You are managing a pharmaceutical product development project following a predictive lifecycle with strict regulatory requirements. During the testing phase, a critical test reveals unexpected results that require investigation before proceeding. This was not anticipated in the risk register. The project schedule has no float, and any delay will impact the launch date that has been publicly announced to investors. The quality manager insists on a thorough investigation that will take three weeks, while the sponsor pressures you to proceed with limited investigation to maintain the schedule. What should you do?

Question

Accepted Answer

The correct answer is D. This situation involves a conflict between schedule constraints and quality/compliance requirements in a regulated industry, which requires escalation to senior management for decision-making (ECO Process Task 1.2 - Manage project compliance). Option D is correct because the project manager should present the situation, analyze risks of each option (including regulatory, safety, and reputational risks), and allow appropriate authority levels to make this critical business decision. Option A could expose the organization to regulatory violations and safety issues. Option B might be the right technical decision but ignores legitimate business concerns and stakeholder input. Option C doesn't address the fundamental conflict between quality requirements and schedule pressure, and may not be feasible for the type of investigation required. In regulated industries, compliance and safety concerns typically override schedule pressures, but this decision should be made transparently at the appropriate organizational level with full understanding of consequences.

PMP Practice Question: Process — Predictive, Medium

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