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  1. Advances in Shop Floor Management and Visibility (CON8765) Stephen Slade, Oracle, Sr. Director, Mfg Industries Marketing Karen Theel, Oracle, Sr. Director, Mfg Strategy Michael P Vigarino II, BioMarin Pharmaceutical Inc., Associate Director, Enterprise Systems AravindanSankaramurthy, Oracle, Director, Mfg Product Management Ram Palaniappan, FCS, Director Consulting Sept, 2013

  2. Safe Harbor Statement The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

  3. Analytics Driven Manufacturing means=

  4. VISIBILITY.

  5. Oracle is in the business to help you gain VISIBILITY

  6. Information. Discovery. Action.

  7. 2 Hrs/Day Searching for Information

  8. Manufacturing Decisions

  9. STATUS Always Current

  10. Shopfloor Information Improved Visibility Better Decisions

  11. VISIBILITY.

  12. How can 1 + 1 + 1 = 4? • How can the Whole be Greater than the Sum of the Parts?

  13. Analytics Driven Manufacturing Gaining Shopfloor Visibility with Improved Intelligence Rapid Results • Accelerate Lean-Six Sigma to drive operational excellence • Architected for long-term scalability and flexibility • Delivers quick value - in weeks not years • Fits into your existing Oracle shopfloor environment • Works with your existing Oracle backend solution • Easy Launch – partner uptake

  14. Program Agenda • Manufacturing Challenges • Oracle Manufacturing Solution Overview • Customer Success Studies • BioMarin • FCS • Discussion

  15. Every ERP Application Manager “Managers spend up to 2 hours each day searching for information, and more than 50% of the informationthey obtain has no value to them.” “ Managers say the majority of information obtained for their work is useless”

  16. Need for the Modern Digital FactoryDealing with Information Overload • ShopFloor Challenge • How is work collaborated? • Are schedules approved and synchronized manually? • How are updates addressed? • How do communications with planning take place?

  17. Need for the Modern Digital FactoryAutomate Information Exchange • ShopFloor Solution • Schedules are delivered to an “electronic” workbench • Operators see and perform with user specific dispatch lists, sync’d to orders and materials • Worker accesses the latest instructions and quality measurements

  18. Need for the Modern Digital FactoryAutomate Supervisory Visibility • ShopFloor Solutions • Role based dashboards • Early alerts to KPIs • Drill-down to root-cause • Prompt analysis, visual aides • Recommendations, options • Resource adjustments

  19. Need for the Modern Digital FactoryAutomate Compliance Reporting and Alerts for Exceptions • ShopFloor Solutions • Drive sustainability goals • Carbon & emission reporting • Compliance achievement • Energy consumption KPIs • Environmental accounting • Linkage to key sensors

  20. Oracle Manufacturing Solution Overview

  21. Planning and Scheduling Analytics Driven Manufacturing Greater Visibility with Enhanced Intelligence Transactional: • MES Workstations: Providesdetailed steps for operators to perform with processing instructions and data capture points. • MSCA: Data capture with full lot/serial tracking • Endeca: Mobile or desktop access to real-time operational stats. Explore and find answers to unanticipated questions without structured queries. Analytics: • Manufacturing Operation Center (MOC): Provides machine-level state, status, performance metrics and certain contextualized analytics in environments that use PLCs to monitor shop equipment. • Manufacturing Analytics: Review and analyze manufacturing performance against targets and historical trends, including views of planning, production, costing, quality and inventory builds ManufacturingAnalytics Flexible, Mixed-Mode Manufacturing ProductLifecycle Mgmt Repetitive Flow / Lean ETO ATO / CTO MTS Process Mfg -Batch/Continuous/Lot Standard Discrete Warehousing / Transportation Visibility from Shop Floor to Top Floor Manufacturing Execution AssetLifecycle Mgmt Quality Mgmt Sample Analyze Adjust Lot / Serial Genealogy Tracking with MSCA option Project Tracking Service MOC - S95-Based Data Integration PartnerCollaboration and Visibility Contract Mfgrs Suppliers Shop FloorSyst

  22. Real-time Manufacturing OperationsOracle Manufacturing Execution Systems (MES) for Discrete & Process Mfg MES for Discrete Mfg MES for Process Mfg ERP • Operator • Work from dispatch list • Record transactions, qualityinfo, work completion, and time • View work instructions andcomponent info • Report production exceptions • Skills certification • Process Engineer • Manage recipes & advanced process instructions • Production Supervisor • Create & manage batch status • Log non-conformances • Dispensing / Prod Operator • Touch Screen User Interface • Pre-weigh designated ingredients • Process batch operations • Operator Certification Corp Mgmt MES Production Mgmt Shop Floor Control • Supervisor • Review & resolve exceptions • Monitor shop floor progress System Automation & Control • Deliver Real-Time Shop Floor Visibility to Multiple Layers of Management • Reduced TCO / Complexity via Integrated Mfg Mgmt & Production Execution

  23. Increase Operator Efficiency with Intuitive Workstation Work Content Actions Dispatch list type Authorization through badge number entry View Instructions Jobs not ready to betaken up for production View Current Employees working Work Content is all the information required to perform work on an operation. It includes component and resource requirements, work instructions, attachments and other job property information.

