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Abstract
Lean Manufacturing Implementation Initiatives
by
University, 2011
University, 2000
Doctoral Study Submitted in Partial Fulfillment
of the Requirements for the Degree of
Doctor of Business Administration
University
[last month of quarter you plan to graduate] 201X
Abstract
Use the following guidelines when writing the abstract. Begin with a wow statement
illuminating the problem under study. Identify the design (case study, phenomenological,
quasi-experimental, correlation) Note: Do not mention the method
(qualitative/quantitative) in the abstract. Identify the study population and geographical
location. Identify the theoretical (quantitative) or conceptual framework (qualitative) that
grounded the study; in APA style, theory/conceptual framework names are lower case.
Describe the data collection process (e.g., interviews, surveys, questionnaires). Describe
the data analysis process (e.g., modified van Kaam method to identify themes in
qualitative studies or t test, ANOVA, or multiple regression in quantitative studies). Do
not mention software used. Identify two or three themes that morphed from the study
(qualitative). Present the statistical results for each research question (quantitative
studies). Describe how these data may contribute to social change (use the word social
change and identify who specifically may benefit). Ensure the first line in the abstract is
not indented. Ensure abstract does not exceed one page. Use plural verbs with data (e.g.,
the data were). Write all numbers as digits (i.e., 1, 2, 10, 20) and not spelled out unless at
the beginning of a sentence. Add an abbreviation in parentheses after spelling out a term
in full only if the abbreviation is used again in the abstract.
Lean Manufacturing Implementation Initiatives
by
University, 2011
University, 2000
Doctoral Study Submitted in Partial Fulfillment
of the Requirements for the Degree of
Doctor of Business Administration
University
[last month of quarter you plan to graduate] 201X
Dedication
I want to dedicate this study to the workers of corporate America who slave
tirelessly to improve working conditions. To my co-workers and subordinates that
supported all of my efforts to make work an effortless thought, and a pleasurable place to
come to.
Acknowledgments
To my family and friends that supported me until I completed my doctorate, thank
you all. A special thanks to my children, Asia Hughes and Max Edwards. I hope I have
paved a path that you both will far exceed beyond my wildest dreams, just know that you
can accomplish your hearts desires. To my fiancé Heith Williams, thank you for all you
have done to lighten my load, the gratitude, and support given far exceeds my
expectations. I want to thank my parents Hazel W. Ulmer, Francis M. Ulmer, Reno L.
Wells, and Gerrard H. Davis (deceased) for believing in me, without you there would be
no me. To my creator, God, my Lord, and Savior Jesus Christ I want to thank you
because I am wonderfully made.
To my all of my colleagues, professors, administrators, and chairperson’s thank
you for your support, encouragement, patience, and understanding while on this journey.
Indebted thanks to my chair representative Dr. G. Velkova, I could not have completed
this without your guidance and support. I love you all!
Table of Contents
List of Tables......................................................................................................................
List of Figures......................................................................................................................
Section 1: Foundation of the Study......................................................................................
Background of the Problem...........................................................................................
Problem Statement.........................................................................................................
Purpose Statement..........................................................................................................
Nature of the Study........................................................................................................
Research Question (Quantitative Only).........................................................................
Research Question (Qualitative Only)...........................................................................
Interview Questions (Qualitative Only).........................................................................
Hypotheses (Quantitative/Mixed Method Only)...........................................................
Theoretical or Conceptual Framework..........................................................................
Operational Definitions..................................................................................................
Assumptions, Limitations, and Delimitations................................................................
Assumptions............................................................................................................
Limitations...............................................................................................................
Delimitations............................................................................................................
Significance of the Study...............................................................................................
Contribution to Business Practice (Heading Optional)...........................................
Implications for Social Change (Heading Optional)...............................................
A Review of the Professional and Academic Literature................................................
i
Transition.......................................................................................................................
Section 2: The Project........................................................................................................
Purpose Statement........................................................................................................
Role of the Researcher.................................................................................................
Participants...................................................................................................................
Research Method and Design......................................................................................
Research Method...................................................................................................
Research Design....................................................................................................
Population and Sampling (Quantitative Only).............................................................
Population and Sampling (Qualitative Only)...............................................................
Ethical Research...........................................................................................................
Data Collection Instruments (Quantitative Only)........................................................
Data Collection Instruments (Qualitative Only)..........................................................
Data Collection Technique..........................................................................................
Data Organization Technique (Qualitative Only)........................................................
Data Analysis (Quantitative Only)...............................................................................
Data Analysis (Qualitative Only).................................................................................
Study Validity (Quantitative Only)..............................................................................
Reliability and Validity (Qualitative Only).................................................................
Reliability..............................................................................................................
Validity..................................................................................................................
Transition and Summary..............................................................................................
ii
Section 3: Application to Professional Practice and Implications for Change..................
Introduction..................................................................................................................
Presentation of the Findings (Quantitative Only)........................................................
Presentation of the Findings (Qualitative Only)..........................................................
Applications to Professional Practice..........................................................................
Implications for Social Change....................................................................................
Recommendations for Action......................................................................................
Recommendations for Further Research......................................................................
Reflections...................................................................................................................
Summary and Study Conclusions................................................................................
References..........................................................................................................................
Appendix A: Title of Appendix.........................................................................................
iii
List of Tables
Table 1. A Sample Table Showing Correct Formatting......................................................9
When you update the List of Tables, the table number and title will come in
without a period between them; you will need to manually add that period after all table
numbers, as shown for Table 1. In addition, the title will retain the italics from the
narrative when the List of Tables is updated. Once your list is finalized, select the entire
list, and change it to plain type.
Note that tables are numbered in sequence beginning with 1. Do not number
tables according to the section in which they appear (Table 4-1, 5-2, etc.) In the List of
Tables, table numbers are followed by a period, not a colon or a dash. This applies to
figure numbers in the List of Figures as well.
iv
List of Figures
Figure 1. Figure caption, sentence case.............................................................................xx
The List of Figures is not set up to automatically update. If you have figures in
your document, type them in manually here, following the example above.
Alternately, follow the instructions in the Instructions for Using the Walden DBA
Template, which will allow automatic updating of the List of Figures.
v
1
Section 1: Foundation of the Study
Lean manufacturing originated with the Toyota Production System (TPS)
(Kosuge, 2014). The birth of lean manufacturing was attributed to Japan in the 1940s,
later becoming known as the TPS in the 1950s (Djekic, Zivanovic, Dragojlovic, &
Dragovic, 2014). The purpose of the lean manufacturing process is to produce products at
the time they are needed, in the quantities necessary to appease demand without
exceeding that demand, thus eliminating excess product inventories (Djekic et al, 2014).
According to Brecht (2012), lean manufacturing has become a way of life in
manufacturing organizations. The use of sustainable resources, including renewable
energy, and the increasing demand for materials has caused global production activities
to grow (Alam & Kabir, 2013). Sustainable development has become an essential part of
almost every company’s corporate policy, making lean manufacturing a part of many
organizational sustainable development plans (Brecht, 2012).
