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
A CAPA was initiated after a field complaint involving patient injury. At which stage should risk management documentation be updated?
Answer: As part of the corrective action planning and implementation process
Risk management files should be updated during CAPA implementation to reflect newly identified hazards and the effectiveness of implemented controls.
Which FDA regulation requires that design controls for medical devices include risk analysis as part of the design process?
Answer: 21 CFR Part 820.30
21 CFR Part 820.30 (Design Controls) requires risk analysis as a component of the design and development process for medical devices.
What distinguishes a 'hazardous situation' from a 'hazard' in ISO 14971 terminology?
Answer: A hazard is the source of potential harm; a hazardous situation is the circumstance where a person is exposed to the hazard
ISO 14971 defines a hazard as the potential source of harm, and a hazardous situation as a circumstance in which people, property, or the environment is exposed to one or more hazards.
In a Process FMEA for a sterile drug manufacturing line, a fill-weight deviation has a Severity of 7, Occurrence of 4, and Detection of 6. What is the RPN?
Answer: 168
RPN = Severity × Occurrence × Detection = 7 × 4 × 6 = 168.
Under EU MDR, which entity is responsible for reviewing and approving the risk management system of a Class III device?
Answer: The Notified Body
For Class III devices under EU MDR, the Notified Body reviews the technical documentation including the risk management system as part of conformity assessment.
When applying HAZOP to a pharmaceutical process, what does the guideword 'MORE OF' typically indicate?
Answer: A parameter exceeds its intended design value or range
The HAZOP guideword 'MORE OF' signals a quantitative increase in a process parameter beyond its design intent, such as excess temperature or pressure.
A company wants to demonstrate that its risk management process meets ISO 14971 for FDA submissions. Which document formally acknowledges ISO 14971 as a recognized consensus standard in the US?
Answer: FDA's Recognized Consensus Standards database listing ISO 14971
FDA maintains a database of recognized consensus standards, and ISO 14971 is listed there, allowing manufacturers to declare conformance in submissions.