SECTION H. DESIGN TRANSFER

I. REQUIREMENTS

§ 820.30(h) Design transfer.

• Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Cross reference to ISO 9001:1994 and ISO/DIS 13485 section 4.2.3(c) Quality planning.

II. DISCUSSION AND POINTS TO CONSIDER

Production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. If a manufactured device deviates outside those capabilities, performance may be compromised. Thus, the process of encapsulating knowledge about the device into production specifications is critical to device quality.

The level of detail necessary to accomplish this objective varies widely, based on the type of device, the relationship between the design and manufacturing organizations, and the knowledge, experience, and skills of production workers. In some cases, devices are produced by contract manufacturers who have no involvement in the development and little or no contact with the designers. At the other extreme, some devices are hand-crafted by 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, workmanship standards, manufacturing instructions, and inspection and test specifications. While these types of documents are widely employed in medical device production, other equally acceptable means of conveying design information exist, and manufacturers have the flexibility to employ these alternate means of communication as appropriate. For example, each of the following could constitute "production specifications" within the meaning of the 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-aided manufacturing (CAM) programming files
• manufacturing jigs and aids, e.g., molds, sample wiring harness to be duplicated

Historically, shortcomings in the production specifications tend to be manifested late in the product life cycle. When the design is new, there is often intensive interaction between the design and production teams, providing ample opportunity for undocumented information flow. Later, as production experience is gained, some decoupling often occurs between design and production teams. In addition, key personnel may leave, and their replacements may lack comparable training, experience, or institutional knowledge.

Particular care should be taken when the product involves new and unproved manufacturing processes, or established processes which are new to the manufacturer. It may not be possible to determine the adequacy of full-scale manufacturing on the basis of successfully building prototypes or models in a laboratory and testing these prototypes or models. The engineering feasibility and production feasibility may be different because the equipment, tools, personnel, operating procedures, supervision and motivation could be different when a manufacturer scales up for routine production.

No design team can anticipate all factors bearing on the success of the design, but procedures for design transfer should address at least the following basic elements.

• First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the production specifications.
• Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
• Third, the procedures should ensure that only approved specifications are used to manufacture production devices.

The first item in the preceding list may be addressed during design transfer. The second and third elements are among the basic principles of document control and configuration management. As long as the production specifications are traditional paper documents, there is ample information available to guide manufacturers in implementing suitable procedures. When the production specifications include non-traditional means, flexibility and creativity may be needed to achieve comparable rigor.