  24. Compile all of the recipe information in the Master Batch Record (MBR) Capture all the batch lifecycle events and data in the Control Batch Record (CBR) Materials, resources, steps, deviations, QC samples, labels, process instructions, e-signatures Append events as they occur Retain MBR and CBR in pdfformat, securely stored in the E-Records Evidence Store* Electronic Batch Records for Process MfgReplace Paperwork and Enable Advanced Record Search * Using Oracle E-Records

  25. Mobile Supply Chain Applications Support Basic Shop Floor Automation Needs Built-in Mobile User Interface Mobile Discrete Manufacturing Mobile Process Mfg Material Mobile Discrete Quality Reservations, Issues, Returns, Create & Update Pending Lots, Incremental Backflush, Product & Byproduct Completions Moves, Issues (eg.Push Parts and Serial Comp to Serial Parent), Returns, Scrap Completions Quality Collections, Deviations, Rejects to MRB, Specs, Rework Mobile Process Mfg LPN Transactions Mobile Process Mfg Resource and Step Mobile Sub-Inventory Replenishment Start/End Resources, Update Resource Usage, Release and Complete Steps Sub-Inventory Transfers, Refills. Bar-coded Pick List Utilization Line Completion into LPN, Completion with Directed Drop, Manual Drop, Directed Load Built-in RF Middleware Mobile Transaction Server RF Base Station Apps / Database LAN or WAN RF Device Telnet Over TCP/ IP SQL Net

  26. Oracle Advanced Query with Endeca ExtensionsSift through Structured & Unstructured Factory Data • Drive Visibility into Operations • Advanced search that unlocks unstructured data • Contextual navigation is data-driven. Freely browse data without predefined paths or writing queries • Interactive. Shows only valid next steps • Easy to use. Familiar online experience • Visual analysis with charts, crosstabs, key metrics, geospatial visualization, tag clouds

  27. Manufacturing Extensions for EndecaSeamlessly integration provides superior data discovery • Discrete and Process Manufacturing: Improve manufacturing operations productivity • Quickly identify and manage component shortages and resource bottlenecks • Find and resolve shop floor exceptions and quality non-conformances as they arise • Cost Management: Optimize your period close process • Identify and correct uncosted WIP and backlog transactions • New Product --Outsource Manufacturing: Increased visibility to manufacturing partner status • Identify subcontract order delays early and adjust production schedules to meet on-time customer delivery • Quickly identify the right alternate supplier to help mitigate outside processing quality non-conformance problems http://www.youtube.com/watch?v=B_WJzR46ek0

  28. Oracle Manufacturing Execution System for Process Manufacturing in BioTech - A Real World Solution Oracle Open World - San Francisco 2013 Michael P Vigarino II Associate Director, Enterprise Systems BioMarin Pharmaceutical Inc.

  29. Objective: The Life Sciences Industry is continually faced with the challenge of limiting manufacturing costs while remaining compliant with regulatory requirements. To maintain compliance we have to do things better and allow for better production tracking. The following presentation details the business drivers and strategy followed to meet these challenges using Oracle's Manufacturing Execution System for Oracle Process Manufacturing (MES for OPM) Module for PreWeigh Kitting and Buffer & Media Prep. as well as Manufacturing Analytics to provide data visibility.

  30. Safe Harbor Statement • This non-confidential presentation contains ‘forward-looking statements’ about the business prospects of BioMarin Pharmaceutical Inc., including potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of BioMarin’s product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission such as 10-Q, 10-K and 8-K reports.

