The Operating Model for Manufacturing Systems

The fastest way to create chaos on the floor is to let MES, ERP, and QMS share ownership of the same data. When no one is sure which system is the source of truth for specifications, revisions, or status, people copy and paste across tools. That creates drift, hidden rework, and genealogy gaps that show up as late releases and tense audits. The cure is not more software. It is a clear operating model for who owns what and how systems sync, grounded in ISA-95 and supported by identifiers and events that travel across your enterprise and partners (International Society of Automation, 2018; MESA International, 2022).

Use ISA-95 to draw the boundary lines. ERP sits at Level 4 and owns commercial orders, financial inventory, and planning signals. MES sits at Level 3 and owns execution context, dispatch, data collection, signatures, and genealogy. QMS governs nonconformance, CAPA, and change controls that affect product quality and compliance across levels. These roles are not opinions. They are how the standard reduces risk and cost by preventing duplicate responsibility between Level 3 and Level 4 systems (International Society of Automation, 2018; ISA InTech, 2020). When you frame decisions in this model, integration debates turn into simple ownership calls.

Define system of record for the big nouns. ERP owns customer orders, financial material master and valuation, and promise dates. MES owns routings or operations as executed, operation parameters and limits, electronic records and signatures, and as-built genealogy. QMS owns nonconformance records, CAPA, change control, and quality documents that govern how work is performed. In the Siemens stack, Opcenter Execution is the Level 3 backbone for discrete and process manufacturing, while Opcenter X Quality serves key QMS processes and integrates with execution and enterprise flows so investigations link to the actual work and results (Siemens Digital Industries Software, n.d.-a; Siemens Digital Industries Software, n.d.-b; Siemens Digital Industries Software, n.d.-c).

Set canonical identifiers before you move any data. You need stable IDs for items, lots or batches, equipment, operations, and orders that do not change when a record crosses a system boundary. GS1 traceability standards give a portable event model and ID keys that simplify cross-site and cross-partner genealogy and product recalls (GS1, 2017). Canonical IDs seem like plumbing, yet they are the reason genealogy queries return complete answers and the reason planners trust the schedule that arrives from APS. Without them, reconciliation becomes a daily tax.

Synchronize with event contracts, not ad hoc queries. A minimal backbone has five events: order release, operation start, operation complete, quality result posted, and put-away or ship confirmation. Each event includes who, what, when, where, and why, and a small payload that carries IDs, quantities, revisions, and state. The contract states success behavior and error handling so retry logic does not create duplicates. In Opcenter, these flows are first class because execution lives on the same backbone that also feeds Opcenter Intelligence and APS, which closes the loop from plan to performance and back (Siemens Digital Industries Software, n.d.-a; Siemens Digital Industries Software, n.d.-d).

Treat quality and compliance as built-in, not bolted on. ISO 9001 change control ensures that master data and process definitions are reviewed and released in a controlled way, which prevents silent drift during integration changes (International Organization for Standardization, 2015). If your process requires electronic records and signatures, FDA Part 11 guidance explains how identity, signatures, and audit trails must work so e-records are trustworthy and acceptable in place of paper (U.S. Food and Drug Administration, 2018). Opcenter Execution supports these controls by design, and Opcenter X Quality enables nonconformance, CAPA, and document control that reference the same identifiers used on the floor, which makes deviations and investigations far easier to complete (Siemens Digital Industries Software, n.d.-a; Siemens Digital Industries Software, n.d.-b).

Respect the industrial context when you integrate. Plant networks are not office networks. Interfaces that cross zones need least-privilege access, segmentation, and monitoring that does not interrupt production. NIST’s OT security guide is the mainstream reference for safe patterns in operational networks and helps IT and OT agree on where to place gateways, what to log, and how to recover from incidents without unsafe improvisation (National Institute of Standards and Technology, 2023). This matters because outages from poor interface design are just as expensive as data errors when the morning shift starts with a blank screen.

Make the model visible so people use it. Create a one-page RACI showing which system is the source for each noun and which owns the verbs that change state, for example release, start, complete, and disposition. Add a short glossary that explains each field and the allowed values. MESA’s current model is a helpful communication aid because it ties operations lifecycles and cross-lifecycle threads to a common language, which speeds buy-in from engineering, quality, and planning (MESA International, 2022). The goal is a shared mental model that reduces meetings and increases flow.

Prove value with a thin slice. Pick one product family and one line. Map ownership for the five key events. Align identifiers and revisions. Configure Opcenter Execution to generate the record and Opcenter X Quality to capture nonconformances when they happen, not weeks later. Publish success and failure counts on a small interface health board next to planners and supervisors so weak spots cannot hide. Lighthouse research shows the sites that standardize data and shorten learning loops sustain gains rather than sliding back into firefighting, which is what this thin slice is designed to achieve (World Economic Forum, 2025).

Close with governance light enough to use. A monthly review looks at three things: data quality in the IDs and masters, event success or retry rates, and open deviations tied to integration or ownership. ISO 9001 provides a workable backbone for these routines, and the combination with ISA-95 reduces debate because the rules are visible and the evidence is short and auditable (International Organization for Standardization, 2015; International Society of Automation, 2018). Over a quarter, you will see fewer swivel-chair updates, faster release decisions, and a plan that holds because the systems that plan and record work operate as one.

