Standards
Hawthorne High School of Manufacturing & Engineering in Los Angeles is not your typical high school program. Led by program coordinator Lucas Pacheco, it’s a hub where young minds are immersed in advanced manufacturing and engineering design courses. With a hands-on curriculum covering multi…
Dr. Donald J. Wheeler has been one of Quality Digest’s most highly read authors for decades. His teaching on the use of control charts in industrial settings has long been considered the gold standard. He has conducted more than 1,100 seminars in 17 countries on six continents, and his books…
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it…
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1…
Quality control (QC) teams need reliable results they can trust to make informed decisions and address manufacturing challenges. This is why they rely on the coordinate measuring machines (CMMs). However, a CMM’s speed is often a limitation, making the idea that routine quality control can be…
