Why and how of requirements tracing

While requirements traceability is explicitly required in US Department of Defense software contracts, it is often hard to sell in other situations. This article explains how Abbott Laboratories Diagnostics Division approaches traceability. To illustrate our program, we describe how we applied it to an R&D project to develop an embedded, real-time in vitro diagnostic instrument. The software is part of a system to test human body fluids for conditions such as cancer or hepatitis. We learned a great deal from this application and continue to experiment with and evolve the traceability-analysis process. In particular, we found that we must establish documentation rules and formats much earlier in the life cycle. Another lesson we learned is that traceability does cost. You need staff to support formal inspections or reviews. For most projects, you need some type of tool to assist in managing the trace matrices. We developed a relatively low-cost tool to handle our needs. Whatever the cost, it is important to include it as well as the costs for developing and maintaining procedures for documentation formats and generation, traceability analysis, and formal inspections. Our biggest lesson is that traceability is critical to project success. We believe it was one of the key factors in releasing our diagnostic instrument on time. Finally, we determined the conditions under which some type of traceability program is necessary.<>