Damn...we failed design verification testing!

Sam Lazzara
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I can think of 3 options when an 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.  Retesting on product made after the corrective action implementation is required.

Sam Lazzara
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