{ "file_id": "06_vertical_manufacturing_supply_chain_logistics", "version": "2026.03.16", "schema_version": "2.2", "status": "Production Authority", "last_authoritative_sync": "2026-03-16", "description": "Comprehensive enumeration library for the Manufacturing, Supply Chain & Logistics vertical. Covers every subdomain where agentic AI is actively deployed as of March 2026: ISA-95 job order and work centre lifecycle, OEE monitoring, physical AI and robotics governance (ISO 10218-2, ISO/TS 15066), OT/ICS cybersecurity zone management (IEC 62443), GS1-based supply chain event tracking, product recall and lifecycle management, customs and trade compliance, predictive maintenance, quality management (ISO 9001 / AS9100), and regulatory reporting for product safety and environmental compliance. Designed for use as OTel span attributes in an agentic AI SDK and as policy vocabulary in an OPA Rego GRC portal.", "vertical_metadata": { "vertical_key": "manufacturing_supply_chain", "industry": "Manufacturing, Supply Chain & Logistics", "primary_standards": [ "ISA-95 Part 1–6 — Enterprise/Control System Integration (ANSI/ISA-95)", "ISA-95 Part 4 — Objects and Attributes for Manufacturing Operations Management — ISA95JobOrderStateEnum (OPC Foundation reference implementation v1.0.0)", "ISA-88 — Batch Control (ANSI/ISA-88) — Equipment Procedural Elements and procedural state machine", "OPC UA Part 1–14 — Unified Architecture (IEC 62541); OPC UA for ISA-95 companion spec", "IEC 62443-1-1 through 4-2 — Industrial Automation and Control Systems (IACS) Cybersecurity", "IEC 62443-3-3 — System Security Requirements and Security Levels (SL1–SL4)", "ISO 10218-1:2011 / ISO 10218-2:2011 — Robots and robotic devices — Safety requirements", "ISO/TS 15066:2016 — Robots and robotic devices — Collaborative robots (cobot safety)", "ISO 22400-1:2014 / ISO 22400-2:2014 — Automation systems and integration — KPIs for MOM", "ISO 9001:2015 — Quality Management Systems", "AS9100 Rev D — Quality Management Systems for Aviation, Space, and Defense", "IATF 16949:2016 — Quality Management System for automotive production", "GS1 General Specifications v23 — Barcodes, RFID, and data standards", "GS1 EPCIS 2.0 (CBV 2.0) — Electronic Product Code Information Services", "GS1 EDI BMS eCom — Transport Status Condition codes", "UN/CEFACT CCTS — Core Components Technical Specification for trade documents", "WCO Harmonized System (HS) 2022 — Tariff nomenclature", "EU Machinery Regulation (EU) 2023/1230 — Replaces Machinery Directive 2006/42/EC (applicable from Jan 20 2027)", "EU AI Act (2024/1689) Annex I & III — AI systems in safety components of machinery", "EU Product Liability Directive (2024/2853) — Revised liability for AI-integrated products (in force Dec 2024)", "EU CSRD (2022/2464) — Corporate Sustainability Reporting Directive — supply chain due diligence", "EU Supply Chain Due Diligence Regulation (CSDDD) (2024/1760) — in force Jul 2024, transposition by Jul 2027", "US CHIPS and Science Act (2022) — Supply chain resilience reporting requirements", "US Uyghur Forced Labor Prevention Act (UFLPA 2021) — Supply chain provenance traceability", "FDA 21 CFR Part 820 — Quality System Regulation (medical devices); harmonised with ISO 13485:2016", "REACH Regulation (EC) No 1907/2006 — Registration, Evaluation, Authorisation of Chemicals", "RoHS Directive 2011/65/EU — Restriction of Hazardous Substances in electrical/electronic equipment" ], "primary_source_urls": [ "https://reference.opcfoundation.org/ISA95JOBCONTROL/v100/docs/6", "https://www.iec.ch/homepage", "https://www.gs1.org/standards/epcis", "https://navigator.gs1.org/", "https://www.iso.org/standard/62091.html", "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1230", "https://www.dhs.gov/uflpa", "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820" ], "otel_namespace": "manufacturing", "opa_namespace": "data.manufacturing", "agentic_ai_deployment_context": "As of March 2026, agentic AI in manufacturing and supply chain is deployed across: autonomous production scheduling and job order management (ISA-95 MOM integration via OPC UA), collaborative robot (cobot) supervision and dynamic task assignment (ISO/TS 15066 force/speed limiting), digital twin-driven predictive maintenance with autonomous work order generation, vision inspection AI for automated quality control and defect classification, AI-driven supply chain risk monitoring and alternate sourcing (UFLPA compliance, CSRD scope 3 traceability), autonomous customs classification and trade compliance document generation, AI-powered OEE optimisation closing the Plan-Do-Check-Act loop, OT/ICS security monitoring agents applying IEC 62443 security level enforcement, and product recall orchestration agents triggered by regulatory notifications. The EU Machinery Regulation (2023/1230) applies from January 20, 2027 and significantly expands AI system requirements for safety-component AI in machinery. The EU AI Act Annex I explicitly includes AI systems used as safety components of machinery as high-risk AI. The EU Product Liability Directive (2024/2853) entered force December 2024 — manufacturers are liable for AI-integrated product defects including software updates.", "key_regulatory_risk_note": "The EU Machinery Regulation (2023/1230) replaces the Machinery Directive effective January 20, 2027. AI systems used as safety components of machinery (including cobot force-limiting AI, vision-guided robot path planning, and autonomous mobile robot obstacle detection) are simultaneously subject to the EU AI Act Annex III high-risk classification AND the Machinery Regulation's essential health and safety requirements — requiring a single technical file demonstrating compliance with both. The UFLPA (US) creates a rebuttable presumption that goods made wholly or in part in Xinjiang were produced with forced labour — supply chain provenance AI must provide traceability evidence to CBP at the line-item level. CSRD Scope 3 Category 1 (purchased goods and services) reporting requires AI-assisted supplier emissions data collection and validation starting for large companies in FY2025 reports." }, "subdomains": [ { "subdomain": "Manufacturing Operations Management (ISA-95 MOM)", "description": "Covers ISA-95 Part 4 job order and work centre state machine enumerations, ISA-88 batch procedural element states, and OEE performance factor taxonomy. These are the exact values defined in the OPC Foundation ISA-95 companion specification and must be used verbatim when integrating with MES/MOM systems via OPC UA.", "relevant_standards": [ "ANSI/ISA-95 Part 4 — Objects and Attributes for Manufacturing Operations Management", "OPC Foundation ISA-95 Job Control companion specification v1.0.0", "ANSI/ISA-88 Part 1 — Batch Control Models and Terminology", "ISO 22400-1 / ISO 22400-2 — KPIs for Manufacturing Operations Management" ], "categories": [ { "enum_name": "JobOrderState", "label": "Job Order State", "otel_attribute": "manufacturing.job_order.state", "opa_policy_path": "data.manufacturing.job_order.state", "rego_input_key": "manufacturing_job_order_state", "stability": "stable", "description": "ISA-95 Part 4 job order lifecycle state. These exact lowercase values match ISA95JobOrderStateEnum as defined in the OPC Foundation ISA-95 Job Control reference implementation v1.0.0. Agentic production scheduling AI must use these exact values when reading or setting job order state via OPC UA.", "permitted_values": [ "waiting", "ready", "running", "completed", "aborted", "held", "suspended" ], "value_labels": { "waiting": "Waiting", "ready": "Ready", "running": "Running", "completed": "Completed", "aborted": "Aborted", "held": "Held", "suspended": "Suspended" }, "code_definitions": { "waiting": "Job order has been created and queued; prerequisites not yet met", "ready": "All prerequisites met; job order is ready to begin execution when work centre capacity is available", "running": "Job order is actively being executed on the work centre; material consumption and production tracking active", "completed": "All work defined in the job order has been successfully completed; output quantities confirmed", "aborted": "Job order execution was terminated before completion due to a fault, safety event, or operator intervention; material reconciliation required", "held": "Job order execution is temporarily paused due to a hold condition (e.g. quality hold, material shortage, equipment alarm); can be resumed", "suspended": "Job order is suspended awaiting an external event (e.g. shift end, planned maintenance window, regulatory inspection)" }, "regulatory_mappings": { "eu_machinery_reg_2023_1230": "Job order state transitions driven by AI scheduling agents are in scope of EU Machinery Regulation (2023/1230) Article 9 if the AI system influences safety-critical work centre operations", "fda_21_cfr_820": "Job order state must be logged for FDA 21 CFR Part 820 device history record (DHR) for medical device manufacturers" }, "use_case": "AI production scheduling agent creates job orders and advances state through the lifecycle. 'Aborted' state triggers automatic root cause analysis and material reconciliation workflow. 'Held' state triggers QA agent investigation before resumption is permitted.", "source": "OPC Foundation ISA-95 Job Control companion specification v1.0.0 — ISA95JobOrderStateEnum", "source_url": "https://reference.opcfoundation.org/ISA95JOBCONTROL/v100/docs/6.3.12", "notes": "Values must be lowercase per OPC Foundation reference implementation. Do not use title case or UPPERCASE variants — MES/MOM systems validate against these exact strings." }, { "enum_name": "ISA88BatchProceduralElementState", "label": "Isa-88 Batch Procedural Element State", "otel_attribute": "manufacturing.batch.procedural_element_state", "opa_policy_path": "data.manufacturing.batch.procedural_element_state", "rego_input_key": "manufacturing_batch_procedural_element_state", "stability": "stable", "description": "ISA-88 Part 1 procedural element state machine values. Used by AI batch orchestration agents controlling batch processes in pharmaceuticals, chemicals, food & beverage, and specialty materials manufacturing.", "permitted_values": [ "idle", "running", "pausing", "paused", "holding", "held", "restarting", "stopping", "stopped", "aborting", "aborted", "complete" ], "value_labels": { "idle": "Idle", "running": "Running", "pausing": "Pausing", "paused": "Paused", "holding": "Holding", "held": "Held", "restarting": "Restarting", "stopping": "Stopping", "stopped": "Stopped", "aborting": "Aborting", "aborted": "Aborted", "complete": "Complete" }, "use_case": "Batch AI agent transitions a pharmaceutical batch procedure through ISA-88 states. 