Running head PROJECT MANAGEMENT BY USING AGILE METHODOLOGY 1PR.docx

Running head: PROJECT MANAGEMENT BY USING AGILE
METHODOLOGY 1
PROJECT MANAGEMENT BY USING AGILE
METHODOLOGY 27
Project Management by Using Agile Methodology
Name: Soumitra Girish Shilotri
Institution: Harrisburg University of Science and Technology
Project Management by Using Agile MethodologyAbstract
In project managements and especially, the management of
software projects, there have been a change from the traditional
project planning to agile project planning. Agile project
management for a while has been viewed as new
transformations that will help in revolutionizing the software
industry.
It is evident that agile project management is arising as an

emerging way for development software projects. The idea of
agile is something that has been existence for some decades,
and even though information and utilization are improving,
agile project management is not the automatic remedy.
Comprehending the right time to utilize agile and the type of
success factor to consider, it is significant to accomplish goals
and objectives.
Agile project management is perceived as a modern and new
methodology that keeps rising. It advocates that the application
of agile practices that is not adequate. Indeed, to effectively and
efficiently start a new business enterprise, projects or products,
there is need to strengthen emphasis on the customers. Even if
the word agile had been existence for some years, a new agile
methodology is still in the process of formation with the urge of
doing agile even to higher level.
The main aim of this particular research paper is to change the
mindset of project managers for using agile methodologies for
projects in FDA regulated industries. More specifically, there is
a need for checking the agile practices that are essential for the
project to be success. In essence, to figure this out, there is a
case of considering some previous researches about the agile
projects.
This research paper continues to explore how agile development
method, prevalent in several industries and currently recognized
as the standard guideline by the FDA industries. It addresses
shortcomings in the waterfall development and how it can be
used for the sake of meeting the safety, reliability, and
regulation demands of the medical devices and diagnostic
industries.
Key Words
Agile practices, project management, FDA industries, Kanban,
Scrum, Project Management Life Cycle, agile methodologies.

Table of Contents
Abstract2
Key Words3
Introduction5
Problem Statement and Justification6
Problem Statement6
Research Questions7
Justification7
Hypothesis9
Literature Review10
Incorporation of Agile Methodology in FDA Regulated
Industry24
Conclusion and Summary28
References31
Introduction

The theme of the research paper is about changing the mindset
of project managers for applying agile project management for
projects in FDA regulated industries. The emphasis lies on the
agile methodologies and agile practices. Intrinsically, agile
project management is something new in the development of
some projects. More and more organizations are applying agile
methodologies in delivering projects in a faster and smarter way
(Stettina & Hörz, 2015). Indeed, Agile methodologies were
initially designed for projects that deal with software, but since
it is beneficial, it is now utilized in a variety of projects (Larson
& Chang, 2016).
Agile software development was systematically reviewed in
2008 (Diebold et al., 2015). It was concluded that a lot of
studies need to be done through the development of the agile
methodologies as well as several benefits and limitations that
are identifiable; its effectiveness may be low. Based on the
review, quality studies about agile methodologies need to be
developed. As such, the research paper is thus relevant for the
purpose of achieving the effectiveness of the agile
methodologies in the FDA industry.
Many projects have failed or contested every year. Through the
CHAOS Manifesto, it was noted that only 37% of all projects
are termed successful, 44% of the projects were contested (there
are either late or having missing features), and 19% of projects
were termed failed (there were either canceled or forwarded but
not utilized). Indeed, there have been gradual improvements on
the rates of success, up from 30% in 2005 (Torrecilla-Salinas et
al., 2015).
The paper continues to indicate the size of the project is more
crucial than whether or the methodologies applied are agile or
traditional. It is argued that the reasons for the use of an agile
methodology that make more accessible in the creation of both
small and large. However, large projects are ten times more
likely to fail, unlike small projects.
Agile knowledge, as well as the usage of agile, is increasing.
According to the 9th State of Agile Survey shows that 46% of

the participants are applying agile methodologies in most of the
projects (Stettina & Hörz, 2015). Besides, at least 92% of the
organizations as reported by the survey have some usage of the
agile development (Larson & Chang, 2016). Eventually, scrum
is given highest preference as the agile methodology, which is
utilized by 55% of the agile team members (Torrecilla-Salinas
et al., 2015). Therefore, the usage will possibly increase in most
of the projects regardless of the industry.
The research paper is hence organized into other parts which
consist of (1) Problem Statement and Justification, (2) relevant
literature review regarding the agile methodologies, (3)
Incorporation of Agile Methodology in FDA Regulated Industry
and (4) conclusion and summary.Problem Statement and
JustificationProblem Statement
An ordinary alert in several software industries is that through
the application of the agile project management styles, the
project has higher probability of succeeding. Despite the fact
that the strength of the empirical evidence does not reach the
threshold, agile has been perceived for some time to be
something that would revolutionize the development of projects
that are associated with software as the FDA industry
(Torrecilla-Salinas et al., 2015). Several studies on the agile
projects elucidate that there might be some certainty in this
particular subject. Bilgaiyan, Mishra & Das, (2016) performed
large-scale research for the sake of testing if using agile
methodologies influences the success of projects. They noted
some indications that the application of the agile methodologies
is indeed correlated to high success rates. It was depicted for
some groups of success including efficiency, general project
success, and success of stakeholders (Stettina & Hörz, 2015;
Kostalova, Tetrevova & Svedik, 2015). Ordinarily, the search in
this paper will succeed in agile based projects with an emphasis
on how agile practices will be factored in terms of their
importance for the sake of achieving project success.
Research Questions
The research question guiding this research comprises of the

following:
1. How to change the mindset of project managers for using
agile methodologies for projects in FDA regulated industries?
2. What should managers do in order to incorporate agile in
FDA Regulated Industry?
3. How can agile project management-based practices result in
the improvements of project success in the upcoming FDA
Regulated Industry?Justification
Project management is a normal phenomenon in various
organizations. In essence, several companies encounter many
challenges while dealing with multiple projects simultaneously;
therefore, they are not capable of finishing it at the right time.
Further to wastage of time, projects are becoming quite
expensive in terms of usage of resources as well as failure to
achieve the projected objectives. Hence, there is a need to
incorporate agile in the management of companies to assist in
proper planning, management as well as the implementation of
projects in the FDA regulated industry. Usman, Mendes &
Börstler, (2015) explains agile project managements as methods
that help in assigning various tasks associated with the intended
projects to be used in the accomplishing goals of the company
regardless of the strict deadlines.
Despite the existing traditional methodology, agile methodology
implementation is still tricky particularly during a situation
when standard needs to be maintained. Since agile has been
seen to help in the definition and to secure the project success
factors, any problem can shift the whole project. As a result,
companies may end up experiencing problems such as delays
when the right methodology is not used. Besides, the quality of
the project can also be changed and finally affect the reputation
and the whole image of an organization (Torrecilla-Salinas et
al., 2015). In most cases, problems are caused due to poor
implementation of the right methodology while attempting to
get the right way of achieving the project's objectives.
According to Usman, Mendes & Börstler, (2015), an appropriate
methodology lies agile methodologies is an effective way of

