Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion

i need a workable preventive action procedure.... i was written up from my last AS 9100 audit becaue I didn't seperate my Corrective Action & Preventive Action procedures out.
Can anyone help me with a sample procedure

Thanks
L. Redhage

a best defintion i found

not sure it was mentioned before...but i found Akio M's analogy of CAPA in the ASQ forum to be the best.....

Capa

The process map is good,however,we are still caught up in the mixup between corrective Action(CA) and preventine Action(PA):21CFR820.100
is very clear on this:CA=prevent reccurency of a problem(after the fact)PA=P revent occurence(before the fact).The two are different loops of the same Quality subsystem called CAPA.There is a little book entitled ,"How to Design a world-class CAPA system for FDA regulated industries",that best explains this.Containment is never preventive action,in my head anyway.
Hekins.

Larry Redhage said:

i need a workable preventive action procedure.... i was written up from my last AS 9100 audit becaue I didn't seperate my Corrective Action & Preventive Action procedures out.
Can anyone help me with a sample procedure

Click to expand...

I have just joined the forum. Is your problem solved or you are still in search of a preventive action procedure? I can help you there.

Tom Hekins said:

The process map is good,however,we are still caught up in the mixup between corrective Action(CA) and preventine Action(PA):21CFR820.100
is very clear on this:CA=prevent reccurency of a problem(after the fact)PA=P revent occurence(before the fact).The two are different loops of the same Quality subsystem called CAPA.There is a little book at www.lulu.com entitled ,"How to Design a world-class CAPA system for FDA regulated industries",that best explains this.Containment is never preventive action,in my head anyway.
Hekins.

Click to expand...

Corrective and preventive actions are two separate and independent processes. The term CAPA was used under old standard which had a single clause for both C&P actions. To understand the concept of these processes in the new standard, one should follow the following sequences:

Corrective action -
Observed nonconformity - Correction - Corrective action - Impact of corrective action.
Note - If needed from root-cause analysis some determined causes may be used for preventing potential nonconformity.

Preventive action -
Identification of potential problems - Preventive action.

Evaluation of effectiveness of actions taken is an integral part of both the processes.

Also see the Elsmar Cove Quality Assurance Glossary Wiki page for definitions.

The specific page is Preventive Action

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Hi guys. I've been swamped for months with major projects, effectively keeping me away from this forum. However, just a little while ago (1 hour or so) I received an E-Mail thru Elsmar from Dan Nelson, the author of the article I referenced in this thread, entitled "Correct Me If I'm Wrong".

He took offense at my comments and I'd like to publically apologize to him as I meant no harm. I simply used his article as a springboard regarding popular confusion over the definitions of correction and prevention.

I, in a 'tongue in cheek' manner (as I've been guilty of doing from time to time), answered his article title request, "Correct me if I'm Wrong", with the answer, 'I will because you are'. He said I was mistaken and suggested that others had already pointed that out to me. None had, so I appreciate his belated reproof.

He also found it difficult to believe that I consider myself a Quality Professional, let alone a Quality Director! I find it hard to believe myself sometimes.

Dan has not posted anything to this forum (other than the PM to me), so I hope this reaches him. Otherwise I'll have to go the simple route and reply to his E-Mail.

Actually, the main reason I wanted to post a reply was to get my number of total posts, on this June 6th of '06, off of the number 666. Phew!

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

I just reread the post you're referring to, and you have nothing to apologize for, imo. The point you were trying to make--that we "quality professionals" sometimes play fast and loose with the language--is well taken. Witness a recent discussion here regarding the concept of "suboptimization" wherein otherwise rational people believe that it's a good idea to refer to something that's operating exactly as is should as "suboptimal." Sometimes you just want to

I haven't read Nelson's article, nor do I have any immediate plans to do so, but I have a feeling his point has to do with the ISO definitions of corrective and preventive, which are stupid. If he's saying that you need to honor those definitions in order to be in harmony with ISO, then he's right, but if he's agreeing with those definitions...well...never mind.

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Jim Wynne said:

but I have a feeling his point has to do with the ISO definitions of corrective and preventive, which are stupid.

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I am so glad that we have this thread - A DEFINITIVE DISCUSSION - at least in the title. Over 11,000 views, 119 posts and (pardon me) no definitive conclusion. The ISO APG has a paper on preventive action.

But Jim, why do you think the definitions are stupid? Actually, imo, the definitions are straightforward. The application of preventive action is the problem, from my view point.

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Sidney Vianna said:

I am so glad that we have this thread - A DEFINITIVE DISCUSSION - at least in the title. Over 11,000 views, 119 posts and (pardon me) no definitive conclusion. The ISO APG has a paper on preventive action.

But Jim, why do you think the definitions are stupid? Actually, imo, the definitions are straightforward. The application of preventive action is the problem, from my view point.

Click to expand...

If the application is a problem, it's because an unnecessary dichotomy has been created. As Rob pointed out in this thread, the definitions put us in the position of having to avoid the word "preventive" when we're actively working to prevent bad things from happening. For instance, the actions taken to prevent nonconforming conditions from occurring aren't preventive action if they happen as a result of a nonconforming condition. It's preventive, but no, it's not preventive. The language is being tortured and not only does no one seem to care, a lot of people seem to delight in tightening the screws.