The document provides an overview of the legislative branch of the US government. It discusses the structure of Congress including the House of Representatives and Senate. Key points include that Congress is bicameral, with the House having 2 year terms and the Senate having 6 year terms. It also discusses the process of reapportionment and redistricting after each census. Gerrymandering seeks to draw districts to benefit one political party. The document then provides more details on the composition and powers of both the House and Senate.

1. The Legislative Branch
Article I
Congress
Terms and Sessions of Congress
A term is the length of time between elections in Congress (two
years).
Each Congressional term consists of two sessions, one during
each year of a term.
Bicameralism
Congress consists of two houses, the House of Representatives
and the Senate, that act to check and balance each other.
Congress has its roots in British and Colonial history.
Our bicameral legislature is a reflection of federalism, and was
part of the Connecticut Compromise of 1787.
House of Representatives
Term: 2 years
No term limits
Qualifications
25 years old
7 years as a U.S. citizen
Resident of represented state

2. Reapportionment
Process of re-dividing the 435 seats of the U.S. House of
Representatives based upon each state's proportion of the
national population.
The preceding census is the baseline for determining how many
House seats are allotted to each state. (CO: 7)
Minimum representation per state: 1 seat
Wesberry vs. Sanders 1964
“One person, One vote” rule: each vote in a congressional
district should be worth about the same
Today each district has around 710,000 people
Seats added or lost in Congressional reapportionment after 2010
census
Redistricting
process of redrawing legislative district boundaries every 10
years based upon changes in population.
State legislatures determine district boundaries.
Drawing boundaries of legislative districts to benefit one party
or group and handicap another is called “gerrymandering.”
Gerrymandering
Gerrymandering seeks to draw legislative districts that isolate

3. members of a particular political party so that a maximum
number of representatives of that party will be elected.
Gerrymandering Cont.
Packing- drawing lines so they include as many of the opposing
party’s voters as possible
Cracking- dividing an opponent’s voters into other districts,
weakens opponents voter base
2010 Kentucky
Congressional Districts
House of Representatives
Emphasizes fiscal policy (government expenditures, revenues,
and debt.)
Special Powers of House of Rep.
All money (appropriations) bills start here
Select the President if no majority in Electoral College
Write the articles of impeachment against high ranking officials
Speaker of the House
Head of House of Representatives
-Presides over the full House.
-Decides on which committees each

4. member of his/her party will serve.
-Assigns bills to committees
-Decides the order in which bills will be
heard and time limits for debate on
House Floor.
Senate
Term of office: 6 years
No term limits
Qualifications:
30 years old
9 years a citizen of the U.S.
Resident of the represented state
Senate
Number of Senators: 100
Representation equal (2 per State)
Filibuster (unlimited debate) unless cloture is invoked. (60
votes to end debate)
President of the Senate: U.S. Vice President
Day-to-day head of Senate: President Pro Tempore

5. Senate
Emphasizes foreign policy
Special Powers
Approves all treaties
Approves all appointments
Chooses the Vice President in an Electoral College tie
Acts as the jury in all trials of impeachment
Congress
Both houses:
Must keep a Journal:
The Congressional Record
Must hold sessions at the same time:
Sessions begin January 3rd each year
Must have a quorum to do business:
51% of members present on the floor
Congress
Both houses make their own rules for behavior and punishments
Censure: formally reprimand, written in the record
Fines and penalties may be set for some offenses
Expulsion: members with gross misconduct may be thrown out
of office
(requires 2/3 vote)
Privileges and Compensation of Congress members:
-Salary $174,200 per year (Leadership:$212,000)
-Medical and dental benefits
-Free office, parking, and trips to home state

6. -Staff budget
-Tax break on second home
-Franking privilege- free postage on all mail to constituents
Privileges and Compensation of Congress members:
Immunity or legal protection:
-Cannot be sued of anything they say or write while carrying
out their duties
-Cannot be arrested for minor offenses while Congress is in
session
Restriction:
May not hold another political office at same time
ELASTIC CLAUSE
The necessary and proper clause gives Congress the power to
make laws “necessary and proper” to carry out its delegated
duties (expressed powers.)
Also known as the ‘elastic clause’, it stretches the power given
Congress.
McCulloch v. Maryland supported this concept of ‘implied
powers’, leading to larger government over time.
Powers denied Congress

7. Cannot suspend the writ of Habeas Corpus- must show cause for
holding a suspect except in wartime
No ex post facto laws: cannot punish a person for an act
committed before there was a law against it.
No bills of attainder: laws that punish people without a trial
Powers denied Congress
No tax on exports
No titles of nobility
All states must be treated equally
Congress must approve all expenditures of POTUS through laws
State Powers
Tenth Amendment: Powers not granted to the national gov’t or
denied to States are reserved to the States and the people.
(“reserved powers”)
States cannot:
coin money
have troops, or navy
collect import or export taxes
pass any law that the Federal government is not allowed to pass
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Overview of Lean
I primarily work for a Pharmaceutical Organization which
develops and maintains the products for public Health. The

