CAPA (Corrective Action Preventive Action) Procedures Separate or Combined

R

RJFisher

Anybody had any experience having these as separate procedures? From what I can gather from the cove and other resources, most companies combine them into one procedure, but we are finding that ours may be lacking something by doing that.

We are considering separating them into the two required procedures so as to get better service out of them.

Any ideas?
 

harry

Trusted Information Resource
Re: CAPA Procedures Separate or Combined

This issue had been extensively debated before. The conclusion was it's up to you.

From a region where English is the second or third language and to reduce the confusion of corrective/preventive actions, we normally opt for 2 procedures.
 

Marc

Fully vaccinated are you?
Leader
Re: CAPA Procedures Separate or Combined

This issue had been extensively debated before. The conclusion was it's up to you.

From a region where English is the second or third language and to reduce the confusion of corrective/preventive actions, we normally opt for 2 procedures.
Thanks! Good summary.

Also see:
Corrective and Preventive Action - One Procedure or Two?
Is a separate Corrective & Preventive Action procedure necessary?
Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?
 
A

arios

I know a lot has been said on this subject, so I apologize for adding one more comment to the same topic.

I see still several companies struggling with the concept of Preventive Action. This requirement was brought since ISO 9001:1994 and for some reason and after 15 years there seems to be still some reluctancy to prevention. Maybe management sometimes feel that it is waste of money to invest on a project for a problem which has not yet occurred, so the concept of Preventive Action is left behind.

My recommendation is to have two procedures to promote further use of the P.A. concept and avoid confusion with C.A. :yes:
 

Marc

Fully vaccinated are you?
Leader
Preventive action has been an important part of any corrective action system for many years. What *does* throw people is preventive vs. predictive action.
 

Sidney Vianna

Post Responsibly
Leader
Admin
I see still several companies struggling with the concept of Preventive Action. This requirement was brought since ISO 9001:1994 and for some reason and after 15 years there seems to be still some reluctancy to prevention.
We can always beat a dead horse a little more...
thsmiley_deadhorse.gif

I don't believe organizations (in general) are reluctant to emphasize prevention over correction. But let's remember that 90% + of a quality system is designed to PREVENT problems, to start with.

I still believe that the TC 176 missed the boat (BIG TIME) with the 2008 Edition of ISO 9001. After all, the amendment was supposed to clarify the unclear parts of 9001:2000. What did they do about clarifying preventive actions? zilch!
Should the TC 176 Re-word the Requirements for Preventive Action?
 

Peter Fraser

Trusted Information Resource
Preventive action has been an important part of any corrective action system for many years. What *does* throw people is preventive vs. predictive action.

Marc

I reckon that the main cause is the wording "A documented procedure shall be established..". This seems to make lots of folk think that they must describe what they do in a single document - when in fact preventive action is (or should be) taken when you recruit a new member of staff, allocate someone to work on a job, take an order from a customer, select a supplier, or take more or less any decision about what you do and how you do it. Do you think that TC176 sees it that way?
 
P

prashantb

Hello ,

Do you have CAPA Effectivness Report format , also its related procedure, (related with ISO 9000:2008) I apprecuate your help.
 

Raffy

Quite Involved in Discussions
Hi,
Before we used to have two procedures for corrective and preventive action. Then, we merged it into one, as our Corrective and Preventive Action Process was incorporated in the 8D Process. We have the Corrective and Preventive Action requirements embedded in the 8D. So far, we don't have any problem using it.
Every company has a unique way of addressing the requirement. Whether its one or two procedures, it should fit the company needs.
Raffy :cool:
 
S

sixsigmais

It doesnt matter you have one or two procedure, as long as you are implementing both the CA and PA. The only concern is which is better and easy for you to run your system, just use it.
 
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