Risk management is especially important for safety critical industries such as healthcare (with the design and manufacturing of medical devices), aviation & aircrafts, transportation, as well as the automotive industry due to the risks associated with the design of cars. Increasing complexity of such safety critical products increases risk for manufacturers as serious injuries or death could result from the malfunctioning of such devices. A way to mitigate these risks is therefore required to compensate for increasing risk levels.
Safety critical industries are regulated by strict standards everywhere in the world. These standards describe the processes and activities that need to be covered in order to achieve high reliability of software. Therefore in safety critical industries, the role of Application Lifecycle Management solutions to support the design, management and audit of regulated lifecycles is vital. In addition to the definition, execution and control of risks, the Risk Management Lifecycle is a key way to achieve high standards of quality application development.
To understand its importance, just look at some statistics from the medical industry published by FDA (the US Food and Drug Administration). After a short analysis of historical data from the past 5 years, it is clear that the number of software recalls increased by 100% from 2010 to 2011. Also, the number of 1st class recalls increased, which is the classification of the most dangerous malfunctions that can cause serious injury or death to patients. In the first half of 2014, 30 new 1st class recalls were published, which means 30 different medical devices contained software with bugs, posing a serious hazard of causing injury or threatening human life.
Let’s have a look at the Risk Management Lifecycle that needs to be followed and supported by proper tools to ensure full traceability on the process and products to avoid malfunctions in devices.
- Risk Identification
- Classification and Assessment
- Hazard Analysis
- Risk Reduction Plan
- Risk Mitigation Actions
- Documentation and Reporting
In Intland Software’s codeBeamer ALM tool, all of theses steps are supported via specific trackers, uniquely designed workflows, as well as a built in wiki and special documentation & reporting features.
By using an ALM tool that specifically support Risk Management Lifecycle the following results can be realized:
- Systematic risk definition, documentation and mitigation
- Easier risk effect analysis and impact assessment – due to an overview of all relations and dependencies, and previous actions regarding all defined risks
- Better monitoring (e.g. proactive escalation management) on risk status, risk mitigation and risk documentation
- Quick overview on responsibilities of the actions according to workflows – assigned to and status
- Historical queries of each risk item
- Full traceability on risk dependencies and changes
Those results can help achieve a full traceability on the whole lifecycle, reduced cost of execution and audits, and increased safety by ameliorating product quality.
Try our Medical ALM solution online by requesting access to our template project.