What are leadership The simple definizion is that leadership - is

What are leadership? The simple definizion is that leadership -
is the art of motivating a group of people to act toward
achieving a common goal. In a business setting it can mean
directing workers and colleagues with a strategy to meet the
company's needs.
This leadership definition captures the essentials of being able
and prepared to inspire others. Effective leadership is based
upon ideas (whether original or borrowed), but won't happen
unless those ideas can be communicated to others in a way that
engages them enough to act as the leader wants them to act.
Put even more simply, the leader is the inspiration for and
director of the action. They are a person in the group that
possesses the combination of personality and leadership skills
to make others want to follow their direction.
<To develop a new medical device for China market >
< PMGT 699 – Applied Project Management >
Prepared By
< Soumitra G Shilotri >
<02/11/2020>
1.Executive Summary 3
2.Project Overview 5
2.1 Project Description 5
2.2 Problem Statement 5
2.3 Goals 5
2.4 Project Background 7

2.5 Product Objectives 7
2.6 Assumptions, Constraints and Dependencies 7
2.7 Project Deliverables 8
2.8 Schedule and Budget Summary 9
2.9 Evolution of the Plan 10
2.10 Definitions and Acronyms 10
3.Stakeholder Register 12
4.Schedule Component 14
5.Resource Plan with RACI 18
5.1Overview/Purpose 18
5.2 Resourcing Strategy & Assumption 18
5.3 Resourcing Development 18
6.Risk Management Plan 21
6.1 Review of Risk Management Plan 21
6.2 Risk Identification 21
7.Communications Plan 24
8. Procurement 28
9.
Cost……………………………………………………………………
……………………..30
10. Integrated Change Control 341.Executive Summary
1.1 Introduction
Johnson and Johnson (J&J) is an American multinational
company that develops medical devices, pharmaceutical drugs
and consumer products. J&J is one of the largest medical device
companies in the world. There are various subsidiaries of J&J,
however the medical device business of J&J includes 3 global
franchises; mainly Ethicon (surgical), Bio-sense Webster
(Cardiovascular & Speciality solutions) and Depuy Synthes
(Orthopaedics). J&J has a presence in over 100 countries
worldwide and the medical device companies manufactures and
does R&D on various different kinds of surgical devices,
implants that are used by doctors in laparoscopic surgeries.
Current project that I will be working on is named as Project
RoadRunner by the project team. The project is to develop a

new medical device implant for China market. The implant is a
sterile product that is used by surgeons during bariatric
surgeries. This implant is used alongside a vascular stapler and
will improve the staple line integrity, force to fire and staple
performance during surgery. This will be a big boost in the
existing line of stapling implants by improving performance
reliability and decrease market complaints. So far for earlier
legacy devices, we were using 2-D staples. However, with this
project, we will concentrate on getting the 3-D staples in the
market, which will improve quality and performance of the
implanted device. Currently, the objective and strategy is to
only launch this device in China.
1.2 Purpose
The purpose of this project is to Develop and Implement Project
RoadRunner in China Market. Project RoadRunner is an Implant
medical device that is used extensively in bariatric surgeries.
Project RoadRunner will improve the stapling and cutting
quality of the device. Hence, improving the performance on the
device and decrease in market complaints. 3-D staples will be
used to improve the quality and performance of the device.
Following factors are equally important for the purpose of the
project:
· Market demand – China is one of the biggest markets for
Johnson & Johnson devices. There is an constant demand in
China market for such devices.
· Organizational need – From business point of view Johnson &
Johnson wants to be ready to deliver quality devices, thus by
stopping any other competitors to enter the business.
· Customer request – There is an unmet need for quality devices
in China. Johnson & Johnson wants to meet this unmet need for
their customers.
· Technological advance – This new device will resolve the
CAPA issue for the legacy devices and the new device will be
marketed with 3-D staples technology which is currently the
most technologically advance system and not available in the

the legacy devices.
· Legal requirement – As the legacy devices have complaints,
Johnson & Johnson had to open a CAPA to fix these designs.
From legal point of view, it is very important that the company
fix this issue, to avoid any patient complaints that could lead to
major legal financial consequences and even affecting company
brand name.
1.3 Scope
RoadRunner in China Market. The project scope will be
controlled by the Project Manager.
3. Project Scope
· Project Initiation
· Project Planning
· Project Execution
· Project Closing2.Project Overview2.1 Project Description
Currently, the boundary for this product is non-CE mark and
can’t be sold in other markets that require CE marking. Current
strategy is to only develop this product for China market and
develop local IFU’s for China only.
2.2 Problem Statement
The key problem in this project is to take care of the complaints
that are currently met in the legacy devices. Complaints such as
staples are not firing during surgical procedures and that the
titanium cartridge clips that are used for stapling the body
tissues during surgical procedures were loosened and were
simply coming out of the cartridges during surgical procedures.

Now these could lead to anxieties during surgery because if the
devices dont fire in surgery or misfires in surgery, it could lead
to blood loss and tissue injury during surgery. This is a grave
concern and hence needs to be fixed.
2.3 Goals
Project Goals:
· Successful development of the project's procedures of
initiation, planning, execution, regulation and closure.
· To provide guidance to the project team's operations towards
achieving all the agreed upon goals within the set scope, time,
quality and budget standards.
· To finish project RoadRunner on time with minimum risk to
business with respect to time and budget
· To follow regulatory guidelines to ensure it meets China’s
regulatory requirement.
· Control budget, time, quality and scope of the project.
· Provide proper communication across industry to various
involved departments.
· Set up weekly meetings with all the involved project teams.
· Achieve SMART (Specific, Measurable, Achievable, Relevant,
Time-based) Goals.
Business Goals:
· Increase revenue income by 10% by end of year 2020 for
RoadRunner Devices in China market.
· Reduce complaints and increase quality and performance of
· Increase market share in China by 15% by end of the year
2020, thus reducing competition from other companies.
· Reach out to maximum hospitals and doctors and make them
aware of the new medical device that Johnson & Johnson is
planning to launch in China that will make surgeries more
comfortable for surgeons.
· Build a robust quality system, validation system and post
market surveillance that will catch any non-conformance in the
device at the manufacturing site or before entering the market.

That will reduce complaints during surgery from doctors /
patients.
· Do an in-depth market study in China to understand what other
companies marketing are and what are the concerns that doctors
are facing in other company devices. Use them at advantage and
develop robust design that will resolve those complaints and
then start marketing those devices to doctors.
2.4 Project Background
Due to continuous complaints in the legacy devices, the
business decided to take care of this complaint problem, by
making technical advances by Research and Development.
Technical advances will take care of the CAPA problem that is
being arising constantly through the legacy device. The new
technical advances in new device will be promoted by using 3-D
staples, which is a new technology in the field of surgery.
Project RoadRunner is being created as a solution for this
problem that will currently target development in China.
2.5 Product Objectives
· To spread out to maximum hospitals and surgeons globally
(starting with China) and make them alert of the new medical
device technology that Ethicon is preparing to launch that will
make surgical procedures more relaxed for doctors when using
the new device.
· Build a superior quality management system and post market
surveillance channel within organization, which will help in
determining any non-conformance in the device at the
manufacturing site or before entering the market. This will help
to reduce or diminish any device related complaints during
surgical procedures from surgeons.
2.6 Assumptions, Constraints and Dependencies
Constraints:
· Time zone constraint to work with China team on the project.
· Manufacturing equipment constraint to work in manufacturing
facility during validation.

· US government shutdown delayed US FDA approval.
Assumptions:
· China Regulatory Approval will be done in 6 months.
· US FDA Regulatory Approval will be done in 3 months.
· The device design will resolve the issue of complaints in
China.
Dependencies:
· US FDA approval required before China can start with their
local FDA registration.
2.7 Project Deliverables
Deliverables
Date Available
Acceptance Criteria
Project Charter
July 2020
Approved by PMO
Project Plan
August 2020
Approved by Sponsor
Project Change Request Draft
September 2020
Approved by Change Review Board members
Project Change Request Initial Review and SME inputs
September 2020
Approved by all SME’s
Project Review Board - Initiate
September 2020
Project Design Review Documentation
September 2021
Approved by Project Lead
Design Review

October 2021
Mitigate Design Review Risk
October 2021
Project Review Board - Approval
December 2021
Final Product Review Approval (PRA)
December 2021
2.8 Schedule and Budget Summary
Department
2020-2021
2021-2022
R&D
$30,000
$30,000
Manufacturing
$50,000
$50,000
Project Management
$10,000
$10,000
Labelling
$20,000
$20,000
Packaging
$10,000
$10,000
Regulatory
$30,000
$30,000
PMO

$50,000
$50,000
Equipment
$10,000
$10,000
Devices
$10,000
$10,000
Reserve Funds for Project
$50,000
$50,000
Total
$270,000
$270,000
2.9 Evolution of the Plan
The evolution of this plan was initiated since it was significant
for the company to take care of the complaints that the business
is fronting with in the legacy devices business that are currently
in the market. From a Legal point of view, it is very imperative
that the business fixes this problem, to circumvent any patient
complaints / deaths that may lead to financial lawsuits against
the company.
2.10 Definitions and Acronyms
Term/Abbreviation
Definition
PMO
Project Management Office
CAPA
Corrective and Preventive Action
CE mark
Conformité Européene
IFU
Instructions for use
R&D

