Risk Management is a top priority in the medical and automotive industry, where malfunctions in software can cause recalls and serious injuries or death of users.
Software embedded in cars and medical devices is one of the most critical parts of functional safety. Application Lifecycle Management tools therefore has to support risk management and measurement, risk mitigation actions and ensure risk traceability. Risk management processes run in parallel with the Software Development Lifecycle (SDLC) of the product, from the design phase to the end of life. An Advanced ALM provides a complete tool set with trackers, workflows, alerts, notifications, history and base lining, all key requirements to manage risk effectively along the SDLC. The first step is todefine risk, what this means is that all risk items regarding a product must be named and analyzed. The risk analysis focuses on:
- The Situation – when the problem may occur,
- The Hazard – what is the consequence of the problem,
- The Triggering event – the event that directly triggers the occurrence of the problem,
- The Harm – the effect of hazard on the person or the environment
- The Likelihood – the probability of the occurrence
- The Severity – a score that represents how serious is the problem
Risk definition in codeBeamer ALM software can be tracked and traced with special risk trackers. Risk management workflow defines what steps need to be completed for effective risk management. In most cases, mitigation or risk reduction action has to be defined. Specific risk mitigation actions can be implemented during either the development or test processes or in both. In codeBeamer ALM solution all processes are documented and therefore the evidence for auditors is readily available for collection and 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. CodeBeamer has a special set of predefined risk trackers, workflow and risk documentation features in the medical and automotive focused template projects. Request a template to test our risk management capabilities here.