All fields on Risk Record work items are read-only in the standard Polarion work item form. Editing is only possible through Nextedy risksheet. This ensures formula integrity for computed fields (probability, risk level) and maintains the audit trail.
Custom Fields
| Field ID | Display Name | Type | Enumeration | Description |
|---|
preHazardProbability | P1-Pre Hazard Probability | Enum | pOccurrence (0-5) | Probability the hazardous situation occurs before risk controls |
preHarmProbability | P2-Harm Occurrence | Enum | p2Occurrence (0-5) | Probability the situation leads to harm before controls |
preControlProbability | Pre Control Probability | Enum | probability (1-5) | Combined P1xP2 bucket (computed by risksheet formula) |
postHazardProbability | P1-Post Hazard Probability | Enum | pOccurrence (0-5) | Post-mitigation hazard probability |
postHarmProbability | P2-Post Harm Occurrence | Enum | p2Occurrence (0-5) | Post-mitigation harm probability |
postControlProbability | Post Control Probability | Enum | probability (1-5) | Combined post-mitigation P1xP2 bucket |
preRisk | Pre Risk | Enum | risk | Pre-mitigation risk level (Acceptable / Investigation / Unacceptable) |
postRisk | Post Risk | Enum | risk | Residual risk level after controls |
hazardousSituation | Hazardous Situation | Rich Text | — | Description of the hazardous situation per ISO 14971 |
benefit | Benefit | Rich Text | — | Clinical or functional benefit justifying residual risk |
riskBenefitResult | Benefit-Risk Result | Enum | riskBenefitResult | Outcome: benefitAcceptable or benefitNotAcceptable |
additionalControlsPossible | Additional Controls Possible | Enum | yesno | Whether further risk reduction is technically feasible |
finalRisk | Final Risk | Enum | finalRisk | Final acceptability: Acceptable / Unacceptable / Benefit-Risk Acceptable |
Risk Evaluation Chain
The three-tier risk resolution path implements the ISO 14971 decision tree:
Link Roles
| Role | Direction | Target Type | Description |
|---|
assesses | Outgoing | useStep, function, systemElement, processStep | What this risk record assesses |
hasHazard | Outgoing | hazard | The hazard that is the source of risk |
hasHarm | Outgoing | harm | The potential harm or injury |
hasCause | Outgoing | cause | The cause mechanism |
analyzedIn | Incoming | failureMode | DFMEA failure modes linked to this risk record |
mitigates | Incoming | riskControl, task | Risk controls or tasks that mitigate this risk |
allocatedTo | Outgoing | systemElement | System element this risk is allocated to |
tracks | Incoming | changeRequest | Change requests tracking this risk record |
Probability Model
The P1xP2 composite probability uses a 5x5 multiplication matrix:
| P1 x P2 Product | Probability Bucket | Label |
|---|
| 1-3 | 1 | Very Low |
| 4-8 | 2 | Low |
| 9-15 | 3 | Medium |
| 16-20 | 4 | High |
| 21-25 | 5 | Very High |
Risk Classification
| Value | Label | Color | Meaning |
|---|
acceptable | Acceptable | Green | Risk is tolerable without further action |
investigation | Investigation | Amber | Requires further analysis or benefit-risk justification (ALARP zone) |
unacceptable | Unacceptable | Red | Mandatory risk reduction required |
Final Risk Classification
| Value | Label | Meaning |
|---|
acceptable | Acceptable | Post-mitigation risk is acceptable |
unacceptable | Unacceptable | Risk remains unacceptable after all controls |
benefitAcceptable | Benefit-Risk Acceptable | Residual risk justified by clinical benefit per ISO 14971 Clause 7.2 |
- All fields are read-only in the default hat (
@all fields locked for _default status)
- Risk records can only be edited through the HARA risksheet view
- Computed fields (
preControlProbability, postControlProbability, preRisk, postRisk, finalRisk) are set by risksheet formulas
- The
status field follows the standard work item workflow: Draft, In Review, Pending Approval, Approved, Rejected, Obsolete
Related Pages
