Hello to all from a newcomer to ISO and the list.

ISO 9001:2000 Clause 8.5.2 states we must have documented Preventive (PA) and Corrective Action (CA) procedures. Does this necessarily mean they have to be separate from our other process procedures?

I ask because, when I start to write the PA and CR procedure (we've decided to combine them), I find we're duplicating everything that is in the individual procedures for every process we've got. With over 20 processes within the company, each with different forms, methods, reviewers, etc - it would be a nightmare to ensure they correlate correctly.

If a separate PA and CR procedure is necessary, can't we just, for example, have a flowchart that says "Identify nonconformance - document it - investigate it - fix it" with a corresponding flow for looking at data for PA, flowing it to our Continual Improvement Board, then to Management Review?

Many thanks,
Christine

Hello to all from a newcomer to ISO and the list.

ISO 9001:2000 Clause 8.5.2 states we must have documented Preventive (PA) and Corrective Action (CA) procedures. Does this necessarily mean they have to be separate from our other process procedures?

I ask because, when I start to write the PA and CR procedure (we've decided to combine them), I find we're duplicating everything that is in the individual procedures for every process we've got. With over 20 processes within the company, each with different forms, methods, reviewers, etc - it would be a nightmare to ensure they correlate correctly.

If a separate PA and CR procedure is necessary, can't we just, for example, have a flowchart that says "Identify nonconformance - document it - investigate it - fix it" with a corresponding flow for looking at data for PA, flowing it to our Continual Improvement Board, then to Management Review?

Many thanks,
Christine
Yes you can combine the two. We currently have seperate procedures, however we are probably going to combine them within the next year.

Christine,

Check out the following thread for more discussion.

Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures? (http://elsmar.com/Forums/showthread.php?t=5985)

:bigwave:
Bill

Christine, Welcome to the Cove! :bigwave:

Follow Bill's link. I think you will find your answer there.

Thanks for responding, Russ and Bill.

I have read everything in the CAPA forum, but I still don't know if a separate procedure really necessary", since all our procedures already have their instructions for carrying out CA & PA action, with associated records.

BTW... We don't have a separate Continual Improvement procedure, but cover all the inputs to the process and its outputs (such as PA & CA) in a flowchart in our quality manual, which then links to Management Review, back to processes, and so on in a loop.

Christine

Christine,

We have two procedures. However, because they are computer network and hyperlinked to each other to the end user they apear as one when they enter the business management system.

If you want to come over and take a look give me a call, your more than welcome.

We have one procedure, but the are addressed seperately within the procedure itself. No problems during my audits with having them combined. :)

We have one procedure and one form to cover CAPA and have been through several audits without any problems.

We also combined our document control and record control into one procedure, but that's a seperate thread.:p

Basically you can design your procedures however you choose as long as you address the basic requirements.

By the way, welcome to the cove :bigwave:

Hi Christine,
Welcome to the Cove!
CarolX

Hello and welcome Christine,

We have two procedures. My preventive action procedure basically is a declaration that we take proactive measures rather than reactive, and we accomplish that through the utilization of SPC charting where we avoid unacceptable conditions prior to them going out or trending out.

Also states that we use APQP and FMEA which are tools to identify potential problems "before" they can occur.

Our corrective action procedure is basically a flow chart of our 8D system.

It is pretty easy. But my opinion (for whatever it is worth) is that you should handle these two things seperately.

Sincerely,
Fox

I started out with one procedure document covering both corrective and preventive action. In an oversite I missed calling out one of the criteria for the preventive action portion. I was called on it by our external auditor. He said it could remain one but just make sure it is written to cover both paths. I decided to split the procedures for ease of auditing and explaining.