Realizing Continuous Improvement in Pharmaceutical Technical Operations - Business Process Model in Roche's Parenterals Production Kaiseraugst

Abstract We present a framework of continuous process improvement which has been established in Roche's new Parenterals production Kaiseraugst in Switzerland. Normally in manufacturing industry, continuous improvement is done by selected experts in a top-down manner using analytical methods, e.g. Six Sigma. In addition to this conventional approach, our framework includes a unique bottom-up activity where all facility staffs are engaged in identifying improvement opportunities and executing projects. Roles and rights of different stakeholders in a project are defined as a communication procedure, for standardized deployment of multiple projects in the organization. Our approach has enabled an organizational transformation already during the facility start-up, and can be applied in other pharmaceutical production.