Question

Your pharmaceutical project is developing a new drug formulation with strict FDA validation requirements. The project is using a stage-gate approach with formal quality reviews at each phase. During the Phase 2 gate review, quality auditors identify that 12 of 47 deliverables from Phase 1 do not fully meet the documented acceptance criteria, though they passed initial reviews. Reworking these deliverables will cost $340,000 and delay the project by 6 weeks. The Phase 1 project manager, who has since left the company, approved these deliverables based on verbal agreements with stakeholders that differ from the documented requirements. What should you do FIRST?

Accepted Answer

Review all Phase 1 deliverables against documented requirements to determine the full scope of non-conformance before taking corrective action

Answer

Escalate to the sponsor to determine whether to proceed with rework or negotiate revised acceptance criteria with stakeholders and regulatory advisors

Answer

Conduct a root cause analysis of the quality control process failure and implement corrective actions to prevent recurrence in future phases

Answer

Document the variance in a change request, obtain stakeholder approval for the rework, and update the project schedule and budget baselines

PMP Practice Question: Process — Predictive, Hard

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