CRAP Risk Assessment & Management 3 — Questions and Answers
Question 1: Under ICH Q9, which risk management tool is best suited for identifying potential failure modes and their effects in a manufacturing process?
- Cause-and-Effect (Ishikawa) Diagram
- Failure Mode and Effects Analysis (FMEA) (Correct answer)
- Preliminary Hazard Analysis (PHA)
- Risk Ranking and Filtering
Correct answer: Failure Mode and Effects Analysis (FMEA)
FMEA systematically evaluates each potential failure mode in a process and its effects, making it ideal for manufacturing process risk assessment.
Question 2: A regulatory affairs professional is preparing a 510(k) submission for a Class II device. Which section should include the risk management summary?
- 510(k) Summary
- Performance Testing section (Correct answer)
- Substantial Equivalence Discussion
- Labeling section
Correct answer: Performance Testing section
The performance testing section of a 510(k) typically includes risk management documentation to demonstrate safety and effectiveness relative to the predicate device.
Question 3: In the EU MDR 2017/745, what is the primary document that summarizes risk management outcomes for a medical device?
- Declaration of Conformity
- Summary of Safety and Clinical Performance (SSCP)
- Technical Documentation Risk Management Report (Correct answer)
- Post-Market Surveillance Plan
Correct answer: Technical Documentation Risk Management Report
The Technical Documentation under EU MDR must include a risk management report summarizing the risk management process and residual risks.
Question 4: Which approach best describes 'inherently safe design' as a risk control measure under ISO 14971?
- Adding warning labels to alert users of hazards
- Using protective guards on machinery
- Eliminating or reducing hazards through design before applying other controls (Correct answer)
- Providing training materials for operators
Correct answer: Eliminating or reducing hazards through design before applying other controls
Inherently safe design is the first priority in the risk control hierarchy—eliminating the hazard at its source through design choices.
Question 5: What is a 'use error' in the context of medical device risk management?
- A software defect causing device malfunction
- An action or inaction by a user that produces an unintended result, potentially causing harm (Correct answer)
- Off-label use of a device by a physician
- A manufacturing defect identified during QC
Correct answer: An action or inaction by a user that produces an unintended result, potentially causing harm
Use errors arise from human interaction with the device and are a critical focus of human factors and usability engineering in risk management.
Question 6: A pharmaceutical company performs a risk assessment for a new excipient. Which ICH guideline would primarily guide the toxicological evaluation?
- ICH Q3A
- ICH Q9
- ICH M7
- ICH Q3C (Correct answer)
Correct answer: ICH Q3C
ICH Q3C addresses residuals for solvents, but for new excipients the key toxicological framework follows ICH Q3C and related impurity guidelines; for genotoxic impurities ICH M7 applies.
Question 7: In risk management, what is the purpose of a 'benefit-risk analysis' when residual risk exceeds acceptability criteria?
- To document that the risk cannot be mitigated further
- To justify market withdrawal of the device
- To determine whether the medical benefits of the device outweigh its residual risks (Correct answer)
- To transfer liability to the prescribing physician
Correct answer: To determine whether the medical benefits of the device outweigh its residual risks
When residual risk exceeds the acceptability threshold, a benefit-risk analysis is conducted to determine if the clinical benefits justify the remaining risk.
CRAP Risk Assessment & Management 3
Under ICH Q9, which risk management tool is best suited for identifying potential failure modes and their effects in a manufacturing process?