  31. Agenda: BioMarin at a Glance Business Climate & Challenges Implementation Goals Implementation Strategy & Execution MES for OPM Solution Overview Challenges Faced & Lessons Learned Realized Solution Benefits Conclusion & Next Steps

  32. BioMarin at a Glance BioMarin is a publicly traded (BMRN), multinational biopharmaceutical company, headquartered in Novato, CA specializing in providing innovative first-to-market therapeutics to patients with rare genetic diseases. Approximately 1250 employees world-wide Operations in over 20 counties Manufacturing Facilities on two continents 4 Commercial Products: Total 2012 revenue $510 M* Naglazyme® for MPS VI Aldurazyme® for MPS I Kuvan® for PKU Firdapse™ for LEMS (EU) Expansive Pipeline & Development VIMIZIM for MPS IVA PEG-PAL for PKU New IND candidates in development Ongoing business development efforts • *Financial information per BioMarin press release issued Jan 2013 • ** Projected non-GAAP net income is calculated in accordance with GAAP but excludes non-cash stock compensation expense, nonrecurring material items and the tax effect of the adjustments

  33. Current Business Climate • Continued Growth: • 2x increase in employees over the past 5 years • 3 new product introductions over the past 2 years • Expanded manufacturing facility in CA & new facility in Ireland • 4x increase in transactional volume within manufacturing • Continued expansion of Development and Clinical pipelines • Maximization of Investment Dollars (“Bang for the Buck”): • Product Development vs Operations • Streamline Business Processes • Gain and Sustain Efficiencies • Positive & Shortened Return on Investment

  34. Business Challenges within Execution • Lack of effective utilization of resources and space to maximize efficiency • Issues & Challenges arising from use of paper batch records: • High administrative overhead for paper batches and long lead & slack time • Continual risk of operator errors and corrections due to manual execution • Lack of real-time material and batch transaction recording in OPM • Lack of system material verification ‘consume before use’ • No electronic data capture via integration with devices • Lack of data visibility because of lack of data capture • Batch-specific pre-weighing activities leading to: • Longer in-process production lead times • Lack of material flexibility

  35. Implementation Goals • Leverage current ERP system modules to perform “phase 1” pre-weigh functionality as a low cost alternative to starting a full MES implementation in the next 24-36 months. • Determine if Oracle MES has the correct functionality to allow for electronic batch records for Buffer and Media Processing at 2 levels: • Verify that Oracle MES has “Paper on Glass” functionality • Verify “Review by Exception” capabilities at 3 levels: • Missed Tasks and Skipped Parameter Fields • Parameter values out of tolerance • Verification of no open deviations/holds (non-conformances) • Solution Elements: • Oracle Manufacturing Execution System for Process Manufacturing (MES for OPM) • Oracle Process Manufacturing (OPM) • Oracle Mobile Supply Chain Applications (MSCA) • Initial Solution Scope: • Standard Scale Integration, Dispensing Rules & Label Generation • Creative Thinking & Process Changes to Drive Additional Benefit: • Setup Pre-Weighed Kits as Lot Controlled Inventoried Items • Decouple Pre-Weigh Operations from Downstream Batch Operations • Setup Standard Control E-Bach Records for Weighed Kit Batches (CBR) • Leverage MSCA to allow for direct material transactions without entry • Online QA Lot Release Approvals as Lot Disposition • E-Signatures for Part 11 compliance

  36. System Configuration Implementation Strategy • Phased approach to implementation • PreWeigh/Kitting as Phase 1 • Buffer/Media as Phase 2 • Perform technical Proof of Concept working with Oracle and system AMS Team • Use system functionality as a basis for user requirements (URS) • Create detailed test scripts to be executed for UAT and OQ • Leverage existing internal resources for implementation • Implement the functionality within 4 months • Absolutely no customization – Leverage Out of Box functions

  37. Process Implementation Strategy • Change Management Approach: • Demo the Complete POC to business • Have shop floor users perform demo and Ensure functionality requirements met • Have Senior Management (QA & MFG) approve the use of the product • Make Quality & Validation project team members • Involve them with the project for a solid understanding of the system & processes • Verify in the POC the additional controls that the system provides “By Exception” • Focus on URS and build scripts that call out and test the requirements • Ensure System Limitations are understood and agreed to • Have users and QA execute all CRP and UAT work and allow hands-on recipe design

  38. Solution Overview: • Solution Elements: • Oracle Manufacturing Execution System for Process Manufacturing (MES for OPM) • Touch screen Workbench for Kitting and Buffer Prep • Oracle Process Manufacturing (OPM) for material transactions and batch management • Oracle Mobile Supply Chain Applications (MSCA) for Material reservations for Kitting • Bar code readers for equipment and standard values to limit manual entry • Oracle Process Quality Collection Plans • Non-conformances for batch comments and quality events recording • Standard scale Integration, Dispensing Rules & Automated Label Generation • Use of Master Batch Records and Controlled Batch Records for electronic record review • Use of Dual-token e-signatures for procedures to comply with CFR Part 11 • Online QA Lot Release Approvals as Lot Disposition • Setup recipes in “test” org within PROD to limit data entry after validation

