ISA-95 Compliance Checklist (Manufacturing Industry)

Description

This ISA-95 Compliance Checklist provides a comprehensive, step-by-step approach for manufacturing organizations to evaluate their current systems against ISA-95 requirements. It covers enterprise planning, manufacturing operations management, data standardization, system interoperability, cybersecurity, and performance management.

The checklist helps organizations:

• Reduce system integration complexity

• Improve production visibility and traceability

• Enable standardized data exchange across IT and OT layers

• Support regulatory compliance and audit readiness

• Accelerate MES, ERP, and Industry 4.0 initiatives

Designed for system integrators, manufacturing engineers, IT/OT teams, and digital transformation leaders, this checklist serves as both an assessment tool and an implementation roadmap.

1. Enterprise–Control System Integration (ISA-95 Levels)

☐ Clear separation and definition of ISA-95 Levels 0–4
☐ Documented data flow between ERP (Level 4) and MES (Level 3)
☐ Defined interfaces between MES and SCADA/PLC (Levels 2–1)
☐ No direct ERP-to-control-system communication

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2. Business Planning & Logistics (Level 4)

☐ ERP system manages orders, inventory, and supply chain
☐ Production schedules are generated at enterprise level
☐ Standardized master data (materials, BOMs, routings)
☐ Change management procedures for business rules

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3. Manufacturing Operations Management (Level 3 – MES)

☐ MES implemented for production, quality, maintenance, and inventory
☐ Work instructions digitally managed and version-controlled
☐ Production execution tracked in real time
☐ Labor, equipment, and material usage captured
☐ Electronic batch/lot records (if applicable)

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4. Quality Operations Management

☐ Quality checks integrated into MES workflows
☐ Non-conformance and deviation tracking
☐ SPC (Statistical Process Control) data collection
☐ Traceability from raw material to finished product
☐ Audit-ready electronic records

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5. Maintenance Operations Management

☐ Preventive and predictive maintenance workflows defined
☐ Equipment health and downtime tracked
☐ Maintenance data integrated with production schedules
☐ Asset lifecycle data standardized

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6. Inventory & Material Management

☐ Real-time inventory visibility at shop-floor level
☐ Material consumption recorded against production orders
☐ Lot/batch traceability maintained
☐ Inventory reconciliation between MES and ERP

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7. Data Modeling & Standardization

☐ ISA-95 object models adopted (Equipment, Material, Personnel)
☐ Standard naming conventions for assets and processes
☐ Consistent data definitions across systems
☐ Master data governance established

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8. Information Exchange & Interoperability

☐ Standard interfaces (API, OPC UA, B2MML) implemented
☐ Message structures aligned with ISA-95/B2MML schemas
☐ Error handling and data validation mechanisms
☐ System interoperability tested and documented

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9. Cybersecurity & Access Control

☐ Role-based access control across all ISA-95 levels
☐ Secure communication between enterprise and control layers
☐ Audit trails enabled for critical operations
☐ Compliance with ISA/IEC 62443 (where applicable)

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10. Performance Management & Reporting

☐ KPIs aligned with ISA-95 (OEE, yield, throughput)
☐ Real-time dashboards for production visibility
☐ Automated reporting to ERP and management systems
☐ Continuous improvement processes supported

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11. Documentation & Governance

☐ System architecture diagrams aligned with ISA-95
☐ SOPs for system integration and data management
☐ Compliance audits scheduled and documented
☐ Training programs for operators and engineers