2 Incident Response & CAPA Policy — Triage, Investigation, Corrective/Preventive Actions
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
| Severity | Impact | Initial Response | Containment | RCA & CAPA |
|---|
| SEV-1 | Safety/legal risk; widespread harm; regulator notice | < 15 min | < 1 hr | RCA < 24 hrs; CAPA start < 48 hrs |
| SEV-2 | Material user harm; major KPI breach | < 30 min | < 4 hrs | RCA < 48 hrs; CAPA start < 5 days |
| SEV-3 | Limited or potential harm; near miss | < 4 hrs | < 24 hrs | RCA < 10 days; CAPA start < 15 days |
| SEV-4 | Minor issue; no harm | < 1 day | < 3 days | RCA < 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)
- D1 Team: Assign IM, Tech Lead, Compliance, DPO.
- D2 Problem Statement: What/when/where/scope; attach artefacts.
- D3 Containment: Kill switch, block routes, revert model.
- D4 RCA: Technical + process factors; verify with data.
- D5 Corrective Actions: Fix defect; tests; risk acceptance by Board.
- D6 Preventive Actions: Improve prompts, guardrails, data QA, monitors.
- D7 Effectiveness Check: KPIs sustained over N periods.
- 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.
A) Incident Ticket (core fields)
| Field | Description |
|---|
| Incident ID | INC-YYYY-NNNN |
| System/Model | Name, version, environment |
| Severity | SEV-1/2/3/4 |
| Impact Summary | Users affected, domains of harm |
| Containment Actions | Rollback, rate-limit, disable feature |
| RCA Summary | Root causes (tech/process) |
| Corrective Actions | Fixes, tests, deployment plan |
| Preventive Actions | Controls to avoid recurrence |
| Evidence Links | EV-IDs, dashboards, logs |
| Status & Owner | Open/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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