Well, in past lives, I had the original known good copies of these recipes
under EC control and when a run was needed, a copy was used. Run changes
and tweaks were allowed but documented in the work order by the operator and
signed off by the SMT Engineer (we only allowed SMT Engineers to change
programs). Depending on the tweak or change, an EC might be generated
depending on if the tweak was deemed an as is condition or a necessary fix
that subsequent builds would also require. Most program changes were done
during development and process stabilization when the program technically
was not locked down but changes did still need to occur depending on the
parts, EC, MFG subtleness on components, etc. The reason I did this is that
I saw instances where an operator felt it would run better one way or
tweaked placements/reflow that were not necessary and then saved the
changes. This caused issues on the next build and there was no
accountability if you had a question. We tried to control all recipes,
software, etc that were needed to build a product but tried to be reasonable
and let the business be able to run without choking it with paperwork. We
did this mainly to meet the "High Degree of Assurance" mandated in the FDA
820 but it was a good practice without the FDA requirement.
My personal opinion is tweaks to programs were typically more determined by
the competency of the design and those tweaks we did to get by should have
really been considered for Gerber changes to stop the need to tweak at all.
Kat
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Douglas McCall
Sent: Wednesday, April 16, 2008 7:51 AM
To: [log in to unmask]
Subject: [TN] AS9100 and SMT/reflow machine program changes
Hi,I have been asked to consider the up-issue of SMT, reflow and stencil
print programs using an engineering change process with respect to
controlling changes made and for products being manufactured to AS9100
specifications.
Has anyone had any experience of this practice? What is the general opinion
of trying to control SMT program issue status (not assembly issue but
SMT/reflow
program issue) using an engineering change. Is this common practice.
When changes are made to the SMT, reflow or stencil print, program there
would
need to be an EC to approve the change. I am a bit unsure if this is
workable!! Thanks for the input in advance.Douglas I McCall.
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