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?

Question

Accepted Answer

The correct answer is D. Before making decisions about rework, budget impacts, or process improvements, the project manager must first understand the complete scope of the problem. Auditors found 12 non-conforming deliverables, but this was from a sample or partial review—there may be additional issues in the remaining Phase 1 work. In a regulated environment like pharmaceutical development, incomplete assessment could lead to later FDA rejections or product recalls. Only after fully assessing the situation can appropriate corrective actions be determined. Option A is the main distractor because escalation seems appropriate for a significant cost/schedule impact, but escalating with incomplete information prevents the sponsor from making an informed decision. The project manager's responsibility is to first gather complete data about the extent of non-conformance, then present options with full cost, schedule, and regulatory risk implications.

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