The change control we have in place requires customer approval for any and all process changes regardless of severity. That will include
anything that deviates from the first article documentation provided to the customer for acceptance.


Experience the benefits of Precision Engagement

Brien Bush
Manufacturing Applications Specialist
Phone: 603.249.9190  |   Fax: 603.249.9192
[log in to unmask]  www.cirtronics.com


ISO 9001 & 13485 Certified
Follow us on LinkedIn|Friend us on Facebook


-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Douglas Pauls
Sent: Thursday, May 26, 2016 11:00 AM
To: [log in to unmask]
Subject: [TN] How much change is change?

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


______________________________________________________________________
This email has been scanned by the Symantec Email Security.cloud service.
For more information please contact helpdesk at x2960 or [log in to unmask] ______________________________________________________________________
WARNING: Export Control This message, including any attachments, may contain technical data within the definition of the International Traffic in Arms Regulations (ITAR), and subject to the Export Control Laws of the U.S. Government. Transfer of such information by any means to a foreign person, whether in the United States or abroad, without proper export authorization or other approval from the U.S. Department of State is prohibited.

______________________________________________________________________
This email has been scanned by the Symantec Email Security.cloud service.
For more information please contact helpdesk at x2960 or [log in to unmask] 
______________________________________________________________________