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

[Tadek]

In my opinion:
One document can cover two processes: corrective and preventive actions.

Who is a customer of your procedure - auditor or your organisation and personel?

Rules:
#1 Auditor is allways right
#2 If auditor is wrong:
a) reread #1 or
b) discus with auditor about written requirements (ISO9001, ISO/TS) - if you
have a good knowledge about requirements; do not discus after audit
process!

 

[JaneB]

In my opinion:
Rules:
#1 Auditor is allways right

No, they are not. And good, professional auditors won't insist on this. They will welcome debate and discussion on the relevant section/s of the Standard and they will want to see reasonable evidence that it is being met. And be open-minded and fair.

We should never just accept blindly the 'Auditor is always right' view. (I've had some very lively encounters & debates with auditors who held that viewpoint.)

 

[rstaz]

Thought I'd throw my

We have one procedure that covers both Corrective and Preventive actions. However, we do make a distinction between the two in the following ways.

• 
  We hold an MRB meeting every other week. In this meeting, we discuss all Corrective actions. (Many times the Corrective actions stem from NCMR)

• 
  We hold a "Continuous Improvement" meeting once a month. In this meeting, we discuss Preventive actions.

• 
  During Management Reviews, we are careful to separate out the Corrective and Preventative Actions.

Hope this helps...

 

[winchm]

I agree with Jane and Renae - I have one procedure for both which is acceptable for ISO9001 - it may not be for Aerospace, Telecommunications, Medical, etc. If you go to www.tc176.org/FAQ.asp and click on SC2 link you will find some excellent information. I'm attaching two items from the link.

 

[somerqc]

I am currently addressing findings and recommendations from our pre-assessment audit for ISO 9001:2000. The auditor and I had a long discussion about this very subject. He presented a very different approach (management friendly possibly).

He concedes that most managers (especially upper levels) won't be open to documenting strict preventative actions. He suggested separating the corrective and preventative action procedures (they started as 2, went to 1, now going back to 2). He recommended and more "open" prevenative action procedure that doesn't require the use of a strict form when conducting preventative actions. This does not exempt us from requiring documentation as objective evidence..however makes it much easier to have documentation (at least for us.).

Due to the nature of our business, we are conducting preventative action on a daily if not weekly basis. I am in the process of ensuring that these incidences are documented so we can present our actions to the auditor.

During the pre-assessment, I showed him one large example (major project we completed for one of our largest clients) of how we took actions to PREVENT possible failure on our part and ensuring customer satisfaction. He loved it. Furthermore, when I presented this to management, they understood it and embraced it. It basically allows them to not change how they do things (they do need to document more) yet we address one of the major requirements of the standard.

Has anyone else been presented with this type of approach?

 

[cheryl mcguire - 2008]

I have one procedure. I have a seperate form to document CAR from PAR.
I am a believer the less procedures the better.

 

[CarolX]

IHas anyone else been presented with this type of approach?

Absolutley - one of the biggest reasons that I place PA in a seperate procedure is that many activities are PA in nature - calibration, preventive maintainence, FEMA activities, etc.

My thoughts are that everyone does a lot in this arena - they just don't identify it as PA.

 

[katschance]

I am very new and can not find your attachments. I am OVERWHELMED with the whole ISO situation.
Kathy

 

[winchm]

Here's some info from Whittington's Newsletter. I suggest using a process turtle to start the document process. A documented form is not a requirement, but you may have processes that you use to initiate preventive action, e.g. Design Review, FEMA (see attached from Whittington Newsletter). You may refer to existing processes that may have forms (Calibration, ESD Logs, PM audits, Internal Audits and an employee incentive form like a Suggestion Box). There's a lot of good suggestions here - it's what works for them. Do what works for you. Somerqc's approach got him a thumbs up from assessor without using a form - all he has to do now is to describe the method he used in the PA Procedure. If it's CA & PA is up to you - just know the difference. Don't be overwhelmed - 2000 ISO is a piece of cake compared to 1994 version.

 

[Helmut Jilling]

....He loved it. ...

Furthermore, when I presented this to management, they understood it and embraced it. It basically allows them to not change how they do things (they do need to document more) yet we address one of the major requirements of the standard.

Has anyone else been presented with this type of approach?

I think that may be the key part of your post. If the approach is compliant, and top management embraces it - that is the intersection of two items that you want. That would seem to be the better approach.