ABSTRACT
This chapter provides information of five elements of product and process validation and their expectations. The five elements are: production trial run, production control plan, preliminary process capability, production validation testing and part submission warrant (PSW). The production trial run is a validation of the effectiveness of the manufacturing and assembly process, using production tooling, equipment, environment, facilities, and cycle times. The production control plan is a written plan of the systems for controlling parts and processes during full production. The production control plan is developed by a cross-functional team led by manufacturing engineering. The preliminary process capability is a statistical study and assessment of the ability to produce product within specifications. Engineering tests validate that products made from the production tools and processes meet engineering specifications. The PSW ensures that engineering design requirements are met by the supplier and that the process used is capable of producing parts that meet these requirements.
