Design Verification

This blog talks about design verification. The main purpose of design
verification is to ensure design outputs met design input requirements.

Design Input = Design Output

Design verifications can be carried out at various phases of the design and can applied to individual components or subsystems as well as the whole design. This verification strategy is to ensure that any one phase or from one subsystem is verified before it is used as design input in the next phase or for another subsystem.

The project manager decides which verification methods are deployed to verify design outputs. Verification method deployed shall be the most appropriate for that subassembly, component or the whole device. Examples of commonly used design verification methods are shown below:

Analysis, Calculations, Checks, Comparisons with similar proven designs, FMEA (Failure Mode and Effects Analysis), Measurements, Studies, Simulations, Tests, Thermal Analysis and Reviews.

Results of these verification reviews are documented in the minutes of design review meetings. If there are distinct design verification activities, such as studies, analyses, calculations and tests are planned and scheduled in the Design Project Plan. Results of these verifications are usually documented in special reports. Records of these verifications are the approval and release signatures on design output documents.

Should there a case when the design does not meet requirements and must be modified or corrected, all necessary actions to rectify the problems are documented and their implementation is recorded clearly and in detail.

As usual, all design verification records include design review minutes, date of the verification, the name of the individual(s) performing the verification, attachment of any verification reports, special reports, studies etc are maintained and updated in the Design History File (DHF).

Reference	Criteria
21 CFR 820.30(f)	Has the company established and maintained procedures for verifying the device design?
21 CFR 820.30(f)	Does design verification confirm that the design output meets the design input requirements?
21 CFR 820.30(f)	Are he results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, documented in the DHF?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.