Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?

the corrective action triggers preventive. for example we have a 1/4 tube that had a test plug still in it when it went to the customer. we corrected this issue and applied corrective actions to ensure opportunity for error does not exist. We also have 1/2" and 3/8 tube that is tested the same way. We have never received a defect for it so we evaluate the other sizes to determine if the defect could occur with them and if so then we create actions to prevent the defect from ever happening. This is what we would call a preventive action because we never got a defect for those sizes but we dont want to wait until we do before we take action. this is how we have been using the preventive action process. When we have been doing true preventive action, we didnt document it as such in a standard form. we have emails or meeting minutes that describe the action needed and how we arrived at the need but no specific form to log it into and then run reports from. this will be an easy fix. no biggee. Our audit is done and I only got 4 cat 2 nonconformances. they are really easy to fix. yeah!!

There is no ISO requirement that a company must have one procedure for Corrective Actions and a second one for Preventive Actions. As a former Notified Body Auditor I saw both approaches and as long as the company is following their own procedure the Notified Body auditor cannot site you. You absolutely need to challenge him/her to show you where that is stated. If you need to go to a higher authority in the ranks of the Notified Body auditor.

Gary Waikle

Hello!
This is my first Post on Cove and I want to thanks everybody for all the posts and usefull information that I found here.

In our company there is one procedure for both.
About this thema I found on ISO site some Guidance made by ISO 9001 Auditing Practice Group and forAuditing Preventive Action is written :
" 2) Auditing Guidance

2.1) ISO 9001:2000 requires the organization to have a documented procedure for preventive action.

Note: The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important for the auditor to verify that the organization understands clearly the difference between the intent of corrective and preventive actions ".


Alin

Marc said:

This poll is over 5 years old (started in February 2003). Shall we close it or leave it open?

Click to expand...

Because of the length of time it's been open, I'm in favour of closing it, If someone wants to start a new poll, I'm sure that will happen. But given that other people are still posting, I may be in the minority!

qualityqueen1974 said:

the corrective action triggers preventive. for example we have a 1/4 tube that had a test plug still in it when it went to the customer. we corrected this issue and applied corrective actions to ensure opportunity for error does not exist. We also have 1/2" and 3/8 tube that is tested the same way. We have never received a defect for it so we evaluate the other sizes to determine if the defect could occur with them and if so then we create actions to prevent the defect from ever happening. This is what we would call a preventive action because we never got a defect for those sizes but we dont want to wait until we do before we take action. this is how we have been using the preventive action process. When we have been doing true preventive action, we didnt document it as such in a standard form. we have emails or meeting minutes that describe the action needed and how we arrived at the need but no specific form to log it into and then run reports from. this will be an easy fix. no biggee. Our audit is done and I only got 4 cat 2 nonconformances. they are really easy to fix. yeah!!

Click to expand...

Sorry for misinterpreting what you were saying. Many people would consider what you described (taking the same action on another process/product) as preventive action. In TS 16949, what you described is called "corrective action effectivity." I notice that you make a distinction between those actions and "true preventive action." I think this is really what is intended.

I agree with Jane - a new thread can always be started

Hello friends,
these are two seprate proceduers
corrective action is action taken to elimainte possible causes detected nonconfirmity.
preventive action is action taken to eliminate possible causes of potential nonconfirmity.

Marc said:

This poll is over 5 years old (started in February 2003). Shall we close it or leave it open?

Click to expand...

My vote is to leave it open so people keep posting their opinions and we are continually amused by the insanity promoted by the TC 176, when it comes to preventive action. Even though preventive action has a clear cut definition, it's application in the real world is most abstract. While the vast majority of effective quality management system requirements are preventive in nature, to this day, the TC 176 has not been able to CLEARLY explain what preventive action is, in addition to all the other preventive requirements contained in the ISO 9001 standard. They put out the Auditing Preventive Action paper (mentioned by the poster below) which still does not provide a definitive answer. For the TC 176 to fail to realize that we do have a problem with the application of PA, is a disgrace. And how do I know they fail to realize that? Simple. The upcoming 4th Edition of ISO 9001 is meant to be an amendment which brings clarifications to ISO 9001. There is no clarification being proposed to PA. Shameful, in my opinion. They either can not solve the PA mess they created, so they pretend there is no need for clarification or, more concerning, they are very out of touch with the actual users of the standard. And that is why I created the Should the TC 176 Re-word the Requirements for Preventive Action? poll.

Al Hector said:

About this thema I found on ISO site some Guidance made by ISO 9001 Auditing Practice Group and forAuditing Preventive Action is written :
" 2) Auditing Guidance

2.1) ISO 9001:2000 requires the organization to have a documented procedure for preventive action.

Note: The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important for the auditor to verify that the organization understands clearly the difference between the intent of corrective and preventive actions ".

Click to expand...

Alin, welcome to The Cove. I posted (above) the link to the paper you mentioned. One thing you have to understand is that this advice

The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended.

Click to expand...

comes from a "group" lead by a representative from a very large CB, which, at the outset of the ISO 9001:2000 release came out with a formal policy that organizations certified by them were mandated to have separate procedures for CA & PA. After a few months of backlash, they had to rescind that nonsensical policy.

sachinsdeokar said:

these are two seprate proceduers
corrective action is action taken to elimainte possible causes detected nonconfirmity.
preventive action is action taken to eliminate possible causes of potential nonconfirmity.

Click to expand...

Sorry, but that is incorrect. These are two separate DEFINITIONS. Not necessarily two separate procedures.

This thread has given lot of views why the CA and PA could be either one / two procedures and now after 5 years, I do not think anything new is coming from this thread. Posters are justing adding on to the already expressed views.

I am in favour of closing this thread.

Sidney wrote:

"Sorry, but that is incorrect. These are two separate DEFINITIONS. Not necessarily two separate procedures."

I don't think it is very clear. Even if they are combined into one procedure, how they are applied must be understood and in practice not mixed together. As I mentioned on an earlier post, I have a client that has combined them improperly. They only do corrective actions. They label them as "Corrective and Preventive Actions". To them, the preventive part is what they do to keep it from happening again. They make no effort to find or record anything they do about potential nonconformities. This is very dangerous. They refuse to do anything different. Since I'm a consultant there, I cannot write a nonconformance, and their 3rd party auditor hasn't caught it yet.

Here is the elements involved.

4.2.1 "The quality management system documentation shall include . . . documented procedures required by this international standard . . . NOTE 1 Where the term 'documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained."

This establishes that you need certain procedures. The required procedures are called out in the standard. Two of them are the ones this thread is about.

8.5.2 Corrective action . . . "A documented procedure shall be established to define requirments for . . ."

8.5.3 Preventive action . . . "A documented procedure shall be established to define requirments for . . ."

Combine the procedures if you wish, but do it properly and make sure you address both actions you perform to prevent recurrence and actions you perform to prevent occurance. I much prefer to not combine them and cut the potential for misapplication.