QRM & Audit

Front

What is the first step in Quality Risk Management?

Back

Risk Identification

Front

What question is asked during the Risk Identification step?

Back

"What might go wrong?"

Front

What techniques are used for Risk Identification?

Back

Information gathering techniques (brainstorming), Delphi technique, interviews, documentation review, checklists, and diagramming techniques.

Front

What is the focus of Risk Analysis?

Back

Understanding the probability that the identified risk will occur.

Front

How are risks categorized in Risk Analysis?

Back

As high, moderate, or low, depending on likelihood and severity/impact.

Front

What is a risk matrix used for?

Back

To define the level of risk by considering the category of probability or likelihood against the category of consequence severity/impact.

Front

What is the purpose of Risk Evaluation?

Back

To compare the identified and analyzed risk against given risk criteria.

Front

What does Risk Control focus on?

Back

Processes for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level.

Front

What is Risk Acceptance?

Back

A decision to accept risk.

Front

What is the purpose of Risk Review?

Back

To review the output/results of the Quality Risk Management process.