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Available Report Guides

Generate the ISO 14971 HARA Report : Run the comprehensive 12-section HARA report covering risk statistics, pre/post/final risk matrices, benefit-risk analysis, and ISO 14971 compliance statements. Read the Risk Matrix Report : Interpret the 5x5 risk distribution matrices showing pre-mitigation and post-mitigation risk placement across probability and severity dimensions. Read the DFMEA Summary Report : Review the RPN-based DFMEA summary with per-module breakdown, system-level statistics, and action items for unacceptable risk levels.

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Report Inventory

diagram
ReportWiki PageData SourceKey Metrics
ISO 14971 HARA Reportiso-14971-hara-reportriskRecord work itemsPre/Post/Final risk counts, benefit-risk decisions, compliance statement
Risk Matrix ReportHara Risk Matrix ReportriskRecord work items5x5 probability x severity distribution
DFMEA Summary ReportSystem DFMEA ReportfailureMode work itemsRPN distribution (Low/Medium/High) per DFMEA module
Home DashboardHome—Quick links to HARA, DFMEA, reports
Data ModelData Model—Work item type and relationship diagram

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How Reports Are Generated

All risk reports are Velocity wiki pages that query live Polarion data at render time:
  1. The report page executes Velocity scripts using $transaction.workItems().search().query()
  2. Work items are filtered by type (e.g., type:riskRecord or type:failureMode)
  3. Risk statistics are computed by iterating over all matching work items
  4. Results are rendered as styled HTML tables, matrices, and summary cards
  5. CSS is scoped to the report container (e.g., .hara-report-container) to avoid style conflicts
Reports always reflect the current state of your risk data. There is no separate “generate” step — simply navigate to the wiki page to see the latest results.
Reports: .polarion/pages/spaces/_default/iso-14971-hara-report/page.xml, Hara Risk Matrix Report/page.xml, System DFMEA Report/page.xml | Dashboard: .polarion/pages/spaces/_default/Home/page.xml