DEMO AI SOLUTIONS AB
RISK MANAGEMENT SYSTEM — IMPLEMENTATION EVIDENCE
Document ID: DEMOAI-EVD-IMPL-001
Version: 1.0 | Prepared by: Erik Johansson, Risk Manager | Date: 2026-04-20

=== FICTIONAL DOCUMENT — FOR DEMONSTRATION PURPOSES ONLY ===

1. LIFECYCLE PROCESS

The risk management system operates as a documented lifecycle process
integrated throughout the lifecycle of the AI system. The system covers
design, development, validation, deployment, and post-deployment phases.

2. MAINTENANCE AND UPDATES

Evidence of maintenance and updates: The risk management policy is reviewed
annually (last review: 2026-01-15). The risk register is updated quarterly.

Maintenance log:
  2025-11-20  Initial risk register created (v1.0)
  2025-12-15  First mitigation measures documented (v1.0)
  2026-01-15  Annual policy review completed (v2.0)
  2026-02-15  Testing report completed, pre-market evidence recorded
  2026-03-01  Drift detection system deployed
  2026-04-10  Quarterly risk register update (v3.1)
  2026-04-15  Mitigation log updated with effectiveness data (v2.0)

3. KNOWN AND FORESEEABLE RISKS

The risk register documents all known risks identified through FMEA.
Foreseeable risks including reasonably foreseeable misuse scenarios have
been assessed: misuse by untrained operators, environmental changes,
and adversarial manipulation of input images.

4. IMPACT ON HEALTH, SAFETY AND FUNDAMENTAL RIGHTS

An impact assessment on health, safety or fundamental rights has been
conducted. False negative classifications (RISK-001) pose a direct safety
risk through defective products reaching end users.

5. EVIDENCE THAT MEASURES ADDRESS IDENTIFIED RISKS

Traceability verification confirms that all measures address identified risks:
  RISK-001 (High)   -> MITI-001 + MITI-002, verification completed
  RISK-002 (Medium) -> MITI-003, verification completed
  RISK-003 (High)   -> MITI-004, mitigation verified
  RISK-004 (Medium) -> MITI-005, verification completed Q1 2026
  RISK-005 (Medium) -> MITI-006, spot-check compliance at 94%

6. SCOPE LIMITATION

The scope limitation methodology defines boundaries for the risk assessment.
Risks outside the documented scope are excluded with documented rationale.

7. NON-ELIMINABLE RISKS

For risks that cannot be eliminated through design measures, control measures
have been implemented. Evidence of implementation for non-eliminable risks
includes operator override procedures (MITI-003), mandatory spot-checks
(MITI-006), and quarterly training data reviews (MITI-005).

8. TESTING AND PERFORMANCE

Test results demonstrate evidence of consistent performance across all three
manufacturing lines. The compliance test confirms all acceptance criteria met:
accuracy 98.7% (threshold 97.5%), false negative rate 1.7% (threshold 2.5%).
Defined metrics and thresholds were established prior to testing. Test results
against defined thresholds show full compliance.