Barry,
You may want to study/review Statistical Procedures
for Machine and Process Qualification by Dietrich and Schulze. To
start, I recommend you flowchart the process and determine the key process
and product characteristics. How these characteristics are measured and
controlled is central to ensuring process performance is adequate.
The qualification will assess the process is capable of sustaining satisfactory
process performance.
You do not indicate the scope of the process you are
assigned to qualify. The approach is basically the same, but the tools will
vary dramatically. Hope this helps.
Steve
Good morning
T-Netters.
I have been tasked
to put together a Process Qualification Plan and would be Extremely
Grateful
for some input
from those in the trenches that might have had to do the same for ISO
Certification.
I really don't
know how to begin or where to start and what goes into
this.
Thank you in
advance for all of your help Tech Net....
Barry
P-
208.955-9771