Risk Enumerations
Core risk assessment scales used by HARA risk records:- Harm Severity Levels — 5-level severity scale from Negligible to Catastrophic
- P1 Hazard Probability Levels — Probability of the hazardous situation occurring (0-5)
- P2 Harm Probability Levels — Probability that the hazardous situation leads to harm (0-5)
- Risk Classification — Acceptable / Investigation / Unacceptable risk levels
- Risk-Benefit Result — Benefit-risk analysis outcome per ISO 14971 Clause 7.2
- Final Risk Classification — Conclusive risk acceptability after all controls and benefit-risk analysis
DFMEA Enumerations
Failure mode assessment scales used by DFMEA:- Failure Mode Severity — 5-level color-coded severity from Negligible to Critical
- Failure Mode Occurrence — Occurrence frequency rating (0-5)
- Failure Mode Detection — Detection capability rating (0-5)
Classification Enumerations
Type classifiers and category enumerations:- Risk Control Type — ISO 14971 three-tier control hierarchy
- System Element Type Hierarchy — 5-level product decomposition
- Design Requirement Subtype — Engineering discipline classification
- IEC 60601 Hazard Taxonomy Cascade — 4-level hazard classification
Enumeration Architecture
Quick Reference
| Enum | Values | Used By | Purpose |
|---|---|---|---|
harm-severity | 5 levels (Negligible to Catastrophic) | Risk Record (via Harm) | Severity axis of 5x5 risk matrix |
pOccurrence | 0-5 (Unanalyzed to Very Likely) | Risk Record | P1 hazard probability |
p2Occurrence | 0-5 (Unanalyzed to Almost Certain) | Risk Record | P2 harm probability |
probability | 1-5 (Very Low to Very High) | Risk Record | Combined P1xP2 bucket |
risk | 3 values (Acceptable/Investigation/Unacceptable) | Risk Record | Pre/post risk level |
riskBenefitResult | 2 values | Risk Record | Benefit-risk outcome |
finalRisk | 3 values | Risk Record | Final risk acceptability |
failureModeSeverity | 1-5 (color-coded) | Failure Mode | DFMEA severity (S in RPN) |
fmOccurrence | 0-5 | Failure Mode | DFMEA occurrence (O in RPN) |
detection | 0-5 | Failure Mode | DFMEA detection (D in RPN) |
riskControlType | 3 values (multi-select) | Risk Control | ISO 14971 control tier |
systemElementType | 5 levels | System Element | Product decomposition |
designRequirement-subType | 5 values | Design Requirement | Engineering discipline |
| Hazard taxonomy | 4 cascade levels | Hazard | IEC 60601 hazard hierarchy |
Related Pages
- Work Item Types — Types that use these enumerations
- Risk Matrix and P1xP2 Probability Model — How probability and severity enums combine
- HARA Risksheet Configuration — Column-level enum bindings
- DFMEA Risksheet Configuration — DFMEA enum bindings