In general, I agree with Dave Hillman. "In God we trust, all others bring data"
Since my sister, in the medical instrumentation field is here, I asked her how the FDA regulates them. Very similar question.
1) You "know" you are making a change- you and have to think about the change.
2) Best - you work out a test plan for the equivalence data before you ask your customer/regulatory body, and then do the tests.
3) Not as good but maybe permissible - you take enough data to prove "no change beyond the normal variation" in your process/product data to show at a later audit.
Now, the burden is on "proof", not the "change".
Denny Fritz
-----Original Message-----
From: David Hillman <[log in to unmask]>
To: TechNet <[log in to unmask]>
Sent: Thu, May 26, 2016 11:07 am
Subject: Re: [TN] How much change is change?
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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