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Prerequisites

  • A populated HARA Analysis document with risk records
  • Risk records with pre-mitigation P1/P2 probabilities and harm severity assigned
  • Risk controls linked (recommended for post-mitigation and final risk sections)

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Step 1: Navigate to the Report

  1. Open your project in Polarion
  2. Navigate to the project wiki pages
  3. Open iso-14971-hara-report
Alternatively, from the Home dashboard, click the HARA Report link under “Explore More Views.” The report generates automatically from live data — there is no separate build or export step.

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Step 2: Understand the Report Structure

The report contains 12 sections that map to ISO 14971 clauses:
SectionTitleISO 14971 ClauseContent
1Scope & PurposeClause 4Purpose, intended use, operating environment
2Methodology SummaryClause 5P1xP2 probability model, severity scale, risk matrix
3DefinitionsClause 3ISO 14971:2019 terminology
4Summary of Identified HazardsClause 5.4Risk counts and hazard categories
5Pre-Mitigation Risk DistributionClause 5.55x5 initial risk matrix
6Post-Mitigation Risk DistributionClause 7.15x5 residual risk matrix
7Final Risk DistributionClause 8.3Final risk with benefit-risk analysis
8Risk Acceptability SummaryClause 8Distribution tables and compliance statement
9Risk Control Measures OverviewClause 7Control hierarchy and documentation
10Residual Risk EvaluationClause 8Overall residual risk decision
11TraceabilityClause 10Full traceability chain
12(Appendices)—Supporting data

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Step 3: Review the Methodology Section

Section 2 documents the risk evaluation methodology used by the solution:

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Probability Model (P1 x P2)

The report renders probability scales dynamically from Polarion enumerations:
  • P1 (Hazard Probability): Read from pOccurrence enumeration (5 levels)
  • P2 (Harm Probability): Read from p2Occurrence enumeration (5 levels)
  • Combined P: Bucket mapping from P1 x P2 product (1-25) to probability bucket (1-5)
The combined probability matrix shows the bucketing:
P1 x P2 ProductProbability Bucket
1-3Bucket 1 (Improbable)
4-8Bucket 2 (Remote)
9-15Bucket 3 (Occasional)
16-20Bucket 4 (Probable)
21-25Bucket 5 (Frequent)

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Severity Scale

Static 5-level severity scale:
LevelDescription
1Negligible
2Minor
3Moderate
4Serious
5Catastrophic

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Risk Acceptability Matrix

A hardcoded 5x5 matrix maps P (1-5) x S (1-5) to three risk levels: diagram

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Step 4: Review the Three-Stage Risk Evaluation

The report computes risk statistics at three stages:

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Pre-Mitigation (Section 5)

  • Uses preRisk field values: acceptable, investigation, unacceptable
  • Renders a 5x5 distribution matrix using preHazardProbability and preHarmProbability
  • Harm severity is resolved by traversing linked harm work items

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Post-Mitigation (Section 6)

  • Uses postRisk field values
  • Matrix uses postHazardProbability and postHarmProbability
  • Conditionally displayed only when post-mitigation data is available
  • Includes residual risk summary with conditional alerts

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Final Risk (Section 7)

  • Uses finalRisk field with three possible values:
    • acceptable — residual risk is within acceptable limits
    • benefitAcceptable — risk justified by benefit-risk analysis (ISO 14971 Clause 7.4)
    • unacceptable — risk requires further action
The final risk section includes:
  • Benefit-risk decision map — details for each benefitAcceptable risk record
  • Unacceptable risks action items — required actions with conditional recommendations
  • Final risk distribution table — counts and percentages

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Step 5: Interpret the Compliance Statement

Section 8 concludes with an ISO 14971 compliance statement:
If finalUnacceptableCount == 0: A green success box confirms all risks meet acceptance criteria.
If finalUnacceptableCount > 0: A red danger box lists regulatory action items, including implementing additional risk controls or re-evaluating device design.
The compliance statement uses the final risk count (not post-mitigation), meaning benefit-risk analysis can resolve risks that would otherwise be flagged as non-compliant.

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Step 6: Export the Report

The HARA report is print-optimized with page-break-inside:avoid on sections. To export:
  1. Use your browser’s Print function (Ctrl+P / Cmd+P)
  2. Select Save as PDF
  3. The scoped CSS (.hara-report-container) ensures consistent formatting
The exported PDF serves as the HARA section of your Design History File (DHF).

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Key Sections for Auditors

Audit FocusReport SectionWhat to Check
Risk identificationSection 4Hazard count and categories
Risk evaluationSections 5-6Pre/post distribution shift
Benefit-riskSection 7.4Decision map completeness
Residual riskSection 10Manufacturer’s acceptability decision
TraceabilitySection 11Hazard-to-test chain

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Next Steps

Report template: .polarion/pages/spaces/_default/iso-14971-hara-report/page.xml (~2200 lines) | Data: type:riskRecord work items | Fields: preRisk, postRisk, finalRisk, preHazardProbability, preHarmProbability, postHazardProbability, postHarmProbability, harm.severity