8. company I work for is, Ironwood Pharmaceuticals, which is
exceptional in developing products for people suffering in
secretion of excessive Uric acid. These products are marketed
all over the world and had a fair share of the market across the
globe producing better results and helping the people health at
the same time.
Pharmaceutical organizations are more towards the regulations
that are controlled by the government since it deals with the
health of the patients and eventually are valuable to the public.
Pharmaceutical companies are bound by rules when
development and delivery of the product is involved, the
projects are treated more carefully, and any failure would loss
in millions. Unlike the Software companies out there, there are
some things which are common when it comes to handling the
projects.
In a Pharmaceutical company, there are projects which are
handled by the Department of IT in implementing new
Software-as-a-Service products that are used within for quality
management. These S-a-a-S products are developed by the
vendor’s who provide the software to the company for use of
their service to help manage the quality process and data
integrity of the document.
The process of implementing such projects are discussed below;
First, The implementation would be kicked with a meeting with
the vendor form who the product is purchased. This meeting is
called Sales-to-service meeting where the scope and the project
assumptions are discussed.
Assumptions include mostly the following;
· Documentation procedures shall be followed as per the
company’s guidelines.
· Storage of the project Documentation shall be in an online
repository of the company
· Existing Systems are not affected by this integration and
proper Standard operating procedures are followed to maintain
the balance of the quality on either of the parties
· Migration activities are determined prior to the system

9. implementation and the actual migration to be taken place
before the system is implemented fully and operational within
the company
· Adequate Business, IT and Quality resources will be available.
· Hardware qualification will be performed by IT as applicable.
· The system being implemented shall ensure a proper
documentation is provided such as User acceptance testing etc.,
· Some Vendors will need to be qualified in parallel with
validation, proceeding at risk
The project is carried in many phases; starting with the
initiation phase where the project starts by deciding the key
factors of the process and what documentation is necessary is
determined by the Regulatory and Applicability documentation
which provides the score for the system that determined whether
it has High, Medium or Low impact. High impact means the
system being implemented has a high risk when implemented at
the company and will have a severe impact and are to be taken
extra care to avoid any risk of losing data. Medium means that
the impact will have minimal to less impact on the data. Low
risk means there is less to no impact on the data. Based on the
score that was observed and the impact it was determined, the
project documentation is determined.
At a minimum the following documentation is provided for each
project;
· Business Requirements (Low Systems);
· User Requirements (Med – High Systems);
· Regulatory Applicability and Criticality Assessment (RAC)
for each system;
· Validation Plan;
· Acceptance of any existing Vendor or Ironwood deliverables;
· IQ/OQ Documentation
· UAT test scripts;
· Validation Release Memo for each system;
· Validation Master Plan Summary Report.
The Second stage involves the Concept phase, at which the
documentation required to prepare the implementation is done

10. during this stage. In our company, the initial plan is drafted
inorder to have a written documentation on how the proceedings
are done as per the project is considered. Once the plan has
been drafted, all the proceedings should comply with standard
documentation and should not deviate from the plan. Any
deviation within the pharmaceutical company will lead to
serious penalty which may be considered the data is altered,
fabricated or even falsified.
Once the plan has been drafted and finalized, the system shall
be in the configuration phase, where the product which was
given as S-a-a-S is configured to the needs of the company and
then the vendor works on delivering the product as configures.
The meeting is set-up withal the stakeholders and the business
along with the IT owner and the Validation persons to see that
the product is configured as requested. These configurations are
matched using the configurations specification to maintain the
documentation that the software stays the same through-out its
lifecycle as configured and would be a evidence. For formal
verification, a configuration verification is created to make sure
that all check-out.
All the concerned parties are then asked to sign all the
documentation to make sure that the configuration is locked and
then the testing is performed on the test environment. This
testing is known as the User Acceptance Testing which means
that a formal execution of al the workflows, process designed
within the software work as intended. This provides a formal
testing evidence that the processes work and is good to be ready
for the Production.
All these activities are documented towards the end, so a
summary report is developed which would detail all the
activities performed during the scope of this project and were
there any deviations during the period, and if so, where they
documented appropriately as determined. This Summary Report
will also provide the document names and numbers following
the post execution and also details the training services required
to ensure that the end users are trained before being able to get

11. access to the system. All of these details accumulate to
determine whether the system is ready for Production or any
other activities are to be dealt with before the system can be
implemented.
Principles Applied
The company I work for right now has limited to none usage of
Lean principles. This is because the company is bound to
operate in some defined regulations by the government since it
is a pharmaceutical company. These regulations add few extra
processes for extra patient health. The government feels this as
responsibility and will also be helpful while auditing to ensure
that the company has stood by the regulations that it was bound
to while developing any drug/device.
To begin with, let’s discuss the lean principles that my
organization uses on day-to-day basis. One good thing of being
bound by regulations help you improve the development process
consistently a there is a lot of documentation involved in the
process. These documentations help the company when they are
paperless and allow e-signatures online, while ours is still not
automated and eco-friendly, we use a lot of paper and wet-sign
them to make sure that the document has been reviewed and
accepted by the concerned parties. However, there is a lot of
waste that is being eventually collected in form of paper and
this waste is just stored for years for the sake of audit purposes
as patient health and safety is involved.
Secondly, the best lean principle that my organization follows is
“Quality”. The quality that was built around the company’s
development techniques has brought successful compliance
results. The quality team are most important while dealing with
the compliance techniques that allows the company to be bound
by the rules of the quality. Quality decides the process,
techniques, implementation, procedure and verification of the
documents, all these activities are defined appropriately.
Also, creating knowledge is important aspect where each team
is entitled with unique skills which on a whole shall form an
efficient interaction to an affluent success in development.

