Jason J. Orloff presents "Metrics: The Balance of Performance & Compliance."

Wave after wave of quality initiatives have come from other industries and failed to take root. This could be because Pharmaceutical Quality Culture is unlike any other industrial culture. Certainly our risk profile of medium volumes, high costs, and high risks are radically different from the high volumes, low risk, low costs of cell phones, cars, and computer chips. Pharmaceutical Quality Culture is a dynamic, self-correcting system that represents both compliance and performance. A maximally efficient, agile, flexible, pharmaceutical manufacturing sector could be achieved with minimal regulatory oversight by formalizing the systems of performance and ensuring that the balance of compliance and performance is maintained. Process capability measured in %OOS is one such metric where compliance with specifications is weighed against the performance of the process. But where does process capability itself belong: As a compliance reportable? Or as a self-audit of performance done by manufacturing for senior management to prioritize continuous improvement?

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