Source file: modules/RiskTemplates/RiskControlPlanTemplate/attachments/risksheet.json
Role in the Solution
The Risk Control Plan is the target document referenced by HARA’s and DFMEA’s task data types (document: 'Risks/RiskControlPlan'). When a risk analyst assigns a risk control in HARA or DFMEA, the control is created in or linked from this document.
Hierarchy Structure
| Level | Name | Control Column |
|---|
| L1 | Risk Control | systemItemId |
Column Reference
| Column | Type | Binding | Width | Description |
|---|
| Title | text | title | 250px | Risk control name (Level 1) |
| Risk Control Type | enum | riskControlType | — | ISO 14971 control category |
| Risk Records | multiItemLink | mitigates -> riskRecord | — | Linked risk records (reverse traceability) |
Risk Control Type Values
The risk control type column uses the Risk Control Type enumeration following the ISO 14971 hierarchy:
| ID | Display Name | ISO 14971 Priority | Description |
|---|
InherentSafetyDesign | Inherent Safety by Design | 1 (highest) | Eliminate the hazard through design changes |
ProtectiveMeasure | Protective Measure | 2 | Physical barriers, guards, interlocks |
InformationForSafety | Information for Safety | 3 (lowest) | Labels, warnings, training, IFU |
Per ISO 14971, risk controls should be applied in priority order: design changes first, then protective measures, then information for safety. This hierarchy is reflected in the enumeration sort order.
Data Type
| Data Type | Work Item Type | Notes |
|---|
risk | riskControl | Direct management (not via task links) |
task data type because it IS the control registry — it manages risk controls directly rather than referencing them.
The Risk Control Plan JSON inherits the full HARA formula set and cell decorator styles:
- Formulas:
riskProbabilityPre, riskProbabilityPost, riskValuePre, riskValuePost, riskValueFinal, description
- Cell decorators:
acceptance and rowHeaderRpnNew with rpn1-rpn3 color classes
These are present for template consistency but are not actively referenced by any columns in this sheet.
Review Workflow
The Risk Control Plan uses CommentBased review manager, enabling inline commenting review workflow consistent with the HARA and FMEA risksheets.
