Six Sigma: Beyond Numbers

Recently, I had an engaging conversation with a group of regulatory professionals about Six Sigma. This discussion brought to light a key benefit of this methodology. In project teams, we often start with certain assumptions. But, we gain valuable insights when we involve hands-on operators and technicians, letting them share their perspectives.

I shared an example from a cleaning validation project. We encountered a critical factor that the project team hadn't initially considered. The equipment we were validating was used to make products examined under microscopes. Any residue left on the process equipment could interfere with these products, even at very small particle sizes.

During our risk analysis, we identified the water temperature used in cleaning as crucial. It was important for dissolving tiny particles. However, the day-to-day workers pointed out that the water wasn't always hot at the point of use. This insight led us to modify the cleaning procedure, adding a flush and temperature check. Without this change, undissolved particles might have compromised the cleaning validation.

Six Sigma is often praised for its statistical applications. Yet, in my experience, it's also incredibly practical. Even before we dive into data collection and analysis, it provides a structured framework for discussions. These discussions can reveal straightforward opportunities for improvement.

Discover how Six Sigma transcends mere data. Join the conversation on LinkedIn and Facebook and share how it's shaped your projects. Let's explore its broader impact together.