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"Failure Mode, Effects and Criticality Analysis (FMECA) or simply (FMEA)
is a disciplined design review technique that focuses the development of
products and processes on prioritized actions to reduce the risk of
product field failures, and documents those actions and the review process.
"FMEAs are intended to result in preventative actions; they are not
"after-the-fact" exercises done to satisfy a customer or obtain QS 9000
status. Time and resources for a comprehensive FMEA must be allotted
during design and process development, when design and process changes
can most easily and inexpensively be implemented. Only after a product
failure or financial crises arising from late changes in production is
the cost of not performing an FMEA revealed. The AIAG [Automotive
Industry Action Group, although FMECA is certainly not limited to the
auto industry--DM] describes an FMEA as a systematic group of activities
intended to:
" * Recognize and evaluate the potential failure of a product or
process and its effects.
" * Identify actions which could eliminate or reduce the chance of
the potential failure occurring.
" * Document the process."
There is no rule that a tech writer should be involved in a FMECA; this
is an engineering function. If the engineers involved decide to invite a
writer to participate because they respect the writer's knowledge and
logical abilities or if they ask one to serve as a scribe, then a writer
will be present; otherwise, the engineers are responsible for
documenting the exercise.
My point was that had this been done in a diligent manner, the question
would have arisen (as it should for almost any component that gets
mounted to a frame or shell of any kind), "Is the mounting designed to
prevent installation in the wrong orientation or position?" Clearly that
question was not asked in this case. Had it been, the mounting would
have been redesigned so that mounting holes or pins or whatever were
arranged asymmetrically.
As the switches were designed and manufactured by a subcontractor, it's
not entirely clear (to me, because I don't have any evidence in front of
me) whether the prime or sub was responsible for the attachment
interface; but clearly somebody was asleep at the, um, switch.
Goldstein, Dan wrote:
The article described a stunning gap in QA. A failure of the gravity
switches would (and did) lead to the total loss of the $264 million capsule.
Was there no way to test their functioning when installed according to the
drawings?
When I posted this, I had no idea whether there was a writer or assembly
instructions. It did occur to me that (a) if there wasn't a writer, there
should have been, and (b) if there was a writer, part of the writer's job
was to ask, "How do I know that it works the way that I described it? What
happens if it doesn't?"
I have not yet been formally trained in QA, but as a technical writer, part
of my job is to ask those questions.
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