ICH guidelines on risk assessment and risk tools MCQs With Answer

ICH guidelines on risk assessment and risk tools MCQs With Answer

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Introduction

Understanding ICH guidelines on risk assessment and the practical risk tools is essential for M.Pharm students who will design, evaluate, and manage pharmaceutical quality systems. This set of MCQs focuses on ICH Q9 principles, systematic steps of quality risk management, commonly used tools (FMEA, HAZOP, Ishikawa, Fault Tree, Bow-tie, HACCP), and regulatory expectations about documentation, decision-making, and lifecycle application. The questions emphasize application-level knowledge: selecting appropriate tools, interpreting severity/likelihood/detectability, and integrating risk-based approaches into product development and manufacturing. Practice with these targeted MCQs will strengthen your ability to apply QRM concepts in real-world pharmaceutical scenarios and regulatory submissions.

Q1. Which ICH guideline specifically addresses Quality Risk Management?

  • ICH Q7
  • ICH Q8
  • ICH Q9
  • ICH Q10

Correct Answer: ICH Q9

Q2. According to ICH Q9, which of the following lists the main components of Quality Risk Management?

  • Risk identification, risk analysis, risk evaluation, risk control
  • Risk design, risk marketing, risk sales, risk distribution
  • Risk budgeting, risk procurement, risk promotion, risk disposal
  • Risk development, risk validation, risk certification, risk termination

Correct Answer: Risk identification, risk analysis, risk evaluation, risk control

Q3. What is the first step in a formal risk assessment process as recommended by ICH Q9?

  • Risk analysis
  • Risk identification
  • Risk control
  • Risk communication

Correct Answer: Risk identification

Q4. Which risk assessment tool is commonly depicted as a cause-and-effect (fishbone) diagram?

  • Failure Mode and Effects Analysis (FMEA)
  • Ishikawa (Cause-and-effect) diagram
  • Fault Tree Analysis (FTA)
  • Bow-tie analysis

Correct Answer: Ishikawa (Cause-and-effect) diagram

Q5. Which risk tool calculates a Risk Priority Number (RPN) as the product of severity, occurrence, and detectability?

  • Hazard and Operability Study (HAZOP)
  • Failure Mode and Effects Analysis (FMEA)
  • Bow-tie analysis
  • Fault Tree Analysis (FTA)

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q6. HAZOP studies are most appropriate for identifying hazards arising from:

  • Supply chain disruptions
  • Process deviations and design intent deviations in continuous processes
  • Administrative policy gaps
  • Marketing strategy failures

Correct Answer: Process deviations and design intent deviations in continuous processes

Q7. Bow-tie analysis is best described as:

  • A bottom-up statistical frequency analysis
  • A cause-and-effect diagram focusing only on root causes
  • A combined top event representation showing preventive and mitigative barriers derived from fault trees and event trees
  • An HACCP-like table for food safety only

Correct Answer: A combined top event representation showing preventive and mitigative barriers derived from fault trees and event trees

Q8. Fault Tree Analysis (FTA) is generally characterized as which approach?

  • Top-down logical analysis using gates (AND/OR)
  • Bottom-up component reliability summation
  • Qualitative brainstorming without logic gates
  • Statistical process control charting

Correct Answer: Top-down logical analysis using gates (AND/OR)

Q9. In the context of QRM, “severity” refers to:

  • The frequency with which a failure occurs
  • The detectability of a failure by control systems
  • The magnitude of impact of a failure on patient safety, product quality, or regulatory compliance
  • The cost to remediate a process deviation

Correct Answer: The magnitude of impact of a failure on patient safety, product quality, or regulatory compliance

Q10. How should an organization determine acceptable levels of risk according to ICH Q9?

  • By following a fixed industry-wide numeric threshold for all products
  • By applying the lowest possible risk irrespective of benefit
  • Using science-based decision making considering company risk tolerance, benefit-risk and level of concern
  • By adopting competitor practices without internal evaluation

Correct Answer: Using science-based decision making considering company risk tolerance, benefit-risk and level of concern

Q11. Which methodology, originally developed for food safety, is also used in pharmaceuticals to identify and manage Critical Control Points?

  • Failure Mode and Effects Analysis (FMEA)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Ishikawa diagram
  • Design of Experiments (DoE)

Correct Answer: Hazard Analysis and Critical Control Points (HACCP)

Q12. In FMEA, “detectability” is defined as:

  • The time taken for a failure to occur after initiation
  • The likelihood that a failure will be detected before it reaches the patient or the next process step
  • The cost associated with detecting the failure
  • The regulatory penalty for failing to detect the issue

Correct Answer: The likelihood that a failure will be detected before it reaches the patient or the next process step

Q13. A risk matrix commonly maps which two factors to prioritize risks?

  • Severity and likelihood (probability)
  • Detectability and supply cost
  • Control effectiveness and marketing impact
  • Regulatory opinion and audit frequency

Correct Answer: Severity and likelihood (probability)

Q14. Per ICH Q9, Quality Risk Management should be applied at what stages of a product’s life cycle?

  • Only during initial development
  • Only during commercial manufacturing
  • Throughout the product lifecycle, from development to discontinuation
  • Only during regulatory inspections

Correct Answer: Throughout the product lifecycle, from development to discontinuation

Q15. What is the regulatory expectation regarding documentation of risk assessments?

  • All risk assessments must be documented in full detail regardless of complexity
  • Risk assessment documentation should be commensurate with the complexity of the issue and the potential impact on product quality and patient safety
  • Documentation is optional if the team verbally agrees on actions
  • Only high-level summaries are acceptable; supporting data should be kept informal

Correct Answer: Risk assessment documentation should be commensurate with the complexity of the issue and the potential impact on product quality and patient safety

Q16. A primary benefit of adopting a risk-based approach in pharmaceutical quality management is:

  • Eliminating the need for validation
  • Improving resource allocation and enabling science- and risk-based decision making
  • Ensuring zero product recalls
  • Replacing regulatory inspections

Correct Answer: Improving resource allocation and enabling science- and risk-based decision making

Q17. Which of the following is NOT a standard step in Quality Risk Management according to ICH Q9?

  • Risk identification
  • Risk analysis
  • Product promotion planning
  • Risk review

Correct Answer: Product promotion planning

Q18. How frequently should risk assessments be reviewed?

  • Only once at initial approval and never again
  • Only when regulatory agencies request them
  • When there are changes, new information, or periodically according to the risk level and organizational procedures
  • Daily for all items regardless of risk

Correct Answer: When there are changes, new information, or periodically according to the risk level and organizational procedures

Q19. Which analysis technique uses logic gates (AND/OR) to model combinations of failures leading to a top event?

  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Ishikawa (Cause-and-effect) diagram
  • HACCP decision tree

Correct Answer: Fault Tree Analysis (FTA)

Q20. In FMEA, an RPN (Risk Priority Number) of 200 (on a 1–1000 scale) generally indicates:

  • A negligible risk that requires no monitoring
  • A moderate to high risk that typically requires corrective or mitigative action
  • An automatically acceptable risk by default
  • That detectability is perfect

Correct Answer: A moderate to high risk that typically requires corrective or mitigative action

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