Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the design requirements that were in place for that product. We were verifying a modification of an existing product, so there was hesitance in changing the specifications from the original product that already passed verification and validation, received regulatory approval, and was currently distributed in the market.
One of the verification tests showed failures in a specification that was associated with minimal risk to the patient. The first action that the team took was to evaluate the results from the study to create a hypothesis for the shown failures. Then we conducted another study with a larger sample size to further evaluate the root cause and determine if there was a possibility for developing an acceptance criteria of the failure. Even though the failure was classified as minimal risk, the additional study demonstrated that the failure was randomized, ultimately meaning that there were concerns in quality control of the product, resulting in purchasing new manufacturing equipment, being a much larger impact than anticipating when reviewing the initial results.
The other failed verification test was associated with packaging verification. One of the larger packaging configurations failed the drop test. The team reviewed the requirement in place for the height of the drop test, and since it was consistent with our other products and aligned with our SOP, we were not in favor for changing the specification. Instead we evaluated alternatives for the adhesive being used on the associated configuration, resulting in a resolution that didn’t impact the current budget or schedule for the project.