Background of the Problem
Lean manufacturing has been applied in many areas of manufacturing, and even
some areas of service delivery; yet in certain areas of industry, challenges still remain
(Brecht, 2012; Hong, James, & Rawski, 2012). One of these areas is within the field of
surgical tools. While lean principles have been applied with some success within the
operating room, the ability to apply such principles to the surgical tools themselves has
not always been met with success (Blackmore, Bishop, Luker, & Williams, 2013;
Farrokhi, Gunther, Williams, & Blackmore, 2013; Matos, Alves, & Tereso, 2016; Toro,
Patel, Lytle, Sweeney, Medbery…& Sarmiento et al., 2015). Sterile instrument
2
processing has worked to further such practices, decreasing the amount of available tools
necessary to have on hand, but due to the complications that may arise during a surgical
procedure, additional tools must still be on hand to combat potential concerns
(Blackmore et al., 2013). Research indicates that if the appropriate process of application
may be found, lean manufacturing will prove a boon to the surgical field as well (Hagg,
Suskovich, Workman-Germann, Scachitti, & Hudson, 2007). Lean instrument
intervention has allowed for a reduction in the number of instruments necessary for the
completion of many surgical procedures, but while these practices reduce the overall
amount of tools in use, they do not reduce the amount of each of those tools necessary for
the hospital to have on hand (Farrokhi et al., 2013). While the advent of 3D printing has
worked to increase the likelihood of lean manufacturing as applied to surgical
instruments, and has worked to decrease the overall cost associated with instruments, not
all supply companies are using this technology, which is still relatively new, and while
decreasing in price, is still moderately expensive (3D Medical Manufacturing, 2016). In
spite of such situations, some organizations are flourishing with the application of lean
manufacturing to surgical instruments, while others are failing due to decreases in profits
and a need to return to previous numbers on the budget sheet. Due to the recent
expansion of lean manufacturing into this area, there is limited research available on such
experiences, particularly in regard to the reasons that such initatives succeed or fail.
Problem Statement
The problem that this study seeks to address is the manner in which lean
manufacturing can be applied within the realm of surgical tools in such a way as to allow
3
for the maintenance of such initiatives without a decrease in profit. The challenge for
leaders of surgical product businesses is sustaining lean manufacturing initiatives after
initial implementation (Hong, James, & Rawski, 2012). Only 2%-3% of worldwide
manufacturers have successfully achieved their lean manufacturing initiative objectives
(Sisson & Elshennawy, 2015). The general business problem is when lean manufacturing
initiatives fail there is decreased profitability. The specific business problem is that some
manufacturing leaders of surgical products lack strategies to implement lean
manufacturing initiatives to increase profitability.
Purpose Statement
The purpose of this proposed qualitative single subject case study is to explore
some of the different strategies that leaders within the surgical product businesses in
South Florida have used to implement lean manufacturing initiatives for the purpose of
increasing profitability. The target population will be leaders from within a surgical
product manufacturing organization located in south Florida selected as a result of the
fact that they have successfully implemented lean manufacturing strategies within their
organization and have increased their overall levels of profitability. Data from this study
may contribute to social change by sharing the strategies leaders of surgical product
businesses in South Florida, allowing a more widespread application of such practices.
Nature of the Study
A qualitative research method was selected for this study in order to be able to
explore the strategies surgical product business leaders in South Florida have
implemented in order to increase the profitability of their organizations. The qualitative
4
methodology is ideal for this type of exploration as researchers often use a qualitative
research method to study real world settings (Yin, 2014). The application of the same will
provide additional insight on how businesses operate, while ensuring that the manner in
which such strategies may be applied successfully is explored in depth. Yin (2014),
suggested qualitative researchers might use a case study to explore a single case, a
process, a program, an activity, an event, or a case bounded by time and place. In
comparison, quantitative studies involve gathering a range of numeric data (Stoudt,
2014). In quantitative studies, researchers test preconceived hypotheses (Bishop &
Lexchin, 2013; Frels & Onwuegbuzie, 2013). As the purpose of this study is to explore
the applied strategies as related to lean manufacturing in the field of surgical instruments,
a qualitative study would, while providing fiscal data, not be sufficient toward
determining the reasons for the success of the strategy or understanding how those
strategies are applied within an organization. A mixed method study points to the desire
to link or integrate quantitative and qualitative data (Padgett, 2012). If the purpose of this
study was to explore the specific means through which the applied strategies had shown
the greatest improvements in terms of the metrics of the organization, a mixed
methodology study would be ideal. This is not, however, the purpose of the study and
quantitative data is not the ideal form of data for the collection of the sought after
information. Likewise, there are no variables to compare, or desire to integrate variables;
therefore, a quantitative method does not suffice.
The four main designs in qualitative research are phenomenology, ethnography,
grounded theory, and case study (Thomas & Stew, 2012). Phenomenology may involve
5
reviewing written statements and drawings by participants based on individual
experiences of a phenomenon (Hycer, 1995; Moustakes 1994). For this study, interviews
with participants, and written statements or drawings are not suitable. An ethnography
depicts the social sciences for a group who relate to one another maintaining a constant
theme (Malinowski, 2014). As themes within society are not being searched for, this
design is not ideal either. Grounded theory allows for alteration of research in the field
and flexibility, making this method best suitable for action research (Liska-Belgrave,
2014). Therefore, grounded theory is not appropriate when conducting interviews. The
case study method is suitable for studies where the researcher’s goal is to explore a given
construct within a specific context in an in depth manner by collecting data from various
sources (Yin, 2014). It is ideally suited for the type of information necessary to explore
the identified problem. A qualitative case study is suitable based upon the desire to obtain
an in depth understanding of the strategies some leaders within the field of surgical
products use to increase profitability. Utilizing a single case study design meets the need
of the study based upon the research question.
Research Question
The research question identified for resolution within the context of this study is:
What strategies do leaders of surgical product businesses in South Florida use to
implement lean manufacturing initiatives to increase profitability?
Interview Questions
The interview technique is a data collection technique available to qualitative
researchers (Yin, 2014). When utilizing this technique for data collection, qualitative
6
researchers develop a set of questions designed to illicit targeted responses from study
participants. Question 1 is an inquiry question, Questions 2-7 are sub-questions that
support the central question, and Question 8 is a conclusive question.
Interview Questions
1. What strategies do you use to implement lean manufacturing initiatives to
increase profitability?
2. What lean manufacturing initiative has had the most impact when it comes to
increasing profitability?
3. How do your lean manufacturing initiatives tie into other profitability initiatives?
4. What is your long-term strategy regarding lean manufacturing?
5. What are you current initiatives in lean manufacturing?
6. Please describe the processes that enhance or hinder the success of lean
manufacturing initiatives post initial implementation within your organization.
7. What are the challenges, if any, that occurred during the implementation of lean
initiatives in your organization, and how did/ do you overcome them?
8. How does lean manufacturing fit into your comprehensive long-term
manufacturing strategy?
Conceptual Framework
Systems theory evolved in the early 1900s, with the application of principles
stemming from and originating in the works of a noted philosopher, von Bertalanffy
(1972). This theory addressed three main aspects: scientific exploration, problems in
7
modern technology, and reorientation of worldview (von Bertalanffy, 1972). Hamersly
and Land (2015) used von Betalanffy’s general systems theory for their project
management frameworks and decomposition model of business processes. The
conceptual framework for this study is general systems theory. The conceptual
framework is the view in which the context of the research is understood (Galea, 2012).
Araújo, Sanches, Júnior, and Gomes (2015) stated general systems theory is as an
interdisciplinary theory within a current position. In order to better understand the role of
leadership in the implementation of lean manufacturing initiatives, it was necessary to
employ the use of general systems theory. Challenges may arise as a result of the manner
in which surgical supply leaders implement initiatives; systems theory allows for an
exploration of this concern as leaders have to implement many different strategies to
sustain profitability.
Operational Definitions
Some unfamiliar terms appear in the discussion of implementing lean
manufacturing initiatives. In the context of manufacturing environment, several terms
occur, and these terms are defined in alphabetical order to articulate and animate them.
5-S. 5-S is a workplace organization tool used in lean manufacturing. This is an
approach that may be applied in order to drive improvements in all areas of business. It is
an acronym for sort, set in order, shine, standardize, and sustain (Samuel, 2010).
Implementation. Implementation is defined as the process or road map, by which
an organization works to tackle improvement areas in order to bridge gaps between the
existing state and the proposed state of a manufacturing firm (Singh & Sharma, 2009).
