PMP Practice: Determine Threats to Compliance

Tomáš Kovář-Novotný is managing a pharmaceutical packaging automation project for Sisu Aerospace. The project involves installing robotic systems in a facility that must comply with FDA Good Manufacturing Practice (GMP) regulations. During the construction phase, the compliance officer discovers that three equipment vendors have provided certificates of conformance, but the project's quality assurance plan only requires verification testing for equipment critical to product sterility—not for the robotic packaging line components. The compliance officer warns that recent FDA guidance now recommends validation testing for all automated systems that interface with regulated products, even packaging. The project baseline includes validation for sterility equipment only, and adding comprehensive robotic validation would require an additional four weeks and $180,000. The project sponsor emphasizes staying on schedule to meet a product launch date tied to a major customer contract. Which approach would be MOST effective for measuring compliance in this situation?