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May 2016

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Subject:
From:
Guy Ramsey <[log in to unmask]>
Reply To:
TechNet E-Mail Forum <[log in to unmask]>, Guy Ramsey <[log in to unmask]>
Date:
Thu, 26 May 2016 15:18:02 -0400
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text/plain (53 lines)
J-STD-001 talks to this, with respect to materials and processing. Section
3.1 on page 7. I have always considered it a significant passage and when
it is debated in committee I defend it as such.
There are customers that want more. They usually provide guidance.

If they ask me why I thought I could change this that or the other thing
without telling them. I describe the validation process, introduce them to
Section 1.2 Purpose and then follow up with Section 3.1.

Guy Ramsey
Assembly Materials and Process Consulting.


On Thu, May 26, 2016 at 10:59 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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