'Held' state is used for planned interruptions (e.g. IPC sampling); 'Aborted' state triggers FDA-required batch failure investigation and deviation report generation.", "source": "ANSI/ISA-88 Part 1 — Batch Control Models and Terminology — Procedural Element State Machine", "source_url": "https://www.isa.org/standards-and-publications/isa-standards/isa-standards-committees/isa88" }, { "enum_name": "EquipmentUseState", "label": "Equipment Use State", "otel_attribute": "manufacturing.equipment.use_state", "opa_policy_path": "data.manufacturing.equipment.use_state", "rego_input_key": "manufacturing_equipment_use_state", "stability": "stable", "description": "ISA-95 Part 2 equipment use state. AI predictive maintenance agents use this to track work centre availability and schedule maintenance without impacting production OEE targets.", "permitted_values": [ "production", "setup", "maintenance", "idle", "down", "standby", "unscheduled" ], "value_labels": { "production": "Production", "setup": "Setup", "maintenance": "Maintenance", "idle": "Idle", "down": "Down", "standby": "Standby", "unscheduled": "Unscheduled" }, "code_definitions": { "production": "Equipment is running and producing output against a job order", "setup": "Equipment is being configured or changed over between product runs; no production output", "maintenance": "Planned or unplanned maintenance being performed; equipment unavailable for production", "idle": "Equipment is available and ready but no job order is assigned", "down": "Equipment has failed or been taken out of service; production capacity lost", "standby": "Equipment is powered and available but held in reserve", "unscheduled": "Equipment is not scheduled for production in the current planning horizon; may be powered down" }, "regulatory_mappings": { "iso_22400": "ISO 22400-2 — OEE availability calculation uses production, setup, maintenance, and down states" }, "use_case": "AI OEE agent tracks equipment use state transitions to calculate availability. Autonomous work order generation triggers when predicted time-to-failure falls below threshold for critical equipment.", "source": "ANSI/ISA-95 Part 2 — Equipment Requirements (ISA-95.00.02)", "source_url": "https://www.isa.org/standards-and-publications/isa-standards/isa-standards-committees/isa95" }, { "enum_name": "OEEPerformanceFactor", "label": "OEE Performance Factor", "otel_attribute": "manufacturing.oee.factor", "opa_policy_path": "data.manufacturing.oee.factor", "rego_input_key": "manufacturing_oee_factor", "stability": "stable", "description": "The three ISO 22400 Overall Equipment Effectiveness (OEE) component factors. AI OEE optimisation agents report improvement actions tagged to the specific OEE factor being targeted.", "permitted_values": [ "availability", "performance", "quality" ], "value_labels": { "availability": "Ratio of Planned Production Time to Actual Available Time", "performance": "Ratio of Actual Throughput to Maximum Rated Throughput", "quality": "Ratio of Good Parts to Total Parts Produced" }, "code_definitions": { "availability": "Ratio of planned production time to actual available time — lost due to unplanned downtime and changeovers", "performance": "Ratio of actual throughput to maximum rated throughput — lost due to minor stoppages, reduced speed, and idling", "quality": "Ratio of good parts to total parts produced — lost due to defects, rework, and startup scrap" }, "use_case": "AI OEE agent tags each autonomous improvement action with the targeted OEE factor. Vision inspection AI reducing defect rate tags actions as 'quality'. Predictive maintenance agent reducing unplanned downtime tags actions as 'availability'.", "source": "ISO 22400-2:2014 — KPIs for Manufacturing Operations Management — OEE definition", "source_url": "https://www.iso.org/standard/62091.html" }, { "enum_name": "WorkCentreCapacityStatus", "label": "Work Centre Capacity Status", "otel_attribute": "manufacturing.work_centre.capacity_status", "opa_policy_path": "data.manufacturing.work_centre.capacity_status", "rego_input_key": "manufacturing_work_centre_capacity_status", "stability": "proposed", "description": "AI production scheduling agent classification of a work centre's current capacity status. Used to drive dynamic job order routing and rescheduling decisions.", "permitted_values": [ "available", "constrained", "at_capacity", "overloaded", "starved", "blocked", "offline" ], "value_labels": { "available": "Available", "constrained": "Constrained", "at_capacity": "At Capacity", "overloaded": "Overloaded", "starved": "Starved", "blocked": "Blocked", "offline": "Offline" }, "use_case": "When work centre enters 'blocked' status (output buffer full), AI scheduling agent routes subsequent job orders to alternate work centres or issues a capacity alert to the production planner.", "source": "ISA-95 Part 4 capacity management concepts; APICS CPIM Body of Knowledge", "source_url": "https://www.isa.org/standards-and-publications/isa-standards/isa-standards-committees/isa95" } ] }, { "subdomain": "Physical AI, Robotics & Collaborative Automation", "description": "Covers ISO 10218 and ISO/TS 15066 safety state enumerations for AI-driven robot and cobot systems, plus physical AI deployment kind taxonomy. Agentic AI systems directing physical robots or AMRs in human-occupied workspaces must use these values for safety event logging and HITL override tracking under EU Machinery Regulation (2023/1230).", "relevant_standards": [ "ISO 10218-1:2011 — Industrial robots — Safety requirements for robots", "ISO 10218-2:2011 — Industrial robots — Safety requirements for robot systems and integration", "ISO/TS 15066:2016 — Robots and robotic devices — Collaborative robots", "EU Machinery Regulation (EU) 2023/1230 — Applicable from January 20, 2027", "EU AI Act (2024/1689) Annex III para 2(b) — AI as safety component of machinery", "IEC 61508 — Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems" ], "categories": [ { "enum_name": "PhysicalAIKind", "label": "Physical AI Kind", "otel_attribute": "manufacturing.physical_ai.kind", "opa_policy_path": "data.manufacturing.physical_ai.kind", "rego_input_key": "manufacturing_physical_ai_kind", "stability": "proposed", "description": "Classification of a physical AI system deployed in a manufacturing or logistics environment. Determines the applicable safety standard, HITL requirements, and EU AI Act risk classification.", "permitted_values": [ "industrial_robot_6dof", "collaborative_robot_cobot", "autonomous_mobile_robot_amr", "automated_guided_vehicle_agv", "autonomous_aerial_drone", "digital_twin_simulation", "vision_inspection_system", "ai_powered_cnc_machine", "ai_powered_pick_and_place", "exoskeleton_human_assist", "autonomous_forklift", "robotic_process_automation_rpa" ], "value_labels": { "industrial_robot_6dof": "Industrial Robot 6-DOF", "collaborative_robot_cobot": "Collaborative Robot (Cobot)", "autonomous_mobile_robot_amr": "Autonomous Mobile Robot (AMR)", "automated_guided_vehicle_agv": "Automated Guided Vehicle (AGV)", "autonomous_aerial_drone": "Autonomous Aerial Drone", "digital_twin_simulation": "Digital Twin Simulation", "vision_inspection_system": "Vision Inspection System", "ai_powered_cnc_machine": "AI-Powered CNC Machine", "ai_powered_pick_and_place": "AI-Powered Pick and Place", "exoskeleton_human_assist": "Exoskeleton Human Assist", "autonomous_forklift": "Autonomous Forklift", "robotic_process_automation_rpa": "Robotic Process Automation (RPA)" }, "regulatory_mappings": { "eu_ai_act_annex3": "Collaborative robots, cobots, autonomous mobile robots, and vision inspection systems used as safety components of machinery are high-risk AI systems under EU AI Act Annex III para 2(b)", "eu_machinery_reg": "EU Machinery Regulation (2023/1230) applies to all physical AI kinds operating as machinery in professional settings from January 20, 2027", "iso_10218": "Industrial robot, cobot, and AGV/AMR kinds must comply with ISO 10218-2 for system integration safety" }, "use_case": "GRC portal registers physical AI system kind on agent onboarding. Policy engine applies the correct safety standard compliance checklist and HITL override requirement profile based on kind.", "source": "ISO 10218-1/2; ISO/TS 15066; IEC 62443; EU AI Act Annex III; EU Machinery Regulation (2023/1230)", "source_url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1230" }, { "enum_name": "CobotSafetyMode", "label": "Cobot Safety Mode", "otel_attribute": "manufacturing.cobot.safety_mode", "opa_policy_path": "data.manufacturing.cobot.safety_mode", "rego_input_key": "manufacturing_cobot_safety_mode", "stability": "stable", "description": "ISO/TS 15066 collaborative operation mode for a cobot operating in a human-occupied workspace. AI cobot supervision agents must log the active safety mode for every span where a human is detected in the collaborative workspace. Safety mode downgrades are irreversible without HITL confirmation.", "permitted_values": [ "safety_rated_monitored_stop", "hand_guiding", "speed_and_separation_monitoring", "power_and_force_limiting", "full_speed_no_human_detected", "emergency_stop_triggered", "protective_stop_triggered" ], "value_labels": { "safety_rated_monitored_stop": "Safety Rated Monitored Stop", "hand_guiding": "Hand Guiding", "speed_and_separation_monitoring": "Speed and Separation Monitoring", "power_and_force_limiting": "Power and Force Limiting", "full_speed_no_human_detected": "Full Speed No Human Detected", "emergency_stop_triggered": "Emergency Stop Triggered", "protective_stop_triggered": "Protective Stop Triggered" }, "code_definitions": { "safety_rated_monitored_stop": "Robot stops when human enters workspace; resumes when human exits. Highest safety margin, lowest productivity.", "hand_guiding": "Human physically guides robot; cobot follows operator input without autonomous motion", "speed_and_separation_monitoring": "Robot continuously monitors distance to human and reduces speed proportionally; maintains minimum separation distance", "power_and_force_limiting": "Robot operates at reduced force and