Setup Guides
Create System Elements : Build the product decomposition hierarchy (System > Subsystem > Assembly > Subassembly > Component) that underpins DFMEA and PFMEA analysis. Create a New Risk Analysis Document : Create HARA, DFMEA, or PFMEA documents from the solution’s pre-configured templates with risksheet integration. Configure the Risk Control Plan : Set up the central Risk Control Plan document that tracks all risk control measures across HARA and FMEA analyses. Configure PowerSheet RTM Views : Customize the Requirements Traceability Matrix (RTM) views for tracking user needs, requirements, and verification evidence.Recommended Setup Order
- System Elements first — DFMEA functions are allocated to system elements, and process steps associate with them
- Risk documents second — HARA, DFMEA, and PFMEA documents reference the system element hierarchy
- Risk Control Plan third — risk controls are linked from HARA and FMEA documents
- PowerSheet views last — RTM configurations reference existing documents and requirements
Key Configuration Files
| File | Purpose |
|---|---|
.polarion/context.properties | Risksheet template paths and powersheet document query |
.polarion/nextedy/models/rtm.yaml | RTM domain model (entity types, relationships) |
.polarion/nextedy/sheet-configurations/*.yaml | PowerSheet view configurations |
.polarion/documents/workflow/*.xml | Document lifecycle workflows |
Related Resources
- Install the Medical Device Safety Solution — initial project setup
- Data Model and Work Item Types — understanding the entity relationships
- V-Model Traceability Chain — how traceability flows through the system
Source References
Source References
Configuration:
.polarion/context.properties | Model: .polarion/nextedy/models/rtm.yaml