Creating a Functional Requirements Management System with Existing Office Tools

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  January 1998 Column

DESIGN CONTROLS

A common bundled office automation product can compile data from various computer programs into an integrated document.

By now, project designers are familiar with the benefits and qualities of a requirements management system (RMS). Unfortunately, off-the-shelf RMS tools, while useful, are relatively expensive and may not be attainable given the budget constraints of smaller companies. The good new is, small companies likely already employ a bundled office automation product that contains drawing, spreadsheet, and word processing tools. These basic components can satisfy the needs of an RMS. A diagram illustrating a bare-bones RMS constructed from these components is shown in Figure 1.

Figure 1. A simplified diagram of an RMS shows the interrelationships between system components.

GRAPHICS TOOL

Drawings are a significant portion of the documents that must be created and maintained on a development project. Many graphics tools are available; one to consider installing is ShapeWare's Visio (Fairport, NY), which reads and writes AutoCAD (.dxf) files. Visio is an easy-to-use application with templates for virtually any engineering discipline; its technical version offers templates for electrical, mechanical, and software technologies.

Visio's numerous features allow traceability of requirements by linking objects and associated data to spreadsheets and databases. By double-clicking objects, users can open new pages or link drawings. Document files and spreadsheets are also opened by clicking on icons.

Drawings can be dragged to their desired document location and dropped into place. These graphics can be embedded into documents and spreadsheets through use of the Object Linking and Embedding (OLE) feature in Windows, which also automatically updates all attached files when changes are made. A simple configuration management approach can be implemented by using different names for various document revisions.

SPREADSHEET TOOL

Current spreadsheet programs are powerful number crunchers that can solve virtually any product development problem in any technical discipline. Analysis and simulation models can be quickly constructed to solve mechanical, electrical, or software problems. Named ranges produce cell formulas that read like equations, allowing ease of creation and maintenance. Powerful features can find optimal solutions to the specification allocation problem (e.g., finding the lowest cost specification). Paste links allow the outputs of one spreadsheet to be used as the input of another, which is useful for flow-down of requirements or flow-up of capabilities. An array of statistical tools provide the rapid data analysis required for verification and validation testing. Best of all, these models can be used by anyone involved with the product. For example, sales and marketing can use a life-cycle cost model to encourage customers to buy the product, while quality control can use the model to determine if nonconforming material is acceptable.

DOCUMENT TOOL

Word processors are used to create specifications, interface control documents, and document analysis and test results. These documents can be linked to drawings and spreadsheets for traceability and to reference data to support the development process. All data on a subsystem, for example, can be integrated into a single stand-alone document that may go into the design history file.

TEAM NETWORK SOLUTIONS

The latest office automation products allow access by anyone on the team, even employees at different locations. Many product features support Internet and intranet applications, work groups, and other network-centric structures, making it easier to share data on product development activities. These tools will undoubtedly continue to increase in capability and performance with each new version released.

Edward V. LaBudde is managing director of LaBudde Systems (Westlake Village, CA).

Copyright ©1998 Medical Device & Diagnostic Industry