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

R

Rezzi

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.

There are a trillion of different products for different purposes regulated under the ISO standards and regulations.

The manufacturing companies are of different culture, training, size and resources.

Therefore I cant see the possibility of only one single "correct" interpretation of the CAPA.

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.
 

CarolX

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

Hi Rezzi,

You do have a point. But, look at it this way. The reason there is so much discussion is because folks are learning the subject matter.

Here at the Cove, a LOT of people come here that have little or no experience in the Quality field, mostly because they are young and are new to their jobs or assignments. A lot of questions are asked, sometimes over and over again. But that is what this site is about....People helping People.

Often, the confusion is what is "preventive action". And, of course since we have over 5000 regular users, we have a variety of opinions and ideas, so often the discussions become long and drawn out. It's just the nature of the site.
 

Randy

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

CA...If it breaks fix it and fix it in a way to keep it from breaking again due to the original cause.

PA...If it looks like it might break find out why and fix it so it doesn't.

What's so hard to understand?:confused:
 

Peter Fraser

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

Randy said:
CA...If it breaks fix it and fix it in a way to keep it from breaking again due to the original cause.

PA...If it looks like it might break find out why and fix it so it doesn't.

What's so hard to understand?:confused:

Randy

Well said. What is so hard to understand is the ISO words - they obviously aren't clear since there is so much confusion and debate. So they need to be changed.
 
S

skappesser

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

Ah - there's the rub! A RAB certified ISO auditor once told me that a CA is a PA in that once it is in place and effective it inherently prevents recurrance...he picked that mindset up from an audit he did at a company in Dubai.
 
C

Craig H.

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

skappesser said:
Ah - there's the rub! A RAB certified ISO auditor once told me that a CA is a PA in that once it is in place and effective it inherently prevents recurrance...he picked that mindset up from an audit he did at a company in Dubai.

Yes, and you can apply a CA to one process in response to a problem, but then apply the same action to similar processes to keep the problem from happening, making what was just a pure CA a hybrid CA/PA.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Rezzi said:
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.
Negative:nope: . 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.
 

Peter Fraser

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

Sidney Vianna said:
Negative:nope: . 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.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: CAPA (Corrective and Preventive Action) discussions getting out of hand

Peter Fraser said:
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:
Top Bottom