CAPA – Corrective and Preventive Actions MCQs With Answer

Introduction

CAPA – Corrective and Preventive Actions is a core element of Quality Management Systems in pharmaceutical industries, ensuring product quality, patient safety, and regulatory compliance. This blog provides M.Pharm students with focused multiple-choice questions to deepen understanding of CAPA principles, workflows, regulatory expectations, root-cause analysis tools, documentation, and effectiveness verification. The questions cover both theoretical concepts and practical applications such as when to initiate CAPA, interfacing with change control, risk assessment, and trending. Use these MCQs to prepare for exams, internships, and industry roles by reinforcing knowledge of how robust CAPA systems prevent recurrence and drive continuous improvement.

Q1. What is the primary objective of a CAPA system in pharmaceutical quality management?

• To document all deviations regardless of impact
• To identify, correct, and prevent recurrence of product and process nonconformities
• To increase production throughput
• To replace change control procedures

Correct Answer: To identify, correct, and prevent recurrence of product and process nonconformities

Q2. Which regulatory guidance explicitly expects pharmaceutical manufacturers to have an effective CAPA system?

• ICH Q7
• 21 CFR Part 820 (FDA) and EU GMP Annex 1
• Pharmacopoeial General Notices
• ISO 9001 only

Correct Answer: 21 CFR Part 820 (FDA) and EU GMP Annex 1

Q3. Which tool is most appropriate for identifying potential causes of a complex deviation using categories like Materials, Methods, Machines, Man, Measurement and Environment?

• 5 Whys
• Fishbone (Ishikawa) diagram
• Pareto chart
• Scatter plot

Correct Answer: Fishbone (Ishikawa) diagram

Q4. In CAPA terminology, what is the difference between corrective action and preventive action?

• Corrective actions address future risks; preventive actions fix current failures
• Corrective actions correct identified nonconformities; preventive actions eliminate potential nonconformities
• They are interchangeable terms
• Corrective actions are optional, preventive actions are mandatory

Correct Answer: Corrective actions correct identified nonconformities; preventive actions eliminate potential nonconformities

Q5. Which step is essential to verify the effectiveness of a CAPA after implementation?

• Documenting the CAPA plan only
• Performing an effectiveness check with defined metrics and observation period
• Closing the CAPA immediately after implementation
• Notifying suppliers only

Correct Answer: Performing an effectiveness check with defined metrics and observation period

Q6. Which root cause analysis technique focuses on repeatedly asking “why” until the underlying cause is identified?

• Fishbone analysis
• 5 Whys
• Fault tree analysis
• Control chart analysis

Correct Answer: 5 Whys

Q7. What is the role of risk assessment within the CAPA process?

• To determine training schedules only
• To prioritize CAPA actions based on patient safety and product quality impact
• To avoid documenting CAPA
• To delay CAPA implementation indefinitely

Correct Answer: To prioritize CAPA actions based on patient safety and product quality impact

Q8. Which document should be updated if a CAPA leads to a permanent change in a validated manufacturing process?

• Batch record variance only
• Process validation documentation and change control records
• Supplier invoices
• Marketing materials

Correct Answer: Process validation documentation and change control records

Q9. Which KPI is commonly used to measure CAPA system performance?

• CAPA closure rate within planned target time
• Number of production shifts
• Average laboratory temperature
• Sales growth percentage

Correct Answer: CAPA closure rate within planned target time

Q10. When a recurring deviation is observed despite previous CAPAs, what is the most appropriate next action?

• Ignore since it is documented
• Re-open CAPA and perform a deeper root cause analysis using cross-functional team
• Change the batch release criteria only
• Increase sample size without investigating cause

Correct Answer: Re-open CAPA and perform a deeper root cause analysis using cross-functional team

Q11. Which of the following best describes an effectiveness check metric for a contamination-related CAPA?

• Number of training sessions delivered
• Trend of environmental monitoring excursions over a defined period
• Quantity of raw materials ordered
• Number of employees in quality

Correct Answer: Trend of environmental monitoring excursions over a defined period

Q12. In relation to CAPA, what is the purpose of a containment action?

• To permanently change the process
• To immediately limit patient or product exposure while root cause is being investigated
• To eliminate the need for further investigation
• To document supplier quotations

Correct Answer: To immediately limit patient or product exposure while root cause is being investigated

Q13. Which element is NOT typically part of a CAPA record?

• Root cause analysis findings
• Actions taken, timelines and responsible persons
• Effectiveness verification plan and results
• Employee personal medical records

Correct Answer: Employee personal medical records

Q14. How should supplier-related nonconformities be managed within CAPA?

• Exclude suppliers from CAPA processes
• Include supplier investigation, corrective actions and supplier performance monitoring
• Terminate supplier contract immediately without analysis
• Only increase incoming inspection frequency and do not inform supplier

Correct Answer: Include supplier investigation, corrective actions and supplier performance monitoring

Q15. Which CAPA prioritization factor is most critical in deciding immediate actions?

• Cost of raw materials
• Impact on patient safety and product quality
• Availability of personnel
• Marketing deadlines

Correct Answer: Impact on patient safety and product quality

Q16. Which quality concept ensures CAPA information is used to drive systemic improvements across the organization?

• Isolated problem solving
• Management review and knowledge management
• Ad hoc reporting
• Confidentiality of CAPA only to QA

Correct Answer: Management review and knowledge management

Q17. What is the correct relationship between CAPA and change control?

• CAPA replaces change control
• CAPA may trigger change control when corrective or preventive measures alter validated processes
• Change control triggers CAPA only for documentation changes
• They are unrelated systems

Correct Answer: CAPA may trigger change control when corrective or preventive measures alter validated processes

Q18. Which of the following indicates an effective CAPA closure?

• CAPA form completed without verification
• Implemented actions documented and effectiveness demonstrated by objective evidence
• Actions assigned but not tracked
• CAPA closed due to elapsed time only

Correct Answer: Implemented actions documented and effectiveness demonstrated by objective evidence

Q19. Which statistical tool is useful to show that most problems are caused by a few common causes, guiding CAPA focus?

• Control chart
• Pareto analysis
• Box plot
• Histogram of room temperatures

Correct Answer: Pareto analysis

Q20. Which action should be taken if a CAPA effectiveness check shows the issue persists?

• Close CAPA and monitor less frequently
• Reassess root cause, revise CAPA plan, and implement additional or alternative corrective/preventive measures
• Archive the CAPA file without changes
• Blame the production team publicly

Correct Answer: Reassess root cause, revise CAPA plan, and implement additional or alternative corrective/preventive measures

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