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PMP Practice: Determine necessary approach and action to address compliance needs

Question 6 of 6 in Plan and Manage Project Compliance

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Bo-Wen Fang is managing a pharmaceutical manufacturing expansion project for Eamon Doyle-Brennan Biotech. The project involves constructing a new sterile production facility that must comply with FDA Good Manufacturing Practice (GMP) regulations. The regulatory framework requires extensive documentation at predefined milestones, formal validation protocols before equipment commissioning, and government inspections at specific construction phases. A team member with agile experience suggests adopting an iterative approach with two-week sprints to improve team engagement and flexibility. The construction permit requires approved architectural drawings before foundation work begins, and the FDA has scheduled compliance audits tied to specific completion gates. What approach should Bo-Wen recommend for managing this project?
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Correct answer: Use a predictive approach with phase gates aligned to regulatory milestones and formal documentation requirements

Explanation

This project operates in a highly regulated environment with fixed regulatory requirements, mandatory phase gates, and predetermined inspection points. The FDA compliance framework, construction permits requiring pre-approved designs, and GMP validation protocols demand a predictive approach with detailed upfront planning and sequential phase progression. Regulatory compliance cannot be addressed iteratively when government agencies require approved documentation before proceeding to subsequent phases. The predictive approach provides the necessary structure for managing mandatory compliance checkpoints, formal validation processes, and inspection schedules that cannot be adapted or changed mid-project. While team engagement is valuable, the regulatory constraints make this unsuitable for agile or hybrid approaches.

**Why not A:** Beginning with agile sprints and transitioning to predictive after design validation contradicts the regulatory reality of this project. The FDA has already scheduled compliance audits tied to specific completion gates, and construction permits require approved architectural drawings before foundation work begins. Starting iteratively would immediately conflict with the permit requirements that exist before a single sprint could be completed.

**Why not B:** Adopting agile sprints for the entire project would make regulatory compliance impossible. FDA GMP validation protocols and government inspections at specific construction phases require sequential, documented progression through predefined milestones. Two-week sprints cannot produce the complete documentation packages required at each compliance gate or align with the external inspection schedule set by regulators.

**Why not C:** A hybrid approach using agile for construction activities fundamentally misapplies where each methodology should go. Physical construction of a sterile manufacturing facility follows fixed sequences determined by engineering, permitting, and physical reality—it cannot be iterated. Regulatory documentation, while important, is the output of a defined process and does not drive the need for predictive scheduling; the construction sequence itself does.

Key Concept

This question covers Determine necessary approach and action to address compliance needs under Plan and Manage Project Compliance (Business Environment).

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