Research and Development
SME
Subject Matter Expert
PRA
Product Review Approval
RA
Regulatory Affairs
Sr.
Senior
FDA
Food and Drugs Administration
3.Stakeholder Register
Stakeholder
Role
Responsibility
Amount of Influence
Impacted by
Kent Baker
Project Manager
Overall project lead
High
Project delay
Craig Smith
Change Lead
To initiate the need to develop the project
High
Project approval
Mike Setser
R&D Design Engineer
To develop design requirements
High
Design equipment’s
Jesse Chesnut
Packaging Lead
To develop packaging requirements for product
High

Insufficient clarity on packaging requirements in China
Carla Strauss
Labelling Lead
To develop labelling requirements for product at R&D
High
Insufficient clarity on labelling requirements in China
Jose Rea
Manufacturing Engineer
To run the batch at plant
Low
Unavailability to machines to run the batches
Christine Elizondo
Labelling Specialist
To develop labelling requirements for product at plant
Medium
Insufficient clarity on labelling requirements in China
Alex Chiang
Software Engineer
To perform software validation
Medium
If line is down and unavailability to machines to run the
software validation
James Cathey
Validation Engineer
To perform PQ validation
Medium
If line is down and unavailability to machines to run the
validation batches
Soumitra
Regulatory Lead (US)
To develop regulatory requirements for product in US
High
Delay is US FDA approval
Liu Ting
Regulatory Lead (China)
To develop regulatory requirements for product in China

High
Delay is China FDA approval
4.Schedule Component
4.1 Purpose/Overview
There will be a meeting that will be set by project manager with
all SMEs that are working on this project to understand
requirement for project completion. Project manager will work
with SMEs to understand each task and how long it takes to
complete the tasks. There will be some buffer that will be
created in the project by the project manager. Project manager
will create dependencies that are required for the project. Once
the project manager creates all tasks they will be reviewed by
the SMEs. Depending on the project tasks, and its difficulty and
dependency, tasks will be decided when they need to be worked
on. Dependencies (internal and external) will be considered
during creating the project plan. Project will have biweekly
meetings with the SMEs to go through their tasks and
understand the status.
Task Dependencies:
1. Finish to Finish: When 2 tasks have Finish to Finish
relationship, and you can’t finish task 2 until task 1 finish.
1. Finish to Start: This is the most commonly used task
dependency. When tasks 1 and 2 have an “Finish to Start
relationship” where task 2 cannot start until task 1 is finished.
1. Start to Finish: When tasks 1 and 2 have an Start to Finish
relationship. In this, task 2 cannot finish until task 1 is started.
1. Start to Start: When tasks 1 and 2 have an Start to Start
relationship. Here, task 2 cannot start until task 1 is started.
4.2 Schedule Baseline
Tasks
Description

Creation of the Activity List and attributes
Here, the project manager will make sure that he schedules
meetings with the SME. Here, project manager will try to
understand what tasks are required and how long will it take for
tasks to be completed. There will be some buffer that will be
created in the project by the project manager. Project manager
will create dependencies that are required for the project. Once
the project manager creates all tasks they will be reviewed by
the SMEs.
Estimation of activity resources
When project manager is done creating the tasks, he will assess
the task with SME and depending on the project tasks, and its
difficulty and dependency, tasks will be decided when they need
to be worked on.
Activity duration estimates
Project manager will have biweekly meetings with the SMEs to
go through their tasks and understand the status. It will be noted
in the project plan. Dependencies (internal and external) will be
considered during creating the project plan.
Approval of the schedule baseline
Project manager along with Project directors and PMO will
approve the project plan.
· Major Milestones:
· Approve project charter
· OC Approval to Apply Resources & Budget to Go
· Labeled Carton Drawings
· IFU Released
· Tyvek Artworks Released
· Vision System Software Upgrade at Torres Completed
· Vision System Software Upgrade at ABQ Completed
· Pull GST45 Samples out of Bulk Inventory / Swap Retainers
· Software Validation at ABQ Completed

· WE0380 for PQ Parts (Gen II Cartridges and 45/60 Retainers)
· PQ at Torres Completed
· PQ at ABQ Completed
· PQ Documentation
· FDA Approval for CFG
· China Regulatory Registration Approval Notice
· Final CRB Meeting
· Final CRB Approval
· Batch released finally to China
4.3. Schedule Control
Performance reviews
Project manager will have biweekly meetings with all SMEs
that are working on the project. Project manager will work with
individual SME on the task that they are responsible for. SMEs
will be asked if they had any constraints during the completion
of task. During the meeting, meeting minutes will be written
down and after the meeting is over, those meeting minutes will
be sent out in email to all involved SMEs. Meeting minutes will
also highlight, milestones completed and what tasks are to be
functioned upon in the next week and who is accountable for
those task completions.
Schedule control thresholds
During the biweekly meetings, all risks shall be monitored and
based on that the project plan will be updated. Higher the risk,
more time it will require to be completed. Dependencies
(internal and external) will be considered during creating the
project plan. Based on risks, if any delays are to be taking place
to the plan, it is responsibility of SME and project manager to
have a meeting to confer the issue before updating the project
plan.
Schedule performance reporting

These meetings generally take place with higher management
team like Project directors. Project manager will have these
meetings once a month to provide project update, milestones,
risks, any delays and how the project will move forward.
5.Resource Plan with RACI5.1Overview/Purpose
The reason for creating this resource plan is to make sure we
can deliver the resource distribution for this project completion
and to confirm that stakeholders that allocated to accurate tasks
contingent to their Responsibility, Accountability, Control, and
Interest. The tasks that are created in the WBS, should be
allocated to the precise stakeholder who will confirm that these
tasks are executed as per the PMP and proper resources are
assigned to individual task. There could be various resources in
the project that includes Full time or contactor employees,
medical devices, equipment’s, and several other things that will
promise effective achievement of the project.5.2 Resourcing
Strategy & Assumption
It is PMs accountability to make sure he or she gets all SMEs
that are required as resources for the project. Secondly, it is
PMs accountability to use the proper resource competently as
per project need. PM when resourcing will talk to department
leads to recognize how many resources will be required and will
be available for task completion. Once, PM gets this
information, PM will make a hypothesis of how many hours the
resource will be dedicated for the task’s completion. there will
be various SMEs from different teams that will assist the
project manager to complete tasks during various project
management phases such as project initiation, project planning,
project execution and project closing to assure the completion
of the project. There will be budget resourcing created for the
budget and the resources will be attained based on the total
budget and timelines of project completion. 5.3 Resourcing
Development

At the start of the project, PMO will supply the funds and
approve the project. It will be then be PMs responsibility to talk
to each department and resource the SMEs that will be
responsible to work on the project. PMs job is also to use the
funds resourcefully towards task completion and also determine
how many resources will be required to get this task completed.
Now the PM is now the technical lead having knowledge from
all departments, therefore it is assumed that all SMEs from
various teams will assist the project manager to complete tasks
during various project management phases such as project
initiation, project planning, project execution and project
closing to assure the completion of the project. All SMEs
working on the project shall comprehensive go through
SOP/technical training and hands on training before they are
assigned to complete the task. There will be a procedure created
for the project before preliminary activities. These procedures
are formed on foundation of company policies and quality
management systems. These trainings will be recorded and
reported as per company procedures. Rewards and
acknowledgements will be given to employees based on
successful completion of project. These rewards and
acknowledgements can be monetary based or simply
correspondences shall be sent out by higher management to the
complete group of participants or SMEs involved in the project.
High Level Responsibility Assignment RACI Matrix
RACI
ROLE
Craig
Kent
Carla
Soumitra
Ting
Christine
Alex
Jose

Jesse
James
Project Charter
A
R
CP0150 CRB Approval - Start
A
R
I
I
I
Prepare DR doc.
A
R
C
C
C
DR

A
R
C
C
I
I
I
I
C
I
Close DR Perils
A
R
I
I
I
I
I
I
I
I
Labeled Carton Drawings
C
I
A
C
C
C
I
I
R
I
IFU Released
C
I
A

C
C
C
I
I
R
I
Tyvek Artworks Released
C
I
A
C
C
C
I
I
R
I
VS Software Upgrade at Torres Completed
C
C
R
A
R
VS Software Upgrade at ABQ Completed
C
C

R
A
R
Pull GST45 Samples out of Bulk Inventory / Swap Retainers
I
I
A
R
Software Validation at ABQ Completed
I
I
R
A
WE0380 for PQ Parts
A
R

PQ at Torres Completed
C
I
I
I
R
A
PQ at ABQ Completed
C
I
I
I
A
R
PQ doc. Completion
A
R
I
I
I
C
C
C
I
C
GEN-II US 510K approval
I

R
A
C
USFDA approval for CFG
I
R
A
C
China regulatory submission
I
R
C
A
Final CRB approval
A
R
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I

I
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PRA approved
A
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C
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Batch released to China
A
R
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C
C
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R
Responsible
A
Accountable
C
Consulted
I

