This reference documents all custom fields defined for the Risk Record work item type, including their types, defaults, enumerations, and usage patterns in risksheet configurations and PowerSheet traceability views.
Risk Records implement a fine-grained risk assessment pattern distinct from FMEA: P1 (probability hazard occurs), P2 (probability harm given hazard), and Control (control failure probability). This model enables targeting risk controls at specific failure points in the hazard-to-harm chain.
Pre-Mitigation Risk Assessment
Pre-Mitigation Severity
| Property | Value |
|---|
| Name | preMitigationSeverity |
| Type | Enum |
| Default | (none) |
| Reference | harmSeverity enumeration |
| Description | Severity rating of potential harm before risk control implementation, based on patient impact or outcome severity. Used in pre-mitigation risk level computation. Examples: Minor Injury, Major Injury, Fatality. |
| Risksheet Usage | Displayed in pre-mitigation risk assessment column group; may drive row color-coding in risk matrix. |
Pre-Mitigation P1 (Hazard Probability)
| Property | Value |
|---|
| Name | preMitigationP1 |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that the hazardous event will occur in the specified operational context, independent of harm outcome. Captures “hazard occurs” before considering whether it causes patient harm. Part of three-probability decomposition per ISO 14971. Values typically: Remote, Low, Medium, High, Very High. |
| Risksheet Usage | Column in pre-mitigation assessment phase; used in preRisk formula calculation. |
Pre-Mitigation P2 (Harm Probability)
| Property | Value |
|---|
| Name | preMitigationP2 |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that harm will result given the hazardous event occurs. Captures the conditional probability “hazard → harm” after exposure. Distinct from P1, enabling analysis of scenarios where hazards are common but harm is rare (low detectability, good mitigation). |
| Risksheet Usage | Column in pre-mitigation risk matrix; combined with P1 and Control probability in risk level formula. |
Pre-Mitigation Control Probability
| Property | Value |
|---|
| Name | preMitigationControlProbability |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that existing preventive or detective controls will fail to prevent or mitigate the hazardous event. Captures control effectiveness baseline before implementing new risk controls. Values indicate likelihood control is ineffective: Remote (control always works), Low, Medium, High, Very High (control unreliable). |
| Risksheet Usage | Third dimension of pre-mitigation risk assessment; influences whether additional controls are necessary. |
Pre Risk (Overall Assessment)
| Property | Value |
|---|
| Name | preRisk |
| Type | Enum (computed or assessed) |
| Default | (computed from S, P1, P2, Control) |
| Reference | riskLevel enumeration |
| Description | Overall pre-mitigation risk level derived from severity, P1, P2, and control probability using risk matrix lookup. Represents unacceptable risk requiring control implementation. Typical values: Unacceptable, Conditional Acceptance, Acceptable. |
| Risksheet Usage | Computed via JavaScript formula combining S×P1×P2×Control values; used to color-code rows and identify high-risk scenarios requiring mitigation. |
preRisk = riskMatrix[preMitigationSeverity][preMitigationP1][preMitigationP2][preMitigationControlProbability]
Post-Mitigation Risk Assessment
Post-Mitigation Severity
| Property | Value |
|---|
| Name | postMitigationSeverity |
| Type | Enum |
| Default | (none) |
| Reference | harmSeverity enumeration |
| Description | Severity rating of potential harm after risk controls are implemented. In most cases, equals pre-mitigation severity (severity inherent to harm, not reducible by controls). Documented for completeness and audit trail. |
| Risksheet Usage | Post-mitigation risk matrix column; typically mirrors pre-mitigation unless risk control reduces harm severity (rare). |
Post-Mitigation P1 (Hazard Probability)
| Property | Value |
|---|
| Name | postMitigationP1 |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that hazardous event will occur after implementing preventive risk controls. Represents effectiveness of inherent safety or protective measures that reduce hazard frequency. Should be lower than preMitigationP1 if prevention controls are effective. |
| Risksheet Usage | Column in post-mitigation assessment phase; demonstrates risk reduction from mitigation strategy. |
Post-Mitigation P2 (Harm Probability)
| Property | Value |
|---|
| Name | postMitigationP2 |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that harm will result given the hazardous event occurs, after implementing detective or mitigating controls. Represents effectiveness of protective measures that reduce harm consequences. Combined with post-mitigation P1 to compute residual risk. |
