Tuttle, John P. (1988, ASQC) Millipore Corporation, Bedford, MA
The introduction of a new product into the marketplace involves learning how to reliably manufacture the product in a Pilot Production Facility. This paper describes the unique quality considerations that must be understood and managed in a pilot manufacturing environment. The early life cycle of a new product poses many quality challenges. Assuring "Quality Excellence" in Pilot Production requires a unique quality management approach. Many vendors are new and not fully qualified. Purchase specifications are preliminary and evolving with the product and process. Significant process variables that must be controlled are being discovered and refined. New technologies must be learned and perfected. Customer expectations and requirements have not been fully tested. Product applications may be new and optimum quality requirements may not be well understood. Process capability studies must be performed repeatedly as process changes take place. Product documentation must be created and continuously updated to reflect the process as it matures. Pilot Production quality programs should also take into consideration the eventual transfer of the product and processes to a full production facility where the product and process must be requalified. The answer to quality excellence in Pilot Production involves establishing and maintaining quality programs that cannot be executed in the traditional manner. The philosophy and systems developed at Millipore to address these important quality considerations are discussed in detail in this paper. The programs necessary for Pilot Production Quality Excellence are also explained relative to traditional quality concepts.