An Introduction To Operational Excellence In The Life Sciences

By Richard Tree

Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is not only to startup as soon as possible once the project is completed, but also to achieve steady state throughput as quickly as possible after the startup begins. This type of startup is called a “Vertical Startup.”

In practice, vertical startups are rare because management teams typically focus their attention on having the facility and the equipment qualified in time to meet the process qualification milestone. As a consequence, a broad range of workstreams are often neglected or receive inadequate attention even though they are critical to startup.

The first step of a vertical startup requires management teams to transition their focus from a process qualification milestone to an operational readiness milestone. Once this happens, operations departments can achieve a vertical startup by applying the principles of operational readiness, a proven methodology used across the spectrum of manufacturing industries. It is a proven methodology, central to the practice of technology transfer. Despite its importance, operational readiness is often not fully understood, incorrectly applied, or confused with the principles of operational excellence.

Gain a better understanding of vertical startups, operational excellence, and operational readiness, the organizational state that must be reached in order for vertical startups to exist.