Corrective Action and Preventive Action clauses - ISO 9001 - Corrective Action

[Ace]

I need some advice petaining to the ISO 9001:1994 Corrective Preventive Action clause.

First - some background information.

We recently endured our registration surveillance audit and had a non-conformance identified with our customer concern process.

Although our database files identified root cause, CA, & PA, the auditor stated we had a non-conformance because our notes were not detailed enough. For example - we had a pc board returned by a customer and after our analysis found it had a hard failure.

The database was documented to show root cause as: Hard Failure
Corrective Action: Replace PC board
Preventive Action: Go thru inventory, retest, and purge per established documentation.

My questions are:

1. Is there an ISO requirement that mandates how detailed our documentation should be?

2. Would I be justified in challenging this non-conformance issued by the auditor?

Thanks in advance for any advice provided.

Redolpho (ACE)

[Laura M]

I would be looking for the documentation to show what caused the hard failure. The information you gave would be all corrective to me - and really all 1st step of corrective which basically establishes the scope of the problem. Corrective action should address why it was a hard failure. Preventive gets alot of discussion in other threads, but I always look at if there was something else to be learned from the failure that hasn't happened yet - possibly on another product line. Or maybe you determine there were 4 potential root causes. If you implement changes to address all 4, then 3 are "preventive" because they haven't happend yet.

In answer to your direct question:
1 - No
2 - No

I believe that the nonconformance as issued as "not detailed" enough could be challanged.

What I would not agree with is the content of the answers for correcive and preventive action.

Maybe if you posted the root cause to the cove we might be better able to help.

[David Mullins]

1. You haven't stated the dispositioning of the failed board.

2. checking your inventory goes a VERY small way in terms of preventive action. PREVENT - prevent it happening again, reduce the likelihood of it happening again, decide that this is an acceptable failure rate as it is technologically and financially not feasible to improve.

3. At the moment you're looking for a lazy (non-quality) exit - are you a manaufacturing manager?

PS - Who cares if it's ISO if it makes good sense!

[Ace]

Dave,

Apparently you missed the bottom line to my inquiry. I wasn't writing in to get lectured on ISO's terms and definitions.

Simply stated, we complied with our documentation in stating root cause, CA & PA on our database records. I was inquiring if there was any ISO requirement dictating how specific we had to be with the amount of details we record on our records.

My job title has no bearing on the question at hand and I certainly didn't appreciate your personal remarks. If you can't keep it professional, why bother responding.

Go have yourself a great day!!!!!

Rodolfo

[David Mullins]

Originally posted by Ace
Apparently you missed the bottom line to my inquiry. I wasn't writing in to get lectured on ISO's terms and definitions.

You said:
"My questions are:
1. Is there an ISO requirement that mandates how detailed our documentation should be?
2. Would I be justified in challenging this non-conformance issued by the auditor? "

1. You have to have enough detail to demonstrate compliance, which apparently you didn't.
2. I'm guessing you lost the argument with the auditor, you can run the argument through the registrar and higher, but this is really a last resort scenario. I'd suggest you just fix it.


You said:
"Simply stated, we complied with our documentation in stating root cause, CA & PA on our database records. "
and,
"the auditor stated we had a non-conformance because our notes were not detailed enough"

I think these are contradictory statements. If you complied, you wouldn't have got pinged.


I think my previous advice was very sound.
Sorry about the wise crack - Experience indicates these things to be generally true.

[Ace]

Thanks for the advice David, and I apologize for my defensive posture.

Rodolfo