getting solutions to the problems affecting the accomplishment
of the issues. In most scenarios, issues are created due to
inadequate focus on the priorities of the project's goals and
objectives. Activities and tasks are supposed to be done in a
way that will allow the project to succeed (Usman, Mendes &
Börstler, 2015). Therefore, project managers need to change
their mindset in the application of the agile methodologies for
projects in FDA regulated industries for the sake of
accomplishment of the project goals and objectives with the
scheduled timeframe.
The world is becoming more advanced in technology; thus
business enterprises must focus on the relevant issues to be
competitive in the corporate world. Ideally, some of the things
that make a company outstanding in the market are how it
manages and conducts its projects (Stettina & Hörz, 2015;
Kostalova, Tetrevova & Svedik, 2015). Often, many companies
are struggling to be more innovative as well as being
technologically advanced. Hence, such companies are faced
with a lot of complicated issues. As such, agile project
management is perceived as a viable remedy to assist in dealing
with the activities within the project. Unfortunately, there are
several factors to consider in the incorporation of the agile
project management methodology to achieve projects’
objectives. Organizations that adopt agile project management
methodology should expect positive improvements in the
project success. Nonetheless, without appropriate redress of the
factors, the expected gains can be an unachievable dream.
The significance of this study is based on the main objective,
"to change the mindset of project managers for using agile
methodologies for projects in FDA regulated industries." The
application of agile project management is inevitable,
particularly, in this period of technological advancement,
whereby organizations are confronted with sophisticated and
multiple projects that may need appropriate initiation and
planning (Stettina & Hörz, 2015; Kostalova, Tetrevova &
Svedik, 2015). Agile project management is critical in the

organization and preparation of the projects. It is vital in the
clarification of the performance metrics as well as the
accounting and oversight of the project activities. Consequently,
project managers have to be competent enough in the
identification and finding of remedy to any problems that can
hinder the successful adoption of the agile project manager in
the projects. It is crucial in the utilization of resources
effectively whereas conducting any project. Intrinsically, this
research assists in understanding how project managers can use
agile in project management.
Hypothesis
The study targets to test the following hypothesis anchored on
the analysis of a variety of existing literature on agile project
management:
1. Effects of using agile methodologies for projects in FDA
regulated industries by project managers.
2. Actions of managers in incorporating agile methodologies in
FDA Regulated Industry
3. Contribution of agile practices in the improvements of
project success in the upcoming FDA Regulated
Industry.Literature Review
In this chapter, begins by describing the project management in
general and specifically in the United States Food and Drug
Administration. Moreover, there is a provision of the review of
essential agile methodologies and practices and discuss some
existing studies that are performed on the agile project
management parameters. Eventually, there will be summarized
links between the literature review and the research questions.
Definition of Software Project Success
There are many means of defining the projects’ success.
Inherently, the traditional methodology is the application of the
project management paradigm in which the scope of cost and
time ends in forming a triangle (Rigby, Sutherland & Takeuchi,
2016). Quality is always included as an element that is separate
in the triangle.

The scope is described as a set of functional features that should
be delivered during the lifetime of a project. Time refers to the
actual duration that is needed for the completion of projects
within their scope. On the other hand, the costs are the number
of resources necessary for the projects to be completed. Ideally,
making any change to one of the features in the triangle affects
other elements in the triangle (Serrador & Pinto, 2015;
Papadopoulos, 2015; Dingsøyr & Lassenius, 2016).
Quality is crucial in the development of software products.
Indeed, the quality is described in many approaches, however,
for the products that use software; there are always some forms
of quality such as functional, process, and structural quality
(Pope-Ruark, 2015).
Structural quality can be defined as the source of quality code
of products. It comprises of the maintainability, efficiency, and
robustness among others as well as how it conforms to the
definition of coding practices (Kupiainen, Mäntylä, & Itkonen,
2015).
Functional quality refers to ways in which the products work for
the targeted users, mainly, the manner in which the software is
conforming to the described necessities and designs, the number
of bugs, the level of the excellent performance and its easiness
to use and learn (Mergel, 2016).
Process quality is described as the means at which systems are
formed with the existing processes. The main elements of the
process quality comprise achieving the rates of delivery,
attaining the required budgets, and repetitive development
processes that reliable in the delivery of quality software
(Kupiainen, Mäntylä, & Itkonen, 2015).
For the projects to be termed as successful when they are
completed on time, in the prescribed budget plus all the
necessary elements and functions. Nevertheless, it is
challenging for determination whether specific projects are
successful or not. A variety of people most likely stakeholders
are involved in the project may have different perceptions of

what consists of success (Silva et al., 2015; Dingsøyr &
Lassenius, 2016). Whereas external stakeholders typically
consider time and cost, internal stakeholders always utilize
quality and scope as the best ways of determining success
(Torrecilla-Salinas et al., 2015; Mergel, 2016). Alzoubi, Gill &
Al-Ani, (2016) describes quality as effective evaluation by
customers of respective behavoral objects that create customers'
satisfactions. As a vital component of the functional quality,
customers' satisfaction is considered as the essential component
of quality (Vijayasarathy & Butler, 2016). It has support from
the 9th Annual State of Agile Survey (Mergel, 2016) in which
customers/users' satisfactions were positioned number three
notably depending on the measurement of success (Sommer et
al., 2015). Product quality and on-time delivery ranked first and
second in the order. Besides, the product score and business
values ranked positions four and five respectively.
Project Management
Projects are defined as temporary activities that lead to unique
products, services or results. Indeed, projects have a planned
beginning and the end. In reality, the end of the project is
reached when the goals and objectives of the project have been
met, or the project is stopped due to some reasons. Therefore,
project management is seen as a way of utilizing skills,
information, and approaches in various project tasks for the
sake of meeting the project requirements (Perkusich et al.,
2015; Saltz & Crowston, 2017; Diebold et al., 2015). According
to Flora, (2018), the project management comprises of five
processes such as initiation, planning, executing, monitoring
and controlling, and closing (Sommer et al., 2015). In the
traditional project management (TPM) most of these processes
are performed linearly and incrementally (Vijayasarathy &
Butler, 2016). In Agile Project Management, these processes are
delivered in a more iterative and adaptive means (Perkusich et
al., 2015).
Based on these processes, Flora, (2018) describes various

project management life cycle processes. Intuitively, processes
include iterative, incremental, and extreme among other
processes. The decision about the project management life cycle
model to opt for solely depends on the goal uncertainty and the
solution level (Kupiainen, Mäntylä, & Itkonen, 2015). The
linear and incremental project management life cycle lies under
the traditional project management. Indeed, they have levels of
the solution that are low, and the objective of the project is
specific (Saltz & Crowston, 2017), while the adaptive and
iterative project management life cycle lies under the Agile
project managements. They have high levels of solutions and
the objective of the projects still specific (Vijayasarathy &
Butler, 2016). Finally, the extreme project management life
cycle is lying under the extreme project management. They have
high levels of the solution with goals of project uncertain
(Sommer et al., 2015). Figure 1 is giving all the illustration.
Figure 1: Project Management Life Cycle
Traditional Project Management Life Cycle
In the linear process, each project management model is done in
the necessary sequence. Indeed, the model is not encouraging
changes in the scope. Products are completed as described by
the scopes that are formed at the beginning of the projects.
The incremental process is somehow same as the linear process,
but the scopes are done in the form of increment. It offers the
provision of the best customer feedback as well as changes in
the scope as encouraged in the model. The benefits are different
from the linear model because the end products are closer to the
demands of the customers.
Agile Project Management
Situations where the goals are clear but solutions and how to
find them becomes unclear then an agile project management
model is utilized (Stettina & Hörz, 2015; Kostalova, Tetrevova

