Process Rationales

ViP Definition
"A Process Rationale is a formal statement of the importance of all parameters associated with each step of a defined process in terms of their potential effect(s) on final product quality."

A Process Rationale should be written at process development stage to evaluate risks to product quality.  This formal compilation of the process critical parameters may comprise a variety of sources, such as R&D reports and technology transfer documents, and forms the basis of a series of risk assessments performed as the User Requirement Specification(s) and the detail of the full scale production model are being developed.

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