This is the first deliverable for Documents Records and Content Management class.

1. Health First Pharmaceutical Company
Health First Manufacturing Division
Project Initiation Document
DR & CM Consulting International

2. Linda Doll, Principal Consultant

3. Project Initiation Document
Purpose
The purpose of the Project Initiation Document is to define the project, the objectives and scope
of the project, and to establish parameters for assessment of its success.
Background
Health First Pharmaceutical Company, a company dedicated to putting its patients first, is a
global company, headquartered in Kent, Ohio, USA, with offices in multiple geographic
locations, including a significant component of its manufacturing division in Sydney, Australia.
The Quality Manager at HFMD has raised the risk that the division may fail a quality audit based
on the current inadequacies in managing quality documents.
o He has identified gaps in HFMD’s current practices and systems,
o He has discovered obsolete documents still in use.
o There are internal risks: e.g., an accident involving chemicals and/or other occupational
health risks and safety issues and
o There are also external risks, such as incorrect dosages applied to the pharmaceutical
products and sold to the community.
The Quality Manager has implemented manual methods to support compliance requirements,
and organized for regular audits. He has instituted procedures to try and rectify instances of
obsolete documents. These measures have failed to adequately address the underlying
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4. inadequacies that have been exposed due to the unparalleled growth in market share and the
necessity of compliance with increased regulations and the additional paperwork such an
increase generates. The system that was once deemed adequate is increasingly inadequate. For
further details, please reference the terms of requirement.
The Quality Manager has been appointed Project Owner by HFMD; he will represent the Project
Sponsor in the operational aspects of the project. The Project Sponsor will ultimately be
responsible for the project outcome. The Quality Manager will be responsible for assembling the
Project Board, and for identifying stakeholders in the project.
HFMD has contracted with DR & CM International Consulting to plan and implement a
solution. Linda Doll wiill be Principal Consultant, with the assistance of two staff members of
DR & CM. Other personnel may be added as deemed necessary by the Project Owner and the
Principal Consultant, with the concurrence of the Project Board. All disputes will be settled by
the Project Board, with a simple majority vote of a quorum of stakeholder members present.
Project Definition
Project Objectives
The primary objective is to effectively manage quality documents within the Health First
Manufacturing Division (HFMD) in Sydney, Australia.
o Deliver an effective solution for managing quality documents within HFMD to support
ISO document control requirements.
o Provide an improved process for managing new and amended quality documents and
tracking review and approval processes.
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5. o Provide search for and retrieval capabilities that allow HFMD users to quickly access
correct versions of quality documents.
o Specify and assess the capability of the technology solution to determine its flexibility,
scalability and extensibility for deployment with HFP for other document management
requirements.
o Transfer existing metadata and documents to the new technology system for managing
quality documents.
Project Scope
The scope of the project will be to assess the current document management system, and to
recommend procedures and products that will amend the current shortcomings of the system, or
to identify a new system, if it is deemed needful and necessary.
Scope Inclusions
o Plan, specify, acquire and implement a solution for managing quality documents that
includes all staff in HFMD’ 70 work centers.
o Assess software packages to determine their flexibility and scalability to be deployed for
other document types and/or across HFP.
o Test the DMS solution to ensure it satidfies user requirements and is inter-operable with
current HFMD networks and systems.
o Assess options for migrating quality data from the Document Control System and existing
quality documents from file systems and databases.
o Devise an implementation strategy that features an approach satisfactory to HFMD and
includes staff training and feedback.
o Evaluate the success of the solution in terms of performance, staff feedback, and quality
audits.
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6. Scope Exclusions
o Engineering drawings will be excluded from the scope of this project, due to the
specialized nature of their storage printing and reproductions needs.
o Headquarters in Kent, Ohio has requested incorporating the requirement for managing
corporate policy documents. This requirement falls outside the scope of this project.
Every effort will be made to select a solution that will be scalable for future expansion
possibilities, or to become part of an Enterprise Content Management System. At this
time, this project lacks the scope or funds to pursue this option further.
Project Approach
Project Deliverables and/or Outcomes
The project deliverables will consist of: a feasibility study, a user requirement study, and an
implementation strategy for the solution.
Outcomes will be deemed successful after identification of the underlying causes of the failure of
the current system, and composition of an appropriate solution that works on operational,
technical and financial levels.
Constraints
The budget for the project shall be $125,000.00; $50,000.00 for DR & CM International
Consulting for personnel for the projected 6 months required to complete the project.
$50,000.00 is to be devoted to hardware and software assessment and purchase. The re
remaining funds are to be dedicated to incidentals, such as flying, room reconfiguration for the
installation of equipment or licensing fees not included in the hardware/software allotment.
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7. The project should be ISO 9001 compliant, to insure the International Standards Organization
accreditation.
The project should be compatible with Dublin Core metadata standards.
Security of HFMD proprietary information will be maintained at all times. DR & CM
International Consulting personnel are required as a condition of their employment to respect and
uphold the security of HFMD’s information.
Interfaces
The project should interface with the Computer Assisted Drafting (CAD) tool employed by
Engineering.
The project should also be compatible with the Health First Intranet.
Assumptions
It is assumed that Health First Manufacturing Division (HFMD) will supply suitable workspace,
