Post-market Monitoring Plan Template (Article 72 compliant)
Download an Article 72 compliant post-market monitoring plan template covering system identification, monitoring objectives, data collection, performance metrics, alerting, review procedures, incident response, and documentation.
Generate a reviewable post-market monitoring plan in 30-60 minutes.
For compliance, risk, product, and ML ops teams shipping agentic workflows into regulated environments.
Dernière mise à jour : 16 déc. 2025 - Version v1.0 - Exemple fictif. Ne constitue pas un avis juridique.
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Ce qu'est cet artefact (et quand vous en avez besoin)
Explication minimale viable, écrite pour les audits, pas pour la théorie.
The EU AI Act Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system. This is not optional. It is a compliance requirement with specific mandates for how you monitor AI systems after deployment.
This template provides a structured 8-section approach covering system identification, monitoring objectives, data collection, performance metrics, alerting, review procedures, incident response, and documentation.
Vous en avez besoin quand
- You are deploying an agent into a regulated workflow (credit, claims, KYC/AML, HR).
- You need to prove ongoing quality, safety, and policy compliance after go-live.
- You are preparing an Annex IV dossier or an audit readiness review.
Common failure mode
A plan that lists metrics but has no thresholds, no named owners, no alert escalation procedures, and no incident response workflow tied to exportable evidence.
À quoi ressemble un bon résultat
Les évaluateurs des critères d'acceptation vérifient réellement.
- System identification links to regulatory classification and Annex IV documentation.
- Monitoring objectives connect to identified risks with clear success criteria.
- Data collection covers all sources with quality requirements and privacy considerations.
- Performance metrics include technical, drift, and fairness thresholds with severity levels.
- Alerting defines severity levels, notification matrix, and escalation procedures.
- Review procedures include continuous monitoring, sampling, and periodic governance reviews.
- Incident response covers definition, immediate response, investigation, and Article 73 reporting.
- Documentation and evidence storage ensures tamper-proof retention with audit readiness.
Aperçu du modèle
Un véritable extrait en HTML donc il est indexable et revisible.
## Section 4: Performance Metrics ### 4.1 Technical Performance Metrics | Metric | Definition | Threshold | Alert Level | |--------|------------|-----------|-------------| | [Accuracy] | [% correct predictions] | [>95%] | [Critical if <90%] | ### 4.2 Drift Metrics | Metric | Calculation Method | Threshold | Check Frequency | |--------|-------------------|-----------|-----------------| | [Feature drift] | [PSI or KL Divergence] | [PSI <0.1] | [Daily] | ## Section 5: Alerting and Escalation ### 5.1 Alert Severity Levels | Level | Criteria | Response Time | |-------|----------|---------------| | Critical | [Immediate risk, compliance violation] | [15 minutes] | | High | [Significant degradation] | [4 hours] |
Comment le remplir (rapide)
Les entrées dont vous avez besoin, le temps de compléter, et un exemple de travail miniature.
Entrées dont vous avez besoin
- System identification with regulatory classification and Annex IV references.
- Monitoring objectives connected to risk register with success criteria.
- Data sources, collection frequency, quality requirements, and privacy considerations.
- Performance thresholds (technical, drift, fairness) with severity levels.
- Alerting configuration with escalation matrix and after-hours coverage.
- Review procedures (continuous, sampling, periodic) with governance integration.
- Incident response procedures including Article 73 regulatory reporting.
Temps de réalisation : 30-60 minutes for a defensible v1.
Mini example: alert severity
Alert Severity Levels: | Level | Criteria | Response Time | |-------|----------|---------------| | Critical | System down, accuracy <90%, discriminatory outcome | 15 minutes | | High | Accuracy <95%, drift threshold exceeded | 4 hours | | Medium | Approaching threshold, unusual pattern | 24 hours | | Low | Minor metric movement, informational | Next business day |
Comment KLA le génère (Gouvern / Mesure / Prouve)
Attachez l'artefact aux primitifs pour qu'il se convertisse.
Govern
- Policy-as-code checkpoints that block or require review for high-risk actions.
- Versioned change control for model/prompt/policy/workflow updates.
Measure
- Risk-tiered sampling reviews (baseline + burst during incidents or after changes).
- Near-miss tracking (blocked / nearly blocked steps) as a measurable control signal.
Prove
- Hash-chained, append-only audit ledger with 7+ year retention language where required.
- Evidence Room export bundles (manifest + checksums) so auditors can verify independently.
FAQ
Écrit pour gagner des réponses de style extrait.
Télécharger l'artefact
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