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  ISO 19011 and the Definition of Observation

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Author Topic:   ISO 19011 and the Definition of Observation
Forum Contributor

Posts: 64
From:West Chester, OH USA
Registered: Jul 1999

posted 28 July 1999 06:08 PM     Click Here to See the Profile for TheOtherMe   Click Here to Email TheOtherMe     Edit/Delete Message   Reply w/Quote
Subject: Re: ISO AUDITING /Tomo/Arter
Date: Mon, 26 Jul 1999 11:27:47 -0600
From: ISO Standards Discussion

From: Dennis Arter
Subject: RE: ISO AUDITING /Tomo/Arter

Handoko Tomo writes:
>I want to know about criteria of audit finding in ISO14001 and
>ISO9001/ISO9002? Are findings different from observations? What's
>the code of practice for ISO14001 auditors and ISO9000 auditors?

To answer the question fully, one must consult three reference
ISO 8402:1994 (Vocabulary)
ISO 10011:1990 (Quality auditing)
ISO 14010:1996 (Environmental auditing)

The 8402 vocabulary standard provides limited information. Only the term QUALITY AUDIT OBSERVATION is given. It is defined as a "statement of fact made during a quality audit and substianted by objective evidence." You can see that an OBSERVATION can be good or bad. It is a fact. In my teachings, I suggest that it not be used, as it has been quite abused over the years. Some of this abuse is my doing. In the first edition of my book (1987), I suggested that an OBSERVATION was a precurser to something more serious. Sort of like a mini-finding. I was wrong. I corrected my oversight in the second edition, released in 1994.

The 10011 quality auditing standard repeats the 8402 definition of OBSERVATION, dropping the words "quality audit." No problem there. The quality auditing standard also picks up NONCONFORMITY from 8402, as "the nonfulfillment of specified requirements." This is an interesting historical point. When 8402 was first published, NONCONFORMITY was placed under the inspection concepts. This placement carried over for the second edition in 1994. But when the quality audit standard, 10011, was being written in 1989 and 1990, the British model of third-party registration was sweeping the world. The British auditors had picked up the inspection term NONCONFORMITY and were now using it in an audit application! They even attached major and minor classifications to it. Because of the huge British influence in the 10011 development, it is only natural that the term nonconformity would appear in the new standard. Now, I am not trashing the British or the French or the Japanese or any other nation. I am merely showing that standards are developed by "those that show up." The British show up on these committees.

Later on in the 10011 quality auditing standard, the text says, "After all activities have been audited, the audit team should review all of its observations to determine which are to be reported as nonconformities." The word FINDING never appears in the 10011 quality audit standard, even though auditors have been using it for centuries. This is one of the many reasons why an international effort was started over five years ago to revise the 10011 standard. (More on that revision effort below.)

The 14010 environmental auditing series of standards (14010, 14011, 14012) came out in 1996. The terms NONCONFORMITY and OBSERVATION are not used. Rather, AUDIT FINDINGS is presented as, "results of the evaluation of the collected audit evidence compared against the agreed audit criteria." This is a very useful definition, as it can be used to report good stuff as well as bad stuff. In actual practice, however, FINDINGS are mostly used in a negative manner.

As I reported a couple weeks ago, the ISO committees are combining the quality and environmental auditing standards into one: 19011. The first working draft was recently released for comment. In that working draft, the terms CONCLUSIONS, EVIDENCE, and FINDINGS are all defined. The term NONCONFORMITY is missing; although, it creeps into the text every now and then. In my comments back to the committee, I suggested use of the terms FINDING OF NONCONFORMITY and FINDING OF CONFORMITY be used as a compromise between the quality registration camps and the environmantal camps. Only time and several more meetings of the committee will tell.

In a reply to Handoko Tomo, Larry Hillyer states:
>A Finding is something that is either a Minor or Major finding.
>Either one, it details what the auditor found to be "not what you
>said you were doing, was or was not found". The Observation is
>something the auditor noticed that is of possible importance to
>the system, and take the advice and do what you want with it. It
>may be in your interests to improve your system by treating as a

I believe Larry has been misinformed. Perhaps he is still using the old version of my book. [smile]

What's the moral of the story? Use the international and published definitions whenever you can. If they don't work for you, use definitions of your own. But put these definitions in your audit procedures! And define the words in your audit reports. Insist that your third-party registration auditors do the same, in both their procedures and their reports.

Dennis R. Arter

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 26 March 2000 12:02 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Some Related Links:

ISO 9001:2000 DIS?

ISO 10011 Dead - 19011 Evolves

CD1-ISO 19011

Outsourcing Internal Audits

Identifying Continuous Improvement Opportunities

ISO 10011 Dead - 19011 Evolves

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