Informed
6.Risk Management Plan 6.1 Review of Risk Management Plan
The main purpose of risk management is to recognize possible
problems before they arise so that risk managing activities may
be planned as required across the product or project lifecycle
and they can be mitigated by avoiding adverse impacts on
accomplishing purposes.
A risk management plan is an official document that describes
how to deal with precise risks and what risk managing actions
need to be taken in order to alleviate or eliminate threat to the
project activities and outcomes.6.2 Risk Identification
Risk can be identified based on criticality of the risk. It can be
categorized into Low, Medium and High Risk. Risk
identification are generally documented in a risk register, which
contains a list of recognized risks along with their basis,
description, impact, probability, severity, response, strategy,
category and owner of the risk.
In the project, different risks are identified based on the
category it belongs to. Whether it is a technical risk,
administrative risk, cost related or is it schedule related. Based
on this category, we can describe what the risk is. We can then
determine the probability and criticality of that risk-taking

place and determine how to mitigate that risk in a proper and
timely manner.
6.3 Risk Analysis
Risk Analysis is a process that assists you recognize and
manage possible problems that could challenge significant
business initiatives within the projects. Therefore, to carry out a
Risk Analysis, you need to first recognize the possible risk that
you face, and then evaluate the probability of those risks that
will emerge.
To analyze a risk, you need to carry out a risk analysis. The
first step in risk analysis is –
1. To identify the risk: one needs to first identify the risks that
you may face as a challenge. It can be related to resource,
material, timeline, gap assessment, improper documentation.
2. Eliminate the risk: Once you've recognized the risks that you
are facing, you require to calculate the probability of these
threats being realized, and their possible impact.
One way of doing this is, to make your best estimate of the
probability of the event occurring, and then to multiply this by
the amount it will cost you to set things right if it happens. This
gives you a value for the risk:
Risk Value = risk probability x risk impact / 100
As per the risks mentioned in the risk register –
Risk ID number R001 = 0.9 x 90 / 100 = 0.81 (PI Score) which
is considered as High Risk.
The risk identification is categorized as follows:
Impact
Description
1 to 40
Risk has minimum to less impact

41 to 70
Risk is medium
71 to 100
Risk is high and needs to be mitigated immediately
Probability Range
Value/ Description
0.1 to 0.3
Low
0.4 to 0.6
Medium
0.7 to 1.0
High
PI Value
Severity (High, Med, Low)/ Description
1 to 40
Low
41 to 70
Medium
71 to 100
High
6.4 Risk Monitoring Plan
Risk monitoring is the process which tracks and evaluates the
levels of risk in an organization. The results which are produced
by risk monitoring processes can be used to help to create new
strategies and update older strategies which may have
demonstrated to be futile.
Risk monitoring is an ongoing process to monitor risk
throughout the project lifecycle. Common elements of risk
monitoring are risk identification, risk analysis, risk controls
and measurement and communication.
7.Communications Plan

7.1 Overview/Purpose
The purpose of the communication plan is to ensure the Project
Management Improvement Project provides relevant, accurate,
and consistent project information to project stakeholders and
other appropriate audiences. By effectively communicating the
project can accomplish its work with the support and
cooperation of each stakeholder group.
The communication plan provides a framework to manage and
coordinate the wide variety of communications that take place
during the project. The communication plan covers who will
receive the communications, how the communications will be
delivered, what information will be communicated, who
communicates, and the frequency of the communications.
The following outlines the targeted audiences, the key
communication messages to be delivered, and the method for
delivering the information, the communicator, and the
frequency of the delivery.
7.2 Communication Message and Delivery (Matrix)
Audience
Message
Delivery Method
Delivery Frequency
Communicator
Project Sponsor, PMO, Project Manager
Project Charter
One on one meeting
Creating an official document and distributing through email
Before Project Kick off
Project Manager
All stakeholders
Kick off meeting Agenda
One on one meeting with all stakeholders

Once after approval of project charter
Project Manager
All Subject Matter Experts (SMEs) involved in the project
Project Status Meetings
One on one meeting with all SMEs
Meeting minutes sent to all SMEs electronically through email
Create Tracker and share with SMEs on One drive
Biweekly
Project Manager
Project Manager
SME
Technical / Functional Meetings
One on one meeting between Project Manager and SME
Weekly
SME
Project Manager, Project Sponsor, Higher management
Directors
Project Meeting with Sponsors
One on one meeting
Once before project kick off and later as needed
Project Manager / Project Director
Project Manager, Project Sponsor, Key Stakeholders
Monthly Project Review
One on one meeting with all SMEs
Meeting minutes sent to all SMEs electronically through email
Create Tracker and share with SMEs on One drive
Monthly
Project Manager / Key Stakeholders
Project Manager, Project Sponsor, Higher management
Directors, Key Stakeholders, Subject Matter Experts (SMEs)
involved in the project
Project Completion Review Meeting
One on one meeting

End of Project
Project Manager / Project Sponsor
7.3 Communications Guidelines
Communication Guidelines—E-mail, Text:
1) Do not use reply all to emails, unless you are sure you want
to communicate with everyone
2) Use appropriate words to communicate
3) Use simple sentence to communicate
4) If addressing specific individuals, try to add his/her name
before starting the message
5) Highlight important tasks, dates in the email if you want the
audience to know that is important
6) Avoid using offensive tone or language will communicating
7) Provide as much clarity as you could in your communication
8) Try and keep one project per email chain. Don’t mix
different projects in the same email even if you are working
with the same stakeholders
9) Use clear and concise subject line to communicate
10) Mark emails important If you want the stakeholders to
respond back to the email immediately.
Communication Guidelines—Meetings:
1) Meetings must have pre-published agendas, prior to meeting
request. Agenda must accompany the OUTLOOK meeting
request or conference call or skype call option for people to call
in to the meeting
2) Make sure you are on time for the meeting. If you are
presenting or if you are the organizer to the meeting come
prepared and arrive little early to connect your laptop to the
system.
3) Contribute to the meeting by providing your views to the
team, but don’t enforce them
4) Take meeting minutes if you are the meeting organizer and

share them with the project team after the meeting is over
5) During the meeting, divide the agenda appropriately so that
all topics are covered, and everyone gets the right amount of
time to express their views and concerns
6) Make sure meeting invitation is sent to all key stakeholders
who are required to be present in the meeting
7) Focus the meeting agenda, so that the meeting ends on time
and doesn’t deviate
8) Arrange a separate meeting with the stakeholder if you need
more time to discuss their concern or if there is no solution to
their problem during the meeting
9) Arrange weekly or biweekly meetings based on project
priority, criticality and urgency
10) Make sure all stakeholders are present in the meeting. If
not, communicate to the team’s management that they need
alternate contact to be present for the meeting
.
7.4 Escalation Process
It’s a process where unresolved issues or concerns are
immediately addressed by a team of members who have the
authority to make high level decisions. In an Escalation process,
the SMEs are entitled to address their concern to the project
manager who later takes the decision to talk to higher
management members. Here a risk management review board
meeting takes place and the issue or concern is brought to the
forum to discuss at the higher level. The risk board consists of
people from every department who are directly or indirectly
involved in the project or business decision. Once the review
board makes the decision here, it is then documented into
company’s Quality Management System and tracked for future
reference. A reference number is assigned in case later it is
required to be traced back during Audit. Further, the decision is
communicated back to the project manager who later
communicates back to the remaining stakeholders in the
monthly project status meeting.

8. Procurement
· Project Initiation Phase:
This document addresses the purchase of manufacturing
equipment parts and device components. This plan helps the
team with general information for possible purchase
requirement.
· Procurement Statement:
The device component parts will depend on research and
development activities. For manufacturing equipment parts, they
can purchase 2 of each part. 1 part for use and the other part as
spare in emergencies.
· Vendor Selection:
All parts and components will be purchased based on
companies’ policies and procedure. Since the company is
looking from a long -term investment with Micro. Selection will
be done by the internal auditing team after vendor audit is
approved.
· Selection Process and Criteria:
Vendor audit passes as per ISO 13485 standard procedure.
· Project Procurement Team:
All purchase needs manufacturing plant manager and project
manager approval and signature. Requesting the above purchase
are project lead, design engineer and process engineer.

· Contract Type:
All contracts use company’s internal policy and standard and
use statement of work to control purchase.
· Contract Standards:
All contracting terms are based on company’s policy and
company’s standard.
· Vendor Management:
Vendor supplying manufacturing equipment parts/component
has service maintenance agreement with the company.
9. Cost
9.1 Introduction
Project costing is one of the important sections of the project
because it talks about the project cost and allocation of funds
towards the completion of the project. The main aspect of cost
management is that the total cost of the project should not
surpass the budget. Cost of the project is mainly provided
before project kick off. That means the costing is already
assigned before the project is started. The importance of this
section is making sure that the actual cost will be compared
against the predicated cost that was provided during project
charter.
Cost Management Plan
Department
2020-2021
2021-2022
R&D
$30,000
$30,000
Manufacturing
$50,000
$50,000
Project Management
$10,000

$10,000
Labelling
$20,000
$20,000
Packaging
$10,000
$10,000
Regulatory
$30,000
$30,000
PMO
$50,000
$50,000
$50,000
$50,000
Equipment
$10,000
$10,000
Devices
$10,000
$10,000
Total
$270,000
$270,000
9.2 Estimate Cost
Resource Name
Type
Material Label
Initials
Group
Max. Units
Std. Rate
Ovt. Rate

Cost/Use
Accrue At
Base Calendar
Craig Smith
Work
C
100%
$70.00/hr
$0.00/hr
$0.00
Prorated
Standard
Carla Strauss
Work
C
100%
$60.00/hr
$0.00/hr
$0.00
Prorated
Standard
Kent Baker
Work
K
100%
$90.00/hr
$0.00/hr
$0.00
Prorated
Standard

Ting Liu
Work
T
100%
$90.00/hr
$0.00/hr
$0.00
Prorated
Standard
Jesse Chesnut
Work
J
100%
$50.00/hr
$0.00/hr
$0.00
Prorated
Standard
Mike Setser
Work
M
100%
$60.00/hr
$0.00/hr
$0.00
Prorated
Standard
Jose Rea
Work

