Lean Six Sigma (LSS) is a methodology that is often used in various industries acting as a tool for reducing waste, enhancing efficiency and creating a friendly and effective environment for the customers. This is a team-centric approach to increase the profitability of the business.

LSS is a combination of Lean Technique and Six sigma method which are used separately to improve business efficiency. While the Six Sigma method focuses on identifying and resolving variations in a process, the lean techniques focus on eliminating the waste generated in the process. The major principle behind this methodology is based upon five phases that are:

1. Define phase: Define the problems and variables in a project
2. Measure phase: Determining the flow of the process
3. Analyze phase: Analysing the key problems and variables
4. Improve phase: Suggest solutions and remedies
5. Control phase: Supervising the solutions and remedies until stability is achieved

Various tools and techniques are employed in LSS, some of which are given below:

1. Visual analysis: Pareto chart, Scatter diagram, Box plots, etc.
2. Statistical analysis: Inferential statistics, ANOVA, the test of proportion, Chi-Square test, etc.
3. Process analysis: Data boxes, TAKT time, Value Stream map, etc.

Every organization following the LSS methodology is divided according to the colored belts also known as LSS belts – Yellow belt, Green belt, Black belt and the Master belt. The Yellow belt generally includes people who are subject matter experts. They collect the data and interpret the results, utilizing a combination of problem-solving tools and techniques. The Green belt, on the other hand, consists of people who are project leaders and are experts in the LSS methodology. Their primary function is to supervise the yellow belt holders and determine the tools and techniques to be used. The black belt holders are the leaders who identify problems in the system and lead the team, additionally providing coaching to new members of the team in the LSS principles. The Master belt holder is the apex member of the organization who is not involved in the projects but is responsible for the overall management of the system, creating a portfolio for the projects, and division of roles and responsibilities.

Implementing the LSS methodology can be an essential tool for the pharmaceutical industry. For instance, it can identify and eliminate wastage in the drug development process. This would lead to an increase in speed and efficiency. LSS methodology can be a crucial tool in Quality control, identifying leaks in the process and thereby strengthening the process. It can be applicable in processes such as clinical trials, drug discovery processes, regulatory processes, etc. It benefits doctors, pharmacists, patients, and healthcare workers by providing quality service and cost.

Lean Six Sigma methodology is a tool to not only improve quality but also to enhance the performance of the process. However, the major challenge lies in successfully integrating the principles of the LSS into the pharma process since the latter is a complex process and it requires a flexible approach.