Design Control Guidance - Food and Drug Administration
Design Control Guidance - Food and Drug Administration
Design Control Guidance - Food and Drug Administration
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the design <strong>and</strong> development plan, <strong>and</strong> the item defines, describes, or elaborates an elementof the design implementation. Examples include block diagrams, flow charts, softwarehigh-level code, <strong>and</strong> system or subsystem design specifications. The design output in onestage is often part of the design input in subsequent stages.<strong>Design</strong> output includes production specifications as well as descriptive materials whichdefine <strong>and</strong> characterize the design.PRODUCTION SPECIFICATIONS. Production specifications include drawings <strong>and</strong>documents used to procure components, fabricate, test, inspect, install, maintain, <strong>and</strong>service the device, such as the following:• assembly drawings• component <strong>and</strong> material specifications• production <strong>and</strong> process specifications• software machine code (e.g., diskette or master EPROM)• work instructions• quality assurance specifications <strong>and</strong> procedures• installation <strong>and</strong> servicing procedures• packaging <strong>and</strong> labeling specifications, including methods <strong>and</strong> processes usedIn addition, as discussed in Section H (<strong>Design</strong> Transfer), production specifications maytake on other forms. For example, some manufacturers produce assembly instructions onvideotapes rather than written instructions. Similarly, a program diskette, used by acomputer-aided milling machine to fabricate a part, would be considered a productionspecification. The videotape <strong>and</strong> the software on the program diskette are part of thedevice master record.OTHER DESCRIPTIVE MATERIALS. Other design output items might be producedwhich are necessary to establish conformance to design input requirements, but are notused in its production. For example, for each part which is fabricated by computer-aidedmachine, there should be an assembly drawing which specifies the dimensions <strong>and</strong>characteristics of the part. It is a part of the design output because it establishes the basisfor the machine tool program used to fabricate the part. Other examples of design outputinclude the following:• the results of risk analysis• software source code• results of verification activities• biocompatibility test results• bioburden test resultsFORM AND CONTENT. Manufacturers must take steps to assure that the designoutput characterizes all important aspects of the design <strong>and</strong> is expressed in terms whichSection D. <strong>Design</strong> Output 3/11/97 Page 20
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