& Svedik, 2015; Vijayasarathy & Butler, 2016). In essence,
these forms of project are described as complicated and need a
method that is non-traditional for the successful execution of
the project (Saltz & Crowston, 2017).
In the traditional project management, every action is planned
out into upfront details. It is known as the plan-driven
approach. On the other hand, the agile project management
project is a change driven (Rigby, Sutherland & Takeuchi,
2016). It implies that rather than avoiding changes in the
projects, changes should be welcomed. It results in more
dynamic relationships between the teams that create products
and the external stakeholders (Kupiainen, Mäntylä, & Itkonen,
2015). In essence, stakeholders must be involved in the process,
but the results of the project need to be close to their demands.
Since the end solutions are uncertain at the start, they are
described during projects as feedback according to the
customers and various stakeholders.
Agile Project Management Life Cycle
The iterative process is used improving the incremental model
through inclusion of the planning in the loop of implementation.
Indeed, every circuit generates potentially shippable codes that
stakeholders can provide feedback on them (Kostalova,
Tetrevova & Svedik, 2015). Often feedback is welcome and
considered as a vital component of the process. According to
the input as well as the general mission of the products, another
iteration is always organized, managed, and employed (Silva et
al., 2015). In this case, solutions are not adequately noted at
the start, but it is described through the lifecycle of the project.
In figure 2 designed by Yamato et al., (2015) depicts an
iterative model and how most of the processes such as planning
tends to be repeated in the loop.
Agile methods can be categorized as both iterative and
incremental. It is incremental since the work undergoes pre-
division into small batches and iterative since the scopes of all
batches are described just prior to the beginning of loops.

Intrinsically, the iterative natures make the whole processes to
be quite flexible.
Figure 2: Iterative Project Management Life Cycle Model
Agile Project management can also be defined as the adaptive
process that is quite same as the iterative processes though they
have short loop periods, making it much easy in responding to
the shifting necessities (Kostalova, Tetrevova & Svedik, 2015).
The primary difference between the iterative and adaptive
models are most of the solutions are uncertain in the adaptive
models. Indeed, the fewer that are determined, the higher the
risks and complicated it would be. Whenever complication
becomes too high, the adaptive models becoming a bit favorable
(Saltz & Crowston, 2017).
Agile Methods
A variety of approaches has various practices. When opting for
techniques for provided projects, these practices need to be
factored in making sure they are suitable precisely in the
projects (Kostalova, Tetrevova & Svedik, 2015). In reality, not
all methods describe to all the practices, but instead they focus
on other aspects. Scrum has the capability of explaining
practices in terms of events and artifacts (Silva et al., 2015).
Extreme programming can describe more than 24 practices in
words of engineering practices.
On the other hand, Kanban comprises of the description of the
five principles that at times are viewed as the practices.
Methods are considered as a group of best practices, values, and
laws that have proved to work for certain forms of projects
(Bilgaiyan, Mishra & Das, 2016). This chapter discusses some
of the commonly applied agile methods.
Kanban
Kanban inclines to mindset instead of methodology. It implies
that it offers little specific rules in the manner which process is

followed, but instead it focuses on possessing the exact attitude
(Sohi et al., 2016). Kanban does not have many principles, and
Khmelevsky Li & Madnick, (2017) identify at least five
principles for the sake of creating of a lean behavior in projects:
limiting work-in-progress, managing flow, visualizing
workflow, making the process to be explicit, and improving
collaboration (Dingsøyr & Lassenius, 2016).
Every item chosen for the development originates from the
prioritized backlog described as a Kanban board. Kanban boards
have several columns where every column is depicted to
represent status. Every item comes from the column and always
moves from one point to another point when they are being
worked on (Bilgaiyan, Mishra & Das, 2016). The work-in-
progress limit sets every column by showing the number of
items that can be held by a column at any given time. In case,
there are too many items appearing to be clustered in one
column, and the whole is responsible for solving those problems
in order to ensure that the flow is working again (Perkusich et
al., 2015).
Figure 3: An Example of Kanban Board
In figure 3, items are placed in a column and appeared to be
higher, and they have higher priorities. They make Kanban an
excellent option for maintaining activities where priorities
always change.
Scrum
Scrum is a framework that is both incremental and iterative,
mainly formed for the management of software in some projects
in the agile ways. Intrinsically, scrum was described around the
mid-1990s, but its popularity increased from 2001 after
founding the Agile Alliance (Sohi et al., 2016). The Scrum
framework has a definition that revolves around roles, events,
and artifacts (Usman, Mendes & Börstler, 2015). Besides, the
Scrum framework is depicted to define only three roles
including product owners, team members, and scrum meters

(Bilgaiyan, Mishra & Das, 2016). The product owner is
involved in controlling the product backlog as well as defining
the requirement. The Scrum masters are ensuring that processes
are duly followed and resolving the impediment. Lastly, team
comprises of other persons such as developer, designer, and
testers among others.
Scrum consists of some events including sprint plan, day to day
standups, sprint retrospectives, and sprint reviews. Every event
has been time-boxed and must facilitate the fast response as
well as a constant flow of information that exist between
stakeholders and team members (Usman, Mendes & Börstler,
2015). A sprint ordinarily is a two-four weekly cycles in which
team members work on an agreed activities (Sohi et al., 2016).
The most significant artifacts comprise of the product backlogs,
sprint backlogs, and product increments (Khmelevsky Li &
Madnick, 2017). The product backlogs contain requirements
that should be developed in the future sprints. The sprint
backlogs include requirements that are recently being operated
on as the active component of the sprints that are ongoing.
Eventually, the products’ increments are the results of the
duties which were performed during sprints.
Figure 4: Scrum Process Flow
In the figure 4 above, the scrum model flow is illustrated. In
every sprint, during the plan, the product owners and the team
members decide on the sets of items that come from the
products’ backlogs for the sake of putting them into the sprint
backlogs (Sohi et al., 2016). The team members work during the
sprint to form shippable products that are potential increments
according to the goods found in the sprints’ backlogs (Diebold
et al., 2015). Daily, there is a scrum meeting to share
information and find solutions to the problems.
Extreme Programming
Extreme programming is referred bas software centered on the
agile methods. Objectively, Usman, Mendes & Börstler who are

one of the first initiators of the agile manifestos and
participated in the creation of extreme programming in 1999
(Usman, Mendes & Börstler, 2015). Currently, extreme
programming has defined about five core values, fifteen
principles, thirteen leading practices, and eleven corollary
practices (Perkusich et al., 2015). Ideally, these aspects are to
be used in the improvement of code quality as well as product
value, and creation of the best development practices (Sommer
et al., 2015; Flora, 2018). Besides, extreme programming
advocates for the short development iterations and emphasizes
on transforming several practices into appropriate action. The
leading practices are quickly adopted and should provide instant
results (Khmelevsky Li & Madnick, 2017). On the other hand,
the corollary practices are somehow sophisticated and demand
more experience in the implementation in the projects
(Torrecilla-Salinas et al., 2015).
The FDA and Agile
Whereas various professionals in the industry believe that FDA
regulations need waterfall, neither quality system regulation nor
other regulations are based on the prescribed development
methodology. There is a sense of confusion that comes up in
various standards that FDA does not consider though written in
a manner to elucidate waterfall (Sohi et al., 2016). Ideally, the
FDA completely cautions against applying the waterfall for
sophisticated devices: the model of the waterfall is useful in
activities that are limited while for advanced devices, another
model is preferred (Diebold et al., 2015). Despite the challenges
in the adoption of agile, several firms in the industry such as
Pathfinder give recognition to the agile value and the adopted
methodology for the sake of complying with the applicable
standards and guidelines. Indeed, they have to apply them in
developing and launching FDA products that are cleared and
approved (Layton & Ostermiller, 2017). For the sake of

