MBSE – Model Based Systems Engineering – is experiencing a renaissance. Organizations are looking at MBSE to address the challenges of raising complexity and more stringent regulatory requirements. But proper MBSE takes a large investment over a long period of time. And unfortunately, many initiatives wither away due to full commitment from leadership, acceptance issues and underfunded initiatives.
To be successful with MBSE, the trick is to start with specific value-driven use cases. And here is the good news: It is possible to implement such value-driven use cases, without having to confront the team with having to to learn MBSE.
Traceability has many benefits in product development. It is also mandatory for regulatory compliance, no matter whether you build cars, trains, planes, medical devices, industrial tech. There are very few exceptions.
Traceability in product development is everywhere:
From regulatory compliance documents to your system description
Between user requirements and system requirements
Between requirements of any kind and tests
Traceability between risks and functions
… and many more
A Glossary is a First Step
Semiant, our automated quality assistant, already provides you with traceability between glossary terms and requirements. This is already useful for compliance activities:
Regulatory compliance requires a controlled vocabulary and a common language, which Semiant helps you establish.
The Glossary provides traceability between glossary term and requirements relating to the term.
Last, it provides traceability between terms, e.g. generalizations or associations between terms.
Risks of Not Having an up to Date Traceability
For products that require functional safety compliance, not having a sound traceability can lead to serious problems:
Missing or incorrect traceability can lead to a rejected audit, leading to delays in product launch and expensive rework.
In case of accident that involve your product, there will be an investigation. Gaps in your traceability could lead to heavy fines, even prison for executives or bankruptcy for the organization.
As an example, consider the cost of the Boeing 737-MAX disaster: Hundreds of people died, thousands of planes grounded for over a year, loss of sales, and a heavily damaged reputation. The investigation uncovered neglect of fulfilling regulatory requirements.
Would you Like to Automate Compliance Activities Related to Traceability?
Traceability is useful beyond compliance. However, creating and maintaining traceability is tedious. That’s why we are exploring how Semiant could help you with this.
We prepared a one-question survey below. We’d love to hear whether any of these ideas resonates, or whether you have even better ideas.