Operating model and EU AI Act risk class
| Operating model | Data type | Network zone | EU AI Act risk class | Key obligation |
|---|---|---|---|---|
| AI-SaaS | Production KPIs, supply chain data, quality metrics, workforce analytics | Corporate IT / cloud boundary | High-risk where used for employment, safety, or critical infrastructure decisions; otherwise limited or minimal | EU AI Act provider obligations (Article 16), deployer obligations (Article 26), post-market monitoring (Article 72) |
| OT-Edge | Sensor streams, PLC/SCADA signals, process variables, historian data | OT/ICS security zone per IEC 62443 zone-and-conduit model | High-risk where AI is a safety component (EU Machinery Regulation Annex I item 5/6) or integrated into critical infrastructure | Zone segmentation, conduit documentation, IEC 62443 SL compliance, air-gap or approved-conduit enforcement, OT change management |
| Product-Embedded | Machine operating state, sensor inputs, user commands | Embedded in product; external network connectivity varies | High-risk for AI safety components under EU Machinery Regulation Annex I items 5 and 6 (automatic high-risk classification under EU AI Act) | Conformity assessment (EU AI Act Article 43), EU declaration of conformity (Article 47), EU AI database registration (Article 49), 10-year technical file retention |
| AI-PaaS | Digital twin state, IIoT telemetry, model training datasets | Cloud or hybrid; data may traverse OT/IT boundary via approved conduit | Minimal-risk for infrastructure only; risk class determined by workloads deployed on the platform | OT/IT data boundary enforcement, data provenance documentation, platform SBOM/AIBOM, model drift monitoring |
The EU AI Act high-risk gap. The EU AI Act (Regulation 2024/1689) high-risk provider and deployer obligations take effect August 2, 2026. The Act requires providers to complete conformity assessments, register high-risk systems in the EU AI database, implement a quality management system per Article 17, and activate post-market monitoring per Article 72. Deployers must implement human oversight, retain automated logs for at least six months, and complete Fundamental Rights Impact Assessments where required. The Act provides no control catalog, no evidence model, and no thresholds. This schema provides all three.
The EU Machinery Regulation 2023/1230 gap. The EU Machinery Regulation applies from January 20, 2027. Annex I item 5 defines safety components with self-evolving behavior using machine learning approaches that ensure safety functions. Item 6 covers machinery embedding such components. Both are automatically high-risk AI systems under the EU AI Act. Manufacturers must protect safety functions against third-party attacks for the operational lifetime of the machine. No existing schema connects Machinery Regulation obligations to the AI Act conformity assessment process; this vertical bridges the two.
The IEC 62443 OT gap. IEC 62443 is the global standard for OT/ICS
cybersecurity. ISA-TR62443-2-2-2025 (December 2025) updated the security protection scheme
guidance but added no AI-specific controls. The standard has no concept of model drift, no
AI accountability assignment per zone, and no evidence model for AI outputs. The
ot_applicability field on every control in this schema requires the deploying
manufacturer to make an explicit OT/IT/both determination and document it, closing the
classification gap IEC 62443 leaves open.
ISO 42001 and the quality management system anchor. ISO 42001:2023 is gaining adoption as the Article 17 quality management system anchor for EU AI Act compliance. ISO 42001 assigns no accountable party per control and provides no thresholds. This schema is a structural complement: use ISO 42001 for QMS certification; use this schema for per-control accountability, thresholds, and evidence.
NIST Cyber AI Profile. The NIST Cybersecurity Framework Profile for Artificial Intelligence (Cyber AI Profile) was published as a preliminary draft on December 16, 2025. All NIST Cyber AI mappings in this schema are marked TBD pending finalization of the profile.
Responsibility split values
shared = documented split required; accountable party owns the split determination.
In this section
Schema design
Each control names one accountable SRF persona. Manufacturing roles map to those
personas in the how-to guide: Plant AI Safety Officer to
ai-system-governance, OT Data Manager to data-provider,
OT/MES Engineer to application-developer, Automation Platform Owner
to agentic-platform-provider, OT Infrastructure/ICS Security Team to
ai-platform-provider, AI Model Vendor / Equipment OEM to
model-provider.
Four lifecycle stages: DES (design, classification, architecture),
VAL (conformity assessment, FAT/SAT, safety validation),
OPS (operational monitoring, post-market), and
CHG (OT change management, version freeze, safety re-validation).
Every control carries an ot_applicability value and an
eu_ai_act_risk_class value. OT change management (CHG stage) is the
distinctive manufacturing stage: model updates in OT environments cannot follow
the IT patch cycle.
Machine-readable evidence uses OCSF event classes where a technical signal exists. Governance artifacts (EU AI Act technical file, FRIA, FAT/SAT report, conformity assessment certificate, safety case, change record) are named explicitly so compliance managers and auditors know what to produce. IEC 61508 SIL assessments and safety case documents may be confidential; document type and custodian role only, no URL.
Coverage by layer
ai-system-governance.
data-provider, ai-platform-provider.
application-developer, agentic-platform-provider.
ai-platform-provider.
model-provider.
NIST Cyber AI Profile mappings are marked TBD pending finalization of the December 2025 preliminary draft. IEC 61508 clause-level mappings are marked TBD across all controls; cite only part numbers (IEC 61508-1 through IEC 61508-7) until verified against primary text. The NIST Trustworthy AI in Critical Infrastructure Profile was still in development as of June 2026 and is not cited.
Regulatory crosswalk