A risk assessment is a documented process for identifying hazards or failure scenarios, analyzing associated risks, and evaluating whether additional controls or assurance activities are needed.
At its core, risk considers the severity of potential harm and the probability of its occurrence. Depending on the approved methodology, detectability, uncertainty, existing controls, or other factors may also inform the assessment.
For a GxP computerized system, the assessment should consider intended use, the regulated process supported by the system, critical data and records, relevant decisions or controls, and the potential consequences if the system fails to perform as intended.
The assessment should inform validation scope, control selection, assurance rigor, supplier-evidence use, and change-management decisions. It should be reviewed when changes or new information could affect intended use, assumptions, identified risks, or the effectiveness of existing controls.
Frequently Asked Questions
What factors does a risk assessment evaluate?
Risk assessment generally considers the severity of potential harm and the probability of occurrence. Depending on the methodology, detectability, uncertainty, control effectiveness, and other relevant factors may also be considered.
What makes a risk assessment a GxP risk assessment?
Its scope and context. It evaluates risks associated with a regulated process, including potential effects on patient safety, product quality, data integrity, required records, and applicable regulatory controls.
How often should a risk assessment be updated?
Review it when a change or new information could affect the system’s intended use, assumptions, risks, controls, or assurance conclusions. Periodic review may also identify a need to update the assessment.
Should risk assessments be qualitative or quantitative?
Qualitative, semi-quantitative, and quantitative methods can all be appropriate. The method should use defined criteria, be applied consistently, and provide enough information to support the decision being made.