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OMAC in new Plants ?

Coordinate. Ready. Record & Analyze. Execute. Process. Machine automation / a User view on Standardization / OMAC & Make2Pack What are our drivers and needs?. OMAC in new Plants ?. OMAC Make2Pac 2010 Ernst Madsen Product Supply IT. Machine automation at Novo Nordisk.

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OMAC in new Plants ?

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  1. DAu OMAC Make2Pac Coordinate Ready Record & Analyze Execute Process Machine automation / a User view on Standardization / OMAC & Make2Pack What are our drivers and needs? OMAC in new Plants ? OMAC Make2Pac 2010 Ernst Madsen Product Supply IT

  2. DAu OMAC Make2Pac Machine automation at Novo Nordisk Machine automation • Many applications • From standard equipment/low coste.g. simple packaging • To very customized/high coste.g. assembly lines • Different architectures • PLC (many vendors, many types) • User interface (none, HMI, SCADA) • MES/EBR integration (customized if any) • Performance monitoring (none, simple, light, full OEE) • Infrastructure integration “Make2Pack” Interface layer Application Platform

  3. DAu OMAC Make2Pac Requirements • Allow high automation levels with a minimum of cost and risk • Not first movers but fast followers • Fast to market • Life cycle requirements: • Operational • Maintenance and support • Analyze and implement

  4. DAu OMAC Make2Pac Operational requirements • Ease of use • Standardization for operators • Efficient workflows and quality reporting (MES/EBR) • Recipes and order information • QC sampling • Alarms and warnings • Reporting / electronic batch record • Material control (quality and advanced transport control) • Performance monitoring (OEE) • Infrastructure • Security • Users • Time • Narrow close down windows

  5. DAu OMAC Make2Pac Maintenance requirements • Disaster recovery • Configuration management • (Backup)

  6. DAu OMAC Make2Pac Analyze and implement Novo Nordisk need: • Terminology • Ability to communicate complex projects • Standard building blocks • Things should not be reinvented • Standard interfaces • Solutions should be plug-and-play

  7. DAu OMAC Make2Pac Standardization Novo Nordisk need and support industry groups: • We don’t want to start from scratch every time • We don’t want to reinvent the wheel

  8. DAu OMAC Make2Pac PLC+HMI PLC+HMI PLC/HMI PLC/HMI ERP MES MES ( API ) (Finished procuct) PLC/MES PCS SCADA SCADA SCADA PLC/SCADA Functional and Interface Requirements StandAlone Utility Processes and Systems

  9. DAu OMAC Make2Pac Types of unit Processes The types of equipment that this report focuses on are: • Washers • Sterilizers • Autoclaves • Filling lines • Inspection machines • Freeze driers • Packaging lines • Assembly lines • Utility, WFI-distribution • Formulation • Weighing • Granulators • Facility Monitoring Systems • Building Management Systems • Black utilities and other auxiliary systems

  10. DAu OMAC Make2Pac Infrastructures in finished Products • PLC Stand alone system • PLC with interface to a SCADA • PLC with interface to a MES

  11. DAu OMAC Make2Pac MES SCADA Same interface for all vendors Interface (Production schedule, Master Recipe, OEE, etc.) Same data for all Same functions for vendors all vendors Equipment Functions Data (Data logging , alarm (Batch data, OEE, etc.) handling, etc.) Strategy & standard goals • Change of paradigm • Equipment suppliers can choose its preferred PLC platform • Equipment suppliers must fulfil functional and interface requirements • A global and agile support and maintenance organization must exist

  12. DAu OMAC Make2Pac 1. System Standards 2. ImplementationApproaches TechnologiesLife CycleManagement 4. Risk Evaluations 3. System Strategies Approach to standards The Technology Standard covers: Description of relevant system configurations Relevant functionalities and interfaces Maintenance and support Generic functional and interface requirements In future development of Unit Process specific interface requirements

