hardMultiple ChoiceObjective-mapped
PK0-005 Practice Question: A project manager is managing a project to…
A project manager is managing a project to develop a new medical device. The project is subject to strict regulatory compliance. Halfway through the project, an audit reveals that several design documents were not properly reviewed and approved as required by the quality management plan. The project manager must address this noncompliance. The project is already behind schedule. What should the project manager do FIRST?
⚠ Common exam trap
CompTIA often tests the misconception that reporting noncompliance (Option A) or working around it (Option B) is acceptable, but the correct first step in a regulated environment is always to stop the noncompliant work to prevent further deviation.
Answer choices
Why each option matters
Answer the question above first, then reveal the full breakdown to understand why each option is right or wrong.
Correct answer & explanation
✓
Stop work on the affected tasks until the documents are properly reviewed.
In a regulated medical device project, noncompliance with the quality management plan (QMP) must be addressed immediately to avoid regulatory penalties, product recalls, or legal liability. Stopping work on affected tasks ensures that no further noncompliant work is performed, and the design documents can be properly reviewed and approved before proceeding, which is a fundamental requirement of ISO 13485 and FDA 21 CFR Part 820. This action also protects the project from cascading defects that would be far more costly to fix later.
Answer analysis
Option-by-option breakdown
For each option: why learners choose it and why it is or isn't the right answer here.
- ✗
Document the noncompliance and inform the project sponsor.
Why it's wrong here
While necessary, action to correct the noncompliance should be taken first.
- ✗
Continue work and retroactively review the documents to save time.
Why it's wrong here
Retroactive review may not satisfy regulatory requirements.
- ✗
Request a waiver from the regulatory body for the missing reviews.
Why it's wrong here
Regulatory waivers are unlikely and time-consuming.
- ✓
Stop work on the affected tasks until the documents are properly reviewed.
Why this is correct
Stopping noncompliant work protects the project from further issues.
Go deeper
Related to this question
About these practice questions
This PK0-005 question is part of Courseiva's 980-question bank — original exam-style content with full explanations and wrong-answer analysis, never real exam questions or exam dumps. Learn why practice questions differ from exam dumps →
JA
Written by Johnson Ajibi, MSc IT Security
Senior Network & Security Engineer · founder of Courseiva
This PK0-005 practice question is part of Courseiva's free CompTIA certification practice question bank. Courseiva provides original exam-style practice questions with explanations, topic-based practice, mock exams, readiness tracking, and study analytics to help learners prepare for the PK0-005 exam.