8
Initiatives. Management initiatives such as Six Sigma, total quality management,
and lean manufacturing have the objective of increasing quality-productivity in the
processes of the organization through improvement projects (Vicencio-Ortiz & Kolarik,
2012).
Lean manufacturing. Lean manufacturing refers to the use of lean operations in
manufacturing, and is characterized by the elimination of obvious wastes occurring in the
manufacturing process, resulting in a facilitation of cost reduction (Vinodh & Chintha,
2011).
Non-value added. Non-value added is a term that is used to describe the
inefficiencies present within the manufacturing process; it may be used to describe
situations such as those incurred through the application of extra motion, or time spent
searching for data, information, or tools (Kattman, Corbin, Moore, & Walsh, 2012).
Six sigma. The Six Sigma model is a model of lean manufacturing that provides
various kinds of sustainability to companies in terms of quality enhancement, market
share enhancement, zero defect level, optimal production level and financial returns
(AlSagheer, 2011).
Sustainability. The concept of sustainability relates to the maintenance and
enhancement of environmental, social, and economic resources, in order to meet the
needs of current and future generations (Marosevic & Drvenkar, 2012).
Workplace. A workplace is a physical location or facility within which
professional activities take place and corporations pursue their profits (Lipton, 2011).
9
Assumptions, Limitations, and Delimitations
What follows is a discussion of the assumptions, limitations, and delimitations of
this study. Assumptions are facts researchers assume are true, but cannot verify (Fisher &
Stenner, 2011). Limitations are circumstances out of the researcher’s control.
Delimitations are the boundaries for set for the study by the researcher, referring to the
aspects that are in the control of the researcher.
Assumptions
Fisher and Stenner (2011) noted that assumptions are facts researchers assume to
be true, but cannot verify. The qualitative case study approach provides a means to
explore participants’ experiences, and to create new ideas and confirm assumptions
regarding communication strategies, consumer behavior, and policy instruments (Judson
& Maller, 2014). For this case study, three primary assumptions are present. The first
assumption is that the use of in-depth interviews as a data collection technique will
enable the researcher to collect rich and detailed data that will foster an understanding of
the strategies that some leaders within the field of surgical products use to implement
lean manufacturing initiatives with the result of increased profitability. The second
assumption is that the participants would provide open and honest responses to the
interview questions. Finally, the researcher assumed that participant responses to the
interview questions and the secondary data would provide enough information to answer
the research question in this study.
10
Limitations
Mitchell and Jolley (2010) noted that limitations are potential weaknesses that
have the potential to adversely affect a study. There are five limitations for this case
study. The first limitation is that only leaders of surgical supply companies are the
participants. Connelly (2013) stated that a selected number of interview participants
imposes the risk of not having diversification in perspectives. The second limitation is the
small sample size. Interviewing only a limited number of participants affects the depth
and breadth of the study results and has the potential to reduce the study’s overall
generalizability. The third limitation is researcher bias, which, according to Shepperd
(2015) can arise when selecting members that are more likely to generate desired results.
The fourth limitation is found in the determination of the trustworthiness of participant
responses.
Delimitations
Delimitations are restrictions or boundaries imposed by the researcher (Mitchell
& Jolley, 2010). According to Yin (2014), researchers conduct qualitative case studies to
identify a particular context in case study descriptions. The study population of business
leaders, sample size, and location are delimitations (Yin, 2014). The participants in this
study will be only leaders of medical product companies in South Florida with 1-2 years
of experience in manufacturing. Leaders of surgical supply companies located outside of
South Florida will be excluded from this research. Due to the limited time allocated for
the completion of this study, a single case study is appropriate for use to explore the
strategies that some leaders of surgical product businesses utilize to implement lean
11
manufacturing initiatives within their organizations for the purpose of increasing
profitability. A single case study is best for this research study due to limited time and
resources.
Significance of the Study
Some leaders of surgical supply products possess the ability to apply strategies to
increase the profitability of their manufacturing businesses using lean manufacturing
initiatives. Yet more than 90% of lean manufacturing initiatives fail in the world market
(Vienazindiene & Ciarniene, 2013). The beneficial strategies that contribute to the
applied success of lean manufacturing in surgical product business profitability in South
Florida are unknown. The challenge for business leaders is sustaining lean manufacturing
initiatives after the initial implementation, with the ability to do so in a manner that
increases profitability much more difficult than that (Hong, James, & Rawski, 2012).
This study may identify areas of improvement for the original implementation of lean
manufacturing within this field, allowing for increased profitability after that.
Contribution to Business Practice
The results from this study might afford some leaders within the field of surgical
products the businesses strategies necessary to implement lean manufacturing initiatives
and to ultimately increase profitability. Lean manufacturing, when appropriately applied,
has the ability to improve the manufacturing industry economy, financially, and socially
(Hadid & Afshin Mansouri, 2014). Lean manufacturing initiatives account for more than
50% of efficiency gains for organizations and provide both waste minimization and
increased profitability (Al-Ashraf & Rahani, 2012; Upadhye, Deshmukh, & Suresh,
12
2010). However, less than 10% of the businesses that implement lean manufacturing
processes achieve significant results (Vienazindiene & Ciarniene, 2013).
Christensen and Rymaszewska (2016) noted that business leaders implement lean
manufacturing initiatives in order to increase the profitability of an organization. Yet it is
not only important to work to increase the overall profitability of an organization, it is
also necessary, particularly in today’s day and age, to ensure increased sustainability
(Longoni & Cagliano, 2015). For these reasons, the results of this study could contribute
to an increased awareness of the manner in which these two areas, lean manufacturing
and sustainability, may converge, providing benefits to those organizations who use them
and ultimately allowing for increased organizational profitability. Lean initiatives support
companies by identifying areas of improvement, including (a) administrative functions,
(b) service, (c) sales, (d) production, (e) shipping, (f) quality, and (g) maintenance; such
improvements can work to not only increase profitability through the reduction of
expense but may also work to increase overall sustainability of resources.
The findings from this study may also provide business leaders with insights and
solutions as to the most effective means through which lean initiatives may be
implemented toward the maximization of business output, increasing profitability in that
regard as well. Additionally, data from this study might provide business leaders with an
understanding of the foundational knowledge necessary to implement and monitor lean
manufacturing initiatives toward the purpose of improving their application within the
field of surgical products and ultimately allowing for increased profitability within that
arena.
13
Implications for Social Change
Business leaders can become socially responsible through the application of lean
manufacturing techniques to monitor production performance (Sledge, 2015). Al-Asharf
and Rahani (2012) stated that the implications of social responsibility for positive social
change included the elimination of non-value added activities, an attribute of lean
manufacturing initiatives. The results from this study may contribute to positive social
change by increasing the knowledge of business leaders about lean manufacturing
initiatives as the initiatives relate to the various aspects of the manufacturing process
toward targeted specific applications within the manufacturing of surgical products,
contributing to success in this regard and ultimately leading to increased profitability.
Researchers have identified the unique role of lean manufacturing initiatives and
their ability to efficiently contribute to the achievement of sustainable development goals
(Konda, Starc, & Rodica, 2015). One aspect of this research is to enlighten business
leaders, manufacturing workers, and the community on sustainable growth as an
important phenomenon in today's real economy. Through the application of the
information gleaned as a result of this study, others within the surgical product field in
the manufacturing industry may be able to not only increase their overall levels of
profitability, but may also be able to work to decrease their overall carbon footprint,
minimize waste, and increase the overall platform of sustainability within their
organizations. Establishing the development of positive social change includes
minimizing waste, conserving resources, and implementing sustainable growth
14
initiatives, help to conserve communities, all of which can ultimately lead to increased
profitability for an organization (Viterna & Robertson, 2015).
