Lean Six Sigma Concept and Implementation

Lean Six Sigma (LSS) is the result of combining two procedures that were originally used independently to increase productivity and effectiveness in businesses. To put it briefly, Six Sigma is a data-driven approach that aims to produce a continuous process with few faults, and lean methodology aims to reduce or eliminate phases in a manufacturing process that do not add value.

Concept of  Lean Six Sigma (LSS)

Lean Six Sigma (LSS) is a methodology that combines the principles of Lean manufacturing and Six Sigma to improve efficiency and quality in business processes. It focuses on identifying and eliminating waste, reducing variation, and improving overall process flow. LSS aims to achieve continuous improvement by empowering employees to identify and solve problems, ultimately leading to increased customer satisfaction and cost savings for the organization.

Thus, LSS may be summed up as the union of two potent procedures designed to enhance output through the removal of waste and errors through the application of special instruments.

LSS was implemented by pharmaceutical companies like GlaxoSmithKline in their drug development procedures. Considering how costly the drug production process is, using Lean Six Sigma improves the likelihood of creating a medicine that will be commercially successful. In statistical words, the application of Lean Six Sigma guarantees that there are only 3.4 defects or less in every million activities. There are several ways that pharmaceutical corporations are not like most other companies. Customers’ minimal influence over the things they use sets it apart from other businesses.

Lean Six Sigma implementation has shown to be essential from molecular discovery through clinical trials and PAT application.

Lean Six Sigma has shortened the time it takes for an innovative drug to be approved for usage on the market after meeting all conditions.

A combination of tools from the two combined processes is used in LSS. Among the lean tools are:

1.      6S (5S + SAFETY): – This is a tool for organizing the workspace.

The 6S tool in Six Sigma is a methodology used to organize and improve the efficiency of a workplace by focusing on five key principles: Sort, Set in Order, Shine, Standardize, Sustain, and Safety.

SORT: Sort involves removing unnecessary items from the work area.

LEAN SIX SIGMA AND 6S

SET: Set in Order focuses on logically arranging necessary items.

SHINE: Shine emphasizes keeping the workplace clean and organized.

STANDARDIZE: Standardize establishes consistent processes, and

SUSTAIN: Sustain ensures that the improvements are maintained over time.

SAFETY: Safety in 6S Six Sigma refers to the implementation of safety measures within the workplace as part of the overall Six Sigma methodology.

This includes identifying and addressing potential safety hazards, promoting a culture of safety awareness, and ensuring compliance with safety regulations. By integrating safety into the 6S framework, organizations can create a safer and more efficient work environment, leading to improved quality, productivity, and employee satisfaction

By implementing the 5S tool, organizations can reduce waste, increase productivity, and create a safer and more efficient work environment.

2.     Kaizen:

This is a process that is accelerated by employees who are committed to making small improvements within the organization.

Kaizen is a key tool in the Six Sigma methodology, focused on continuous improvement. It involves making small, incremental changes to processes to improve efficiency, quality, and overall performance. By encouraging a culture of continuous improvement, Kaizen helps organizations to identify and address issues, reduce waste, and optimize operations. This tool is essential for achieving and maintaining high levels of quality and productivity within an organization

3.     Gemba (Go & See):

This method involves continuously monitoring the process to identify problems in real time.

Gemba (Go & See) is a fundamental tool in Six Sigma methodology that emphasizes the importance of observing processes firsthand to identify inefficiencies, waste, and opportunities for improvement. By physically going to the location where work is being done, team members can gather accurate data, engage with employees, and gain a deeper understanding of the root causes of problems. This hands-on approach enables organizations to make informed decisions and implement effective solutions to enhance quality and efficiency.

4.     Value stream mapping (VSM):

A method for identifying the source and scope of waste in processes.

Value Stream Mapping (VSM) is a vital tool within the Six Sigma methodology, designed to visualize and analyze the flow of materials and information throughout a production process. By identifying value-added and non-value-added activities, VSM enables organizations to streamline operations, reduce waste, and enhance overall efficiency. This systematic approach not only fosters continuous improvement but also empowers teams to make data-driven decisions that lead to higher-quality outcomes and increased customer satisfaction. Implementing VSM can significantly contribute to achieving operational excellence and sustaining competitive advantage in today’s dynamic market

5.    Jikoda/Autonomy:

When a defect arises, this stops manufacturing.

