The Pre-Production Quality and Planning Procedure outlines the steps, planning, and reviews for implementing the orderly transfer of a new or modified product upon completion of its design phase into full-scale production. This procedure applies to all departments and individuals involved with the development and release of a new or modified product prior to full-scale production. (14 pages, 2172 words)
Pre-production quality planning must include consideration of all significant aspects of the product, the manufacture of it, and its ultimate use. Reviews should be performed to make certain that the following two goals are fully met. Company programs and procedures will be developed and continually maintained and redefined to assure that appropriate pre-production activities are performed correctly, which will result in the orderly development and transfer into production of new or modified products.
Production processes should be planned, developed, validated, and documented to assure they will routinely achieve the intrinsic level of quality designed into the new or modified product. The adequacy of present facilities and equipment or requirements for additional space and/or equipment for manufacturing the product should be determined in conjunction with the anticipated production rate or volume.