7.5.2 Validation of Processes - Robotic welding of steel components

K

katie

#1
7.5.2 still not quite getting it

We are close (October) to 9001:2000 Registration audit and have still not hammered out 7.5.2 - We seem to be having differences of interpretation - Our Manufacturing process is Robotic welding of steel components.

We do daily random sample testing including hardness/breakdown and measurement on each component each run. There are no "processes that cannot be verified by subsequent measurement" on the sample components. We do not test each part of the run, just every area on 1 sample component per day according to 8.2.4.

Occasionally changes or improvements are made to the process or Equipment. Trial components manufactured using the new process or equipment are re verified according to 7.2 and 7.1 before the changes go into production. Again, Every area on the trial components can be verified.

Because we can verify all areas of the product do we need to validate the process? We don't have any "Hidden" or "special" processes. Should we exempt ourselves from 7.5.2 or are we already validating the process and just don't realize it because it is covered under different elements.

Let me know your thoughts. Thanks in advance
 
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R

Randy Stewart

#2
Katie,
I'd use my teardowns as validation. You know all you're doing in validation is proving the process. So by doing a teardown you validate the weld integrity, in turn a pull test may validate the teardown, tip checks can validate the pull test, etc.
IMO don't exempt use what you have.
 
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