[time-nuts] TAC/TDC

Bill Hawkins bill at iaxs.net
Thu Dec 16 01:01:25 UTC 2010


Just finished editing 25 papers on process control for FDA (Food
and Drug Administration) regulated industries, so here are a few
reflexive neuron firings.

The FDA requires that the user requirements be captured first, in
a way that can be understood by both the user and the vendor of
the required hardware or software, but with no vendor contribution.

Once agreement has been reached, the vendor prepares a functional
specification that can be understood by the user and the people
who will build the thing that is proposed.

When the functional specification is approved, the technical team
prepares design requirements and builds what the user needs (they
hope). When built, it is tested against the design specification,
then the functional spec, and finally the user spec. The user signs
off on the last tests to accept the product.

This only works when everybody is on familiar ground, and all of the
technical principles (if not the details) are understood. Otherwise,
you enter a design, prototype, and feedback cycle until the user and
the vendor can agree on what the vendor will provide. Only then can
the user write requirements that don't require transmutation of
elements or time travel.

Concisely, the requirements must refer to feasible design properties.

They can't be kept separate until it is known that the thing can be
done. After that, the FDA process (V-Model) assures a win-win result,
if you have the people and the time to handle the documentation and
negotiations.

All IMHO, of course.

Bill Hawkins


-----Original Message-----
From: Magnus Danielson
Sent: Wednesday, December 15, 2010 3:50 PM

------------%<--------------

You mix requirements and sketch of design-idea. Keep requirements and 
proposed design properties separate.

Cheers,
Magnus






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