| Risksheet Usage | Post-mitigation risk matrix dimension; reflects control effectiveness at harm reduction phase. |
Post-Mitigation Control Probability
| Property | Value |
|---|
| Name | postMitigationControlProbability |
| Type | Enum |
| Default | (none) |
| Reference | riskProbability enumeration |
| Description | Probability that post-mitigation controls will fail, capturing residual control unreliability after adding new safeguards. Should be lower than pre-mitigation if new controls improve overall system reliability. Documents control redundancy and diagnostic coverage. |
| Risksheet Usage | Third dimension of post-mitigation assessment; combined with P1 and P2 in residual risk formula. |
Post Risk (Residual Risk)
| Property | Value |
|---|
| Name | postRisk |
| Type | Enum (computed) |
| Default | (computed from post-mitigation S, P1, P2, Control) |
| Reference | riskLevel enumeration |
| Description | Overall residual risk level after all mitigation controls are implemented. Determines whether risk is acceptable or requires additional controls per ALARP principle. Typical values: Unacceptable (requires more controls), Conditional Acceptance (risk/benefit analysis needed), Acceptable (controls sufficient). |
| Risksheet Usage | Key input to Final Risk decision logic; drives workflow escalation for unacceptable residual risks. |
Risk Context and Mitigation Linkage
Hazardous Situation
| Property | Value |
|---|
| Name | hazardousSituation |
| Type | Text (1000+ characters) |
| Default | (empty) |
| Description | Description of the specific scenario where hazard and operational context combine to create potential for harm. Bridges hazard identification and risk analysis. Should include: what triggered hazard, operational context, when/where, who/what affected. Example: “During parking in bright sunlight, camera sensor becomes saturated due to glare, preventing obstacle detection within 1 meter stopping distance.” |
| Risksheet Usage | Displayed in hazardous situation column; provides context for risk reviewers and auditors. Mandatory for traceability to upstream hazard analysis. |
Linked Hazard (Reference)
| Property | Value |
|---|
| Name | linkedHazard |
| Type | Work Item Link |
| Link Role | assessesRisk |
| Target Type | Hazard, HazardousEvent |
| Description | Reference to the Hazard work item that identifies the hazardous event being assessed. Establishes traceability from risk record back to formal hazard analysis. Used in reports and RTM views to demonstrate coverage. |
| Risksheet Usage | ItemLink column at Level 1 or 2 grouping; supports drill-down from hazard to all associated risk records. |
Linked Harm (Reference)
| Property | Value |
|---|
| Name | linkedHarm |
| Type | Work Item Link |
| Link Role | resultsInHarm |
| Target Type | Harm |
| Description | Reference to the Harm work item describing potential patient injury or adverse outcome. Captures severity classification from formal harm analysis. Optional but recommended for medical device projects requiring harm traceability. |
| Risksheet Usage | ItemLink column; enables cross-linking to harm severity ratings and clinical endpoints. |
Risk Control and Acceptance
Risk Control Type
| Property | Value |
|---|
| Name | riskControlType |
| Type | Enum |
| Default | (none) |
| Reference | controlType enumeration |
| Values | inherent-safety-design, protective-measure, information-for-safety |
| Description | Classification of risk control strategy according to ISO 26262 control hierarchy. Inherent safety (preferred) eliminates hazard source. Protective measure detects/mitigates consequences. Information-for-safety (weakest) relies on warnings/procedures. Selection drives mitigation effectiveness and ASIL allocation. |
| Risksheet Usage | Enum dropdown; controls column cell decoration (green for inherent, yellow for protective, orange for informative). Used in control effectiveness scoring and design review. |
Additional Controls Possible
| Property | Value |
|---|
| Name | additionalControlsPossible |
| Type | Enum Boolean |
| Default | (none) |
| Values | Yes, No |
| Description | ALARP (As Low As Reasonably Practicable) determination: indicates whether further risk reduction measures are technically feasible or economically justifiable. “Yes” = additional controls exist but not yet implemented. “No” = at state of art limit or cost disproportionate. Required for risk acceptance justification. |
| Workflow Context | Triggers escalation in risk acceptance: if postRisk is Unacceptable AND additionalControlsPossible is No, requires executive approval and documented justification. |
| Risksheet Usage | Boolean column in acceptance decision phase; combined with postRisk to drive Final Risk logic. |
Risk/Benefit Analysis (Medical Device Context)
Benefit (Risk/Benefit Justification)
| Property | Value |
|---|
| Name | benefit |
| Type | Text (1000+ characters) |
| Default | (empty) |
