Standards
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…
A safe work environment will foster productivity, reduce hazards, and enhance overall work morale. Keeping your team and assets safe requires implementing the right policies, medical necessities, vigilant oversight, ongoing assessments, and proper training.
As the COO of DUSAW,…
The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection…