12. Knowledge is most resourceful in the company and helps the
development process with new techniques with the knowledge.
A team or person shall allow the flow of the knowledge in the
company than to keep the teams in divisions and not let them
flow the knowledge which will help succession easier. There
should be a weekly meeting session that will hold the
knowledge session to discuss the difficulties of any task that is
rendering the flow of outcomes and all teams can be sat together
to discuss the strategies and share knowledge upon the issue to
come with any probable outcomes to resolve them.
However, creating commitment is one lean principle that our
company is lacking, especially when work is outsourced, no
definite process to check the work that was being done or a
verification of the process to make sure that accurate procedures
are followed. This creates a lack of commitment within the
organization. The internal members tend to lean towards the
company that was outsourced. Though, the work is outsourced,
a minimum verification procedure must be in place and this was
lacking which leads to lack of commitment.
Although, lack of commitment is shown by the employee, there
is certain respect towards each team member or a team on a
whole. This creates mutual respect between the individuals, by
creating mutual respect, there is a confidence that grows in
between the peers which will allow them trustworthy and this
trust will in turn enable work efficient behavior. Mutual respect
also allows peers to be more skillful and will allow track of the
progress and will allow any member to ask about the status
without hesitation and the work shall be transparent.
There is one big asset that our company has is the pro-
activeness in delivering the work around. Each employee shall
be accountable for the work that is given to him/her. In a
pharmaceutical organization, the work is pro-actively done
either it be a periodic review, SOPs draft and revision of
documents that are already existing. The pro-activeness allows
to use structured development and help plan the activities ahead

13. of the year. Once these activities are established, the company
divides the goals and objectives to be achieved based on the
quarter. The goals and objectives are combined into projects
and the projects are divided upon the teams. These teams work
around these projects to achieve success and help the company
progression into successive revenue.
Apart from all these lean principles, there is one principle that
each department follows are the procedural techniques that are
implemented in the company and all are bound to follow the
procedure. These procedures help define the company and how
it manages. These procedural techniques also allow the value
stream process. In our organization the procedures are written
for all processes that involve in development stages. By
developing such procedures, it will help everyone to be aligned
with what to be done at a particular time. If the process Is
deviated, there is a procedure written to consolidate that as
well, where the deviation is taken and a proper written page is
submitted explaining why the deviation has occurred and what
has been involved in causing the deviation. Essentially root
cause is developed. These sort of writtem instructions always
allow our organization to maintain a value stream map and help
to stay within the proven success graph.
However, our organization as mentioned above should learn to
automate some of the procedures that will ensure that some
waste is eliminated. Right now, there are no proper waste
elimination procedures which is one of the lean principles. By
reducing the waste eliminatin there are lot of under relying
activities that will be reformed as well such as the reduction of
waste in the paper which will reduce the amount of paper used
and also the inventory that is brought in everyday for the use of
paper shall be reduced which in turn will create possibility of
lean procedure implementation.
References:
https://leankit.com/learn/lean/principles-of-lean-development/

14. Seven Wastes
The concept of wastage was first introduced by the Toyota
during early stages of lean manufacturing. These seven wastes
are taken as an initiative by the Mary and Tom Poppendieck
who translated these wastes “Seven Wastes of Software
Development”
The seven wastes are;
1. Partially Done Work
2. Extra Features
3. Re-learning
4. Handoffs
5. Delays
6. Task Switching
7. Defects
As my organization is a pharmaceutical organization, which
involves in developing drugs and devices. The software projects
that happen in my organization are pretty small as I have
mentioned in the earlier sections. The projects that we do is not
developing the software development, but the software has
already been developed and provided to us for the vendor for
day-to-day operations. But I had once worked for a software
development project with a contract form my organization,
which helped me to see few things up-close but not for too long.
However, I saw the following wastes that effect the
organization and how it may be handled;
Partially Work Done –
The organization has too many tasks that are assigned to each
other at the same time to reduce the amount of burden that has
within the employee. For example, as soon as the project sets to
the initiative phase, there are number of documents such as
planning, smoke test, execution and summary of the results etc.
All these activities are tied to each other but the summary is
done at a later time. However, these all activities are committed
to a single sprint. While a single sprint is going on , there is
another sprint that isbeing started and the work is being left

15. undone by the end of the day. As these compilation takes place,
there is a lot of work that is not done or partially done and
never completed. This was the first thing that developed to
failure of our first project.
Extra Features –
The decision of what features to include in the software is done
prior to the tasks being assigned and the sprint being started.
These are developed into stories by a meeting that was
held with all the concerned parties together to come up with the
ideas and make them successful. The reason these meetings are
held once is that all provide their ideas and there is no going
back on the features. However, this was not the case, one of our
consultant decided to go-over the manager to include a feature
that allows the date to be modified by the user to suit best
purposes and add extra feature to change the report schedules
based upon the date setting across the world. The standard
feature was to allow users with pre-defined reports and a pre-
defined date format. But, as these extra features allowed extra
stories with a few extra week for a sprint which ttaly disrupted
the schedule and made an unnecessary interruptions to meet the
deadlines.
Re-learning –
This was the most particular reason why we failed to meet our
last sprint cycle eventually delaying and unsuccessful project.
There was a feature where the document request approval
process to be included within the approval workflow. This was a
major tweak because this involves two codes one to which
allows the workflow to surpass to a superior if it was not
attended in 30 days. The development took several days, and the
developer had not included any work notes while performing
this function. We encountered the same issue while deploying
the production and the tweak was not covered in the PROD
installation where the developer had to re-do all the work from
the scratch because the notes was not saved. This made the
PROD install on a week delay that has affected the business of
the stakeholder.

