Painfree Project - Assignment Example

 The Usefullness of Project Management To what extent has the Painfree Project been successful? It depends entirely on who is answering this question how it will be answered, and this particular fact is actually a factor in the success or failure of any project. In truth, it is extremely difficult to judge the success of this project, since such criteria for judgment were not established. Success rate statements could conceivably range from 50% down to zero, depending on how this is assessed. From the sales view, one would have measure the sales revenue against losses to gauge success, and the data is not available in this case study. However, from the diagram of sales only, the success rate, as measured in sales, sinks to about 1% or less. However, one has to consider that this figure would be changed by U.S. figures after product launch, if that is still on the agenda. Since we have no cost figures, this question really cannot be answered in concrete terms with any semblance of accuracy. However, certain less tangible benefits are certainly present. The company has a great deal to learn from closely examining the whole process of development of this project. I would certainly recommend that a thorough post-mortem be done using a group created for that purpose composed of a team of experts in all phases of pharmaceutical project development, and that post-mortem be used to examine the current cancer drug development process for parallel problems before releasing that drug, even though there would be definite differences concerning the fault tolerance, since the purpose of this drug is to cure disease, a considerably higher level of need than mere pain relief. One should remember that while the end may justify the means, the opposite is also true. When the end does not carry a high level of justification, perhaps the means would be more carefully scrutinized. The desired end in both projects, and all others in the industry is when all is said and done, profit. In order for any pharmaceutical to be profitable, the revenue must outweigh the cost of development and there is no evidence that this is yet so for Painfree. 2. Evaluate the ways in which the Painfree Project has been organized and managed. To what extent can the project be criticized? The Painfree Project suffered from several major problems caused by not following the best practices in project management. 1The best practices for project management require that careful planning be done and documented from the beginning, and one person should be responsible for overseeing and managing communications and documentation. The aims and scope of the project should be clearly outlined and all phases must be monitored by some individual or group responsible to corporate and not involved in the project to any further extent than this. Every major facet of the project should be the responsibility of one or more stakeholders and such should also be documented. Clear development steps must be described and milestones set. Most important, plans for change and risk management must be developed and documented from the beginning with all stakeholders sighing off on these. Then last, but most important for any learning organization, a complete finalization should include documentation of lessons learned and strategies identified for avoiding the same problems in the future as were encountered in the just finished project. The problems with the Painfree Project began with poor or incomplete planning for managing mergers and acquisitions. The great potential for profit was seen even before the acquisitions took place, and they greatly affected the negotiations. Some kind of clause should have been included in the final agreement to hook some of the monetary benefits of the acquisition to the success, with very clear outcomes defined, of current projects. This would have been extra inducement to monitor all aspects of the project. The various management changes introduced confusion as to which stakeholders shouldered which responsibilities, and this should have been defined as the changes took place. This project shows clearly the dangers of autonomous development teams in any project involving products which can have serious consequences, such as pharmacology. With multinational companies, care must be taken to monitor all development phases objectively, using someone outside the development team. This is generally the role of a project manager. The Painfree Project utilized only managers from within the project, who each had their own objectives. This literally pushed monitoring outside the company to the government regulatory departments. The change in the pharmacovigilance management mid-project was actually counterproductive in its effect, since it introduced more confusion and did not actually have any real effect upon the oversight of the development project, other than increasing the communications problems caused by not resolving the chain of command problems which developed early on. The major problems encountered by the Painfree Project could have been avoided if the company restructuring had included naming a project manager from outside any of the involved companies whose mandate was simply to coordinate the overall project, manage communications and document the development. This manager should have been answerable to the corporate head, and should have had the authority to effect change. (Stuckenbruck 222-227) Too many management changes allowed miscommunication and poor documentation. Cultural differences were also ignored, since all reporting and documentation took place from within each of the multinational teams. With one overall project manager, whose sole responsibility was this project, these problems could have been addressed. Especially detrimental was not allowing for the differences in culture among test subjects. (Ambler and Witzel 2003, 4) This resulted in skewed data, because cultural differences were not documented during testing, while results were treated as identically valid. Examples of these cultural differences include the differences in activity levels of Chinese subjects versus German subject. Another crucial difference is the ethics of reporting results truthfully. In the Chinese company it is considered ok not to report problems which