power limits sufficient to avoid injury if contact occurs with human", "full_speed_no_human_detected": "No human detected in workspace; robot operates at full programmed speed and force", "emergency_stop_triggered": "Category 0 or 1 emergency stop initiated; requires HITL reset before resumption", "protective_stop_triggered": "Category 2 protective stop from safety-rated sensor; robot halted pending human clearance" }, "regulatory_mappings": { "iso_ts_15066": "ISO/TS 15066 defines four collaborative operation types — all four are represented in permitted_values", "eu_machinery_reg": "EU Machinery Regulation Annex III EHSR 1.4.2 — Emergency stop requirements; EHSR 1.3.7 — Risks from moving parts", "eu_ai_act_annex3": "AI cobot supervision system is high-risk AI if it determines which safety mode to apply" }, "use_case": "AI cobot supervision agent continuously classifies active safety mode based on vision sensor data. Every mode transition is logged as an OTel span event. Emergency stop spans are routed to safety investigation workflow.", "source": "ISO/TS 15066:2016 Section 5 — Collaborative operation requirements; ISO 10218-2:2011 Section 5.4", "source_url": "https://www.iso.org/standard/62996.html" }, { "enum_name": "RobotSafetyEventType", "label": "Robot Safety Event Type", "otel_attribute": "manufacturing.robot.safety_event_type", "opa_policy_path": "data.manufacturing.robot.safety_event_type", "rego_input_key": "manufacturing_robot_safety_event_type", "stability": "stable", "description": "Classification of a safety-relevant event on an industrial robot or cobot system. All safety events must be logged and retained per EU Machinery Regulation Article 23 (technical documentation) and EU AI Act Article 12 (logging for high-risk AI).", "permitted_values": [ "emergency_stop_operator", "emergency_stop_ai_triggered", "protective_stop_sensor", "speed_limit_exceeded", "force_limit_exceeded", "workspace_intrusion_detected", "collision_detected", "human_contact_detected", "safeguard_bypass_attempted", "software_safety_function_fault", "encoder_feedback_fault", "torque_overload", "near_miss_recorded" ], "value_labels": { "emergency_stop_operator": "Emergency Stop Operator", "emergency_stop_ai_triggered": "Emergency Stop AI Triggered", "protective_stop_sensor": "Protective Stop Sensor", "speed_limit_exceeded": "Speed Limit Exceeded", "force_limit_exceeded": "Force Limit Exceeded", "workspace_intrusion_detected": "Workspace Intrusion Detected", "collision_detected": "Collision Detected", "human_contact_detected": "Human Contact Detected", "safeguard_bypass_attempted": "Safeguard Bypass Attempted", "software_safety_function_fault": "Software Safety Function Fault", "encoder_feedback_fault": "Encoder Feedback Fault", "torque_overload": "Torque Overload", "near_miss_recorded": "Near Miss Recorded" }, "regulatory_mappings": { "eu_ai_act_art12": "EU AI Act Article 12 — Logging for high-risk AI: robot safety events must be logged with sufficient detail to enable post-market monitoring", "eu_machinery_reg_art23": "EU Machinery Regulation Article 23 — Technical documentation must include safety event analysis", "iso_10218_2": "ISO 10218-2 Section 5.4 — Risk assessment must account for all safety event types" }, "use_case": "Every AI cobot supervision span is enriched with safety event type when a safety-relevant condition is detected. 'Human_contact_detected' events trigger mandatory incident report and temporary suspension of autonomous operation pending safety review.", "source": "ISO 10218-1/2; ISO/TS 15066; EU Machinery Regulation (2023/1230) EHSR requirements", "source_url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1230" } ] }, { "subdomain": "OT/ICS Cybersecurity & Industrial Network Security", "description": "Covers IEC 62443 security zone, security level, and OT incident classification enumerations. AI security monitoring agents protecting operational technology (OT) and industrial control systems (ICS) must use these values for compliance with IEC 62443 and NIST SP 800-82.", "relevant_standards": [ "IEC 62443-1-1 — Industrial Automation and Control Systems Security — Concepts", "IEC 62443-3-2 — Security Risk Assessment for System Design", "IEC 62443-3-3 — System Security Requirements and Security Levels", "IEC 62443-4-2 — Technical Security Requirements for IACS Components", "NIST SP 800-82 Rev 3 — Guide to Operational Technology (OT) Security (2023)", "NERC CIP v7 — Critical Infrastructure Protection for bulk electric systems", "Purdue Reference Model / ISA-95 network zone architecture" ], "categories": [ { "enum_name": "OTSecurityZone", "label": "OT Security Zone", "otel_attribute": "manufacturing.ot.security_zone", "opa_policy_path": "data.manufacturing.ot.security_zone", "rego_input_key": "manufacturing_ot_security_zone", "stability": "stable", "description": "IEC 62443-based security zone classification for industrial network segments, derived from the Purdue Reference Model. AI security monitoring agents must tag all OT network events with the zone where they originated. Cross-zone data flows must be approved by security policy.", "permitted_values": [ "enterprise_zone", "dmz_industrial", "supervisory_zone", "control_zone", "field_zone", "safety_instrumented_zone", "remote_access_zone" ], "value_labels": { "enterprise_zone": "Level 4-5 Purdue", "dmz_industrial": "Industrial DMZ", "supervisory_zone": "Level 3 Purdue", "control_zone": "Level 2 Purdue", "field_zone": "Level 1-0 Purdue", "safety_instrumented_zone": "Safety Instrumented Zone", "remote_access_zone": "Remote Access Zone" }, "code_definitions": { "enterprise_zone": "Level 4-5 Purdue — ERP, MES, business systems; IT-OT boundary above industrial DMZ", "dmz_industrial": "Industrial DMZ — data diode or firewall-protected buffer between enterprise and supervisory zones; historians and data aggregation servers", "supervisory_zone": "Level 3 Purdue — SCADA servers, historian, operations management systems", "control_zone": "Level 2 Purdue — DCS, PLC controllers, HMI workstations; direct control of physical processes", "field_zone": "Level 1-0 Purdue — sensors, actuators, intelligent electronic devices (IEDs); direct physical interaction", "safety_instrumented_zone": "Separate air-gapped or highly isolated zone for Safety Instrumented Systems (SIS) per IEC 61511; highest integrity classification", "remote_access_zone": "Jump server and VPN gateway zone for authorised remote access to OT; all access logged and session-recorded" }, "regulatory_mappings": { "iec_62443_3_3": "IEC 62443-3-3 SR 5.1 — Network segmentation; zones and conduits architecture", "nist_sp_800_82": "NIST SP 800-82 Rev 3 — OT network segmentation guidance", "nerc_cip_005": "NERC CIP-005 — Electronic Security Perimeter for BES Cyber Assets" }, "use_case": "AI OT security monitoring agent tags all security events with their source zone. OPA policy blocks any AI agent from initiating a connection from enterprise_zone directly to field_zone or safety_instrumented_zone — all cross-zone access must traverse the industrial DMZ.", "source": "IEC 62443-3-3 Section 5 — Zones and conduits; Purdue Reference Model; NIST SP 800-82 Rev 3", "source_url": "https://www.iec.ch/homepage" }, { "enum_name": "IEC62443SecurityLevel", "label": "IEC 62443 Security Level", "otel_attribute": "manufacturing.ot.security_level", "opa_policy_path": "data.manufacturing.ot.security_level", "rego_input_key": "manufacturing_ot_security_level", "stability": "stable", "description": "IEC 62443-3-3 Security Level (SL) target classification for an IACS zone or component. AI agents performing OT security assessments must classify each zone's target and achieved security level. AI systems themselves must meet the SL requirements of the zone they are deployed in.", "permitted_values": [ "sl0_no_requirement", "sl1_protection_against_casual_violation", "sl2_protection_against_intentional_simple_means", "sl3_protection_against_sophisticated_means", "sl4_protection_against_state_sponsored_actors" ], "value_labels": { "sl0_no_requirement": "SL 0 — No Requirement", "sl1_protection_against_casual_violation": "SL 1 — Protection Against Casual Violation", "sl2_protection_against_intentional_simple_means": "SL 2 — Protection Against Intentional Simple Means", "sl3_protection_against_sophisticated_means": "SL 3 — Protection Against Sophisticated Means", "sl4_protection_against_state_sponsored_actors": "SL 4 — Protection Against State Sponsored Actors" }, "code_definitions": { "sl0_no_requirement": "No specific security requirements; applicable to non-safety, low-consequence zones", "sl1_protection_against_casual_violation": "Protection against unintentional or incidental violation; basic access controls sufficient", "sl2_protection_against_intentional_simple_means": "Protection against intentional violation using simple means (e.g. default credentials, unpatched CVEs); standard security controls required", "sl3_protection_against_sophisticated_means": "Protection against sophisticated intentional violation using IACS-specific skills; defence-in-depth and network segmentation required", "sl4_protection_against_state_sponsored_actors": "Protection against nation-state level sophisticated attacks with extended resources; applicable to most critical CNI assets" }, "ordered": true, "value_ordinals": { "sl0_no_requirement": 1, "sl1_protection_against_casual_violation": 2, "sl2_protection_against_intentional_simple_means": 3, "sl3_protection_against_sophisticated_means": 4, "sl4_protection_against_state_sponsored_actors": 5 }, "regulatory_mappings": { "iec_62443_3_3": "IEC 62443-3-3 — Security Level requirements SR 1.1 through SR 7.7 define countermeasures for each SL", "nerc_cip": "NERC CIP v7 — High and Medium impact BES Cyber Systems implicitly require SL2+ equivalent controls" }, "source": "IEC 62443-3-3 Security Level definitions", "source_url": "https://webstore.iec.ch/publication/7031" }, { "enum_name": "OTIncidentType", "label": "OT Incident Type", "otel_attribute": "manufacturing.ot.incident_type", "opa_policy_path": "data.manufacturing.ot.incident_type", "rego_input_key": "manufacturing_ot_incident_type", "stability": "stable", "description": "Classification of an OT/ICS cybersecurity incident per NIST SP 800-82 Rev 3 and IEC 62443. AI OT security monitoring agents use these to trigger appropriate incident response playbooks and regulatory reporting