3 Reasons to Build Your Traceability Matrix in Real Time

You already know that design traceability is a cornerstone of staying compliant with the FDA’s product development traceability requirements and other international standards for submissions and validation. In many organizations, building traceability matrices is a painful and inefficient process that typically includes manually updating a spreadsheet sometime near the end of a development cycle as the team wraps up loose ends and prepares for release.

Building traceability history in a spreadsheet at the end of a project turns the whole process into a clerical effort, and prevents the team from realizing any value from the work. Doing it to satisfy the auditors, while required, certainly isn’t something anyone will be excited to take on. To truly benefit from traceability, and help your team understand its benefits, you need to maintain your traceability matrices in real time. Here are three key areas where maintaining traceability in real time (or close to it) can positively help your team.

Stronger Collaboration

Successful projects rely on team communication and collaboration, or “social” as the young ones call it. With an up-to-date traceability matrix, any team member can quickly gain insight into test coverage for specific design elements or look at risk artifacts in specific areas of the product. Real-time traceability can also be used to communicate change when it happens. A requirement was updated? No problem, the testing team can be notified of which associated test cases need to be run again. This kind of proactive communication and collaboration ensures changes are being managed and keeps the team working toward the common goal of releasing the product.

Greater Visibility

Beyond strengthening collaboration, traceability gives management greater visibility into the product development cycle. Whether management needs information about risk mitigation, coverage, or testing results, the traceability matrix can provide a good overview of project status if trace relationships are maintained throughout the development cycle.

Real-time traceability also simplifies project management and reporting duties, reducing the need for constant status updates about test case development and execution. As work is completed, and the links and relationships between items are maintained, traceability naturally becomes part of the everyday work that the team does. There’s some overhead, of course, but the tools your team is already using to manage the development lifecycle should be able to help in maintaining those link relationships.

Better Decision-Making

Real-time traceability gives you flexibility in responding to change and insight into the impact of that change, so you’ll have a greater ability to deliver innovative products. Innovation is risky of course, which is why it’s important to reduce risks elsewhere when you can.

For example, making the decision to change a design element to better meet user needs or mitigate a known risk is much easier to evaluate if making that change doesn’t create uncertainty in the development schedule, or impact an unknown number of already-run test cases. Having trace relationships in place when change happens gives you the ability to make the tough decisions with as much information as possible. Conducting impact analysis to quickly identify design, development, and validation efforts that will need to be done if a change is accepted into the product cycle can help to eliminate the unknowns.

Conclusion

Traceability can be a necessary evil for your team, or you can embrace it and realize benefits beyond just compliance. Whether you schedule more time into the development schedule for the team to manually update traceability matrices, or implement a tool to help do it for you, traceability provides an opportunity to improve team collaboration and agility while giving you the flexibility to respond to change and out-innovate your competition.