Traceability is the ability to track upstream and downstream relationships between requirements and other artifacts, ranging from test cases to higher-level system or subsystem requirements. Through end-to-end traceability, teams can see if a product’s development process is currently on track, as well as view any and all of the history and context associated with it.
That’s the ideal, at least.
Where Traceability Can Come Up Short – And How to Fix It
Traditionally, traceability has been performed using document-based workflows involving applications such as Microsoft Word and Excel. A team member creates a traceability matrix in a text document or spreadsheet and updates it manually throughout the product development lifecycle. Unfortunately, this approach has distinct limitations and is prone to error.
When teams trace requirements within discrete and static documents, they often create extra work for themselves, while also running the risk of missing out on critical updates or making mistakes.
Let’s say someone updates a matrix in Excel with the latest statuses of test cases related to a medical device that’s in development. It might seem like everything is proceeding smoothly on the surface, but multiple problems could be lurking underneath:
Since everything is done by hand, this individual must regularly revisit the matrix to keep it in sync and up to date with product development activities across the whole organization. The complexity of the traceability matrix in question – with its numerous tables showing how requirements and test cases connect to one another – makes such work inherently complicated and error-prone.
Meanwhile, these updates to the matrix are primarily communicated via email. Between the normal flow of messages into everyone’s inboxes, people being out of the office, and other complications -like poor version control – and mishandling of incorporating everyone’s comments, it is likely that errors will occur and misunderstanding will necessitate rework down the line.
No Built-In Compliance
Finally, even if everything goes according to plan, there’s no guarantee that the traceability workflows in use will account for all relevant requirements and risks. For instance, in the case of a medical device, a matrix created within Excel won’t come with frameworks aligned with industry standards like ISO 14971, making it more difficult to ensure coordinated traceability and ensure successful proof of compliance.
Fortunately, these types of issues don’t have to hold your teams back and expose your product development processes to undue risk. End-to-end traceability is possible by upgrading from document-oriented workflows to a comprehensive requirements management platform that enables real-time collaboration, bidirectional traceability, and integrated risk management.
Let’s look at four central benefits of implementing end-to-end traceability with a solution like Jama Connect®.
1. Holistic, Actionable Visibility into Requirements and Stakeholders
Traceability is ultimately about relationships, not just between requirements and other artifacts, but between all of those items and the people responsible for managing them. With end-to-end traceability in place, teams can see:
- How requirements trace forward to their implementations within work products, along with how those products trace back to original requirements and designs.
- How all requirements were tested – i.e., the test cases linked to them, whether the tests passed or failed, and any associated defects identified along the way.
- Who was involved in the development of specific requirements and test runs, so that they can be notified right away about necessary next steps or actions required.
This comprehensive visibility creates a system of action – one that teams can use to not only trace the life of each artifact but to initiate the appropriate activities to sustain product development and ensure coverage. Is a medical device safe to use? Does it comply with applicable standards? Can the processes used for building it stand up under an audit? A full-fledged traceability solution provides clear answers to these questions and others.
2. Better Impact Analysis of Changes
Truly informed impact analysis isn’t possible without end-to-end traceability. That’s because such analysis is rooted in being able to see how specific changes to an artifact will affect other items connected to it. Knowing those impacts requires traceability.
In traditional document-based workflows, it can be difficult to know how different items are affected by change. But in a platform with end-to-end traceability, much of this work is automated and becomes a byproduct of your daily work. The solution will instantly flag downstream links as “suspect” so that teams can attend to them as needed.
For example, teams can see if an altered requirement has test cases downstream and what share of them have passed – all in real time. This setup saves immense time and effort compared to manual processes.
3. Easier Identification of Gaps in Test Coverage
Speaking of tests, a requirement is typically only considered “covered” if it has corresponding test cases against it, as well as test engineers assigned to it. But too often, gaps in coverage only become apparent after the fact, when a product issue reveals how a key flaw was overlooked during development.
In fields with rapid change and innovation, such as medical device development and automotive manufacturing, any unidentified coverage gaps are risky to end users and costly to remediate. Improved tracking of test coverage in a platform with end-to-end traceability helps eliminate these blind spots and ensure quality.
More specifically, this level of traceability within a requirements management solution helps test engineers and project managers visualize where gaps exist and whether tests have been approved, completed, rejected, or drafted. As a result, product development becomes less risky overall.
4. Simplified, More Accurate Audit Passage
“Show your work” is a familiar adage to anyone who’s completed a mathematics assignment, and it is crucial advice when tracing requirements, too. Passing an audit will require presenting specific information about those requirements, in formats acceptable to reviewers and regulators.
A platform like Jama Connect simplifies this process by letting teams show clear supporting evidence of comprehensive traceability. It provides export templates like trace reports to provide this evidence, simplifying regulatory submissions and the audit process.