Ron,
You're right about DFM. CE is concurrent engineering and is required, in my
book, for DFM to succeed. The following is section 7.3 excerpted from ISO
9000/2000 varying considerably from the 94 version. In 7.3.1, though not
called CE, it is clearly implied:
7.3 Design And Development
7.3.1 Design And Development Planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification and validation that are appropriate to each
design and development stage, and
c) the responsibilities and authorities for design and development
The organization shall manage the interfaces between different groups
involved in design and development to ensure effective communication and
clear assignment of responsibility. Planning output shall be updated, as
appropriate, as the design and development progresses.
7.3.2 Design and Development Inputs
Inputs relating to product requirements shall be determined and records
maintained (see 4.2.4). These inputs shall include
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similary designs, and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy. Requirements shall be complete,
unambiguous and not in conflict with each other.
7.3.3 Design and Development Outputs
The outputs of design and development shall be provided in a form that
enables verification development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and service
provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its
safe and proper use.
7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be
performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet
requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions
concerned with the design and development stage (s) being reviewed. Records
of the results of the reviews and any necessary actions shall be maintained
(see 4.2.4).
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see
7.3.1) to ensure that the design and development outputs have met the design
and development input requirements. Records of the results of the
verification and any necessary actions shall be maintained (see 4.2.4).
7.3.6 Design and development validation
Design and development validation shall be performed in accordance with
planned arrangements (see 7.3.1) to ensure that the resulting product is
capable of meeting the requirements for the specified application or
intended use, where known. Whenever practicable, validation and any
necessary actions shall be maintained (4.2.4).
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained.
The changes shall be reviewed, verified and validated, as appropriate, and
approved before implementation. The review of design and development changes
shall include evaluation of the effect of the changes on constituent parts
and product already delivered.
I thought I had posted this before. It seems innocent enough with about 20
shall statements demanding the organization do them. Again, I'm not
defending or stating an opinion about ISO, but it does supply a fremework
for continuous process improvement.
MoonMan
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