Genentech Error Proofs Its Batch Records.pdf - Juran Institute

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DOCUMENTATIONKey FindingsThe key findings and their associatedimplementations include the following:•More timely feedback.•Better timing of changes.•Reduced change volume.•Different ink color.•Centralized equipment log locationand other rapid improvements.•Reduction of documentation ruleconfusion.•Central coordination for documentchanges and other actions todecrease word processing errors.• Less complex documents.• Improvements to other factors.More timely feedback. Based oninterviews across all shifts, the projectteam concluded the timing and utilityof feedback provided varied acrossproduction teams. In particular, theproject team found a mechanism fortimely feedback was present only incertain instances.The team set out to correlate thepresence or absence of timely feedbackto document error rates. Table 2shows the correlation.Teams with timely feedback performed50% better than those withincomplete or delayed feedback (seeFigure 3).As predicted by the team, the documenterror rate took its first significantshift toward a new zone of control inApril 2004, immediately after the timelyfeedback mechanisms were introduced.Better timing of changes. The changevolume and timing project team—workingon a DMAIC project—set out toinvestigate the relationship betweendocument effective and release dateswith regard to errors per document.By correlating the interval betweenrelease and effective dates to the documenterrors recorded per execution ofthe ticket, the team was able to show10FIGURE 39876543210TABLE 2Master Ticket Errors Per MonthAverage for poor performers(groups without timely feedback)Chi-Square Test Showing CorrelationBetween Timely Feedback and DocumentError RatesExpected counts are printed below observed counts.Chi-square contributions are printed below expected counts.< One weekFeedback S 0 Feedback S Total1 25 19 4420.20 23.801.138 0.9672 20 34 5424.80 29.200.928 0.788Total 45 53 98Chi-square = 3.820; delayed feedback = 1; P-value = 0.051.There is a statistical relationship of dependence between the lack of feedbackand the groups identified as high and low performers (on document errors).Feedback S = timely feedback provided (< one week).0 Feedback S = no timely feedback or feedback provided.Close the gapCombined groups50%Average for high performers(groups with timely feedback)28 IJULY 2005 Iwww.asq.org
FIGURE 4Count discrepancies per weekthe documents madeeffective within three daysof their release dates carrieda disproportionatenumber of error discrepancies(see Figure 4).Because 45.7% of ticketshad less than two daysbetween release and effectivedates, these documentsrepresented a significantdriver of document errorson the floor. As the teaminvestigated further, theyconfirmed one- to threedayintervals did not permitmeaningful documenttraining to take placeacross shifts.Currently, the centralizeddocument managementfunction created inresponse to recommendationsfrom this team (andthe document developmentand complexityteams) uses the release toeffective date interval as aleading indicator of documenterror generation. We can expect the documenterror rate to remain low as long as we enforcethe minimum interval.Reduced change volume. Another driver of documenterrors confirmed by the change volume andtiming team was the number of times a documentgets changed in a year. More than 1,440 ticketchanges were initiated by Genentech’s South SanFrancisco (SSF) manufacturing facility—the company’smain operation—in 2003. By comparing thediscrepancy rates recorded for documents changedmore than three times in a year to those changedless often, the team confirmed frequent revisionsdrove errors (see Table 3 and Figure 5, p. 30).The team proposed enforcement of a mechanismto pull documents with more than three changesper year, coupled with a system to make revisionsmore visible. The team remained convinced thesemeasures would yield further document errorreduction benefits.706050403020100-10-201Relationship of Time Between ReleaseAnd Effective Dates and DiscrepanciesFitted line plotCount discrepancies per week = 50.57 – 5.229 averagetime between release and effective dates234Average time between release and effectivedates for documents and discrepancies56Different ink color. The lean/VSM team ingrowth hormone recovery operations generated alist of error proofing implementation ideas duringits rapid improvement phase. One of the ideas withevident universal utility grew out of an analysis ofthe factors that contribute to omission errors.The team noted when entries were made in blackink on batch records, forms and logs printed inblack ink, it could be hard to see where an entry thatwas required might be missing. The team proposedswitching to blue ink in an attempt to enhance thecontrast between entries made and printed text.After the details were negotiated with SSF qualityassurance and compliance, the necessary SOPchanges were made to permit the use of blue inkwithout requiring it. A memo was circulatedexplaining the rationale for the change and askingmanagers to enforce the consistent use of blue ink.The blue ink initiative was implemented inMarch 2004, just as the omission error rate droppedbelow five for the first time. Manufacturing online78Regression95% confidence interval95% prediction intervalS 13.1169R-square 30.7%R-square (adjusted) 28.2%QUALITY PROGRESS IJULY 2005 I 29
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