Design Control Guidance - Food and Drug Administration

SECTION H. DESIGN TRANSFERI. REQUIREMENTS§ 820.30(h) Design transfer.• Each manufacturer shall establish and maintain procedures to ensure that thedevice design is correctly translated into production specifications.Cross reference to ISO 9001:1994 and ISO/DIS 13485 section 4.2.3(c) Qualityplanning.II. DISCUSSION AND POINTS TO CONSIDERProduction specifications must ensure that manufactured devices are repeatedly andreliably produced within product and process capabilities. If a manufactured devicedeviates outside those capabilities, performance may be compromised. Thus, the processof encapsulating knowledge about the device into production specifications is critical todevice quality.The level of detail necessary to accomplish this objective varies widely, based on the typeof device, the relationship between the design and manufacturing organizations, and theknowledge, experience, and skills of production workers. In some cases, devices areproduced by contract manufacturers who have no involvement in the development andlittle or no contact with the designers. At the other extreme, some devices are handcraftedby skilled artisans with extensive knowledge about the use of the product.One normally associates the term “production specifications” with written documents,such as assembly drawings, component procurement specifications, workmanshipstandards, manufacturing instructions, and inspection and test specifications. While thesetypes of documents are widely employed in medical device production, other equallyacceptable means of conveying design information exist, and manufacturers have theflexibility to employ these alternate means of communication as appropriate. For example,each of the following could constitute “production specifications” within the meaning ofthe quality system requirements:• documentation (in electronic format as well as paper)• training materials, e.g., manufacturing processes, test and inspection methods• digital data files, e.g., programmable device files, master EPROM, computer-aidedmanufacturing (CAM) programming files• manufacturing jigs and aids, e.g., molds, sample wiring harness to be duplicatedSection H. Design Transfer 3/11/97 Page 37