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  ISO 9001/4:2000
  No more "Observations" ?

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Author Topic:   No more "Observations" ?
Ross Simpson
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Posts: 13
From:Irvine, Ca., USA
Registered: Dec 1999

posted 16 July 2001 02:50 PM     Click Here to See the Profile for Ross Simpson   Click Here to Email Ross Simpson     Edit/Delete Message   Reply w/Quote
Quite recently, I read or heard that the latest revision of the audit standard (ISO 19011, I think ?) will no longer have "observations" and all negative findings will require a corrective action. Help!! Somebody please tell me I'm wrong.


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Forum Contributor

Posts: 90
From:Rochester, NY
Registered: Jan 2000

posted 16 July 2001 03:16 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote

ISO 19011 has not been released (maybe next year). I have the 10/1/99 draft of 19011 and I do not see anything in it about all negative findings will require requiring a corrective action, where did you see this?

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Ross Simpson
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Posts: 13
From:Irvine, Ca., USA
Registered: Dec 1999

posted 16 July 2001 03:25 PM     Click Here to See the Profile for Ross Simpson   Click Here to Email Ross Simpson     Edit/Delete Message   Reply w/Quote
ISOGUY: As I said, can't remember whether I read it Or heard it. Hell, I'm lucky I remember where the ON switch is for this computer!
All kidding aside, I saw it or heard it some where. Maybe it's a new auditors requirement to create even MORE paper work for these poor guys.
Will see if I can find or remember the source. Let's hope I'm all wet !


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Marc Smith
Cheech Wizard

Posts: 4367
From:West Chester, OH, USA

posted 19 July 2001 02:53 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
The following from the ISO listserve may shed some light on this topic:

Date: Wed, 18 Jul 2001 14:39:28 -0500
Subject: Re: Findings vs. Observations /Tingerthal/Arter

From: Dennis Arter Arter@Quality.Org

Tom Tingerthal recently wrote:

> When there is a "finding" during an audit, a corrective action is
> created. When there is an "observation" we use the same forms and
> distribution methods to get the problem addressed.
> The questions is, does the observation require action to be
> taken?

As of today, there is no accepted international definition of the word "finding." The draft ISO 19011 is attempting to solve this difficulty, but it may be another year in committee.

As many know, quality (and environmental) auditing has its roots in financial auditing. The standards for financial auditors and their professional societies use the term finding, but don't define it. When you analyze their usage, though, you will see that it means something bad. When I wrote my book back in 1987, I did a thorough literature search and found but one definition of the word (in an obscure government regulation for nuclear research). So, I made up a definition and put it in the back of my book! I said it was a) bad, b) violated a requirement, and c) was significant.

Around 1989, the ASQ Quality Audit Technical Committee (now Quality Audit Division) was working on the Certification for Quality Auditors. We argued into the night, but finally came up with: "A conclusion of importance based on observation(s)." This was done to account for those organizations who used "finding" in a positive manner. The definition was published in the CQA exam brochure.

In 1994, when we started the revisions to ISO 10011 (the quality auditing standard), we came up with: "results of the evaluation of the collected audit evidence compared against the agreed criteria, and which provide the basis for the audit report." Ugh! As you know, that effort was stopped in 1998, when international pressure built for a combined quality and environmental auditing standard, ISO 19011.

The current draft of 19011 says that a finding is "results of the evaluation of the collected audit evidence against audit criteria." The note to this definition states that "audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement."

It is becoming clear to many that an audit finding, while good or bad, needs to focus on the bigger picture, rather than the symptoms of the condition. In the class I teach, I state that findings must contain two elements: cause and effect.

(I'm almost done here.)

"Observations" are even even more screwed up! In the beginning days of financial auditing, one would gather facts (observations) and then draw conclusions (findings) from those facts. Over the years, though, observations have morphed into a sort of mini- finding. As though the auditor is saying, "I can't quite write you up, but I believe this is wrong." Even though we always said, "This is not a violation," the implication was, "You better look at this or I'm gonna make your life miserable."

Many auditors saw this sorry state and stopped using the term "observation" in the mid-1990s. When we started drafting the ISO 10011 revisions and then the ISO 19011 document, we removed the term. In its place, we use the term "objective evidence." We hope this will reduce the amount of confusion out there and "observations" will slowly fade away.

Finally, the answer to your question. Because neither of these terms are defined, you may treat "findings and observations" however you decide in your own quality/environmental management system manuals and procedures. The third-party registrars must accept your approach. Likewise, the registrars can use "findings and observations" however they please. You hired them and you can fire them.


Also see: /level2/m-vs-m.html

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