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Prerequisites

  • A HARA document exists (created from the HARATemplate)
  • The Hazards Catalog and Standard Harms catalog are populated
  • Use steps have been defined in the Requirements space
  • You have access to the Nextedy risksheet editor

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Overview

Each risk record in the HARA represents one hazard chain: diagram You will repeat these steps for every combination of use step and hazard that applies to your device.

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Step 1: Open the HARA Document in Risksheet

  1. Navigate to Risks > HARA-ANALYSIS (or your HARA document)
  2. Click the Edit Risks with Nextedy RISKSHEET link in the document header panel
  3. The risksheet opens with columns for the hazard chain, probability scores, risk controls, and benefit-risk fields
The direct URL pattern is: /polarion/#/project/{projectId}/risksheet?document=Risks/HARA-ANALYSIS

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Step 2: Create a New Risk Record

  1. In the risksheet, click Add Row (or use the keyboard shortcut) to create a new risk record
  2. A new row appears with all fields set to their defaults
The new risk record is a riskRecord work item created inside the HARA document. It will receive a work item ID automatically.
  1. In the Use Step column, click the cell to open the picker
  2. The picker shows use steps from the Requirements space (24 use steps in the reference project)
  3. Select the use step that describes the operational scenario you are analyzing
The assesses link role connects the risk record to the use step. This answers: “During which operation does this hazard arise?” Example: Select “Infusion Setup — Load Tubing Set” as the use step for analyzing tubing-related hazards.
  1. In the Hazard column, click the cell to open the hazard picker
  2. The picker shows entries from the Hazards Catalog (68 entries organized by the IEC 60601 taxonomy)
  3. Use the taxonomy levels to narrow your search:
    • Level 1: Energy (root)
    • Level 2: Electrical, Mechanical, Thermal, or Radiation
    • Level 3: Specific mechanism (e.g., Leakage, Shock)
    • Level 4: Exact hazard (e.g., Earth leakage, Enclosure leakage)
  4. Select the hazard that matches your analysis
The hasHazard link role (many-to-one) connects the risk record to the catalog hazard. Multiple risk records can reference the same hazard.
The Hazards Catalog is shared across all HARA documents. You do not need to recreate hazards for each analysis — link to existing catalog entries.

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Step 5: Describe the Hazardous Situation

  1. In the Hazardous Situation column, type a description of the specific circumstance where a person is exposed to the hazard
  2. Be specific about the conditions, user actions, and device state
The hazardousSituation field is a rich text field. ISO 14971 defines a hazardous situation as “a circumstance in which people, property, or the environment is/are exposed to one or more hazards.” Good examples:
Use StepHazardHazardous Situation
Infusion SetupMechanical — tubing occlusionTubing kinked during loading, resulting in partial occlusion that is not detected by the occlusion sensor
Continuous InfusionElectrical — pump malfunctionFirmware lockup causes pump to deliver at maximum rate without user-commanded flow increase
Battery OperationThermal — battery overheatingCharging circuitry fault during simultaneous charging and infusion in high ambient temperature
A hazardous situation is not the same as the hazard itself. “Electrical leakage” is a hazard. “Patient connected to applied parts while the device has a single-fault condition in the power supply, exposing the patient to leakage current exceeding 500 uA” is a hazardous situation.
  1. In the Harm column, click the cell to open the harm picker
  2. The picker shows entries from the Standard Harms catalog (25 entries, each with a severity level)
  3. Select the harm that would result if the hazardous situation leads to injury
The hasHarm link role (many-to-one) connects the risk record to the catalog harm. The harm carries a severity value (1-5, Negligible to Catastrophic) that automatically populates the severity column.
SeverityLabelDefinition
1NegligibleTemporary discomfort, no medical intervention
2MinorTemporary injury, no medical intervention required
3SeriousInjury requiring medical intervention
4CriticalPermanent impairment or life-threatening
5CatastrophicPatient death
You do not manually set severity on the risk record. It is inherited from the linked Harm work item. To change severity, you must link to a different harm or update the harm catalog entry.

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Step 7: Verify the Hazard Chain

After completing steps 3-6, verify that the risk record row has all four elements:
  • Use step is linked (the operational context)
  • Hazard is linked (the source of potential harm)
  • Hazardous situation is described (the specific exposure scenario)
  • Harm is linked (the injury that could result, with severity)
Repeat steps 2-7 for every hazard-harm combination that applies to each use step. A single use step may have multiple risk records if multiple hazards are relevant.

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Systematic Identification Strategy

To ensure no hazards are missed, work through the hazard catalog systematically:
  1. By use step — For each of the 24 use steps, consider which hazards apply
  2. By hazard taxonomy — For each L2 category (Electrical, Mechanical, Thermal, Radiation), consider which use steps are exposed
  3. By system element — For each of the 35 system elements, consider which hazards it introduces
After completing hazard identification, check for taxonomy branches with no risk records. An empty L2 category (e.g., no thermal hazards) should be a conscious decision, not an oversight.

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Next Steps

With hazard chains identified, proceed to Evaluate Initial Risk (Pre-Mitigation) to score the P1 and P2 probabilities for each risk record.