GCP Risk Assessment & Management

Question 1

What is the first step in GCP risk assessment?

Accepted Answer

Identifying potential hazards and threats relevant to the activity or project

Answer

Risk assessment begins with systematic identification of all potential hazards and threats, as you cannot manage risks you haven't identified. This foundation supports all subsequent analysis and mitigation.

Question 2

What is the hierarchy of controls in GCP risk management?

Accepted Answer

Elimination, substitution, engineering controls, administrative controls, then PPE

Answer

The hierarchy prioritizes the most effective controls first: eliminate the hazard entirely, substitute with something safer, use engineering controls, implement administrative measures, and use PPE as the last resort.

Question 3

What is the purpose of a risk matrix in GCP practice?

Accepted Answer

To evaluate risks by plotting likelihood against severity of potential impact

Answer

A risk matrix plots the probability of occurrence against the severity of potential consequences, helping prioritize which risks need immediate attention and which can be monitored.

Question 4

What does residual risk mean in GCP risk management?

Accepted Answer

The remaining risk after all control measures have been implemented

Answer

Residual risk is the level of risk that remains after all practical control measures have been applied. Some residual risk is usually accepted as it may not be feasible to eliminate all risk entirely.

Question 5

Why is regular review important in GCP risk management?

Accepted Answer

Because conditions change and new risks emerge requiring updated assessments

Answer

Regular reviews ensure risk assessments remain current as conditions change, new hazards emerge, operations evolve, and lessons from incidents or near-misses are incorporated into updated controls.

GCP Test Practice Test

GCP Test Practice Test

GCP Risk Assessment & Management