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January 2002

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Subject:
From:
Brian Ellis <[log in to unmask]>
Reply To:
TechNet E-Mail Forum.
Date:
Tue, 1 Jan 2002 12:30:04 +0200
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Earl

As you know, I'm a great proponent of DFM and, above all, CE. However, I
believe this is, above all, a state of corporate mind that cannot be
controlled by standards or specifications. Like all the ISO 9000/14000
standards, it is up to the enterprise, to a very large extent, to
determine how they wish to go through the procedure and implement it. As
long as the procedure is written down in the manual, it is valid, but it
becomes far too rigid. This lack of flexibility is then exploited by the
neinsägers to stifle future progress, "because it is not written in the
manual". Furthermore, the implementation of such measures becomes a
time- and money-wasting exercise in bureaucracy, causing highly-paid
senior staff to be bogged down in details when they could be doing
something far more productive and profitable for the company.

Call me a Luddite, but instilling the state of mind is FAR more
important than being able to say we conform to ISO 9000/2000 and, IMHO,
you can never do the first by imposing the second. Put it bluntly, I'm a
bureaucratic minimalist and believe in getting the job done: you do NOT
need an expensive bureaucracy to implement DFM and CE, only a helluva
lot of commonsense and, above all communications and flexibility within
the organisation.

Let me cite a parallel. In the 17th century, the main lingua franca
throughout the world was French, which was far richer than English. Then
along came Cardinal Richelieu who founded the Académie française with a
view to simplifying the languauge and to fix the rules of orthography,
grammar and syntax. This was initially very successful and did a good
job but "les immortels" soon started to rigidify their work by the
introduction of new rules of procedure and not allowing new words into
the language until they had been long debated. This stultified the
natural development of the language and caused the French to become
xenophobic in adopting new words from other languages, to the extent of
coining ridiculous neologisms to make them appear Gallic. For example,
where the term CD-ROM is used universally, the French use cédérom and
anyone who offers anything other than un ordinateur (not un computer or
computeur), with un logiciel (not un soft or software) containing un
pilote (not un driver) for le lecteur cédérom (not le CD-ROM drive) in
their publicity is liable to swingeing fine (and this despite that the
other terms are quite frequently used in the spoken language, especially
outside Metropolitan France where they are also acceptable in publicity.

In contrast, the language of Shakespeare was, surprisingly, very poor,
in comparison with that of Molière and, in fact, had only about 40,000
words catalogued, against more than double that in French. Today, French
demonstrates its stultification by a mere 200,000 words, compared with
600,000 in English, because the latter is a living language without an
Academy making decrees on either side of the Atlantic. English easily
accepts foreign words into the language, simply by usage and nobody
objects to this neologistic introduction to find le mot juste and so we
now have a much richer vocabulary.

In other words, ISO is doing today what l'Académie did in the 17th
century: it is introducing new rules, which initially appear as useful
but which will stultify the free development of technology. The country
which has the courage to reject the need to conform to these ISO
standards will become the world technological leaders in a few decades,
because their spirit will be free to roam.

So, although I may appear as Luddite by rejecting the need to conform to
ISO or similar standards, I believe I'm actually promoting a good
technological advance.

Just some thoughts.


And a Happy New Year, Earl.

Best regards,

Brian

Earl Moon wrote:
>
> I've received some interesting off line comments concerning my last question
> concerning DFM/CE. I need to be more specific, I think, as always.
>
> There are about 20 SHALL statements in section 7.3 (Design and development)
> alone. There were about 137 shall statements in all of the previous ISO
> version. The following is section 7.3 and my question is how well is
> everyone dealing with converting these shall requirements into "we are"
> statements and ARE YOU REALLY DOING THEM and, if so, what are your results -
> GOOD OR BAD? In other words, hows your DFM/CE program working?
>
> 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 ot 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.
>
> Records of the results of the review of changes and any necessary actions
> shall be maintained (see 4.2.4).
>
> What I'm getting at here is if you are registered to the 2000 version of ISO
> 9000, you must be doing everything ISO requires. If so, you are applying and
> practicing good DFM/CE principles, right?
>
> Just want some input about how everyone is approaching this important, to us
> all, subject and how well it is working so far.
>
> Thanks a lot,
>
> Earl Moon
>
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