ISO 9001:2000 Preventive Action Procedure: Seeking examples

Shortly after I found this great forum (better late than never – I just wished I had done so sooner) I posted the list of procedures I had identified and wondered if I had too many. At the time, I had 24, and now, happy to say, I am all the way down to 23! Anyway, 15 have been written, six are in process, and two remain to be started. I’m happy with the progress.

The one with which I have been wrestling the most, something that I did not anticipate, is Preventive Action. I know it probably will be short, but I am having a difficulty ‘getting my arms around it’.

I searched here and found several discussions about it, but the perception of what the procedure should encompass, what it should address, and how it may best be worded are as varied as there were contributors discussing it. If it is not too much to ask, could a couple of you, sympathetic contributors, post example of some of the wording for this procedure, or the approach you followed in writing it? I am not asking that the entire procedure to be posted; just perhaps a portion or an outline would be OK?

Thanks!

Alex

Example of procedure for preventive action

Alex,

I hope this helps.

Preventive Action

Preventive Actions are documented on the Corrective Action form. Inputs for preventive actions may be internal audits, customer audits, customer concessions, non-conformities, customer complaints or improvements.

The QA Manager and President have the authority to initiate and discuss potential problems that may be occurring in order to minimize the impact on production. The steps required to perform the preventive action are detailed. The QA Manager reviews and follows up preventive actions to ensure they have been effectively implemented.

Corrective and preventive action records are documented using the Corrective Action Request, maintained by the QA Manager and discussed at the management review.


Danny

Alex,

IMHO: This thread will probably turn nasty as ALL of the previous threads on this topic have. You have obviously done a search and know what to expect. This will deteriorate into a Push or Pull?, Chicken or the Egg? type of argument but I hope that the moderators stop it and allow people to let there contributions be accepted.

Now to the question at hand:
I have listed below three definitions from my old CAPA procedure (it will soon become a porocess chart with minimal wording). I have only one procedure and it basically deals with the use of Corrective & Preventative Action Reports (CARs). We call them Quality Reports.

Preventative Action Plan (PAP): Measures taken to ensure that conditions and the potential non-conformity, which have created quality problems, are eliminated or rectified so that they will not recur in the future.

Corrective Action (CA): Requirement to immediately rectify the result of existing problems.

Preventative Action (PA): Implement change to prevent or minimise recurrence of the problem identified and is intended to prevent problems from occurring in the first place.

Hope this helps some

Greg B

I agree with both Danny and Greg on their definitions and comments. They are consistent with how I have always thought of corrective and preventative action.

The only addition I would make is that all complaints, nonconformances etc. would require a corrective action but possibly not a preventative action. It could be that the problem was an isolated incident and doing nothing more is sufficient. If one takes preventative action on every incident it would be equivalent to reacting to an outlier on a control chart. Obviously, it would be necessary to assess what caused the problem before deciding what additional action is required.

Bill

Hello all,
I perfectly agree with all of the above. We have addressed these issues in a single procedure titled "Improvement". In actual fact we addressed clause 8.5 Improvement (ISO 9001:2000). What is called a CAR we call an NCR "non conformance report", it's a one page report allowing for any corrective action as well as preventive action to be recorded.

1.0 Purpose

The purpose of this procedure is to define the methods used within JB Plastics Ltd., to instigate and supervise the continual improvement, corrective and preventive actions agreed when improvements are identified and a non-compliance is detected during audit and the inspection and test process on the product or the environment.
2.0 Scope

The requirements of this procedure shall be applied to:
- All processes, products and areas (stores, perimeter road etc..) at all times;
- All activities from the receipt of the raw materials, through the processing and despatch;
- Receipt of customer complaints;
- Non-conformance found at any stage in the procedure;
- Non-compliance found during an internal audit.......................................
7.0 Records

Records of all Corrective and Preventive Actions implemented and checks carried out to check their effectiveness shall be maintained as required by the company procedure QMS 1042.

Thanks guys,

That gives enough to get my Preventive Action procedure off the 'stalled' mode.

Alex

My opinion

3.6.4
preventive action
action to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action (3.6.5) is taken to prevent recurrence.

3.6.5
corrective action
action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation
NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.6.4) is taken to prevent occurrence.
NOTE 3 There is a distinction between correction (3.6.6) and corrective action.

3.6.6
correction
action to eliminate a detected nonconformity (3.6.2)
NOTE 1 A correction can be made in conjunction with a corrective action (3.6.5).
NOTE 2 A correction can be, for example, rework (3.6.7) or regrade (3.6.8).



Although I agree that these two functions can be addressed in one procedure, and yes CA can lead to Preventative Action, I have always been one to believe that preventative action stems from a positive empoyee suggestion/feedback system. True preventative action can only be initiated by those who perform the specific functions. I prefer to think of preventative action as "employee suggestions" to improve the process and identify a problem before it happens. These employees may stretch into the management system as well, be it a process engineer, technical writer, supervisor, etc.
Granted a CA may lead to a Preventative Action, but I interpret the intent of the mandate to set up a procedure to allow those who use the system to provide suggestions and identify problems before they happen.
I personally consider it two procduredes, with CA linked to PA if required.
Just my opinion!!. I firmly believe that as long as you have a system in place for employee suggestions which emphasizes preventative action, no matter which procedure it is in, you have fulfilled the intent of the requirement.
Once again, just my opinion.

Hi Alex,

Aaahhh...the dreaded PA....not really so bad.
Take a look at the PA board here
https://www.elsmar.com/Forums/forumdisplay.php?f=41
Lots of great examples, advice and real life situations to chew over.

Regards,
CarolX