- About "Design control"
On the website of Seibido, the surveillance record says that the
assessor advised to delete design control function from the organization
chart, because design control meant only to control outsourced design
process. Seibido has not such outsourced processes. Then the assessor
said the advice. But the advice is extremely nonsense! Because "4.4
Design control" in ISO9001: 1994 means control of design works in
an organization, not outsourced ones. Outsourced design processes
are handled in " 4.6 Purchasing". In ISO9001: 2000, the word of
"control" has disappeared from "7.3 Design and development", but
the content is the same as 1994 version. It should have been " 7.3
Control of design and development" to avoid the misinterpretation
brought about by Mr. T.
- Confusion with product tests and management assessments
On the same website, the surveillance record says that the assessor
questioned about detailed product requirements which was totally
irreverent to ISO90001 assessments.
- Misinterpretation of design
On the website, the surveillance record says that the assessor said
frequently the system design of Seibido had no characteristics of
design works He said pilling already known facts up was not a design
activity. He has been notorious for his misinterpretations of meaning
of design activities. I will pick up some examples of his misinterpretations.
(1) Design of landscape gardening
The assessor said in an assessment of a landscape gardener that
planning of a landscape garden was a design work, but to make
a plan how to make a designed garden was not design works, because
the plan was a product of combination of known construction works.
I assume that he confused with product design and process design.
To plan construction of a garden is a process design and it is
one of design activities (ISO9000: 2000 says in 3.4.4 that design
includes product design and process design), but not compulsory
applied by ISO9001: 2000. Because NOTE 2 in 7.1 clause of ISO9001:
2000 says that the organization may apply the requirements given
in 7.3 to the development of product realization processes. The
word of "may" means to apply 7.3 clause for process design is
not compulsory. Therefore he should have said that a plan of gardening
was one of design activities (process design) according to the
ISO9000: 2000 definition, but not mandatory requirements that
7.3 Design and development clause must be applied to a process
design.
(2) Design of scaffolding
A few years ago I did consultancy to a company for getting ISO9001:
1994. The company designed scaffolding being given construction
drawings from customers. The design was very similar to playing
with building blocks and designers made various shapes of scaffoldings
by combining and pilling standard pipes (" known facts") up. The
company, of course, got ISO9001 by applying 7.3 clause to the
scaffolding design.
(3) " Face design" of a vending machine
Several years ago, I did consultancy to get ISO9001 certification
for a company that supplied various cans for vending machines.
I noticed an alley of cans in the front of a machine to attract
customers and assumed that the planning of alley of cans was a
design activity. Thus the company got ISO9001: 1994. The design
was just pilling various cans up according to circumstances where
a machine was installed. At that time coincidently an assessor
was Mr. T and he admitted planning of a pilling various cans up
was one of design activities.
- Misinterpretation of traceability
Mr.T went to a small assembly maker for an assessment and insisted
that the company had to record lot numbers of all parts including
even screws, nuts and bolts used in its assembled product. There
was no specified traceability requirement for the company to the
extent to all parts. Insisting so, the company rejected his indication.
If Seibido were an assembly maker, Mr.T would have required the
same extent of traceability.
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