posted 16 February 2000 09:14 PM            

quote:

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Originally posted by Tom Goetzinger:
Welding is normally defined as a "special process", in that it is only through destructive testing that the quality (strength) of the weld can be determined. For that reason,I would caution use regarding inspection criteria, unless it is the cosmetic aspects that you are concerned with.
I would suggest relying on the skill of your operators as opposed to inspection. We covered special processes in our procedures, indicating that those functions could only be performed by certified operators or operators in-training. Those in-training work under the direction of those certified and are allowed to perform those type of operations at which they have become proficient.

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My question is this: Is there such a thing as a "Special Process" in the 2000 revision, or is this a term devised by an individual company? I can find no reference to this concept in the Standard.

In my industry (building design), the outcome of the design process likewise cannot be tested through traditional 'inspection' regimes (short of trying to knock down new buildings), but must rely on the skill of the designers. What implications does this have for compliance? How can we prove we've followed the relevant building standards short of documenting everything with checklists? Or can we rely on the fact that our designers are highly qualified, highly competant professionals?

...Or am I just confusing the issues (probable, given the day I'm having!)?

In fact, I think I'll go and have a lie down...

posted 27 February 2000 07:35 PM               

quote:

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Originally posted by David Mullins:

9000:2000 DOES mention special processes.

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Thanks for pointing out the verbiage.

posted 28 February 2000 12:02 AM               

Think I'll have a risk assessment and a little lie down too!

posted 29 February 2000 07:09 PM            

Thank you to rrramirez for pointing out the reference to "special processes" in the revision of ISO 9000. There it was all along, right under my nose!

My chief concern in writing my original post revolved around being able to DEMONSTRATE the quality of designs outside the traditional manufacturing paradigm. I think all of your responses have helped.

First of all, the skills and competence of the designers remains (I believe) important at a foundation level (ref: 5.4.2, 6.2, 7.3.2a, 7.5.1, 7.5.5 in the 2000 std). Second, compliance with regulatory requirements (building codes etc)should be demonstrated (7.2.1c, 7.3.2b). Third, the choice of contractors (suppliers), and all communications with them, should be key factors in ensuring the designs are realised as intended: validation of service thus extends beyond the organisation (and beyond Design/Development (7.3) into Service Operations (7.5)).

Taken together, these three factors should prove sufficient, n'est pas?