Risk Assessment & Management Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Assessment & Management flashcards as text
Under ICH Q9, which risk management tool is best suited for identifying potential failure modes and their effects in a manufacturing process?
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.
A regulatory affairs professional is preparing a 510(k) submission for a Class II device. Which section should include the risk management summary?
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.
In the EU MDR 2017/745, what is the primary document that summarizes risk management outcomes for a medical device?
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.
Which approach best describes 'inherently safe design' as a risk control measure under ISO 14971?
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.
What is a 'use error' in the context of medical device risk management?
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.
A pharmaceutical company performs a risk assessment for a new excipient. Which ICH guideline would primarily guide the toxicological evaluation?
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.
In risk management, what is the purpose of a 'benefit-risk analysis' when residual risk exceeds acceptability criteria?
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.