There is a significant difference between ISO 9001-1994 and ISO 9001-2000
regarding what a process is.  In the 1994 version, processes were normally
considered to be manufacturing processes (e.g. hole drilling).  In the new
ISO, a process in more global in that it covers anything that has an input
and an output.  For example, the steps that Engineering takes to create a
drawing is considered a process under the new ISO.  The other significant
difference is that under the old ISO, one performed audits to determine if
the procedures for the process are being adhered to on the shop floor.
Under the new ISO, auditing alone is not sufficient.  One must establish
metrics to measure the effectiveness of the process, and to use the metrics
to create continuous process improvement.  For example, an Engineering
metric might be to document how many Engineerring errors were created during
the drawing creation process.  I don't believe most OEMs realize the bottom
line impact of transitioning to ISO 9001-2001.
----- Original Message -----
From: "Kathy Kuhlow" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Wednesday, September 05, 2001 12:51 PM
Subject: Re: [TN] Process Qualification


I would start by deciding if the process qualification can be done by
product or by process.  By product would be my choice.   I would devise a
quality plan that lists the process and also includes customer
requirements/expectations.  Then from that I would confirm that the process
is capable and the operator who perform the task are competent.  That is the
inputs that ISO-9000:2000 will be looking for.  From that I would perform in
process checks to prove if the process is correct and still capable.  These
checks become the outputs for you to judge the process by.  Then a quick
acknowledgment at the end to say yea or nay to it should be fine.  Be
careful about processes that can degrade a component's life but not cause a
latent failure.

Kathy

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