Risk assessment, control, review MCQs With Answer

This collection of 20 multiple-choice questions (MCQs) is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T), focusing on risk assessment, control, and review. The questions target critical concepts such as ICH Q9 principles, risk identification techniques, qualitative and quantitative estimation, FMEA/RPN calculations, risk control strategies, residual risk evaluation, and periodic review. Each MCQ challenges your application-level understanding — not just recall — to prepare you for exams and professional practice. Use these items to assess strengths and identify learning gaps; detailed reasoning and reference to guidelines like ICH Q9, ISO 31000, and GMP practices will help consolidate your risk management competence.

Q1. Which ICH guideline specifically provides a structured approach to pharmaceutical quality risk management?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11

Correct Answer: ICH Q9

Q2. In risk assessment, which three factors are most commonly combined to estimate risk in FMEA?

• Severity, Probability, Detectability
• Likelihood, Consequence, Cost
• Impact, Frequency, Duration
• Benefit, Hazard, Exposure

Correct Answer: Severity, Probability, Detectability

Q3. What does RPN stand for in Failure Mode and Effects Analysis?

• Risk Priority Number
• Residual Probability Number
• Risk Prevention Number
• Reliability Performance Number

Correct Answer: Risk Priority Number

Q4. Which of the following is a qualitative risk assessment tool commonly used in pharmaceutical quality?

• Monte Carlo simulation
• Fishbone (Ishikawa) diagram
• Regression analysis
• Survival analysis

Correct Answer: Fishbone (Ishikawa) diagram

Q5. In a risk matrix, a high-severity, low-probability event typically requires which approach?

• Ignore the risk because probability is low
• Document and monitor only during routine review
• Implement risk controls to reduce severity or probability
• Perform a recall immediately

Correct Answer: Implement risk controls to reduce severity or probability

Q6. Which concept describes the risk level that is as low as reasonably practicable?

• ALARA (As Low As Reasonably Achievable)
• ALARP (As Low As Reasonably Practicable)
• QbD (Quality by Design)
• CAPA (Corrective and Preventive Action)

Correct Answer: ALARP (As Low As Reasonably Practicable)

Q7. Which is the most appropriate immediate action when a new critical process deviation is identified affecting product quality?

• Initiate product disposition decision and containment actions
• Wait for trend data before acting
• Only update the SOP in the next revision cycle
• Notify marketing to delay distribution

Correct Answer: Initiate product disposition decision and containment actions

Q8. Which document should capture the overall risk management activities for a pharmaceutical product or process?

• Risk Management File
• Batch Manufacturing Record
• Stability Protocol
• Validation Master Plan

Correct Answer: Risk Management File

Q9. During risk control, what is the preferred sequence when selecting risk reduction measures?

• Accept risk → Monitor → Review
• Control at source → Reduce likelihood → Reduce detectability
• Reduce severity → Reduce probability → Accept residual risk
• Reduce probability → Reduce detectability → Implement monitoring

Correct Answer: Reduce severity → Reduce probability → Accept residual risk

Q10. Which regulatory expectation emphasizes the importance of periodic review of identified risks?

• Periodic review is optional and discouraged
• Periodic review must be conducted only at product launch
• Periodic review is required to ensure controls remain effective over time
• Periodic review should be replaced by one-time risk assessment

Correct Answer: Periodic review is required to ensure controls remain effective over time

Q11. Which tool is most appropriate for quantifying uncertainty where probabilistic distributions and forecasting are needed?

• Fault Tree Analysis
• Monte Carlo Simulation
• Fishbone Diagram
• Control Chart

Correct Answer: Monte Carlo Simulation

Q12. In FMEA, if Severity = 8, Occurrence = 4, Detection = 2, what is the RPN?

• 14
• 64
• 56
• 32

Correct Answer: 64

Q13. What is the key purpose of risk communication in pharmaceutical quality management?

• To keep risk information confidential within QA only
• To inform stakeholders so that informed decisions and actions can be taken
• To delay regulatory inspection by providing excess documentation
• To eliminate the need for corrective actions

Correct Answer: To inform stakeholders so that informed decisions and actions can be taken

Q14. Which risk control option aligns with the hierarchy of controls by addressing the hazard most effectively?

• Personal protective equipment for operators
• Administrative controls like SOP training
• Engineering control to eliminate exposure
• Periodic monitoring only

Correct Answer: Engineering control to eliminate exposure

Q15. Which statement best describes residual risk?

• Risk before any controls are applied
• Risk eliminated completely by controls
• Risk remaining after applying risk control measures
• Risk associated with financial loss only

Correct Answer: Risk remaining after applying risk control measures

Q16. When performing benefit-risk assessment for a change in manufacturing, what should be documented?

• Only the benefits, not the risks
• Both anticipated benefits and potential risks, with rationale for proceeding
• Only the regulatory citations
• Only the cost-benefit ratio

Correct Answer: Both anticipated benefits and potential risks, with rationale for proceeding

Q17. Which of the following best indicates a need to escalate a risk to senior management?

• Low severity and low probability risk
• High residual risk after planned controls with potential patient harm
• Minor deviation with clear corrective actions
• Routine equipment calibration overdue by one day

Correct Answer: High residual risk after planned controls with potential patient harm

Q18. Which standard focuses on risk management principles beyond pharmaceuticals and is often referenced for organizational risk frameworks?

• ISO 9001
• ISO 14971
• ISO 31000
• GP 2

Correct Answer: ISO 31000

Q19. In a root cause analysis following a quality failure, which output is essential for preventing recurrence?

• Corrective and Preventive Action (CAPA) plan with measurable effectiveness checks
• Only a disciplinary note for the operator
• Updated marketing materials
• Archival of the failed batch without further action

Correct Answer: Corrective and Preventive Action (CAPA) plan with measurable effectiveness checks

Q20. What is the recommended relationship between change control and risk management?

• Change control should be independent and not use risk assessment
• Change control should incorporate risk assessment to evaluate potential quality and safety impacts
• Risk management should be used only after change implementation
• Change control is only necessary for major capital investments

Correct Answer: Change control should incorporate risk assessment to evaluate potential quality and safety impacts

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