Calibration Excellence: Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK

1. Calibration Excellence Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK

2. Presenters  Don Brady  Richard Barnes

3. Development of a calibration solution forGSK  Introduction - GSK, ‘Agile’ & Calibration Excellence  Emerson Beamex background  GSK Cork & Project Requirements  Project Challenges  Results & Next Steps

4. GSK ‘Agile’, Calibration Excellenceinitiative  Q1 2009 GSK launched Primary Supply Agile Engineering  Group identified problem of Cost of Calibration  Pilot project identified for Cork site to reduce the cost of calibration utilising any or all available technologies  Project was to focus on three areas – Instrument Diagnostics ,remove calibrations of non critical instruments from on schedule to on demand relying on SMART diagnostic information from the instrument – Paperless Calibration ,move to paperless calibration system which significantly reduces the process of calibration and eliminates non calibration support functions such as document management ,manual approvals and correction of transcription errors – Calibration Analysis ,Analyze historical data to recommend interval extension provided data shows that previous calibrations meets stringent corporate policy

6. Emerson Beamex Background ...  The Calibration Management ‘Power Users’ – often from the highly regulated industry sectors such as Life Science($/FDA) and Power ($/HSE) – usually need functionality that AMS Device Manager’s Calibration Assistant Snap-On can not provide – Strategic decision not to invest product development resources to add and maintain necessary ‘Power User’ Calibration Management functionality to AMS Device Manager. – Therefore, develop an integrated solution with Beamex, a global Specialist company with compliant Calibration Management Software, Hardware and Services.  AMS Device Manager’s ‘Native’ Calibration Management and Calibration Assistant Snap-On still provide a simple viable solution for users with less demanding functional requirements – Documenting Calibrator support, including Beamex MC5, MC2 etc.

7. Summary of Beamex & cooperationwith Emerson Beamex is one of the world’s largest companies solely devoted to the development and manufacture of process calibration hardware & software. – HQ in Finland, Major offices in the UK , US, India & China Sales offices worldwide. – More than 25 years experience – Known for high quality solutions focused on reducing time and cost in the calibration process.  Working with Emerson since 2002 – Driver for Beamex calibrator in AMS v6.0  Beamex launched the world’s first (and only) portable calibrator (MC5) for Foundation Fieldbus Transmitters at Emerson Exchange 2006  Public Announcement of intention to further work together at Emerson Exchange 2007

8. Integration of AMS Device Manager and Beamex CMX SystemsAMS Device Manager Summary ( SAP integration not CMX Summary part of Enables Predictive Phase 1 GSK project )  Tightly integrates with diagnostics of intelligent AMS Device Manager devices – Instruments,  Best in Class scalable off- Valves, Electrical the-shelf Calibration Configuration Management Management Software Diagnostics and Condition  Advanced Scheduling Monitoring  Support for Documenting Calibration Management Calibrators and PDAs  Native functionality, or  GMP and 21CFRpart11 integration with ER/ES compliant advanced CMX (paperless) Documentation  Powerful data Analysis Connectivity  Comprehensive  Device and IT protocols; Certificate and Report  Multi-vendor Devices design package  Multi-vendor Control  Connectors to ERP and Systems, MMS applications

9. Emerson / Beamex CalibrationExcellence Value Proposition:  Calibration efficiencies are achieved from two main approaches – Reducing the number of Calibrations performed • Critical Devices have realistic, justified, time-based calibration schedule supported by Condition Monitoring • Less critical Devices have no, or significantly extended, time-based calibration schedule, relying on Condition Monitoring to trigger event- based Calibration. – Performing the remaining Calibrations in a time and manpower efficient manner • Synchronise instrument data between calibration management system and asset management system • Use documenting calibrators • Optimise scheduling of planned periodic calibrations • Remove paper from the calibration process

10. Condition Monitoring with AMS DeviceManager Alert Monitor  Alert Monitor enables Online Condition Monitoring for Instruments, Valves and Electrical Equipment such as Drives and UPS  Prioritisation of alerts according to the nature of the diagnostic and the importance of the device – Colour/Wording indication of alert severity – Categorisation of a Device’s importance • Pre-configured for Emerson devices • IMPLEMENT from AO Services can define these

12. GSK Cork  GSK Cork is a highly automated manufacturing facility, including an R&D Pilot Plant, and is the primary production site for a number of GSK’s best selling products. GSK Cork employs 300+ personnel.  Site has ~4000 Instruments  Instruments are from a range of manufacturers based on predominantly HART and Foundation Fieldbus Technology installed over the last 12 years  Vast majority of Instruments are connected to one of the sites six Delta V systems using classic I/O ,Remote I/O or Foundation Fieldbus I/O

13. Cork Overview

14. Cork Project  Requirements / Deliverables  Paperless Calibration Management System  Audit Trail Instrument Loops calibration History  Analyse Instrument Loops Calibration History  CFR 21 Part 11 compliant Signatures for Data Entry and Approvals  Monitor 1100 Smart Instrument Diagnostics  Audit Trail 1100 Changes to Smart Instrumentation  Electronically Document Smart Instruments Configuration  Challenges  Legacy Calibration system and Data Migration  Legacy Automation Architecture i.e. Remote I/O  People Inertia / Reluctance to Change  Validation Challenge