J
100%
$50.00/hr
$0.00/hr
$0.00
Prorated
Standard
Christine Elizondo
Work
C
100%
$50.00/hr
$0.00/hr
$0.00
Prorated
Standard
James Cathey
Work
J
100%
$50.00/hr
$0.00/hr
$0.00
Prorated
Standard
Alex Chiang
Work
A
100%

$50.00/hr
$0.00/hr
$0.00
Prorated
Standard
Soumitra Shilotri
Work
S
100%
$60.00/hr
$0.00/hr
$0.00
Prorated
Standard
Equipment
Material
E
$10,000.00
$0.00
Prorated
Medical Device
Material
M
$10,000.00
$0.00

Prorated
PMO
Work
P
100%
$60.00/hr
$0.00/hr
$0.00
Prorated
Standard
OC
Work
O
100%
$0.00/hr
$0.00/hr
$0.00
Prorated
Standard
xh
Work
x
100%
$0.00/hr
$0.00/hr
$0.00
Prorated
Standard
Joe

Work
J
100%
$0.00/hr
$0.00/hr
$0.00
Prorated
Standard
USFDA
Cost
U
Prorated
CRB
Cost
C
Prorated
9.3 Contingency Reserve Project Purpose or Justification
For contingency, a total of $100,000 are kept aside for the

entire project duration. These are kept aside taking regulatory
cost, registration cost, material cost, damage done to device and
device components during shipping and custom fees that
constantly can change.
9.4 Budget
[Once the project costs or cost baseline is determined, a time-
phased project budget is developed. Project budget shows how
the project cost will be incurred by appropriate periods (months,
weeks, quarter, etc.) during project performance period.
Describe how your budget is developed.]
Cost Control and Monitoring
[The approved project budget with contingency reserves serves
as a baseline for project control. This section usually include
project approach to monitor actual versus planned performance,
approach ( e.g. Earned Value analysis), and how any cost
changes will be managed.]
9.5 Performance Monitoring
[Describe your approach to monitor planned versus actual
performance and matrices that will be used]
9.6 Project Reports
[Include name and description of 2 to 3 reports that you plan to
use for performance monitoring, status reporting or other
reports. These are the reports for which you will be submitting
a Microsoft Project mpp file. See section below. ]

9.7 Cost Change Control
[Describe briefly how any changes to the cost baseline will be
administered and implemented.]
Microsoft Project Deliverables
9.8 Project Budget
[Include your project WBS (in .mpp format) that represents your
project cost. Ensure that contingency reserves as a separate line
item. The report submission is in Moodle]
9.9 Microsoft Performance Report
[Include report name and describe how the report will be used]
9.10 Microsoft Performance Report
[Include report name and describe how the report will be used]
10. Integrated Change Control
Change control process is defined as an internal organizational
process to make changes to cost, risk, documentation,
manufacturing, product design, component design, material,
labelling, packaging, sterilization, quality, etc. This process is

controlled by the change specialist and change lead and
approved by the change review board.
This process involves all stakeholders that are working on the
project. Stakeholders are all made aware before making changes
to the process because changing the process can significantly
delay the project or the outcome of the project. The change
process includes PMP update, approval from review board, and
documentation update.
The following process is being followed for change control.
Change Request Process Start
Change Process Initiated
Change Request Recevied
Change Approved
Change Review Decision
Change Request Denied
No
No Impact
Impact
Change Action Implementation Required
Review Board Decision

No
Yes
Change Action Implementation Approved
Change Action Implementation Denied
Yes
Change Request Process End
Change Request Approved
Change Request Denied
Review Board Decision
Change Request Approved
Any change in a project requires the implementation team to
initiate a change request which goes through the change
process. The change review board makes the final decision if
the change is approved or denied.
Change Request Form:
CHANGE REQUEST FORM
Change Request Number
ECR0000100
Change Request Initiator
Erica Walters
Brief Description of Request
Increase in duration of performance testing
Submission Request Date
11/05/2019

Request Approve Date
11/10/2019
Reason for Change
Current manufacuring equipment parts are old and need to be
replaced before completing the performance testing
Project Impact
1. Cost of manufacturing equipment parts are expensive and will
result in 10% increase in manufacturing budget cost.
2. Manufacturing equipment parts are imported from a vendor
outside USA, therefore it will take time to ship them and arrive
at manufacturing site in time to complete performance testing.
This will result into 10% increase in the schedule timeline.
Change Review Board Decision
Approved
Change Review Board Electronic Signature
Tom Bostico
Date
11/15/2019
Page 24
< Develop and Implement Project RoadRunner in China >
Revision: <1.0>
Project Charter
Date: 11/02/2019
<Johnson & Johnson >
<Johnson & Johnson >
<Soumitra Girish Shilotri>
<11/02/2019>

<Kim Young- Sponsor, PMO>
< Develop and Implement Project RoadRunner in China
>Project CharterRevision <1.0>
PMGT 699 Project Charter v.1 April 2018 (Adapted from
Document Code: PMBOK4.1.3.1)
List of Changes
Date
Revision
Description
Author
<11/02/2019>
<1.0>
Publication for use for J&J Project
<Soumitra Girish Shilotri>
Table of Contents
1. General Provisions 4
2. Terms, Notations, Abbreviations 4
3. Project Purpose 4
4. Measurable Project Goals and Objectives5
5. High-level Project Description and Boundaries 6
6. High-Level Requirements6
7. Overall Project Risk 7
8. High Level Constraints and Assumptions 7

9. Summary Milestone Schedule 8
10. Key Project Deliverables 8
11. Preapproved Financial Resources 9
12. Key Stakeholder List 9
13. Project Approval Requirements 9
Project Exit Criteria 9
Project Managers 10
Name 10
Position 10
Signature 10
Date 10
Appendixes 10
1. General Provisions
This document refers to the project "< Develop and Implement
Project RoadRunner in China >", which is implemented by the
organization "<Johnson & Johnson >".
The Project Charter formulates the practical requirements and
documents the high-level description of the product, service or
other deliverable that should meet these requirements and will
be result of the project.
The Project Charter is issued and signed by the Initiator or
Sponsor of the project and formally legitimized the existence of
the project. It provides the Project Manager with the authority
to use the organizational assets in the project operations.
The approved Project Charter formally initiates the project.
If the project consists of several phases, the Charter can be
updated to verify or improve the decisions taken during the
previous iteration of the Project Charter development. In such a
case the Charter is re-issued and signed as amended.
Terms, Notations, Abbreviations

Term/Abbreviation
Definition
PMO
Project Management Office
CAPA
Corrective and Preventive Action
CE mark
Conformité Européene
IFU
Instructions for use
R&D
Research and Development
SME
Subject Matter Expert
PRA
Product Review Approval
RA
Regulatory Affairs
Sr.
Senior
FDA
Food and Drugs Administration
Project Purpose
Following factors are equally important for the purpose of the
project:
· Market demand – China is one of the biggest market for
Johnson & Johnson devices. There is an constant demand in

China market for such devices.
· Organizational need – From business point of view Johnson &
Johnson wants to be ready to deliver quality devices, thus by
stopping any other competitors to enter the business.
· Customer request – There is an unmet need for quality devices
in China. Johnson & Johnson wants to meet this unmet need for
their customers.
· Technological advance – This new device will resolve the
CAPA issue for the legacy devices and the new device will be
marketed with 3-D staples technology which is currently the
most technologically advance system and not available in the
the legacy devices.
· Legal requirement – As the legacy devices have complaints,
Johnson & Johnson had to open a CAPA to fix these designs.
From legal point of view it is very important that the company
fix this issue, to avoid any patient complaints that could lead to
major legal financial consequences and even affecting company
brand name.
Measurable Project Goals and Objectives
Project Goals:
· Successful development of the project's procedures of
initiation, planning, execution, regulation and closure.
· To provide guidance to the project team's operations towards
achieving all the agreed upon goals within the set scope, time,
quality and budget standards.
· To finish project RoadRunner on time with minimum risk to
business with respect to time and budget
· To follow regulatory guidelines to ensure it meets China’s
regulatory requirement.
· Control budget, time, quality and scope of the project.
· Provide proper communication across industry to various

involved departments.
· Set up weekly meetings with all the involved project teams.
· Achieve SMART (Specific, Measurable, Achievable, Relevant,
Time-based) Goals.
Business Goals:
· Increase revenue income by 10% by end of year 2020 for
· Reduce complaints and increase quality and performance of
· Increase market share in China by 15% by end of the year
2020, thus reducing competition from other companies.
· Reach out to maximum hospitals and doctors and make them
aware of the new medical device that Johnson & Johnson is
planning to launch in China that will make surgeries more
comfortable for surgeons.
· Build a robust quality system, validation system and post
market surveillance that will catch any non-conformance in the
device at the manufacturing site or before entering the market.
That will reduce complaints during surgery from doctors /
patients.
· Do an in-depth market study in China to understand what other
companies are marketing and what are the concerns that doctors
are facing in other companies device. Use them at advantage
and develop robust design that will resolve those complaints
and then start marketing those devices to doctors.
High-level Project Description and Boundaries

Currently, the boundary for this product is non-CE mark and
can’t be sold in other markets that require CE marking. Current
strategy is to only develop this product for China market and
develop local IFU’s for China only.
High-Level Requirements
For successful development and implementation of Project
RoadRunner in China following requirements needs to be
fulfilled:
· Approval from higher management to execute the project.
· Approved financial budget and timeline for this project
· Project initiation requirements -
· Successful completion of process for generating new product
codes for China
· Creating manufacturing assembly for component development
· Manufacturing site vision system software validation upgrades
· Design Validation
· Performance Qualification Testing
· Labelling Requirements to be approved as per China
Regulatory Body
· Regulatory Approval Process
· Project Documentation
· Design Change documentation
· Labelling documentation
· Packaging documentation
· Manufacturing documentation
· Regulatory documentation
Overall Project Risk

Risk
Description
Impact
Probability
Mitigation Plan
Availability of Human Resources for timely completion of
Project
Lack of available resource because of illness and vacations
Medium
Low
Good Project Planning
Assign back up person to primary resource
Project Completion in twelve months
Non-conformities are observed leading to not having enough
time for project implementation
High
Medium
Add reserve days for testing devices in project plan and also
managing non-conformities
Regulatory Approval
Regulatory Approval from regulatory agencies
High
High
Face to face meeting with regulatory body reviewers to
understand exact regulatory requirements for approval
High Level Constraints and Assumptions
Constraints:
· Time zone constraint to work with China team on the project.
· Manufacturing equipment constraint to work in manufacturing
facility during validation.
· US government shutdown delayed US FDA approval.

