PMP Practice: Measure Compliance Extent

When a compliance gap is discovered mid-project, the project manager must first understand the specific nature and severity of the non-compliance before taking corrective action. Meeting with the compliance officer and legal team allows Mei-Ling to assess exactly what documentation gaps exist, determine which completed work may still be acceptable, and develop a targeted remediation plan that brings the project into compliance while minimizing unnecessary rework. This approach balances the regulatory obligation with the business constraint of the fixed launch date. The compliance officer has already flagged this as critical, so assessment and planning must happen immediately, but a thoughtful remediation strategy will be more effective than either halting everything or ignoring the issue.

**Why not A:** Continuing with current validation testing to maintain schedule and updating documentation during closing is reckless in a regulated medical device environment. Completing 60% of validation testing under non-compliant documentation templates would produce test records that cannot be submitted to the FDA, meaning the work may need to be redone entirely. Deferring compliance correction to the closing phase compounds the rework and jeopardizes the launch date far more severely than addressing the gap now.

**Why not B:** Halting all validation testing immediately and escalating to the sponsor to negotiate a revised timeline assumes worst-case remediation before understanding the actual scope of the compliance gap. A full halt may be unnecessary—the gap between old and new FDA requirements may be addressable with targeted documentation updates that allow some testing to continue. Escalating for timeline renegotiation before assessing the specific gap skips the essential diagnostic step that determines what remediation is actually required.

**Why not C:** Requesting that the compliance team submit a formal change request through the change control board to determine whether new requirements apply introduces unnecessary bureaucratic delay for a regulatory matter that is already confirmed by the compliance officer. The compliance officer has flagged this as a critical issue requiring immediate resolution—its applicability is not in question. The change control process is appropriate for scope decisions, not for determining whether the organization must comply with enacted federal regulations.