ISO Confusion - Do we comply and other questions

Q

Q rex

#1
I'm going to use the terminology of 9k-'94, because I am a lot more familiar with it, apologies.

My company is basically in the information field. Our product is information, used by our customer to build or retrofit a facility, make a decision, purchase equipment or material.

Our business is "design". Our product is "design documents". We have a business process approach in place that served to migrate from our TQM program to ISO 9001 certification.

In my opinion, we have many of the requirements of the standard for, e.g., design, applied to our product, because it is "design". Similarly, we seem to have crosslinked the definitions of document, record, and product, and applied all of the requirements of the standard for each of these to all of them in our QMS documentation.

We have a documentation matrix that 0points to where we appear to have pasted someone's idea of key phrases from the standard into sometimes unrelated sections of our business procedures.

We map control of nonconforming product into our Corrective Action procedure, which in practice looks at projects during audit, when nonconforming product, if it existed, is already in the client's hands.

We have a procedure for calibration, even though the scope of this procedure in no way relates to instruments that measure the quality of our product.

Following the thoughts of The Audit Guy, nonconforming product only exists when tested or inspected and found to fail. In the case of an intangible product such as information, there isn't a warehouse of off-spec widgets to be concerned about. When defects in information become known, the information includes the correction.

The model the '94 standard embodies does not seem all that well suited to an iterative endeavor, such as "design". Preliminary information is developed, review with client elucidates many of the client's requirements that he/she was unable to communicate without benefit of the preliminary information developed. The linear, unbranched, uniterated model of the standard is difficult to impose on the iterative processes of design. Lack of understanding of how to go about this produces a cobbled together QMS that gets ignored by users, like VCR manuals that appear to have been translated from Japanese into Finnish, Finnish to Swahili, Swahili into English.

I'd like to hear the thoughts of the
Forum on this. Thanks.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
->The model the '94 standard embodies does not seem all that
->well suited to an iterative endeavor, such as "design".
->Preliminary information is developed, review with client
->elucidates many of the client's requirements that he/she
->was unable to communicate without benefit of the
->preliminary information developed. The linear, unbranched,
->uniterated model of the standard is difficult to impose on
->the iterative processes of design. Lack of understanding
->of how to go about this produces a cobbled together QMS
->that gets ignored by users, like VCR manuals that appear
->to have been translated from Japanese into Finnish,
->Finnish to Swahili,

Well, you have me. Design is iterative. That is to say designs are changed from time to time. Some are changed quite frequently. In the actual process, there are many times where the process 'loops back upon its self'. A good example is where you validate your design. The validation may fail which causes you to loop back and try again. Where in the design process it loops back to depends upon the failure mode and the root cause.

ISO 9001:1994 is not linear per se. Nor is the 2000 version. I think you better break down what you are trying to say in simplier terms.

In my implementation guide I stress that each everything a company does is interactive. You talk about a 'cobbled together QMS'. How so? You should be able to put together a high level flow chart which outlines top level interactions. In the same vein, you can do the same to the sub-processes.

Take a look through the slides from about http://Elsmar.com/Imp/sld025.htm

If you can be a bit more specific with less complex verbiage maybe I can better comment.

[This message has been edited by Marc Smith (edited 20 April 2001).]
 
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