providing clarity as well as the guidance on aligning the agile at
both concept and practical levels.
Incorporation of Agile in FDA Regulated Industry by Project
Managers
The Agile can be incorporated in the industry by the project
managers through three major principles that can be used in
promoting safety for medical tool software: risk management,
quality management, and software engineering (Diebold et al.,
2015). Indeed, agile can be used in addressing all these
principles in a manner that is superior to the traditional
waterfall (Torrecilla-Salinas et al., 2015).
It can start by comparing risk management with Agile. Like
other perspectives of the software development processes, not
all risks are detected at the start of the project and at the same
time majority of the hazards are discovered as the system is
evolving (Layton & Ostermiller, 2017). As acknowledged in the
ISO 14971, the international standards for the risk management
system for the medical devices: risk is always introduced in the
product lifecycle and fact, risk becomes apparent in the product
life cycle that can be managed through activities that can take
an entirely different occasion in the product life cycle (Larson
& Chang, 2016). The application of the agile can be depicted in
the risk management at every level of the product life cycle,
with output and output from every task within a particular level
— besides, risk analysis, evaluation, and risk controls that are
done in the sprints or iterations. There are aspects of
maintaining backlogs of requirements with related risk scores
for each task (Layton & Ostermiller, 2017). For any problem,
increment, risk assessment forms part of the definition done.
The new hazards have been introduced; the DFMEA needs to be
updated (Stettina & Hörz, 2015). Customers' stories are used in
the implementation of mitigations as well as reviewing the
results in the demonstration of iteration. Early embedment of
risk management in the process, there is discovery and
elimination or mitigation of more risks and doing much earlier

in the phase of change. The approach is thoroughly illustrated in
the modified of AAMI TIR45: 2012 version in figure 5.
Figure 5: Modified version of AAMI TIR45: 2012
Attaining Quality at Speed with Agile
Quality is one of the primary objectives of the agile
methodology, and a variety of central core agile practices that
are designed for the sake of improving software quality at the
same time maintaining the speed of the project (Larson &
Chang, 2016). Intuitively, traditional software development
members always spend a third or half of their time on defecting
the troubleshooting and reworking, and agile practices have a
design to be used in catching and fixing early defects when they
are comfortable and cheap to catch and fix (Torrecilla-Salinas et
al., 2015).
Incorporation of the human factors in agile to improve
effectiveness and risk mitigation. Intrinsically, human factors in
the software become more significant. With more complication,
excellent access and availability and mostly the user types that
come with the richness of opportunity for the users' error
(Stettina & Hörz, 2015). Majority of the risks for sophisticated
medical devices are directly associated with human factors such
as permitted misuses, user interface design, user interface
confusions, and user complacency which are not adapted to the
users' workflow (Larson & Chang, 2016).
Conclusion
In this chapter, several topics are created in the theoretical
foundation for the research. There is a description of the
identified in the project success for the software projects
through considering four components; quality, time, scope, and
cost. There is background information about traditional project
management and agile project management. Besides, there are
many ways of using agile. Various agile methodologies have
several practices, devices, and ways. Indeed, there are several

practices and not equivalently essential in attaining success.
Most of the agile practices used in the identification of the State
of Agile Survey. Ideally, the combination of all these identified
practices from the topics covered and finally describing
practices mostly significant for agile projects.
The Agile can be incorporated in the industry by the project
managers through three major principles that can be used in
promoting safety for medical tool software: risk management,
quality management, and software engineering. The
combination of agile practices and methodologies can be used to
change the mindset of project managers in conducting projects
in FDA regulated industries.Incorporation of Agile
Methodology in FDA Regulated Industry
When agile methodology was initially introduced, there were
some comprehendible resistances because it had not been
proved as a new approach. While some organizations were
adopting agile in different industries, a variety of researches
were performed for the sake of analyzing the effectiveness of
agile (Saltz & Crowston, 2017). The Standish group did a report
known as CHAOS report which is published yearly since 1994;
it is one of the studies that are respected among the software
projects (Kostalova, Tetrevova & Svedik, 2015; Vijayasarathy
& Butler, 2016). Indeed, it has continuously depicted a high
correlation between the agile and the success of several
organizations since its adoption in the mid-2000s.
By 2012, the Standish Group applied one of the best languages
to explain the significance of agile: "an agile process is
universally a solution for the software development project
failures. In fact, the software applications that are developed
through the process have higher success rates than traditional
project management and with much lower cost as well as time-
saving (Vijayasarathy & Butler, 2016). Other researches
comprise of the medical service industry, which has depicted
continuous improvements in the project quality and success
(Mergel, 2016).
Agile project management is suitable for the FDA regulated

environment. Over the last two decades, agile has been used and
depicted better results in several industries such as the FDA
regulated industries in terms of reliability and safety. Since the
agile methodologies have proved to produce better results,
therefore they can be used in the medical service and diagnostic
industry despite being adopted in the slow pace (Stettina &
Hörz, 2015; Kostalova, Tetrevova & Svedik, 2015;
Vijayasarathy & Butler, 2016). The objections to the adoption
of agile in the medical device industry have focused on the
following issues:
Medical devices should be reliable, effective and preferable
safe, as well as they cannot pose some added risks to the
patients. Agile methodologies do not have enough rigor and
complexity to be applied in safety critical systems
(Vijayasarathy & Butler, 2016). Agile methodologies eschew
planning, processes that are controlled, and documentation,
most of which are needed by the Quality System and Regulation
of FDA (Torrecilla-Salinas et al., 2015).
Even if agile methodologies had proper processes to comply
with the FDA regulations, it would not matter since the FDA is
not prescribing to the waterfall processes (Saltz & Crowston,
2017).
As can be seen all these concerns are based on the
misconception. In reality, agile methodologies applied
appropriately leads to the improvement of reliability,
effectiveness, and safety if it is compatible with the Quality
System and Regulation of FDA, and indeed, recognized as part
of the standard by the FDA (Rigby, Sutherland & Takeuchi,
2016).
Whereas various professionals in the industry believe that
regulations of FDA need waterfall, neither of the Quality
System and Regulation of FDA nor other regulations can be
formed to prescribe to the specific development of the
methodology. There is confusion that arises since most of the
standards do not recognize several ways elucidated by the
traditional project management (Kostalova, Tetrevova &

