2005 07 Genentech Error Proofs Its Batch Records Chua 2

DOCUMENTATION

Genentech Error Proofs Its Batch Records
by Robert Bottome and Richard Chua

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n Food and Drug Administration (FDA) regulated manufacturing environments, such as those in the life sciences, biotech and pharmaceutical industries, complete and accurate documentation of processes and the completion of process steps are critical.

Documentation, however, is prone to avariety of human errors: slips, lapses, mistakes and violations (see Table 1 for a few characteristic examples). Even though these are common problems across these industries and the majority of document errors do not impact product quality, FDA regula-

In 50 Words Or Less
• Genentech, a biotechnology firm regulated by the Food and Drug Administration, chartered an error proofing project. • Thegoal was to reduce the rate of errors by 50% and maintain the new rate for three months or more. • Six Sigma and lean tools led to sustainable breakthrough improvements.

TABLE 1

Document Errors Caught During Batch Record Review
Description • Forgot to record storage location, time and transfer after moving product from cold room. • Forgot to make required entry on one of three equipment uselogs tied to transfer lines and tanks. • Forgot to enter information just entered on ticket on a use log.

Type of error Attention lapse

Slip

• Transposed lot number. • Forgot to initial and date a page as reviewed for completeness.

Rule based mistake • Incorrectly excluded entry as not applicable.

QUALITY PROGRESS

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tions meanthey have to be controlled. A decision by Genentech’s senior management to error proof such documentation resulted in the achievement of sustainable breakthrough improvements through the focused deployment of Six Sigma and lean project teams.

Launch
The error proofing project was chartered in September 2003 by the good manufacturing practices core team at Genentech. The objective of the projectwas to reduce the inspection risk associated with document errors and lost tickets. This objective was expressed as the following dual goal: • Goal one—Reduce the rate of document errors recorded in the discrepancy management system by 50% relative to the first and second quarter 2003 baseline by September

2004. Maintain the document error rate within this new zone of control: less than fivedocument errors per 100 tickets (main batch record documents) for three months or more. • Goal two—Reduce the overall volume of master ticket errors by 50% relative to the first and second quarter 2003 baseline. Six error proofing teams were chartered in October 2003 to investigate the drivers for this pattern of error and variability. Consultants working with the teams asked them to use one ormore of the following industry standard methodologies: • DMAIC (define, measure, analyze, improve and control), which is intended to analyze and diagnose the root causes of the problem, develop and implement remedies and hold the gains— as Joseph Juran would put it—to achieve breakthrough results that are sustainable.

FIGURE 1

Document Error Rate
Discrepancies per 100 tickets Jan. 2003 toFeb. 2005 with change in process

20.00 18.00 16.00 UCL = 18.11

Number of discrepancies

14.00 12.00 10.00 8.00 6.00 UCL = 5.24 4.00 2.00 0.00
ch t. ch ne ne ril ril g. c. ay ay p.

Process change: reduced variation and mean Mean = 9.87

Mean = 3.74 LCL = 2.25 LCL = 1.64

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Errors/100 tickets

Event 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.
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