Managing Risk Items — Analysis, Control Measures & Residual Risk

Transcript: Managing Risk Analysis, Control Measures, and Residual Risk

Introduction

Hello and welcome to eLeaP. In this quick tutorial, we are looking at how to manage risk items, perform analysis, apply control measures, and evaluate residual risk. Identifying risks is only the beginning; the eLeaP QMS provides the tools to actively mitigate and monitor those risks.

Defining Risk Items

Each risk element in the system—from hazards to harms—contains tailored fields to ensure comprehensive documentation:

Hazards: Capture the title and description, along with the Sources and Causes of the risk using fully customizable dropdown fields.
Hazardous Situations: These must be linked to a Foreseeable Event. You then set the Probability of the situation occurring on a standard five-point scale.
Harms: These are linked to the contributing Hazardous Situation. For each harm, you define both the Probability of Harm and the Severity.

Automated Risk Calculation

The eLeaP QMS uses a calibrated formula to drive an automated risk calculation system:

Initial Risk: This represents the inherent risk level (e.g., Critical) before any mitigation is applied. It is calculated based on your probability and severity inputs.
Visualization: You can view these scores in the artifact summary table. Keep an eye out for the Umbrella Icon, which indicates that a control measure has been applied to that specific item.

Applying Control Measures & Mitigation

Control measures are the actions you take to reduce the impact or likelihood of a risk:

Add Control Measure: Define the mitigation action and estimate its Impact Percentage (e.g., a 60% reduction in risk).
Set the Status: Choose the current stage of the measure: Defined, Verified, or Implemented.
Realizing the Reduction: > Note: The reduction in risk is only realized in the system once the status is set to Implemented.

Residual Risk and the Closed Loop

Once a control measure is implemented, the system automatically calculates the Residual Risk:

Residual Risk: This is the remaining risk level after mitigation (e.g., dropping from Critical to Medium).
Acceptability: Once the residual risk reaches an acceptable level, the item moves into a Monitored phase.

Conclusion

The eLeaP QMS ensures a closed-loop format where risks are not just identified but actively controlled, reviewed, and mitigated to ensure product safety and regulatory compliance.

As usual, if you have any questions about risk analysis or any other features in the system, please do not hesitate to contact us.