Svedik, 2015). Intrinsically, the FDA completely cautions
against the usage of the traditional project management for the
sophisticated devices: the practice of the waterfall's model is
useful though limited for complicated devices same as the
engineering models which are more representatives (Saltz &
Crowston, 2017).
Even though there are barriers in the adoption of agile, several
companies in the industry such as Pathfinder, indeed have
recognized the usefulness of agile methodologies and have
adopted the methodology in all its standards and guidelines
(Mergel, 2016); therefore, it has used it in the development and
launching of products that are cleared and approved by the
FDA.
Agile methodologies through the promotion of safety of medical
device software are addressed through the following principles;
risk management, quality management, and software
engineering. All these principles help in showing how the agile
methodologies are seen to be superior to the traditional project
management methods.
Risk management with agile methodology is crucial since it
helps in the integration of the risk with agile practices. In
reality, the combination helps in the embedment of risk
management at stages of the project’s lifecycle with input and
output from every task with that stage (Silva et al., 2015;
Dingsøyr & Lassenius, 2016). Besides, the risk analysis, risk
control, and risk evaluation are done in particular iteration for
the sake of maintaining the backlog of requirements which are
related to the risks identified in each stage of the project
lifecycle. Through embedment, risk management is discovered
early in the project lifecycle, and it is immediately eliminated
or mitigated followed by reviewing the results during the
iteration demonstration as well as the release of the reviews.
In the traditional project management in the product
development, release dates are always fixed since most of the
dangers are discovered late thus leading to high cost and
consumption of more time to eliminate or mitigate, making the

projects to either being extended or inadequately worked with
or tested (Kostalova, Tetrevova & Svedik, 2015). Intrinsically,
the hazard response is quite challenging unless it is performed
at early stages in the project lifecycle. Intuitively, agile
methodologies allow exceptional and targeted prioritization of
characteristics after every iteration. Ideally, the application of
the risk-based prioritization of attributes and consistent risk
assessment; there is a high possibility of spending the right
effort on the most critical risk sections at a low cost. It can be
related to the incorporation of human factors in the
improvement of effectiveness and risk mitigation.
Human factors are essential in the development of software used
in projects. With complications, excellent access and
availability provide a great opportunity in the industry. Most of
the risks for complicated medical devices that are connected to
the human factors such as user interface confusions and user
interface designs that cannot be adapted to user workflow (Silva
et al., 2015; Dingsøyr & Lassenius, 2016). The expectations of
the FDA on user errors that get much rigorous and higher focus
on being placed on comparative safety as well as effectiveness
(Silva et al., 2015) and conducting formative usability tests as
well as dealing with the best usability issues by training and
labeling that are no longer acceptable. Insufficient focus on the
user experiences can have significant business influences:
systems that are difficult to apply and do not offer what users
need, when it is required, in actionable ways, do not get used.
Besides, systems that do not get utilized do not lead to future
sales (Vijayasarathy & Butler, 2016). Inherently, human factors,
experience, and methodologies to the team assigned to develop
products contribute to the dramatic improvements of the project
quality and speed, and user satisfaction (Kostalova, Tetrevova
& Svedik, 2015).
Agile methodologies can be adapted in the direct incorporation
of human factors into the process of development. User
experience and human factors create task flow, storyboard, and
wireframe, as well as, creating detailed designs with the binding

acceptance to help product developers to have clear guidelines.
Product developers have the capability of getting usability
feedback from the product end users as improvements are made
by the software development team (Rigby, Sutherland &
Takeuchi, 2016). Therefore, hazards associated with the human
factors are mitigated at early stages to help in quick designing
and testing. It is significant in achieving project quality at the
right speed with agile methodologies.
Quality is one of the primary targets of the agile methodologies,
and several of the agile practices that are designed for the sake
of improving the project quality at the same time maintaining
the projected velocity (Stettina & Hörz, 2015). Whereas
traditional project management makes the development team
spend at least half of their time for defecting troubleshooting
and rework, agile methodologies are designed in a way that they
have capability of catching and fixing defects early enough,
when they are needed at the most comfortable time and cheapest
cost to fix such errors (Silva et al., 2015; Dingsøyr &
Lassenius, 2016). Eventually, the agile practices that include
users' stories, tests, and tests based on the development,
consistent integration and tolerance on the zero bugs that are
designed for the sake of improving and maintaining the project
quality. It allows the team to move much faster with fewer
defects than in the traditional project management
methodologies (Bilgaiyan, Mishra & Das, 2016). Therefore,
agile methodologies are supported by several practices that
result in the improvement of quality, reduction of risks, and
improvement of project speed.Conclusion and Summary
The goal of this research was to get the changing the mindset of
project managers for application of the agile management for
projects in FDA regulated industries. Besides, it extended to
looking at how agile practices are contributing to the success of
projects. Most of the studies reviewed depicted significant
relevance of the agile methodologies; however, their
perceptions about importance are entirely different.
At least five agile practices were discovered to be extremely

significant. The most crucial aspect for the application of the
iterative development as well as the sprint reviews was noted to
the earliest feedback from the customers. Intrinsically, iterative
development is applied to deal with the changing priorities as
well as uncertainty in solution and accomplishing a shorter time
to get to the market. Incremental sprint planning, stories, and
designs were utilized while responding to the changing
priorities and needs of the customers.
The main reason for the application of the sprint retrospective
and collaborative improvement was meant to enhance the
process for improving the effectiveness of the product
development teams. The objective of which was to attain a
change in the mindset of project managers for using agile
methodologies for projects in FDA regulated industries in terms
of improving the working environment as well as working pace.
Probably they were depicted as the most significant practices
that product development team can utilize.
All the practices perceived to be significant were associated
with quality and scope. It is not amazing since all the
participants were treated as the internal stakeholders and most
of the stakeholders always utilize quality and scope as the best
criteria for the determination of success. In summary, agile
practices and other practices such as incremental designs, sprint
retrospective are considered as the most crucial in the research.
It was reported that results are indicating that practices can
improve customer feedback and the processes used by the
product development team, as well as assisting the team in
comprehending the essential needs of customers as very
important with a lot of significance.
Agile methodology if duly incorporated to the quality system
regulations of FDA, it has the capability of providing superior
outcomes to the current traditional project management
methods, particularly for the complicated system with
significant software elements.
Agile methodologies are designed for the sake of getting more
feedback early and even during the product design process as

well as applying this feedback to improve products consistently.
Consequently, it is suitable for the development of sophisticated
systems that have new requirements. Ideally, the loop of
feedback is adaptable in the incorporation of risk management,
human factors, and validation. The agile methodologies are
critically through making organizations adapt quickly to
changes, rapid reduction of uncertain requirements,
development of project speed and reduction of waste, and
reduction of risks and defects. Therefore, organizations should
incorporate agile methodology to have better opportunities in
the rise of challenges posed by the dynamic changes in
regulations, reimbursements, and technological landscape and
converting them to competitive market success and advantage.
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Inflammatory Bowel Disease Case Study
The patient is an 11-year-old girl who has been complaining of
intermittent right lower quadrant pain and diarrhea for the past
year. She is small for her age. Her physical examination
indicates some mild right lower quadrant tenderness and
fullness.
Studies
Results
Hemoglobin (Hgb),
8.6 g/dL (normal: >12 g/dL)
Hematocrit (Hct),
28% (normal: 31%-43%)
Vitamin B12 level,
68 pg/mL (normal: 100-700 pg/mL)
Meckel scan,
No evidence of Meckel diverticulum
D-Xylose absorption,
60 min: 8 mg/dL (normal: >15-20 mg/dL)
120 min: 6 mg/dL (normal: >20 mg/dL)
Lactose tolerance,
No change in glucose level (normal: >20 mg/dL rise in glucose)
Small bowel series,
Constriction of multiple segments of the small intestine
Diagnostic Analysis
The child's small bowel series is compatible with Crohn disease
of the small intestine. Intestinal absorption is diminished, as
indicated by the abnormal D-xylose and lactose tolerance tests.