A Review of the Professional and Academic Literature
The purpose of this proposed qualitative single subject case study is to explore the
strategies that some leaders of surgical product businesses in South Florida have used to
implement lean manufacturing initiatives within their organizations to increase their
overall profitability. The research question asked by this study is: “What strategies do
leaders of surgical product businesses in South Florida use to implement lean
manufacturing initiatives to increase profitability?” This research subject is important to
this researcher, as this researcher believes that the future of the economy relies on
sustainable solutions.
Lean Manufacturing Initiatives
Lean manufacturing is one initiative that many manufacturing plants have
attempted to adopt in order to remain competitive in an increasingly competitive global
market (Al-Ashraf & Rahani, 2012). The focus of lean manufacturing is on cost reduction
through the elimination of non-value added activities, allowing for the creation of a value
stream (Al-Ashraf & Rahani, 2012). The authors, Al-Ashraf and Rahani (2012), focus on
the identification and elimination of waste within the production chain with respect to
energy, time, motion and resources (Al-Ashraf & Rahani, 2012). The birth of the Toyota
Production System (TPS) spawned the creation of many other tools and techniques of
lean manufacturing including the just-in-time (JIT), total productive maintenance,
cellular manufacturing, single-minute exchange of dies, and production smoothing
15
methods (Al-Ashraf & Rahani, 2012). This research explored the application of the lean
manufacturing initiative referred to as the Toyota Production System (TPS), a systematic
approach to the identification and elimination of waste activities through continuous
improvement within an organization.
Lean manufacturing has to become a way of life in manufacturing (Brecht, 2012).
To highlight previous research on lean manufacturing, Sebastian Christoph Bernhard
Brecht (2012) structured his dissertation in accordance with lean manufacturing strides
relating to cost efficiency, high quality, and customized products. The use of renewable
energy resources and the demand for materials caused global production activities to
grow limitlessly (Brecht, 2012). Since entering the twenty first century, depletion of
natural resources, environmental degradation, and unequal proportions of wealth have
gained global consciousness. As oil shortages loom ever present, energy costs continue to
rise, the ozone layer becomes more depleted, and environmental disasters occur, the
paradigm of continuous growth fails (Brecht, 2012). Sustainable development has
become an important part of a company’s corporate policy as a result.
Meybodi (2013) examined the relationship between the alignment of strategic
benchmarking performance measures and lean manufacturing practices. A set of nine
hypotheses were used to examine the differences between conventional companies and
lean manufacturing companies in setting organizational goals and objectives, scanning
environmental factors, building core competencies, setting competitive priorities,
establishing manufacturing objectives, and aligning competitive capabilities with
competitive priorities (Meybodi, 2013). Statistical results indicated, as compared with
16
conventional companies, that lean manufacturing organizations were overall better in
setting long-term goals and objectives, recognizing external environmental factors,
building organizational core competencies, aligning competitive capabilities with
competitive priorities, and utilizing a broad range of balanced performance measures
(Meybodi, 2013).
Pope (2013) offered information about Lean Six Sigma programs. Lean Six
Sigma was implemented within several organizations associated with the clinical trial
industry for the purpose of addressing the negative effects of industry at the sponsor
level, the contract research organization (CRO) level and the institutional review board
(IRB) level (Pope, 2013). Pope (2013) determined that Lean Six Sigma combined the
best process improvement methodologies toward the improvement of productivity and
the delivery of sustainable and continuous improvement.
Grima, Marco-Almagro, Santiago, & Tort-Martorell (2014) conducted a study
that was able to conclusively show the manner in which Six Sigma has proven to be a
powerful system for improving quality and productivity within the organizational
context. However, the successful implementation of the methodology is not simple, and it
is therefore normal – especially in the early phases – to experience problems that may
impede taking full advantage of the methodology. We have grouped some of the most
frequent ones into four main areas: implementation and organizational aspects, adherence
to DMAIC methodology, tools and statistical techniques and implementation of
improvements and project closure. For each of them, the paper discusses some of the
difficulties and issues that should be taken into account.
17
All Six Sigma seminars, talks, manuals, etc. emphasize the importance of management,
leadership, and commitment (e.g. Hahn, 2005; Shanmugam, 2007). Dahlgaard and
Dahlgaard-Park (2006) took this a step further and argued that, in order to have success
with Six Sigma (and Lean) manufacturing, management has to apply leadership skills
within the organization in order to change the corporate culture to one that is receptive of
such processes while warning of the dangers that may arise in the application of the Six
Sigma roadmap without the right company culture. Unfortunately, the process as to how
that leadership is converted into concrete activities within the organization is not always
specified. This failure to define tasks, or the improper performance thereof, is a frequent
source of problems in Six Sigma programs and, in many cases, leads to failure and,
ultimately, to the abandonment of the program (Grima et al., 2014).
The objective Grima et al.’s (2014) study was to evaluate the effects of lean
manufacturing implementation within a Serbian production company over the course of
24 months, emphasizing observed benefits and constrains. The company employed within
the case study was a leading confectionery producer in Serbia with annual production of
more than 25,000 t (Grima et al., 2014). The approach to implementing lean
manufacturing practices within this organization was structured in five phases, as
follows: (i) training, (ii) analysis of lean wastes on one technological line, (iii) choice of
lean tools to be implemented in the factory, (iv) implementation of lean tools in
production and maintenance, and the (v) development of continual improvement sector
and further deployment of lean tools (Grima et al., 2014). Lean manufacturing tools
implemented in the production process were visual control and single minute exchange of
18
dies (SMED); maintenance process implemented 5S with total productive maintenance
(TPM) and problem solving sessions being the tools implemented in both processes
(Grima et al., 2014).
Organizational Leadership
There are several different types of organizational leadership that may be applied
within a given organization. Commonly referred to as either models or styles, the most
common of these include situational leadership, transactional leadership, participative
leadership, and transformational leadership (Miller, 2016). The leadership style that will
be the most effective for an organization will vary depending on the situation that the
organization is in, the life cycle stage of the organization, the field of industry in which
the organization operates, and even the department within that organization (Northouse,
2016). There is no one right type of leadership and the only form of leadership that can be
detrimental to an organization is an ineffective one (Northouse, 2016). Understanding the
different types of leadership styles is the first step to understanding what type of
leadership will be best suited for a given situation within a given organization and a given
department.
Situational leadership, thus, may seem the most effective leadership style to
employ, as this type of leadership requires the leader to adapt his or her leadership style
based on the needs of the given situation (Miller, 2016; Northouse, 2016). Transactional
leadership refers to a leader who operates on the system of punishments and rewards,
with punishments doled out based on errors and rewards granted to those who meet or
exceed the expectations or the needs of the given situation (Miller, 2016; Northouse,
19
2016). Transformational leadership is the process through which the leader motivates and
inspires his or her workers toward the improvement of the organization for the betterment
of all, while participative leadership simply requests, and takes into account, the
suggestions and commentary of individuals at all levels of the organization, regardless of
position (Miller, 2016; Northouse, 2016). While transformational leadership and
participative leadership may seem similar, the key difference is that transformational
leadership works all angles of a given situation to ensure that all parties and the
organization come out ahead, to the degree possible (Miller, 2016; Northouse, 2016).
Participative leadership, on the other hand, solicits suggestions and comments, but does
not act on all and if the business gains a competitive advantage or changes as a result of
those suggestions and comments, it is not active, but instead a passive process (Miller,
2016; Northouse, 2016). The style that best suits the organization will depend on all of
the aforementioned factors, but it will also depend on the type of person the leader is, as
some individuals are more effective in the application of certain leadership styles than
they are compared to the application of other leadership styles.
Increasing Profitability
One of the primary goals of lean manufacturing is to increase overall profitability
(Fullerton, Kennedy, & Widener, 2014; Hofer, Eroglu, & Hofer, 2012; Ward & Sobek,
2014). While some researchers indicate that this process occurs over time (Fullerton,
Kennedy, & Widener, 2014), other researchers indicate that the speed through which an
increase in profit margin occurs has more to do with the effectiveness of the applied
principles within the organization (Hofer, Eroglu, & Hofer, 2012; Ward & Sobek, 2014).
