ViP Definition
"A Production Rationale is a formal compilation of all the parameters, at each stage of a production process, that can have an impact on finished product quality."

Process development iterations culminate in a Production Rationale, which should be a step by step analysis of the proposed production process and the subsequent compilation of all parameters, that may have an impact on the quality of the finished product, along with, where possible, their set-points and ranges or tolerances.  It should not just focus on the hardware and software process systems, every step needs to be considered, from the arrival on site of raw materials and components.  The way materials and components are specified, procured, transported, off-loaded, handled, sampled, analysed, stored, dispensed and charged can all have an adverse effect on quality unless properly controlled, as can in-process sampling, handling, analysis, and subsequent finished product storage and dispatch.