Genentech Error Proofs Its Batch Records

Abstract:Like other firms subject to Food and Drug Administration (FDA) regulation, Genentech must provide complete and accurate documentation of processes. In September 2003 an error-proofing project was launched by the good manufacturing practices core team at the biotech firm to reduce the inspection risk associated with document errors and lost tickets. The goal for the project was to achieve a sustainable 50 percent reduction in errors. Coupled with the right management priority and commitment, Six Sigma and lean tools enabled the error proofing teams to identify the drivers of error and variability and achieve sustainable breakthrough …

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