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

I also prefer two procedures. I also prefer two forms. All too often I find companies that have so bady tangled the two that preventive actions are completely misunderstood.

One company I call on has the two combined and they call it "Corrective and Preventive Action". Their understanding is that the preventive part is what you do to a corrective action to prevent it from happening again. They have no other concept about preventive actions.

It should be remembered that corrective actions are to eliminate the cause of nonconformities in order to prevent recurrance. Preventive actions are to eliminate the causes of potential nonconformities in order to prevent their occurance.

Big Jim said:

I also prefer two procedures. I also prefer two forms. All too often I find companies that have so bady tangled the two that preventive actions are completely misunderstood.

Click to expand...

I think having two documents is a good thing if it helps people to understand that there must be preventive action exclusive of the CA system.

Big Jim said:

It should be remembered that corrective actions are to eliminate the cause of nonconformities in order to prevent recurrance. Preventive actions are to eliminate the causes of potential nonconformities in order to prevent their occurance.

Click to expand...

Recurrence is occurrence.

Susan, welcome to the Elsmar Cove.

As i mentioned previously ISO 9001:2000 or ISO9001:2008 Draft, it does not specify CA/PA how many procedures you need, its entirely up to your organisation needs, and yes there will always be an argumentive/opinion for one or two procedures and that is good because its someone opinion.

I am a QMS/OHS consultant in Australia and I have developed several QMS for various organisations. One company specifically I have developed Control of Nonconforming product/Corrective action in one procedure and for this company it suits their needs.

However as for the auditor, he gave you an OFI for one procedure? In my opinion the auditor is being subjective, and not auditing the fact against the standard. I would ask the auditor to show you, where in the Standard it specifies how many procedures you need. Also as a lead auditor myself, Auditors opinions sometime are very good as Helmut mentioned it makes you look at a problems from another angle.

Just for the purpose of an exersice, why not use the 5 Why's Quality Tool to detemine how many procedures you need for CA/PA and see what answer your organisation comes up with?

ps: Well done with your accreditation.

Robert



-----------------------------------------------------------------------

"In my opinion the auditor is beign subjective, and not auditing the fact. I would ask the auditor to show you, where in the Standard specifies how many procedures you need. The Auditor needs to stick to the facts."

His claim was that the standard explains CA/PA separately. Also, that both 8.5.2 and 8.5.3 calls for a documented procedure. I was quite surprised by this. I almost felt like if he didn't find something he wasn't doing his job. However, it seems that there are strong opinions for both sides. I feel that the way we have our procedure set up works well for us. We're a very small company (20 employees) so there aren't tons of CARs and PARs pouring into my office on a daily basis. I just want to do what's right by the standard.

Thank you all for the kind words!

reaganmom said:

His claim was that the standard explains CA/PA separately. Also, that both 8.5.2 and 8.5.3 calls for a documented procedure. I was quite surprised by this. I almost felt like if he didn't find something he wasn't doing his job. However, it seems that there are strong opinions for both sides. I feel that the way we have our procedure set up works well for us. We're a very small company (20 employees) so there aren't tons of CARs and PARs pouring into my office on a daily basis. I just want to do what's right by the standard.

Click to expand...

Perhaps you could remind him that a "procedure" is just "a specified way to carry out an activity" - so that you can (if you can justify it in relation to your own business) specify your "method" in only one place and refer to it more than once, or (as is the case with PA) you can define it as a step in every process where it takes place (such as processing a sales enquiry, purchasing or sub-contracting, recruiting a new member of staff, designing a new product, management review, internal audit).

PA does not need to be described in a single "document" or even in part of one document. If you are managing your processes well, you are taking PA every time you spot the potential for something to go wrong, and take action to avoid it) in any of the processes. Tell him to forget the standard for 5 minutes and look at how you run the business!

Folks,
Note that the wording in the DIS ISO 2001:2008 allows flexibility in combining documented procedures. Please visit https://www.squidoo.com/iso90012008changes to get more details of what changes to expect.

Regardless of whether you use one procedure or two, one must understand the definition and intent of "corrective action" and "preventive action" to implement it correctly. There are clear ISO interpretation and guidance documents on this.

Many company QA Managers and Registrar auditors just don't get it.

Regards,
Art

Susan

You are right in saying, if an Auditor cannot find any Action Request (Non-conformances), they will raise one or two just to justify their actions and this sounds like one.

If this is the case, tackle the issue like I always done over the years, work with the auditor and get him to look at areas/department where you know there are issues that you cannot fix.

It does not matter how many times you try, in every organisation there is always someone or a department that argues the point against the QMS and never comes to the party, by working with the auditor he or she will appreciate the suggestion and this way you will fix your issues/area of concern.

ps: By receiving 5 or 6 justifiable Action Requests will continually Improve your QMS.

Robert

reaganmom said:

His claim was that the standard explains CA/PA separately. Also, that both 8.5.2 and 8.5.3 calls for a documented procedure.

Click to expand...

Your auditor IS auditing based on his opinion, and not on facts. He has some things right: yes, they are two separate types of action & yes they are itemised in 2 separate clauses and yes, both clauses call for a documented procedure. But his conclusion is erroneous.

1. He is definitely not right that this must mean 2 separate procedures and
2. He is either unaware of or not keeping up with the changes in the new version of ISO 9001 due out on time later this year (October).

See this Note (italics mine):

You'll see that this Draft (not yet released) version has specifically included that Note, presumably to make it clear to obstinate people (including auditors) who think this 'must' mean 2 separate procedures! No, it does not.

And you're right that some people in the Cove have quite strongly held opinions about whether CA and PA should/should not be 2 separate procedures.

I'm with you: if the way we have our procedure set up works well for you, and you can demonstrate this, and show that yes, you're aware of the difference and that it's being done, then you keep doing it your way! It often makes little sense in a small organisation to have two. But key point = it's your system, not your auditors.

The Standard is about good practice, not rigid rule.

Jim Wynne said:

I think having two documents is a good thing if it helps people to understand that there must be preventive action exclusive of the CA system.


Recurrence is occurrence.

Click to expand...

The two terms, recurrence and occurrence, are not fully mutually inclusive. The fact that both are needed is clearly called out in the standard.

JaneB said:

...I'm with you: if the way we have our procedure set up works well for you, and you can demonstrate this, and show that yes, you're aware of the difference and that it's being done, then you keep doing it your way! It often makes little sense in a small organisation to have two. But key point = it's your system, not your auditors.

The Standard is about good practice, not rigid rule.

Click to expand...

...I thirdly emotion…