Risk Management is a top priority in the medical and automotive industries, where malfunctions in software can result in costly recalls, and even worse: serious injuries or death of users.
Functional safety is fundamental when it comes to software embedded in cars and medical devices. The use of advanced software tools to support development is vital in these safety-critical areas. Application Lifecycle Management tools are widely used in the development of such safety-focused systems.
Therefore, a fundamental requirement for ALM tools is to support risk management and measurement, the orchestration and documentation of risk mitigation actions while maintaining risk traceability across the entire lifecycle.
Risk management processes run in parallel with the Software Development Lifecycle (SDLC) of the product, from the design phase straight through to the end of life. An advanced ALM platform provides a complete toolset with trackers, workflows, alerts, notifications, history, and baselining – all of them key to an efficient risk management lifecycle.
The first step of the risk management process is to define risks, meaning that all risk items pertaining to a product must be named and analyzed. Risk analysis focuses on:
- Situation: where the problem may occur
- Hazard: what is the consequence of the problem
- Triggering event: the event that directly triggers the occurrence of the problem
- Harm: the effect of the hazard on the user or environment
- Likelihood: the probability of the occurrence
- Severity: a score that represents how serious the problem is.
Risks in codeBeamer ALM may be tracked and traced with special risk trackers. Risk management workflows define the steps of an effective risk management lifecycle. In most cases, mitigation or risk reduction actions also have to be defined. Specific risk mitigation actions can be implemented during either development or testing.
In codeBeamer ALM, all processes are documented and therefore the evidence for auditors is readily available for analysis. From a quality audit and safety management point of view, the full traceability of risk management process and the evidences of executed mitigation actions are the most critical issues.
A special set of predefined risk trackers, workflows, and risk documentation features are built into our preconfigured medical and automotive templates. To learn more about risk management with codeBeamer ALM, watch the webinar recording below, start your free trial, or simply get in touch with us!