Using Process Capability to Enhance Product Quality(PPT)

摘要

1. Patient first: clinical relevant specification based on safety and efficacy 2. Consider not only process mean & variability but also in relation to the specification 3. Process capability index (Cpk): in control and capable 4. Quantitative and action enabling 5. Applicable for cross sectors (brand, generic, OTC and biotech) 6. No additional testing is required since batch release data is available per current regulation 7. A valuable tool to transform from the reactive trouble shooting paradigm to a proactive failure reduction or prevention paradigm.