| Mr. A: |
I think to reduce evry
written procedures is questionable. Detailed documents are necessary
for personnel changes. And they are also useful for training tools
for a newcomer.
|
| I : |
Let’s talk on concrete matter to
make the discussion fruitful.
|
| Mr. A: |
Then I take up written procedures
on design and development review. Our quality manual says about
design and development review as follows.
７．３．４ Design and development review
Design section performs at suitable stages systematic
reviews of design and development in accordance with planned
arrangements to see whether design and development satisfy
customers’ needs. Records of the reviews requirements
have to be maintained by the section. The details of the
review are prescribed in “Design review management procedure”. |
Planning and implementation of DR (Design review) are written
in “Design review management procedure”. Moreover management
procedures how to identify any problems and propose necessary
actions are described. Those detailed procedures are not able
to absorb in the quality manual.
|
| I : |
I cannot imagine your design
section manager does his management jobs every day referring to
the procedure. At personnel changes there will be
takeovers and generally no experienced person will be selected
as a design section manager.
And I cannot understand why procedures for planning of design
reviews at suitable stages should be written in “Design review
management procedure”.
As 7.3.1 clause requires you will plan design stages. Therefore
it is enough to write in the quality manual that DRs are done
at stages according to its design plan. Even if there are a hundred
kinds of new products, management procedures are the same.
It is more effective for a new section manager to make several
design plans and refer to actual samples rather than to read detailed
general written procedures.
If you do DR according to the form of “Planning and records of
DR”, it will be enough for you to write in the quality manual
that a designer plans, implements DRs and takes necessary actions
according to the form of “Planning and records of DR”. There
will be hundreds of written “Planning and records of DR”, with
different contents, but management procedures are the same.
Do your designers really refer to “Design review management procedure”
every time they do DRs? What is complicated and important
in DRs are technical and engineering matters, not managerial matters.
I think you confuse management procedures with technical ones.
The quality manual generally does not contain detailed technical
matters (refer to “What is a single manual?: Mar.1W,2006” in Basic
knowledge of ISO9001:2000 corner on this website).
This confusion may basically come from confusing management
systems with production realization systems (core systems). It
is same as the relation between a cormorant fisherman and his
or her cormorants (refer to “Q&A on relations between processes
of quality management and product realization Part 1/2: Q&A
with Mr. A: Aug.5w,2005” in Basic knowledge of ISO9001:2000 corner
of ISO9001:2000 on this website).
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| Mr. A: |
I see. I understand my confusion.
I will try again to reconstruct my documentation with right understanding
of management systems.
|