CAPA CAPA Change Control & Management 1 — Questions and Answers
Question 1: What is the primary purpose of change control within a CAPA system?
- To ensure changes are documented, reviewed, and approved before implementation (Correct answer)
- To speed up the correction process without delays
- To eliminate all process changes after a CAPA is opened
- To assign blame for quality failures
Correct answer: To ensure changes are documented, reviewed, and approved before implementation
Change control ensures that any modification to a process, product, or system is formally evaluated and authorized before it is enacted.
Question 2: Which document typically initiates the formal change control process within a CAPA?
- Change Request (CR) (Correct answer)
- Deviation Report
- Complaint Record
- Audit Finding Log
Correct answer: Change Request (CR)
A Change Request formally describes the proposed change, its rationale, and its potential impact, triggering the review and approval workflow.
Question 3: In the context of CAPA, what does 'impact assessment' during change control evaluate?
- The potential effect of the change on product quality, safety, and regulatory compliance (Correct answer)
- The cost savings expected from the change
- The number of employees affected by the change
- The timeline for implementing the change
Correct answer: The potential effect of the change on product quality, safety, and regulatory compliance
Impact assessment identifies all systems, processes, and documents that may be affected so that risks to quality and compliance are understood before approval.
Question 4: When must a CAPA-driven change be verified before full implementation in a regulated US environment?
- After a risk-based review confirms the change does not introduce new hazards (Correct answer)
- Only when a customer requests verification
- After annual management review
- Verification is optional if the change is minor
Correct answer: After a risk-based review confirms the change does not introduce new hazards
21 CFR Part 820 and FDA expectations require that changes be verified or validated as appropriate before implementation to ensure they achieve the desired outcome without introducing new risk.
Question 5: Which of the following best describes 'uncontrolled change' in a CAPA context?
- A modification implemented without formal approval, documentation, or assessment (Correct answer)
- A change approved only by the department manager
- A minor wording update to an SOP
- A change reviewed during a management meeting
Correct answer: A modification implemented without formal approval, documentation, or assessment
Uncontrolled change bypasses the formal change control process, creating regulatory risk and potential product quality issues.
Question 6: How should obsolete procedures affected by a CAPA-driven change be handled under change control?
- They should be formally retired, archived, and replaced with updated versions (Correct answer)
- They should be kept active to maintain historical reference
- They should be deleted immediately from all systems
- They require no action if the change is minor
Correct answer: They should be formally retired, archived, and replaced with updated versions
Proper document control requires that superseded procedures are formally retired and archived so only current, approved versions are in use.
CAPA CAPA Change Control & Management 1
What is the primary purpose of change control within a CAPA system?