Manufacturing quality evaluation is a critical discipline that focuses on assessing a process’s ability to produce outputs within pre‐defined tolerance limits. Recent advances combine traditional ...

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data. The principles of quality by design (QbD) and life cycle management, as outlined in ...

Process capability indices (PCIs) have long served as crucial metrics in assessing the performance and quality of manufacturing processes. Recent advances in statistical estimation techniques have not ...

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient ...