Phil,

There are some templates for Process Validation but it is easier to create your own.
Start with defining what is a Prospective Validation vs. a Retrospective Validation.  Then
define what you want to do, describe the process, define the important parameters, detail the
experiments or tests, write your conclusions.  Then subject it to some kind of review, we use
peers like the other engineers and then the engineering manager.

Good Luck,

Chuck Brummer
818-734-4930

Phil Nutting 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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