Post-Market Monitoring & Serious Incidents (EU/UK aligned)
Post-Market Monitoring & Serious Incidents (EU/UK aligned)
EU AI Act Compliance Regulatory Knowledge EU/UK aligned
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Key takeaways
- High-risk AI obligations span the full lifecycle: design → operation → monitoring → corrective action.
- Providers own risk management & documentation; Deployers run operations, oversight & incident reporting.
- Serious incidents require rapid triage, evidence bundles and (where applicable) regulatory submission.
Summary
Post-market monitoring (PMM) is a lifecycle obligation for high-risk AI under the EU AI Act and a core element of responsible AI in the UK. It observes live behaviour, compares against tolerances and triggers action when residual risk rises.
- Provider: designs PMM, KPIs, regulatory reporting and CAPA.
- Deployer: operates the system, monitors incidents, controls and reports serious incidents promptly.
- Evidence: telemetry, logs, model versions, data lineage, decisions, outcomes, explanations.
Monitoring objectives & KPIs
- Define objectives tied to harms, fairness, security, privacy, explainability and operational KPIs.
- Set tolerances/thresholds and attach owners, review cadence and escalation paths.
- Track drift, bias, model degradation, outage and misuse patterns.
Telemetry, logging & data minimisation
- Capture signals needed to prove safety, fairness, privacy, explainability, security and robustness.
- Minimise personal data; prefer hashed or synthetic fields; support data subject rights.
- Maintain clear retention & disposal aligned to your Record of Processing Activities (ROPA).
Drift & bias surveillance
- Detect data and concept drift; run bias metrics (pre/post-deployment) and compare vs tolerances.
- Record affected cohorts, magnitude, decision impact; trigger CAPA where thresholds are breached.
Safety & security monitoring
- Continuously validate performance/robustness; log adversarial patterns and abuse signals.
- Apply hardening: input validation, guardrails, rate-limits, rollbacks, fail-safes.
Alerts, thresholds & escalation
- Encode thresholds → alert severities → runbook actions → escalation to AI governance forum.
- Ensure paging/on-call for P1/P2; log every action with timestamps and owners.
What is a “serious incident”?
A serious incident is any event that results in or is likely to result in material harm (health, safety, fundamental rights, significant economic loss), or a systemic breach of the provider’s declared risk controls. Maintain a typed incident taxonomy with mapped workflows.
Reporting workflow (EU/UK)
- Detect → triage severity → stabilise system (rollback, throttle, disable affected flows).
- Collect bundle: logs, prompts/inputs, outputs, version hashes, data slices, impact analysis.
- Notify stakeholders and (where mandated) authorities within the prescribed timelines.
- Root-cause → CAPA → validation → controlled return to service.
CAPA: corrective & preventive actions
- Corrective: hotfixes, model rollback, config changes, temporary guardrails.
- Preventive: data quality programs, new checks, strengthened thresholds, retraining gates.
Feedback loop & model updates
- Close the loop from incidents & metrics into backlog, retraining and policy updates.
- Record decisions in your AI governance minutes and change log.
Governance, evidence & records
- Maintain living risk file, KPI dashboards, SI registry, CAPA tracker and audit-ready evidence.
- Keep data lineage, model cards, evaluation reports and deployment approvals.
Implementation checklist
- Objectives & KPIs defined, thresholds set, owners assigned, cadence established.
- Telemetry mapped; minimisation & retention applied; privacy/security reviewed.
- Drift/bias monitors live; alerting & runbooks tested; SI workflow rehearsed.
- CAPA process operational; governance minutes & evidence library maintained.
© Zen AI Governance UK Ltd • Regulatory Knowledge • v1 05 Nov 2025 • This page is general guidance, not legal advice.
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