Presented by GSK's Don Brady and Emerson's Richard Barnes at the 2011 Emerson Exchange conference in Nashville, TN USA. Abstract: The project for an innovative integrated PlantWeb asset and calibration management solution went live in Nov 2010 at GSK’s Cork facility, a primary API production plant. This workshop presents GSK’s Calibration Excellence program and the significant improvements in business operations and management of regulatory compliance that it is delivering in support of GSK’ s world class manufacturing program. This system forms part of the GSK global engineering strategy. The author has received the GSK Excellence Recognition Award in acknowledgement of the importance and success of this project.

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 for
GSK
 Introduction - GSK, ‘Agile’ & Calibration Excellence
 Emerson Beamex background
 GSK Cork & Project Requirements
 Project Challenges
 Results & Next Steps

4. GSK ‘Agile’, Calibration Excellence
initiative
 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

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

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 & cooperation
with 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 Systems
AMS 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 Calibration
Excellence 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 Device
Manager 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

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

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

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

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

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

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