16. Handoffs –
The project that we were working was a important development
as the software is used for adding the audit log files to the
server as the SAS folders are not monitored before which lead
to the audit observation by the FDA. I was assisting in the
project with the contractor. The project was to be completed
before the audit observation was submitted to the FDA i.e.,
within the 90 days of the observation. During this phase the
company was also undergoing a merger with a high-profile
company that bought the organization. This merger has led to
too many complications in between the project and all of a
sudden, the team that developed the project and were close to
completion are moved to a different project. This led to a
serious set of complications where the new team was to be
handed off the work with all the knowledge transfer and the
work status was discussed in a variety of many meetings. These
unnecessary meetings and the handoff had led to the delay and
was very hard to meet the tight deadline the company has been
impounded with.
Delays –
As mentioned earlier in the Handoffs, the project getting
transitioned to a new team is major delay that I had
encountered whilst also I have seen that a project pan
completely getting altered on half way through the project.
However, the transition is the most concerning part in my
career. Th transition made the company stall the work that was
done by the team. In addition, th team had to put in extra work
to get all the updates that were done till date into a presentation
or work notes to bring that to the transition meeting held
between the new team. These meetings cost the time delays,
work delays and moreover, hindering the project furthermore
into the date meeting with the deadline.
Defects –
The most important thing that anyone would not want in the
project is that the software that has developed has defects. Well,
in our case there was this one instance in a project had lot of

17. defects during the first stage of the development. This has
happened due to the fact of negligence by the entire tema to
cross-check the work that has been done before and this led to
multiple defects while reaching the end of the sprint testing. A
particular reason was that developer was working on two
different projects and had made a mistake on putting the wrong
codes. These codes were then sent to the quality who had
completely missed these small defects which ultimately led to
the demise of the software and the work had to be re-done and
this cost the company.
Value Stream Mapping
Value Stream Mapping 2
The pharmaceutical organization is also a place where quality
precedes the time taken to get the request completed
successfully. However, the time is pertinent at times when the
request is tied to a observation by the quality and it helps them
get it done sooner the better.
The Survive ticket response time is one process that my
organization had for a very long time. This service request is
used for many operations within the company/ It is used for
software request, hardware request, Configuration change
updates, hiring ticket, decommissioning systems and request for
change services that handles all the change process for the
systems that are implemented with the company. These systems

18. are used for GxP purposes, which means that these are regulated
systems which comply with the regulations within the company
that are followed as best standard practice.
Right now, the service now ticket implementation is right now
implemented in providing service as displayed below;
First, the ticket is created by the user that has any request that
he/she has for. Be that specifically a software request to be
installed or a hardware accessory that is needed for the person.
After the ticket is submitted, based on the category and the
need, the ticket is then sent to the manager intended for based
on the category. This ticket is approved by the manager which
is indeed sent to the support center that works down to get the
tickets completed successfully, the ticket processing time takes
more than twelve hours and the support center is off-shore
which sometimes takes more time than required. Once the
request is completed successfully, a notification is sent to the
user that had opened the ticket and let them know that the
process is completed with no exceptions. The time that takes to
complete all the process is around 3 to 4 business days. I feel
that the process is very vast and can be reduced to some extent
to get the request completed successfully. Three or four day is
more that any user could ask when a ticket is of high priority.
Though the high priority tickets are completed within a certain
limited time to accommodate the needs but the change is
inevitable to complete the normal ticketing service as requested
and then the emergency tickets are completed more faster.
There are several wastes that I think personally can be
identified from this process; Hand-offs and Delays. These are
the two details I think that can be reduced from the above
process, which makes the service ticket process time more
efficient and effective so that the users may find it easy to use
and help the service time reduce to get their needs completed

19. successfully as expected. First thing I would recommend is to
eliminate the delay issue of sending the ticket to manager first
then the support center. The manager approval is redundant
where as the request is already sent to the support center and
they would verify the confirmation form manager instead. This
would save the time of ticket processing by 12 hrs and reduce
one day. It would also increase the time that a support person
can work on the ticket and get the things going before the
approval comes. Second the ticket processing time can be
divided into two parts, right now all the tickets go to the
support centre no matter what the type and category is, but I
feel that the hardware requests go the internal on-site IT
department that can handle the request and software push tickets
to the support center. Meanwhile the change requests that are
helping perform system change implementations are handled by
the validation or IT R & D that handle these tickets. By
absorbing these integrations into three different departments for
three different tickets will not only reduce the amount of time
but also increases the completion rate at which the tickets can
be implemented.
Document Change Request Process is one more process that is
currently used in the quality department,
This process is used for having any document that needs to be
uploaded into the system to make sure that the document is
followed through a standard operating practice and the reviews
and approvals take place in a planned and proposed procedure.
This takes place within 2-3days but then this procedure can be
reduced to a day if the proper protocol is followed and few
steps are eliminated that are waste; one is partially done work
and the other is the defects. The system that this procedure is
carried out uses a unique feature that it allows the user to
initiate the Dcouemnt change request process and then once the
process is initiated it is sent for approval within the system to
get a DCR Process number and name with also a template that
can be used by the user based on the document they chose. This

20. template is the base that should be used for the draft that user
can complete the work before sending for review. Sometimes,
the user has a template ready before head to send the document
for review, but one the system generates a template and turn out
to be it is a different template because without a notification the
quality has changed the template. This allows a partially work
done document to be rendered invaluable and the work time
spent ahead is completely irrelevant. One more process is that,
the navigation to the system is not very convenient as the users
can only get through to the docuemnt approvals via a
notification that is received in an e-mail once the DCR Process
sis assigned. Reducing the navigation defects will allow the
user to reduce some time of the process. Also, reducing the time
of drafting by giving the correct template before head by
placing the templates in the sharepoint local to the network. The
process only requires the document attached to the slot that is
provided by the company and not to stress time on the template.
These processes can reduce a lot amount of time and help the
users. However, the review and approvals in the process work
according to the procedure.
Lean Activities
The Lean activities are shown below in a Kanban board, The
Kanban board is divided into three categories,
To-Do List – is used for letting the members know what hings
are expected to be completed.
In-Progress – is used by members to recognize the work that is
in progress
Completed – is used to identify the work that is completed.
Project Implementation Kanban Board is shown below;
Service Ticket Response Time Kanban Board is shown below;

