Medical Device Design Control: Design Transfer

The FDA device guidance require that each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Production specifications must ensure that manufactured devices are repetitively 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.

Production specifications is usually associated with written documents, such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications. 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

All the factors cannot be anticipated 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.

Source:

Related Training: