ABSTRACT
The most common driver for pharmaceutical companies to adopt Lean is to improve the overall manufacturing efficiency. However, for Lean to be effective in a GMP environment it is essential to frame the problem and success metrics in both business and compliance terms. One of the most attractive elements of Lean is the ability to rapidly realize focused improvement without having to commit long-term resources which is often the case in Six Sigma projects. The project was managed by a technical project manager within the OpEx group. The structure of the project team is a key component to how quickly and effectively it is possible to move through the LSS exercise. The Rapid Changeover Exercise (RCE) is called Quick Changeover, Machine Changeover, Single Minute Exchange of Dies (SMED), and One Minute Exchanges of Dies (OMED). The focus was the heat-sealing process. The Critical Process Parameters (CPP) determined during the old validation was identified as pressure, dwell time, and temperature.