21. Document Change Request Process Kanban Board is shown
below;
Agile Lean Product Development at Ironwood Pharmaceuticals
Gemba Walk Approach
It involved in-person observation to better understand how a
certain IT Department uses software to enhance effectiveness
and efficiency of processes and procedures within the company.
A walk through the Ironwood Pharmaceuticals a company that
develops products for persons suffering from secretion of
excessive uric acid was to assess lean product development at
the company. The focus was on the IT Department that handles
projects related to quality management and data integrity. A
process is followed in implementation of these projects aimed at
controlling and managing quality within the company. The
implementation process has many phases including the initiation
phase, the concept phase and the configuration phase.
Unfortunately, the company has limited use of lean principles
probably because it operates under some regulations controlled
by the government.
Execution
The Gemba walk allows people to visit a workplace and see how
specific processes, procedures or operations are done. There
was observation of the processes, procedures and techniques
used at the Ironwood Pharmaceutical. The in-person observation
shows the difference between what is actual happening on a job
and what is assumed to happen. People interact while doing the
job and the observer is in a position to exactly see what is being
done as well as listen to experiences. Interaction with
participants resulted to more rich data and perspectives based
on experience and values (Whitehead et al, 2012).
Being a participant observer, data was captured in more natural
circumstances and environment. Observation and interaction
helped identify use of lean principles and areas that needed
improvement. Through observation, experience and interaction

22. with its employees, we learnt that Ironwood uses some lean
principles in its daily operations.
First, it is bound by regulations that helps it improve the
development process. Documentation is critical in this company
that involves a lot of paper work. The documents are wet-signed
as prove of agreement by concerned parties. One key challenge
of a lot of paper work is storage for audit purposes and wastage.
Second, the company is guided by quality. It has built its
development techniques in a manner that enhances compliance.
Its techniques, processes, documentation and procedures are
governed by quality. All departments follow procedural
techniques that define the company and its management. Third
and last, it creates knowledge to enhance efficiency to
successful developments with new techniques. However, the
company lacks commitment especially when outsourcing work.
Ironwood lacks procedures to manage outsourced work. It lacks
a definite process to check work progress or verification process
to confirm that procedures are followed accordingly. A lack of
commitment makes its employees rely on the outsourced
company. Despite the lack of commitment, its team members
respect each other enhancing trust. They value ideas of others
making them more skillful.
Findings of the Gemba
Ironwood lacks effective use of lean principles that could be
hindering it from attaining its full potential. The company faces
challenges in employee commitment to outsourced work and
wastes in various areas. The company has wastes in software
development that is critical in enhancing efficiency and
effectiveness. It experiences the “Seven Wastes of Software
Development.” For instance, in terms of partially work done,
the company engaged in a lot of tasks at the same time leaving
out some work that may not be completed. This contributes to
project failure. Similarly, in terms of re-learning, the company
lacked adequate knowledge on performing a certain function
that led to delay and project failure. The developer failed to
illustrate how a certain function was to be performed. The lack

23. of understanding led to delays in execution of the function.
Again, there is waste in documentation where a lot of paper
work is involved and stored for future audits. Waste was to be
addressed for improved performances.
Remediation Plan
First, the company can implement an automated and eco-
friendly system that will allow documentation without the need
of a lot of paper work. The company can create a system that
will allow documentation in soft copies and e-signatures online
when reviewing and accepting agreements. This should help
minimize use of paper that require storage areas and could be
tiresome when searching for past information. Secondly, the
company can use Extreme Programming to help address the
“Seven Wastes” (Silvius, 2013). This software development
methodology helps improve the quality of implemented software
and responsiveness. It will help minimize waste by adding value
and focusing on people who add value to the company.
However, training is essential on employees to enhance its
effectiveness in improving productivity.
Lean Metrics
The most work that is done within our company is to the
ServiceNow ticket turnaround times. As mentioned above in the
value streaming, ServiceNow in our company is implemented
for lot of purposes; access to systems, request for change
tickets, access to software and hardware and any access that is
requested by the employee and needs a manager approval. For
example, if an employee joins in Regulatory Department of the
company, he/she requires Adobe acrobat standard for more
efficient work on the submission materials. To get the access,
the employee must put in a service ticket and the notes for what
purpose the software is requested. Manager then approves the
ticket and the software is installed. Hence, the timely process of
implementation of ServiceNow ticket is not inly important but
also mandatory. This implementation however takes some time
when the ticket is raised.
The implementation process is shown below;

24. First, the ticket is created by the user that has any request that
he/she has for. Be that specifically a software request to be
installed or a hardware accessory that is needed for the person.
After the ticket is submitted, based on the category and the
need, the ticket is then sent to the manager intended for based
on the category. This ticket is approved by the manager which
is indeed sent to the support center that works down to get the
tickets completed successfully, the ticket processing time takes
more than twelve hours and the support center is off-shore
which sometimes takes more time than required. Once the
request is completed successfully, a notification is sent to the
user that had opened the ticket and let them know that the
process is completed with no exceptions. The time that takes to
complete all the process is around 3 to 4 business days. I feel
that the process is very vast and can be reduced to some extent
to get the request completed successfully. Three or four day is
more that any user could ask when a ticket is of high priority.
Though the high priority tickets are completed within a certain
limited time to accommodate the needs, but the change is
inevitable to complete the normal ticketing service as requested
and then the emergency tickets are completed faster.
Refer to “Value Stream Mapping 2” section for more
information on the ServiceNow Waste and Lead times.
Actual Arrival Rate and Actual Departure Rate:
Actual Arrival Rate is the defined as the average rate at which
the ticket processing takes place from the start of the ticket
entry to the rate at which the ticket stays in the system. As of
ServiceNow, the total tickets that are created in the system
average at 20 per day and the average time that a ticket stays in
the system is 2 days or more depending on the rate at which the
processing time takes place.
So, average arrival rate is 10 i.e., 20/2 = 10.
Average Departure Rate is calculated as the number of scenarios
that are in the system are 40 and the number of scenario process
times average from 2 to 3 days.

