2 Incident Response & CAPA Policy — Triage, Investigation, Corrective/Preventive Actions

2 Incident Response & CAPA Policy — Triage, Investigation, Corrective/Preventive Actions

Zen AI Governance — Knowledge Base Incident & CAPA Governance Updated 15 Nov 2025 www.zenaigovernance.com ↗

Incident Response & CAPA Policy — Triage, Investigation, Corrective/Preventive Actions

Governance & Policies EU/UK Aligned
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Key takeaways
  • All AI incidents flow through a standard triage → investigation → CAPA cycle with time-bound SLAs.
  • Every action produces auditable evidence (EV-ID) reused across ISO, NIST, and EU AI Act obligations.
  • PMM dashboards collect signals and automatically open incidents when thresholds are breached.

Purpose & definitions

  • AI incident: Any unplanned AI behaviour or process failure causing or likely to cause harm (technical, privacy, ethical, legal, operational, reputational).
  • Serious incident (EU): Death/serious injury, systemic bias, significant disruption, or breach of fundamental rights.
  • Near miss: Risk materialised without downstream harm but requiring mitigation.

Detection signals & triggers

  • Model drift or performance drop > agreed thresholds (e.g., F1 ↓ 10% week-on-week).
  • Bias metrics breach (e.g., TPR gap > 5%).
  • Security alerts (prompt injection, data exfil, jailbreak success rates).
  • Privacy events (PII leakage in outputs or logs).
  • User or regulator complaints; AnswerBot feedback spike.

Severity matrix & SLAs

SeverityImpactInitial ResponseContainmentRCA & CAPA
SEV-1Safety/legal risk; widespread harm; regulator notice< 15 min< 1 hrRCA < 24 hrs; CAPA start < 48 hrs
SEV-2Material user harm; major KPI breach< 30 min< 4 hrsRCA < 48 hrs; CAPA start < 5 days
SEV-3Limited or potential harm; near miss< 4 hrs< 24 hrsRCA < 10 days; CAPA start < 15 days
SEV-4Minor issue; no harm< 1 day< 3 daysRCA < 20 days; CAPA as needed

Triage flow & role matrix

  • Incident Manager (IM): opens ticket, sets severity, coordinates containment.
  • Tech Lead: disables feature/rolls back model; gathers logs & metrics.
  • Compliance Lead: classifies regulatory impact; starts evidence capture (EV-IDs).
  • DPO/Security: engages for privacy/security events; assesses reporting duties.
ALERT → IM assigns severity → Contain (kill switch/downgrade) → Notify stakeholders
→ Collect artefacts → Decide on regulator/client notifications → Begin RCA → Launch CAPA

Investigation & evidence

  • Preserve logs, prompts, inputs/outputs, model/version hashes, feature flags.
  • Create a time-lined event narrative; attach plots (drift, bias, latency) with EV-IDs.
  • Root Cause Analysis (fishbone, 5-Whys, fault tree) with corrective hypothesis.

CAPA process (8D)

  1. D1 Team: Assign IM, Tech Lead, Compliance, DPO.
  2. D2 Problem Statement: What/when/where/scope; attach artefacts.
  3. D3 Containment: Kill switch, block routes, revert model.
  4. D4 RCA: Technical + process factors; verify with data.
  5. D5 Corrective Actions: Fix defect; tests; risk acceptance by Board.
  6. D6 Preventive Actions: Improve prompts, guardrails, data QA, monitors.
  7. D7 Effectiveness Check: KPIs sustained over N periods.
  8. D8 Closure: Evidence pack, lessons learned, policy update.

Regulatory & client communications

  • Assess notification triggers (EU AI Act serious incident; UK ICO breach rules).
  • Client notice template with timeline, scope, user impact, remediation.
  • Public statement (if required): approved by Authorising Officer and Legal.

Post-Market Monitoring linkage

  • PMM thresholds auto-open incidents (webhook) and pre-populate ticket fields.
  • Incident trends feed quarterly management review and continuous improvement.

Templates & forms

A) Incident Ticket (core fields)
FieldDescription
Incident IDINC-YYYY-NNNN
System/ModelName, version, environment
SeveritySEV-1/2/3/4
Impact SummaryUsers affected, domains of harm
Containment ActionsRollback, rate-limit, disable feature
RCA SummaryRoot causes (tech/process)
Corrective ActionsFixes, tests, deployment plan
Preventive ActionsControls to avoid recurrence
Evidence LinksEV-IDs, dashboards, logs
Status & OwnerOpen/Monitoring/Closed + Role
B) CAPA Log (exportable CSV headers)
CAPA_ID,Incident_ID,Action_Type,Description,Owner,Due_Date,Status,Effectiveness_Check_Date,Linked_Risk_ID,EV_IDs,Notes
  
C) Regulator Notification Outline (serious incidents)
  • What happened (timeline, scope, data subjects)
  • Immediate containment and residual risk
  • Root cause and corrective actions
  • User communications and remediation
  • Evidence references (EV-IDs)

Implementation checklist

  • Severity matrix and SLAs approved by Governance Board.
  • Incident runbook integrated with PMM thresholds and alerts.
  • CAPA log live with owners, due dates, and effectiveness checks.
  • Evidence IDs applied to all artefacts; quarterly trend review in Management Review.
  • Regulator & client notification playbooks rehearsed (table-top exercise).

© Zen AI Governance UK Ltd • Regulatory Knowledge • v1 15 Nov 2025 • This page is general guidance, not legal advice.

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