adjacent to the Quality Manager’s office and Information Systems (IS), and reasonably close to
the main floor of the facility.
HFMD will also furnish the workspace, and supply computers, scanners, printers, phones and fax
machines, and all other equipment deemed necessary in the pursuance of the project objectives.
HFMD will supply staff, appointed by the Quality Manager, to assist DM & CR International
Consulting Staff, pursuant to the completion of the project.
Any unforeseen costs will be the responsibility of HFMD. Every effort will be made by DR &
CM to see that this does not happen.
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8. Initial Business Case
The intangible benefits of implementing the project include proactively addressing the gaps and
shortcomings insures ISO compliance. This will maintain credibility, which is the basis of our
business viability.
Tangible benefits will also accrue due to increased efficiency which will directly translate to
productivity. Systems that are easier to deal with improve company morale, which may
favorably impact employee turnover.
Cost savings will result from improved efficiencies.
Securing the firm from legal liability may be the ultimate intangible benefit. Intangible as it may
be, peace of mind and the securing of the firm’s reputation and good will is not to be
underestimated.
Communication Plan
To keep stakeholders and other employees informed of the project, its progress and future
milestones, the Project Manager and Quality Manager will institute an internal blog/wiki
combination. Information will be posted on the wiki; questions and/or concerns will be
answered by either the Project Manager or the Quality Manager, or both, as deemed appropriate.
The questions on the blog will be submitted anonymously, and all questions posted will be
answered. This should keep interest in the project high, and keep rumors and misinformation to
a minimum. After the successful project completion, the wiki/blog may continue to be part of
the HFMD communication landscape.
Project Quality Plan
The quality expectations of the project are that the deliverables, taken together, will define the
problems with the current system, assess potential solutions, and present them to the Project
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9. Owner and the Project Board for consideration, along with professional assessments as to the
advantages and disadvantages of each potential solution. Through this method, the perceived
shortcomings of the current system should be amended, or replaced, and ISO 9001 accreditation
should be assured.
Initial Project Plan
The project is to start within four weeks of the signing of the contract. The intervening time
should be used to arrange for adequate office space and equipment and materials for the use of
the DR & CM staff, upon their arrival. The initial 6 weeks should be used in assessment,
through observation in the main facility, interviews with stakeholders, and construction of a
flowchart detailing the current system, with any additions or exceptional cases accounted for.
The second six weeks will be utilized in investigating the feasibility of correcting the current
system of document management, or the possible replacement of the current system. This period
should end with the production and presentation of the Feasibility Study. Formal presentation
will be to the Project Owner and the Project Board, with any other stakeholders also invited. The
third 6 week period will be devoted to assessment of possible solutions, and the development of
the User Requirement Specification, to be presented to the Project Owner and the Project Board
and other stakeholders at the end of that time. The final 6 week period will see the
Implementation Strategy unfold, and at the end of that timeframe, the assessment of the project
by the Project Owner, the Project Manager and the Project Board.
Initial Risk Log
The project may be unnecessarily enlarged by ambitious parties; all scope changes must be
presented to the board, along with an assessment of the time and money constraints that this will
impose on the project.
The project may suffer from bad timing, and be too late to stop the failing of a quality audit by
ISO; every effort will be made on the part of DM & CR to complete the project before the next
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10. slated quality audit. HFMD will do its part by keeping DM & CR informed of the dates of the
next quality audit, and by cooperating fully and in a timely manner with the requests for
information and the interview process.
Any unforeseen risk will be met by the Project Owner and the Project Manager in concert, with
the guidance and assistance of the Project Board.
Project Controls
The steering of the project will be the responsibility of the Project Manager, with input from the
Project Owner, and with guidance from the Project Board, which will be comprised of
stakeholders appointed by the Project Owner. The stakeholders will make themselves available
to DR & CM International Consulting staff, as needed in a timely manner. The Project Owner
will arraign for the duties of the stakeholders to be adjusted and compensated for to reflect their
new status and responsibilities.
Exception Process
If a basic parameter of the project falls outside the margin of plus-or-minus 10%, the Project
Board will convene, to consider if the project is still viable.
Contingency Plans
If a basic parameter of the project falls inside the margin of plus-or-minus 10%, the project will
go forward, with the substitution of alternate products or suppliers that fall within the budget
constraints. This will be at the discretion of the Project Owner, in consultation with the Project
Board.
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11. Project Filing Structures
DR & CM International Consulting staff will maintain all raw data collected for the HFMD
project, while the project is current until completion.
HFMD staff, as appointed by the Project Owner, will be responsible for the maintenance of all
data collected after the completion of the project. Any additional training necessary for the
completion of this clause will be the responsibility of HFMD, and handled through the
Professional Development Department.
Evaluation
The deliverables and projected outcomes will be assessed at the end of six months. At that time,
the Project Owner, the Project Manager and the Project Board will convene to consider the
information and assessments, and to evaluate the success of the project as presented by the
Project Manager.
Conclusion
DR & CM International Consulting looks forward to working with Health First Manufacturing
Division to resolve their quality document control issues. We feel that by working together, we
can find a solution to this problem that will work on operational, technical and financial levels.
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