workflows.", "permitted_values": [ "unauthorised_remote_access", "malware_ot_network", "ransomware_ot_impact", "reconnaissance_ot_network", "plc_firmware_tampering", "historian_data_manipulation", "control_logic_modification_unauthorised", "safety_system_interference", "it_ot_lateral_movement", "insider_threat_ot", "supply_chain_software_compromise", "denial_of_service_control_system", "physical_access_cyber_event" ], "value_labels": { "unauthorised_remote_access": "Unauthorised Remote Access", "malware_ot_network": "Malware OT Network", "ransomware_ot_impact": "Ransomware OT Impact", "reconnaissance_ot_network": "Reconnaissance OT Network", "plc_firmware_tampering": "Plc Firmware Tampering", "historian_data_manipulation": "Historian Data Manipulation", "control_logic_modification_unauthorised": "Control Logic Modification Unauthorised", "safety_system_interference": "Safety System Interference", "it_ot_lateral_movement": "It OT Lateral Movement", "insider_threat_ot": "Insider Threat OT", "supply_chain_software_compromise": "Supply Chain Software Compromise", "denial_of_service_control_system": "Denial of Service Control System", "physical_access_cyber_event": "Physical Access Cyber Event" }, "regulatory_mappings": { "eu_nis2_art23": "OT incidents on essential entities (energy, manufacturing, water, transport) may trigger NIS2 Article 23 significant incident reporting", "nerc_cip_008": "NERC CIP-008 — Incident Response Plan: events affecting BES reliability must be reported", "cisa_ics_cert": "US CISA ICS-CERT voluntary reporting for industrial control system incidents" }, "use_case": "AI OT SOC agent classifies all security events against these incident types. 'Safety_system_interference' type always triggers immediate plant shutdown assessment and regulatory notification workflow regardless of confirmed impact.", "source": "NIST SP 800-82 Rev 3 OT incident taxonomy; IEC 62443; CISA ICS-CERT incident categories", "source_url": "https://csrc.nist.gov/publications/detail/sp/800-82/rev-3/final" } ] }, { "subdomain": "Supply Chain Event Tracking & Traceability", "description": "Covers GS1 EPCIS 2.0 (CBV 2.0) event type and disposition code enumerations, transport status condition codes, and supply chain risk classification. Agentic AI systems consuming or producing EPCIS events must use the exact GS1 CBV 2.0 vocabulary for interoperability.", "relevant_standards": [ "GS1 EPCIS 2.0 Standard — Electronic Product Code Information Services", "GS1 CBV 2.0 — Core Business Vocabulary (disposition codes, business steps, event types)", "GS1 General Specifications v23", "GS1 EDI BMS eCom — Transport Status Condition codes", "UN/CEFACT CCL — Code Component Library for trade document codes", "US UFLPA (2021) — Uyghur Forced Labor Prevention Act supply chain traceability", "EU CSDDD (2024/1760) — Corporate Sustainability Due Diligence Directive" ], "categories": [ { "enum_name": "EPCISEventType", "label": "EPCIS Event Type", "otel_attribute": "manufacturing.epcis.event_type", "opa_policy_path": "data.manufacturing.epcis.event_type", "rego_input_key": "manufacturing_epcis_event_type", "stability": "stable", "description": "GS1 EPCIS 2.0 event type classification. These are the four fundamental event types in the EPCIS object model. Agentic supply chain visibility agents must use these exact type names when creating or consuming EPCIS events.", "permitted_values": [ "ObjectEvent", "AggregationEvent", "TransactionEvent", "TransformationEvent" ], "value_labels": { "ObjectEvent": "Objectevent", "AggregationEvent": "Aggregationevent", "TransactionEvent": "Transactionevent", "TransformationEvent": "Transformationevent" }, "code_definitions": { "ObjectEvent": "One or more EPCs changed status or disposition at a point in time and place (e.g. item commissioned, item shipped, item received)", "AggregationEvent": "One or more EPCs were added to or removed from a parent container/pallet/case (e.g. packing, unpacking, palletising)", "TransactionEvent": "One or more EPCs became associated with or disassociated from a business transaction (e.g. purchase order, shipment notice, invoice)", "TransformationEvent": "One or more input EPCs were transformed into one or more output EPCs (e.g. manufacturing process consuming components to produce finished goods)" }, "use_case": "AI supply chain visibility agent creates a TransformationEvent when a manufacturing AI agent completes a job order — consuming component EPCs and producing finished good EPCs. This event anchors the traceability chain for recall and provenance tracking.", "source": "GS1 EPCIS 2.0 Standard — Section 7.4 Event Types", "source_url": "https://www.gs1.org/standards/epcis", "notes": "EPCIS 2.0 (published 2021, widely adopted 2023+) uses these four event types exactly as shown. The capitalisation is canonical GS1 CBV 2.0 — do not convert to snake_case for these values as they are GS1 interoperability identifiers." }, { "enum_name": "EPCISDispositionCode", "label": "EPCIS Disposition Code", "otel_attribute": "manufacturing.epcis.disposition", "opa_policy_path": "data.manufacturing.epcis.disposition", "rego_input_key": "manufacturing_epcis_disposition", "stability": "stable", "description": "GS1 CBV 2.0 disposition codes describing the current business condition of a physical object. These exact URN-suffix values must be used in EPCIS events for cross-organisation interoperability. Shown here as the CBV short suffix form.", "permitted_values": [ "active", "container_closed", "damaged", "destroyed", "dispensed", "disposed", "encoded", "expired", "in_progress", "in_transit", "inactive", "no_pedigree_match", "non_sellable_other", "partially_dispensed", "recalled", "reserved", "retail_sold", "returned", "sellable_accessible", "sellable_not_accessible", "stolen", "unknown", "unreachable", "needs_replacement" ], "value_labels": { "active": "Active", "container_closed": "Container Closed", "damaged": "Damaged", "destroyed": "Destroyed", "dispensed": "Dispensed", "disposed": "Disposed", "encoded": "Encoded", "expired": "Expired", "in_progress": "In Progress", "in_transit": "In Transit", "inactive": "Inactive", "no_pedigree_match": "No Pedigree Match", "non_sellable_other": "Non Sellable Other", "partially_dispensed": "Partially Dispensed", "recalled": "Recalled", "reserved": "Reserved", "retail_sold": "Retail Sold", "returned": "Returned", "sellable_accessible": "Sellable Accessible", "sellable_not_accessible": "Sellable not Accessible", "stolen": "Stolen", "unknown": "Unknown", "unreachable": "Unreachable", "needs_replacement": "Needs Replacement" }, "use_case": "AI recall management agent sets disposition to 'recalled' for all affected serial numbers when a regulatory recall notification is received. Downstream logistics AI agents check disposition before shipping and block 'recalled' items automatically.", "source": "GS1 CBV 2.0 — Core Business Vocabulary — Disposition Code Vocabulary (Section 7.2)", "source_url": "https://www.gs1.org/standards/epcis", "notes": "Full CBV 2.0 URN form is urn:epcglobal:cbv:disp:. The short suffix form is used here as the permitted_value per OTel convention. AI agents constructing EPCIS JSON-LD events should expand to full URN." }, { "enum_name": "TransportStatusCondition", "label": "Transport Status Condition", "otel_attribute": "manufacturing.transport.status_condition", "opa_policy_path": "data.manufacturing.transport.status_condition", "rego_input_key": "manufacturing_transport_status_condition", "stability": "stable", "description": "GS1 TransportStatusConditionCode semantic labels for shipment tracking. Snake_case semantic labels are used as permitted_values per OTel convention. GS1 numeric code equivalents are provided in code_map for EDI interoperability. GS1 GDD has been deprecated; current codes are from GS1 Navigator.", "permitted_values": [ "to_be_done", "cleared_by_customs", "collection_completed", "transhipment", "delayed_in_transit", "en_route", "unloaded", "departure_completed", "proof_of_delivery", "customs_hold", "damaged_in_transit", "returned_to_sender", "delivery_failed", "out_for_delivery", "arrived_at_port", "held_by_authority" ], "value_labels": { "to_be_done": "To Be Done", "cleared_by_customs": "Cleared by Customs", "collection_completed": "Collection Completed", "transhipment": "Transhipment", "delayed_in_transit": "Delayed in Transit", "en_route": "En Route", "unloaded": "Unloaded", "departure_completed": "Departure Completed", "proof_of_delivery": "Proof of Delivery", "customs_hold": "Customs Hold", "damaged_in_transit": "Damaged in Transit", "returned_to_sender": "Returned to Sender", "delivery_failed": "Delivery Failed", "out_for_delivery": "Out for Delivery", "arrived_at_port": "Arrived At Port", "held_by_authority": "Held by Authority" }, "use_case": "AI logistics agent monitors shipment status and flags 'customs_hold' and 'held_by_authority' events for UFLPA compliance review. 