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Thu, 26 May 2016 10:07:05 -0500 |
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Hi Doug:
Major change: a change in form/fit/function of the product
Minor change: everything else as demonstrated by data that there is no
product impact
Dave Hillman
Rockwell Collins
[log in to unmask]
On Thu, May 26, 2016 at 9:59 AM, Douglas Pauls <
[log in to unmask]> wrote:
> 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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