Lean

The real test of a quality system isn’t what happens when everything works. It’s what happens when something doesn’t.

Recently, two of my cameras failed. They were newer versions of models whose older predecessors still worked, so I contacted the manufacturer to report the problem…

Poor quality rarely announces itself as a single, contained problem. In manufacturing environments, it may first appear as a rejected batch, a scrapped component, an unexpected line stoppage, or a customer complaint that requires investigation. These visible failures matter, and most…

Recent cyberattacks highlight the growing threat to operational technology (OT) used in critical infrastructure. Whether you work for an infrastructure owner/operator or are a consumer of an infrastructure service, recent events have made it clear that cybersecurity is an important factor in…

Quality management system software helps life sciences organizations manage documents, training, quality events, change controls, audits, and other regulated processes in one controlled environment.

Most electronic quality management systems (eQMS) offer some version of these core…

In my last post, I reflected on a couple of different whys to interrogate a process—either to solve a problem or to create a process improvement. Here are a few more contextual uses of the question “Why?” that I’ve found very helpful as a manager and improvement leader.

A sound that’s slightly off before a bearing fails. A smell that shows up before a chemical reaction runs hot. A texture that feels wrong before any instrument confirms it. Frontline workers pick up on signals like these constantly and, most of the time, nothing in the plant is built to capture…