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 ...

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 ...

SAS/QC software provides one procedure for the analysis of process capability. The CAPABILITY procedure compares the distribution of output from an in-control process to the specification limits of ...

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 ...

While healthcare systems universally complete an HVA, a CMS requirement, the HVA alone does not define what the system must be able to do. FEMA’s Threat and Hazard Identification and Risk Assessment ...

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 ...