Post-Market Monitoring (PMM) — Lifecycle Operations

Post-Market Monitoring (PMM) — Lifecycle Operations

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

Post-Market Monitoring (PMM) — EU/UK aligned

EU AI Act Compliance Lifecycle Operations EU/UK aligned
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Key takeaways
  • PMM turns real-world behaviour into measurable signals with owners, thresholds and actions.

Objectives & KPIs

  • Safety, fairness, privacy, explainability, security and operational continuity metrics per cohort.

Telemetry & minimisation

  • Log schema consistent with RMS/incident needs; minimise raw content; pseudonymise identities.

Drift & bias surveillance

  • Detect covariate/label drift and parity deviations; review windows; auto-open CAPA when breached.

Safety & security monitoring

  • Abuse filters, adversarial triggers, RAG provenance failures, tool misuse, jailbreak attempts.

Alerts, thresholds & escalation

  • Paged alerts with runbooks; escalation ladders; regulator notification triggers.

What is a “serious incident”?

  • Actual or potential serious harm to health/safety/fundamental rights; material breach of law; defined internally with examples.

Reporting workflow (EU/UK)

  • Immediate triage; initial notice within required timelines; investigation bundle; corrective actions and follow-up reports.

CAPA & effectiveness

  • Root cause; corrective and preventive tasks; owners; deadlines; effectiveness checks; RMS updates.

Feedback loops & model updates

  • Controlled data/product updates; waiver handling; cohort-wise monitoring post-fix.

Governance & reviews

  • Monthly safety reviews; quarterly executive summaries; annual independent assurance.

Evidence & records

  • Dashboards, alerts, incident bundles, CAPA tickets, approvals; immutable snapshots for audits.

Implementation checklist

  • Metrics, thresholds, paging, incidents, CAPA and reviews are live and linked to evidence.

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