Design team documentation needs

The people who will use your product need to see the requirements, although not the design. How this works depends on what sort of clients they are. If they are another design team using your software component, you can expect them to understand the documents directly. Still, it is essential that you clearly separate the external view from the internal workings. The requirements documents form part of the client s contract with you. 

In applying the project management approach recommended in Chapter 15, the effort should begin with a scope definition for the effort. This often is built around as-is process documentation, or mapping by the project Design Team. Later in the project, modified or new processes will be needed. They too must be mapped. 

Both top-down and bottom-up mapping are required in supply chain improvement efforts. Table 24.1 describes the role for process analysis in the application of these tools. A column in the table indicates the likely type of mapping — top down or bottom up. Depending on the needs of the organization, the Design Team can employ Table 24.1 in designing its documentation approach to a particular process. Teams should review the list to be sure they are capturing the information required to apply a listed concept or tool. 

One aspect of engineering that is always needed is to plan the information flow required for the design stage of the SIS. Associated with this is the list of deliverable documents expected from the design team to define the manufacture and then to support maintenance. 

Software and computer systems that are subject to validation must be designed using strict procedures with sufficient documentation. During the process of system design, strict controls must be in place to allow future validation success. The system designer must ensure that documentation of the system meets minimum requirements necessary to satisfy the needs of the validation team. 

When the clinical research team has decided on their research question, and the appropriate study design and methodology to acquire optimum quality data with which to answer this question, all this information needs to be documented. The clinical study protocol is the document that is written for this purpose. Chow and Chang (2007, p 1) noted that the study protocol is "the most important document in clinical trials, since it ensures the quality and integrity of the clinical investigation in terms of its planning, execution, conduct, and the analysis of the data."... 

At the end of this process, the Project team will have a document that will identify and address 95% of the bottlenecks in the system, including existing facilities that need to be modified, and items that need to be revised in the current design for the winze at its related facilities. 

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