Design Control Guidance - Food and Drug Administration

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Another self-documenting verification method is the traceability matrix. This method isparticularly useful when the design input and output are both documents; it also has greatutility in software development. In the most common form of the traceability matrix, theinput requirements are enumerated in a table, and references are provided to each sectionin the output documents (or software modules) which address or satisfy each inputrequirement. The matrix can also be constructed “backwards,” listing each feature in thedesign output and tracing which input requirement bears on that feature. This reverseapproach is especially useful for detecting hidden assumptions. Hidden assumptions aredangerous because they often lead to overdesign, adding unnecessary cost and complexityto the design. In other cases, hidden assumptions turn out to be undocumented designinput requirements which, once exposed, can be properly tracked and verified.However, many verification activities are simply some sort of structured assessment of thedesign output relative to the design input. When this is the case, manufacturers maydocument completion of verification activities by linking these activities with the signoffprocedures for documents. This may be accomplished by establishing a procedurewhereby each design output document must be verified and signed by designated persons.The presence of the reviewers’ signatures on the document signifies that the design outputhas been verified in accordance with the signoff procedure.Section F. Design Verification 3/11/97 Page 32
SECTION G. DESIGN VALIDATIONI. REQUIREMENTS§ 820.30(g) Design validation.• Each manufacturer shall establish and maintain procedures for validating the devicedesign.• Design validation shall be performed under defined operating conditions on initialproduction units, lots, or batches, or their equivalents.• Design validation shall ensure that devices conform to defined user needs andintended uses and shall include testing of production units under actual orsimulated use conditions.• Design validation shall include software validation and risk analysis, whereappropriate.• The results of the design validation, including identification of the design,method(s), the date, and the individual(s) performing the validation, shall bedocumented in the Design History File.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.8 Designvalidation.II. 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.Section G. Design Validation 3/11/97 Page 33
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Design Control Guidance - Food and Drug Administration

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