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September 2002

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Subject:
From:
Earl Moon <[log in to unmask]>
Reply To:
TechNet E-Mail Forum.
Date:
Fri, 6 Sep 2002 15:44:08 -0500
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Good explanation Mark but, in the simplest terms, the evaluation and
qualification processes must be taken one step further if defect is
determined at the inspection level. Reevaluation and requalification may
have to be performed. Again, this is in the most basic terms.

For some types, such as Class 3 product, qualification must be performed on
a regular basis starting with government permission, specimen production,
and independent laboratory analysis approval. Evaluations are ongoing in
accordance with 6012 as an example. Also, just because the 6012
qualification is forthcoming does not mean that customer evaluations and
qualifications are not required for individual products.

Earl

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