Absorption is so bad that she cannot absorb vitamin B12. As a
result, she has vitamin B12 deficiency anemia. She was placed
on an aggressive immunosuppressive regimen, and her condition
improved significantly. Unfortunately, 2 years later she
experienced unremitting obstructive symptoms and required
surgery. One year after surgery, her gastrointestinal function
was normal, and her anemia had resolved. Her growth status
matched her age group. Her absorption tests were normal, as
were her B12 levels. Her immunosuppressive drugs were
discontinued, and she is doing well.
Critical Thinking Questions
1. Why was this patient placed on immunosuppressive therapy?
2. Why was the Meckel scan ordered for this patient?
3. What are the clinical differences and treatment options for
Ulcerative Colitis and Crohn’s Disease? (always on boards)
4. What is prognosis for patients with IBD and what are the
follow up recommendations for managing disease?
Running head: OVERCOMING CHALLENGES OF
IMPLEMENTING PMO2
OVERCOMING CHALLENGES OF IMPLEMENTING PMO2
OVERCOMING PMO PROPBLEMS FACED IN PROJECT
MANAGEMENT
Srinivasa Yadlapalli
Harrisburg University
GRAD 695 PGMT

Overcoming Challenges of Implementing PMOAbstract
Project Management Office (PMO)is a common phenomenon in
many organizations. Many of these firms are confronted with
the challenge to manage multiple competing projects
successfully which is possible through the incorporation of
PMO. In this regard, firms are ratcheting up their governance
structure and corporate culture by implementing PMO.
However, many existing anecdotal pieces of evidence indicates
that PMO enforcement is quite an uphill task. This research
highlights the main challenges involved in implementing PMO
and the possible ways that can be applied by organizations to
overcome the difficulties. The research addresses issues such
as: Why do organizations implement PMO? What are the
challenges of implementing PMO? What measures are put in
place to deal with the challenges involved? The project,
basically, analyzes the existing literature on PMO and how to
overcome challenges associated with it. It also helps in ranking
the challenges in order of importance. Thirdly, the literature is
critical in discovering how various top-level organizations have
overcome the major challenges of PMO. Some of the major
PMO challenges highlighted in the research include; (1) lack of
experienced personnel to manage the PMO software, (2) Poor
PMO leadership, (3) inappropriate change management strategy,
(4) rigid corporate culture due to the organization’s resistance

to change. The research also addresses various mitigation
measures that can be undertaken to overcome the challenges
associated with PMO. The actions include, among others, hiring
experienced project managers and personnel to help in the
proper implementation of the PMO. Besides, the organization
needs a flexible change management strategy that is in tandem
with the implementation processes. Other measures include
efficient utilization and allocation of resources, standardizing
process before the PMO implementation stage, hiring the most
talented project managers to manage the implementation team,
having strong PMO champion and opinion leaders who can
demonstrate the value of PMO. Lastly, the research
acknowledges the difficulty in implementing PMO tools and
calls for proper project management and planning culture to
mitigate the challenges.Key Words:
project manager, Project Management, Implementing PMO,
Project Management Office (PMO)
Table of Contents
Contents
Abstract2

Key Words:3
Introduction5
Problem Statement and Justification7
Problem Statement7
Research questions7
Justification8
Hypothesis10
Literature Review10
Definition and History of PMO10
The Changing Roles of PMO13
Challenges of implementing PMO15
Conclusion17
Proposed
Solution
Approaches to the Challenges17
Conclusion and Summary22
References24
Introduction

Organizations are faced with many challenges including the
challenge of PMO to deliver value to the organizations.
Regardless, the Project Management Office (PMO) plays a
critical role in spearheading the success of a project by
improving its overall productivity, performance, and
profitability. In this regard, the main reason for implementing
PMO is to empower the organization to thrive. The world is now
more advanced, and IT-enabled innovations are taking center
stage of many organizations focusing on the execution of the
organizational projects. The Standish Group report of 1994
cited only 16% of successful IT projects within the stipulated
time and budget (Aubry & Hobbs 2011). In 2006 Standish report
found out that the estimated success rate of IT projects varied
from 35% to 67% in a survey of over 400 project managers
(PMs) (Letavec 2006). The statistics create a clear impression
that about 33 to 65% of projects are somehow less successful.
Such a scenario results in both cost and time overruns. It also
causes a deficiency in features and function prompting the
organization’s failure to meet customer expectations.
Aubry & Hobbs (2011) note that many large-scale organizations
are confronted with the challenge to manage IT projects due to
increasing organizational complexities, technological
complexity and size of projects that continue to grow over time.
Most of the project failures can be attributed to inadequate
skills, knowledge, and expertise in project management

discipline. Therefore, the organizations must initiate
appropriate measures to address the challenges causing the
project failures. In that regard, the organization should first
address its software capability before implement any project
management discipline. The assumption is that organizations
with higher software capabilities yield the most successful
project outcomes. A firm’s software capability can be accessed
by either OPM3 (Organizational Project Management Maturity
Model) or CMMI (Capability Maturity Model Integration)
models. OPM3 and CMMI are products from the Project
Management Institute (PMI) and Software Engineering Institute
respectively. They focus on testing the maturity of the process
involved in project management.
Another approach of improving organizational project
management is by establishing PMO strategy into its operations
(Letavec 2006). The focus of this revolves around identifying
the obstacles that impedes PMO implementation. Many existing
literature advocates for the implementation of PMOs to improve
the performance and outcome of projects. One of the most
regularly mentioned significance of PMO is the training and
mentoring of project managers and personnel. PMOs are also
instrumental in developing standards for project management
and delivery of the project’s objectives. PMO would also
facilitate the development of best project management practices
in an organization, i.e., appropriate planning and resource

allocation. Most companies are in the dilemma of choosing the
approach that would successfully implement the PMOs. Without
an appropriate approach, the PMO initiatives are futile. Hence,
the challenges must be identified and evaluated to curb their
threat on the implementation of PMO. Project coordinators and
managers must be guided on how to overcome the challenges
they are likely to encounter during the implementation exercise
of PMO. Therefore, more research needs to be conducted to help
in understanding the challenges associated with PMO
implementation and the best possible ways of addressing the
problems.
The paper is thus organized into other four sections which
include (1)problem statement and justification, (2)review of the
relevant literature relating to PMOs, (3)proposed solution
approach and (4)conclusion. Problem Statement and
JustificationProblem Statement
PMO is a relatively recent phenomenon having lasted for about
10 to 15 years only. Nevertheless, it is emerging as a prominent
feature in many organizations engaged in multiple and
sophisticated projects. For many organizations, PMO is applied
as a centralized unit for planning and overseeing project
management. Despite, the positivity of PMO, many
organizations continue to face challenges in implementing PMO
as part of project management. The problems are so ingrained
that the organizations sometimes opt to abandon the use of

