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 ...

Performance metrics for processes are an area of much regulatory interest currently. There isn’t always a readily available clear definition of what is needed, however, and guidance from regulators is ...

This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...

Quality costs may consume 25% of total revenues in manufacturing businesses, mostly from rework, scrap, warranty, product-liability claims, and recalls. The Six Sigma quality initiative helps ...