Design Control Guidance - Food and Drug Administration

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III. DISCUSSION AND POINTS TO CONSIDERWhereas verification is a detailed examination of aspects of a design at various stages inthe development, design validation is a cumulative summation of all efforts to assure thatthe design will conform with user needs and intended use(s), given expected variations incomponents, materials, manufacturing processes, and the use environment.VALIDATION PLANNING. Planning for validation should begin early in the designprocess. The performance characteristics that are to be assessed should be identified, andvalidation methods and acceptance criteria should be established. For complex designs, aschedule of validation activities and organizational or individual responsibilities willfacilitate maintaining control over the process. The validation plan should be reviewed forappropriateness, completeness, and to ensure that user needs and intended uses areaddressed.VALIDATION REVIEW. Validation may expose deficiencies in the originalassumptions concerning user needs and intended uses. A formal review process should beused to resolve any such deficiencies. As with verification, the perception of a deficiencymight be judged insignificant or erroneous, or a corrective action may be required.VALIDATION METHODS. Many medical devices do not require clinical trials.However, all devices require clinical evaluation and should be tested in the actual orsimulated use environment as a part of validation. This testing should involve deviceswhich are manufactured using the same methods and procedures expected to be used forongoing production. While testing is always a part of validation, additional validationmethods are often used in conjunction with testing, including analysis and inspectionmethods, compilation of relevant scientific literature, provision of historical evidence thatsimilar designs and/or materials are clinically safe, and full clinical investigations or clinicaltrials.Some manufacturers have historically used their best assembly workers or skilled labtechnicians to fabricate test articles, but this practice can obscure problems in themanufacturing process. It may be beneficial to ask the best workers to evaluate andcritique the manufacturing process by trying it out, but pilot production should simulate asclosely as possible the actual manufacturing conditions.Validation should also address product packaging and labeling. These components of thedesign may have significant human factors implications, and may affect productperformance in unexpected ways. For example, packaging materials have been known tocause electrostatic discharge (ESD) failures in electronic devices. If the unit under test isdelivered to the test site in the test engineer’s briefcase, the packaging problem may notbecome evident until after release to market.Validation should include simulation of the expected environmental conditions, such astemperature, humidity, shock and vibration, corrosive atmospheres, etc. For some classesSection G. Design Validation 3/11/97 Page 34
of device, the environmental stresses encountered during shipment and installation farexceed those encountered during actual use, and should be addressed during validation.Particular care should be taken to distinguish among customers, users, and patients toensure that validation addresses the needs of all relevant parties. For a consumer device,the customer, user, and patient may all be the same person. At the other extreme, theperson who buys the device may be different from the person who routinely uses it onpatients in a clinical setting. Hospital administrators, biomedical engineers, healthinsurance underwriters, physicians, nurses, medical technicians, and patients have distinctand sometimes competing needs with respect to a device design.VALIDATION DOCUMENTATION. Validation is a compilation of the results of allvalidation activities. For a complex design, the detailed results may be contained in avariety of separate documents and summarized in a validation report. Supportinginformation should be explicitly referenced in the validation report and either included asan appendix or available in the design history file.Section G. Design Validation 3/11/97 Page 35
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Page 7: TABLE OF CONTENTSFOREWORD .........
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Page 18 and 19: design and development team, and pr
Page 20 and 21: more likely to be made with appropr
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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
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Page 48 and 49: DOCUMENT CONTROL. The features of a
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Page 52 and 53: software in each machine. The contr

Design Control Guidance - Food and Drug Administration

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