  39. Challenges & Lessons Learned • Master Data… Master Data… Master Data… • Must be well understood by business (MFG, Quality) • Must have solid procedures that support its maintenance, with dedicated resources • Must have complete process alignment with Change Control System • Backup Procedures • Must be able to revert to paper backups for unexpected outages with procedures on: • When to resort to backup process • How to enter transactions in the system after issue resolution

  40. Realized Benefits: • Overall Process: • Process time reduction for 4 FTE’s for paper batch administration • Process time reduction of 1.5 hours per executed batch • Complete removal of Quality Document Control work • Improved Transaction Accuracy & Real-Time Inventory transacting • Scalable and Flexible use of pre-weighed raw material kits • Process Improvement by eliminating non-value added batch activities • Integration of scales & use of bar code scanners to eliminate manual user entry • Process reduced from 2 operators to 1 due to MSCA functionality • Oracle Electronic Batch Records (EBR): • Batch Record approval cycle time is reduced by 80% • EBRs now electronically available for reviewers and regulators automatically • Secure Control Batch Record Storage, and Elimination of archiving of paper batch records

  41. Conclusion: • Results: • Were able to successfully utilize Oracle MES for Process Manufacturing to realize immediate and significant savings at a cost lower than more traditional options • While not all nice-to-have functionalities are available, yet, we were able to use the system to meet our critical requirements related to business use, quality, and compliance • Obtained a high enough level of success to justify the continued investment in use of MES for OPM functionality for addition functionality and operations • Capturing all data to fully use Manufacturing Analytics

  42. Next Steps: • Implement device integration with Automation and Historian System • Use Process Quality to allow for batch parameter calculations • Utilize Manufacturing Analytics for collected data to improve processes • Evaluate Oracle Collection Plans as a solution for electronic logbooks • POC is scheduled for Q4, 2013 with a review of Oracle Asset Management

  43. THANK YOU

  44. Driving the Modern Digital FactoryAnalytics Driven Manufacturing • Shopfloor Intelligence • Advanced Search & Discovery • Drill-down Mobile Visibility MES Endeca MA* MOC** MSCA *MA - Manufacturing Analytics **MOC – Manufacturing Operations Center

  45. Manufacturing Operations Center Oracle Provides… • Real-Time Intelligence for Plant Operations • Unified Plant Data Repository • Integration to Shop Floor Systems and Equipment • Event Management Framework …Supported by Oracle Analytics Platform & Engine The Foundation for Continuous Process Improvement

  46. Manufacturing Operations Center At-a-Glance Users ERP Systems • Production Schedules • Quality • Cost Mgmt Corporate BI Cross-Plant KPIs • Yearlyimprovement goalsand trends • By department, plant Production Actuals EAM Maintenance Work Requests Schedules Master/Reference Data Plant Manager ERP Agnostic Manufacturing Operations & Sustainability Data Model Plant-Specific KPIs • OEE by department, • Production Performance • Metrics by equipment Production Manager Contextualization Engine Role-Based Dashboards MES/Data Historians Shop Floor Communication Drivers Manual Data Automation& ProcessControlSystems Advanced Process Control CNCMachines SCADASystems PLC

  47. Oracle Applications PlanningMfg Operations Center Current Release and Roadmap • ISA-95 based data model • Role based dashboards • EBS adapter for discrete and process mfg • Shop floor connectivity • Data contextualization • Event Management Framework • Sustainability Sensor Data Management • Extensible attribute framework • Support OBIEE 11g • Technology upgrade from OWB to ODI • Reprocessing of operations data • Asset performance dashboard • Production supervisor dashboard • Improved usability for error correction and resubmission • Mobile support • Tighter and seamless integration with EAM • Enhancements to EBS Integration • MOC Operator Interface • Extensible Attributes Enhancements • Customer driven enhancements • Integration with Mfg Analytics, Production Scheduling, JDE E1 MOC 12.1.3 MOC 12.2 Available now Future DirectionsPost 12 Month Planning Cycle

  48. OEE By Asset OEE Breakup by Asset Asset Events Asset Production Performance Asset Output and Scrap Asset Status Trend Asset Downtime Analysis Asset Operation Parameter Trend Asset Performance Dashboard Production Asset Page • Reports Available 51

  49. Production Supervisor Dashboard • Reports Available 52 • Equipment Status, • Equipment Status Analysis • Equipment Status Trend • Equipment Output Trend • Equipment Downtime Analysis

  50. A Few MOC Customers…