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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.
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Calibration ExcellenceCalibration Excellence
Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK
PresentersPresenters
Don Brady
Richard Barnes
Development of a calibration solution for GSKDevelopment of a calibration solution for GSK
Introduction - GSK, ‘Agile’ & Calibration Excellence Emerson Beamex background GSK Cork & Project Requirements Project Challenges Results & Next Steps
GSK ‘Agile’, Calibration Excellence initiative 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
Development of a calibration solution for GSKDevelopment of a calibration solution for GSK
Introduction - GSK, ‘Agile’ & Calibration Excellence Emerson Beamex background GSK Cork & Project Requirements Project Challenges Results & Next Steps
Emerson Beamex Background ... 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.
Summary of Beamex & cooperation with EmersonSummary 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
Integration of AMS Device Manager and Beamex CMX SystemsIntegration of AMS Device Manager and Beamex CMX Systems
CMX Summary
Tightly integrates with AMS Device Manager
Best in Class scalable off-the-shelf
Calibration Management Software
Advanced Scheduling
Support for Documenting Calibrators and
PDAs
GMP and 21CFRpart11 ER/ES compliant
(paperless)
Powerful data Analysis
Comprehensive Certificate and Report
design package
Connectors to ERP and MMS applications
AMS Device Manager Summary
Enables Predictive diagnostics of intelligent
devices – Instruments, Valves, Electrical
Configuration Management
Diagnostics and Condition Monitoring
Calibration Management
Native functionality, or integration with
advanced CMX
Documentation
Connectivity
Device and IT protocols;
Multi-vendor Devices
Multi-vendor Control Systems,
( SAP integration not part
of
Phase 1 GSK project )
Emerson / Beamex Calibration Excellence Value Proposition: 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
Condition Monitoring with AMS Device Manager Alert MonitorCondition 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
• Pre-configured for Emerson devices–
Categorisation of a Device’s importance
•IMPLEMENT from AO Services can define these
Development of a calibration solution for GSKDevelopment of a calibration solution for GSK
Introduction - GSK, ‘Agile’ & Calibration Excellence Emerson Beamex background GSK Cork & Project Requirements Project Challenges Results & Next Steps
GSK CorkGSK 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
Cork OverviewCork Overview
Cork ProjectCork 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
ChallengesLegacy Calibration system and Data Migration
ChallengesLegacy 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
Development of a calibration solution for GSKDevelopment of a calibration solution for GSK
Introduction - GSK, ‘Agile’ & Calibration Excellence Emerson Beamex background GSK Cork & Project Requirements Project Challenges Results & Next Steps
ChallengesLegacy Automation Architecture i.e. Remote I/O
ChallengesLegacy Automation Architecture i.e. Remote I/O
Architecture
Component ConnectionsComponent Connections
Launch in context from DeltaVLaunch in context from DeltaV
ChallengesPeople Inertia / Reluctance to Change
ChallengesPeople 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
ChallengesValidation Challenge
ChallengesValidation 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
Development of a calibration solution for GSKDevelopment of a calibration solution for GSK
Introduction - GSK, ‘Agile’ & Calibration Excellence Emerson Beamex background GSK Cork & Project Requirements Project Challenges Results & Next Steps
Compliance /Engineering BenefitsCompliance /Engineering BenefitsSimplified calibration
Workflow
Proper analysis of historical calibration data
Predicative maintenanceof Instruments
Automated documentingof Instruments parameters
Elimination of transcriptionerrors
Live instrument alerts
Continuous monitoring ofInstrument diagnostics
Full Instrument audit trail
Full calibration audit trail
Increased Compliancealigning with CFR21 11
Aligning with NPGS startegy
Elimination of papermanagement
Easier Audit Preparation
Reduction in number of non value added hoursPaperless Calibration
Data Analysis
Instrument Monitoring
Increased Plant Uptime
Workflow ComparisonWorkflow Comparison
Work OrderIssued by SAP
Lead Craftreviews
Workorder andIssues to Craft
Craft PrintsCOMPUCAL
Sheet
Craft retrievesCAL equipmentand Proceeds to
Plant
Craft performs 5point calibration
Craft TranscribesData to
COMPUCALSheet
Craft passescompleted Compucal
sheet toOffice Admin
TranscriptionErrors
Out ofTolerence
Errors
Admin Closes outCOMPUCAL Data
Entry
Lead CraftApproves
Compucal Sheet
Lead Craft ClosesCOMPUCAL Loop
Admin FilesCOMPUCAL
Sheet as MasterPrimary Record
CalibrationPassed
Craft Issues PASS/FAIL Status onSAP Workorder
Lead Craft ClosesSAP Workorder
Office AdminEnters Data into
COMPUCAL
Work Order Issuedby SAP
Lead Craft reviewsWorkorder andIssues to Craft
CRAFT UploadsCAL DATA to
Handheld
Craft retrieves CALequipment and
Proceeds to Plant
Craft performs 5point calibration
Craft Enters CALData via Handheld
or Delta VWorkstation
CalibrationPassed
Craft Issues PASS /FAIL Status on SAP
Workorder
Lead Craft ApprovesPaperless CAL
Sheet via DigitalSignature
Lead Craft ClosesSAP Workorder
Previous State Cork Current State
SAP step
Compucal to be removed
Calibration Step
AMS Step new ways of work
Overall Calibration process reduced from 17 Steps to 10
Removed 2 steps with risk of Human data entry Error
Emerson/Beamex consultancy workshops helped review the
existing processes, and optimise and refine the new
processes to leverage technology
System’s flexibility used to manage workflow as well as
primary function of managing calibrations.
Business Results AchievedBusiness 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.
Next StepsNext 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
Q & AQ & A
?
Thank You
Where To Get More InformationWhere 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
Calibration ExcellenceCalibration Excellence
Intelligent Application of Smart Technology is Just the Medicine for Improving Business Results at GSK
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