Design Control Guidance - Food and Drug Administration

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III. DISCUSSION AND POINTS TO CONSIDERThe essential quality aspects and the regulatory requirements, such as safety, performance,and dependability of a product (whether hardware, software, services, or processedmaterials) are established during the design and development phase. Deficient design canbe a major cause of quality problems.The context within which product design is to be carried out should be set by themanufacturer’s senior management. It is their responsibility to establish a design anddevelopment plan which sets the targets to be met. This plan defines the constraintswithin which the design is to be implemented.The quality system requirements do not dictate the types of design process that amanufacturer must use. Manufacturers should use processes best suited to their needs.However, whatever the processes may be, it is important that the design controls areapplied in an appropriate manner. This guidance document contains examples of how thismight be achieved in a variety of situations.It is important to note that the design function may apply to various facets of the operationhaving differing styles and time scales. Such facets are related to products, includingservices and software, as well as to their manufacturing processes.Senior management needs to decide how the design function is to be managed and bywhom. Senior management should also ensure that internal policies are established fordesign issues such as:• assessing new product ideas• training and retraining of design managers and design staff• use of consultants• evaluation of the design process• product evaluation, including third party product certification and approvals• patenting or other means of design protectionIt is for senior management to ensure that adequate resources are available to carry outthe design in the required time. This may involve reinforcing the skills and equipmentavailable internally and/or obtaining external resources.Section A General 3/11/97 Page 8
SECTION B. DESIGN AND DEVELOPMENT PLANNINGI. REQUIREMENTS§ 820.30(b) Design and development planning.• Each manufacturer shall establish and maintain plans that describe or reference thedesign and development activities and define responsibility for implementation.• The plans shall identify and describe the interfaces with different groups oractivities that provide, or result in, input to the design and development process.• The plans shall be reviewed, updated, and approved as design and developmentevolves.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 sections 4.4.2 Design anddevelopment planning and 4.4.3 Organizational and technical interfaces.II. DISCUSSION AND POINTS TO CONSIDERDesign and development planning is needed to ensure that the design process isappropriately controlled and that device quality objectives are met. The plans must beconsistent with the remainder of the design control requirements. The following elementswould typically be addressed in the design and development plan or plans:• Description of the goals and objectives of the design and development program;i.e., what is to be developed;• Delineation of organizational responsibilities with respect to assuring qualityduring the design and development phase, to include interface with anycontractors;• Identification of the major tasks to be undertaken, deliverables for each task, andindividual or organizational responsibilities (staff and resources) for completingeach task;• Scheduling of major tasks to meet overall program time constraints;• Identification of major reviews and decision points;• Selection of reviewers, the composition of review teams, and procedures to befollowed by reviewers;• Controls for design documentation;• Notification activities.Planning enables management to exercise greater control over the design and developmentprocess by clearly communicating policies, procedures, and goals to members of theSection B Design and Development Planning 3/11/97 Page 9
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Page 32 and 33: capabilities. The external focus is
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Design Control Guidance - Food and Drug Administration

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