20
In spite of this, the one thing that all researchers are able to agree on when it comes to the
application of lean manufacturing and increasing the profitability of the organization is
that the application of lean manufacturing principles and practices does work to increase
the overall profitability of the organization (Fullerton, Kennedy, & Widener, 2014;
Hofer, Eroglu, & Hofer, 2012; Ward & Sobek, 2014).
By working to ensure that the lean manufacturing practices are appropriately
implemented, the first steps toward an increase in the profitability of the business have
been taken (Ferguson & Souza, 2010; Fullerton, Kennedy, & Widener, 2014; Hofer,
Eroglu, & Hofer, 2012; Ward & Sobek, 2014). Other factors that must be taken into
consideration are the size of the organization and the health of the industry (Dora, Van
Goubergen, Kumar, Molnar, & Gellynck, 2014). While this may at first appear as though
there are a great many variables in determining the success levels of the organization, and
there are, the primary purpose is not to look at the number of variables, but the manner in
which those variables interact with one another.
The structural design of the organization plays a large factor in its overall levels
of success (West & Dellana, 2016). An organization that has a sloppy supply chain, or
which does not have enough workers to effectively deliver on the promises of the
organization cannot gain a great deal from the implementation of lean manufacturing. In
such instances, the organization must resolve its structural issues first. By the same token,
the organization that does not have a great deal of warehouse space, and thus is already
primed for lean manufacturing principles, may not increase their profitability as quickly
as an organization that had a large warehouse, cleared the inventory out via sale, and
21
rented a smaller warehouse and started receiving smaller shipments of inventory. In this
situation, not only would the company be reducing their storage costs via the warehouse,
the organization would also be decreasing its expenditures, wherein less of a product was
ordered, and thus less of the capital of the organization would be tied up in merchandise,
instead being able to be diverted to other means of the organization and different areas of
the business. The overall point is that, regardless of the manner employed, barring issues
with the structural design of the organization, the organization will be able to increase its
profitability as a result of the implementation of such practices, though it will be unclear
until the time of implementation, the amount by which that increase will occur (Fullerton,
Kennedy, & Widener, 2014; Hofer, Eroglu, & Hofer, 2012; Ward & Sobek, 2014).
Pitfalls and Success in Lean Manufacturing Implementation
Chowdary and George (2012) explained the current good manufacturing practices
(cGMP) that are followed in the pharmaceutical sector to ensure that products are
produced and controlled consistently. Improvement experiences were shared due to the
implementation of lean principles in combination with cGMP in a pharmaceutical
company (Chowdary & George, 2012). Chowdary and George (2012) used the 5-whys
methodology for analysis of the problems existing within the selected production line. A
current state value stream map (VSM) and a future state VSM were developed
(Chowdary & George, 2012). Reductions in cycle times, lead times, and WIP inventory
were all evaluated (Chowdary & George, 2012). Lean strategies were shown to have
increased improvement in the areas of production efficiency and the effectiveness of
22
manufacturing operations. The driving principles of cGMP’s are the quality standards
built into a product (Chowdary & George, 2012).
Miina (2013) analyzed the critical success factors concerning the implementation
of lean rationality in manufacturing companies located in Estonia. The research resulted
in the development of a lean thinking implementation model that could be modified for
manufacturing companies ensuring the desired results of the lean implementation process
(Miina, 2013). According to the study, by managing supply chains, issues concerning low
efficiency and productivity should be solved (Miina, 2013).
Organizational issues that can enhance or hinder successful lean implementation
have also been examined. In order to do so, Sim and Chiang (2012) placed a specific
emphasis on exploring the situation within three manufacturing companies located in the
eastern part of the United States. Each company represented a different mode of
implementation, varying in the degree of resistance, success, and plateauing (Sim &
Chiang, 2012). Job satisfaction was found to be an important factor in connection with
successful implementation of lean production (Sim & Chiang, 2012). In addition, more
than half of the respondents felt that management had not and would not follow through
with the resolution of open issues and had not or would not address the aspects or issues
that needed to be resolved that originated as a result of the implementation of such
improvements. In one company, interview results from three randomly selected
employees indicated that management had been pushing harder and did not respect the
workers, leading to a decline in the quality of work life (Siam & Chiang, 2012). In lean
manufacturing, due to the fast-paced nature of work and/ or the claim that lean becomes
23
mean, resistance to the change is common, as is the failure of the implementation (Sim &
Chiang, 2012). As a result, additional nurturing from management has been shown to be
a useful tool to ease the pressures of overwork, a common syndrome often found in lean
enterprises. Finally, job security, which is at the heart of most employees' concerns,
remains an issue that should be carefully dealt with. Performance improvements are not
likely to be sustained over time if employees fear that by increasing productivity, they
will work themselves out of their jobs (Sim & Chiang, 2012).
Campos (2012), discussed how Lean Six Sigma principles improved workflow,
turnaround times (TATs) and patient outcomes at a microbiology lab at the Children's
National Medical Center (CNMC). It was stated that a Kaizen approach, an approach for
continual improvement and constant change designed to increase core values of any task,
was employed through the involvement of the entire staff of the lab. It involved an
observational audit of existing lab processes and provided the customer with a roadmap
that outlined the improvements being made to reduce waste and improve efficiency,
while simultaneously increasing the quality of results and reducing errors.
For clarity, the lean manufacturing process succeeds in some instances and fails in
others; as such, it is necessary to study the reasons for each in order to determine the
factors of organizational change and explore the manner in which they are able to
influence successful outcomes, all of which ultimately result in improved performance
for the organization (Bhasin, 2015). Lean processes have been evident for several
decades, and a number of implementation strategies and barriers have been identified
within the extant body of literature. Current research emphases the prominent obstacles
24
inhibiting organizations from embracing lean practices and or frustrating its wider
application. Whilst some of the aforementioned analysis has revealed definite barriers
indirectly, this section will explore in greater depth the issues that organizations, lean
practitioners, and executives need to consider in their efforts to implement lean
manufacturing processes within their organizations.
The barriers to lean manufacturing explored include their origins, interrelations,
and their relative importance. The ultimate aim of any organization should be to link its
lean initiatives to organizational financial improvements. A perfect example of where this
fails is found in a lack of senior management support, however, it is important to try to
determine why some managers are more supportive than others are and it is as yet unclear
as to how this may be empirically measured. In respect to the numbers of successful lean
initiatives, it is necessary to explore the reasons as to why so many companies have not
been able to achieve the benefits they had hoped for through the application of their lean
strategies, or, in some cases, why they abandoned their efforts altogether (Bhasin, 2015).
Organizational Sustainability
There has been a growing awareness of the adoption of lean principles within UK
construction organizations (Ogunbivi, 2014). The UK Government has recognized the
importance of the construction industry achieving the overall goals of sustainable
development. To this end, the Government has put several policies and strategies in place
in order to achieve increased sustainability within the construction industry (Ogunbivi,
2014). Assessment and performance improvements have been advocated by many
researchers, and there is a substantial interest in performance measurement by
25
construction organizations. Assessing the implementation efforts and benefits of lean
approach in sustainable construction has become more critical to organizations in pursuit
of continuous improvement (Ogunbivi, 2014). The inadequacy of many frameworks and
tools developed to address this advancement in the areas of lean manufacturing and
sustainability practices provided the motivation for this research. Therefore, the aim of
Ogunbivi’s (2014) research was to develop a conceptual framework for assessing the
implementation efforts and benefits of the lean approach in sustainable construction
within contracting organizations.
