CAPA CAPA Change Control & Management 2 — Questions and Answers
Question 1: What role does a Configuration Management Board (CMB) or Change Control Board (CCB) typically play in CAPA-driven changes?
- It reviews, approves, or rejects proposed changes based on technical and regulatory criteria (Correct answer)
- It only tracks the financial cost of changes
- It trains employees on the new change
- It generates the initial deviation report
Correct answer: It reviews, approves, or rejects proposed changes based on technical and regulatory criteria
A CCB provides cross-functional oversight to ensure proposed changes are thoroughly evaluated before authorization.
Question 2: Which FDA regulation specifically requires medical device manufacturers to establish and maintain change control procedures?
- 21 CFR 820.70(b) (Correct answer)
- 21 CFR 211.68
- 21 CFR 600.14
- 21 CFR 58.81
Correct answer: 21 CFR 820.70(b)
21 CFR 820.70(b) mandates that device manufacturers establish change control procedures to ensure process changes are reviewed and approved.
Question 3: What is 'design change control' in the context of a CAPA for a medical device?
- A formal process to manage changes to device design and ensure they meet design input requirements (Correct answer)
- A log of cosmetic changes to product packaging
- An informal process for minor design tweaks
- A customer complaint handling system
Correct answer: A formal process to manage changes to device design and ensure they meet design input requirements
Design change control per 21 CFR 820.30(i) ensures that any modification to device design is reviewed, verified, validated, and approved before implementation.
Question 4: Why is it critical to re-validate a process after a CAPA-driven change in a pharmaceutical manufacturing environment?
- Because changes can alter process parameters that were previously validated, potentially affecting product quality (Correct answer)
- Because the FDA requires annual re-validation regardless of changes
- Because validation is a one-time activity that resets with each CAPA
- Because customer complaints require re-validation
Correct answer: Because changes can alter process parameters that were previously validated, potentially affecting product quality
Changes to validated processes can invalidate previous qualification data, making re-validation necessary to confirm the process still consistently produces acceptable results.
Question 5: In CAPA change management, what is the significance of a 'change effectiveness check'?
- It confirms that the implemented change achieved its intended purpose without introducing new issues (Correct answer)
- It measures the cost of the change after implementation
- It tracks how many employees were trained on the change
- It schedules the next audit of the changed process
Correct answer: It confirms that the implemented change achieved its intended purpose without introducing new issues
A change effectiveness check verifies that the change resolved the original problem and did not create unintended negative effects on quality or compliance.
Question 6: What should be done if a CAPA-driven change is found to have introduced a new quality issue during the change effectiveness check?
- Open a new CAPA or deviation to address the newly identified issue (Correct answer)
- Reverse the change without documentation
- Close the original CAPA and ignore the new issue
- Wait until the next scheduled audit to address it
Correct answer: Open a new CAPA or deviation to address the newly identified issue
A newly discovered quality issue must be formally documented and addressed through the quality system, which may require initiating a new CAPA.
CAPA CAPA Change Control & Management 2
What role does a Configuration Management Board (CMB) or Change Control Board (CCB) typically play in CAPA-driven changes?