Most investigations rush toward a conclusion before establishing what actually happened, in order. Here's why building the timeline first changes everything that follows.

A few years ago, at a large global biopharmaceutical company, a piece of critical equipment was validated without the sample valves needed for product testing and release. Multiple functional groups had been involved. Subject matter experts had reviewed the work. Everyone was trying to do it right. And the error still happened. That event became the catalyst for a Human and Organizational Performance implementation we led at the company. We tested new investigation methods, n

Most organizations don't set out to run bad investigations. The people doing the work are capable, experienced, and trying their best. They follow the process, complete the documentation, close the records on time. And yet the same problems keep coming back. If that sounds familiar, the issue probably isn't your investigators. It's the methodology they've been given to work with. Here are five signs that your investigation program has a methodology problem — and what they usu

The phrase "learning-focused investigation" gets used a lot in quality and safety circles. But what does it actually mean in practice? And how does a learning-focused investigation look different from a traditional one? The answer isn't just about process steps or documentation templates. It's about a fundamentally different set of assumptions regarding why events happen, how people work, and what organizations can actually do to prevent recurrence. Starting with a Different

If you've been investigating workplace events for any length of time, you've seen it happen. Someone makes an error. A deviation occurs. The investigation team digs in, asks why it happened, and eventually lands on a conclusion that sounds something like this: "The operator failed to follow the procedure." Or: "Human error during the filling process." The CAPA gets written. Retraining gets assigned. The deviation record closes on time. And six months later, a nearly identical