Assumptions:
· China Regulatory Approval will be done in 6 months.
· US FDA Regulatory Approval will be done in 3 months.
· The device design will resolve the issue of complaints in
China.
Summary Milestone Schedule
No.
Milestone
Responsible Party
Date
1.
Successful completion of process for generating new product
codes for China market
Change Review Board / Project Manager
December 2021
2.
Design Change Documentation
Project Manager
December 2020
3.
Creating manufacturing assembly for component development
Manufacturing Lead
March 2021
4.
Manufacturing site vision system software validation upgrades
Manufacturing Lead
March 2021
5.
Design Validation
R&D Lead
March 2021

6.
Performance Qualification Testing
R&D / Manufacturing Lead
March 2021
7.
Labelling Approval
Labelling Lead
January 2021
8.
Packaging Approval
Packaging Lead
March 2021
9.
Regulatory Approval
Regulatory Lead
December 2021
Key Project Deliverables
Deliverables
Date Available
Acceptance Criteria
Project Charter
July 2020
Approved by PMO
Project Plan
August 2020
Approved by Sponsor
Project Change Request Draft
September 2020
Project Change Request Initial Review and SME inputs
September 2020
Approved by all SME’s
Project Review Board - Initiate
September 2020

Project Design Review Documentation
September 2021
Design Review
October 2021
Mitigate Design Review Risk
October 2021
Project Review Board - Approval
December 2021
Final Product Review Approval (PRA)
December 2021
Preapproved Financial Resources
Department
2020-2021
2021-2022
R&D
$30,000
$30,000
Manufacturing
$50,000
$50,000
Project Management
$10,000
$10,000
Labelling
$20,000
$20,000

Packaging
$10,000
$10,000
Regulatory
$30,000
$30,000
PMO
$50,000
$50,000
$50,000
$50,000
Equipment
$10,000
$10,000
Devices
$10,000
$10,000
Total
$270,000
$270,000
Key Stakeholder List
Full Name
Position/Organization
Role in the Project
Telephone/E-mail
Kim Young
Sponsor, PMO
Project Sponsor, PMO
[email protected]
Kent Baker
Project Manager
Project Lead
[email protected]

Kimberly Schumacher
Sr. Director, RA
Regulatory Lead
kschumacher.com
Brian Ruble
Director, Quality & Compliance
Quality & Compliance Lead
[email protected]
Project Approval Requirements
Project approval requirements will be performed by Johnson &
Johnson designated Subject Matter Expert’s (SME’s)
employees, through the approval of the project's deliverables
listed in Section 10 of this document
Final Project Approval will be performed by the Change Review
Board Members that will include SME’s from Research &
Development (R&D), Project Management, Manufacturing,
Regulatory Affairs, Quality Assurance, and Marketing.
Project Exit Criteria
Product Review Approval form (PRA) needs to be signed and
sent to PMO office for exit criteria.
Project Managers
Kent Baker and Craig Smith will be acting as the Project
Manager from Johnson & Johnson for the RoadRunner Project
for China. They will be responsible from initiating stage to
execution stage of the RoadRunner project and also making sure
all tasks are completed on time for project completion from
other SME’s as well.
Signed/Project sponsor(s) or charter approving authority

Name
Position
Signature
Date
Brian Ruble
Director, Quality & Compliance
Kent Baker
Project Manager
Kimberly Schumacher
Sr. Director, RA
Kim Young
PMO
Joanne Hull
Director Marketing
Appendixes
<N/A>
Implementing oracle for Tesla Motor Company
Implementing Oracle ERP for Tesla
By- Govind Rao Kurupathi
Harrisburg University

GRAD 699
Table of Contents
OVERVIEW 4
TRADITIONAL PROJECT MANAGEMENT ANALYSIS 8
AGILE PROJECT MANAGEMENT ANALYSIS 10
CONCLUSION/ PERSONAL REFLECTION 13
REFERENCES 14

Overview:
Client-Tesla Motor company is one of the leading electric car
manufacturers in the world. Tesla, Inc. is an American
automotive and energy company based in Palo Alto, California.
The company specializes in electric car manufacturing and,
through its SolarCity subsidiary, solar panel manufacturing.
Implementing Partner-Real Tech Inc is an Oracle
implementation specialist and hs over a decade of experience
when it comes to implementing projects for manufacturing,
service and finance industries. Tesla Motor company has
awarded Real Tech the contract to implement the Oracle E-
Business suite of applications. The Implementation will
constitute the following modules:
· Inventory
· Purchasing
· Order Management
· Manufacturing Modules
· Financial Modules
The project is scheduled to complete in one year and the
implementation team consists of a project manager, business
analysts, developers, and testers.
The implementation will be built on the e-business platform
version 12.2.3. The version 12 is Oracle's newest release which
has added multiple functionalities which streamlines the
business process and offers multiple communication methods
between the customers and the organization. The single
integrated platform offered by Oracle will help Tesla capture
the end to end business transactions like procure to pay and
order to cash in a single system. This Project is aimed at

replacing the existing applications with Oracle e-business suite
by the beginning of the year 2020.
Implementation methodology: Tesla will be implementing this
project on the traditional or also called the waterfall based
implementation methodology. Stakeholder involvement is
critical to the project and is encouraged to provide feedback and
suggestions in every step of the implementation. Stakeholders
will be included requirements, design and testing phases of the
project. The project will advance to the next phase only after a
formal signoff is received from the stakeholders of Tesla. This
methodology is solution driven and the solutions are defined
before the start of the project. It is based on the iterative
approach based where multiple runs of UAT sessions are done
to make sure the solution meets the business needs.Project
Scope
The scope of the project is to implement Oracle’s e-business
suite of application and help the organization perform the end to
end business cycles like procure to pay, order to cash, finance
to accounting in the new system. In addition, the newly
implemented system must allow future enhancements based on
business requirements.
Objectives
The main objective is to implement a robust application that
will support the growth of the company and meet the following
objectives.
Reference No.
Business Objective Description
Specific Goal
1
Minimize time and effort involved in the period close process
Complete all pending transactions for each month
2
Provide analytical results with manufactured inventory
Show accurate on-hand quantities for inventory organization
3
Integrate all manufacturing, finance and supply chain modules

To provide reports by capturing data from all the modules
4
Minimize time to process a Sales order
Deliver the product to the customer as soon as possible once the
order is placed
5
Minimize to purchase equipment for the company
Purchase raw materials for manufacturing in an efficient manner
6
Effective communication between suppliers and customers
Communicate the sales and purchase between customers and
suppliers
Benefits
The benefits associated with implementing the new version of
Oracle EBS can enormous. Below are important benefits.
· Ability to recognize partial revenue for a period
· Funds optimization with cash pooling and zero balancing
· Disabled Accounts Replacement
· Oracle Payments allows an organization to centrally credit and
debit payments
· Single point of access allows efficient management of Bank
accounts and numerous banks
· Enhanced reporting for transactions
· Clock In/Clock Out for actual time capture
· Cosigned inventory allows a reduction in carrying and order
management cost
Risk: Implementing an ERP system is often thought of as an
expensive and risky project. Implementing an ERP project often
takes 1-2 years to complete based on the modules implemented.
Second, the entire business process is changed and as the
transactions are done in a unique way in the new software as
previously done in the legacy systems. Quality time must be
spent by the business and the implementing partner to identify
the risks in the current business process and find ways to

mitigate the risks.
Constraints: below are a few constraints that were observed.
· Some users do not like the idea of migrating to a new system.
Hence the managers must put an effort to help them understand
the benefits of the new system and how it can overcome their
current issues.
· Training does not come cheap; the upper management must
invest in training users with the new software. In a situation
where a trained user leaves the company, the newly hired
employees must get up to speed with the new system/ software.
· As the entire implementation costs an arm and leg for the
company. The top management personnel must invest time and
money to support the training users and hire business systems
analysts to support the day to day system related activities
TRADITIONAL PROJECT MANAGEMENT ANALYSIS
The waterfall methodology has been a successful methodology
in most Oracle ERP implementation in a manufacturing
environment. A manufacturing industry relies heavily on
accuracy and standardization as their main goal in their business
processes. Hence, Implementing the ERP software for Tesla in a
waterfall framework will help the company adhere to
standardizing their day to day business process in the system.
The methodology is called waterfall because each phase of the
project will flow to the next phase after the prior phase is
completed. However, most Oracle implementations may not
always experience linear progression. There could be some
uneventful instances where the phases in the project may have
to shift places. For instance, if issues are found in the
implementation stage, the must go back to the design phase to
see if the code was not built properly or in some cases the
project may have to go all the way back to the requirements
stage to reinvent the wheel.

