CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand

[Bev D]

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

Umm, you did a nice job of describing the ISO definition accurately. Why then, would you develop an alternate definition that does not comply with that definition?

If ISO defines it pretty clearly (just as you described) then I as an ISO auditor am supposed to assess whether you are doing those things? Where is the "Whammo?"

Well, if you read the posts carefully I wasn't saying that *I* personally woudl have a different interpretation - but responders previously to me including the original post supplied the different interpretations. You as anuditor would hol dthese individuals to the standard (as you said) and would issue findings. THIS is where the 'out of hand' stuff comes from (in my opinion from reading a thousand posts on the topic.) Some peopel jsut want to improve things no matter what you call them: correction, corrective action or preventive action. Unfortunately those people who don't worry about strict definitions and compliance also find themselves trying to get registered adn then the definition matters - only they dont' get it. That's the whammo! They think they are doing the right thing, but they're not exactly per the standard. reread the first posting...

 

[Rezzi]

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!!!

Dear Greg,
I'm so sorry. Its all my fault to start this thread. Is it possible to take this thread back. I was trying to express my dislike of "I'm right-you're wrong" kind of discussions but appearantly I wasn't aware of that I actually have contributed to one more so please if you are abale as a moderator to stop this tread pls do so.

 

[CarolX]

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

Dear Greg,
I'm so sorry. Its all my fault to start this thread. Is it possible to take this thread back. I was trying to express my dislike of "I'm right-you're wrong" kind of discussions but appearantly I wasn't aware of that I actually have contributed to one more so please if you are abale as a moderator to stop this tread pls do so.

Rezzi -

I will jump in on Greg's behalf for the time being.

Please - do not appologize for starting this thread. As you can see, it is a hot topic, and I think that some really good discussions have bee had in this thread.

You have a valid point about the "I'm right - you're wrong" discussions that have prevailed in the past - that it really shouldn't matter - but most of us come from companies that have, at least, implemented 9K2K - and there is a significant difference between the two subjects in the standard. If a newbie comes here looking for information on how to satisfy the standard, we must address them as two seperate subjects. That is one of the reasons that ca and pa have seperate boards here at the Cove.

 

[Sidney Vianna]

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

Some peopel jsut want to improve things no matter what you call them: correction, corrective action or preventive action.

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.

On the preventive side, does anybody disagree that, in the perfect World, we would have 100% preventive action and 0% corrective action? Does anybody disagree that preventing a problem from happening altogether is way better than preventing it's recurrence? Still, by and large, the mind set out there is: If ain't broke don't fix it. So, imo, this discussion is very valid and is is NOT a semantics issue. It is a mind-set and cultural issue.

 

[skappesser]

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...

 

[David Hartman]

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.

 

[skappesser]

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?

 

[Bev D]

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

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.

 

[Sidney Vianna]

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

*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

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!

 

[Bev D]

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...