Glaxosmithkline, Beamex, and Emerson Team up to Streamline

field CALIBRATORS

Search for the Asset Management Holy GrailPart 2 GlaxoSmithKline, Beamex and Emerson Process Management team up to streamline calibration and asset software — and use far less paper—at GSK’s plant in Cork, Ireland.

by Jim Montague

Calibrating one device isn’t so hard. Doing a few “We used to have a mostly paper-based calibration hundred or a few thousand is tougher. But, cali- process. Forms were filled in by the technicians, and brating all of them in a large pharmaceutical plant, then data was entered manually by the administrators. It which is governed by the U.S. Food and Drug Ad- was very static system,” says Don Brady, GSK Cork’s au- ministration’s CFR 21 Part 11 regulations, is a whole tomation engineer. “So, in the first quarter of 2009, we different ballgame of required validations, certifica- launched our Primary Supply Agile Engineering team, tions—and documentations. and they confirmed our calibration cost problem, and To streamline this traditionally difficult process, assigned us to identify ways to reduce these expenses.” GlaxoSmithKline’s (GSK) plant in Cork, Ireland, GSK is a research-based pharmaceutical firm with recently replaced its legacy, mostly manual calibra- about a 5% share of the world’s pharmaceutical market. tion method with a combined software solution, It employs 96,500 people in more than 100 nations, in- including Asset Management Suite (AMS) DM cluding 13,000 in R&D. Its prescription medicines treat and CMX Professional. The new system has been infections, depression, skin conditions, asthma, heart up and running at GSK Cork for about one year, and circulatory disease, cancer and other conditions, though its calibration application usually runs in and its consumer brands include Alli, Ribena, Horlicks, manual rather than automatic. Lucozade, Aquafresh, Sensodyne, Panadol and Tums. field CALIBRATORS Of ine devices AMS device manager

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CMX connector AMS device AMS connector manager CMX calibration software Catch Some Data, Throw It Back Figure 1: Calibration data at GSK Cork collected by AMS DM software; transferred to portable MC5 calibrators and CMX software for analysis, verification and sign off; and then sent back to AMS for documentation and certification. This streamlined process can save users hundreds of hours compared to traditional calibration and validation procedures. Linking Software Speeds Up Data Exchange tion with help from CMX Connection and greatly re- To assist GSK Cork and their other pharmaceuti- duce calibration times.” Brady and Barnes presented cal end users, Emerson Process Management (www. “Calibraton Excellence” and a separate live demon- emersonprocess.com) and Beamex (www.beamex. stration of the new AMS DM and CMX tool last Oc- com) recently developed an innovative method for tober at the 2011 Emerson Global Users Exchange in linking Emerson’s AMS Device Manager (DM) Nashville, Tenn. software with Beamex’s MC5 portable calibrators Because of its cooperation with Emerson and Bea- and CMX Professional calibration management mex, GSK Cork’s calibration improvement project fo- software. Basically, this technical partnership al- cused on three areas: lows calibration data to be collected by AMS DM; • Instrument diagnostics—including shifting cali- transferred to MC5 and CMX for analysis, verifica- brations of non-critical instruments from “on tion and sign off; and then sent back to AMS for schedule” to “on demand,” and relying on smarter documentation and certification. This streamlined diagnostics from instruments; process can save users hundreds of hours compared • Paperless calibration—to help shorten calibra- to traditional calibration and validation procedures. tion time and eliminate non-calibration sup- This data transfer also is aided by Beamex’s CMX port functions, such as document manage- Connection software (Figure 1). ment, manual approvals and correction of “Emerson recognized that our existing DM tools transcription errors; and strategies might not be enough for users in the • Calibration analysis—to examine historical more regulated process industries,” says Richard data and help recommend interval extensions Barnes, Emerson’s plant asset management and asset between caibrations, so long as existing data optimization consultant. “As a result, we integrated shows that previous calibrations met stringent AMS DM and CMX, so they can exchange informa- corporate policy. field CALIBRATORS

“We’re trying to achieve calibration efficiencies • Conduct Emerson and Beamex consulting work- by using condition monitoring to reduce our total shops to review existing processes and optimize number of calibrations and then performing the re- and refine the new processes to use improved maining calibrations in a timely and efficient man- technologies; ner,” explains Brady. “This means synchronizing in- • Use the new system’s flexibility to manage work- strument data between the calibration management flow in addition to carrying out its primary func- system and the asset management system; using tion of managing calibrations. documenting calibrators; optimizing scheduling of For instance, its integrated asset management and planned periodic calibrations; and removing paper calibration solution has allowed GSK Cork’s staff to from the calibration process.” obtain history reports and identify adverse trends Beady added that GSK Cork is an highly auto- so they can reduce calibration frequency without mated manufacturing facility and serves as the pri- hindering production or quality. In fact, CMX also mary production site for several of GSK’s best-selling helped find more than 100 hours of savings in its products. The plant employs more than 300 people first three months of operation. Also, one-third of and contains about 4000 instruments, including lower-criticality instruments, which aren’t directly mostly HART and Foundation fieldbus devices, related to quality or regulatory requirements, were which were installed over the last 12 years. The vast moved from scheduled calibration to calibration on majority of these instruments are connected to one demand. This means an instrument’s own self-diag- of the plant’s six Delta V systems, which employ nostics can trigger a work order for calibration. GSK classic I/O, remote I/O or Foundation fieldbus I/O. Cork reports this method has saved about 300 hours “Besides being required to have CFR 21 Part per year. 11-compliant signatures for data entry and approvals, “We’ve also eliminated 21,000 sheets of paper per we also had to monitor 1100 smart-instrument diag- year,” adds Brady. “And we streamlined our end-to- nostics, develop an audit trail for 1100 changes to that end workflow, which reduced our calibration time smart instrumentation, and electronically document by about 15 minutes per calibration. We’ve also our smart-instrument configurations,” adds Brady. eliminated calculation errors and rework because “We also had full participation from staffers, who did pass/fail calculations are performed in real time training and learned how beneficial the new calibra- out in the plant. In addition, we reduced sched- tion system was going to be. Our craft supervisors uled calibrations by 8%, which was part of the data and technicians were included in the project from migration from legacy system. We’re also gener- day one, so there were no operational surprises by the ating email alerts when a calibration failure hap- time we reached the go-live date.” pens, but now only calibration failures need to be Calibration, Asset Integration Yields Big Benefits reviewed and approved. Finally, we’ve been able to Brady reports that GSK Cork’s calibration improve- extend some intervals between calibrations, which ment project, including using the combined AMS are recommended by the devices and system in the DM and CMX, helped the plant to: form of email alerts. So far, we removed 234 cali- • Reduce the steps in its overall calibration process brations from our schedule during first 12 months from 17 steps to 10 steps; of analysis, and this should peak during the third year of operation.” • Remove two steps that each posed risks of human data-entry errors; Jim Montague is Control’s executive editor