25. So, average departure rate is 20 i.e., 40/2 = 20.
As per the above results, the average departure rate is higher
than the average arrival rate. Which means the work in progress
is higher than the arrival rate. Which means that there is
negative deficit. The rate should be brought to neutral lining by
making sure that the ticket processing is increased. To do so,
the resources must be increased.
Cycle Time and Lead Time:
Lead time measures the total time it takes for work to move
through the value stream, from the moment the work is
requested to the time it’s delivered. Measuring lead time allows
you to understand the overall (positive or negative) impact of
changes you make on the system.
Cycle time Cycle time measures how long it takes a work item
to get from point A to point B. Short cycle time is the key
metric for lean teams. Optimizing cycle time makes for stronger
forecasting. T-Shaped team members reduces cycle time.
Calculations – Lead Time – 12 hour + 8 hour + 12 hour + 1 hour
+ 1 hour – 34 hrs
Value Time – 12 hour + 8 hour + 2 hour – 22 hrs
Cycle Time – 34 hrs / 22 hrs = 1.54
The above results suggest that the cycle time is 1.54 days which
is the average time for a ticket to be released into the the final
stage after processing. To get to the neutral zone the resources
can be added to manage the lead time and cycle time to be
processes together. One more suggestion is that the
implementation of the ticket time can be reduced by the
elimination of waste i.e., time allocated to the approval of
manager can be reduced by the pre-approval of the ticket in the
processing phase or while the implementation is being occurred.
References –
1. https://www.minterapp.com/takt-time-vs-cycle-time-vs-lead-
time/
2. https://kanbantool.com/kanban-library/analytics-and-

26. metrics/kanban-definition-of-lead-time-and-cycle-time
3. http://itsadeliverything.com/littles-law-the-basis-of-lean-and-
kanban
4. Class Slides – Unit 8 – Lean Metrics
Lean Startup Approach
Lean startup refers to a business methodology in the
development of products with the aim of shortening product
development cycles thus discovering easily if the proposed
model is viable. This achievement can be through adopting a
combination of validated learning, iterative product releases and
business-driven hypothesis experiment (Paço, 2016).
Problem Statement: Since when this program started the
Ironwood pharmaceutical department has released a detailed
case analysis of public health products to their agencies. The
major problem is that since the last five years the quality
management if most products have been stagnant.
Product Offering: Working in Pharmaceutical Company in the
department of IT, one of the key products we need to release is
the implementation of new Software-as-a-service which can be
used in quality management to meet a vendor’s quality for
merchandise purchased.
Lean Start-Up Approach: Behind every positive, sustainable
growth in a business there are happy customers. As a final
supplier, the primary consideration of the company is
exceptional to the provision of quality products which can
benefit their agencies efficiently. For instance, the quality of
products vendor vendors supply and technologies used should
be stable, quick and reliable to develop and maintain
(Suomalainen, 2015). It makes it easier for people suffering
from the secretion of excessive Uric acid to have a chance to
consume quality services. Customers have been complaining
about suppliers not meeting standard qualities of the health
products, more comfortable access to the products and
understanding how they fit the qualifications.

27. Experiments
1. Identification of minimal requirements: The first step is to
identify a set of tests which can be used to determine the
minimum number of needs which can be established to receive
customer responds about the services. During the initial stage as
a pharmaceutical company, documentation can take place as
precedence as a wireframe design in giving a sense of how the
services could look like in the market. However, the main issue
is to be able to create a quality service version of the report
which targets the early adoptions to get response feedback.
1. Identification of measures and metrics to address customer
key points: Due to poor customer quality service management,
these customers have regularly been complaining. Runtime
delay is another cause which is significantly leading to other
complains when waiting for a supply of the end products.
However, the software-as-a-Service implementation aims to
ensure that metrics such as quality service management and
delays are identified and measured at every step for an efficient
outcome.
1. Use of actual products for the experiment rather than
designed documents: In most cases, consumers will be able to
respond effectively in situations where they can see the actual
product than written records. For instance, it enables them to
get a better sense the report’s importance thus providing added
ideas which they have therefore made the dashboard and report
better. Consequently, it is critical for the implementation team
to focus their efforts on providing a minimal set of actual
features which can entice the consumers during the
implementation stages for adequate feedbacks.
1. Use short time in marketing: Articulation of customer reports
requires the team to produce tangible products which the final
consumers can review within the shortest time possible and
establish a regular cadence review development and feedback
which is of higher quality.
1. Have a strong Marketing Strategy: Robust Marketing Strategy