Djekic, Zivanovic, Dragojlovic, & Dragovic (2014) set forth to explore the
process of implementation of the lean approach throughout all the levels of construction
organizations, investigate the linkages between lean and sustainable construction, review
the concept of lean and its application to sustainable construction, analyze the barriers
and factors contributing to the success of such initiatives, and to identify the benefits of
lean in sustainable construction. An exploratory method of investigation and study
involving both quantitative and qualitative methodology was utilized in this research
(Djekic et al., 2014). An in-depth literature review was conducted, allowing for the
foundational information necessary to understand the topic being explored; following the
presentation of the same, results from a questionnaire survey conducted among UK-based
construction professionals on issues relating to sustainability and lean processes in order
to identify the barriers, success factors and linkages between sustainability and the lean
concept were presented (Djekic et al., 2014). The data collected were analyzed using
SPSS version 19.0 using the percentile method, factor analysis, Kruskal Wallis test,
26
Cronbach's Alpha reliability test, and the Severity Index Analysis (Djekic et al., 2014). A
case study was also provided which employed the use of content analysis in order to
allow for a better understanding of the implementation process and drivers of lean
manufacturing at the organizational level (Djekic et al., 2014).
The success factors associated with the implementation of lean processes and
sustainability practices were subjected to factor analysis (Djekic et al., 2014). The factor
analysis of the data yielded two (2) critical success factors, which were labelled as
management and resource factors, and organizational culture factors. All the identified
benefits of implementing lean construction were classified into economic, social, and
environmental benefits. In addition, the drivers of implementing lean were discussed and
classified into internal and external drivers (Djekic et al., 2014).
The research further revealed that a reduction in waste was the most important
benefit of synchronizing lean processes with sustainability initiatives (Djekic et al.,
2014). The most significant barrier to the successful implementation of both was
identified as the resistance to change. The adoption of lean techniques have the potential
to significantly impact the realization of sustainable construction as there are linkages
between lean processes and sustainability initiatives (Djekic et al., 2014). The framework
developed by the researchers of a lean implementation process at the strategic level was
made up of three sections, namely: policy and strategy deployment, assessments criteria,
and the application and implementation phase, all with their own respective subsections
(Djekic et al., 2014). The framework highlighted the need to understand the
implementation issues within a contracting construction organization as well as the
27
implementation drivers of lean manufacturing. This study offered theoretical, practical,
and methodological significance in the study of successful lean implementation in
contracting construction organizations in the UK.
Transition
Section 1 has offered up the foundation of the study, discussing the purpose and
history of the practice of lean manufacturing. It has identified the problem to be
addressed, namely that the study seeks to determine the manner in which lean
manufacturing can be applied within the realm of surgical tools in such a way as to allow
for the maintenance of such initiatives without a decrease in profit. The purpose of the
study was explored in greater detail, and the issues that the surgical tool field has faced,
combined with the reasons why such a practice has not yet been implemented in most
surgical instrument companies, has been discussed. The nature of the study was
presented, and the research questions, allowing for the ultimate answers to the problem
set forth, were presented. The study, seeking to interview those who have been able to
successfully implement the use of lean manufacturing within the surgical tool field, will
serve to provide insight to those who may otherwise be unable to accomplish this task
within the field, while at the same time seeking to determine the manner in which the
other companies may have gone wrong in order to provide the knowledge necessary
regarding how to best improve the situation.
28
Section 2: The Project
Section 1 provided an introduction to the problem of utilizing lean manufacturing
processes within the industry of surgical tools. The research questions were presented and
the problem, complete with background information, was provided. The research
question identified for resolution within the context of this study is: “What strategies do
leaders of surgical product businesses in South Florida use to implement lean
manufacturing initiatives to increase profitability?”
In order to explore this topic in great depth, it becomes necessary to not only
explore the relevant literature to the topic, as was presented, but also to look forward,
identifying the means and methods used in the completion of the study to ensure that
should another individual wish to do so, he or she could recreate the experiment and
obtain the same results. To this end, the research design, methodology, ethical concerns,
population, sampling, and data collection, organization, and analysis processes, among
other equally pertinent topics, are presented within section 2.
Purpose Statement
The purpose of this proposed qualitative single subject case study is to explore the
strategies that have been implemented by leaders of surgical product businesses in South
Florida toward the purpose of implementing lean manufacturing initiatives and increasing
profitability. The target population was leaders from within a surgical product
manufacturing organization located in south Florida. They were selected because they
have successfully implemented lean manufacturing strategies increasing profitability.
29
Data from this study may contribute to social change by sharing the strategies leaders of
surgical product businesses in South Florida use to increase profitability.
Role of the Researcher
In a qualitative case study, researchers gather data from multiple resources, such
as (a) interviews, (b) artifacts, (c) records, and (d) documentation (Yin, 2014). In this
sense, the researcher focuses on data organization, data collection, and data analysis
(Collins & Cooper, 2014) while instituting methodological rigor (Gray, 2013). As the
primary data collection instrument for this qualitative single case study, interviews, using
the previously described interview guide were conducted for the purpose of exploring
participants’ views and experiences.
The participants are business leaders from one medical supply product company
in South Florida (BIOMET, 2012). There is a need to provide additional data, however,
so that the reader can draw conclusions while also providing enough interpretation of that
data (Pettigrew, 2013). The researcher has a previous working relationship with the
organization, though no direct experience with the participants of the study; it was
through this relationship that the door was opened to gain access to the participants in the
completion of the study. While the company will receive a complimentary copy of the
completed study results, no remuneration was asked for nor given to the company or to
those participating, nor did the company have any control over the interview process or
results.
The researcher in keeping with an awareness of the need for ethical research
standards, the researcher reviewed the Belmont report’s ethical principles and guidelines
30
for the protection of human subjects of research. With this in mind, throughout the course
of the study, the researcher adhered to the three ethical principles identified therein; these
are (a) respect for persons, (b) beneficence, and (c) justice (The Belmont Report, 1979).
The role of the researcher in this research project was to ensure that participants
understood that participation was voluntarily after receiving sufficient information as to
the nature of the study, that the participants provided signed informed consent forms, as
well as ensuring that no harm came to the participants, and that each was treated equally
(The Belmont Report, 1979).
When completing any research study, it is important to avoid bias in interpreting
the data provided (Marshall & Rossman, 2016). In order to do so, it is beneficial for the
researcher to have personal experience, knowledge, and values from an interviewee
perspective; however, increased familiarity with a given subject can result in researcher
bias when analyzing research data (Torras & Surie, 2015). Bracketing was employed as a
means of mitigating bias, allowing the researcher to disregard beliefs, experiences, and
previous knowledge that relate to the topic under investigation (Chan et al., 2013).
Member checking is a quality control procedure designed to strengthen the validity,
accuracy, and credibility of the interview data (Harper & Cole, 2012). Member checking
is a way to minimize bias interpretation throughout the interview process (Harper & Cole,
2012).
Equally important to the validity of the study, an interview protocol was
employed. According to Jacob and Furgerson (2012), the use of an interview protocol
provides a guide for a fair and ethical interview process. An interview protocol contains
31
procedural prompts to follow during the meetings. Procedural prompts include (a) a
reminder to obtain informed consent (b) a brief introduction before the interview, and (c)
information on the data a researcher wants to collect (Jacob & Furgerson, 2012).
