Prerequisites
- Polarion ALM server with Nextedy Risksheet and Nextedy Powersheet extensions installed
- Administrator or project-creator role on the Polarion instance
- Network access to the Polarion server (VPN if required)
Both Nextedy Risksheet and Nextedy Powersheet are commercially licensed products. Contact Nextedy Systems for licensing details before proceeding.
Step 1: Create the Project from Template
- Log in to Polarion as an administrator
- Navigate to Administration > Projects > Create Project
- In the template selector, choose Nextedy Risk Management (ISO 14971)
-
Set the project fields:
Field Example Value Project Name Smart Infusion Pump V Series Project ID infusion-pump-v1 Tracker Prefix RTM Project Lead (your username) - Click Create
- 8 spaces: Requirements, Design, Risks, Testing, Catalogs, RiskTemplates, Documentation, _default
- 4 risk templates: HARATemplate, DFMEATemplate, PFMEATemplate, RiskControlPlanTemplate
- 2 catalogs: HazardsCatalog (68 entries), Standard Harms (25 entries)
- 7 PowerSheet configurations: Whole RTM, Component RTM, Use Steps, Process Steps, and 3 verification sheets
Step 2: Verify the Risksheet Configuration
The project template configures four risksheet templates via thecontext.properties file:
- Navigate to the Risks space using the sidebar
- Click the Risksheets favorite in the sidebar navigation
- Confirm that you see the document browser with risk analysis documents listed
- Open the HARA-ANALYSIS document
- Verify the risksheet editing panel loads with the HARA column structure
Step 3: Verify the PowerSheet Configuration
- Click RTM Sheet in the sidebar favorites
- The Whole RTM PowerSheet should load, showing:
- User Needs column group (green headers)
- System Requirements column group (purple headers)
- Design Requirements column group (blue headers)
- Confirm that rows are populated with traceability data linking user needs through system requirements to design requirements
Step 4: Verify the Hazard and Harm Catalogs
The solution ships with pre-populated catalogs aligned with IEC 60601:- Navigate to Catalogs space
- Open HazardsCatalog — confirm 68 hazard entries organized by the 4-level taxonomy (Energy > Electrical/Mechanical/Thermal > specific types)
- Open Standard Harms — confirm 25 harm entries with severity levels from Negligible (1) to Catastrophic (5)
Step 5: Verify Reports
Three Velocity-powered reports are configured as wiki pages:- From the sidebar favorites, click HARA report — confirm the ISO 14971 report renders with risk record tables
- Click Risk Matrix Report — confirm the 5x5 pre-mitigation and post-mitigation matrices display with color-coded cells
- Click DFMEA Summary Report — confirm the executive DFMEA summary renders with subsystem statistics
Verification Checklist
| Check | Expected Result |
|---|---|
| Project created | Project visible in Polarion project list with RTM prefix |
| Risksheet templates | 4 templates listed in risksheet document browser |
| HARA document | Risksheet editing panel loads with Use Step / Hazard / Harm columns |
| PowerSheet RTM | Whole RTM Sheet shows 3 column groups with live data |
| Hazard catalog | 68 entries with 4-level taxonomy |
| Harm catalog | 25 entries with severity scale 1-5 |
| HARA report | ISO 14971 report renders from live data |
| Risk Matrix | Two 5x5 matrices (pre/post-mitigation) with color coding |
| DFMEA summary | Executive summary with per-subsystem breakdown |