Integration and Connection Strategies to Maximize the Benefits from Your MES System

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1 Integration and Connection Strategies to Maximize the Benefits from Your MES System Jerry Gonzalez Business Systems Manager B. Braun Medical Inc Baha Korkmaz, PMP. Senior VP Operations North America m Tips and tools for MES creating 2015 and presenting wide format slides 10 th Annual Forum on Manufacturing Execution Systems

2 Workshop Objective Integrating MES with Level 2, Level 3 and Level 4 systems enables manufacturers to capitalize on their investment and harness the full potential of the MES system. The successful integration of these systems reduces the time needed to introduce new products, decreases manufacturing mistakes and improves engineering changes. During this workshop, gain best practices and sustainable strategies for integrating the MES system with SCADA, ERP, DCS, and LIMS to achieve a fully paperless facility and improve the production process.

3 Key Questions to be addressed: How does MES work with SCADA, ERP, and LIMS? What is the value of MES integration with other systems? What are the top strategies for successful MES/ Serialization integration? What are proven methods for integrating these systems? How do you ensure these integrated systems remain compliant and validated?

4 Workshop Outline Integration Strategies to Produce a Flexible and Agile MES System Maximize the Benefits of System Integration and Network Sharing Takeaway Best Practices and Methods for System Integration and Equipment Connections

5 Foundational Work - Integration What is the practical goal of an integrated system? What is covered in each integration phase? Is it technically possible to interface all automation systems? Is there a practical gain from doing so? Is there a data strategy in place? Which system collects and reports each type of data? Summaries/statistics of continuous data trends transferred to the ebr? Key and critical parameter indicators: How are these going to be reported? Is the batch context known and aligned across systems?

6 Overcoming Challenges with MES Technically, MES enables true integration ERP alone cannot meet business needs of complex manufacturing operations MES fills the gaps by introducing near real time data exchange, work instructions and true integration across all steps of the complex manufacturing process.

7 Apply Standards for MES integration

8 S88/S95 Model Framework Integrated information management can be accomplished by utilizing S88/S95 model Recipe based framework creates a solid foundation for data integration Horizontally from R&D to Process Development/Clinical to Scale Up to Commercial production (Internal and external contract manufacturing) Vertically from field instruments to control to automation to data historian to Manufacturing Execution Systems to ERP Goal: Accurate representation of material and information flow.

9 ISA S95 functional model supports Integration MES fills the gaps by introducing near real time data exchange and true integration. S95 uses term MOM for level 3 functions. Level 4 Level 0,1,2 Level 4 Level 3 Level 0,1,2

10 ISA S95 levels Business Planning & Logistics Plant Production Scheduling, Operational Management, etc 4 - Establishing the basic plant schedule - production, material use, delivery, and shipping. Determining inventory levels. Time Frame Months, weeks, days, shifts Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Reliability Assurance, Work flow / recipe control to produce the desired end products. Maintaining records and optimizing the production process. Time Frame Shifts, hours, minutes, seconds Level 1 Level 0 Manufacturing Control Basic Control, Supervisory Control, Process Sensing, Process Manipulation, 2 - Monitoring, supervisory control and automated control of the production process 1 - Sensing the production process, manipulating the production process

11 Possible Manufacturing System Landsa Maint Cal Master Data Item BOM Lot Shop Order Creation & Update Material Consumption & Creation Sample SOP Deviations Training Lot Variable Data Recipe Selection Data Read Write RBE Flag Batch Report Room Condition

12 Workshop Sessions to begin

13 Lets Start with WHY MES?

14 Reduce time to market PD level MES deployment Improved tech transfer process Shortened clinical phases Optimized MES system integration project cycle shorter project life cycle Validation Master Plan risk based validation Ease of commissioning and validation Shortened go-live No paper EBR and electronic Data Integrity Risk based approach

15 Maximize Gain and Operational Excelle Right the First Time RBE (Review by exception) Increased Productivity/yield Decreased production cost Lean application No duplicate entry Minimized human error Electronic batch review and release

16 Prolong Lifecycle Continuous Improvement Avoiding deviations Proper implementation of RBE No consent decree equals longer sales cycle Faster deviation resolution, therefore longer lifecycle Utilization of Equipment Management module

17 MES integration impact ERP Integration PCS and Automation Integration LIMS Integration LMS Integration EDM Integration Asset Management Integration Data Historian Integration PDAT Integration Trackwise Integration

18 IT Infrastructure impact to MES integration IT Infrastructure to support the envisioned integrated system.

19 IT Visibility IT Domain 19 Level 4 ERP, APO, Logistics Systems Business Information Network Level 3 MES, LIMS, WMS, CMM Systems Operations Information Network Level 2 HMI, SCADA, Batch Systems Level 1 Automation Network Device Networks PLC, DCS, Packaged Systems I/O, Devices, Sensors

20 In Conclusion Systems integration should be approached strategically, in alignment with business objectives The requirements of Manufacturing Operation Management and the need for integrated systems can be achieved with the technology available today. We hope that the objectives of the workshop are achieved today Options of what to implement Options of when and what project phases Pros and cons of various options

21 Workshop items to consider What to integrate How tight the integration should be Impact on project and lifecycle cost When to integrate Migration and upgrade issues

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