The waterfall methodology is seen in the below diagram.
Initiating phase: This phase the vision of the project what needs
to be accomplished. The scope of the project is defined,
stakeholders are identified and the project charter is created.
Planning Phase: This is a very important phase of the project
where the scope is defined in a more detailed level. The risks,
milestone, and budget are defined in this phase.
Executing phase: In this phase, what was planned in the
planning phase is now executed in the execution phase. Here the
project team is working on the project whereas the project
manager is coordinating the resources.
Closing phase: The closing of the project is done by the project
manager. The PM formally closes the project by archiving the
lessons learned document and releasing the resources form the
project. The lessons learned document must be centrally present
in the database so that in case if any issue comes up the future,
the documented related to the issue must be easily accessible.
AGILE PROJECT MANAGEMENT ANALYSIS
Agile methodology is around since the year 2000. Agile was a
new framework that was developed to overcome the issues
present in the waterfall model. The projects related to Waterfall
often led to over expenditure and a large number of process
documentation. Agile on the other hand focuses on an iterative
approach that broke a task into a smaller task and took an
iterative approach to complete the work. The Agile frameworks’
s main principle is to quickly respond to customer demands in
an accurate manner.
Implementing Agile Methodology:
User story: instead of over documenting the workflow and
technical requirements as done in the waterfall framework,
Agile uses a much simpler approach to called “user story

writing” to record the requirements. Each feature is considered
a story and each story is prioritized in placed in the product
backlog for the team to work on.
Sprints: Agile uses “sprints” to deliver finished segments to the
ERP implementation. Each sprint can last up to 2 to 3 weeks
based on the what is set by the team. A sprint is worked on by
the players and stakeholders to solve the roadblocks and
successfully complete a feature also called as a potentially
shippable product. A the end of each sprint, the scrum team
performs a “sprint retrospective” to understand what went
right, wrong and how to make sure the same mistakes do not
happen in the following sprints.
Scrum Planning meetings:
One of the failures of the waterfall model is that there is very
little flexibility in terms of introducing a change in the project.
In Sprints, the change is worked on by the scrum team and the
roadblocks if any, are cleared by the concerned team member
and alternates are discussed if the roadblock is not easy to
overcome in the project. In a scrum planning meeting, the
product owner and the scrum team sit together and discuss the
complexities of the various stories present in the product
backlog.
Daily scrum: Every day the scrum team sped 15 minutes of
their day to go over what was done yesterday, what is being
done today and discuss the impediments that are stopping a
team member from completing these tasks. The scrum master
can act to involve additional resources to over the impediment.
Conclusion: Once the feature “goes live” the team can use
create lessons learned document to capture all the mistakes that
were done in the current feature before going live. The lessons
learned document is useful for the team as the same mistakes
can be avoided in the upcoming sprints.
Framework #2: Lean Software Development
The principle of lean software development is built on the idea

that less is more and to streamline every process in the software
development cycle so that the wastes associated with the
business process is eliminated.
The concept of efficiencies is applied to in order to reduce
wastes associated with each individual, department,
interdepartmental operations and the organization as a whole
The different types of wastes are listed as follows:
Waste 1: Partially done work
As the above title suggests, it means that when the work is not
completed as per what is defined as done. Incomplete work
cannot be demoed or showcased to the client as the client will
not accept partially completed work and thus causes a delay in
the process
Waste 2- Extra features
This type of waste is also called gold plating in project
management. I’ve often observed that the team puts in extra
effort to satisfy the client by providing more features than what
is asked for
Waste #3: Relearning
The waste 3 relearning is like reinventing the wheel and not
using the existing resources present in the team. This can be a
lack of knowledge sharing within the team and also because of
the team members are scattered in different departments of the
company.
Waste #4: Hand-offs
Handing off work from one person of the team to another can
often result in waste as there is time involved in the passing as
well as the time involved for the next person to start working on
the story.
Waste #5: Delays
Delays are considered the highest wastage in the project as a
delay is created to deliver value add and a delay is created
before a value add is initiated. A delay can also be caused
because of approval from a certain member of a department

before initiating change in the process.
Waste #6: Task Switching
This is a common waste in most of the teams in a project where
a team member skips the current task in hand and moves on to
the next task. This creates incomplete work which cannot be
demoted to the client.
Waste #7: Defects
This defect is based on the fact garbage in garbage out, good in
good out. Wrong functionality can lead to the wrong output of
the system. Hence it is necessary to understand the story of
carefully before designing the functionality
Conclusion:
In conclusion, the capstone paper talks about the two different
framework i.e. Agile and waterfall methodologies. Both
frameworks have their own pros and cons as listed above. The
above information was reviewed from a few selected published
articles and studies indicate that the implementation of
methodologies (Agile/ waterfall) success does not purely
depend on the either Agile or waterfall methodology, but
depends on selecting the methodology based on the nature of the
industry. Hence, it would be difficult to conclude with the
framework is best suited for implementing an ERP software. As
most of the issues are discovered in the maintenance phase of
the project, the framework used must have the scope to welcome
changes in the project.

References:
Mrpeasy. (2018, November 27). Using Agile Methodology for
ERP System Implementation. Retrieved from
https://manufacturing-software-blog.mrpeasy.com/erp-system-
implementation
ERP Implementation Approaches: Waterfall vs. Agile. (n.d.).
Retrieved from https://www.handshake.com/blog/erp-
implementation
Alleman, G. B. (2002). Agile Project Management Methods for
ERP: How to Apply Agile Processes to Complex COTS Projects
and Live to Tell about It. Extreme Programming and Agile
Methods — XP/Agile Universe 2002 Lecture Notes in Computer
Science, 70-88. doi:10.1007/3-540-45672-4_8
Kraljić, A., & Kraljić, T. (2018). Agile Software Engineering
Practices and ERP Implementation with Focus on SAP Activate
Methodology. Lecture Notes in Business Information Processing
Perspectives in Business Informatics Research, 190-201.
doi:10.1007/978-3-319-99951-7_13
2

CAPSTONE REFLECTION PAPER
Shreya Pai
PMGT 699 – Applied Project Management
11/26/2019
Contents
Traditional Project Management Background 3
Project Initiation 3
Project Planning 3
Project Execution and Controlling 3
Project Closing4
Application of Agile Methodology in Project Management 4
Integrating Agile in the Development 5

Application of Agile Scrum Technique 5
Strategic Enterprise Awareness 5
References 6
Traditional Project Management Background
Bausch Health used Traditional Project Management for the
project “EC Authorized Representative Change for BREXIT”.
The decision to utilize traditional project management was since
the needs of this project were clearly defined before planning,
implementation, estimation and control of project related
activities (Mrsic, 2017). The approach to use traditional
waterfall methodology for this project was mainly due to the
project changes being small but legally considered to be big.
The applied technique would ensure that the project gets
accomplished in the estimated period and accomplish the
required success criteria by ensuring that the allotted budget
does not go overboard. Planning, Execution, Implementation
and Closing are the four stages that this project covers for
successful completion.
Project Initiation
BREXIT has caused Bausch Health to prioritize this project
over others running parallelly as this project will impact
international business and profits. The BREXIT project is to
change the existing EC Representative from United Kingdom to
Germany in order to continue uninterrupted business in the

Europe. The timeline for this project’s completion is
approximately a year. Once the Change of EC Representative is
performed in Bausch Health, this will aid in maintaining our
business activities in Europe and not have any impact in the
revenue and profits before BREXIT kicks-in.
The stakeholders and SMEs were tasked to identify the risks
that can occur looking at similar or past projects for success.
The major stakeholder for this project is regulatory affairs. It is
challenging because the implementation has to be performed
before BREXIT can go live and, in a way, that we comply to EU
regulations. Some of the risks that we managed to identify as a
part of this exercise was the time constraint, label printing
corrections, qualified resources, submission response time and
new EC Representative agreement guidelines.
Project Planning
Planning is important to understand the objectives of the project
for success. As a part of this, it is also important to simplify the
scope and create a task list for the project (ProjectManager.com,
Inc., 2019). The Project Planning for EC Representative Change
will include determining the true scope of the project which will
include Vision care and Surgical care products and collecting
project artifacts to understand the project requirements. A
project tracker will also be created as a part of planning to
ensure that the products are captured and traced as required.
The Project plan, project schedule, budget and cost approval for
the project from the stakeholders will be conducted as a part of
project planning as well.
Project Execution and Controlling
Project execution is to put the project’s resources into action to
achieve the organization’s goals. Project Implementation is the
phase where plans from the previous phases are put into action
(Orangescrum, 2019). For a change to take place in a company,
an execution is necessary. Similarly, for the EC Representative
to take place at Bausch Health, an execution of a series of
regulatory activities and label production is required. This
execution would include activities like finalizing strategy with

