The harm work item type implements the fourth level of the ISO 14971 risk identification hierarchy:
Each hazardous situation can lead to one or more harms. Harm identification drives severity assessment and risk evaluation.
Core Properties
| Name | Type | Default | Description |
|---|
| ID | String | Auto-generated | Unique work item identifier in Polarion (e.g., TA-HARM-001) |
| Title | String | (required) | Name or concise description of the harm (e.g., “Loss of consciousness”, “Permanent vision impairment”) |
| Description | Text | (empty) | Detailed description of the injury or health damage, including affected body systems or organs |
| Status | Enum | DRAFT | Workflow state: DRAFT → REVIEW → APPROVED → ARCHIVED. Controls visibility in reports and compliance dashboards |
| Assignee | User | (unassigned) | Responsible person for defining and validating harm details |
| Created | Timestamp | (system) | Automatic timestamp when work item is created |
| Modified | Timestamp | (system) | Automatic timestamp of last edit |
| Priority | Enum | MEDIUM | Risk assessment priority: LOW, MEDIUM, HIGH, CRITICAL |
Severity and Classification
| Name | Type | Default | Description |
|---|
| Severity | Enum | (empty) | Harm Severity reference classification: S0 (no injury) through S3 (fatal injury). Directly influences risk probability assessment |
| Classification | Enum | (empty) | Harm category for ISO 14971 compliance: Injury, Illness, Disability, Death. Used for traceability filtering and compliance metrics |
| Affected System | String | (empty) | Name of body system affected (e.g., “Central Nervous System”, “Musculoskeletal System”, “Cardiovascular System”) |
| Affected Organ | String | (empty) | Specific organ or tissue affected (e.g., “Brain”, “Heart”, “Lungs”) |
| Recovery Time | String | (empty) | Estimated time to recover from harm if it occurs (e.g., “Permanent”, “6-12 months”, “2-4 weeks”) |
Relationship Properties
| Name | Type | Link Role | Cardinality | Description |
|---|
| Hazardous Situation | ItemLink | causesHarm | Many → One | Back-linked relationship to Hazardous Situation work items that can lead to this harm. A single harm can result from multiple hazardous situations |
| Risk Record | ItemLink | identifies | One → Many | Forward link to Risk Record work items that track this harm through the ISO 14971 risk management process |
| Mitigation Tasks | TaskLink | mitigatedBy | One → Many | Back-linked Risk Control or Risk Mitigation tasks that reduce probability or severity of this harm |
| Test Cases | ItemLink | validatedBy | One → Many | Back-linked Validation Test Case work items that verify controls prevent this harm |
| Related Harm | ItemLink | relatedTo | One → Many | Links to similar or related harm work items for grouping and traceability (informational, no control flow) |
Harm Severity Scale
The Severity enumeration maps to ISO 14971 definitions and automotive industry practice:
S0: No injury or health damage
S1: Minor injury (temporary, fully recoverable, e.g., minor bruise)
S2: Serious injury (significant medical intervention, permanent minor disability, e.g., loss of finger)
S3: Life-threatening or fatal injury (e.g., quadriplegia, death)
- S0 should rarely appear in harm records; if harm is impossible, remove the hazardous situation instead
- S1 applies to temporary, reversible injuries with no lasting effect
- S2 is the most common classification for automotive safety; includes permanent but non-life-threatening disability
- S3 is reserved for fatality or permanent incapacity (loss of consciousness, paralysis, etc.)
Traceability Flow Example
For the AEB (Automatic Emergency Braking) system:
Use Step: "Driver approaching obstacle at highway speed"
↓
Hazard: "Obstacle detection failure"
↓
Hazardous Situation: "Camera or radar sensor becomes occluded by rain/snow"
↓
Harm: "Delayed braking response prevents collision avoidance"
(Severity: S3 — potential fatality)
↓
Risk Record: Assigns probability P2 (harm occurs if situation exists)
↓
Risk Controls: Software filter calibration, sensor redundancy, system self-test
Usage in Risksheet
The Harm work item type is typically managed within a HAZID Risksheet configuration as Level 4 in the hierarchical grid:
- Level 1 (row group): Use Step
- Level 2 (row group): Hazard
- Level 3 (row group): Hazardous Situation
- Level 4 (data rows): Harm
Columns displayed at Level 4 include:
| Column | Type | Purpose |
|---|
| Harm ID | Work Item ID | Displays unique identifier and link to Harm work item form |
| Harm Description | Text | Displays Title + Description from work item |
| Severity | Enum | Severity rating for this harm; used in Risk Probability calculation |
| P2 (Probability Harm Occurs) | Formula | Calculated probability that hazardous situation results in this harm (input to Risk × Probability matrix) |
| Risk Level | Formula | Final risk classification: Acceptable (green), ALARP (yellow), Unacceptable (orange) |
| Risk Controls | ItemLink | Multi-item column displaying mitigation tasks linked via mitigatedBy role |
Use the zoom column on Level 3 (Hazardous Situation) to expand/collapse all Level 4 (Harm) rows. This enables safety engineers to:
- First identify all hazards and hazardous situations (collapse Level 4)
- Then drill down to severity/probability assessment for each harm (expand Level 4)
- Track mitigation effectiveness by comparing pre-control and post-control risk levels
Workflow States
Harm work items follow the Risk Specification Workflow with these states:
| State | Meaning | Allowed Transitions |
|---|
DRAFT | Initial creation; severity and classification not yet confirmed | → REVIEW |
REVIEW | Under risk assessment review; severity/P2 probability being evaluated | → DRAFT, → APPROVED, → REJECTED |
APPROVED | Harm severity and probability confirmed; included in risk analysis reports | → ARCHIVED |
ARCHIVED | Obsolete or superseded harm; excluded from active risk analysis | → DRAFT (rare, for re-analysis) |
Linking Harm to Requirements and Test Cases
To satisfy ISO 14971 risk control verification requirements:
- Link Risk Controls to Requirements: Each Risk Control mitigation task should link to one or more Design or System Requirements via
mitigates relationship
- Link Requirements to Test Cases: The Requirements should have back-linked Test Cases via
verifies relationship
- Validate Complete Chain: From Harm → Risk Record → Risk Control → Requirement → Test Case
Example query to find unverified harms:
type:harm AND NOT backlinkedWorkItems:identifies=TA-RR*
Custom Fields
The following custom fields extend Harm properties for advanced ISO 14971 and SOTIF (ISO 21448) analysis:
| Field | Type | Enum Values | Purpose |
|---|
harmCategory | Enum | Injury, Illness, Disability, Death, Psychological | ISO 14971 harm type classification for statistical reporting |
populationAtRisk | Multi-Select | Public, Operators, Maintenance, Bystanders | Who can experience harm; affects exposure probability |
sensitivePopulation | Boolean | Yes / No | Flag if vulnerable populations (children, elderly) at risk; may increase severity assessment |
permanence | Enum | Temporary, Reversible, Permanent, Fatal | Recovery expectation; influences harm severity rating |
societalImpact | Text | (free text) | For high-severity harms (S3): societal or regulatory impact (e.g., “Potential recall requirement”, “Regulatory notification required”) |
Cross-References
