Lean Six Sigma Framework for Business Improvement: A Detailed Analysis

This report provides a comprehensive overview of the Lean Six Sigma framework, a methodology designed to improve processes by eliminating problems, inefficiencies, and waste. It combines the principles of Lean and Six Sigma, emphasizing a team-oriented approach to maximize operational efficiency and profitability. The report delves into the elements of the framework, including mindset, culture, tools, techniques, process, and methodology. It explains the background of the framework, including continuous improvement, Lean principles, and Six Sigma methodology. Furthermore, it highlights the similarities and differences between Lean and Six Sigma, the Lean Six Sigma principles, and the benefits of implementing this framework, both organizationally and personally. The report also details the DMAIC phases (Define, Measure, Analyze, Improve, Control) and provides an overview of Lean Six Sigma tools and techniques. Finally, it includes a real-world application of the model in addressing a FDA Drug Recall Solution.

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Lean Six sigma Framework
Student’s Name
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Contents
Overview..........................................................................................................................................4
Elements of the Framework.........................................................................................................4
Background of the Framework........................................................................................................5
Continuous Improvement............................................................................................................5
Lean.........................................................................................................................................5
Six Sigma.................................................................................................................................7
Similarity and Differences.......................................................................................................8
The Lean Six Sigma Principles......................................................................................................10
Addressing real world problems................................................................................................10
Analysis of the methodology is accomplished by the team.......................................................10
Analysis is majorly focused on the process...............................................................................10
Process analysis in dependent on data.......................................................................................10
Solutions of the model address the root cause of the problem..................................................11
The solution proposed includes a control system that helps it stick..........................................11
Benefits of lean six sigma..........................................................................................................11
organizational benefits...........................................................................................................12
Personal Benefits...................................................................................................................14

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Lean six sigma belts.......................................................................................................................15
Yellow belt.................................................................................................................................15
Green belt...................................................................................................................................16
Black belt...................................................................................................................................16
master black belt........................................................................................................................17
Phases of Lean Six Sigma Model – DMAIC.................................................................................18
Definition of lean six sigma DMAIC........................................................................................18
Phase 1: Define......................................................................................................................18
Phase 2: Measure...................................................................................................................19
Phase 3: Analyze....................................................................................................................19
Phase 4: Improve...................................................................................................................19
Phase 5: Control.....................................................................................................................19
Lean six sigma tools and techniques.............................................................................................19
Process analysis tools................................................................................................................20
FDA Drug Recall Solution Using the Model................................................................................21
application of the model............................................................................................................21
References......................................................................................................................................22

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Overview
Lean Six Sigma is a model designed to improve processes by eliminating problems,
inefficiencies, wastes, and improving the working conditions in order to provide the desired
response to the needs of the customers. The model combines various tools, principles, and
methods of six sigma and lean-to form one robust methodology in improving overall operations
in the organization (Shah et al., 2019). The framework has a team-oriented approach that has a
proven outcome in its application in maximizing operations efficiencies and promptly improving
profitability for organizations.
Elements of the Framework
Mindset and culture: it fosters a way of thinking that is dependent on data and the processes to
realize operational performance objectives and continuous improvement

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Tools and techniques: a set of tools and analytical techniques that are used in identifying and
providing solutions to the problems
Process and methodology: consist of a series of phases that organize the utilization of various
problem-solving tools to ensure that the root cause of the problem is identified and a solution to
the problem is fully implemented.
The three elements complement and reinforce each other. Analytical tools cannot be used
efficiently unless there is an effective approach in which they can be used and the adoption of a
mindset of continuous improvement that will lead in creating a need for them.
Background of the Framework
Continuous Improvement
Continuous improvement is a business strategy developed as a result of Frederick Winslow
Taylor’s Principles of Scientific Management. Frederick postulated a business as a series of
interlocking workflows that should be effectively managed using available data.
Lean
Lean was originally developed in Toyota as the main part of the Toyota Production System. The
primary objective of lean process is to eliminate wastes. basically, the ideal description of lean
process can be represented as a set of tools that aid in waste identification and elimination. Large
scale firms will lead to generation of large-scale high-quality waste in their processes (Tagge et
al 2017). The lean model uses different techniques to analyze all the business processes.

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Principles of Lean Manufacturing Framework
1. Value: Value in an organization is determined by what is important to the customer in a
product or service as compare to the development process of the product or service or
channels of delivering the product.
2. Value stream: it represents the steps and the necessary activities involved in developing a
new product and service and delivering it to the customer. It is the interconnection of
various steps put together rather than comparing individual steps.
3. Flow: represent the level of smooth and uninterrupted flow of procedures, activities and
tasks that add value to the product or service and thus to the customer, rather than
inefficiency that impedes the overall flow through the value stream of the company’s
processes.
4. Pull: it is the level in which the value chain is processing the products and services that
have demand in the market, rather than developing a product and service and hope that
there will be demand in the market.
5. Perfection: continuous analysis of value stream performance of the firm with the aim of
identifying and improving the overall value created and delivered to final customer,
rather than fighting changes that will lead in improving the process of creating and finally
delivering value to the final customer.
Types of Wastes
The lean framework strives to eliminate the following types of wastes:
Mura (unevenness in flow) – unpredictable variation that requires compensation elsewhere in the
production process
Muda (non-value-added work) – refers to the pure waste generated during production

