Introduction
What is Quality Risk Management?
In ICH Q9, risk is defined as the combination of harm and the severity of that harm. However, risk can be defined in different ways when being used to manage risks within specific areas (e.g. information technology, security or health and safety).
For the purposes of this course, risk will be defined as an event, with an uncertain or unpredictable probability of occurrence, which if it occurs would result in a definable consequence.
It is important to remember that risks can be both positive or negative.
