posted 07 May 2000 07:31 AM               

From: [email protected]

> From: Rob Udo [email protected]
>
> Does anyone have suggestions on implementing section 6.3 Facilities
> and 6.4 Work environment of ISODIS9001:2000? How do you make
> this auditable?

The "quick and dirty" answer is in the word "identify" which appears in both sections and is very easy to audit (simply say, "Show me..." as in: The side of the car that I can see is painted blue...). That's the first half.

The other half would be part of what I refer to as the "background noise" of an audit as a whole. The "background noise" answers some systemic questions such as "Is the Quality Policy implemented effectively?" and "Is this really a quality system or just a bunch of managers who want that free trip to Vegas if they pull this off with me?" (If you have no "gut level feelings" then you shouldn't be an auditor, simple as that.)

Finally and as an aside, if you lump 6.3 and 6.4 together with the old 4.1 as you review complaints, corrective actions, preventive actions and management review documentation, you'd probably "cross t's and dot i's" about as well as could be done by an outsider.

posted 07 May 2000 07:32 AM               

From: "Hankwitz, John" [email protected]

Rob,

Section 6.3 states, "The organization shall identify, provide and maintain the facilities it needs to achieve
the conformity of product, including:

a) Workplace and associated facilities;
b) equipment, hardware and software;
c) supporting services

To audit this requirement, I would start by looking at nonconforming product history. If their quality records indicate they are producing very little of it, I would not spend lot of time investigating it. If they have a significant amount of nonconforming product, I would then look for objective evidence that they have taken an effort to maintain the three listed areas.

Section 6.4 states, "The organization shall identify and manage the human and physical factors of the work environment needed to achieve conformity of product."

Once again, I'd start by checking nonconforming product history. Corrective actions taken to eliminate existing, and prevent future nonconformity should be addressing the "workplace, equipment, support and environment" in their corrective action reports. If they aren't, I'd have a case for issuing another finding based on these clauses.