Good morning all,

One of the IPC groups that I am leading is presently wrestling with the
issue of minor vs. major change.  Generally along the lines that if you
have a baselined or qualified manufacturing process, how much can that
process change before it needs to be re-baselined or re-qualified?
Sometimes this is referred to as Level 1 vs. Level 2 change.

So far, every quality documentation system that I have looked at, like
AS9100, ISO9000, etc., gets really fuzzy and uses vague terms when you
approach this issue.  Most of these documentation systems have change
better defined for products, but get extremely fuzzy and extremely vague
about manufacturing processes.

This forum has a lot of very smart, very experienced people. How would you
differentiate a minor change, which would not impact form fit or function,
from a major change, which "could/would" impact form fit or function?

And I want all you lurkers to come out of the woodwork on this one.

Doug Pauls
Principal Materials and Process Engineer
Rockwell Collins


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