Planning project

Once the portfolio has been designed, planned, and managed for optimization, it is the project team s job to make it happen. 

Biopharmaceutical projects, like all projects, consist of three components, which must be planned and 

TABLE 27.7 Project Management Dimensions in the Biopharmaceutical Industry 

Project planning Project scheduling Team management Resource allocation Decision-making 

Project resources (the how/where ) includes funding/ staff (both internal and external)/ study participants/ bedS/ clinical supplies/ bulk drug/ animalS/ cageS/ and in-house and outsourced facilities. 

As already mentioned in the introduction, project planning comprises the period from the idea for a new or modified product to the conclusion of the contract for the manufacturing of a process plant. During this period the focus is on estimate of costs, cost determination and negotiations. 

The development process should be carefully planned and clear evidence should be provided that the process has been followed in order to facilitate the licensing of systems important to safety. Project plaiming should be documented in a comprehensive and specific safety plan for the computer based system, or as a set of plans that cover all aspects of the project. Section 4 describes each aspect as a separate plan, but it is equally valid to place all these plans in a single document. Modifications to the system should not be excluded and provisions should be made for possible further iterations of the safety analysis. 

A development plan should define a set of development activities and the essential characteristics of each activity. Other aspects of the project which should be 

The development plan should identify and define the development process that will be used on the particular project. Paragraphs 4.4-4.10 indicate what the computer system development plan should cover. 

The methods to be used in the development should be identified. This selection should be related to the quality assurance programme description, in which standards and procedures are established. 

The tools to be used should be identified in the development plan. The tools should be selected so as to facihtate the proper application of the methods, standards and procedures selected. Planning in advance for the entire project will help in the selection of an integrated set of tools. The tools should be properly qualified for their function in the development, management or verification of the system. The correctness of their output should be ensured by a tool certification process, by means of cross-verification or by reverse engineering. 

There are many ways to segment planning. As described in previous sections, compliance activities are usually initiated by new or updated applications, infrastructure or services, and one or more project teams manage this work. All compliance activities to be undertaken should be detailed in a plan. 

Where new infrastructure is being installed to support a new or updated application, the infrastructure is considered to be qualified and part of a larger project. Where a new infrastructure service is being provided, it may have its own plan. Infrastructure itself does not require validation. It is important that compliance steps and terminology are made clear. 

The roles that each group plays in the validation of the total system should be clearly defined. This includes a description of who is responsible for qualifying each element of hardware and software. Similarly, it must be clear which groups are responsible for maintaining, reviewing and approving the procedures. 

Corporate IT places considerable reliance on many suppliers for infrastructure products and services. Where possible, the infrastructure should be constructed from proven standard components from approved suppliers. Caution is required when introducing new technologies, which may involve more in-depth trials and testing. 

It is the responsibility of the pharmaceutical company to ensure that the products and services that are purchased are fit for their intended purpose. This should be achieved through auditing of the life-cycle development for bespoke products and adherence to quality procedures for services. 

Because of the extensive and important roles of operators and other plant personnel in the operation and use of I C systems important to safety (and of the plant as a whole), human factor processes should be integrated into the overall design process. 

The design should take into account the possibility of human error—both errors of omission and errors of commission — on the part of the system s users. To minimize the likelihood of serious adverse consequences resulting from user errors, the human-machine interface should, to the extent possible, be structured in design such that single errors on the part of the operator are inconsequential and are detectable and correctable. Simations in which human error has both a relatively high likelihood of occurrence and major adverse consequences should be avoided by means of a suitable system structure or design of the user interface, or by automation. 

On the basis of the results of these analyses, the requirements for the safety system are elicited. Specialists in nuclear safety and other engineering disciplines, as appropriate, should contribute to the definition of the requirements for the safety system. Normally, changes to the initial design are necessary and a new design is created, followed again by safety analysis. After a few iterations, a configuration of mechanical, process and I C systems is reached in which all current nuclear safety requirements are met. 