'Held_by_authority' events on goods with Xinjiang-origin components trigger mandatory supply chain provenance evidence package assembly.", "source": "GS1 TransportStatusConditionCode EDI standard", "source_url": "https://navigator.gs1.org/edi/class-details?name=TransportStatusConditionCode&version=2", "notes": "returned_to_sender, delivery_failed, out_for_delivery, arrived_at_port, and held_by_authority are semantic extensions beyond the core GS1 list, widely used in carrier API integrations (FedEx, UPS, DHL). Standardised GS1 code references: to_be_done=1, cleared_by_customs=12, collection_completed=13, unloaded=10, departure_completed=11, en_route=31, transhipment=100, delayed_in_transit=101, proof_of_delivery=20E, customs_hold=24E, damaged_in_transit=29E." }, { "enum_name": "SupplyChainRiskCategory", "label": "Supply Chain Risk Category", "otel_attribute": "manufacturing.supply_chain.risk_category", "opa_policy_path": "data.manufacturing.supply_chain.risk_category", "rego_input_key": "manufacturing_supply_chain_risk_category", "stability": "proposed", "description": "AI supply chain risk monitoring agent classification of identified supply chain risks. Used to trigger investigation, escalation, and regulatory reporting workflows.", "permitted_values": [ "forced_labour_uflpa", "forced_labour_csddd", "child_labour", "conflict_minerals_3tg", "sanctions_restricted_party", "single_source_concentration", "geopolitical_disruption", "logistics_capacity_constraint", "supplier_financial_distress", "environmental_violation_supplier", "counterfeit_components_suspected", "quality_non_conformance_supplier", "cybersecurity_vendor_compromise", "natural_disaster_supplier_site" ], "value_labels": { "forced_labour_uflpa": "Forced Labour Uflpa", "forced_labour_csddd": "Forced Labour Csddd", "child_labour": "Child Labour", "conflict_minerals_3tg": "Conflict Minerals 3tg", "sanctions_restricted_party": "Sanctions Restricted Party", "single_source_concentration": "Single Source Concentration", "geopolitical_disruption": "Geopolitical Disruption", "logistics_capacity_constraint": "Logistics Capacity Constraint", "supplier_financial_distress": "Supplier Financial Distress", "environmental_violation_supplier": "Environmental Violation Supplier", "counterfeit_components_suspected": "Counterfeit Components Suspected", "quality_non_conformance_supplier": "Quality Non Conformance Supplier", "cybersecurity_vendor_compromise": "Cybersecurity Vendor Compromise", "natural_disaster_supplier_site": "Natural Disaster Supplier Site" }, "regulatory_mappings": { "uflpa": "US UFLPA — 'forced_labour_uflpa' risk triggers rebuttable presumption assessment; CBP evidence package required for goods with Xinjiang-origin content", "eu_csddd": "EU CSDDD (2024/1760) — 'forced_labour_csddd', 'child_labour', 'environmental_violation_supplier' risks require due diligence response plan", "eu_csrd": "EU CSRD — Scope 3 supply chain emissions reporting requires supplier sustainability data; 'environmental_violation_supplier' links to CSRD reporting obligations", "dodd_frank_1502": "US Dodd-Frank Section 1502 — 'conflict_minerals_3tg' risk triggers SEC conflict minerals reporting obligations" }, "use_case": "AI supply chain risk agent continuously monitors supplier news, government watchlists, and EPCIS provenance data. When 'forced_labour_uflpa' risk is flagged for a supplier, OPA policy blocks new purchase orders and triggers compliance review workflow.", "source": "UFLPA Enforcement Guidance; EU CSDDD (2024/1760); SEC Conflict Minerals Rule; industry supply chain risk taxonomy", "source_url": "https://www.dhs.gov/uflpa" } ] }, { "subdomain": "Quality Management & Product Lifecycle", "description": "Covers ISO 9001/IATF 16949/AS9100 quality event classification, product lifecycle state management, product recall taxonomy, and AI-driven quality inspection result enumerations. Agentic quality management AI must use these values for EQMS (Enterprise Quality Management System) integration and regulatory device history records.", "relevant_standards": [ "ISO 9001:2015 — Quality Management Systems", "IATF 16949:2016 — Automotive Quality Management System", "AS9100 Rev D — Aerospace Quality Management System", "FDA 21 CFR Part 820 — Quality System Regulation (QSR) for medical devices", "ISO 13485:2016 — Medical devices Quality Management Systems", "GS1 US Data Hub — Product Lifecycle Status vocabulary", "EU General Product Safety Regulation (GPSR) (EU) 2023/988 — Applicable from December 13, 2024" ], "categories": [ { "enum_name": "ProductMarketStatus", "label": "Product Market Status", "otel_attribute": "manufacturing.product.market_status", "opa_policy_path": "data.manufacturing.product.market_status", "rego_input_key": "manufacturing_product_market_status", "stability": "stable", "description": "Product lifecycle market status. AI product lifecycle management agents use this to control which operations are permissible on a product at each lifecycle stage.", "permitted_values": [ "concept", "draft", "pre_market", "in_use", "limited_distribution", "archived", "discontinued", "recalled_voluntary", "recalled_mandatory", "under_regulatory_review", "market_withdrawal" ], "value_labels": { "concept": "Concept", "draft": "Draft", "pre_market": "Pre Market", "in_use": "In Use", "limited_distribution": "Limited Distribution", "archived": "Archived", "discontinued": "Discontinued", "recalled_voluntary": "Recalled Voluntary", "recalled_mandatory": "Recalled Mandatory", "under_regulatory_review": "Under Regulatory Review", "market_withdrawal": "Market Withdrawal" }, "code_definitions": { "recalled_voluntary": "Product subject to a voluntary manufacturer recall; distribution blocked, retrieval initiated", "recalled_mandatory": "Product subject to a mandatory regulatory recall order (e.g. FDA Class I, CPSC mandatory recall); immediate action required", "market_withdrawal": "Product removed from market for reasons other than safety (e.g. minor labelling issue not constituting a recall per FDA definition)", "under_regulatory_review": "Product is under active regulatory investigation or field safety corrective action assessment" }, "regulatory_mappings": { "eu_gpsr": "EU General Product Safety Regulation (2023/988) — AI-assisted product safety monitoring must detect 'recalled_mandatory' status within 24 hours of regulatory notification", "fda_21_cfr_7": "FDA 21 CFR Part 7 — Recall procedures: 'recalled_voluntary' and 'recalled_mandatory' statuses trigger FDA notification and status reporting obligations", "eu_ai_act_art61": "EU AI Act Article 61 — Post-market monitoring for high-risk AI: changes to 'recalled_voluntary' or 'recalled_mandatory' status for AI-integrated products must trigger post-market plan review" }, "source": "GS1 US Data Hub Product Lifecycle; FDA Recall classifications; EU GPSR (2023/988)", "source_url": "https://www.gs1us.org/tools/gs1-company-database-gepir" }, { "enum_name": "QualityNonConformanceCategory", "label": "Quality Non Conformance Category", "otel_attribute": "manufacturing.quality.nonconformance_category", "opa_policy_path": "data.manufacturing.quality.nonconformance_category", "rego_input_key": "manufacturing_quality_nonconformance_category", "stability": "stable", "description": "Category of non-conformance detected by AI vision inspection, statistical process control, or other quality monitoring agents. Used to route NCRs (Non-Conformance Reports) to appropriate disposition workflows.", "permitted_values": [ "dimensional_out_of_tolerance", "surface_defect_cosmetic", "surface_defect_functional", "material_wrong_grade", "material_contamination", "missing_component", "wrong_component", "assembly_sequence_error", "label_error", "documentation_missing", "functional_test_failure", "electrical_test_failure", "sterility_failure", "process_parameter_deviation", "calibration_out_of_date", "supplier_non_conformance" ], "value_labels": { "dimensional_out_of_tolerance": "Dimensional Out of Tolerance", "surface_defect_cosmetic": "Surface Defect Cosmetic", "surface_defect_functional": "Surface Defect Functional", "material_wrong_grade": "Material Wrong Grade", "material_contamination": "Material Contamination", "missing_component": "Missing Component", "wrong_component": "Wrong Component", "assembly_sequence_error": "Assembly Sequence Error", "label_error": "Label Error", "documentation_missing": "Documentation Missing", "functional_test_failure": "Functional Test Failure", "electrical_test_failure": "Electrical Test Failure", "sterility_failure": "Sterility Failure", "process_parameter_deviation": "Process Parameter Deviation", "calibration_out_of_date": "Calibration Out of Date", "supplier_non_conformance": "Supplier Non Conformance" }, "regulatory_mappings": { "fda_21_cfr_820": "FDA 21 CFR 820.90 — Nonconforming product control: all categories require disposition decision and record retention", "iatf_16949": "IATF 16949 Clause 8.7 — Control of nonconforming outputs: customer notification requirements for certain categories", "as9100": "AS9100 Rev D Clause 8.7 — Nonconforming outputs in aerospace require escape analysis and customer notification" }, "use_case": "AI vision inspection agent classifies detected defects. 'Functional_test_failure' and 'sterility_failure' categories automatically block product from proceeding and trigger mandatory disposition review by quality engineer.", "source": "ISO 9001:2015 Clause 8.7; IATF 16949 Clause 8.7; FDA 21 CFR Part 820.90; AS9100 Rev D", "source_url": "https://www.iso.org/standard/62085.html" }, { "enum_name": "NCRDispositionDecision", "label": "Ncr Disposition Decision", "otel_attribute": "manufacturing.quality.ncr_disposition", "opa_policy_path": "data.manufacturing.quality.ncr_disposition", "rego_input_key": "manufacturing_quality_ncr_disposition", "stability": "stable", "description": "Disposition decision for a non-conforming product or material. AI quality management agents can recommend but must not autonomously execute 'use_as_is' or 'deviate' dispositions for regulated product — these always require HITL approval.", "permitted_values": [ "rework", "repair", "scrap", "return_to_supplier", "use_as_is", "deviate_concession_approved", "regrade", "pending_review", "customer_deviation_required" ], "value_labels": { "rework": "Rework", "repair": "Repair", "scrap": "Scrap", "return_to_supplier": "Return to Supplier", "use_as_is": "Use As Is", "deviate_concession_approved": "Deviate Concession Approved", "regrade": "Regrade", "pending_review": "Pending Review", "customer_deviation_required": "Customer Deviation Required" }, "code_definitions": { "use_as_is": "Non-conforming item accepted without rework; requires documented engineering justification and quality authority approval", "deviate_concession_approved": "Approved deviation from specification for a defined quantity; customer concession required in many regulated industries", "customer_deviation_required": "Non-conformance cannot be dispositioned without customer approval; applicable in aerospace (AS9100) and automotive (IATF 16949) supply chains" }, "regulatory_mappings": { "fda_21_cfr_820": "FDA 21 CFR 820.90(b) — 'use_as_is' disposition requires documented justification and approval by authorised individual", "as9100": "AS9100 Rev D — Customer notification mandatory when 'use_as_is', 'deviate_concession_approved', or 'customer_deviation_required' disposition applies to flight safety parts", "iatf_16949": "IATF 16949 — Customer-specific requirements often mandate zero-tolerance for 'use_as_is' on safety-relevant characteristics" }, "use_case": "OPA policy blocks AI quality agent from autonomously setting 'use_as_is' or 'deviate_concession_approved' dispositions on any regulated product. These require human quality authority sign-off logged in the system.", "source": "ISO 9001:2015 Clause 8.7.4; FDA 21 CFR Part 820.90; AS9100 Rev D; IATF 