Design Control Guidance - Food and Drug Administration

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action. In other cases, the reviewers are given limited or broad authority to make decisionsand commit resources to resolve problems. The approach used should be documented.In the real world, reviews often leave unresolved issues. Therefore, review proceduresshould include a process for resolving differences, and provide reviewers with enoughleeway to make practical decisions while protecting the integrity of the process.Implementation of corrective actions. Not all identified concerns result in correctiveactions. The reviewers may decide that the issue is erroneous or immaterial. In most cases,however, resolution involves a design change, a requirements change, or a combination ofthe two. If the solution is evident, the reviewers may specify the appropriate correctiveaction; otherwise, an action item will be assigned to study the problem further. In anycase, action items and corrective actions are normally tracked under the manufacturer’schange control procedures.RELATIONSHIP OF DESIGN REVIEW TO VERIFICATION ANDVALIDATION. In practice, design review, verification, and validation overlap oneanother, and the relationship among them may be confusing. As a general rule, thesequence is: verification, review, validation, review.In most cases, verification activities are completed prior to the design review, and theverification results are submitted to the reviewers along with the other design output to bereviewed. Alternatively, some verification activities may be treated as components of thedesign review, particularly if the verification activity is complex and requiresmultidisciplinary review.Similarly, validation typically involves a variety of activities, including a determination thatthe appropriate verifications and reviews have been completed. Thus, at the conclusion ofthe validation effort, a review is usually warranted to assure that the validation is completeand adequate.Section E. Design Review 3/11/97 Page 28
SECTION F. DESIGN VERIFICATIONI. REQUIREMENTS§ 820.30(f) Design verification.• Each manufacturer shall establish and maintain procedures for verifying the devicedesign.• Design verification shall confirm that the design output meets the design inputrequirements.• The results of the design verification, including identification of the design,method(s), the date, and the individual(s) performing the verification, shall bedocumented in the Design History File.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.7 Designverification.I. DEFINITIONS§820.3(y) Specification means any requirement with which a product, process, service, orother activity must conform.§ 820.3(z) Validation means confirmation by examination and provision of objectiveevidence that the particular requirements for a specific intended use can be consistentlyfulfilled.(1) Process Validation means establishing by objective evidence that a processconsistently produces a result or product meeting its predetermined specifications.(2) Design Validation means establishing by objective evidence that devicespecifications conform with user needs and intended use(s).§820.3(aa) Verification means confirmation by examination and provision of objectiveevidence that specified requirements have been fulfilled.III. DISCUSSION AND POINTS TO CONSIDERVerification and validation are associated concepts with very important differences.Various organizations have different definitions for these terms. Medical deviceSection F. Design Verification 3/11/97 Page 29
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Design Control Guidance - Food and Drug Administration

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