If any of the customers require PPAP's, are in aerospace or medical then they have no choice but to requalify the process unless, the customer says otherwise. This is one of the main reasons why a capability study should take place before and after the change. If the supplier can prove capability it could limit the number of hoops one has to jump through.
In any event, the proper protocol is to contact the customers, let them know what will be changed, and the two can agree on the proper actions needed to requalify the line. In some cases it maybe completely unnecessary.
I would not define what constitutes enough change in a process to warrant a re-qualification or re-baseline. I would leave it up to the customer and supplier to decide. There are too many variables to think about or cover to create a one size fits all model that’s why ISO is so fuzzy on the terms.
Ted T
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of David Hillman
Sent: Thursday, May 26, 2016 10:07 AM
To: [log in to unmask]
Subject: Re: 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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