| Description | Documentation of clinical, operational, or societal benefits of the product/function when risk cannot be further reduced. Required for medical device risk/benefit analysis per ISO 14971 Annex C. Should quantify benefits (lives saved, function preserved, cost reduction) and demonstrate benefits outweigh risks. Optional for automotive applications unless safety/performance trade-off exists. |
| Example | ”AEB system reduces collision frequency by 35% in real-world testing, preventing ~5,000 injuries annually at cost of <0.1% residual false-positive braking events. Clinical benefit outweighs sensor saturation risk.” |
| Risksheet Usage | Text cell in benefit analysis section; referenced in risk acceptance reports and audits. |
Risk Benefit Result (Decision Outcome)
| Property | Value |
|---|
| Name | riskBenefitResult |
| Type | Enum |
| Default | (none) |
| Values | BenefitsOutweighRisks, RisksOutweighBenefits, InsufficientData, NotApplicable |
| Description | Formal outcome of risk/benefit analysis comparing documented benefits against residual risk. Determines whether unacceptable residual risk is acceptable based on clinical/operational value. “NotApplicable” for low-risk scenarios not requiring benefit justification. |
| Workflow Impact | If postRisk=Unacceptable AND riskBenefitResult=BenefitsOutweighRisks, risk can be accepted with executive sign-off. |
| Risksheet Usage | Enum dropdown; combined with additionalControlsPossible in Final Risk decision matrix. |
Risk Acceptance Decision
Final Risk (Acceptance Decision)
| Property | Value |
|---|
| Name | finalRisk |
| Type | Enum |
| Default | (computed from decision logic) |
| Values | Acceptable, ConditionalAcceptance, Unacceptable |
| Description | Ultimate risk acceptance decision after considering residual risk (postRisk), ALARP assessment (additionalControlsPossible), and risk/benefit analysis (riskBenefitResult). Represents formal approval by risk management authority. Drives project progression: Unacceptable risk blocks release unless escalated. |
| Workflow Context | Output of risk acceptance gate. Changes to Acceptable only after sign-off by authorized reviewer (project lead, safety officer, executive). |
| Risksheet Usage | Enum column; color-coded (green=Acceptable, yellow=Conditional, red=Unacceptable). Used in dashboards to highlight unresolved risks. |
| postRisk | additionalControls | riskBenefitResult | Recommended finalRisk | Escalation Required |
|---|
| Acceptable | — | — | Acceptable | No |
| ConditionalAcceptance | Yes | — | ConditionalAcceptance | Yes (implement additional controls) |
| ConditionalAcceptance | No | BenefitsOutweighRisks | Acceptable | Yes (executive approval) |
| ConditionalAcceptance | No | RisksOutweighBenefits | Unacceptable | Yes (design change required) |
| Unacceptable | Yes | — | Unacceptable | Yes (must implement controls) |
| Unacceptable | No | — | Unacceptable | Yes (design review required) |
Work Item Links and Traceability
Risk Records participate in the following link relationships enabling traceability across the V-model:
Outgoing Links (Risk Record → Other Items)
| Link Role | Target Type | Purpose |
|---|
| assessesRisk | Hazard | Connects risk record to hazard identified in HARA analysis |
| resultsInHarm | Harm | References harm that may result from the hazardous event |
| mitigatedBy | RiskControl | Links to safety controls implementing risk mitigation |
| verifiedBy | TestCase | Links to test cases that verify control effectiveness |
| tracesFrom | SafetyGoal | Traces risk back to safety goal derived from hazard |
Incoming Links (Other Items → Risk Record)
| Source Type | Link Role | Purpose |
|---|
| RiskControl | mitigates | Risk control documents how it addresses this risk record |
| TestCase | verifies | Test case demonstrates control implementation |
| SafetyGoal | relatesTo | Safety goal provides mitigation strategy |
Usage in Risksheet Configurations
Risk Records appear in the Risk Control Plan Risksheet, which implements ISO 14971 risk acceptance workflow. Column groups organize fields chronologically:
Pre-Mitigation Assessment:
- System Element (itemLink, Level 1 grouping)
- Hazardous Situation (text)
- Linked Hazard (itemLink)
- Severity, P1, P2, Control Probability (enums)
- Pre Risk (computed, color-coded)
Mitigation Strategy:
- Risk Control Type (enum with cell decoration)
- Controls (taskLink to RiskControl items)
Post-Mitigation Assessment:
- Post-Mitigation P1, P2, Control Probability (enums)
- Post Risk (computed, color-coded)
- Additional Controls Possible (boolean)
Acceptance Decision:
- Benefit (text, conditional visibility if medical device)
- Risk Benefit Result (enum)
- Final Risk (enum, color-coded)
All of the following must have values before risk can transition to Acceptable or Unacceptable (not ConditionalAcceptance):
- preMitigationSeverity, preMitigationP1, preMitigationP2, preMitigationControlProbability
- postMitigationP1, postMitigationP2, postMitigationControlProbability
- additionalControlsPossible
- finalRisk (must be set explicitly by authorized reviewer)
