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SMT electronics assembly manufacturing forum.


IQ/OQ, and PQ

Pat Copeland

#9598

IQ/OQ, and PQ | 14 September, 1999

I am looking for help on doing smt equipment qualifications. I need to find some examples to follow. The equipment to be qualified is a Stencil Machine, Pick and place machine, and Reflow oven. We manufacture medical devices so it has to be somewhat acceptable for FDA requirements. Can anyone lead me in a direction with some examples.

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#9599

Re: IQ/OQ, and PQ | 15 September, 1999

| I am looking for help on doing smt equipment qualifications. I need to find some examples to follow. The equipment to be qualified is a Stencil Machine, Pick and place machine, and Reflow oven. We manufacture medical devices so it has to be somewhat acceptable for FDA requirements. Can anyone lead me in a direction with some examples. | Hey Pat: The FDA requirements are very broad. Fundamentally, they require that you qualify the process equipment that affects the quality of your device. They do that to force you to understand how a machine operates, before you start making devices with it. It provides information to prevent you from doing something dumb (hopefully) and to show that you�re responsible, if you get blamed for someone else doing something dumb.

The method you use in entirely up to you, it will be acceptable to the FDA, if it is reasonable. So when qualifying your SMT equipment, you should use the same equipment qualification template that you used for your other process equipment, so that you are consistent. The FDA likes consistency.

Baring that, because the FDA also likes documentation, you might:

� Document that the machine meets your purchase criteria. Often suppliers provide (or you can get from them) their "book." You might use their book instead of acceptance testing on complicated equipment. Generally, it�s a good idea to send someone to observe the supplier do the testing at their plant though. Some times, you might require in your PO that the supplier to develop a "book" at our site as an element of your acceptance test at your plant. � Calculate (and document of course) Cpk and gauge R&R, when appropriate. � Write a work instruction describing how your operators would verify and record machine performance periodically.

Good luck

Dave F

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