are considered internally to have been resolved, thereby putting the company’s best face forward. (Ambler, and Witzel 84) After all the management changes following the acquisitions, the Painfree Project Manager should have gone personally to all the development centers and collected documentation. Meetings should have been held to identify changes in stakeholders and a new plan should have been developed covering the overall project. It should have clearly identified problems, defined change and risk management and it should have been signed off on by all stakeholders. (Turner, and Moorman) Communications channels and the responsibilities of the people involved should have been clearly documented and this information should have been communicated to all employees involved in the project. By redefining the project, creating and documenting the management plans and assuring that all phases were the responsibility of one person, a less adversarial attitude could have been fostered. Past problems and mistakes would have been included as lessons for future development without assigning blame to any entity. Such a clear development plan could have brought all the different multinationals together as an overall team with the objectives clearly defined. Segmentation of development, testing and marketing geographically was clearly responsible for some of the problems which caused the eventual losses. One major problem with the development of this project was the concentration on marketing as opposed to development and testing. An overall plan which defined testing and identified differences among the samples would have possibly foreseen the problems with the more active German population. Testing and initial release plans should be clearly defined for all countries from the project management team in order to avoid problems with licensing and problems caused by variations in populations. If the initial German releases had been proposed to mitigate results by initially only including release through more expert channels and releasing the product only for the more severe indications the huge problems which developed from prescribing the drug for migraines might have been avoided. It was known from the beginning that physical activity increased the risk of hypotension. Therefore, the initial release should have been for a class of patients who would naturally not increase physical activity immediately. Since migraines are only debilitating in and of themselves, there is a natural consequence that patients will likely return to normal activity as soon as the pain is gone. By releasing this medication in an active German population for relief of migraine, the company was courting disaster of the sort which occurred. A very thorough post-mortem should always be done at the end of each phase of any project. It is clear that this project had grave problems well before the release of the product in North America. Such careful consideration of the overall successes, failures, problems and solutions would avoid further losses. In addition, documentation of lessons learned would be readily available for other projects. 3. The company is about to launch a new drug. What would you do differently this time? From the first paragraph, it is obvious that some of the problems still exist, or the questions being discussed and considered by the two people involved would already have been answered. John Hammer would already know of parallels and potential problem areas. The meeting chair would not have closed with merely an admonition, but with a reminder of the steps taken to avoid another debacle. There is no mention of an overall project manager, nor any documentation. Launch plans should include plans for monitoring, plans for reacting to change and risk management. If this were so, the questions of the possibilities of a parallel between the projects would already be known. John Hammer would know if the Painfree Project were an anomaly or an ongoing problem which required adjustments. Consideration of such questions should not be limited to the thoughts of one person, but should have been part of the final documentation of the European release of Painfree. The company is obviously not looking carefully enough at project management practices during the development phase. There appears to be no company policy on managing change or risk. In addition, no mention of an overall project manager is made for the Toraxin, so the company is clearly still not separating project management and product development. There should be no such questions under consideration just preceding a launch of a product. Answers to such questions should have been found before the European Painfree project was signed off by the various stakeholders. Lessons learned should have been part of the early planning for Toraxin and any other product under development. Such corporate knowledge is not useful if it is not documented and shared across the company. Lessons learned are not learned if they are not documented and considered in early planning stages for further development projects. This company must separate project management from the development process as an important facet of corporate development. Best practices should be documented and followed, and all development projects should have overall corporate policy regarding testing, communication, documentation, stakeholder responsibilities, change and risk management and the development of corporate knowledge from documented lessons learned to guide them. While the difference in the aims of the drugs will make a difference in the tolerance for side effects, since Toraxin is aimed at a fatal disease, this is not enough to insure success. In addition, by applying best practices in project management and applying the lessons learned from previous projects, any project can be made better. That should be the overall goal, rather than simply avoiding massive loss. Appendix A: Brief Description of Best Practices in Project Management The Importance of Communication, Documentation and Clearly Defined and Assumed Project Scope and Responsibilities of Stakeholders Communication is essential in good project management. Therefore, it should be managed by one person who takes responsibility. In addition to documenting all phases of the project and distributing regular