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Hazard Analysis Guide

Managing Hazards​

The Hazard Analysis interface allows you to view, filter, and manage all identified hazards for your product.

  • Grouping: Organize hazards by category (e.g., Electrical, Biological, User Error) for better manageability.
  • Listing Page: View a comprehensive list of all identified hazards, filter by severity or status, and export for reporting.
  • AI Generation Reference: Leverage AI to suggest potential hazards based on similar device profiles and historical data.
Hazard Analysis Dashboard

Key columns in the Dashboard:​

  • Actions: Edit, View, or Delete a hazard entry.
  • Hazard ID & Name: Unique identifier and descriptive name for the hazard.
  • Sequence of Events: The chain of events leading to the hazardous situation.
  • Hazardous Situations: The specific condition in which people, property, or the environment are exposed to one or more hazards.

Adding a New Hazard​

When creating a new hazard entry, ensure all critical fields are populated to perform an accurate risk assessment.

New Hazard Entry Form

Required Fields:​

  • Hazard ID & Name: Define a clear, unique ID and name.
  • Sequence of Events: Describe the step-by-step process leading to harm.
  • Harm Name & Code: Specify the potential harm and its classification code.
  • Severity: Rate the severity of the harm if it were to occur.
  • P1 & P2:
    • P1: Probability of the hazardous situation occurring.
    • P2: Probability of the hazardous situation leading to harm.
  • Risk: The overall risk score calculated from Severity and Probability (P1 x P2).

Risk Scoring​

  • Methodology: Likelihood × Severity to compute relative risk.
  • Calibration: define scales for likelihood and severity consistent with your QMS.

Mitigation Tracking​

  • Create corrective actions tied to hazards.
  • Track owner, status, due dates, and verification of effectiveness.
  • Link mitigations to events or failure modes for traceability.