According to the 2013 State of Medical Device Development Survey
Report, published by Seapine Software, most medical device companies burn several hours or days creating and maintaining a traceability matrix. Some lose weeks of productivity to this one task! Only 14% of survey respondents said they can create and update a trace matrix in minutes.
So what’s their secret? In a word, automation
Building and maintaining a traceability matrix is often a mandated requirement for gaining regulatory approval to sell a product, but it can be much more than a tick box on an audit checklist. A well-maintained traceability matrix can help you estimate how many tests will be needed, provide the visibility you need to manage change throughout the product development cycle, and make audits go much smoother. Most importantly, a traceability matrix serves as evidence that all requirements have been implemented and tested, and all hazard mitigations have been implemented and validated for effectiveness.
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74% of those surveyed report that it takes hours, days, or even weeks to create and maintain a traceability matrix. (Image Source: 2013 State of Medical Device Development Survey Report)[/caption]
Unfortunately, traceability matrices can be very time-consuming to create and maintain when done manually—not to mention prone to human error. Links need to be created and maintained across all product development artifacts. You need visibility into those links—and the ability to trace them upstream and downstream—to truly understand the impact a requirement has on the deliverable. And when requirements change or business priorities shift, you need to be able to see the impact of the change quickly.
Creating and maintaining links, without adding overhead to the project, is the key challenge to implementing effective traceability. In today’s lean organizations, teams have little downtime when they can update spreadsheets or a homegrown traceability matrix. The time needed to manually compile a trace matrix or perform impact analysis just delays the project, making it that much more difficult and time-consuming to respond to change.
Automation Saves Time
Savvy development teams save themselves time and headaches by automating traceability through an automated product development solution. The best of these solutions provide a bird’s eye view of an entire project, showing how everything is linked together. For example, you might filter the matrix to see only items that are not linked, items that are linked, all items, specific links types, and so on.
Tracing artifacts with an automated product development solution is easy. You can create and manage requirements or user stories hierarchically, and organize them in the tool to define the product or component you’re building. Because requirements can be arranged hierarchically, they are automatically related to parent requirements. If a child requirement changes, or is labeled “not met,” this hierarchical relationship ensures the parent is also marked as suspect.
Automatically Link Test Cases and Requirements
With a product development solution, test cases generated from approved requirements are automatically linked to the requirement. This ensures there is a link from every requirement to the test cases that will validate the requirement. Even if you don’t automatically generate test cases from the requirements, you can write your own test cases and link them manually.
Every execution of a test case is also automatically linked to the test case itself, enabling testers to determine if requirements have been met based on the results of test runs. If each requirement has one or more test cases linked to it, and the test cases accurately reflect the intent of the requirement, successfully executing those test cases lets you confidently assert that the requirement has been met.
With all of those links in place, it’s also easy to view the progress of your testing effort with traceability reports. You can see test execution results broken out by requirement, providing insight into the team’s progress in validating requirements. The traceability matrix also gives you the ability to look at test coverage, identifying requirements that don’t have associated test cases and prioritizing them with the team.
Automatically Link Defects and Source Code, Too
Whether tests are manual or automated, results can change as you run regression tests throughout the development lifecycle. When a test fails, you need the ability to create a defect and automatically flag the associated requirements for follow up.
With a product development solution, the defect is automatically linked to the test case. If a defect is recorded as a part of a test run, that means the run fails. That failure is propagated through the test case and the requirement cannot yet be considered implemented. Linking the defect back to the affected requirement makes it possible to understand the impact of the fix, while the fix is being scoped. This enables product teams to easily make triage decisions about which defects should be addressed to meet higher-priority requirements.
The Secret Is Out
Now you know the secret of the 14% of medical device developers who can generate a traceability matrix in minutes. Because product development solutions allow you to automatically link requirements with downstream artifacts, they give you the foundation of traceability.
Traceability with a product development solution should be a lightweight process that doesn’t require a lot of overhead. Because much of it is automatic, and creating a manual link requires only a mouse click or two, linking artifacts becomes a natural, and mostly invisible, part of the team’s daily work. There will be no question whether a specific requirement or user story has been met, and when it has been met.
By linking requirements to downstream artifacts, you can be confident that the product your team is designing, building, and testing will meet all of the documented user needs. And you’ll be able to create and update your traceability matrix in no time. The only question remaining is what you will do with the hours, days, or weeks that you save.