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Muri (resource overburdening beyond their normal capabilities) – damages or stresses resources
in a way that they are unable to perform their normal and intended functions.
From the above wastes, it implies that the lean model can be applied in any operation or business
process.
Six Sigma
The six-sigma methodology focuses on variation identification and elimination in organization
processes. Elimination of variation can lead to accurate processes prediction at any given time
(Gallo et al., 2019). Thus, the system can be designed to ensure that the predicted outcome fall
within the limits of the desired performance outcome from the viewpoint of the customer.
The model is organized in five phases
Five Phases of six Sigma
 Define: the limits of the processes being assessed are set and the general expectations are
defined following the customer expectations. the main purpose of this phase is to ensure
that change introduction in the processes does not degrade the customers overall
experience but should enhance his experience levels
 Measure: the prevailing performances of the product, service or process is measured to
determine the activities that are occurring, especially from the customer’s viewpoint. this
is important to make sure that the analysis is conducted and the solutions are realized
based on the actual performance and not anecdotal

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 Analyze: In this stage, the product, process or service is analyzed using the
predetermined and measured data to identify the sources of variations causing the
experienced problems. this is important to ensure that the root cause of the problem is
identified.
 Improve: this phase of the model covers the possible changes that can be introduced are
designed and tested. this is important to ensure that the proposed solution achieves the
desired results and the variation is minimized.
 Control: in this stage of the model, the proposed changes are implemented, the necessary
supportive system is updated and the products, services or the processes are put under
control of the changes to ensure the desired solution is fully implemented in a more
sustainable manner and identify the possibility of performance degrade.
Similarity and Differences
Six Sigma model and the Lean model have been combined due to the fact that they are
complementary despite their differences. The available similarities allow them to effectively
mesh together. The available differences portrayed by each system ensure that there are options
available that will play a big role in improving the overall working of the system in order to
improve the overall processes, products or services (Pugna, Negrea, and Miclea, 2016). The
similarities allow both models to be used in analysis simultaneously.
Similarities
a. Both of the models heavily rely on data definition based on the overall customer
experience.
b. Both model use process flow mapping in their analysis in order to understand the process.
this is used even when the conducted analysis is based on a service or product.

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c. In determining the current performances of the processes, products or services, both
systems rely on the use of data. the collected data in lean six sigma can be used to support
both models during the analysis. overreliance of data ensures that both models lead to the
identification of the root cause of the variability and inefficiency.
d. both models are applied using various improvement projects that can be implemented by
a small cross-functional team. the overall size of the team and project duration will be
determined by the scale of the process, scope of the project.
despite the numerous similarities that exists between these two models, there are a number of
differences. however, the differences do not lead to the creation of a conflict within the two
models rather, the give the management various paths that can be followed to achieve similar
results. a lean six sigma process should allow the defects nature dictate the tools that can be used
following the definition of the customer value, and the prevailing state of the organization’s
processes. The final outcome is mostly a hybrid combination of a both the six sigma
improvements and the lean improvements.
Differences
a. Different focus point in problem identification. lean framework is fully focused on waste
elimination while six sigma focuses of product, services and processes variation and
deviation from the desired outcome.
b. different styles of solution documentation. lean framework solution documentation is
done using a revised value stream map that lead to change workflows and changes on
instructions on doing things. the six-sigma framework is documented according to the
changes set up procedures and the available control plan for process monitoring and
variation response.

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The two models are compatible is several ways that they can be easily be merged to form one
methodology so as to ensure synergistic effect of them both. Lean six sigma as is normally
referred helps in avoiding various pitfalls from the failed approaches experienced earlier.
The Lean Six Sigma Principles
Addressing real world problems
The combined framework is both a bottom-up and top-bottom methodology. The top-bottom
feature is related to the selection of the problem. The managing team in implementing the Lean
six sigma methodology is focused in the real-world problems which are directly affecting the
organization’s processes and the customer experience.
Analysis of the methodology is accomplished by the team
The projects conducted using the methodology is in most cases staffed using a cross functional
teams involved in various functions within the project being analyzed.
Analysis is majorly focused on the process
The model is one of the most efficient tools of analyzing various processes in the organization.
Even during the problem investigation, the model will be highly effective when applied to
various processes that develop, build or design a product rather than fully focusing on the
defective product.
Process analysis in dependent on data
Lean six sigma model is heavily reliant on data and not normal guesses. the lean value stream
map is a verified process with a walk-through of the analysis process and the collection of data is

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done at any given step. The captured data is used during the analysis and is important in
determining the actual cause of processes variation and inefficiencies.
Solutions of the model address the root cause of the problem
the model represents one of the strongest problem-solving tools and enhances continuous
improvement in the organization because it points out the features of the real problem.
The solution proposed includes a control system that helps it stick
The model does not end after the identification of the problem or after the proposed solution has
been implemented. the final stage of the lean six sigma methodology is the control phase. this is
created to address the resistance to change experienced in most organizations. in the control
phase of the lean six sigma approach, the solution is implemented and the firm starts to use it.
while this is being conducted, the project team works to ensure that all the parameters required to
ensure that the implemented solution works are put in place to reflect the changes made and the
required training is done for process managers and operators on the effective use of the
implemented solution. this is even done to ensure that the control system that monitors the entire
process is put in place to establish instances of the process reverting to the previous behaviors.
Benefits of lean six sigma
Lean six sigma model is a continuous improvement tool.

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organizational benefits
Simple processes
lean six sigma model helps in simplifying organizational processes. the cross functional value
stream map identical to the model will help identify processes, products and services
inefficiencies and wastes (Tomatis and Scorsetti 2018). Most of the processes in the organization
have embedded on workarounds and processes reworks for some of the persistent problems.
when the model is used in removing the persistent problems and the rework wastes are
eliminated, the resulting processes are simple and are easier to control and manage. this leads to
faster processes hence better customer service and improved levels of customer satisfaction.
reduced instances of errors and mistakes
lean sigma model starts by defining the acceptable quality in the firm basing on the customer
values and experience. This allows the model to focus on external factors on quality priorities