16949", "source_url": "https://www.iso.org/standard/62085.html" }, { "enum_name": "ProductRecallClass", "label": "Product Recall Class", "otel_attribute": "manufacturing.product.recall_class", "opa_policy_path": "data.manufacturing.product.recall_class", "rego_input_key": "manufacturing_product_recall_class", "stability": "stable", "description": "Regulatory recall severity classification. AI recall management agents use this to determine response timelines, notification scope, and regulatory reporting obligations.", "permitted_values": [ "class_i_serious_health_hazard", "class_ii_temporary_adverse_health", "class_iii_unlikely_adverse_health", "market_withdrawal_fda", "medical_device_field_safety_corrective_action", "automotive_safety_recall_nhtsa", "cpsc_mandatory_recall", "voluntary_recall_not_regulated" ], "value_labels": { "class_i_serious_health_hazard": "Class I — Serious Health Hazard", "class_ii_temporary_adverse_health": "Class II — Temporary Adverse Health", "class_iii_unlikely_adverse_health": "Class III — Unlikely Adverse Health", "market_withdrawal_fda": "Market Withdrawal FDA", "medical_device_field_safety_corrective_action": "Medical Device Field Safety Corrective Action", "automotive_safety_recall_nhtsa": "Automotive Safety Recall Nhtsa", "cpsc_mandatory_recall": "Cpsc Mandatory Recall", "voluntary_recall_not_regulated": "Voluntary Recall not Regulated" }, "code_definitions": { "class_i_serious_health_hazard": "FDA Class I: use of or exposure to a violative product will cause serious adverse health consequences or death", "class_ii_temporary_adverse_health": "FDA Class II: use of or exposure to a violative product may cause temporary adverse health consequences", "class_iii_unlikely_adverse_health": "FDA Class III: use of or exposure to a violative product is not likely to cause any adverse health consequences", "medical_device_field_safety_corrective_action": "EU MDR/IVDR Field Safety Corrective Action (FSCA): any corrective action taken to reduce risk of death or serious deterioration in health" }, "regulatory_mappings": { "fda_21_cfr_7": "FDA 21 CFR Part 7 — Class I recall: immediate notification required; Class I/II: 10-day FDA status report", "eu_gpsr": "EU GPSR (2023/988) Article 35 — Mandatory recall notification to Safety Gate within 2 working days of discovering unsafe product", "eu_mdr": "EU MDR 2017/745 Article 87 — FSCA: 15-day serious incident report to competent authority" }, "use_case": "AI recall orchestration agent classifies the recall severity and automatically initiates the correct regulatory notification timeline. Class I recalls trigger immediate executive HITL escalation and all-stop on affected lot dispatch.", "source": "FDA 21 CFR Part 7 recall classifications; EU GPSR (2023/988); EU MDR 2017/745; NHTSA recall authority", "source_url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-voluntary-recalls" } ] }, { "subdomain": "Predictive Maintenance & Asset Management", "description": "Covers AI predictive maintenance action classification, asset health state enumerations, and maintenance work order type taxonomy. Used by AI condition monitoring agents integrated with CMMS (Computerised Maintenance Management Systems) and digital twin platforms.", "relevant_standards": [ "ISO 55000:2014 — Asset Management", "ISO 13374-1 — Condition monitoring and diagnostics of machines", "IEC 61499 — Function Block Standard for distributed control", "MIMOSA CCRM — Common Condition and Reliability Model for asset health", "OPC UA for Machinery — OPC 40001 companion specification" ], "categories": [ { "enum_name": "AssetHealthState", "label": "Asset Health State", "otel_attribute": "manufacturing.asset.health_state", "opa_policy_path": "data.manufacturing.asset.health_state", "rego_input_key": "manufacturing_asset_health_state", "stability": "proposed", "description": "AI-assessed health state of a manufacturing asset based on condition monitoring signals. Drives predictive maintenance scheduling and production planning decisions.", "permitted_values": [ "healthy", "watch", "advisory", "alert", "danger", "failed", "indeterminate" ], "value_labels": { "healthy": "Healthy", "watch": "Watch", "advisory": "Advisory", "alert": "Alert", "danger": "Danger", "failed": "Failed", "indeterminate": "Indeterminate" }, "code_definitions": { "healthy": "All condition indicators within normal limits; no action required", "watch": "One or more indicators trending toward threshold; increased monitoring cadence recommended", "advisory": "Condition indicators approaching alert threshold; maintenance should be planned within normal scheduling cycle", "alert": "One or more indicators have exceeded alert threshold; maintenance required within defined SLA window", "danger": "Condition indicators in danger zone; immediate action required; production scheduling impact imminent", "failed": "Asset has failed or been taken out of service; emergency maintenance work order required", "indeterminate": "Insufficient sensor data or model confidence below threshold to classify health state" }, "use_case": "AI predictive maintenance agent publishes asset health state as an OTel gauge metric. When state transitions to 'alert', agent autonomously creates a maintenance work order in CMMS. When state reaches 'danger', HITL escalation to plant manager is mandatory.", "source": "MIMOSA CCRM asset health classification; ISO 13374-1 condition monitoring categories; ISO 55000", "source_url": "https://www.iso.org/standard/55088.html" }, { "enum_name": "MaintenanceWorkOrderType", "label": "Maintenance Work Order Type", "otel_attribute": "manufacturing.maintenance.work_order_type", "opa_policy_path": "data.manufacturing.maintenance.work_order_type", "rego_input_key": "manufacturing_maintenance_work_order_type", "stability": "stable", "description": "Classification of a maintenance work order type. AI predictive maintenance agents must correctly classify work orders to trigger the appropriate approval workflow, spare parts reservation, and safety procedure.", "permitted_values": [ "preventive_scheduled", "predictive_ai_generated", "corrective_breakdown", "corrective_deferred", "emergency_safety", "condition_based", "statutory_inspection", "modification_engineering_change", "lubrication", "calibration" ], "value_labels": { "preventive_scheduled": "Preventive Scheduled", "predictive_ai_generated": "Predictive AI Generated", "corrective_breakdown": "Corrective Breakdown", "corrective_deferred": "Corrective Deferred", "emergency_safety": "Emergency Safety", "condition_based": "Condition Based", "statutory_inspection": "Statutory Inspection", "modification_engineering_change": "Modification Engineering Change", "lubrication": "Lubrication", "calibration": "Calibration" }, "regulatory_mappings": { "eu_machinery_reg": "EU Machinery Regulation (2023/1230) — 'statutory_inspection' work orders for safety-relevant components require documented competent person sign-off", "fda_21_cfr_820": "FDA 21 CFR 820.72 — 'calibration' work orders for inspection, measuring, and test equipment require traceable calibration records" }, "use_case": "AI predictive maintenance agent creates 'predictive_ai_generated' work orders. OPA policy enforces that 'emergency_safety' and 'modification_engineering_change' work orders require HITL approval before execution.", "source": "ISO 55000 asset management; SMRP (Society for Maintenance and Reliability Professionals) maintenance type taxonomy", "source_url": "https://www.smrp.org/" }, { "enum_name": "PredictiveMaintenanceTrigger", "label": "Predictive Maintenance Trigger", "otel_attribute": "manufacturing.maintenance.predictive_trigger", "opa_policy_path": "data.manufacturing.maintenance.predictive_trigger", "rego_input_key": "manufacturing_maintenance_predictive_trigger", "stability": "proposed", "description": "The signal or model output that triggered an AI-generated predictive maintenance recommendation. Logged for model explainability and audit purposes under EU AI Act Article 13 (transparency) for high-risk AI systems.", "permitted_values": [ "vibration_anomaly", "temperature_anomaly", "acoustic_emission_anomaly", "oil_analysis_degradation", "power_consumption_anomaly", "pressure_deviation", "time_based_threshold", "cycle_count_threshold", "digital_twin_simulation", "ml_remaining_useful_life_model", "corrosion_detected", "leak_detected" ], "value_labels": { "vibration_anomaly": "Vibration Anomaly", "temperature_anomaly": "Temperature Anomaly", "acoustic_emission_anomaly": "Acoustic Emission Anomaly", "oil_analysis_degradation": "Oil Analysis Degradation", "power_consumption_anomaly": "Power Consumption Anomaly", "pressure_deviation": "Pressure Deviation", "time_based_threshold": "Time Based Threshold", "cycle_count_threshold": "Cycle Count Threshold", "digital_twin_simulation": "Digital Twin Simulation", "ml_remaining_useful_life_model": "Ml Remaining Useful Life Model", "corrosion_detected": "Corrosion Detected", "leak_detected": "Leak Detected" }, "regulatory_mappings": { "eu_ai_act_art13": "EU AI Act Article 13 — Transparency: high-risk AI systems must provide sufficient information for users to understand and verify AI-generated maintenance recommendations" }, "use_case": "Every AI-generated predictive maintenance work order is tagged with its trigger. Maintenance engineers can review the trigger type to assess model confidence before approving the work order.", "source": "ISO 13374-1 condition monitoring inputs; MIMOSA CCRM signal classification", "source_url": "https://www.iso.org/standard/33936.html" } ] }, { "subdomain": "Customs, Trade Compliance & Export Control", "description": "Covers AI-driven customs classification, export control screening, and trade compliance event enumerations. Agentic AI systems automating customs filing, dual-use screening, and import/export compliance must use these values.", "relevant_standards": [ "WCO Harmonized System (HS) 2022 — Tariff nomenclature", "US Export Administration Regulations (EAR) — Commerce Control List (CCL)", "US International Traffic in Arms Regulations (ITAR) — US Munitions List (USML)", "EU Dual-Use Regulation (EU) 2021/821 — Export controls for dual-use items", "UN Comtrade — International merchandise trade statistics", "US UFLPA (2021) — Customs enforcement for supply chain provenance" ], "categories": [ { "enum_name": "CustomsEntryStatus", "label": "Customs Entry Status", "otel_attribute": "manufacturing.customs.entry_status", "opa_policy_path": "data.manufacturing.customs.entry_status", "rego_input_key": "manufacturing_customs_entry_status", "stability": "stable", "description": "Lifecycle state of a customs entry or import/export declaration as processed by AI customs agents. Maps to WCO SAFE Framework and major customs authority system states.", "permitted_values": [ "draft", "submitted", "accepted", "under_examination", "physical_inspection_required", "held_detained", "released", "rejected", "abandoned", "post_clearance_audit" ], "value_labels": { "draft": "Draft", "submitted": "Submitted", "accepted": "Accepted", "under_examination": "Under Examination", "physical_inspection_required": "Physical Inspection Required", "held_detained": "Held Detained", "released": "Released", "rejected": "Rejected", "abandoned": "Abandoned", "post_clearance_audit": "Post Clearance Audit" }, "use_case": "AI customs agent manages entry lifecycle. 