Design Control Guidance - Food and Drug Administration

INTRODUCTIONI. PURPOSEThis guidance is intended to assist manufacturers in understanding quality systemrequirements concerning design controls. Assistance is provided by interpreting thelanguage of the quality systems requirements and explaining the underlying concepts inpractical terms.Design controls are an interrelated set of practices and procedures that are incorporatedinto the design and development process, i.e., a system of checks and balances. Designcontrols make systematic assessment of the design an integral part of development. As aresult, deficiencies in design input requirements, and discrepancies between the proposeddesigns and requirements, are made evident and corrected earlier in the developmentprocess. Design controls increase the likelihood that the design transferred to productionwill translate into a device that is appropriate for its intended use.In practice, design controls provide managers and designers with improved visibility of thedesign process. With improved visibility, managers are empowered to more effectivelydirect the design process—that is, to recognize problems earlier, make corrections, andadjust resource allocations. Designers benefit both by enhanced understanding of thedegree of conformance of a design to user and patient needs, and by improvedcommunications and coordination among all participants in the process.The medical device industry encompasses a wide range of technologies and applications,ranging from simple hand tools to complex computer-controlled surgical machines, fromimplantable screws to artificial organs, from blood-glucose test strips to diagnosticimaging systems and laboratory test equipment. These devices are manufactured bycompanies varying in size and structure, methods of design and development, and methodsof management. These factors significantly influence how design controls are actuallyapplied. Given this diversity, this guidance does not suggest particular methods ofimplementation, and therefore, must not be used to assess compliance with the qualitysystem requirements. Rather, the intent is to expand upon the distilled language of thequality system requirements with practical explanations and examples of design controlprinciples. Armed with this basic knowledge, manufacturers can and should seek outtechnology-specific guidance on applying design controls to their particular situation.When using this guidance, there could be a tendency to focus only on the time and effortrequired in developing and incorporating the controls into the design process. However,readers should keep in mind the intrinsic value of design controls as well. It is a wellestablishedfact that the cost to correct design errors is lower when errors are detectedearly in the design and development process. Large and small companies that haveachieved quality systems certification under ISO 9001 cite improvements in productivity,product quality, customer satisfaction, and company competitiveness. Additional benefitsIntroduction 3/11/97 Page 1