CAPA Root Cause Analysis & Investigation Techniques 1 — Questions and Answers
Question 1: What is the purpose of root cause analysis in the CAPA process?
- Assign blame to departments
- Generate audit reports
- Find the underlying reason for a problem (Correct answer)
- Track employee absences
Correct answer: Find the underlying reason for a problem
Root cause analysis is used to identify the underlying cause of a nonconformity to prevent recurrence.
Question 2: Which of the following tools is commonly used in root cause analysis?
- Gantt Chart
- Fishbone Diagram (Correct answer)
- Control Chart
- Flowchart
Correct answer: Fishbone Diagram
The Fishbone Diagram helps visualize and categorize possible causes of a problem, supporting systematic analysis.
Question 3: Which technique is used to drill down through layers of symptoms to find the root cause?
- Pareto Analysis
- 5 Whys (Correct answer)
- SWOT Analysis
- Pugh Matrix
Correct answer: 5 Whys
The '5 Whys' technique involves asking 'why' multiple times to explore the cause-and-effect relationships.
Question 4: What is the benefit of a multidisciplinary team in CAPA investigations?
- Reduces documentation
- Eliminates team meetings
- Ensures broader analysis of issues (Correct answer)
- Simplifies purchasing decisions
Correct answer: Ensures broader analysis of issues
A multidisciplinary team brings diverse perspectives and expertise, improving the accuracy and completeness of the investigation.
Question 5: Which factor is most important when selecting a root cause analysis method?
- Availability of budget
- Issue complexity (Correct answer)
- Number of auditors
- Vendor preferences
Correct answer: Issue complexity
The complexity of the issue should guide the choice of RCA method to ensure it effectively uncovers the true root cause.
Question 6: After identifying a root cause, what should be done next in the CAPA process?
- Document nonconformance again
- Conduct another investigation
- Develop corrective and preventive actions (Correct answer)
- Close the case immediately
Correct answer: Develop corrective and preventive actions
Developing corrective and preventive actions based on the root cause ensures the problem is addressed and future issues are avoided.
CAPA Root Cause Analysis & Investigation Techniques 1
What is the purpose of root cause analysis in the CAPA process?