CRAP Risk Assessment & Management 2

Question 1

Under ISO 14971, what is the primary purpose of a risk management file?

Accepted Answer

To provide a record of all risk management activities performed throughout the product lifecycle

Answer

ISO 14971 requires a risk management file that records all risk management activities—analysis, evaluation, control, and residual risk review—throughout the product lifecycle.

Question 2

Which FDA guidance document establishes recommendations for applying risk management principles to combination products?

Accepted Answer

ICH Q9 Quality Risk Management

Answer

ICH Q9 Quality Risk Management provides principles and examples of tools applicable to pharmaceutical and combination product risk management.

Question 3

In a risk matrix, a hazard with 'Critical' severity and 'Remote' probability would typically fall into which risk category?

Accepted Answer

Medium risk requiring risk reduction consideration

Answer

Critical severity combined with remote probability typically produces a medium risk level that warrants consideration of risk reduction measures.

Question 4

What does the term 'residual risk' mean in the context of ISO 14971?

Accepted Answer

Risk remaining after all risk control measures have been implemented

Answer

Residual risk is the risk remaining after risk control measures have been implemented, and it must be evaluated against acceptance criteria.

Question 5

A company conducts a Fault Tree Analysis (FTA). What does a top-level event in an FTA represent?

Accepted Answer

An undesired event or failure mode being analyzed by working backwards to causes

Answer

In FTA, the top-level event is the undesired outcome, and the analysis works deductively backward to identify all contributing causes.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Risk Assessment & Management 2