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References

• GS1. (2017). GS1 Global Traceability Standard (Release 2.0). https://www.gs1.org/sites/default/files/docs/traceability/GS1_Global_Traceability_Standard_i2.pdf 
  This standard is relevant because consistent identifiers and event models make genealogy portable across MES, ERP, and partner systems. It covers ID keys, event capture, and data sharing patterns for end-to-end traceability. Two takeaways are that canonical IDs reduce reconciliation and that consistent event capture speeds investigations. 
  
  
• International Organization for Standardization. (2015). ISO 9001:2015 — Quality management systems — Requirements. https://www.iso.org/standard/62085.html 
  This standard is relevant because it provides practical change-control and document-control scaffolding for integration and validation work. It covers QMS requirements that keep mapping, testing, and approvals auditable and repeatable. Two takeaways are that controlled change prevents drift and that defined responsibilities speed decisions. 
  
  
• International Society of Automation. (2018). ISA-95: Enterprise-Control System Integration (overview). https://www.isa.org/standards-and-publications/isa-standards/isa-95-standard 
  This reference is relevant because it clarifies data ownership and interfaces between enterprise systems and manufacturing operations systems. It covers models and responsibilities that prevent ambiguity and re-keying. Two takeaways are that clear ownership maps end debates about where data lives and that event choreography becomes simpler when each layer owns its nouns and verbs. 
  
  
• ISA InTech. (2020). The ISA-95 enterprise-control system integration standards. https://www.isa.org/intech/2020/september-october/the-isa-95-enterprise-control-system-integration-s 
  This article is relevant because it explains how ISA-95 levels are logical boundaries that support integration without hardcoding. It covers how levels guide interface placement and reduce cost and errors. Two takeaways are that logical boundaries endure even as technology shifts and that level clarity reduces brittle integrations. 
  
  
• MESA International. (2022). The MESA Model: A framework for smarter manufacturing. https://mesa.org/topics-resources/mesa-model/ 
  This page is relevant because it provides a communication model for MoM scope that helps align stakeholders. It covers lifecycles, cross-lifecycle threads, and enabling technologies that connect enterprise and operations. Two takeaways are that a shared model accelerates buy-in and that examples translate concepts into projects. 
  
  
• National Institute of Standards and Technology. (2023). SP 800-82 Rev. 3: Guide to operational technology (OT) security. https://csrc.nist.gov/pubs/sp/800/82/r3/final 
  This guide is relevant because interfaces often cross OT networks where safety and reliability are paramount. It covers OT architectures, risks, zoning, and monitoring patterns that fit manufacturing. Two takeaways are that segmentation and least privilege reduce blast radius and that logs near the cell enable faster diagnosis. 
  
  
• Siemens Digital Industries Software. (n.d.-a). Opcenter Execution (MES) portfolio. https://plm.sw.siemens.com/en-US/opcenter/execution/ 
  This page is relevant because it shows how Opcenter Execution orchestrates work, enforces specs, captures results and signatures, and generates compliant records. It covers industry-specific MES offerings and capabilities linked to genealogy and quality. Two takeaways are that execution is tailored by industry and that e-records and enforcement live at Level 3. 
  
  
• Siemens Digital Industries Software. (n.d.-b). Opcenter X Quality (cloud QMS). https://plm.sw.siemens.com/en-US/opcenter/quality-x-cloud-qms/ 
  This page is relevant because it explains how Siemens’ QMS capabilities manage inspections, nonconformance, and CAPA. It covers process control, deviation handling, and analytics across shop-floor quality. Two takeaways are that QMS must anchor deviations to real execution data and that closed-loop CAPA speeds learning. 
  
  
• Siemens Digital Industries Software. (n.d.-c). Opcenter Manufacturing Operations Management overview. https://plm.sw.siemens.com/en-US/opcenter/ 
  This page is relevant because it positions Opcenter as Siemens’ MoM suite that connects planning, execution, quality, and intelligence. It covers end-to-end visibility and closed-loop improvement on a single backbone. Two takeaways are that one platform reduces silos and that shared data shortens improvement cycles. 
  
  
• Siemens Digital Industries Software. (n.d.-d). Opcenter Advanced Planning and Scheduling (APS). https://plm.sw.siemens.com/en-US/opcenter/advanced-planning-scheduling-aps/ 
  This page is relevant because APS creates finite-capacity schedules that ERP can trust. It covers constraint modeling, setup rules, and case evidence for faster planning and more reliable due dates. Two takeaways are that finite planning cuts expedites and that modeling real rules frees capacity. 
  
  
• U.S. Food and Drug Administration. (2018). Part 11, electronic records; electronic signatures — Scope and application [Guidance]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application 
  This guidance is relevant because regulated plants must ensure that electronic records and signatures remain trustworthy through integrations and change. It covers applicability, audit trails, and expectations for risk-based testing and documentation. Two takeaways are that compliant e-records can replace paper and that validation should focus on functions that affect product quality and data integrity. 
  
  
• World Economic Forum. (2025). Global Lighthouse Network 2025: The mindset shifts driving impact and scale. https://reports.weforum.org/docs/WEF_Global_Lighthouse_Network_2025.pdf 
  This report is relevant because it documents how leading plants use standardized metrics and fast learning cycles to sustain gains. It covers operating models, quantified results, and scaling patterns for digital operations. Two takeaways are that common definitions enable replication and that short feedback loops convert data into daily action.