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Related Topic Tags
capa (corrective and preventive action), corrective action (ca), preventive action (pa)
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  Post Number #9  
Old 12th August 2006, 04:05 AM
Peter Fraser's Avatar
Peter Fraser

 
 
Total Posts: 455
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Sidney Vianna

Negative . When a organization self declares compliant or is certified to ISO 9001, their customers have the "right" to expect that they know the difference between correction, corrective action and preventive action. If it was not important, ISO 9000 would not have such terms DEFINED. If you disregard the official interpretations, then the whole concept of standardization vanishes...
It is CRITICAL that organizations implementing ISO 9001 understand the difference, and act accordingly.
Sidney

Agreed - but it is the concepts that need to be understood and dealt with (ie fix it if it goes wrong, and try to avoid it happening again but, even better, recognise that something might go wrong in future and take steps to avoid that too). The ISO9000 definitions must be part of the problem otherwise we wouldn't still be discussing this after all this time!

I believe that one of the problems lies in the implication that "preventive action" is a standalone process. To me, how you recruit staff / take a customer order / design a process / allocate resources / audit your processes - all are intrinsic to PA.

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  Post Number #10  
Old 12th August 2006, 10:41 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,450
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Peter Fraser

The ISO9000 definitions must be part of the problem otherwise we wouldn't still be discussing this after all this time!

I believe that one of the problems lies in the implication that "preventive action" is a standalone process. To me, how you recruit staff / take a customer order / design a process / allocate resources / audit your processes - all are intrinsic to PA.
I agree that 8.5.3 of ISO 9001 is very poorly written. And the requirement for PA in ISO 9001 begs for clarification. But I disagree with your last paragraph. The examples you cited are all part of a QMS, which, BY DEFINITION, is implemented to PREVENT problems. If EVERYTHING preventive in nature was to be considered what ISO 9001 8.5.3 is aiming at, as a requirement, then 8.5.3 would be redundant.

Last edited by Sidney Vianna; 12th August 2006 at 02:37 PM.
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  Post Number #11  
Old 12th August 2006, 12:43 PM
Peter Fraser's Avatar
Peter Fraser

 
 
Total Posts: 455
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Sidney Vianna

If anything preventive in nature was to be considered what ISO 9001 8.5.3 is aiming at, as a requirement, then 8.5.3 would be redundant.
Perhaps it is?
  Post Number #12  
Old 12th August 2006, 03:05 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,450
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Peter Fraser

Perhaps it is?
One could hope that the members of the TC 176 SC2 WG?? are listening INTENTLY to the feedback about countless discussions on PA and doing "continual improvement" and fixing the problem, by clarifying PA in the next Edition of ISO 9001. Unexplainably (?) the March 06 WD (Working Draft) of ISO 9001:2009 has ZERO amendments to clause 8.5.3.

I can not believe TC 176 does not realize that 8.5.3 is creating incredible confusion (to say the least) in the market place. Or could it be that they can't get consensus on how the clause should be re-written.....?
  Post Number #13  
Old 13th August 2006, 12:03 PM
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Bev D

 
 
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Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Rezzi View Post

Hi all
Having looking through the excessive amount regarding different interpretations, discussion and arguments regarding CA and PA, I must say it is somehow getting out of hand...
I would say if your CAPA process cuts costs, results in a better product/process, your collegues (and the registrar) are satisfied and the product is safe, then hey, good work, in this case the question about whether an action is correction, corrective action or preventive action of a more academic interest.
well, you may be correct, but if so, I would argue that it is not us a thet cove, but the ISO/Registrar system that is then "getting out of hand".

ISO has a somewhat ambiguous defintion but it DOES require a documented system with objective evidence of Corrective Actions to eliminate the causes of nonconformities and prevent their recurrence and Preventive Actions that eliminate the causes of potential nonconformities to prevent their occurence. Then the Registrars come in and insist that we comply with that. If we disagree or have a different interpretation then WHAMMO! we get a finding requiring Corrective action. and that's where it all gets "out of hand" as you contend.
  Post Number #14  
Old 13th August 2006, 09:05 PM
Greg B's Avatar
Greg B

 
 
Total Posts: 831
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Those of you that have had the pleasure of knowing me these past three years will know that I HATE this subject with a passion and wonder why ANYONE would bring it up AGAIN!!!! I am a moderator for this fair thread and wish I weren't

YES! The wording is rubbish but no matter what words they used, we (the quality profession) would surely debate it as we do every other clause in the standard. It really is up to the individual company to get it right for THEM. Correct issues as they arise and Prevent issues before they arise(at least TRY). Semantics are the biggest problem here, with: "When does one become the other?" So for all of you that are wrangling for an argument in cyberspace then start your own forum and you can start by arguing these beauties:

Does a horse really Pull a cart or Push it?
Is a glass half full or half empty? If it's half full then when does it become half empty?

IMHO people should leave the CAPA topic alone for fear of being attacked unmercifully by the semantics police...PLEASE!!!
  Post Number #15  
Old 13th August 2006, 10:58 PM
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Laura M

 
 
Total Posts: 762
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

I recently had a client classify an internal reject as 'preventive action' because they prevented a problem from getting to a customer. So a semi-lengthy discussion ensued.

The problem with preventive action is that all companies that do a fair PFMEA, or print review probably take all kinds of preventive action when they develop the processes. Providing examples, or filling out a separate preventive action form becomes the nuisance part of ISO. Writing the preventive action procedures around FMEA, training, print review has worked for progressive companies that actively do the above.
  Post Number #16  
Old 13th August 2006, 11:23 PM
Helmut Jilling

 
 
Total Posts: 4,357
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Laura M View Post

I recently had a client classify an internal reject as 'preventive action' because they prevented a problem from getting to a customer. So a semi-lengthy discussion ensued.

The problem with preventive action is that all companies that do a fair PFMEA, or print review probably take all kinds of preventive action when they develop the processes. Providing examples, or filling out a separate preventive action form becomes the nuisance part of ISO. Writing the preventive action procedures around FMEA, training, print review has worked for progressive companies that actively do the above.

Since FMEAs are already a very good exercise, rewriting them again as preventive actions adds no value. I believe the kind of preventive actions the standard is promoting is just like corrective actions, but BEFORE the failure.

In other words, look for next week's failures this week, and take action while there is still time. Now that, would be value-added, in my opinion.
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