Quality risk management principles MCQs With Answer

Introduction

Quality Risk Management (QRM) is an essential component of pharmaceutical quality systems, enabling systematic assessment, control, communication, and review of risks to product quality throughout the product lifecycle. This blog presents targeted MCQs designed for M.Pharm students to deepen understanding of QRM principles, tools, and regulatory expectations (especially ICH Q9). The questions focus on risk assessment techniques, risk control and communication, practical applications in manufacturing and quality systems, and interpretation of risk outcomes. Attempting these MCQs will strengthen analytical skills required to prioritize quality issues, design effective controls, and support science- and risk-based decisions in pharmaceutical practice.

Q1. Which document is the primary global guideline specifically dedicated to Quality Risk Management in pharmaceuticals?

• ICH Q8 Pharmaceutical Development
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• GMP Annex 1

Correct Answer: ICH Q9 Quality Risk Management

Q2. In the ICH Q9 risk management process, which step is focused on identifying potential sources of harm and the events that may lead to those harms?

• Risk Control
• Risk Assessment
• Risk Communication
• Risk Review

Correct Answer: Risk Assessment

Q3. Which of the following best describes the purpose of risk control within a QRM framework?

• To determine the probability of a hazard occurring
• To implement measures to reduce or accept risk to an acceptable level
• To communicate risk levels to regulatory authorities only
• To perform retrospective audits of quality events

Correct Answer: To implement measures to reduce or accept risk to an acceptable level

Q4. Which risk assessment tool quantitatively combines severity, occurrence, and detection into a single Risk Priority Number (RPN)?

• Process Flow Diagram
• Fault Tree Analysis (FTA)
• Failure Mode and Effects Analysis (FMEA)
• Risk Matrix

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q5. What is the main limitation of using a simple 3×3 or 5×5 risk matrix for decision-making?

• It provides exact numerical probabilities for events
• It can oversimplify risk ranking and introduce subjectivity
• It requires complex statistical input data
• It always mandates immediate mitigation measures

Correct Answer: It can oversimplify risk ranking and introduce subjectivity

Q6. In QRM, which of the following is NOT typically considered a component of risk assessment?

• Risk Identification
• Risk Estimation
• Risk Prioritization
• Regulatory Approval Timeframes

Correct Answer: Regulatory Approval Timeframes

Q7. Which technique is most appropriate for analysing causal relationships that can lead to a specific undesired event?

• Bow-Tie Analysis
• Statistical Process Control (SPC)
• Design of Experiments (DoE)
• GMP Self-Inspection

Correct Answer: Bow-Tie Analysis

Q8. When performing FMEA, what action is typically taken for failure modes with very high RPN values?

• Document and accept without changes
• Prioritize and implement corrective or preventive controls
• Ignore if they are rare events
• Remove the process step entirely

Correct Answer: Prioritize and implement corrective or preventive controls

Q9. Which principle requires that risk management actions be proportional to the level of risk?

• Risk-based decision-making
• Zero-risk tolerance
• Independent verification
• Continuous improvement

Correct Answer: Risk-based decision-making

Q10. During risk communication, which stakeholder group should be engaged to ensure practical control measures are feasible?

• Only senior management
• Cross-functional teams including operations, quality, and engineering
• Only external regulators
• Only the original process designer

Correct Answer: Cross-functional teams including operations, quality, and engineering

Q11. Which of the following best describes “residual risk” in QRM?

• The risk before any controls are implemented
• The risk that remains after control measures are applied
• The hypothetical worst-case risk scenario
• A risk that is deliberately ignored

Correct Answer: The risk that remains after control measures are applied

Q12. Which metric is most commonly used in FMEA to reflect how easily a failure mode can be detected before it reaches the customer?

• Severity score
• Occurrence rating
• Detection rating
• Control effectiveness coefficient

Correct Answer: Detection rating

Q13. In a risk review, which of the following activities is essential to ensure ongoing suitability of controls?

• One-time approval of initial risk assessment only
• Periodic monitoring, trending, and reassessment based on new data
• Discontinuation of controls once production stabilizes
• Replacing documented controls with verbal instructions

Correct Answer: Periodic monitoring, trending, and reassessment based on new data

Q14. Which QRM tool is most useful for mapping a process step-by-step and identifying where risks can arise?

• Process Flow Diagram
• Risk Priority Number (RPN)
• Pareto Chart
• Control Chart

Correct Answer: Process Flow Diagram

Q15. Which of the following reflects a science-based justification used in QRM for selecting acceptable risk levels?

• Historical precedence without data
• Validated scientific evidence, process capability, and patient impact
• Management opinion only
• Arbitrary numerical thresholds copied from another industry

Correct Answer: Validated scientific evidence, process capability, and patient impact

Q16. When assessing the risk of a change in manufacturing equipment, which factor is most relevant to estimate occurrence?

• Severity of potential harm if the change fails
• Historical frequency of similar equipment failures or deviations
• Organizational chart for maintenance staff
• Color of the equipment panels

Correct Answer: Historical frequency of similar equipment failures or deviations

Q17. Which statement best describes the role of senior management in QRM?

• Senior management should have no involvement and delegate all decisions
• Senior management should provide resources, define risk tolerance, and support risk-based decisions
• Senior management must perform all risk assessments personally
• Senior management should only approve final reports without context

Correct Answer: Senior management should provide resources, define risk tolerance, and support risk-based decisions

Q18. Which of the following is an example of a preventive risk control measure?

• Customer complaint handling after product release
• Routine calibration of critical instrumentation
• Recalling products after detecting contamination
• Root cause analysis following a deviation

Correct Answer: Routine calibration of critical instrumentation

Q19. What is the main advantage of integrating QRM into change control processes?

• It allows changes to be implemented without documentation
• It ensures potential quality impacts are evaluated and controls justified prior to implementation
• It prioritizes speed over patient safety
• It eliminates the need for validation

Correct Answer: It ensures potential quality impacts are evaluated and controls justified prior to implementation

Q20. Which documentation practice is essential to demonstrate a robust QRM process during regulatory inspection?

• Undated notes in personal notebooks
• Complete, signed, and dated risk assessment records with rationale for decisions and review history
• Only verbal assurances from team leads
• Encrypted files with no access logs

Correct Answer: Complete, signed, and dated risk assessment records with rationale for decisions and review history

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