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

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

Sidney Vianna said:

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.

Click to expand...

Perhaps it is?

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

Peter Fraser said:

Perhaps it is?

Click to expand...

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.....?

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

Rezzi said:

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.

Click to expand...

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.

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!!!

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.

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

Laura M said:

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.

Click to expand...

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.

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

Bev D said:

...

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.

Click to expand...

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?"

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

hjilling said:

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.

Click to expand...

I agree - but what I was saying is write the PA procedure to reflect preventive measures already in place. The recommended action part of the PFMEA and completed of the action meets all the requirements of PA.

Taking action on SPC charts that are drifting is also PA.

So do you need a form that looks like a CAR form? Or just describe and have evidence of preventive action. That was my point.

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

Laura M said:

I agree - but what I was saying is write the PA procedure to reflect preventive measures already in place. The recommended action part of the PFMEA and completed of the action meets all the requirements of PA.

Taking action on SPC charts that are drifting is also PA.

So do you need a form that looks like a CAR form? Or just describe and have evidence of preventive action. That was my point.

Click to expand...

I understood your comment, and sure, all of these things are preventive in nature. So is preventive maintenance, and calibration. But, if that is what they intended your answer to be, why would they have given it its own clause section?

The way they describe it obviously asks for preemptive corrective actions. Determine where potential failures lie, and do a corrective style action PREEMPTIVELY. Therefore they called it PREventive action, in the same format as corrective action. Why make it something different?

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

I'm just saying that you don't need to fill out a preventive action 'form' to have evidence of meeting the preventive action requirements.