  13. DAu OMAC Make2Pac Recommendations • Functional • Development of unit process specific (“PLC”) requirements • Make requirements suitable for central library storage to impose direct harmonization and reuse (testable) • Gradual implementation of the Make2Pack standard as itmatures and vendors start to comply with the standard • Competences • Development of support and maintenance organization supporting multiple PLC platforms • Enable knowledge sharing across sites and countries • Develop procedures for support and maintenance • Enable remote service capability for use by equipment suppliers and supporters

  14. DAu OMAC Make2Pac Functions (Generic) • Scan materials at the destinations Log / Verify materials that have been received • Download recipe to equipment Transfer of process parameters to equipment • Categorization of recipe parameters Recipe parameters must be split in Production / Machine recipes and individually version controlled • Download batch information Transfer of batch information to equipment • Equipment control Batch execution Send execution commands on the unit level (must comply with S88). Also includes receiving of status changes

  15. DAu OMAC Make2Pac Functions cont. • Equipment control Batch execution S88 OMAC Phase/operation/sequence control • Equipment control - S88 OMAC em/cm module operation mode(AUTO, MANUAL...) • Equipment control – S88 OMAC em/cm module control commands (OPEN, CLOSE…) • Equipment control - S88 OMAC Module control - Control Values • Time synchronization Synchronize the system time on equipment • Line clearance, before production Include in batch report

  16. DAu OMAC Make2Pac Functions cont. • Operator assignment log (Electronic records) Log which operators was working on the machine • Critical alarm log (Electronic records) List of critical equipment alarms • Non-Critical alarm log (Electronic records) List of non-critical equipment alarms • Log book (Electronic records) List of events occurring during a batch e.g. parameter change, etc. • Process data (ER) Data that must be logged in order to approve a batch • Manage IPC Sampling Take and record in-process samples as specified • Line clearance, after prod. Include signatures for line clearance in batch report • Reconciliation report Log number of produced goods in categories e.g. Good, Rejects, Manually removed, etc.

  17. DAu OMAC Make2Pac Functions cont. • Prepare batch report Generate production batch report (containing data specified above or by user) • Evaluate equipment (Manual OEE data logging) Log manual OEE data to OEE database (stop causes). Compliant with MAKE2PACK and OMAC standards. • Evaluate equipment (Automatic OEE data logging) Log automatic OEE data to OEE database (from e.g. critical alarms). Compliant with MAKE2PACK and OMAC standards. • Data analysis (OEE data) Analyze OEE data and optimize production • Data analysis (KPI data) Analyze KPI data and optimize production

  18. DAu OMAC Make2Pac Functions cont. • Prepare OEE/KPI data report Generate OEE data report (containing data specified above or by user) • Issue preventive maintenance job Send notification when preventive maintenance is required. Scheduling or operation counters • Change management A well defined baseline of critical items must be supplied • Disaster recovery A disaster recovery plan and installation media must be supplied (incl. definition of critical data) • Documentation standards The documentation supplied must fulfill e.g. standards for engineering • Programming standards All programming must fulfill listed standards • Data communication interface Communication protocol used by PLC to communicate with external systems

  19. DAu OMAC Make2Pac Supply Chain Management Enterprise Management Manufacturing Management Plant Management Production Unit Management Production Process Management Machine Management Plant Operation Analysis Production Scheduling Capacity Planning Process Control Recipe / Work Order Execution Machine Logic Process Management Agreeing on Point of Sameness – The balance central versus local Demand, Capacity Planning, Customer Requirements Specification Management Production Orders, Plant Schedules Corp Standards Production Throughput Site Autonomy Production Processes Machine, Material Execution, Procedures

  20. DAu OMAC Make2Pac Questions - ? Functions, Data, Interfaces & Dataflow is production EndUser Domain – Input to std. Organisations Machine standards as OMAC & Make2Pac is supplier and integrator Domains (and of partial EndUser maintenance interest)

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