Participants
A researcher can conduct a qualitative case study with multiple participants from
a single organization within the same location (Yin, 2014). The eligibility criteria for
participants in this case study was that they be (a) 18 years old and above, (b) currently
employed at a surgical supply product company in South Florida, (c) work in a position
as a manager, administrator, quality assurance personnel, or supervisor within that
organization, and (d) that they had participated in the implementation of lean
manufacturing initiatives and sustainability efforts within that organization. To gain
access to participants, the researcher contacted the company’s leadership team by phone
to set an appointment to speak with them face-to-face and explained the proposed study
in more detail. The researcher then provided further information to the leadership team
regarding the study and explained to them the expectations for the participants. Once
written permission was received from the leadership team to conduct the study, the
researcher obtained the contact information of potential participants from the company’s
HR director, and set up a meet and greet forum to discuss the purpose and nature of the
study with prospective participants. Prospective participants received an invitation to
participate face-to-face and via e-mail. After participants signed an inform consent form
following the completion of that meeting, the participant pool was set and the forms were
collected in person at that time indicating their agreement to participate.
32
Embedded in qualitative research were the concepts of power and relationships
between participants and researchers (Swauger, 2011). To develop a working relationship
with participants, the researcher was clear about the values, intentions, and views
associated with the study when establishing a working relationship with the participants.
Furthermore, the researcher worked to ensure that the participants felt comfortable if they
decide to withdraw from the research study at any time during the research process, and
conscious efforts were made to ensure that the researcher did not use power to control
participants. In addition, the researcher employed an ethic-of-care approach; an approach
that involves connecting with participants through consistent communication while
maintaining the values of the researcher’s responsibility towards research participants
(Swauger, 2011). Additionally, the researcher used the process of reciprocation through
story sharing as a means of strengthening the researcher-participant relationship by
encouraging rapport and eliminating power inequities, improving the quality of data
collected, and conveying value for the experiences and stories of participants (Hayman,
Wilkes, Jackson, & Halcomb, 2012).
Research Method and Design
The research method and design are perhaps two of the most important parts in
the completion of research studies (Yin, 2014). To conduct a study, researchers can use
quantitative, qualitative, or mix-methods. A researcher can employ a quantitative,
qualitative, or mix-methods to conduct his or her study; however, it is crucial for
researchers to understand the need for the most appropriate choice of a research method
and design, both of which depend on the nature of the study and the research question or
33
questions being explored (Maxell, 2013). In this sense, whether the research is
qualitative, quantitative, or mix methods, it is important that researcher chooses the
method and design that best suits the purpose of the study (Cakiroglu, 2012).
Research Method
A qualitative research methodology depicts the perceptions and lived experiences
of the participants involved in the research (Fogle, 2012). This study employs the use of a
qualitative methodology, which enables an understanding of the data obtained from
secondary sources (Marshall & Rossman, 2011). The qualitative method is appropriate to
explore strategies surgical product business leaders in South Florida use to increase
profitability. Furthermore, qualitative research depends on specific forms of data,
including narratives, observations, images, and primary text (Namey & Trotter II, 2012).
In addition, qualitative research proposes processes and techniques designed to help
illuminate relevant issues through an examination of the given phenomena explored
within the context of the research study (Namey & Trotter II, 2012). In a qualitative
methodology, an analysis of open-ended explanations address issues in reference to the
research; as such, a qualitative approach is used to explore the strategies surgical product
business leaders use to increase profitability as opposed to a mixed method or the
quantitative method (Daniels, Park, Harmon, & Brayley, 2013). Unlike quantitative
research, a qualitative approach has a background targeted toward addressing or handling
issues (Weathers et al., 2011). The qualitative research method is appropriate for use in
researching the strategies that leaders of surgical supply companies use to increase
34
profitability as it allows the researcher to analyze primary and secondary data provided
by the participants.
When selecting a research method, in addition to the qualitative approach, the
researcher also has the option of selecting a quantitative approach. One aspect of a
quantitative approach is the generation of numeric measures for simple and effective
comparison, selection, and ranking (Thamhain, 2014). The process of measurement is
fundamental to quantitative research because measurements provide a connection
between the relationships among variables (Payne & Wansink, 2011). Often
times, quantitative methods do not always produce the most reliable inputs for decision-
making, nor are all methods equally suited for all circumstances (Thamhain, 2014). A
quantitative research method is not appropriate for this study, as quantitative research is
systematic while qualitative research is unstructured (Allwood, 2012). Quantitative
research provides concrete evidence of a research topic based on the numerical results,
but numerical results are not required for the sustainability research explored (Weathers,
Barg, Bowman, Briggs, Delmoor, Kumanyika, & Halbert, 2011).
The final method the researcher may consider is a mixed method approach, one
that allows for a combination of both quantitative and qualitative methods. Social science
has categorized mixed methods research as the uniting of qualitative and quantitative
research methodologies (Collins & Frydenlund, 2015). A mixed methods way of thinking
rests on assumptions that there are multiple legitimate approaches to social inquiry and
that any given approach to social inquiry is inevitably partial (Greene, 2008). The
obligation to be open to the use of mixed methods is based on the need to find the most
35
appropriate methodology to meet the purpose of any specific research project, and to
answer its questions (Bazeley, 2015). As this study will not support known data. the use
of the mixed method approach was not an appropriate choice of methodology either.
Implementing lean manufacturing initiatives can be an option to achieve long-term
sustainability of success and profitability. This study involves exploring the various
strategies surgical product business leaders use to increase profitability.
Research Design
A case study research design allows for the identification, investigation, and
interpretation of data to gain understanding as to the strategies employed by business
leaders for the implementation of lean initiatives to drive profitability. The case study
research design is suitable for studies where the researcher’s goal is to search in-depth by
collecting data from various sources (Yin, 2014). The aim of this study is to gain an
understanding of the participants’ viewpoints regarding the lean implementation process
and the strategies business leaders have implemented to sustain profits within the
organization. The goal is to seek greater understanding of the strategies business leaders
use to become successful at implementing lean manufacturing initiatives. This research
design allows the reseearcher to collect in-depth information that is valid while
identifying participants’ viewpoints of the problems encountered during lean
implementation and the strategies used to make it successful.
Ethnographic studies are culturally related and are concerned with presenting
shared experiences of language and behavior (Koning & Can-Seng, 2013). Ethnographic
designs are most appropriate for gathering observed data on cultures and human societies
36
(Koning, & Can-Seng, 2013). An ethnography includes organizational cultures, which in
turn using an ethnographic design, but the use of such a design would limit the researcher
to observations without participatory involvement. Narrative design involves the
researcher engaging individuals to learn about the stories that have influenced their lives
(Brooks, 2012). When the researcher finds details concerning emotions, feelings, and
processes it is the basis of a narrative design which moves the plot forward (Flory &
Iglesias, 2010).
A case study was used as it involved the observation and description of the
behavior of a subject without influencing the subject in any way (Jalil, 2013). A
descriptive research design broadens the data collection method to include interviews.
The descriptive research design allows participants to express their likes and dislikes as
pertaining to the process of implementing lean manufacturing processes within an
organizational setting (Manuel, & Delgado, 2011). The goal of the data collected was to
identify the strategies leaders of surgical supply products use to implement lean
manufacturing initiatives while identifying the variables to improve operation strategies
associated with lean manufacturing implementation.
Population and Sampling
There is a global increase in the number of manufacturing companies
implementing lean processes in recent years (Miina, 2013). Lean thinking increases the
sustainability of manufacturing companies by improving productivity and efficiency
(Miina, 2013). Using the criteria of manufacturing companies who have implemented
lean manufacturing within the past 10 years, the researcher chose to study manufacturing
37
companies within the surgical supply industry for the study because of their recent
experiences with lean manufacturing, access to information on sustainability, length of
existence, and the ease of access to the company’s information. One of the three top
surgical supply product manufacturers of interest is located in South Florida.
A population is a group of people regarded as a subset or class within a larger
group (Krieger, 2012). The population for the study consists of employees of a medical
device manufacturing company located in the South Florida. To narrow the qualitative
case study, a single company was selected.
According to Yin (2011), it is appropriate to a case study with multiple
participants if all those participants are from a single company within the same location.
The targeted subsidiary of the company is in the southeast region of the United States.
