Seven steps toward regulatory excellence - Step 3 - Requirements Traceability
By: Simone Bernardi, Anders Ekman, Celeris AB
Organizing work and artifacts
Work can be organized and tracked by means of a Work Breakdown Structure where I am pretty sure that during your career, you have experienced various levels of depth in tracking work. Some managers like to track steps and actions in a very detailed manner while others prefer to focus on milestones and outcomes. The levels of tracking are hierarchically related and with proper tool support it becomes straightforward to zoom in or out in the Work Breakdown Structure of the work at hand.Not only the work at hand but also the artifacts that are being created or modified during the work can be organized and tracked. Market requirements can be translated into system requirements. System requirements can be translated into software and hardware requirements, and so on. A similar hierarchical breakdown can be done with a lot of other artifacts (architecture, test plans, code components, etc.). This is the way to manage complexity. For any artifact, there is a cost related to specifying the artifact at an increasing level of detail. At some level the cost outweighs the benefit, and it is important to address this tradeoff. See for example Ralph (2012) on the tradeoff between defining too many or too few requirements in software development.
Step 3 – Requirements Traceability
We have argued that the main way to manage complexity is to organize tasks and artifacts hierarchically, to allow for the zooming in and zooming out of groups of tasks and groups of artifacts of certain kinds. Now, organizing tasks and artifacts of a certain kind hierarchically is a good way to manage complexity. In addition, since works and artifacts of various kinds are interrelated, it is very useful to track these relationships. Sample relationships are the interdependency between project tasks and project requirements, project requirements and software components, project requirements and test cases. It is often useful to keep track of interdependencies between artifacts of the same kind, such as requirement conflicts or implementation order between requirements. The tracking of interdependency between work and artifacts of various kinds is referred to as traceability. Proper traceability is a critical success factor for any project, since the traceability makes it straightforward to assess the impact of change, to ensure that all high-level requirements are being properly implemented, that all software components have requirements that justify the existence of the software component, and a host of other things. With traceability, requirements management has taken a big step forward towards excellence.
For regulatory requirements, you want to prove compliance. This is done, not only by tracing requirement to products, but also their verification and testing. Being able to prove compliance in an effective and efficient manner, under the increasing constraint of agile product development naturally induces companies to step back from cumbersome and fancy Excel files (perhaps enriched with heavy and hardly manageable VBA scripts) to increasingly embrace professional requirements management software to track requirements in a dynamic and crowded product development environment. Traceability is key in minimizing risk, controlling for quality of delivery, ensure efficiency of operations, and proving compliance. Traceability is essential in highly regulated industries and the related products.
References: P. Ralph (2012), The Illusion of Requirements in Software Development, Requirements Engineering.Source: Seven steps toward regulatory excellence – Step 3 – Requirements Traceability | LinkedIn