'Physical_inspection_required' state triggers logistics rerouting and notify-shipper workflows. 'Held_detained' state for Xinjiang-origin goods triggers UFLPA evidence package assembly.", "source": "WCO SAFE Framework; CBP ACE entry status; EU Customs Decision System (CDS) entry states", "source_url": "https://www.wcoomd.org/en/topics/facilitation/instrument-and-tools/conventions/pf_safe_package.aspx" }, { "enum_name": "ExportControlClassification", "label": "Export Control Classification", "otel_attribute": "manufacturing.export_control.classification", "opa_policy_path": "data.manufacturing.export_control.classification", "rego_input_key": "manufacturing_export_control_classification", "stability": "stable", "description": "Export control regulatory classification of a product or technology. AI export control screening agents use this to determine licence requirements before approving shipments.", "permitted_values": [ "ear99_no_licence_required", "eccn_controlled_licence_exception_available", "eccn_controlled_licence_required", "itar_controlled_usml", "eu_dual_use_controlled", "un_sanctions_prohibited", "us_entity_list_restricted", "unclassified_pending_review" ], "value_labels": { "ear99_no_licence_required": "Ear99 No Licence Required", "eccn_controlled_licence_exception_available": "Eccn Controlled Licence Exception Available", "eccn_controlled_licence_required": "Eccn Controlled Licence Required", "itar_controlled_usml": "Itar Controlled Usml", "eu_dual_use_controlled": "EU Dual Use Controlled", "un_sanctions_prohibited": "Un Sanctions Prohibited", "us_entity_list_restricted": "Us Entity List Restricted", "unclassified_pending_review": "Unclassified Pending Review" }, "regulatory_mappings": { "ear": "US EAR — ECCN classifications determine licence requirements by destination, end-user, and end-use", "itar": "US ITAR — USML items require State Department approval for export; no EAR licence exceptions apply", "eu_dual_use": "EU Dual-Use Regulation (2021/821) — national competent authority authorisation required for listed items" }, "use_case": "OPA policy blocks AI logistics agent from creating a shipping label for any item classified as 'itar_controlled_usml', 'eccn_controlled_licence_required', or 'un_sanctions_prohibited' without a valid licence number in the shipment record.", "source": "US EAR Commerce Control List; US ITAR USML; EU Dual-Use Regulation (2021/821)", "source_url": "https://www.bis.doc.gov/index.php/regulations/export-administration-regulations-ear" } ] }, { "subdomain": "Environmental, Health & Safety (EHS) Compliance", "description": "Covers AI-driven EHS incident classification, chemical substance compliance status (REACH/RoHS), and environmental performance enumerations for CSRD scope 3 reporting and product environmental compliance.", "relevant_standards": [ "EU REACH Regulation (EC) No 1907/2006 — Registration, Evaluation, Authorisation of Chemicals", "EU RoHS Directive 2011/65/EU — Restriction of Hazardous Substances", "EU CSRD (2022/2464) — ESRS E1 Climate / E2 Pollution / E3 Water / E4 Biodiversity", "ISO 14001:2015 — Environmental Management Systems", "ISO 45001:2018 — Occupational Health and Safety Management", "OSHA 29 CFR 1910.119 — Process Safety Management (PSM)", "EU Seveso III Directive 2012/18/EU — Control of Major Accident Hazards" ], "categories": [ { "enum_name": "EHSIncidentSeverity", "label": "EHS Incident Severity", "otel_attribute": "manufacturing.ehs.incident_severity", "opa_policy_path": "data.manufacturing.ehs.incident_severity", "rego_input_key": "manufacturing_ehs_incident_severity", "stability": "stable", "description": "Severity classification of an EHS incident detected or reported by AI safety monitoring systems. Determines regulatory reporting obligations and HITL escalation requirements.", "permitted_values": [ "near_miss", "first_aid_case", "medical_treatment_case", "restricted_work_case", "lost_time_incident", "serious_injury", "fatality", "process_safety_event_tier1", "process_safety_event_tier2", "environmental_spill_reportable", "major_accident_seveso" ], "value_labels": { "near_miss": "Near Miss", "first_aid_case": "First Aid Case", "medical_treatment_case": "Medical Treatment Case", "restricted_work_case": "Restricted Work Case", "lost_time_incident": "Lost Time Incident", "serious_injury": "Serious Injury", "fatality": "Fatality", "process_safety_event_tier1": "Process Safety Event Tier1", "process_safety_event_tier2": "Process Safety Event Tier2", "environmental_spill_reportable": "Environmental Spill Reportable", "major_accident_seveso": "Major Accident Seveso" }, "regulatory_mappings": { "osha_300": "US OSHA 300 Log: 'lost_time_incident', 'restricted_work_case', 'medical_treatment_case', and 'fatality' require OSHA 300 log entry; 'fatality' requires OSHA notification within 8 hours", "eu_seveso": "EU Seveso III — 'major_accident_seveso' requires immediate competent authority notification and post-accident report within 1 year", "eu_csrd_esrs_s1": "EU CSRD ESRS S1 — Serious injuries and fatalities are material disclosures; 'process_safety_event_tier1' is typically material" }, "use_case": "AI EHS monitoring agent classifies all safety events. 'Fatality' or 'major_accident_seveso' classification triggers immediate plant shutdown assessment and regulatory notification workflow. AI agent is blocked from autonomously clearing events at these severity levels — HITL is mandatory.", "source": "OSHA recordkeeping criteria; API RP 754 process safety event tiers; EU Seveso III Directive", "source_url": "https://www.osha.gov/recordkeeping" }, { "enum_name": "ChemicalComplianceStatus", "label": "Chemical Compliance Status", "otel_attribute": "manufacturing.chemical.compliance_status", "opa_policy_path": "data.manufacturing.chemical.compliance_status", "rego_input_key": "manufacturing_chemical_compliance_status", "stability": "stable", "description": "Regulatory compliance status of a chemical substance or material in a product. AI product compliance agents use this to flag products that cannot be shipped or sold in specific markets.", "permitted_values": [ "compliant_no_restrictions", "reach_svhc_candidate_list", "reach_authorisation_required", "reach_restriction_applies", "rohs_compliant", "rohs_non_compliant", "rohs_exemption_applies", "california_prop65_warning_required", "pending_assessment", "data_insufficient" ], "value_labels": { "compliant_no_restrictions": "Compliant No Restrictions", "reach_svhc_candidate_list": "Reach Svhc Candidate List", "reach_authorisation_required": "Reach Authorisation Required", "reach_restriction_applies": "Reach Restriction Applies", "rohs_compliant": "Rohs Compliant", "rohs_non_compliant": "Rohs Non Compliant", "rohs_exemption_applies": "Rohs Exemption Applies", "california_prop65_warning_required": "California Prop65 Warning Required", "pending_assessment": "Pending Assessment", "data_insufficient": "Data Insufficient" }, "regulatory_mappings": { "eu_reach": "REACH Candidate List substances require SCIP database notification; REACH Annex XIV substances require authorisation", "eu_rohs": "RoHS 2011/65/EU — 'rohs_non_compliant' items cannot be placed on EU market; 'rohs_exemption_applies' requires documented exemption reference", "california_prop65": "California Prop 65 — 'california_prop65_warning_required' items must carry warning label before sale in California" }, "use_case": "AI product compliance agent checks chemical compliance status before generating a CE marking declaration of conformity. 'Reach_authorisation_required' status blocks CE marking until authorisation is confirmed.", "source": "EU REACH Regulation (EC) No 1907/2006; EU RoHS Directive 2011/65/EU; California Prop 65", "source_url": "https://echa.europa.eu/regulations/reach/understanding-reach" } ] } ], "opa_rego_policy_patterns": { "description": "Manufacturing, Supply Chain & Logistics-specific OPA Rego policy patterns referencing enum values from this file and from 00_core_sdk_and_governance.json. Illustrative patterns, not production policies.", "patterns": [ { "pattern_id": "manufacturing.block_cobot_autonomous_operation_without_safety_mode_logging", "pattern_name": "block_cobot_autonomous_operation_without_safety_mode_logging", "enforcement_effect": "deny", "description": "Block any AI cobot supervision agent span from proceeding to execution if the active safety mode has not been explicitly set and logged. Ensures every cobot action span is tagged with the ISO/TS 15066 collaborative operation mode — required for EU AI Act Article 12 logging and EU Machinery Regulation technical file.", "applicable_enums": [ "CobotSafetyMode", "PhysicalAIKind", "RobotSafetyEventType" ], "regulatory_basis": "EU AI Act Article 12 — Logging for high-risk AI; EU Machinery Regulation (2023/1230) EHSR 1.2.1 — Safety-related control systems; ISO/TS 15066 collaborative operation mode documentation", "rego_sketch": "package manufacturing.cobot_safety\n\nrequires_safety_mode := {\"collaborative_robot_cobot\", \"autonomous_mobile_robot_amr\"}\n\nblockable_safety_modes := {\"emergency_stop_triggered\", \"protective_stop_triggered\"}\n\ndeny[msg] {\n input.manufacturing_physical_ai_kind in requires_safety_mode\n not input.manufacturing_cobot_safety_mode\n msg := \"EU AI Act Art 12 / EU Machinery Reg: Cobot span must include manufacturing.cobot.safety_mode. Attribute missing — execution blocked for audit trail integrity.