Repeatability means the ability to produce parts that have identical properties. As with other manufacturing processes, this capability is very important in injection molding because it has a crucial ...

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 ...

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

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 ...

When developing medical device products and the parts that comprise them, engineers must usually decide what elements of the design are critical to function and, therefore, what dimensions require ...

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 ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...