Risk Region and Risk Impact

Risk Priority Number (RPN)

This section displays a side-by-side comparison of the Current Risk Priority Number (RPN) from the previous Risk Assessment and the New RPN recalculated in the Failure Mode & Effect Analysis (FMEA).

Each RPN is determined by multiplying the selected Severity, Occurrence, and Detectability rankings. The comparison helps assess the impact of risk mitigation measures and determine whether additional corrective actions are necessary. A lower New RPN indicates an improvement in risk reduction efforts, enhancing overall process reliability and compliance.

Risk Region

This section allows you to compare the risk regions from the initial Risk Assessment and the updated regions calculated in the Failure Mode & Effect Analysis (FMEA). These classifications are determined based on the Risk Priority Number (RPN). The assigned Risk Region is derived from the Risk Region & Classification Table, ensuring consistency in evaluating process risks.

Risk Impact

The risk impact is determined based on the assigned risk region, reflecting its severity before and after mitigation. The Current Risk Impact represents the initial assessment, while the New Risk Impact evaluates the effectiveness of corrective actions. Both are categorized into three levels: Low, Medium, and High, based on priority and the need for further mitigation.

• Low (Acceptable): Minimal impact, negligible effects on operations or stakeholders.

• Medium (Tolerable): Moderate impact, requiring evaluation but not necessarily corrective action.

• High (Unacceptable): Critical impact, posing a significant threat that requires immediate attention.

Each impact level is predefined in the Risk Assessment Type Definition, and is automatically pulled from the Risk Assessment selected in the FMEA. The impact can range from catastrophic consequences to a minor inconvenience, depending on the defined criteria and its effect on the company, project, or stakeholders.

Risk Region & Classification

The table to determine the RPN's region is as follows:

Acceptable Region

Represents minimal risk with negligible effects, where the combined factors of severity, occurrence, and detectability result in an overall low-risk classification. Risks in this category do not require mandatory design re-evaluation or corrective actions. Functionalities within this region are classified as harmless and pose no significant concern.

Tolerable Region

Represents a medium risk level, also known as As Low As Reasonably Practical (ALARP). Re-evaluating and improving the design is recommended but not mandatory. Risks in this region are classified as practical functionalities, indicating that they can be accepted with proper monitoring.

Unacceptable Region

Identifies an intolerable risk where the combined factors of severity, occurrence, and detectability result in the highest overall risk classification. Risks in this region require immediate intervention, re-evaluation, and potential design modifications. Preventive and corrective actions must be considered. Functionalities associated with this risk level are classified as intolerable and may result in permanent impairment.