\"\n}\n\ndeny[msg] {\n input.manufacturing_physical_ai_kind in requires_safety_mode\n input.manufacturing_cobot_safety_mode in blockable_safety_modes\n input.gen_ai_hitl_decision != \"approved\"\n msg := sprintf(\"ISO/TS 15066: Cobot is in '%v' state. Autonomous operation blocked — HITL reset required before resumption.\", [input.manufacturing_cobot_safety_mode])\n}" }, { "pattern_id": "manufacturing.enforce_uflpa_supply_chain_hold", "pattern_name": "enforce_uflpa_supply_chain_hold", "enforcement_effect": "deny", "description": "Block any AI logistics agent from creating a shipping label or customs entry for goods where the supply chain risk category includes 'forced_labour_uflpa' and no CBP UFLPA evidence package has been approved. Implements the UFLPA rebuttable presumption in automated fulfilment.", "applicable_enums": [ "SupplyChainRiskCategory", "TransportStatusCondition", "CustomsEntryStatus", "EPCISDispositionCode" ], "regulatory_basis": "US Uyghur Forced Labor Prevention Act (UFLPA 2021) — Rebuttable presumption that goods with Xinjiang-origin content were produced with forced labour; CBP enforcement guidance (June 2022)", "rego_sketch": "package manufacturing.trade_compliance\n\ndeny[msg] {\n input.manufacturing_supply_chain_risk_category == \"forced_labour_uflpa\"\n not input.uflpa_evidence_package_approved == true\n msg := sprintf(\"UFLPA: Shipment '%v' contains components with Xinjiang-origin risk. Shipping blocked until CBP-approved UFLPA evidence package is on file.\", [input.shipment_id])\n}\n\ndeny[msg] {\n input.manufacturing_export_control_classification in {\"un_sanctions_prohibited\", \"us_entity_list_restricted\"}\n msg := sprintf(\"Export Control: Item '%v' classified as '%v'. Shipment creation blocked — licence review required.\", [input.item_id, input.manufacturing_export_control_classification])\n}" }, { "pattern_id": "manufacturing.block_ai_disposition_of_regulated_nonconformance", "pattern_name": "block_ai_disposition_of_regulated_nonconformance", "enforcement_effect": "deny", "description": "Block any AI quality management agent from autonomously setting 'use_as_is' or 'deviate_concession_approved' disposition on non-conforming regulated product (medical device, aerospace, pharmaceutical). These dispositions require human quality authority sign-off.", "applicable_enums": [ "NCRDispositionDecision", "QualityNonConformanceCategory", "ProductMarketStatus" ], "regulatory_basis": "FDA 21 CFR 820.90(b) — Nonconforming product disposition requires documented justification and authorised individual approval; AS9100 Rev D Clause 8.7.4; IATF 16949 Clause 8.7", "rego_sketch": "package manufacturing.quality\n\nrestricted_dispositions := {\"use_as_is\", \"deviate_concession_approved\", \"customer_deviation_required\"}\n\nregulated_product_types := {\"medical_device\", \"aerospace\", \"pharmaceutical\", \"automotive_safety\"}\n\ndeny[msg] {\n input.manufacturing_quality_ncr_disposition in restricted_dispositions\n input.product_regulatory_type in regulated_product_types\n not input.quality_authority_hitl_approved == true\n msg := sprintf(\"FDA 21 CFR 820.90 / AS9100: Disposition '%v' on regulated '%v' product requires human quality authority approval. AI disposition blocked.\", [input.manufacturing_quality_ncr_disposition, input.product_regulatory_type])\n}\n\ndeny[msg] {\n input.manufacturing_product_market_status in {\"recalled_voluntary\", \"recalled_mandatory\"}\n input.requested_action != \"block_and_retrieve\"\n msg := sprintf(\"Recall Management: Product in '%v' status cannot be shipped or issued. All transactions blocked pending recall completion.\", [input.manufacturing_product_market_status])\n}" }, { "pattern_id": "manufacturing.enforce_ot_cross_zone_access_policy", "pattern_name": "enforce_ot_cross_zone_access_policy", "enforcement_effect": "deny", "description": "Block any AI agent or automated process from initiating a direct connection from enterprise_zone or remote_access_zone to field_zone or safety_instrumented_zone. All OT cross-zone access must traverse the industrial DMZ. Enforces IEC 62443-3-3 zones and conduits architecture.", "applicable_enums": [ "OTSecurityZone", "IEC62443SecurityLevel", "OTIncidentType" ], "regulatory_basis": "IEC 62443-3-3 SR 5.1 — Network segmentation; NIST SP 800-82 Rev 3 OT network segmentation; EU NIS2 Article 21 security measures for essential entities in manufacturing sector", "rego_sketch": "package manufacturing.ot_security\n\nhigh_integrity_zones := {\"field_zone\", \"safety_instrumented_zone\"}\n\ndirect_access_prohibited_from := {\"enterprise_zone\", \"remote_access_zone\"}\n\ndeny[msg] {\n input.source_ot_zone in direct_access_prohibited_from\n input.destination_ot_zone in high_integrity_zones\n not input.dmz_traversal_confirmed == true\n msg := sprintf(\"IEC 62443-3-3 SR 5.1: Direct access from '%v' to '%v' is prohibited. All connections must traverse the industrial DMZ.\", [input.source_ot_zone, input.destination_ot_zone])\n}\n\ndeny[msg] {\n input.manufacturing_ot_incident_type == \"safety_system_interference\"\n input.gen_ai_hitl_decision != \"approved\"\n msg := \"IEC 62443 / NIS2: Safety Instrumented System interference detected. All automated responses blocked — immediate HITL escalation to plant safety officer required.\"\n}" }, { "pattern_id": "manufacturing.ehs_fatality_regulatory_notification_gate", "pattern_name": "ehs_fatality_regulatory_notification_gate", "enforcement_effect": "deny", "description": "Block any AI EHS agent from marking a fatality or major accident incident as resolved or closed until mandatory regulatory notifications (OSHA 8-hour report or Seveso III immediate notification) have been confirmed as submitted. Ensures AI incident management cannot inadvertently bypass statutory reporting deadlines.", "applicable_enums": [ "EHSIncidentSeverity", "JobOrderState", "ProductMarketStatus" ], "regulatory_basis": "US OSHA 29 CFR 1904.39 — Fatality notification within 8 hours; EU Seveso III Article 16 — Immediate major accident notification to competent authority", "rego_sketch": "package manufacturing.ehs_compliance\n\nimmediate_notify_severities := {\"fatality\", \"major_accident_seveso\", \"process_safety_event_tier1\"}\n\ndeny[msg] {\n input.manufacturing_ehs_incident_severity in immediate_notify_severities\n input.regulatory_notification_submitted != true\n input.incident_hours_elapsed > 7\n msg := sprintf(\"OSHA 1904.39 / Seveso III: Incident severity '%v' requires regulatory notification. %v hours elapsed without confirmed submission — HITL escalation to legal/EHS director required immediately.\", [input.manufacturing_ehs_incident_severity, input.incident_hours_elapsed])\n}\n\ndeny[msg] {\n input.manufacturing_ehs_incident_severity in immediate_notify_severities\n input.requested_ticket_status in {\"resolved\", \"closed\"}\n not input.regulatory_notification_submitted == true\n msg := \"EHS Compliance: Fatality/major accident incident cannot be closed until regulatory notification is confirmed as submitted.\"\n}" } ] }, "agent_registry_fields": { "description": "Recommended fields for registering a manufacturing, supply chain, or logistics domain agentic AI system in the GRC portal. Supplements the core agent identity schema from 00_core_sdk_and_governance.json.", "fields": [ { "field": "physical_ai_kind", "type": "enum", "enum_ref": "PhysicalAIKind", "description": "If this AI agent directly controls or supervises a physical system (robot, AMR, drone, CNC machine), its physical AI kind must be registered. Determines which safety standards and HITL requirements apply.", "required_when": "All AI agents directly controlling or supervising physical manufacturing or logistics equipment" }, { "field": "eu_machinery_regulation_in_scope", "type": "boolean", "description": "True if this AI system qualifies as a safety component of machinery under EU Machinery Regulation (2023/1230). Applicable from January 20, 2027. Triggers dual compliance assessment with EU AI Act Annex III.", "required_when": "All physical AI agents in EU-market manufacturing environments" }, { "field": "iec_62443_target_security_level", "type": "enum", "enum_ref": "IEC62443SecurityLevel", "description": "The IEC 62443-3-3 target security level for the OT zone(s) this AI agent operates in. Agent's own security posture must meet or exceed this security level.", "required_when": "All AI agents operating in OT/ICS environments" }, { "field": "uflpa_traceability_scope", "type": "boolean", "description": "True if this AI agent processes supply chain data for goods that may contain Xinjiang-origin components. Activates UFLPA evidence package tracking and CBP hold response workflows.", "required_when": "Supply chain visibility, logistics, and customs AI agents for goods potentially containing Xinjiang-origin content" }, { "field": "epcis_producer", "type": "boolean", "description": "True if this AI agent creates GS1 EPCIS events as part of its normal operation. Ensures the agent is registered in the EPCIS event audit trail for recall and provenance traceability.", "required_when": "All AI agents performing manufacturing transformations, logistics events, or inventory management operations" }, { "field": "regulated_product_types", "type": "array", "description": "List of regulated product types this AI agent has authority to process. Determines which quality management policies (FDA 21 CFR 820, AS9100, IATF 16949) apply to AI-generated quality decisions. Typical values include medical_device, pharmaceutical, aerospace, automotive_safety, food_fda, consumer_product_cpsc, chemical_reach, and unregulated.", "required_when": "Quality management, production scheduling, and inspection AI agents" }, { "field": "export_control_screening_enabled", "type": "boolean", "description": "True if this AI agent performs or relies on export control screening. Required for logistics, procurement, and order management agents to confirm EAR/ITAR/EU Dual-Use screening is in the automation chain.", "required_when": "All AI agents creating shipping documents, purchase orders, or product transfer records" }, { "field": "csrd_scope3_data_producer", "type": "boolean", "description": "True if this AI agent collects, aggregates, or validates supplier emissions or ESG data used in CSRD Scope 3 Category 1 (purchased goods and services) reporting.", "required_when": "Procurement, supplier management, and supply chain visibility AI agents for CSRD-reporting entities" } ] } }