Production Specifications

Production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. 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. 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