PMO. Due to the challenges in implementation, PMO has not
been successful in realizing the kind of improvements that
project stakeholders hoped to achieve. The challenges range
from incompetent personnel and project leaders to inefficiency
in resource allocations for the successful implementation of
PMO. In most cases, the project managers are clueless about
matters about PMO; thus, making the whole project
unattainable. In such a scenario, the managers lack the requisite
guidelines on how to tackle any potential challenges associated
with PMO implementation. Research questions
The research questions guiding the research include the
following:
· What are the Main challenges in PMO implementation in
project management?
· Do the challenges have any significance?
· What measures should organizations adapt to curb the
challenges associated with PMO?
· What is the role of PMO in project management?Justification
PMO has become a common phenomenon in many
organizations. Most companies encounter numerous problems in
handling multiple projects simultaneously; hence, they could
not finish the projects within the stipulated time. In addition to
time wastage, the projects become unnecessarily costly, in
terms of resource utilization and failure to meet the expected
objectives. Therefore, most companies have opted to

incorporate PMO to help them in proper planning, management
and implementation of projects. Dai & Wells (2004) describes
PMO as an organizational body or entity assigned various tasks
relating to a given project intended to be accomplished by an
organization. PMO has a direct influence on the management
process of a project, i.e., it facilitates project management
functions.
Despite any existent Work Breakdown Structure (WBS), PMO
implementation is still challenging, especially when it comes to
maintaining standard in project management. Since it is the
PMO that is responsible for defining and maintain project
management process, any slight problem in the department
(PMO) is likely to alter the whole project. Such a problem
impacts negatively on the overall budget and schedule of the
projects. As a result, the organization experience delays in the
completion of the project. Besides, the quality of the project is
altered and eventually harming the image and reputation of the
company. The problems can also occur due to lack of proper
change management mechanism. According to Aubry & Hobbs
(2011), a proper change management model is an effective
remedy to challenges associated with PMO. The problems are
also necessitated through a lack of a prioritization during the
project. Activities are supposed to be placed or performed in
order of priority throughout the project management exercise
(Hornstein 2015).

The world is more technologically advanced; hence, businesses
must tighten up to be relevant in the competitive corporate
world. Some of the things that make organizations stand out in
the market are how they manage and conduct their projects
(Aubry & Hobbs 2011). Often, organizations are striving to be
more innovative and technologically advanced. Therefore, such
organizations are confronted with multiple complex projects. As
such, PMO becomes the only viable solution to help in handling
the tasks associated with the project. Unfortunately, there exist
challenges in PMO implementation which must be addressed for
the organizations to achieve its objectives. Companies that
implement PMO expects positive improvements in the success
of the project. However, without proper redress of those
challenges, the improvements expected by project-oriented
companies remains an unachievable dream.
The significance of this research is anchored on its main
objective, “to overcome challenges associated with PMO
implementation.” The use of PMO is inevitable, especially, in
this era of advanced technology, whereby companies are
confronted with complex projects that require proper planning
and initiation,” (Aubry & Hobbs 2011). PMO is a collection of
management, planning and review process involved in a project.
It is useful in clarifying performance metrics and the
responsibilities of oversight and accountability. Project
managers must be competent enough to identify and find a

solution to any challenges that would hinder the successful
implementation of PMO in project management. It is important
to utilize resource efficiently while performing any project.
Most projects fail due to limited resources and incompetent
project stakeholders. This study helps in understanding the
nature of problems that PMO face during project management.
It also accesses the probable cause of the challenges and the
best possible measures to undertake in addressing them.
Hypothesis
The research aims to test the following hypothesis based on
analysis of different existing literature on PMO:
· The challenges in implementing PMO cause of project failure.
· PMOs are catalysts of positive project outcomes
· Inefficiency in resources hinders the successful
implementation of PMO
· Incompetent Project Managers impedes the functionality of
PMO and overall project completion.Literature Review
The review of the relevant literature about PMO follows a
theoretical framework. The literature outlines the meaning of
PMO and the various perspectives that project stakeholders
should keep in mind before implementing PMO into an
organization’s project framework. In this case, the goal of the
literature review is to assess the meaning and significance of
PMO. It also discusses the main challenges in the
implementation of PMO.Definition and History of PMO

According to Kwak & Dai (2000), the use of PMO can be dated
back to 1930s. Today, PMO is a popular aspect of many project-
oriented organizations. The project office long-term vision is to
facilitate an organization’s projects to success. Kwak & Dai
(2000), provides two key definitions of the Project Management
Office. The authors describe PMO as an organizational entity
that helps project managers and other project stakeholders on
the strategic issues about the project in question. The project
teams are advised of the functional entities in the organization
to help them in implementing the project management
principles, practices, tools, methodologies, resources, and
techniques. Secondly, the authors, Kwak & Dai (2000),
attributes PMO to the entity vital for managing a given project
headed by project managers.
The article, ”The project management office as an
organizational innovation,” by Hobbs, Aubry & Thuillier (2008)
views PMO as a formal, centralized layer of control that
facilitates the information sharing amongst projects teams
which include senior management, staffs and project
management. PMO provides the opportunity for centralized
integration within an organization (Aubry, Hobbs & Thuillier
2007). For instance, PMO is a crucial source of knowledge that
is instrumental in the effective and efficient enforcement of
organizational projects, such as IT project or a marketing
project. Other researchers such as Singh, Keil & Kasi (2009);

Παπαχαραλάμπους & Papacharalampous (2017), (Aubry, Hobbs
& Thuillier 2011), and Hornstein (2015) views PMO
implementation as fundamental part of the organization. As an
administrative mechanism, PMO harness project activities and
procedures with the policies and cultures of the enterprise.
Therefore, successful implementation of PMO reflects the
organization’s maturity and advancement in project
management.
Παπαχαραλάμπους & Papacharalampous (2017), argues that
PMO’s is to ensure corporation amongst teams and groups
within an enterprise; thus, PMO ensures that team coordinates
well and working as planned. The author further provides
insights into the project office’s role in facilitating the
functionality of project teams. However, Hauck (2007) insists
that PMO is the most valid approach for the simultaneous
management of multiple projects in a multi-functional setting.
Letavec (2006) and Hornstein (2015) argue that PMO ensures
the efficient utilization of finite organizational resources. It
rejuvenates an organization’s growth by facilitating the parallel
efforts involved in a multi-sectoral business environment.
Through PMO, the project teams and managers are aware of
their roles in the project. Every organization wants to fulfill its
mission in providing goods and services that meet the market
demand and customer specifications. The organization must also
ensure that it realizes increased sales to create enough profit for

the shareholders. The organization, therefore, must adopt the
best practices in project management by ensuring that its
projects are properly planned and executed Hornstein 2015).
The Project Management institute defined PMO as a firm’s
entity assigned various roles based on the types of projects
under the organization’s domain (PMI 2015). In this regard, the
implementation of PMO, undoubtedly, poses significant change
in the culture and structure of any given organization. Hauck
(2007) asserts that every institution has a unique culture due to
the different individuals sharing common work ethics and
values. Hence; PMO must facilitate the structural development
of a system that supports systemic, repeatable and documented
processes. As argued by Hobbs, Aubry & Thuillier (2008),
PMOs must be geared towards conduct projects in the right way.
In that sense, the most fundamental functional groups of PMOs
are monitoring and control of projects. According to Hobbs &
Aubry 2007, the role of PMO in enhancing project management
competencies include: PMO helps in reporting the status of the
project to the senior management. Secondly, it critical in the
development and implementation of standard methodologies and
metrics for measuring the success of a project. Fourth, PMO
mentors and guides project managers are improving their
functionality. Fifth help in monitoring of project performance.
Sixth, it documents the training and development of personnel.
PMOs also monitor the project information system and maintain