28. is essential if established through the formulation of a
committee which can help in providing early feedback about the
dashboard and reports. For instance, if the strategy is active, it
will keep the start-up approach moving within the direction of
continuous advancement with all necessary feedback of the
start-up. Mostly it helps the mainstream customers to focus on
quality service management.
Innovation Accounting Strategy: In the Ironwood
Pharmaceutical Company, the strategy for establishing
innovation accounting occur as follows;
· Establishment of a minimum viable product: The minimum
feasible for pharmaceutical product for supporting people
suffering from excessive Uric acid are measured based on the
Software-as-a-service, accuracy, quality of data presented in the
products, accurate definitions of all the qualifying terms in the
report, speed of execution in each product, and the meaning of
dashboard to the final consumer. All products measurement can
be at any point of time against the factors defined by the
complaints. For instance, such a process is the fastest in
receiving and evaluating consumer feedback.
· The engine of Growth: Given that Ironwood Pharmaceutical
Company has a various targeted audience of agency
management as well as caseworker staff, the overall count of all
targeted audiences will be predominantly static. Therefore the
recommendation will be to focus on propelling the engine of
growth by beginning by word of mouth and pursuing of the
sticky engine of the growth model. For instance, this model
helps in retaining customers over a more extended period due to
the provision of quality service. Therefore, in this case, we will
be required to pursue all feedbacks received from the consumers
to make sure they accommodate their needs. In most cases,
critical factors which enhance a consumer to the sticky engine
of growth is complying to their customer feedback and
responses with a short period thus focusing on day to day
management of their products. References
Paço, A. F. (2016). Development of entrepreneurship education

29. programmes for HEI students: The Lean Start-Up Approach.
Journal of Entrepreneurship Education, 19(2), 39.
Suomalainen, T. K. (2015). Continuous planning: an important
aspect of agile and lean development. International Journal of
Agile Systems and Management, 8(2), 132-162.
Business Model Canvas
Most new business organizations neglect to take off. The
general ability to organize and begin operating a business model
based on a prepared strategy for success is gathering of fantasy
groups, the inspiration of speculators to back it, getting an item
in production and putting hard impulse on it. To make the
operations systematic, organization focus on a business model
that will enhance successful business operation, identification
of revenue sources, products, financing details and the target
customer base. In this part, I will use the nine items of canvas
to explain the Business Model.
1. Customer Segments
For this assignment, I am working for Ironwood Pharmaceutical
Company in the IT department. It is an exceptional organization
which developing products used by people suffering from the
secretion of excessive Uric acid. It focuses on reaching all
customers across the world suffering from the secretion of Uric
acid.
2. Value Proposition
Most customers buy from this organization because it develops
quality products and aims at reaching all patients in all areas
across the world. The organization markets all their products
across the globe thus having a fair share of the pharmaceutical
market due to high performances, and ability to customize. Such
achievement makes it produce quality and better results thus
making patients with health problems approach their services.

30. 3. Channels
Lean startup technique is the method this organization can put
into consideration when taking care of the organizations
complex advancement issues. It favors the constructed research
theory, client satisfaction or criticism and iterative item
discharges over a forthright arrangement with bunches of
instinct, exact and tried ways of thinking. The organization IT
department takes responsibility to “implement projects such as
S-a-a-S developed and provided by vendors to the company for
use in their pharmaceutical services to help in managing the
quality process and data integrity of the service” (McWilliams,
2012). However, this organization uses its Kanban Board to
evaluate service quality.
4. Customer Relationship
Through the use of lean startup technique, Ironwood
Pharmaceutical proceeds the market place to grow more
customers and keep them by decent habitation through lean
startup considering (Sadri, 2001). For instance, people suffering
from the secretion of excessive Uric acid across the world do
not get a chance to get quality treating products. Therefore, it
advertises and markets its products globally; thus those weak
and affected by this disease get an opportunity to seek
treatment.
5. Revenue Streams
Ironwood Pharmaceutical struggles with slump sales in fixed
oral dose combinations across the world through minimizing its
net losses. This organization has a revenue of $346.6 million. It
has raised $652.8 million in funding. For projects such as the
development of the S-a-a-S, this organization pay google to
advertise it by placing it in front of users to increase curiosity
to users with buying intentions. Customers then find it easy to
stream through this adverts, view the product details and make
decisions whether to place orders for the advertised product or
not. Through this form of advertisement, Ironwood
pharmaceutical can sell its products globally thus grow its
revenue abundantly.

31. 6. Key resources
Ironwood Pharmaceutical is an Independent Company with
headquarters located in Cambridge, Massachusetts and operates
publicly under NASDAQ: IRWD Stock Symbol. It has total
funding of $609 million thus ranked by CB Rank Company as
number 5,261. It has 47 registered patent rights which are
primarily in the “Medical or Veterinary Science; Hygiene'
category and Ironwood Pharmaceuticals has registered 11
trademarks with the most popular class being Pharmaceutical,
veterinary and sanitary products” (McWilliams, 2012). In term
of human resource, Ironwood has 515 employees. Ironwood had
revenue of $346.6 million by the end of FY 2018, which made it
be ranked 2nd among the top ten competitors.
7. Key Activities
Ironwood has built teams and capabilities to deliver products
which can help patients suffering from the secretion of Uric
acid. The key activities include manufacturing drugs, develop
and market medicines for the quality treatment of chronic
idiopathic constipation and irritable bowel syndrome. According
to the goals Cali Brian, the co-founder of the organization, it
aims at helping translate scientific insights into the supplied
medicines thus making a difference to patients (Sadri, 2001). In
the case of problem-solving Ironwood consults Phebe Wilson,
Mark Pollack, and Robert Busby. The organization also utilizes
various platforms such as Facebook and Twitter to update their
customers on new products or product upgrading.
8. Key Partners
In most cases organizations require key partners to build their
economies of scale, acquisition of activities or resources and
reduction of uncertainty and risk. Ironwood has partnered with
LINSESS in North America, CONSTELLA in Europe,
GLOBALIZATION OF INTERNAL R&D and IN-LICENSING
OF EXTERNAL R&D to reach patients across the world.

