ISO9001 Major for repeat issue.

Ron Rompen

Trusted Information Resource
#11
I agree with Jim regarding the bafflegab........I read it twice, and still can't really get much sense out of it. The additional information by the OP (the SAME nonconformances were found on the second audit) is definitely a red flag, however. This does indicate that the Corrective Action Process is not functioning properly - I don't know if I would have issued a major against the CA process without having actually done the audit myself, but I would definitely have considered it.
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#12
Right....the NC was poorly written.

Maybe issue the internal auditor a NC for writing a NC that cannot stand on its own and be understood! (I'm kidding...mostly.)

However.... If in fact 2 different NCs recurred it could show the RCCA process is ineffective. It's an internal audit so major/minor is less important than fixing the problem, IMO.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#13
As a 1st party auditor my employer had written in Major for a repeat nonconformance in the procedures.

As a 3rd party auditor by CB did the same of course, but our AB wanted us to additionally issue a minor for failure of the Nonconformance process.

In both cases it was critical that the problem statement very clearly show the exact same problem recurred.

Majors are serious but I want to point out that they are not meant to condemn anyone's character etc. There is always a risk that the root cause analysis did not recognize everything. Not every problem is a Dandelion, so to say. A Major NC would, I hope, generate some focus on that and seek to gather cooperation and maybe resources in addition to what was applied to the issue originally.
 

Mikey324

Quite Involved in Discussions
#15
That NC statement is pure bafflegab. You should ask for it to be updated and clarified before doing anything else.
Thank you for adding a new word to my vocabulary. This seems to be the way NC statements are being written now. Most all that I've seen, including the ones I've received say "The process of XYZ is not completely effective"
 

Randy

Super Moderator
#18
Repeat occurrences can have different root causes. Someone can fix the root case of one occurrence but overlook other ways of causing the same problem.
Possibly, but that also might be a dog that don't hunt.

Why?

10.2.1..........
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:
1) reviewing and analyzing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;

Somewhere someone needs to mention 1-3 happening
 

Mike S.

Happy to be Alive
Trusted Information Resource
#19
I've had some very difficult to diagnose issues crop up. It can be especially hard when the rate of occurrence is low.

For example, got a NC, thought we had isolated the RC, implemented a CA, customer was happy with the RCCA response, problem went away....for awhile... then cropped up again. Uh-oh.

Rinse and repeat twice more! :oops:

Only after the 4th try did we finally isolate and solve the real RC and implement permanent CA. It took a LOT of engineering resources from us, our customer, and our supplier.

Should we have been issued a "major" by any auditor - internal or external?

This was not an issue of laziness.
 

Kronos147

Trusted Information Resource
#20
If there is a minor NC issued by the registrar\auditor in 2021, and they can not say it is effectively managed when they return in 2022, it will be escalated to a major non-conformance.

I think it's possible that was what the auditor thought when it was issued, but then screwed up their notes, and hence, your report.

As worded, I would appeal and fix the issue on your own time, and your own dime.
 
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