Project Management Defined

Create project management procedures (where applicable) that define interfaces with line departments, customers, and suppliers. 

The standard requires that if a project management approach is used, a project manager and project team be assigned, that appropriate resources be allocated, and any special responsibilities and organizational interfaces be defined. 

Accepted solutions are usually covered by specifications and codes of practice. These documents are important for three reasons they form part of the contract they define methods of design and fabrication proven by experience and they act as a means of communication between the parties involved in design, fabrication, construction and inspection. There is a strong incentive to use standard solutions as unexpected problems or misunderstandings are less likely to occur than if a novel solution is attempted such problems lead to the cost of rectification, but the delay that they cause is usually more importantConsequently project managers are often reluctant to be the first to use a novel solution. 

The major technical problem was the inability to define subsurface geohydrologic conditions with the initial data. Expertise in the area of geohydrology was clearly needed. A lack of specific analytical techniques precluded meaningful environmental and risk assessments. Cleanup efforts were complicated because poltiners are not regulated under RCRA but are regulated under state law. In the middle of the cleanup effort, the site became involved in Superfund activities, and to date this involvement has not been clarified. Project management has become very difficult because of the many players and laws involved. As a result, public confidence has been affected. 

The first issue that should be addressed when a process analyzer project is proposed is to define project roles who will be doing what. There are four basic roles in an analyzer project the customer(s), the sponsor, the project manager, and the receiver. These are described below. 

Table 2.8. Typical issues addressed when designing a clinical trial protocol. The trial objectives should clearly define what questions the trial should answer. The study design section should contain comprehensive information detailing trial size, criteria used to choose the study population, and enrolment procedures. Description of intervention section should give the background to the intervention itself, its therapeutic rationale and how it is to be administered. Measurement of response should detail the data to be collected, how it will be collected and analysed. The organization and administration section should give full details of all the investigators, where the trial is being run, and its project management details...

Books on project management tend to take for granted that a project has been defined and discuss only how to put a given project in train. But these projects had to start somewhere. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

To start with, the project organization must be defined. The different positions must be defined and people need to be found with the necessary knowledge to fill these positions. The most commonly required areas of expertise for a project leader are organizational know-how, social skills, project management knowhow, time management, validation know-how, and general technical know-how. A team member should have expertise in communication skills, validation know-how, and detailed technical know-how. 

In the same dictionary, innovation is defined as the introduction of novelties the alteration of what is established and something newly introduced a novel practice or method . We can re-interpret this for the industrial environment as the introduction of new products, application processes or services to the market based on prior knowledge . Thus, innovation in R D is the generation of new ideas, which can then be used to produce these new products, processes and services. It should be obvious that this is an activity that does respond directly to planning. Certainly, at the development end of the innovation chain, rigorous planning is a prerequisite and this is covered in Section D on Project Management. 

The work breakdown structure is therefore a method of describing the work to be done in the project in terms of deliverables and the tasks to be accomplished. It involves defining major deliverables and accomplishments during the project and fisting a hierarchy of sub-deliverables and accomplishments. The deliverables and accomplishments are a sum of their sub components and the WBS is a sum of all the elements. A more detailed description of this can be found in any of the general books on Project Management [D-13]. 

The following subchapters describe how to define the aim of a development project and propose a basic structure for a project plan which eliminates the main risk factors in the earliest possible stages but keeps the main dependencies in mind. Since the success of development projects depends on an efficient and well-organized use of human resources and because dealing with human resources is the most difficult task of a project manager, the human and organizational aspects of project work will also be discussed. 

Delegating responsibility to a project manager and to project team members also includes the delegation of decisions to them. Extent and limits of the delegated responsibility and authority should be defined in job descriptions. Only if there is trust and confidence in their capabilities, responsibility and decision making can be delegated. 

A brief system description covering the system s history (whether it is an entirely new system, a replacement system, or an existing system) and its business purpose is necessary. GxP regulatory authorities expect replacement systems to be as least as reliable as their predecessor manual or automatic system. The aim is to provide a management overview of the project boundaries, defining what is and what is not included within the scope of work. The system description may be supplemented later by a separate System Overview document, especially for larger systems (see Chapter 8). 

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