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Prerequisites

  • A project created from the Medical Device Safety Solution template
  • System elements created (required for DFMEA subsystem scoping)

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Available Templates

The solution provides four document templates in the RiskTemplates space:
TemplateTypeUse Case
HARATemplateHARA (ISO 14971)Hazard Analysis and Risk Assessment with P1xP2 probability model
DFMEATemplateDFMEADesign Failure Mode and Effects Analysis with SxOxD RPN scoring
PFMEATemplatePFMEAProcess FMEA for manufacturing process analysis
RiskControlPlanTemplateRisk Control PlanCentral registry of all risk control measures
All templates create documents of type riskSpecification and follow the same document lifecycle: Draft -> In Review -> Approved -> Published.

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Step 1: Navigate to the Risks Space

  1. Open your project in Polarion
  2. Navigate to the Risks space using the space navigation
  3. The Risks space contains all risk analysis documents and two sub-spaces:
    • Catalogs — hazard and harm catalogs
    • RiskTemplates — document templates

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Step 2: Create the Document

  1. Click Create New Document in the Risks space
  2. Select the appropriate template from the template list
  3. Enter a document title following the naming convention:
TemplateNaming ConventionExample
HARAHARA-ANALYSIS”HARA-ANALYSIS”
DFMEA (system)FMEA-SYS-NNN”FMEA-SYS-001”
DFMEA (subsystem)DFMEA-SUB-NNN”DFMEA-SUB-001”
PFMEAPFMEA - {Device Name}”PFMEA - Smart Infusion Pump”
Risk Control PlanRiskControlPlan”RiskControlPlan”
  1. Click Create

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Step 3: Configure Document Metadata

Each risk document includes an FMEA header metadata table rendered via Velocity. Update the document-level custom fields:
FieldSourceDescription
Item$document.getValue('item')Product or system name
Model$document.getValue('model')Product model identifier
Version$document.getValue('version')Document version (float, e.g., 1.0)
Owner$document.getValue('owner')Document owner (Polarion user)
Core Team$document.getValue('team')Review team members
For DFMEA subsystem documents, also set the subsystem custom field. This value is used by the DFMEA Summary Report to label each DFMEA module and by the risksheet top panel to display subsystem context.

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Step 4: Configure Sheet Binding (Optional)

Documents can be explicitly bound to a sheet configuration using the nextedySheetConfig field:
  1. Open the document properties
  2. Set nextedySheetConfig to the desired sheet configuration
  3. The @NextedySheetConfigs enum auto-discovers available configurations at runtime
If not explicitly set, the document uses the risksheet configuration attached to its template.

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Step 5: Open in Risksheet

Each template includes a styled edit panel with a direct link to open the document in risksheet: 
[Edit Risks with Nextedy RISKSHEET]
-> /polarion/#/project/{projectId}/risksheet?document=Risks/{DocumentName}
The risksheet URL follows the pattern: /risksheet?document={Space}%2F{DocumentName}
Both riskRecord and failureMode work items are configured as fully read-only in the standard Polarion form. All fields use @all read-only status, meaning editing is only possible through Nextedy risksheet. This ensures formula consistency (RPN calculations, risk matrix lookups) and audit trail integrity.

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Step 6: Verify Template Configuration

After creating the document, verify these elements are in place:
ElementHARADFMEAPFMEARisk Control Plan
FMEA header tableYesYesYesYes
Risksheet edit panelYesYesYesYes
Scope checklistNoYesYesNo
Rendering layout (risk type)YesYesYesNo
Revision history tableNoYesYesNo
Outline numberingYesYesYesYes

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Template Configuration Paths

The risksheet templates are registered in .polarion/context.properties: 
nextedy.risksheet.risksheetTemplatePath=\
  RiskTemplates/DFMEATemplate,\
  RiskTemplates/HARATemplate,\
  RiskTemplates/PFMEATemplate,\
  RiskTemplates/RiskControlPlanTemplate
Each template path is relative to the project’s modules/ directory.

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Next Steps

Templates: modules/RiskTemplates/HARATemplate/module.xml, DFMEATemplate/module.xml, PFMEATemplate/module.xml, RiskControlPlanTemplate/module.xml | Registration: .polarion/context.properties | Document fields: .polarion/documents/fields/custom-fields.xml