report to stakeholders, all communication should be documented, right up to the distribution of reports to stakeholders. There are a number of different sub-documents which should be created at this point, including: Change Management Plan The Change Management Plan is the definition of the formal process for making changes to the project's original scope and for handling problems. A good change management plan created with the input and lively discussion of major stake holders can go far towards averting disaster when the nearly inevitable change occurs. To prepare a Change Management Plan describe the project's complete process for managing requested project changes in great detail. To be effective you must communicate the Change Management Plan to all project team members and stakeholders, and all stakeholders must buy into it. Well-documented change request descriptions, resolutions and action plans are key to successful change management. Most important, adjustments to other related plans must be made every time there is a change, for example, budgeting, scheduling or staffing. All stake holders should sign off on this plan. Review of Past and Present Lessons Learned This document begins from past experiences, and is mostly written during the previous project, and then continues to document things as they happen. It ideally includes causes, rationales, solutions tried or applied and the outcomes, plus evaluation of the strategy and suggestions for improvement. Issue Management Plan The primary goals of an Issue Management Plan are to ensure that: 1. Issues are identified, evaluated and assigned for resolution. 2. Issue resolutions determined to impact the scope, schedule, or quality of the project will be passed to the change management process. 3. Issue and resolutions or decisions are communicated to all affected parties and documented. The Issue Management process brings visibility, accountability, and often in timely resolution. Risk Management Plan Risk is whatever threatens or limits project goals, objectives, or deliverables. Risk management is a systematic method for considering all possible undesirable outcomes before anything happens and setting up avoidance procedures or ways to minimize or cope with the impact. It is important to think ahead in order to avoid or minimize risk. Large projects will require more detailed planning and a often include the development of alternative strategies and evaluation criteria. The ranking and development of mitigation strategies may also require more detail. Quality Assurance Plan The Quality Assurance Plan describes the strategy and methods by which to things will be insured: the sand and reasonable development and management of the project and the quality of the deliverable soon before they reach the clients Scheduling and Task Plans The Project schedule sets the tasks and due dates. It begins with an estimate of persons and time, or man hours, including a Work Breakdown Structure (WBS). Often project scheduling software will enhance the process. The plan outlines major objectives and detailed tasks associated with them. It plots dependencies and relationships among tasks and activities. Staffing Plan The Staffing Plan defines the required human resources needed to insure the successful outsourcing project and the required deliverables. For outsourcing projects this is typically quite small, involving a manage, a documentation specialist and a tester, typically only on a part time basis for all but the manager. This plan also provides for resources that are not personnel, such as space and computer equipment for testing. However, these resources both people and tangibles need to be skillfully allocated by the overall project manager. Investment Plan This plan will be used in the case where the company prefers to use and joint venture or to acquire a company to provide the necessary deliverables. Generally, the legal department and top management plus the finance department will have considerable input into this plan and may create it themselves. It is probably not necessary for the project manager in charge to do much on this plan, but his or her input will be required in order to justify a joint venture or acquisition. Communications Plan Of all the documents needed for the communications plan is, perhaps, one of the most important, as it outlines completely the roles and responsibilities of all the participants in the project for review, approval and distribution of information about everything in the project, including events documents and milestones. Test Plan The test plan involves the description of the approach for all product testing and should be company policy. It covers the unit of deliverables, integration, the system for testing, the qualification and acceptance testing that is needed to comply with all authorities involved across the board. In the case of pharmaceuticals and other costly development, uniform testing plans which meet or exceed the highest standards will avoid any approval problems in all distribution areas. Prepare a Test Plan describing the scope, processes and criteria for testing particular deliverables of the project. The plan should describe the following elements: Defining The Scope The Scope Statement is created by or in partnership with the project architect. This will be done in collaboration with all stake holders. The Project Scope Statement is a complete documentation of the needs and responsibilities of all stake holders for the project. References Ambler, T., & Witzel, M. (2003). Doing Business in China. London: Routledge. Retrieved January 21, 2007, from Questia database: http://www.questia.com/PM.qst?a=o&d=104269728 Hong Kong Software Development Association . 2004 . Software Procurement: A Study of Outsourcing . (Internally developed and published book for outsourcing best practices.) . Section IV Stuckenbruck, L. C. (Ed.). (1981). The Implementation of Project Management: The Professional's Handbook. Reading, MA: Addison-Wesley. Retrieved January 21, 2007, from Questia database: http://www.questia.com/PM.qst?a=o&d=85919029 Turner, R., & Moorman, J. (1994, April). Using Project Management to Ensure Quality Control. Corrections Today, 56, 138+. Retrieved January 21, 2007, from Questia database: http://www.questia.com/PM.qst?a=o&d=5000207854 Read More