Design Control Guidance - Food and Drug Administration

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are described in comments received from a quality assurance manager of a medical devicefirm regarding the value of a properly documented design control system:“...there are benefits to an organization and the quality improvement of anorganization by having a written design control system. By defining this system onpaper, a corporation allows all its employees to understand the requirements, theprocess, and expectations of design and how the quality of design is assured andperceived by the system. It also provides a baseline to review the systemperiodically for further improvements based on history, problems, and failures ofthe system (not the product).”II. SCOPEThe guidance applies to the design of medical devices as well as the design of theassociated manufacturing processes. The guidance is applicable to new designs as well asmodifications or improvements to existing device designs. The guidance discussessubjects in the order in which they appear in FDA's Quality System regulation and is crossreferencedto International Organization for Standards (ISO) 9001:1994, QualitySystems⎯Model for Quality Assurance in Design, Development, Production,Installation, and Servicing, and the ISO draft international standard ISO/DIS 13485,Quality Systems⎯Medical Devices⎯Particular Requirements for the Application of ISO9001, dated April 1996.Design controls are a component of a comprehensive quality system that covers the life ofa device. The assurance process is a total systems approach that extends from thedevelopment of device requirements through design, production, distribution, use,maintenance, and eventually, obsolescence. Design control begins with development andapproval of design inputs, and includes the design of a device and the associatedmanufacturing processes.Design control does not end with the transfer of a design to production. Design controlapplies to all changes to the device or manufacturing process design, including thoseoccurring long after a device has been introduced to the market. This includesevolutionary changes such as performance enhancements as well as revolutionary changessuch as corrective actions resulting from the analysis of failed product. The changes arepart of a continuous, ongoing effort to design and develop a device that meets the needsof the user and/or patient. Thus, the design control process is revisited many times duringthe life of a product.Some tools and techniques are described in the guidance. Although aspects of their utilityare sometimes described, they are included in the guidance for illustrative purposes only.Including them does not mean that they are preferred. There may be alternative ways thatare better suited to a particular manufacturer and design activity. The literature contains anabundance of information on tools and techniques. Such topics as project management,design review, process capability, and many others referred to in this guidance areIntroduction 3/11/97 Page 2
available in textbooks, periodicals, and journals. As a manufacturer applies design controlsto a particular task, the appropriate tools and techniques used by competent personnelshould be applied to meet the needs of the unique product or process for thatmanufacturer.III. APPLICATION OF DESIGN CONTROLSDesign controls may be applied to any product development process. The simple exampleshown in Figure 1 illustrates the influence of design controls on a design process.UserNeedsR eviewDesignInputDesignProcessv erificationDesignOutputMedicalDeviceV alidationFigure 1 – Application of Design Controls to Waterfall Design Process (figure used withpermission of Medical Devices Bureau, Health Canada)The development process depicted in the example is a traditional waterfall model. Thedesign proceeds in a logical sequence of phases or stages. Basically, requirements aredeveloped, and a device is designed to meet those requirements. The design is thenevaluated, transferred to production, and the device is manufactured. In practice,feedback paths would be required between each phase of the process and previous phases,representing the iterative nature of product development. However, this detail has beenomitted from the figure to make the influence of the design controls on the design processmore distinct.Introduction 3/11/97 Page 3
Page 1: Center for Devices and Radiological
Page 5 and 6: PREFACEEffective implementation of
Page 7: TABLE OF CONTENTSFOREWORD .........
Page 12 and 13: The importance of the design input
Page 14 and 15: patient. Because the problem was no
Page 16 and 17: III. DISCUSSION AND POINTS TO CONSI
Page 18 and 19: design and development team, and pr
Page 20 and 21: more likely to be made with appropr
Page 22 and 23: Unfortunately, there are a number o
Page 24 and 25: SCOPE AND LEVEL OF DETAIL. Design i
Page 26 and 27: • The environment in which the pr
Page 28 and 29: the design and development plan, an
Page 30 and 31: Section D. Design Output 3/11/97 Pa
Page 32 and 33: capabilities. The external focus is
Page 34 and 35: Qualifications. Formal design revie
Page 36 and 37: action. In other cases, the reviewe
Page 38 and 39: manufacturers are encouraged to use
Page 40 and 41: Another self-documenting verificati
Page 42 and 43: III. DISCUSSION AND POINTS TO CONSI
Page 44 and 45: Section G. Design Validation 3/11/9
Page 46 and 47: Historically, shortcomings in the p
Page 48 and 49: DOCUMENT CONTROL. The features of a
Page 50 and 51: Section I. Design Changes 3/11/97 P
Page 52 and 53: software in each machine. The contr

Design Control Guidance - Food and Drug Administration

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