Design Control Guidance - Food and Drug Administration

patient. Because the problem was not identified until the design was near completion, anexpensive, independent, back-up timer had to be added to monitor exposure times.THE QUALITY SYSTEM AND DESIGN CONTROLS. In addition to proceduresand work instructions necessary for the implementation of design controls, policies andprocedures may also be needed for other determinants of device quality that should beconsidered during the design process. The need for policies and procedures for thesefactors is dependent upon the types of devices manufactured by a company and the risksassociated with their use. Management with executive responsibility has the responsibilityfor determining what is needed.Example of topics for which policies and procedures may be appropriate are:• risk management• device reliability• device durability• device maintainability• device serviceability• human factors engineering• software engineering• use of standards• configuration management• compliance with regulatory requirements• device evaluation (which may include third party product certification or approval)• clinical evaluations• document controls• use of consultants• use of subcontractors• use of company historical dataIntroduction 3/11/97 Page 6