Project Initiation Document Linda Doll


Published on

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

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Project Initiation Document Linda Doll

  1. 1. Health First Pharmaceutical CompanyHealth First Manufacturing Division Project Initiation Document DR & CM Consulting International
  2. 2. Linda Doll, Principal Consultant
  3. 3. Project Initiation DocumentPurposeThe purpose of the Project Initiation Document is to define the project, the objectives and scopeof the project, and to establish parameters for assessment of its success.BackgroundHealth First Pharmaceutical Company, a company dedicated to putting its patients first, is aglobal company, headquartered in Kent, Ohio, USA, with offices in multiple geographiclocations, 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 basedon 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 ofobsolete documents. These measures have failed to adequately address the underlying 1
  4. 4. inadequacies that have been exposed due to the unparalleled growth in market share and thenecessity of compliance with increased regulations and the additional paperwork such anincrease generates. The system that was once deemed adequate is increasingly inadequate. Forfurther details, please reference the terms of requirement.The Quality Manager has been appointed Project Owner by HFMD; he will represent the ProjectSponsor in the operational aspects of the project. The Project Sponsor will ultimately beresponsible for the project outcome. The Quality Manager will be responsible for assembling theProject Board, and for identifying stakeholders in the project.HFMD has contracted with DR & CM International Consulting to plan and implement asolution. Linda Doll wiill be Principal Consultant, with the assistance of two staff members ofDR & CM. Other personnel may be added as deemed necessary by the Project Owner and thePrincipal Consultant, with the concurrence of the Project Board. All disputes will be settled bythe Project Board, with a simple majority vote of a quorum of stakeholder members present.Project DefinitionProject ObjectivesThe primary objective is to effectively manage quality documents within the Health FirstManufacturing 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. 2
  5. 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 ScopeThe scope of the project will be to assess the current document management system, and torecommend procedures and products that will amend the current shortcomings of the system, orto 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. 3
  6. 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 ApproachProject Deliverables and/or OutcomesThe project deliverables will consist of: a feasibility study, a user requirement study, and animplementation strategy for the solution.Outcomes will be deemed successful after identification of the underlying causes of the failure ofthe current system, and composition of an appropriate solution that works on operational,technical and financial levels.ConstraintsThe budget for the project shall be $125,000.00; $50,000.00 for DR & CM InternationalConsulting 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 reremaining funds are to be dedicated to incidentals, such as flying, room reconfiguration for theinstallation of equipment or licensing fees not included in the hardware/software allotment. 4
  7. 7. The project should be ISO 9001 compliant, to insure the International Standards Organizationaccreditation.The project should be compatible with Dublin Core metadata standards.Security of HFMD proprietary information will be maintained at all times. DR & CMInternational Consulting personnel are required as a condition of their employment to respect anduphold the security of HFMD’s information.InterfacesThe project should interface with the Computer Assisted Drafting (CAD) tool employed byEngineering.The project should also be compatible with the Health First Intranet.AssumptionsIt 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 tothe main floor of the facility.HFMD will also furnish the workspace, and supply computers, scanners, printers, phones and faxmachines, 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 InternationalConsulting 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. 5
  8. 8. Initial Business CaseThe intangible benefits of implementing the project include proactively addressing the gaps andshortcomings insures ISO compliance. This will maintain credibility, which is the basis of ourbusiness viability.Tangible benefits will also accrue due to increased efficiency which will directly translate toproductivity. Systems that are easier to deal with improve company morale, which mayfavorably 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 maybe, peace of mind and the securing of the firm’s reputation and good will is not to beunderestimated.Communication PlanTo keep stakeholders and other employees informed of the project, its progress and futuremilestones, the Project Manager and Quality Manager will institute an internal blog/wikicombination. Information will be posted on the wiki; questions and/or concerns will beanswered 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 beanswered. This should keep interest in the project high, and keep rumors and misinformation toa minimum. After the successful project completion, the wiki/blog may continue to be part ofthe HFMD communication landscape.Project Quality PlanThe quality expectations of the project are that the deliverables, taken together, will define theproblems with the current system, assess potential solutions, and present them to the Project 6
  9. 9. Owner and the Project Board for consideration, along with professional assessments as to theadvantages and disadvantages of each potential solution. Through this method, the perceivedshortcomings of the current system should be amended, or replaced, and ISO 9001 accreditationshould be assured.Initial Project PlanThe project is to start within four weeks of the signing of the contract. The intervening timeshould be used to arrange for adequate office space and equipment and materials for the use ofthe 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 aflowchart 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 currentsystem of document management, or the possible replacement of the current system. This periodshould end with the production and presentation of the Feasibility Study. Formal presentationwill be to the Project Owner and the Project Board, with any other stakeholders also invited. Thethird 6 week period will be devoted to assessment of possible solutions, and the development ofthe User Requirement Specification, to be presented to the Project Owner and the Project Boardand other stakeholders at the end of that time. The final 6 week period will see theImplementation Strategy unfold, and at the end of that timeframe, the assessment of the projectby the Project Owner, the Project Manager and the Project Board.Initial Risk LogThe project may be unnecessarily enlarged by ambitious parties; all scope changes must bepresented to the board, along with an assessment of the time and money constraints that this willimpose on the project.The project may suffer from bad timing, and be too late to stop the failing of a quality audit byISO; every effort will be made on the part of DM & CR to complete the project before the next 7
  10. 10. slated quality audit. HFMD will do its part by keeping DM & CR informed of the dates of thenext quality audit, and by cooperating fully and in a timely manner with the requests forinformation and the interview process.Any unforeseen risk will be met by the Project Owner and the Project Manager in concert, withthe guidance and assistance of the Project Board.Project ControlsThe steering of the project will be the responsibility of the Project Manager, with input from theProject Owner, and with guidance from the Project Board, which will be comprised ofstakeholders appointed by the Project Owner. The stakeholders will make themselves availableto DR & CM International Consulting staff, as needed in a timely manner. The Project Ownerwill arraign for the duties of the stakeholders to be adjusted and compensated for to reflect theirnew status and responsibilities.Exception ProcessIf a basic parameter of the project falls outside the margin of plus-or-minus 10%, the ProjectBoard will convene, to consider if the project is still viable.Contingency PlansIf a basic parameter of the project falls inside the margin of plus-or-minus 10%, the project willgo forward, with the substitution of alternate products or suppliers that fall within the budgetconstraints. This will be at the discretion of the Project Owner, in consultation with the ProjectBoard. 8
  11. 11. Project Filing StructuresDR & CM International Consulting staff will maintain all raw data collected for the HFMDproject, while the project is current until completion.HFMD staff, as appointed by the Project Owner, will be responsible for the maintenance of alldata collected after the completion of the project. Any additional training necessary for thecompletion of this clause will be the responsibility of HFMD, and handled through theProfessional Development Department.EvaluationThe 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 theinformation and assessments, and to evaluate the success of the project as presented by theProject Manager.ConclusionDR & CM International Consulting looks forward to working with Health First ManufacturingDivision to resolve their quality document control issues. We feel that by working together, wecan find a solution to this problem that will work on operational, technical and financial levels. 9