Genentech Error Proofs Its Batch Records.pdf - Juran Institute

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DOCUMENTATIONDOCUMENTATIONtions mean they have to be controlled.A decision by Genentech’s senior managementto error proof such documentation resulted in theachievement of sustainable breakthrough improvementsthrough the focused deployment of SixSigma and lean project teams.LaunchThe error proofing project was chartered inSeptember 2003 by the good manufacturing practicescore team at Genentech. The objective of theproject was to reduce the inspection risk associatedwith document errors and lost tickets. This objectivewas expressed as the following dual goal:• Goal one—Reduce the rate of documenterrors recorded in the discrepancy managementsystem by 50% relative to the first andsecond quarter 2003 baseline by September2004. Maintain the document error rate withinthis new zone of control: less than five documenterrors per 100 tickets (main batch recorddocuments) for three months or more.• Goal two—Reduce the overall volume of masterticket errors by 50% relative to the first andsecond quarter 2003 baseline.Six error proofing teams were chartered in October2003 to investigate the drivers for this pattern of errorand variability. Consultants working with the teamsasked them to use one or more of the followingindustry standard methodologies:• DMAIC (define, measure, analyze, improve andcontrol), which is intended to analyze and diagnosethe root causes of the problem, developand implement remedies and hold the gains—as Joseph Juran would put it—to achieve breakthroughresults that are sustainable.FIGURE 1Document Error Rate20.0018.00Discrepancies per 100 ticketsJan. 2003 to Feb. 2005 with change in processUCL = 18.1116.00Number of discrepancies14.0012.0010.008.00Mean = 9.87Process change:reduced variationand mean6.00UCL = 5.244.002.00Mean = 3.74LCL = 2.25LCL = 1.640.00Jan.Feb.MarchAprilMayJuneJulyAug.Sept.Oct.Nov.Dec.Jan.Feb.MarchAprilMayJuneJulyAug.Sep.Oct.Nov.Dec.Jan.Feb.Errors/100 ticketsEvent codes e1.1, e1.2 and e1.3 per 100 tickets stamped complete in production operations management system per month, January 2003 through November 2004.UCL = upper control limit. LCL = lower control limit.26 IJULY 2005 Iwww.asq.org
FIGURE 2Master Ticket Errors Per Month1009080706050Average: 49master ticketerrors403020Average: 10master ticketerrors100Feb.MarchAprilMayJuneJulyAug.Sept.Oct.Nov.Dec.Jan.Feb.MarchAprilMayJuneJulyAug.Sept.Oct.Nov.Dec.Jan.Feb.MarchAprilMayJuneJuly2002 20032004• DMADV (define, measure, analyze, designand verify), which is intended to guide a teamin the development and deployment of a newsystem or process that will prove capable ofreliably meeting the prioritized needs of customers—internaland external, as appropriate.• Lean/value stream mapping (VSM): a leanmanufacturing technique designed to achieveerror free operations through cycle time compressionand simplification. This approach ischaracterized by a team’s decomposing aprocess through VSM, followed by quickanalyses and brainstorming and rapid implementationof improvements.The wave one teams were chartered so theirimplementations would begin in March 2004 anddeliver measurable document error rate reductionsby June 2004.The six projects were:1. Timely feedback using DMAIC.2. Change to volume and timing using DMAIC.3. VSM in growth hormone and recovery operationsusing lean/VSM.4. Document rule clarification using DMAIC.5. Document development using DMADV.6. Document complexity using DMADV.Breakthrough ResultsAnd New Control ZoneAs illustrated in Figure 1, the teams achievedthe first goal in May of 2004, and document errorshave been held within the new zone of controlever since.The teams achieved the second goal almostimmediately, and the incidence of master ticketerrors has not returned to first and second quarter2003 levels since the project began (see Figure 2).Heightened awareness, improved visibility andcontrol over the document development processwere recently formalized into an improved managementsystem through the efforts of the documentdevelopment team.QUALITY PROGRESS IJULY 2005 I 27
Page 4 and 5: DOCUMENTATIONKey FindingsThe key fi
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Genentech Error Proofs Its Batch Records.pdf - Juran Institute

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