisdom is often incorrect!
yes - it's just soooooo difficult to get past the statemetn in the internal audit section "The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes". If the statement stopped at eliminate nonconformities, simple correction would be accepted as allowable. but alas "and their causes" takes us beyond simple correction...:(
 

Big Jim

Super Moderator
#34
I think you're over thinking this. defective product in and of itself has never been interpreted to be a nonconformance to the QMS. a corrective action as to cause to prevetn reocurrence for every defect would be completely onerous and absurd. the entire purpose of 8.3 is to deal with the inevitability that defective product will be made. 8.5.2 does not say ALL. in fact the second sentence says "Corrective actions shall be appropriate to the effects of the nonconformities encountered", meaning that sometimes corrective action is simply rework or throw away and move on...teh nonconformities in this case refer to both QMS and product requirements. you must read the standard as a whole and not as stand alone bits and pieces.
I think you and I are closer than you realize. I'm the one who first posted that I don't believe that ALL is the intent of the standard.

The point in which we may need to agree to disagree is about product nonconformance being included in QMS nonconformance. Reading the entire standard as a whole, I don't understand how it could be any other way. In either case, we both have lots of company.
 
#35
If the statement stopped at eliminate nonconformities, simple correction would be accepted as allowable. but alas "and their causes" takes us beyond simple correction...:(
Only if you let it..........

Too many QMS folks spend way too much time agonizing over root cause. Often the cause is right under our noses, so I fail to see why it can't be considered as part of the correction. Just like how we treat non-conforming product really! Don't forget, Mr. West is on TC 176, so I take it they talked at length about this! I'm sure they didn't all mean root cause for all audit non-conformities.

Of course, if I ruled the world, the audits would tackle issues that management have a vested interest in, so their responses wouldn't rely on any wording in the standard - they'd get on with it because their (personal functional) performance depended on it! Maybe the next revision of ISO 9000 might address a more robust focus for internal audits!
 
J

JaneB

#36
There are times when Corrective Action is required...a full blown root cause analysis, an action plan, a verification plan, etc.

There are times when (working for a steel mill) I say it's a 'quick wham-bam-let's-get-back-to-making-steel' approach. This means we implement a correction and get back to making our product.

Each process owner(s)/department should define their own set of triggers, but it is great to consolidate this information. By structuring the processes/departments in a sequential flow that mimics the creation of your product or service, this Matrix helps to show how a failure in one process can adversely impact their internal Customer (i.e., the next process/department in line).

The good part about this approach is that if you focus and properly apply your problem solving skills and resources on those top issues, your organization will get them under control and they will cease to be problems. As part of a regular data analysis program (e.g., annual review of trends, indicators, etc.), a new "top 20" list may arise and you can revise your triggers for the following cycle.
Yes - great advice and a very practical approach. I couldn't agree with you more.

Some organisations may choose a 'corrective action' for every nonconformity. That's their choice, and hopefully for sound reasons. But it's not one I'd recommend in 99% of circumstances, and I'd really want to discuss with any company proposing it their reasons for doing so. 80/20 rule tends to be more valuable.

I have seen companies impose this kind of blanket, B&W rule... and also seen that in many cases, it can take far longer to fill the form in than to actually fix whatever the issue is... and for virtually zilch value! At times it seriously does become 'quality gone mad'. Definitely the kind of thing that tends to turn people off.

If only common sense were more common. :(
 
J

John Nabors - 2009

#37
I'm with RC and Jane. There are issues that really are indicators of a broken system, and there are issues that are just a bug on the windshield of progress. A bug on the windshield does not necessitate removing the windshield to wipe it off.
 
B

BobA5835 - 2009

#38
AndyN said:
I'm going to step in here and offer some thoughts, I've no doubt Geoff will too.

-Snip-

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.
Mr. Andy:

Thank you for the additional information. I've shared this thread with Dr. P, my Audit Manager. The Cove has helped generate some lively interaction for us.:applause:

However, Dr. P says, sorry, no, as the concept of the OP's original question has been shifted somewhat. Some of this is putting the cart before the horse. It is not up to me to be influenced by possible "economic" considerations while doing our (Regulatory) Audits. As far as the Results of the Audit and any Corrective Actions and dealing with Management, that's his job, not mine (as the Auditor). :)

BobA5835
 
Last edited by a moderator:
#39
AndyN said:
I'm going to step in here and offer some thoughts, I've no doubt Geoff will too.

-Snip-

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.

Mr. Andy:

Thank you for the additional information. I've shared this thread with Dr. P, my Audit Manager. The Cove has helped generate some lively interaction for us.:applause:

However, Dr. P says, sorry, no, as the concept of the OP's original question has been shifted somewhat. Some of this is putting the cart before the horse. It is not up to me to be influenced by possible "economic" considerations while doing our (Regulatory) Audits. As far as the Results of the Audit and any Corrective Actions and dealing with Management, that's his job, not mine (as the Auditor). :)

BobA5835
The OP didn't state anything about doing regulatory audits, which is a different kettle of fish.

However, I still maintain, that any internal auditor should have their antenna up regarding the cost impact of what they're seeing.

Dr. P may not see it that way, not many do (IMHO) and, as a result, organizations tend to get little to no benefit from their audits.......
 
M

maxwell

#40
I want to thank everyone who contributed to the discussion (Do non conformances always result in corrective action). I appreciate being able to get different so many different opinions from so many quality professionals (thank you cove). In the end I guess it is ultimately the organizations choice. :thanks:
 
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