Manufacturing companies within the same industry adopted lean manufacturing as an
element to support their sustainability long-term. The company selected for the case
study was a representative of other companies in the same industry.
The researcher employed a purposive sampling method to select the sample size
for the qualitative case study. This case study consisted of participants both male and
female, with respondent selection based on purposeful sampling. Purposeful sampling
requires access to key informers in the arena who can identify important information
filled cases (Suri, 2011). In light of this and in light of what this study seeks to explore,
purposeful sampling is the appropriate sampling method for this qualitative case study.
Yin (2014) stated that the demands of case study research require the intellect,
ego, and emotions of the researcher, which are far greater than those of any other
38
research method are. Most studies reach theoretical saturation roughly in the same range
(Marshall, Cardon, Poddar, & Fontenot, 2013). A researcher usually conducts several
interviews past the point of theoretical saturation to justify data saturation (to indicate
that the dataset is becoming redundant) as the data collection procedures are not
routinized (Marshall, Cardon, Poddar, & Fontenot, 2013). Among the most difficult types
of qualitative research to classify are case studies (Marshall, Cardon, Poddar, & Fontenot,
2013). Yin (2014) recommends a minimum of six sources of evidence. Morse (2000)
recommends 20 to 30 interviewees with 2 to 3 interviews per person. Based on the
information obtained a purposeful sample of three participants was determined to be an
appropriate sample size for this qualitative case study.
Participants for the study ranged from shop floor employees to department
managers. Some participants had extensive lean manufacturing experience and some had
minimal experience. Each participate had initial involvement with lean activities or had
prior experience addressing the strategies that impeded or contributed to lean
manufacturing sustainability within the organization.
Ethical Research
Managing responsible research includes making sure conclusions are relevant,
valid, and supportable following ethical principles. There are five ethical principles that
are considered characteristics of responsible qualitative research: (a) protection of
vulnerable populations, (b) beneficence, (c) respect for participants, (d) autonomy, and
(e) justice (Choi, Sae, & Jai, 2010; Wester, 2011). According to the authors Drake,
39
Gerde, & Wasieleski (2011), ethical research should respect, inform, contribute to the
professional knowledge of, and minimize the risk of research participants.
Participation in the study was on a voluntary basis. Study participants received
information about the study and a consent form to read and sign, indicating that they
agreed with the study guidelines as stated. Study participants were verbally informed and
informed in writing that they could withdraw from participating in the study at any time.
Excluded from participating in the study were individuals under the age of 18 years old.
No incentives were provided.
A copy of the study’s findings and conclusions was made available to each
participant upon request. The identity of the participants remains confidential, but the
name of the targeted company will not, though data has been de-identified to maintain
anonymity. Participants received unique aliases in order to protect their identity. To
protect the identities of each of the three participants, the voice recordings and transcript
of each interview will remain in a lockbox for 5 years. The researcherwill retain sole
access to the lockbox and destroy the voice recordings after 5 years.
Data Collection Instruments (Qualitative Only)
For content guidance, consult the DBA Doctoral Study Rubric and Research
Handbook.
Data Collection Technique
For content guidance, consult the DBA Doctoral Study Rubric and Research
Handbook.
40
Data Organization Technique (Qualitative Only)
For content guidance, consult the DBA Doctoral Study Rubric and Research
Handbook.
Data Analysis (Quantitative Only)
Data analysis involves discussing the statistical test(s) you will use to answer each
research question and justifying its/their selection. Indicate the nature of the scale for
each variable (e.g., nominal, ordinal, interval, and ratio). Why is the selected statistical
test more appropriate than another? (Hint: The statistical test is usually selected due to the
nature of the question and scale of measurement of the variables you defined.) Describe
how you will deal with discrepant cases (e.g., missing data, data that cannot be
interpreted). Identify the software that will be used to analyze the data.
For additional content guidance on this section, consult the DBA Doctoral Study
Rubric and Research Handbook.
Data Analysis (Qualitative Only)
For content guidance, consult the DBA Doctoral Study Rubric and Research
Handbook.
Study Validity (Quantitative Only)
For information on the content of this subsection, consult the DBA Doctoral
Study Rubric and Research Handbook.
41
Reliability and Validity (Qualitative Only)
Reliability
For information on the content of this subsection, consult the DBA Doctoral
Study Rubric and Research Handbook.
Validity
For more information on the content of this subsection, consult the DBA Doctoral
Study Rubric and Research Handbook.
Transition and Summary
End with a transition that contains a summary of key points and provides an
overview of Section 3. Do not include any new information in the summary
This is the end of the proposal.
42
Section 3: Application to Professional Practice and Implications for Change
Introduction
Begin with the purpose of the study. Do not repeat the entire purpose statement;
typically the first sentence of the purpose statement will suffice. Provide a brief summary
of the findings, not to exceed one page.
Presentation of the Findings (Quantitative Only)
Describe the statistical test(s), the variables, and the purpose of the test(s) and
how they relate to the hypotheses. Present relevant descriptive statistics (i.e., mean,
standard deviation for scale variables; frequencies, and percentages for nominal
variables). Provide evaluation of statistical assumptions. Report inferential statistical
analyses results, organized by research question, in APA statistical notation/format.
Include alpha level chosen for the test, test value, p (significance) values, effect size,
degrees of freedom, confidence intervals (when appropriate), and so on. Include
appropriate tables and figures to illustrate results, as per the current edition of the
Publication Manual of the American Psychological Association. Consult the Instructions
for the DBA Template document for correct APA style for formatting and labeling tables
and figures. Summarize answers to research questions. Describe in what ways findings
confirm, disconfirm, or extend knowledge of the theoretical framework and
relationship(s) among variables by comparing the findings with other peer-reviewed
studies from the literature review. Includes studies addressed during the proposal stage
and studies added since writing the proposal. Tie findings or dispute findings to the
existing literature on effective business practice. Analyze and interpret the findings in the
43
context of the theoretical framework, as appropriate. Ensure interpretations do not exceed
the data, findings, and scope.
Presentation of the Findings (Qualitative Only)
List the overarching research question. Identifies each theme, and analyzes and
discuss findings in relation to the themes. Describe in what ways findings confirm,
disconfirm, or extend knowledge in the discipline by comparing the findings with other
peer-reviewed studies from the literature review; includes literature added since writing
the proposal. Tie findings to the conceptual framework, and tie findings or dispute
findings to the existing literature on effective business practice.
Applications to Professional Practice
Provide a detailed discussion on the applicability of the findings with respect to
the professional practice of business. This major subsection provides a rich academic
argument why and how the findings are relevant to improved business practice.
Implications for Social Change
The implications are expressed in terms of tangible improvements to individuals,
communities, organizations, institutions, cultures, or societies, as the finding could affect
social change/behavior.
Recommendations for Action
Recommendations (a) should flow logically from the conclusions and contain
steps to useful action, (b) state who needs to pay attention to the results, and (c) indicate
how the results might be disseminated via literature conferences, training, and so on.
44
Recommendations for Further Research
List recommendations for further study related to improved practice in business.
Identify how limitations identified in Section 1, Limitations, can be addressed in future
research.
Reflections
Include a reflection on your experience within the DBA Doctoral Study process,
in which you discuss possible personal biases or preconceived ideas and values, the
possible effects of those on the participants or the situation, and changes in your thinking
after completing the study.
Summary and Study Conclusions
The work closes with a strong concluding statement making the take-home
message clear to the reader.
45
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Appendix A: Title of Appendix
Insert appendix here. Appendices are ordered with letters rather than numbers. If
there is but one appendix, it has no letter designation.
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appendix; no label is needed for the table itself. If you have text in addition to a table or
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A2, Table B1, and so on). These tables would be listed in the List of Tables at the end of
the Table of Contents.
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domain, you must also include permission to do so.
Template updated 2/18/15.