ExpertPMP · Question 01 · Task 1: Plan and manage project compliance
A project manager is leading a medical device development project. During the execution phase, a team member suggests a minor modification to the device's casing material to reduce costs by 15%. This change would not affect functionality but involves a material not originally listed in the FDA compliance documentation approved during planning. The project is currently over budget.<br/><br/>What should the project manager do FIRST?
A project manager is leading a medical device development project. During the execution phase, a team member suggests a minor modification to the device's casing material to reduce costs by 15%. This change would not affect functionality but involves a material not originally listed in the FDA compliance documentation approved during planning. The project is currently over budget.<br/><br/>What should the project manager do FIRST?
Answer options:
Approve the change to address the budget variance as it does not impact functionality.
Review the compliance requirements and assess the impact of the material change on regulatory approval.
Reject the change immediately because the material was not in the original plan.
Submit a change request to the Change Control Board (CCB) to update the cost baseline.
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