the project scoreboard.
Based on the literature reviews, it is evident that PMOs plays a
crucial role in the management of an organization. Therefore,
PMOs can be viewed as part of the organizational innovation
that improves project management practices resulting in the
transformation of an organization. Since its inception in the
1930s, PMO has been reported in numerous fields including
business entities, healthcare organizations, aerospace, telecom,
and defense industries (Kwak & Dai 2000). Today, there is a
widespread interest in the establishment of PMO as a means of
improving the performance of IT projects in different
organizations. The aim is to limit issues of project failure and
overall failure in the organizations’ performance. Most PMOs
were established in the mid-1990s as a means to oversee IT-
related project, e.g., the Y2K project. However, some of the
organizations opted to disband their PMOs on completion of the
IT projects. Other companies retained the PMOs by expanding
their scopes to perform other projects. PMO is now a popular
phenomenon in most organizations and has been instrumental in
the management and execution of projects. The Changing Roles
of PMO
PMO is not only helpful to the project manager but also a
relevant aspect of every organization. It helps in the
understanding of professional practices involved in project
management (Dai & Wells 2004). It also facilitates the

integration of business interests with the efforts of project
management. Letavec 2006 suggests four different roles
facilitated through proper implementation of PMO, i.e.,
consulting, management of knowledge, the setting of standards
of doing the project, and hands-on implementation of the
program. Otherwise, PMO has many other different roles all of
which aims at improving the overall success of the project. The
many different roles have contributed to the configurations of a
wide spectrum of different PMOs. On one spectrum is PMO-
light which plays a rather passive role in facilitating project
managers. In such configuration, the PMO features very
minimal staffs and does not have direct control over the
management of projects.
Nonetheless, such PMO still helps in creating standards for
implementation of the project and acts as a repository for
project information. On the contrary, PMO-heavy offers more
direct control over the project and project teams. In such a
configuration, PMO plays a more proactive role and is
responsible for the overall outcome of the project. The two
configurations of PMO are set such that they facilitate the
project management (Hobbs, Aubry & Thuillier 2008). First,
PMO offers a consulting opportunity for Project managers
through training and guidance on the best project management
practices. Secondly, the centralized version which involves the
guidance of temporary staffs loaned out to business units to

perform certain organizational projects. Organizations need to
focus more on the PMO-Heavy model more than the PMO-Light
Model. According to Hauck, C. (2007), PMO-Light model of
configuration exhibits little resistance to change. Nevertheless,
the model occupies just a supporting role of PMO. It also has
minimal influence on the project execution implying that it
cannot be directly liable for the failure of the project. The
model is highly criticized for its limited impact on the project
execution.
Besides, the PMOs’ role in the organization depending on the
configuration adopted by the enterprise, i.e., PMO-Heavy or
PMO-Light. Above all, the structure and functionality of PMO
are continuously evolving depending on the organizations
changing needs and capability (Dai & Wells 2004). The PMO
competency and associated roles and abilities can be
highlighted as follows:
Image 001: The changing roles of PMO.
Source: (Singh, Keil & Kasi 2009).
The figure indicates how PMO and organization achieve more
maturity. The PMO plays the basic project oversight role. It
also acts as a formidable epicenter of excellence that is in a
strategic position to meet organizational business goals. In that
regard, PMO establishes itself as a basic ingredient of achieving
organizational competency.Challenges of implementing PMO
Stanleigh (2006) argues that the implementation rate of PMO is

very low, i.e., most of the project-oriented organizations have
been unsuccessful in implementing PMO. Stanleigh conducted a
survey of 750 organizations to test the implementation rate of
PMO into their system. Based on the survey, Stanleigh (2006)
discovered that over 75% of the companies that adopted PMO
initiative abandoned it citing failure to meet its intended
purpose. The organizations shut down the PMOs after realizing
no added value to their ongoing and prospective projects. A
similar conclusion was made by Hobbs, Aubry & Thuillier
(2008) upon the survey of over 500 project managers. The
researchers noted that most of the PMOs are too expensive and
has very minimal contribution to the project and organizational
performance. Based on the researchers’ findings, the outcome of
PMOs is often unpredictable. They (PMOs) are unstable
structures, i.e., companies waste too much time and resources in
reconfiguring the PMOs every time they malfunction or fail to
meet their intended purpose. The findings are also backed up by
Singh, Keil & Kasi (2009) and Dai & Wells (2004) who
considers the implementation of PMO as the most difficult task
of an organization.
There exist many factors that impact on the success of PMO
implementation. Such factors include the agreed upon structure
and whether the organization’s corporate culture is conducive
for the development of PMO (Παπαχαραλάμπους &
Papacharalampous 2017). Other factors are the scope of

governance and mission of the organization. Hauck (2007)
argued that with a clearly defined mission, structure and scope
of governance, the likelihood of the PMO failing is very high.
Stanleigh (2006) also stresses the importance of PMO being part
of the companies’ corporate culture. He suggests that project
management exercise must reflect, an organization’s corporate
culture.
According to Aubry & Hobbs (2011), the possible major causes
of failure in implementation of PMO are as follows: (1) In cases
where there is no clearly defined value proposition for PMO,
the project, definitely, fails to meet its objective. ( 2) The
PMOs might lack the ability to consolidate and utilize resources
effectively leading to many wastages. (3) Incompetent program
managers who have not idea on how to implement PMO. The
implementation of PMO also becomes a challenge in situations
where PMOs become too authoritative and starts to
micromanage organizational projects. In some scenarios, PMOs
create unnecessary overhead costs making the organizational
project very expensive (Aubry, Hobbs & Thuillier (2007).
Besides, today’s business landscape is continuously changing,
and PMOs are typically struggling to achieve the desired
objectives.
Other challenges include the failure of the project planners to
develop a PMO based on specific needs of the company and lack
of commitment by stakeholders in implementing the common

methodologies and tools of PMO. Thirdly, an inadequate
support system from the senior management and PMO
stakeholders. Besides, the organizers of the project can have
trouble in identifying the most suitable and experienced
personnel to occupy the PMO. In some cases, there is no
specific training and communication mechanism on how to
implement PMO. Sometimes, the project manager may fail to
align the PMO implementation strategy with that of the
organization. The implementation challenge further persists due
to poorly designed scope and size of PMO. Conclusion
The literature review provides an elaborate illustration of PMO
and the challenges associated with its implementation. The
publications assert that the main reason why organizations
incorporate PMOs into their system is to facilitate project
management. The project manager must ensure that all the tasks
associated with a project are handled within the stipulated time
frame. Successful completion of a project is a vital component
for enhancing organizational growth and success. The main
challenge associated with implementing PMOs is the case of a
rigid corporate culture and the firms’ resistance to change. The
lack of competent and experienced project managers and PMO
leadership is also an impediment to successful implementation
of PMO. In a nutshell, successful implementation process
requires that the role, responsibility, and authority of PMO is
simple, clear and coherent.Proposed

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