Calibration Excellence: Intelligent Application of Smart Technology is Just the Medicine for...

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

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

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

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

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

Calibration Excellence: Intelligent Application of Smart Technology is Just the Medicine for...

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