Is a Procedure required for Corrective, Preventive, and Non Conformities

I was wondering if I had to make a specific procedure for each thing.

Bit of Background: I am working on creating a new Q.A. Department for my company which only offers, services (Human resources, I.T., Accounting, Customs, and Operations) To companies opening up in Mexico form the USA.

We do not have any sort of QMS in place and I am working on writing all the Quality Procedures and I was looking if we had to write a separate procedure for each or can they all be combined?

And does anyone have examples of Procedures for these three ISO Requirements?

Re: Corrective, Preventive, and Non Conformities

Welcome to The Cove!

While ISO 9001:2008 requires those procedures, there is no requirement that they be separate documents, if that's what you mean. Combining the Corrective Action and Preventive Action procedures is a rather common practice with many companies. My company, while we have separate procedures, uses one form for both reports (either/or). A simple check box indicates if it's CA or PA.

I, personally, would not want to lump a Non-Con procedure in with those two, but there's no reason it cannot be done.

Good luck.

Re: Corrective, Preventive, and Non Conformities

I agree with what Paul said. We combine the CA/PA on one form, and have a separate procedure for non-conformances.

Re: Corrective, Preventive, and Non Conformities

PaulJSmith said:

I, personally, would not want to lump a Non-Con procedure in with those two, but there's no reason it cannot be done.

Good luck.

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I have one! By combining NCP and CA you confuse people. NCP should "feed" the need for data analysis and hence CA. You force an often missed step. Some NCP just needs a disposition. Fix it, scrap it, regrade it, whatever. But by combining the two procedures, I guarantee you will make people think all instances of NCP require CA...

Ahh, Okay.

The way I was writing the Procedure was by having 2 forms. A Non-Conformity form which will have the requester and the person responsible fill out the immediate action and the corrective action plan.

If they did not complete there plan in the time they said they would, it would go to a Improvement action (CAR) which will require them to find the Root cause and and define the actions in more detail and ensure they meet the goal.

Then Im not sure what should be in the two procedures, or at least the NC procedure?

Re: Corrective, Preventive, and Non Conformities

AndyN said:

I have one! By combining NCP and CA you confuse people. NCP should "feed" the need for data analysis and hence CA. You force an often missed step. Some NCP just needs a disposition. Fix it, scrap it, regrade it, whatever. But by combining the two procedures, I guarantee you will make people think all instances of NCP require CA...

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That's why I said "cannot." From the viewpoint of the Standard, it's not prohibited. That, of course, doesn't mean it's a good idea ... which, like you, I believe it is not.

Re: Corrective, Preventive, and Non Conformities

AndyN said:

I have one! By combining NCP and CA you confuse people. NCP should "feed" the need for data analysis and hence CA. You force an often missed step. Some NCP just needs a disposition. Fix it, scrap it, regrade it, whatever. But by combining the two procedures, I guarantee you will make people think all instances of NCP require CA...

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What should be in the procedure of a NC then?

View attachment Control of Nonconformities and Corrective actions.doc This is what i have so far

Javiddemexico said:

View attachment 17441 This is what i have so far

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The standard calls for a documented procedure to address each of the three requirements (clauses 8.3, 8.5.2, and 8.5.3). Good thing is that the standard does not tell you how to do this. My approach is to prepare process maps or flow charts depicting first, the source, description and controls (8.3) with defined procedure steps for initial problem reporting actions through correction/recovery and disposition decisions recorded. Not every single occurrence of nonconformity requires analysis therefore after the problem reporting processes there's a diamond in the flow chart depicting a decision point: CA needed? (Y or N). If N, then the rationale for closure based on correction or significance is entered on the source report and the process stops there. If Y, then a CAR is generated and the analysis, corrective actions and follow up procedure steps are followed. A final decision point in the process charts is a diamond depicting if an opportunity for preventive action exists based on a review of the causes that have been recorded. If Y, then a PAR is generated and the procedure for evaluating, defining and removing potential causes is followed. This end-to-end approach for problem solving can be applied appropriately to anysituation and for any type of business. The form you have is not a very good start in understanding all of the logical sequences and interactions in a typical problem solving scenario...Good luck.

Del Foster said:

My approach is to prepare process maps or flow charts ...

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Do you by chance happen to have one that you could post here? I'm getting beaten-up on my ISO-14001 CA/PA procedure that is 'missing some elements' even though it is almost a clone of our ISO-9001 CA/PA procedure.