Auditing rule restrictions on how nonconformances are "worded"?

[Jim Biz]

Are there auditing rule restrictions on how nonconformances are "worded"?

For example can an external auditor state in a noncoformance report (Major or Minor) "the suppliers purchasing staff has not followed (insert any section that applies here)

OR are there restrictions that only allow a very general statement such as "the suppliers management has not followed section x paragraph y etc.

 

[barb butrym]

the preference is a clear statement of the evidence/facts at hand and the requirement.........

So wording that indicates the requirement (where it came from p# etc), and the evidence reviewed (x of xx purchase orders reviewed did not have the required authorization signatures as required by doc #yyyyy paragraph zzz ...then list some PO #s)...

or, for another example, simply state that there was no evidence that requirement xxxxxx has been implemented.

When the absence of evidence in support of an ISO shall is found...you need to reference the ISO requirement clearly...i typically restate it word for word..in addition to referencing the Paragraph...why? cause i think its important to...simply my personal preference

Does it say anywhere the words that are required? NO

[This message has been edited by barb butrym (edited 30 March 2000).]

 

[Jim Biz]

Thanks Barb - Guess It's been my experience that the wording in the few minors we have recieved, although clear as to what was observed and why it was written, may be too "generic" for lack of a better term... It tends to allow upper level management to look directly back to the ISO group for resolution, requiring adjustment of the written documents - instead of focusing on the specific area that may not be following the physical responsibility steps that are already written signed-off and agreed to.(not that written adjustments aren't necessary in some cases but not an improvement "cure all" for each issue)

IMHO if it is allowable it would be better for some programs out there if external auditors would "Focus" the statements on the area in question. "The suppliers "purchasing group" or the suppliers "Processing/administration/ depatement management" Etc.. has not ..... instead of using the generic "the supplier has not".... I know there are a lot of places out there that are operating on the "let the ISO group rewrite it" philosophy.

 

[Marc]

Originally posted by Jim Biz:

Are there auditing rule restrictions on how nonconformances are "worded"?

No.

For example can an external auditor state in a noncoformance report (Major or Minor) "the suppliers purchasing staff has not followed (insert any section that applies here)

Yes.

OR are there restrictions that only allow a very general statement such as "the suppliers management has not followed section x paragraph y etc.

The idea is to be as specific as possible. This second 'version' could be used. However, were it me I would choose the first option ("...the suppliers purchasing staff has not..."). I would want to define as specifically as possible what the anomaly was without naming actual names. In some cases a name may even be appropriate. In the case of "...there was no evidence that requirement xxxxxx has been implemented..." it is left 'open' for obvious reasons.

...It tends to allow upper level management to look directly back to the ISO group for resolution...

The corrective action should contain a root cause. The root cause should be specific enough that there should not be an issue as to whether the procedure or system is non-compliant (fix the system documentation) or whether another factor is in play (people not following procedure).

it would be better for some programs out there if external auditors would "Focus" the statements on the area in question. "The suppliers "purchasing group" or the suppliers "Processing/administration/ depatement management" Etc.. has not ..... instead of using the generic "the supplier has not"....

Why not ask them to be more specific? But again, the corrective action should be specific enough to address responsibility issues.

 

[Jim Biz]

Sorry it's taken so long to get back on this one. After considering Barb & Marc's input/reasonings, I did approach our auditors with the same basic question and I was greeted with a very positive response. They seemed to understand that placing increased focus wording on the specific "responsible area" (short of finger-pointing of course) could only lead to a more rapid program "improvement".

The way it looks right now it's a win-win situation - Thanks to you both.