Module Overview

Stakeholders in the Pharmaceutical Industries have repeatedly emphasised the need for graduate attributes such as an understanding and ability to apply Quality Systems. Of the many Quality Systems that have been developed the most successful and widely adopted in the Pharmaceutical Industry have been Lean Manufacturing Systems and Six Sigma. Lean is concerned with the elimination of waste of any kind including defects requiring rework, unnecessary processing, movement of materials, people, time-wasting, excess inventory and overproduction. It involves identifying and removing such issues and is facilitated by a focus on measurement and continuous improvement. Six Sigma is a customer-focused and results-orientated quality system that contains many quality improvement tools and methods that utilise a systematic approach to Define, Measure, and Analyse, Improve and Control (DMAIC) non-conformities and defects. Recently, Lean tools have been combined with the Six Sigma tools to address not just problems of quality but other factors such as cost reduction and efficiency. Application of such systems require an operation-wide involvement of staff. Many staff are trained as yellow-belt (familiar with the concepts), green-belts (key members of design and implementation teams) but working under the direction of a black-belt who designs and directs the overall Lean Six Sigma approach. It is anticipated that this module will provide students with the knowledge at the level of green-belt and that if the opportunity arises in industry that they may do further training to apply for validation as a greenbelt.