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Verification and PM's

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(@mmk68)
Posts: 30
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[#1578]

In the first simulation that we were given this week, we met with an issue where a part of a product failed verification testing, and we had to propose ideas to rectify that. In a real-world situation, what would the overlap between the Project Manager and the verification team be? How would the R&D teams fit in? I would assume the project manager and verification team should be independent to prevent any biases during the testing, however, verification is an important part of a product's development. Have you encountered any situations similar to the project simulation in a corporate environment? How were they resolved?


 
Posted : 15/02/2026 9:12 pm
(@jacobthomas64)
Posts: 25
Eminent Member
 

In real-world product development, especially in regulated industries like medical devices, the Project Manager (PM), Verification team, and R&D team have distinct but coordinated roles: the PM owns schedule, budget, risk tracking, and cross-functional communication; the Verification team independently designs and executes test protocols to confirm that the product meets predefined requirements; and R&D designs the product, investigates failures, and implements technical fixes. While the PM and Verification team overlap in planning timelines, resource allocation, and risk discussions, the PM should not influence test outcomes, as verification must remain objective to prevent bias, particularly under schedule pressure. When a component fails verification, the typical process is that Verification documents the failure, the PM assesses the impact on milestones and escalates as needed, and R&D conducts root cause analysis and proposes corrective actions, followed by controlled design changes and re-testing. In mature organizations, Verification often reports through Quality or Regulatory rather than directly to the PM to preserve independence, while strong documentation systems (such as design controls and change management processes) ensure traceability and compliance. Situations like the simulation are common in corporate environments, and successful resolution typically involves transparent communication, data-driven decision-making, structured root cause analysis, and a willingness to delay timelines if necessary to ensure safety, performance, and regulatory integrity rather than compromising standards to meet launch dates.


 
Posted : 15/02/2026 11:33 pm
(@andres-86)
Posts: 60
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I agree that in the real world, with a regulated environment in medical device development, there has to be a clear separation between roles while still maintain collaboration. The PM should not influence the verification outcomes, but they would absolutely NEED visibility into what the results are because verification failure directly impacts the timeline and scope of the entire project. In regards to our simulation, the verification team identified a failure during the submersion testing (as for everyone else). There is a situation where that team would document the failure formally and escalate it through quality systems. The PM would then be able to evaluate the schedule impact and coordinate discussions across all systems, but would not be able to dictate how the data could be interpreted. With that said, the simulations help greatly, as I myself have not encountered a real world situation involving these kinds of devices in a corporate environment.


 
Posted : 16/02/2026 12:56 am
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