German Regulators Pull Pharmaceutical Manufacturing License for Bad Root Cause Analysis
How can bad root cause analysis get a pharmaceutical manufacturer in trouble? Read this article:
See the regulator’s report here:
The first step to using advanced root cause analysis is to get your people trained. But AFTER the training, management must ensure that the system is being used, the results are being documented, and the corrective actions are getting implemented.
What does management need to know about root cause analysis? They should know at least as much as the investigators and they need to know what their role is in the root cause analysis process. That’s why we wrote the new book:
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