| Mr.
A ：: |
I am much interested
in your article of “Control by classification of production realization
processes: Feb.3W, 2006” in Weekly News corner of this website.
In some cases as design consultants, understanding of 7.3 Design
and Development may be difficult, because the product is the design
itself.
|
| I ：: |
For typical industry such as electric
products and car manufacturing ISO9001:2000 may be easy to understand.
|
| Mr. A ： |
In the article one of the most important
themes is substantial difference between 7.3 and 7.5.
|
| I ： |
In a word, a design activity
starts without clear destination, but a manufacturing starts with
clear destination of product realizations.
Now, I will ask you an applied question. Which clause does handle
an activity to specify a criminal of a murder case clause, 7.3
or 7.5?
|
| Mr. A ： |
Some police detectives go to the
scene of a crime on the information of founding a dead body.
At first they do not know who is a right murder.
Then investigations follow. Sometimes CSI will give useful information.
With judging such relevant information the detectives will specify
the murderer(s) by trial and error. In Japan CSI is responsible
for correct data analysis, but not responsible for judgment on
who is a murder. But an arresting starts with the specified “destination”.
So, the activities of detectives are design ones.
Then what is the design output?
|
| I ： |
I think it is to bring
the right crime scene to life on correct evidences
for arresting, prosecution and judgment.
|
| Mr. A ： |
Yes, it seems to me 7.3
clause can be applied to activities of detectives.
But still I wonder information from CSI is one of design inputs.
|
| I ： |
Inputs referred to 7.3.2 clause are
shown before the design starts and made input to the assigned
designer. Then the designer will sometimes request for “CSI”.
The problem is who should input to the designer.
|
| Mr. A ： |
Your opinion is the design manager
should do, isn’t it?
|
| I ： |
Right. By the cormorant fishing model
mentioned in “Q&A on relations between processes of quality
management and product realization Part 1/2: Q&A with Mr.
A: Aug.5w, 2005” of Basic knowledge corner on this website, a
cormorant fisherman makes inputs to the cormorants. Then the cormorants
will survey where fishes are. No cormorant can be fishing without
their cormorant fisherman’s input.
7.3 clause requires what a cormorant fisherman should do to control
cormorants. Therefore the title of 7.3 should be “Design
and development control”.
|
| Mr. A ： |
In 1994 version it was said as “4.4
Design control”, but the words of “control” was deleted
in 2000 version.
|
| I ： |
Not only the title, but also for 4.4.1
in 1994 version. 4.4.1 required to control and verify design of
the product. This means items from 4.4.2 to 4.4.9 should be under
the control. But this clause was deleted. And in 2000
version you will find only in 7.3.1 clause the words of “control”
and “manage”.
|
| Mr. A ： |
That means in 1994 version “a cormorant
fisherman” should control items from 4.4.2 to 4.4.9, but in 2000
version “a cormorant fisherman” should control only 7.3.1 item.
Something is wrong, isn’t it?
|
| I ： |
I think the confusion comes from the
miss application of PDCA model in 2000 version( refer to “A critical
misapplication of the PDCA model:2002,May.3w” in 4.1 of Individual
clauses relating ISO9001:2000 corner on this website).
The difference about 7.3 between the both version is shown in
the following chart (refer to “Duplication of monitoring of processes
over internal audits: Jan.2w, 2004” in 8.2.2 of Individual clauses
relating ISO9001:2000 corner on this website).
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