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June 2001

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Subject:
From:
Richard Hamilton <[log in to unmask]>
Reply To:
TechNet E-Mail Forum.
Date:
Fri, 22 Jun 2001 10:42:04 -0700
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Phil,

WOW, all that for ISO-9001? Are you sure you want to do that?

In my past life we were certified ISO and any testing or validating we did
was of normal processing, not for ISO.

The big thing about ISO is that you need to DO what you say your going to
do. If you would normally do that kind of thing, then document it and
incorporate it and DO it. Do yourself, and management, a big favor and
don't add headaches (and capital) to your process. ISO can be a big
headache if you make it one, we always wanted it to be invisible to daily
operations.

Some people take on ISO as though it needs to be addressed as a separate
monster all on its own. Try not to do that because you will be sorry in the
end.

If testing for your product is done outside now, and at specified times
(initial product testing, once a year, whatever), document it that way and
continue to do it that way.

Believe me, ISO inspectors are not have the technical expertise to
determine the results themselves, only to verify that what you say is going
to happen DOES happen.

ISO can be a simple thing. A lot of people fall into the trap of making it
a lot bigger than they really need.

Let me give you a specific example. Wave soldering. We do not test the wave
soldering process specifically. We DO clean for dross every day, test the
solder pot regularly using an outside service, and keep up the maintenance.
All of this is documented.

Now for the soldering result. We have incorporated into the Quality Manual
that a visual inspection is used to determine what is acceptable BY OUR
STANDARDS, not ISO standards. Of course our standards are based on industry
standards.

All ISO is interested in is are we doing what we say we are going to do?
Records are kept for all the above processes. Including the inspection
criteria for soldering connections which is well known on the floor by both
production and QC personnel. That is where ISO inspectors will go to 'test'
the system, to the personnel and ask them what criteria do you use to
accept or reject solder connections. If the personnel site what the QM
indicates they should, and they can show where they are instructed from,
then all is OK.

I view ISO as a process improvment activity as opposed to process additive.
I say improvement because if it is designed right, everyone will know
exactly what is supposed to happen and they will follow it and if a problem
comes up, they will deal with it (which brings into the picture another ISO
process within 9001!).

I hope this helps. Do let me know if you would like some more blabbing on
about this!

Richard


At 01:01 PM 6/22/01 -0400, you wrote:
>Hi all,
>
>As part of our ISO-9001 effort we need to validate some of our processes.
>Specifically wave solder, crimping, pwb cleaning and encapsulating.  Did I
>miss any?
>
>To validate wave solder do I need to micro-section a sample board and look
>at it with a microscope or SEM?  If I have to micro-section a "sample"
>board, how do I do that without destroying the pad I'm cutting through?  Yet
>another piece of equipment?
>
>For crimps it would be a pull test.  Any equipment suggestions?
>
>For PWB cleaning it would be an ionic test.  What equipment would be used?
>
>For encapsulation it would have to be a destructive test to saw it apart and
>inspect the cross section and maybe a hardness test to confirm that the
>ratios provided the proper cure hardness.
>
>I'm open to suggestions.  Keep in mind that management will laugh if I bring
>in requisitions for hundreds of thousands of dollars.  We like the "keep it
>simple" approach.
>
>Thanks in advance.
>
>Phil Nutting
>Manufacturing Engineer
>Kaiser Systems, Inc.

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