15. Challenges Legacy Calibration system and Data Migration  Legacy system paper based  Data organically grew over 20+ years of service  Loop components included non calibrated items such as barriers  Almost became a holding area or sandbox for items that had no natural home i.e. Software limits  Challenge was to migrate data from legacy system to CMX but exclude items that were not part of calibration activity.  Initial Export to Excel was 28000 lines of data  Import from Excel to CMX was 7000 lines of data

17. Challenges Legacy Automation Architecture i.e. Remote I/O Architecture

18. Component Connections

19. Launch in context from DeltaV

20. Challenges People Inertia / Reluctance to Change  Biggest change in Operational Engineering since introduction of SAP in 1999  End users were seconded to project from day one i.e. Craft Supervisors and Technicians.  By go live date there was no operational surprises  Seen as benefit to existing ways of working  Stake Holder Management with regular feedback and communications was key to success

21. Challenges Validation Challenge  GSK Cork FDA regulated environment  Moving from paper based calibrations to Electronic systems required rigorous testing  System had to go through GSK’s inhouse Quality control testing (i QMS) which defines each step from Business Requirements to system testing  AMS ,CMX and the connector between were critically assessed and tested according to IQMS and GAMP complying with CFR21 requirements where necessary  Documentation and test scripts written independently of pilot site and are being re-used globally

23. Compliance /Engineering Benefits Simplified calibration Elimination of paper Workflow management Elimination of transcription Reduction in number Paperless Calibration of non value added hours errors Full calibration audit trail Easier Audit Preparation Data Analysis Proper analysis of historical calibration data Automated documenting Increased Compliance of Instruments parameters aligning with CFR21 11 Full Instrument audit trail Instrument Monitoring Continuous monitoring of Instrument diagnostics Increased Plant Uptime Live instrument alerts Predicative maintenance of Instruments Aligning with NPGS startegy

24. Workflow Comparison Overall Calibration process reduced Previous State Cork Current State from 17 Steps to 10 Work Order Issued by SAP Work Order Issued by SAP Lead Craft Lead Craft reviews Removed 2 steps with risk of reviews Workorder and Workorder and Issues to Craft Issues to Craft CRAFT Uploads Human data entry Error Craft Prints COMPUCAL CAL DATA to Handheld Sheet Craft retrieves Craft retrieves CAL equipment and Emerson/Beamex consultancy CAL equipment and Proceeds to Proceeds to Plant Plant Craft performs 5 workshops helped review the Craft performs 5 point calibration point calibration Craft Enters CAL Craft Transcribes Data via Handheld existing processes, and optimise Data to COMPUCAL Sheet or Delta V Workstation Calibration and refine the new processes to Calibration Passed Passed Craft Issues PASS / leverage technology Craft Issues PASS /FAIL Status on SAP Workorder Craft passes completed Compucal sheet to Office Admin FAIL Status on SAP Workorder Lead Craft Approves Paperless CAL System’s flexibility used to manage Office Admin Sheet via Digital Enters Data into Signature COMPUCAL Lead Craft Closes workflow as well as primary function Transcription Errors SAP Workorder of managing calibrations. Out of Tolerence Errors Admin Closes out COMPUCAL Data Entry SAP step Admin Files COMPUCAL Sheet as Master Primary Record Compucal to be removed Lead Craft Approves Compucal Sheet Calibration Step Lead Craft Closes COMPUCAL Loop Lead Craft Closes SAP Workorder AMS Step new ways of work

25. Business Results Achieved  Paperless Calibration – Elimination of 21,000 sheets of paper per annum. – Workflow has been significantly streamlined end to end which reduces cal time by estimated 15 minutes per cal. – Elimination of calculation errors and reworks as pass/fail calculations are provided in real time out on plant. – 8% reduction in scheduled calibrations implemented during data migration from legacy system. – Generation of email alerts upon calibration failure; only calibration failures now need to be reviewed and approved.  Historical Analysis – Extension of calibration intervals, recommended by the system via email alerts. This so far has resulted in 234 calibrations per annum being removed from schedule during first twelve months of analysis and should peak year three of operation.  Instrument Diagnostics – Removal of 33% of P4 loops (not related directly to quality, EHS or regulatory) from scheduled calibration to calibration on demand based on an instrument’s self diagnostics. Approximately 300 hours have been saved per annum.

26. Next Steps  Build on the success of the Cork Project  Make system available to network by centralising installation including existing licenses – Make system a globally validated library item – Mirrored hosting servers across GSK regions – Token Licenses to be shared across time zones  Drive cost of the system down so low cost manufacturer geo locations are not excluded – leverage common standards – Costs should only include data migration – License share  On going communications about the benefits of paperless and diagnostics

27. Q&A  ?  Thank You

28. Where To Get More Information  Other training sessions – Session ID: 1A-2647: A Demonstration of the Principles Deployed for the EDF Energy West Burton Asset Management Solution • Calibration Excellence solution integrated with SAP – paperless workflow from SAP to the Calibrator and back to SAP – Session ID: 2-2603: Calibration Excellence: Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK • Calibration Excellence higher level Business considerations  List books, articles, electronic sources  Consulting services, other sources

29. Calibration Excellence Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK