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 ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

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 ...