Design Control Guidance - Food and Drug Administration

Historically, shortcomings in the production specifications tend to be manifested late in theproduct life cycle. When the design is new, there is often intensive interaction between thedesign and production teams, providing ample opportunity for undocumented informationflow. Later, as production experience is gained, some decoupling often occurs betweendesign and production teams. In addition, key personnel may leave, and their replacementsmay lack comparable training, experience, or institutional knowledge.Particular care should be taken when the product involves new and unprovedmanufacturing processes, or established processes which are new to the manufacturer. Itmay not be possible to determine the adequacy of full-scale manufacturing on the basis ofsuccessfully building prototypes or models in a laboratory and testing these prototypes ormodels. The engineering feasibility and production feasibility may be different because theequipment, tools, personnel, operating procedures, supervision and motivation could bedifferent when a manufacturer scales up for routine production.No design team can anticipate all factors bearing on the success of the design, butprocedures for design transfer should address at least the following basic elements.• First, the design and development procedures should include a qualitativeassessment of the completeness and adequacy of the production specifications.• Second, the procedures should ensure that all documents and articles whichconstitute the production specifications are reviewed and approved.• Third, the procedures should ensure that only approved specifications are used tomanufacture production devices.The first item in the preceding list may be addressed during design transfer. The secondand third elements are among the basic principles of document control and configurationmanagement. As long as the production specifications are traditional paper documents,there is ample information available to guide manufacturers in implementing suitableprocedures. When the production specifications include non-traditional means, flexibilityand creativity may be needed to achieve comparable rigor.Section H. Design Transfer 3/11/97 Page 38