Lean Management : how to reduce the number of deviations in the Packaging Department of GSK Vaccines

Details

Supervisors

Semal, Pierre

Faculty

Louvain School of Management

Degree label

Master [120] en Ingénieur de gestion

Abstract

This thesis is based on a case study made in the Packaging Department of GlaxoSmithKline Vaccine (GSK). After performing a global quality audit, the Food and Drug Administration (FDA) has required GSK to reduce the number of deviations in its Packaging Department. In order to do that, GSK has decided to use the Mini-T (Mini-Transformation) approach, which is the McKinsey & Company methodology for Lean Management. From January to April 2015, several employees of the Packaging Department and Lean management experts have worked together on a project with the goal to reduce the number of deviations in the Packaging Department, focussing mostly on the deviations caused by human errors. Such deviation represents any action realized by an operator that is not specified or different from the procedures in the documentation. I joined this team as an intern responsible for a part of the project. The structure of this thesis will first cover the quality improvement theory and than follow the one of a Mini-T project. It will consist in first analyzing the current situation to identify potential room for improvement, then to create a solution tailored to the needs of the business, to finally implement the designed solution. During the Diagnostic phase of this project, we will analyze the root causes of the deviations and come to the conclusion that the quality of the department can be improved on four main areas: the documentation structure, the documentation revision process, employee’s training efficiency and human factor. We will work on these four areas in order to improve the general structure of the Packaging Department, and in fine, reduce the number of deviations. This thesis provides a critical opinion on the current documentation structure of the Packaging Department of GSK Vaccines and bring a new perspective to its documentation review process, its trainings and the human factor. It will also develop a framework to prevent complexity to arise again in the future. Furthermore, It demonstrates the importance of documentation in a production environment and also define best practices to apply in the future.