posted 11 July 1999 12:43 AM               

rom: R2 Innovations
Subject: Re: Q: Re-organizations regarding documents /Roberts/Robinson

Teresa Roberts recently forwarded the following:

> We are ISO 9001 and QS-9000 registered. Our quality system documentation at
> levels 1 and 2 has been organized around the ISO and QS standard. We have a
> quality manual and one regulation for each applicable section of the ISO
> standard. However, we are finding this system unwieldy and find that our
> documentation system all too often is cumbersome and impends our primary
> purpose of manufacturing connectors.
>
> We would like to transform our quality system documentation so that it
> reflects how we operate rather than how we document those operations. We
> would most likely reorganize around our functional units, but we might also
> reorganize around our departments. Is one of these models better than the
> other? And has anyone undergone such a reorganization of their quality
> documentation?
>

My employer has just spent considerable time and effort to move from functional-based documentation to process-based documentation because of the immense amount of duplication that occurs -- every department had different employee performance review procedures, with the resulting variance in results.

Needless to say, developing procedures that are not process-based will cause difficulty for auditors, both internal and external. How can they accurately assess the effectiveness of the preventive action process if each department handles things differently?

ISO is processed-based and companies should adopt this methodology in their operations and documentation or they will end up with a documentation nightmare on their hands.

Just my $.02 worth