The Jikoda/Autonomy tool in Six Sigma is a method used to empower employees to make decisions and take ownership of their work processes. This tool encourages individuals to identify and solve problems on their own, leading to increased efficiency and effectiveness within an organization. By promoting autonomy, employees can contribute to continuous improvement efforts and drive positive change within the company.

6.    Kanban:

An inventory management approach that highlights low or excessive inventory.

Kanban is a visual tool used in Six Sigma methodology to manage workflow and improve efficiency in manufacturing and service industries. It helps teams visualize work, limit work in progress, and maximize efficiency by signaling when to start new tasks based on the availability of resources. Kanban boards typically consist of columns representing different stages of a process, with cards representing individual tasks moving through the columns as work progresses. This tool enables teams to identify bottlenecks, prioritize tasks, and continuously improve their processes to achieve optimal performance.

Six Sigma tools

To overcome any problems, this procedure applies the DMAIC framework.

The DMAIC framework in Six Sigma is a structured problem-solving methodology used to improve processes by eliminating defects and variations.

DMAIC stands for Define, Measure, Analyze, Improve, and Control, representing the five phases of the framework.

D – In the Define phase, the project goals and customer requirements are established. At this phase, the project’s objectives and the problem are both defined

M – The Measurement phase involves collecting data to quantify the current process performance. At this point, process variables, data, and capabilities are collected and assessed

A – The Analyze phase focuses on identifying the root causes of defects and variations. A defect’s root causes are investigated.

I – During the Improve phase, solutions are implemented to address the identified issues. Approaches to address the problem and enhance the procedure are recommended.

C – The Control phase ensures that the improvements are sustained over time through monitoring and standardization. A control system is implemented to ensure that the improvements are sustained

Conclusion 

Lean Six Sigma makes use of the synergistic power of the combined process by collaborating to address the variations in the process that Lean has shown. This maintains a cycle that lowers production costs and guarantees that consumers will receive the desired product.

Waste and errors in the manufacturing of medicines have been eliminated because of the implementation of LSS in the pharmaceutical industry. This method has reduced production costs and has shown to be one of the most effective tools in this sector.

Frequently Asked Questions (FAQs) on Lean Six Sigma

Q. How does Lean Six Sigma aim to improve processes within organizations?

Lean Six Sigma aims to improve processes by identifying and eliminating inefficiencies and reducing variability, ultimately leading to improved quality, reduced costs, and increased customer satisfaction.

Q. What are the key principles of Lean Six Sigma?

The key principles of Lean Six Sigma include customer focus, process improvement, data-driven decision-making, and continuous improvement.

Q. Explain the difference between Lean and Six Sigma methodologies.

Lean focuses on eliminating waste and increasing efficiency in processes, while Six Sigma focuses on reducing defects and variation in processes to improve quality and consistency.

Q. How are process improvement projects typically identified and selected in a Lean Six Sigma initiative?

Process improvement projects are typically identified and selected based on criteria such as impact on customer satisfaction, potential cost savings, and alignment with organizational goals and objectives

Q. What is the DMAIC methodology in Lean Six Sigma?

DMAIC stands for Define, Measure, Analyze, Improve, and Control, and it is a structured problem-solving methodology used in Lean Six Sigma for process improvement projects.

Q. How can Lean Six Sigma tools such as value stream mapping and root cause analysis be used to identify opportunities for improvement?

Value stream mapping can help visualize the flow of materials and information in a process to identify areas of waste and inefficiency, while root cause analysis can help determine the underlying causes of problems and defects.

Q. What is the role of leadership in driving a successful Lean Six Sigma initiative?

Leadership plays a critical role in setting the direction and vision for Lean Six Sigma, providing resources and support for improvement projects, and creating a culture of continuous improvement throughout the organization.

Q. What are some common challenges organizations face when implementing Lean Six Sigma initiatives?

Some common challenges organizations face include resistance to change, lack of buy-in from employees, difficulty in sustaining improvements, and the need for ongoing training and support.

Q. How can data analysis and statistical tools be used to measure the success and impact of Lean Six Sigma projects?

Data analysis and statistical tools can be used to track key performance indicators, measure process improvements, and quantify the financial benefits of Lean Six Sigma projects, providing empirical evidence of their success and impact.

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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