Damn…we failed verification testing!

 I can think of 3 options when engineering specification (design verification spec) is not met.

1. Change the specification based on a technical justification and comparison to design validation results if available (actual clinical use is the best design validation if it is applicable to the design that failed verification testing). No retesting is required – if it meets the intended use and user needs that is a great justification for “loosening” the engineering specification.

Note – For this approach it is important to look at how the engineering spec was originally derived. The original logic must have been flawed.

2. Find fault with the test method (either human-error or equipment deviations from the approved method or other problems encountered with the method as written). Retesting using the correct test method is required.

3. Implement a corrective action for the product design or manufacturing process.  Testing product made after the corrective action implementation is required.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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