posted 16 December 1999 12:16 AM               

From: "C.W. Russ Russo"

>From: Len Litvan
>
>In a comment related to follow up audits, Dennis Arter wrote;" I have
>been pushing to get this *requirement* removed for some time now. It is
>much too restrictive and costly."
>and Len Litvan commented favorably
>"Thanks for your effort to remove mandatory follow up audits. With a
>gazillion ways to ensure that corrective actions are implemented and
>effective, it was presumptuous of the writers to require follow up audits."

Sorry, Gentlemen, but unhappily the new DIS version has reestablished the requirement for follow up audits within the clause on internal audits. This along with other significant changes between the CD-2 and DIS are IMHO backward steps for ISO. Others include:

1. the removal of most references to "customer" throughout the standard.

2. the removal of the language "product and/or service" in favor of continuing a definition of a service as a product. This continues the misconception that ISO is not applicable to service organizations.

3. the significant reductions in clause 8 that effectively eliminates the push toward fact-based decision making.

4. reinserted the practice of making parenthetical reference to the records clause when mandating a record. IMHO this language encourages practitioners to rely on mandated records rather than determining which records are appropriate for the organization's needs.

5. Also, the writers have not cleaned up the distinction between a record and document. And in fact have added a sentence that tells companies (5.5.6) "Documents defined as quality records shall be controlled." INHO this approach will cause considerable confusion among practitioners.

Some good things -- among others -- that have happened are:

1. elimination of the term "system level procedure"

2. elimination of specific requirements for many procedures.

3. elimination of reference to "ethics" not because that isn't a good idea, but because it was so ill-defined.

posted 16 December 1999 08:07 PM            

I take your point about the DIS, it is still somewhat neglectful of the service industries in both language and emphasis (calibration?, yeah, right), and the definition of a "service" as "...an intangible product" is stretching a long bow for mine (even though strictly speaking, it is correct).

Even so, I can't find any reference to follow-up audits in the DIS version published in Australasia (AS/NZS ISO 9001(Int):2000 - we live in the future, you see). And I quote (forgive)...

"8.2.2 Internal audit
The organisation shall conduct periodic internal audits to determine whether the quality management system
(a) conforms to the requirements of this International Standard;
(b) has been effectively implemented and maintained.
The organisation shall plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit scope, frequency and methodologies shall be defined. Audits shall be conducted by personnel other than those who performed the activity being audited.
A documented procedure shall include the responsibilites and requirements for conducting audits, ensuring their independence, recording results and reporting to management.
Management shall take timely corrective action on deficiencies found during the audit.
Follow-up actions shall include the verification of the implementation of corrective action, and the reporting of verification results.
NOTE: see ISO 10011 for guidance."

No reference there to compulsory follow-up audits. Seems to me the Org is given carte blanche to decide what should be audited and how, so long as it fits in with their system requirements, is recorded and acted on...

But yeah, the document/record distinction gives me the s#!ts. Solution? I'm going to ignore it.

FYI, the vocab given in AS/NZS ISO 9000(Int):2000 defines document as: "information and its support medium" and record as a "document stating results achieved or evidence of activities performed". Given that I don't want my quality system creaking under the weight of superfluous documentation, the only 'documents' I'll be using will be records anyway.

Well, apart from the 6 'documented procedures' required.

Yup, the DIS still has its faults, but I think that its arrangement is superior and its requirements less prescriptive.

Reminds me of those weightless ants in the Simpsons when Homer breaks their glass case in the space shuttle:
"Freedom, horrible freedom!"
they cry...

J.