notified body, approval of master QCRs, assess regulatory
impact, update quality agreements and register new Authorized
Representative. Following this, there will be change notification
sent to the Notified Body, updating RA documentation and
notifying international countries by notifications. Along with
this execution, there will be a gate review in order to receive
approval from senior management which will qualify as a
project controlling process. This will ensure that all the
processes are monitored to ensure there is no scope creep and to
track everything to ensure the implementation is smooth
(Orangescrum, 2019).
The project manager for the EC Representative project is in
charge for recording all the changes and variations that can
come up at the time of implementation. Observed changes
should be sent to the project manager so that it can be escalated,
and solutions can be found. The person responsible for this
would be the project manager. This needs to be completed by
the time gate review is performed.
Project Closing
In the last phase, which is project closing, the final formalities
are completed. This stage is to ensure all labeling changes are
complete with international notifications. Here, the project
needs to be signed-off by the stakeholders to ensure that they
acknowledge the successful completion of the project. The
Master Quality Change Control needs to be formally closed
which would mark the closure of the desired change of this
project and the formalities have been executed. Once, all the
deliverables are met, this project is still incomplete without
project closing and the project manager needs to complete this
procedure to mark the end of this project (Simplilearn,
2019).Application of Agile Methodology in Project Management
If agile methodology is used for the Change in EC
Representative project, this technique will allow us to work on
this project by distributing the project in stages in association
with the stakeholders. The Agile Methodology works by gaining
insight about the delivery of the project through the clients. The

clients provide the requirements that would help achieve the
product that they expect with quality (Sacolick, 2018). It is
always said that agile methodology is the best project
management technique to use for projects and is trending in the
market as the project manager is able to understand the
customer/client expectations. Hence, the project manager is able
to make necessary adjustments to project development to
achieve the desired final product by executing the process in
multiple cycles by keeping in mind the product needs of the
customer. Project managers and stakeholders collaborate in
Agile methodology in order to get the best project results. This
also brings about quality results through testing and conducting
project control procedures.
Integrating Agile in the Development
Agile Framework can be applied to a portion of the Change in
EC Representative project for Bausch Health as waterfall
method is preferred given the set of deliverables and
milestones. The technique of agile will be helpful in the
labeling change process which has various stages (Sacolick,
2018). This method can be improvised using agile as it can
prevent or minimize the error during printing labels. This
change is critical to the organization as it is critical for
maintaining business and profits. This label change using agile
technique will enhance the process and expedite the labeling
production process and approval. By using Agile methodology,
the company can enhance the effectiveness of the label
precision and increase the process timeline, approval from
stakeholders in a brief interval of time.Application of Agile
Scrum Technique
If Allied with Scrum is applied to Change of EC Representative
project as a project management methodology for Bausch
Health, the project manager will have to divide the resources of
the team into small groups and each of these groups will be
controlled by a Scrum Master who have the expertise in
delivering procedures and methods that can be utilized in order
to reduce or eliminate the identified risks (Sacolick, 2018). The

project manager must also ensure that may affect in
implementation of the EC Representative Label changes to
safeguard that the project is finished in the stipulated planned
timeline. Application of Agile with Scrum if used with the
Change in EC Representative project, the project tasks would
have to be conducted in short cycles which is also known as
sprints. As this project is well suited for waterfall methodology,
if Agile with Scrum is used, this can only be applied to the
Implementation Phase. This implementation phase would mainly
include Label Production Changes. While performing this, the
teams can talk about the risks and tasks. They can collectively
also find a way to resolve them for success (Sacolick, 2018).
Strategic Enterprise Awareness
In this particular project, the strategic financial management
was very critical as this determines the fate of the project and it
is also essential for success. For the BREXIT project, strategic
financial management is important as this made us jot down the
objectives of this project towards the beginning and to estimate
the number of resources that would be needed to fulfil the goals
of the project. This management and planning will also help us
to utilize the existing financial reserve and additional capital
funds so that the strategic objective of this project of changing
EC Representative for BREXIT is achieved (Thibodeaux, 2019).
CAPSTONE PROJECT REFLECTION
Similarly, organizational awareness is a similar component that
was required for this project. This awareness will aid in
recognizing the right stakeholders who are reliable and have the
potential to show a positive impact on this project and pave its
way to success. Appropriate project and executive leadership is
crucial as it brings in a sense of capability and expanding social
network which can be useful in this particular project, like a
project manager who can help Bausch Health be successful in
achieving Change in EC Representative to achieve the goal of
compliance to BREXIT by complying to EU regulations and
maintaining uninterrupted business (Thibodeaux, 2019).
2

References
Mrsic, M. (2017, May 17). activecollab.com/blog/project-
management/traditional-project-management. Retrieved
November 29, 2019, from Traditional Project Management:
https://activecollab.com/blog/project-management/traditional-
project-management
Orangescrum. (2019). Execution In Project Management.
Retrieved November 29, 2019, from
www.orangescrum.com/tutorial/introduction-to-project-
management/execution-in-project-management:
https://www.orangescrum.com/tutorial/introduction-to-project-
management/execution-in-project-management
ProjectManager.com, Inc. (2019). The Ultimate Guide to Project
Planning. Retrieved November 29, 2019, from
www.projectmanager.com/project-planning:
https://www.projectmanager.com/project-planning
Sacolick, I. (2018, March 15). What is agile methodology?
Modern software development explained. Retrieved November
29, 2019, from www.infoworld.com/article/3237508/what-is-
agile-methodology-modern-software-development-
explained.html:
https://www.infoworld.com/article/3237508/what-is-agile-
methodology-modern-software-development-explained.html
Simplilearn. (2019, October 4). How to Close a Project?
Retrieved November 2019, 2019, from
https://www.simplilearn.com/how-to-close-a-project-article:
www.simplilearn.com/how-to-close-a-project-article
Thibodeaux, W. (2019). The Relationship Between Strategic &
Financial Planning. Retrieved November 29, 2019, from
smallbusiness.chron.com/relationship-between-strategic-
financial-planning-21063.html:
https://smallbusiness.chron.com/relationship-between-strategic-
financial-planning-21063.html

Final Capstone Reflection Paper
Please submit your Final Capstone Reflection Paper to provide
an overview of your project.
Part 1: Traditional Project Management. Provide an overview
and summary of your project within a traditional project
management framework.
Part 2: Agile Methodology. Discuss how you might incorporate
Agile, Agile with Scrum, Scaled Agile and/or Lean
methodologies to accomplish this project.
Part 3: Strategic Enterprise Awareness. Discuss how your
project demonstrates strategic financial and organizational
awareness and contributes to the organization’s strategic goals.
Please make sure to review the Final Capstone Reflection Paper
Rubric before starting paper.
Your paper must be formatted in APA Style and include a title
page and references. It should be a minimum of 7 to 8 pages
(1500-2000 words) double-spaced.
PMGT 699 KA2: CAPSTONE REFLECTION PAPER
ASSESSMENT RUBRIC
ASSESSMENT CRITERIA
POOR
BELOW
MEETS
EXCEEDS
CRIT THINKING 0.1
Work with Context, Evidence, Opinion

Provide evidence, key facts, data, theories, or terminology with
no interpretation or evaluation.
Provide evidence, key facts, data, theories, or terminology with
some interpretation or evaluation.
Provide, interpret, and evaluate information, key facts, data,
theories, or terminology. Develop a sufficient analysis or
synthesis of that information. Begin to investigate concepts by
asking relevant questions to clarify facts, concepts, and
relationships.
Provide, interpret, and evaluate information, key facts, data,
theories, or terminology. Develop a comprehensive analysis or
synthesis of that information. Investigate concepts by asking
relevant questions to clarify facts, concepts, and relationships.
CRIT THINKING 0.2
Analyze Connections and Draw Conclusions
Work with key concepts by relating or comparing them. State
conclusions based on simplistic reasoning, biased information,
or emotional judgments. Demonstrate no ability to generalize or
extrapolate concepts for future consideration.
Work with key concepts / information / theory by distinguishing
key elements and describing key information generally. Connect
conclusions logically to information chosen to fit the desired
conclusion; identify some related outcomes, consequences and
implications. Demonstrate little ability to generalize or
Work with key concepts / information / theory by identifying
patterns, interpreting challenging concepts, drawing logical
conclusions and sketching potential applications or extensions
to new problems or contexts. Connect conclusions logically to a
range of information, identify related outcomes, consequences
and implications clearly. Demonstrate ability to generalize or
Work with key concepts / information / theory and conduct a
thorough analysis by applying or extending them to new
problems or contexts, making predictions, drawing inferences

and analyzing patterns. State conclusions and related outcomes,
consequences, and implications which are based on logic and
reflect student’s informed evaluation. Demonstrate ability to
generalize or extrapolate concepts or processes, as well as to
critique the value and credibility of these ideas for future
consideration.
INFO LITERACY 0.2
Collect and retrieve the needed information
Use minimal information sources, relying on the first search
result or the easiest to find.
Demonstrated use of moderate keyword search. Less than 10
quality resources on basis of authority, objectivity, currency,
accuracy, and relevancy.
Demonstrated use of thorough keyword search. Uses 10 quality
resources on basis of authority, objectivity, currency, accuracy,
and relevancy.
Demonstrated use of accurate keyword search. Exceeds 10
quality resources on basis of authority, objectivity, currency,
accuracy, and relevancy.
INFO LITERACY 0.6
Access and use information ethically and legally
Use of information with many (10 or more) errors in attribution
or usage of citation rules. Plagiarize and/or failure to cite
sources.
Reference information sources with 10 or more errors in
attribution or usage of citation rules.
.
Reference information sources with few (fewer than 4) errors in
attribution or usage of citation rules.
Reference information sources with proper attribution and
citation that is substantially error-free.
ENTREPRENEURSHIP
Practice Innovative Thinking

List opportunities for improvement, innovation, or optimization
of a given situation.
Analyze given opportunities for improvement, innovation, or
optimization of a given situation.
Develop opportunities for improvement, innovation, or
optimization of a given situation.
Develop and critique opportunities for improvement,
innovation, or optimization of a given situation.
CIVIC KNOWLEDGE
Connect knowledge of Civic Engagement
Identify knowledge (facts, theories, etc.) from academic study
or experience that may be relevant to civic engagement in
general and to the student’s own participation in civic life,
politics, and government and vice versa.
Discuss connections between knowledge (facts, theories, etc.)
from the student’s own academic study or experience and civic
engagement in general and the student’s own participation in
civic life, politics, and government and vice versa.
Connect knowledge (facts, theories, etc.) from the student’s
own academic study or experience to civic engagement in
general and to the student’s own participation in civic life,
politics, and government and vice versa.
Create new connections between knowledge (facts, theories,
etc.) from the student’s own academic study or experience and
apply them to civic engagement in general and the student’s
own participation in civic life, politics, and government and
vice versa.
COMMUNICATION 0.3
Adhere to Conventions
Fails to adhere to provided guidance or APA format.
Uses provided guidance or APA format inconsistently with 10
or more errors.
Uses provided guidance and APA format consistently with
relatively few errors.

