Companies in regulated industries often struggle to get the functional safety team involved at the right stage of the development process.
When building complex products that must adhere to standards such as ISO 26262, IEC 61508, or DO-178C, for instance, too often the functional safety team gets looped in after the system is already designed and development has begun. And, by that point, it’s too late.
Imagine a company that uses Word documents to house multiple test cases defined using ID strings to refer to other artifacts like design or requirements.
When it comes time to review the test cases or adapt to changes in design, think of all the agonizing time the functional safety team will waste manually going through the list. Then consider the increased risk and quality issues should something being missed.
Time for Change
We’re at a pivotal point in defining when and where the functional safety team fits in a modern systems development process.
In a recent webinar, Jan Mauersberger, Lead Software Architect with our partner ANSYS, described the four roles of the functional safety team, as well as the negative effects of integrating the functional safety team too late in the development process:
This is done in order to know the criticality of failures in the system. The risk assessment results may imply more testing or development effort, and can have a big impact on both the timeline and cost of the project. Logically, the earlier this can take place, the better.
Typically, not a one-and-done solution, a safety analysis needs iterations and refinement – which may affect the design several times. The results of a safety analysis have to be visible early in order to react to the required changes.
Dynamic formulas — based on industry standards and handbooks — calculate reliability data and have to be quickly adapted. If the functional safety team does not know of a change in design, for example, it can cause a lot of manual work.
The functional safety team has to compile and sign off on the safety case, and they are responsible for the product. Involvement and traceability from start to finish is essential for eliminating issues in safety, development and testing.
A Modern Approach
Today’s processes are iterative, with modifications introduced later and later. That’s why it’s recommended – and why most safety standards demand – that safety management and engineering start at the beginning of the development process.
The functional safety team can then mitigate issues early and stay connected throughout. It’s also critical that the team’s tools integrate with other solutions in the development process – without that, traceability is near impossible.
To learn more about the challenges of modern systems development in a regulated environment, watch our webinar with ANSYS. Plus, you’ll find out how the integration of Jama Connect and ANSYS medini analyze can help address these issues.