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 ISO 14971, what is the primary purpose of a risk management file?
Answer: To provide a record of all risk management activities performed throughout the product lifecycle
ISO 14971 requires a risk management file that records all risk management activities—analysis, evaluation, control, and residual risk review—throughout the product lifecycle.
Which FDA guidance document establishes recommendations for applying risk management principles to combination products?
Answer: ICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management provides principles and examples of tools applicable to pharmaceutical and combination product risk management.
In a risk matrix, a hazard with 'Critical' severity and 'Remote' probability would typically fall into which risk category?
Answer: Medium risk requiring risk reduction consideration
Critical severity combined with remote probability typically produces a medium risk level that warrants consideration of risk reduction measures.
What does the term 'residual risk' mean in the context of ISO 14971?
Answer: Risk remaining after all risk control measures have been implemented
Residual risk is the risk remaining after risk control measures have been implemented, and it must be evaluated against acceptance criteria.
A company conducts a Fault Tree Analysis (FTA). What does a top-level event in an FTA represent?
Answer: An undesired event or failure mode being analyzed by working backwards to causes
In FTA, the top-level event is the undesired outcome, and the analysis works deductively backward to identify all contributing causes.
Which risk acceptability principle states that a risk should be reduced as far as reasonably practicable, even if it is already below the acceptable threshold?
Answer: ALARP (As Low As Reasonably Practicable)
ALARP requires that risks be reduced as far as reasonably practicable, even when they fall below the broadly acceptable threshold.
During post-market surveillance, newly identified field failures prompt a risk reassessment. Which step in ISO 14971 does this represent?
Answer: Production and post-production information review
ISO 14971 Clause 10 addresses production and post-production information, requiring manufacturers to review field data and update the risk management file accordingly.