ABSTRACT
This chapter explores the seven process design and development elements, and describes where each process design and development element fits in the advanced product quality planning process. The seven development elements are: facilities, tools, and gauges; manufacturing process flow; process failure mode and effect analysis (PFMEA); measurement system evaluation; pre-launch control plan; operator process instructions; and packaging specifications. Facilities, tools, and gauges: this element identifies the new, additional, refurbished, and relocated facilities and resources necessary to manufacture the customer-specified product at the designated quantity and quality levels. The PFMEA is a systematic approach used by a manufacturing-responsible team to ensure that potential process-related failure modes and their associated causes have been considered and resolved. Measuring system evaluation element assesses the variation of the measurement system and determines whether it is acceptable for monitoring the production process. Operator process instructions element describes the details of the controls and actions that operating personnel must perform currently to produce quality products.