Once the design has been developed to a stage where it is known how the requirements are to be fulfilled and how the major plant systms and components will be configured, the design documentation is usually issued as specifications for procurement. In negotiating the contracts for plant systems and equipment, the designer 

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Project planning techniques are employed to prepare realistic schedules within manpower, materials and funding constraints. Realistic schedules are those that include a time allocation for delays where past experience has shown they may be likely, and... 

The project planning activities may be much more complex than illustrated... 

This book is designed as a handy desk reference covering fundamental engineering principles of project planning schemes and layout, corrosion principles and materials properties of engineering importance. It is intended as a general source of typical materials property data, useful for first pass materials selection in process design problems. 

To make sure that all contractors and subcontractors maintain a minimum level of safety performance, the client, or general or main contractor, should establish standards for compliance. During the project planning stage, affected prime contractors should have an opportunity to provide input and resolve differences. Cross-cut committees are encouraged to allow prime contractors to standardize or normalize such essential elements as procedures, permit systems, and training. 

The requirements for quality are the objectives which the organization is committed to achieving through the contract. They may relate to products, services, or both. The vehicle for you to define and document how these objectives will be met is called a quality plan but may be known by other names such as a project plan or contract plan. In some cases the requirement may be met in the form of a technical proposal by the supplier to the customer. 

A statement of work which you require the subcontractor to perform - it might be design, development, management, or verification work and will include a list of required deliverables such as project plans, quality plans, production plans, drawings, test data, etc. You need to be clear as to the interfaces both organizationally and technically (see Part 2 Chapter 4). 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

Project plans for introducing new equipment, services, operations, etc. 

VDA 4 Part 3 Quality assurance prior to serial application - project planning... 

The form these end products take should be consistent with your company s style for example, if you have specific protocols for project planning or developing Standard Operating Procedures, these will probably apply to comparable tasks within the PSM initiative. 

Once you have developed the program plan and schedule, and estimated resource requirements, you should organize this information in a manageable form for presentation to your PSM sponsor. If you have kept management informed about your progress you should have a clear idea of what is expected in terms of form, content, and level of detail. A sample table of contents for a project plan appears as Figure 5-12, and Figures 5-13 and 5.14 provide additional detail on selected portions of the plan. 

FIGURE 5-12. Sample Project Plan Table of Contents... 

FIGURE 5-13. Example of Project Plan Sections on Installation and Verification and Financial Controls ... 

PSM installation is proceeding consistent with the approved project plan with the following exceptions ... 

Once the detailed project plan has been developed, your estimates of costs and schedule in a number of areas will have firmed up ... 

Profilpriifer, m. profilometer. projektieren, v.t. project plan, design purpose. 

There are many other factors which affect project planning as it is related to process engineering. However, these are usually peculiar to the process or objective of the project. On first glance some of the items listed in Table 1-11 may appear to be unrelated to the process engineering requirements, and this can be the case for some types of projects. In these situations they become more of a project engineering responsibility. However, in many cases these have a relationship either to the process engineering requirements or to the decisions which must take this into account. 

Once the primary considerations of size, height, conceptual layout, structural loads, servicing (mechanical, electrical, communications, public health, statutory services) requirements, access, material and personnel traffic, etc. have been addressed, a facility brief can be produced to allow collation of the basic project planning information ... 

Project plans for the installation and commissioning of new plant should be prepared in order to ... 

The project plan should be started as soon as possible so that all aspects of the early layout planning can be incorporated into the plan. 

Formulation of specific R D project plans, including choice of screening sequence... 

Below, we focus on aids to R D project planning and process improvement, exploring the extent to which IT really can help managers to be more effective in decision making through simulation that fosters the ability to... 

Even the optimization of outcome distributions does not normally take account of the value of flexibility (i.e., by reacting to project events and flnd-ings as they emerge, one can make better decisions for the future than could be made in advance of the project, planning blind ). 

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