Uses provided guidance and APA format consistently that is
substantially error-free.
COMMUNICATION 0.4
Use Sources and Evidence
Demonstrate an attempt to use and document sources or
evidence to support ideas in the writing.
Demonstrate use and documentation of credible and/or relevant
sources or evidence to support ideas appropriate for the
discipline and genre of the writing.
Employ consistent use and documentation of credible, relevant
sources or evidence to support ideas appropriate to the
discipline and genre of the writing.
Support ideas appropriate to the discipline and genre of the
writing by using and documenting high-quality, credible,
relevant sources or evidence.
Top of Form
LEARNING OUTCOMES
POOR
BELOW
MEETS
EXCEEDS
Program Goal 1 Technical Expertise in Traditional Project
Management. Demonstrate the applied knowledge and technical
expertise in the management of a single project to meet
stakeholder needs within constraints and aligned with
traditional project management frameworks with industry
standard artifacts
Criterion 1.1 - Demonstrate the applied use of the traditional
PMBOK Process Groups and Knowledge Areas with industry
standard artifacts in the initiating of projects to meet
stakeholder needs within constraints
Poor demonstration in the applied use of the traditional PMBOK
Process Groups and Knowledge Areas with industry standard
artifacts in the initiating of projects

Limited demonstration in the applied use of the traditional
standard artifacts in the initiating of projects
Effective demonstration in the applied use of the traditional
Exceptional demonstration in the applied use of the traditional
standard artifacts in the planning of projects to meet stakeholder
needs within constraints
artifacts in the planning of projects
standard artifacts in the planning of projects
standard artifacts in the closing of projects to meet stakeholder
needs within constraints
artifacts in the closing of projects
standard artifacts in the closing of projects

Program Goal 2 - Technical Expertise in Agile Project
Management. Demonstrate the applied knowledge and technical
expertise in the management of a single team to meet
stakeholder needs within constraints and aligned with agile
project management frameworks with industry best practices
Criterion 2.1 -Demonstrate the applied use of Agile Project
Management knowledge and expertise in the management of a
single team to meet stakeholder needs within constraints for
agile frameworks other than Scrum
Poor demonstration in the applied use of Agile Project
single team for agile frameworks other than scrum
Limited demonstration in the applied use of Agile Project
Effective demonstration in the applied use of Agile Project
Exceptional demonstration in the applied use of Agile Project
Criterion 2.2 - Demonstrate the applied use of Agile Project
single team to meet stakeholder needs within constraints using
Scrum agile framework
Poor demonstration in the applied use of Agile Project
single team for the Scrum agile framework
Limited demonstration in the applied use of Agile Project

Effective demonstration in the applied use of Agile Project
Exceptional demonstration in the applied use of Agile Project
Program Goal 3 - Professional Behavior. Student will be able to
demonstrate how successful project management will use
stakeholder engagement, communication, leadership, and
teamwork that is ethical, and culturally aware
Criterion 3.1 - Demonstrate the use of project management
communication strategies and stakeholder management
processes
Poor demonstration in the use of project management
processes
Limited demonstration in the use of project management
processes
Effective demonstration in the use of project management
processes
Exceptional demonstration in the use of project management
processes
Criterion 3.2 - Demonstrate the use of ethical and culturally
aware leadership and teamwork methods that result in high
performing teams
Poor demonstration in the use of ethical and culturally aware
leadership and teamwork methods that result in high performing
teams
Limited demonstration in the use of ethical and culturally aware
leadership and teamwork methods that result in high performing
teams
Effective demonstration in the use of ethical and culturally
aware leadership and teamwork methods tha result in high

performing teams
Exceptional demonstration in the use of ethical and culturally
aware leadership and teamwork methods that result in high
performing teams
Program Goal 4 - Strategic Enterprise Awareness. Student will
be able to demonstrate financial and organizational contextual
awareness and insight by linking key stakeholder objectives to
sustainable competitive strategies required to deliver value
across operational functions using traditional and agile
techniques
Criterion 4.1 - Demonstrate the use of strategic organizational
management principles as it applies to selecting and managing
projects
Poor demonstration in the use of strategic organizational
projects
Limited demonstration in the use of strategic organizational
projects
Effective demonstration in the use of strategic organizational
projects
Exceptional demonstration in the use of strategic organizational
projects
Criterion 4.2 - Demonstrate the use of enterprise project,
program, and portfolio management methods in traditional
project management environments
Poor demonstration in the use of enterprise project, program,
and portfolio management methods in traditional project
management environments
Limited demonstration in the use of enterprise project, program,
and portfolio management methods in traditional project
management environments
Effective demonstration in the use of enterprise project,

Exceptional demonstration in the use of enterprise project,
Criterion 4.3 - Demonstrate the applied use of scaled agile
techniques at the enterprise wide level
Poor demonstration in the applied use of scaled agile techniques
at the enterprise wide level
Limited demonstration in the applied use of scaled agile
Effective demonstration in the applied use of scaled agile
Exceptional demonstration in the applied use of scaled agile
Updated 2018
PMGT 699 Final Capstone Reflection Paper Rubric
CRITERION
LEARNING OUTCOMES
MAX PTS
YOUR PTS
FEEDBACK
Program Goal 4: Strategic Enterprise Awareness:
Demonstrates financial & organizational contextual awareness
by linking key stakeholder objectives to sustainable competitive
strategies required to deliver value across operational functions
using traditional & agile techniques (4.1-4.3
OVERVIEW
· Provides an overview of the company and its strategic goals
· Provides broad description of project and relationship to

stakeholder objectives
· Explains the sustainable business value of the project across
operational functions
· Presents high-level review of key objectives, scope,
milestones, deliverables, risks and constraints in appropriate
detail
· Definitions/ explanations of any critical terms included
10
Program Goal 1 - Technical Expertise in Traditional PM
Demonstrates applied knowledge & technical expertise in
project management to meet stakeholder needs within
constraints & aligned with traditional PM frameworks with
industry standard artifacts (Criterion 1.1-1.4)
TRADITIONAL PROJECT MANAGEMENT ANALYSIS
· Describes how project management plan uses the traditional
standard artifacts in the initiating, planning, execution and
control and closing of project
· Describes how project was organized and managed to meet
stakeholder needs within constraints of scope, cost, time and
quality
25
Program Goal 2 - Technical Expertise in Agile PM
Demonstrates applied knowledge and technical expertise in the
management of a single team to meet stakeholder needs within
constraints and aligned with agile project management
frameworks with industry best practices
AGILE PROJECT MANAGEMENT ANALYSIS
· Provides a description/overview of Agile project management
· Explains how an Agile project management framework could

be implemented in executing the project
· Discusses at least two Agile frameworks including Scrum
· Discusses at least three agile ceremonies
25
Program Goal 3 - Professional Behavior
Demonstrates how successful project management will use
stakeholder engagement, communication, leadership, and
teamwork that is ethical, and culturally aware
CONCLUSION/ PERSONAL REFLECTION
· Thoroughly summarizes content of the research paper
· Proposes solutions that reflect ethical and culturally aware
project management practices in leadership, communication,
stakeholder management and teamwork
· Provides supportive evidence/ knowledge of opposing
viewpoints
10
1
HU Core Competencies
INFO LITERACY 0.2
Collect and retrieve the needed information
COMM 0.2
Develop Content
CRIT THINKING 0.2
Analyze & Draw Conclusions
Solve Problems
CONTENT & ANALYSIS

· Demonstrates use of appropriate thorough research
· Uses quality resources based on authority, objectivity,
currency, accuracy, and/or relevancy
· Meets minimum number of 3 scholarly sources
· Meets minimum required paper length of 1500-2200 words
· Demonstrates knowledge of key concepts, processes and
theories
· Provides thorough analysis by applying ideas to new contexts,
making predictions, and/or communicating contrasts and
comparisons
10
COMM 0.5
Control Grammar and Mechanics
WRITING MECHANICS
· Uses language that communicates meaning to readers with
clarity
· Writing is reflective of graduate level work & substantially
error-free
· Reflects appropriate proofreading for grammar, spelling and
sentence structure
10
COMM 0.3
Adhere to Conventions
COMM 0.4
Use Sources and Evidence
APA STYLE & FORMATTING

· All direct quotes, ideas, concepts and data are accurately cited
· All sources cited in the text are listed in the references section
· Consistently APA format that is substantially error-free (i.e.
title page, TOC, contents, body of paper, references, etc.)
10
OTHER
· Plagiarism, Lateness
TBD
TOTAL
Updated 2018

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