Serious Incident Reporting (EU/UK) — Lifecycle Operations

Serious Incident Reporting (EU/UK) — Lifecycle Operations

Zen AI Governance — Knowledge Base EU/UK alignment Updated 05 Nov 2025 www.zenaigovernance.com ↗

Serious Incident Reporting (EU/UK) — workflow & evidence

EU AI Act Compliance Lifecycle Operations EU/UK aligned
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Key takeaways
  • Agree definitions, owners and timelines in advance; keep pre-filled forms and an evidence bundle checklist.

Definition & triggers

  • Serious harm/potential harm to health, safety, or fundamental rights; unlawful processing; systemic failure.
  • Trigger list with examples (e.g., bias surge, unsafe recommendations, privacy breach, security compromise).

Triage & ownership

  • Incident commander; safety, security, legal, comms, and product owners; timeline clock starts at detection.

Initial notification

  • Send initial notification within required window; include scope, impact to date, mitigations underway, contacts.

Investigation & bundle

  • Evidence bundle: prompts/inputs/outputs, model/data versions, decisions/overrides, logs, screenshots, timelines.

Corrective actions

  • Immediate protective measures; rollbacks; kill-switch where warranted; roadmap for structural fixes.

Follow-up reports

  • Root cause, impact analysis, CAPA, effectiveness plan, and communication to affected parties.

Roles & comms

  • Single point of contact to regulator; internal comms cadence; user notices where required.

Templates & forms

  • Pre-approved notification templates; redaction guidance; evidence checklist; demo path for investigators.
  • Data protection & confidentiality maintained; legal hold; discovery-ready exports; counsel oversight.

Table-top tests

  • Quarterly drills; measure time-to-notify; bundle completeness; effectiveness of mitigations and runbooks.

Lessons & RMS updates

  • Feed findings to RMS/PMM; update thresholds, controls, training and documentation.

Reporting checklist

  • Definition agreed; owners trained; forms prepared; evidence bundle pattern tested; regulator contacts current.

© Zen AI Governance UK Ltd • Regulatory Knowledge • v1 05 Nov 2025 • This page is general guidance, not legal advice.

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