Six Sigma

Six Sigma is a methodology for quality improvement based on reducing defects and process variation. 

Six Sigma was initially implemented by Motorola and has become a popular management and process improvement strategy. The successful adoption of Six Sigma methodology by Jack Welch at General Electric has instilled a strong sense of Six Sigma philosophy across many industries. In statistical terms, Six Sigma refers to the the study of process capability, a Six Sigma process has less than 3.4 DPMO (defects per million orders) and there are six standard deviations between the mean and the nearest specification limit (upper or lower specification limit).

Six Sigma Methodology

Six Sigma has a strong emphasis on statistical analyses, metrics and the DMAIC approach to problem solving: define, measure, analyze, improve, and control. DMAIC is central to any process improvement intitative. 

The ASQ definitions of DMAIC

• Define the problem, improvement activity, opportunity for improvement, the project goals, and customer (internal and external) requirements.

• Measure process performance.

• Analyze the process to determine root causes of variation, poor performance (defects).

• Improve process performance by addressing and eliminating the root causes.

• Control the improved process and future process performance. 

Six Sigma and lean philosophy are contiguous, both strive towards quality and process improvement with similar strategies. Six Sigma utilises empirical measures and statistical analyses to detect and eliminate defects and process variation. Lean is primarily focused on waste minimisation and value. Both systems operate in synergy for maximum efficiency, productivity and quality improvement.

Implementing a Lean Six Sigma Project in your company and laboratory

Six Sigma Organisation

Six Sigma Hierarchy

An effective Six Sigma (SS) project is reliant on knowledge of Six Sigma philosophy and statistics, successful use of the tools and metrics, team engagement and commitment from all stake holders. In a Six Sigma organisation there is a hierarchy of members that are involved in Six Sigma initiatives, ranging from the Champions or Sponsors to Black belt leaders and team members. Six Sigma project requires support from management and company executives i.e. Champions or enables that provide resources for SS implementation. A Master Black Belt (MBB) is a highly skilled and experienced Black Belt who is an expert in the use of Six Sigma tools and statistics. The MBB is a mentor to other black belts and is responsible for the management and implementation of numerous Six Sigma programs. Black Belts lead Six Sigma projects and are highly skilled in Six Sigma methodologies with extensive knowledge of the use of statistics, SS tools and project management. Green belts are trained in Six Sigma methodologies and statistics; Green Belts generally assist Black Belts on large projects or lead smaller projects. Team members also include Yellow Belts, White Belts and process owners who assist in project realisation and effective implementation of Six Sigma. 

Team Lean Sigma

Defining the problem and goals are the first steps in the DMAIC cycle to continuous improvement! After defining the project a Lean Six Sigma team must be established. Leadership and team commitment is critical to the success of a project. Toyota House of Quality emphasises employee empowerment and respect for people, two attributes which contribute Lean Six Sigma (LSS) success. When establishing a team for a LSS project in your laboratory it is important that members range from having a diverse skills background to subject matter experts. Members should adopt a culture of LSS culture and be involved in assisting with data collection and feel "empowered" to implement changes for process improvement.  Regular meetings must be scheduled to ensure consistent deployment of LSS tools, data collection metrics analysis, review progress and present results. The use of tools and statistics at all stages of the DMAIC process is the main strategy towards Lean Six Sigma deployment .

Lean Sigma Toolbox

Lean manufacturing, Lean thinking, Lean culture...

What is Lean?

Lean is typically associated with waste minimization, continuous improvement and respect for people. All of these measures contribute to more productive and efficient processes. Lean manufacturing is modelled on the Toyota Production System (TPS).

A leaner laboratory can make significant improvement in routine testing and analyses. Lean is already widely adopted to the manufacturing industry where many processes have benefited from continuous improvement projects. The laboratory is no exception! Whether it’s a clinical, diagnostic, analytical, quality control or microbiology lab, a lean lab will result in: 

         

• Enhanced productivity
• Reduced waste (muda)
• Increased throughput
• Faster turnaround times (TAT) 
• Significant cost reductions!
• Better employee morale

   

5 Lean Principles 

1. Value: define what is of value to the customer
2. Value Stream: identify the value stream, eliminate waste
3. Flow: Create a constant flow
4. Pull: Produce on demand
5. Perfection: Continuous improvement

Continuous Improvement - Kaizen

By adopting a Lean culture, laboratory processes can be improved significantly. Identifying and eliminating waste can really reduce costs. When the lab and processes are optimized in the Lean Six Sigma way, lab life is made a lot simpler and more productive. The Lean culture has a strong emphasis on respect for people – continuous improvement relies on this attribute. The lean culture values the process owners - i.e. lab technicians, scientists, supervisors etc. and has a policy of empowerment, each individual is responsible and engaged in a team effort to ensure continuous improvement or Kaizen. A lean lab should be an enhanced and more simplified productive environment with the added advantage of boosting morale.

Principles of Kaizen

Lean Six Sigma in the Laboratory

Lean manufacturing to Lean analysis - extending the potential of Lean Six Sigma in biopharmacutical industry

This blog is designed to introduce the concepts and techniques of continuous improvement in laboratory work spaces using Lean Six Sigma tools and techniques to create an efficient and productive. Lean Six sigma is a well established tool in manufacturing and it is gaining imminence in health care and services industries also. Lean Six Sigma can be applied to any project or any facility to improve efficiency by reducing waste, minimizing defects and adopting a philosophy of continuous improvement. In this blog, I will address the benefits of implementing lean six sigma in the laboratory. Lean is not a new concept in the biopharmaceutical industry, as it is adopted by most high profile biomanufacturing companies including Johnson and Johnson, Pfizer, Abbott, Baxter. The practical applications are not merely confined to the production area, it is a culture and methodology that is adopted throughout the industry. This blog will highlight the benefits of Lean Six Sigma in the QC laboratory and explores the tools and techniques that can be used to improve workflow efficiency and create a leaner, more productive quality laboratory.

Lean Six Sigma in biopharmaceutical QC laboratories creates efficient and productive workflow, reduces waste and increases sampling throughput.