32. 9. Cost Structure
In many cases, to access quality pharmaceutical products and
services are both costly and a burden. A significant number of
these patients face more sufferings from indoor contaminations
than when exposed to quality product and services (Ermer,
2006). Therefore, instead of undertakings the products with
traditional methodologies and huge financing, subsidizing and
improving pharmaceutical centers could be better to enable most
patients can access quality management out of limited funding
levels.
References
Ermer, J. &. (2006). Method validation in pharmaceutical
analysis: A guide to best practice. John Wiley & Sons.
McWilliams, V. W. (2012). Linaclotide. Drugs, 72(16), 2167-
2175.
Sadri, G. &. (2001). Developing corporate culture as a
competitive advantage. Journal of Management Development,
20(10), 853-859.
Seethamraju, R. (2015). Adoption of software as a service
(SaaS) enterprise resource planning (ERP) systems in small and
medium-sized enterprises (SMEs). Information systems
frontiers, 17(3), 475-492.
Create ServiceNow Ticket
1hr
Send Ticket for Authorized Manager for Approval
12hr
Send Ticket for ECS Support Branch
12hr

33. ECS Branch member assigns the ticket
8hr
Ticket Processing
12hr
Close Ticket
2hr
Send Notification
1hr
Analyses the ticket information and notes
8hr
PMGT 574 Final
(Example 1)
Paul Harvey
Setting Context
• Explain your setting, your role, and your level of

34. influence
• Set a brief context of how work is currently
accomplished
• Establish an understanding for the rest of the
class about your
industry in an elevator pitch(45-60 seconds)
Principles Applied
• Which if any of the principles are currently applied
at your work?
• How is value defined and measured?
• How is waste defined and measured?
• What is the current appetite for Lean and Agile
thinking?
Value Optimization
• Assume now you are in a position of authority,
how would you deliver
more value in the organization?
• Reference (but try not to present) you value
stream mapsand lean canvas as
guides
• Also look to the continuous improvement section
and lean metrics, how
would you ensure you are setting and meeting
goals?
• How would you manage waste?

35. Emerging Practices
• How could you promote or leverage the
following (if any) in your
work [you may want to only choose one to keep to
the 7-10 min total
timebox]
• Lean UX
• Lean Startup
• Lean Change Management
• Lean Canvas
• Six Sigma
Continuing Lean
• In about 30 seconds pitchhow you would
position the Lean journey
for your company going forward.
PMGT 574 Final
(Example 2)
Paul Harvey
Setting Context
• I work in a pharmaceutical promotions warehouse
• I am a project manager that schedules new product
launches and
system rollout

36. • Our team makes hundreds of drug promotional
item shipments
domestically a day to promote our clients
products to doctors and
clinicians. Typical products include:
• Notepads
• Pens
• Flash drives
• Binders
Principles Applied
• We typically practices of deliver fast and buildquality
in.
• Value is defined as the percentage of correct
shipments on time. Our
Target is 95% complete and accurate shipments per
month.
• Waste is any shipment that is either returned,
sent late, or requires
shipping more than one day to complete.
• We practice Lean manufacturing, but would benefit
from more
incremental thinking and continuous improvement.
Value Optimization
• We should begin measuringtypical order sizes to
set a
control/standard deviation
• There have been multiple wasteful shipments because of
a “fat fingered”

37. number in the quantity of an item. While
we shipped the right amount, it
should have been challenged prior to sending.
• We are seen as order fulfillers, our leadershipshould
execute more
Gemba Walks to see how the work is done to be
closer to the value
delivery.
• We currently mange work in lists and paper
manifests,controlled by
supervisors. We should shift to managing in a
Kanban System to
better optimize the entire delivery process.
Emerging Practices
• We should begin to leverage the Lean Change
approach. Often we
have process changes or new product launches that
are not
understood and cause confusion/waste:
• By using Lean Change Management, we should
see improvements in
communication by:
• Optimizing how the change is shared
• Having a more meaningful list of options
• We will know Lean Change Management is having
a positive effect
after 3 new product launches when we do not
have <95% waste the
first month after the launch

38. Continuing Lean
• We should work with leadershipto have a better
executive
understanding of Lean Principles and metrics
• We should have the leadershipteam attend a Lean
Change
Management workshop
• We should have new project managers attend
Harrisburg University
PMGT 574 course J
Unit 1 Government Exam
Essential Skills: You will be assessed on these criteria. The
Assessment skills are graded on a point system, 0 to 5. Review
the below rubric. Be thorough in your answers- do not sell
yourself short from a lack of motivation or laziness. Relevant
EVIDENCE from notes or activities MUST be present in your
answer.
0
1
3
5
No answer
• Answer attempted
• No vocabulary used
• Weak reasoning missing detail and justification
• Short, incomplete, or “one-word” answer
• Answer attempted
• Vocabulary used, but can be partially vague or
incorrect
• Ambiguous evidence of comprehension
• Answered completely and fully.

39. • Vocabulary used is correct and applied well.
• Clear comprehension of question, term, problem.
• Prompt answered fully.
• How is the way the House and Senate are divided
among the states show why compromises are needed while
forming a constitution/social contract?
• How can Federalist 10 and 51 be used to explain why
our system is designed to work slowly?
• How can gerrymandering be used to explain the
dangers that Madison and Hamilton warned the nation about in
Federalist 10 and 51?

40. • What do you think are the three most important
powers of Congress are? Why?
• How does James Madison’s argument in Federalist 10
(factions) fit together with the process Congress uses to write
laws?