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capa (corrective and preventive action), corrective action (ca), preventive action (pa)
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  Post Number #25  
Old 14th August 2006, 01:42 PM
skappesser's Avatar
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Total Posts: 35
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

During ISO audits at one of my previous employers, the auditor required documented objective evidence for PAs, and really liked the form we created for that. The form could be used for CAs or PAs. It helps to use tools like this to make the audit experience easier and more efficient for the auditor. Auditors appreciate efforts to ensure a value added, compliant process is not difficult to audit...

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  Post Number #26  
Old 14th August 2006, 01:49 PM
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David Hartman

 
 
Total Posts: 564
Re: CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand

Alas poor Yurik, if I correct a trend that appears to be moving towards an unacceptable condition I have NOT corrected it, but prevented it. But, if I prevent the recurrence of a nonconformity I have NOT prevented it, but have corrected it. I stand at the edge of insanity and believist that I might succumb.
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  Post Number #27  
Old 14th August 2006, 01:56 PM
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Total Posts: 35
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

I am not understanding this seemingly insensitive reply from a moderator(?) Rezzi felt crushed enough to apologize for asking questions! Please someone tell me what am I missing? People want to and need to learn. Does this forum and its moderators tolerate and cultivate youth and inexperience? Were we not all young once and asking elementary questions to build our knowledge?
  Post Number #28  
Old 14th August 2006, 02:16 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 Sidney Vianna View Post

That is not the problem. The problem is EXACTLY the opposite. As demonstrated NUMEROUS times in this Forum, some people still think that fixing the non-conforming situation is corrective action (rather than correction). If auditors would allow that go go unchecked, it would set us back 3 or 4 decades in terms of quality management practices. An organization that does not understand the need for TRUE corrective action and keep doing re-work and repair, thinking that they are doing "corrective action" is not doing ANY improvement whatsoever. So, by enforcing the definition and concept of TRUE corrective actions, the auditor is FORCING the organization to raise the bar and become more effective.
Whoa Sydney. no body works harder for true Corrective and Preventive Actions within their organization me. I do understand and agree with the interpretations given in the standard. but as a point of clarification of my input on the "getting out of hand" comment (and as a counterpoint to your experience), what I have expereinced from many audits in many different organizations and from many different auditors and registrars and customers is in fact the semantical part of the argument.

Before I get started I want to again reiterate that I believe that organizations must do all 3 - correction, corrective and preventive actions - at various 'volume' levels depending on the maturity of the organization and the state of their quality performance.

*I* have experienced findings based on incorrect categorization of actions into correction, Corrective and Preventive categories. One auditor came in during a preregistration audit and absolutely insisted that our ESD protection wasn't sufficient. he based this on the protection levels he had seen at other organizations, mostly board assembly houses. we are not a board assembly house we are an instrument house and have only minimal board handling. we had soem level of ESD in place of course and absolutely no data indicating that we were generating ESD failures (and YES, we knew this for certain). However, he wouldn't accept it because it wasn't what others were doing...he even refused to look at our data. At the same time, we wer etold we needed more preventive actions in order to get registered. SO, we put the incresaed ESD protection in as a Preventive Action. durignthe registration audit he didn't like that and insisted we reclassify it a Corrective. or he would issue a finding. Then he looked at a second preventive action that I had tried - in vain - to have moved to a Corrective Action since the action was to replace a battery during preventive maintenance since it had been determined thru previous investigation into field failures that the battery was running down and causing a specific failure mode. He thought that was a grand Preventive action! And I have a hundred such stories.

MY point was that if the organization is doing it correctly and well - who cares what you 'officially' call it...that is getting into semantics and that's frustrating as all get out. Of course if they're not doing it, even if they think they are, they need to be educated and steered in the correct direction...that isn't semantics, it's not understanding the real levels of corrective action. and that's a shame.
Thanks to Bev D for your informative Post and/or Attachment!
  Post Number #29  
Old 14th August 2006, 02:52 PM
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Sidney Vianna

 
 
Total Posts: 8,671
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by Bev D View Post

*I* have experienced findings based on incorrect categorization of actions into correction, Corrective and Preventive categories. One auditor came in during a preregistration audit and absolutely insisted that our ESD protection wasn't sufficient. he based this on the protection levels he had seen at other organizations, mostly board assembly houses. we are not a board assembly house we are an instrument house and have only minimal board handling. we had soem level of ESD in place of course and absolutely no data indicating that we were generating ESD failures (and YES, we knew this for certain). However, he wouldn't accept it because it wasn't what others were doing...he even refused to look at our data. At the same time, we wer etold we needed more preventive actions in order to get registered. SO, we put the incresaed ESD protection in as a Preventive Action. durignthe registration audit he didn't like that and insisted we reclassify it a Corrective. or he would issue a finding. Then he looked at a second preventive action that I had tried - in vain - to have moved to a Corrective Action since the action was to replace a battery during preventive maintenance since it had been determined thru previous investigation into field failures that the battery was running down and causing a specific failure mode. He thought that was a grand Preventive action! And I have a hundred such stories.
So you had an uneducated/misguided auditor. Next time they engage in these meaningless discussions, educate him/her by showing this ISO APG Guidance document on Auditing Preventive Actions. Emphasis on
Quote:
There is often significant “philosophical” discussion between the auditor and the organization about where corrective action ends, and where preventive action begins. For example, if a nonconformity is detected in process “A”, are actions taken to avoid future nonconformities in processes “B”, “C” and “D” preventive actions, or simply within the scope of the corrective actions taken for process ”A”? The auditor should avoid being “side-tracked” by these discussions, and concentrate on whether or not the actions were effective. The “labeling” of the actions taken is of secondary importance!
  Post Number #30  
Old 14th August 2006, 03:55 PM
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Bev D

 
 
Total Posts: 3,472
Re: CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand

I wish it were only auditor...it han't even been one registrar or one industry, but time and time again...

and yes I have tried to point out guidance documents and having them "show me the shall" and then I get even more negative feedback, although that never stops me from trying - never tell an auditor they don't know what their doing. a bad auditor is a bad auditor and while there are many good ones out there there a lot of the bad ones too...
  Post Number #31  
Old 14th August 2006, 04:17 PM
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Sidney Vianna

 
 
Total Posts: 8,671
Re: CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand

Quote:
In Reply to Parent Post by Bev D View Post

I wish it were only auditor...it han't even been one registrar or one industry, but time and time again...
Did you have any input on the registrar selection and auditor assignment in all of these cases?
  Post Number #32  
Old 14th August 2006, 04:35 PM
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Coury Ferguson

 
 
Total Posts: 4,460
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Quote:
In Reply to Parent Post by skappesser View Post

I am not understanding this seemingly insensitive reply from a moderator(?) Rezzi felt crushed enough to apologize for asking questions! Please someone tell me what am I missing?
I really don't think anyone needs to apologize, and I really don't think you are missing something. The point is that this is one of the most debated (CAPA) issues from Registrars and Companies. We all know that there are so many different opinions on this subject that I doubt that this would be conclusive. Kinda like Religion and Politics. Stay away from these topics.


Quote:
In Reply to Parent Post by skappesser View Post

People want to and need to learn. Does this forum and its moderators tolerate and cultivate youth and inexperience? Were we not all young once and asking elementary questions to build our knowledge?
That is why the cove is here to help people that might be lacking some of the practical experiences. Yes, we all were young at one point in our careers and have learned through asking "elementary questions." In my opinion.

Last edited by Coury Ferguson; 14th August 2006 at 05:21 PM.
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