Risk analysis

The main motivation for analyzing and managing risks is liability in case of accidents. Design companies should be able to show, in a constructive way, that they have put sufficient effort to reduce risks potentially incurred when operating a device. Other motivations lie in that reducing risks will enhance the overall quality of the final product and inspire the design from a perspective other than e.g. the functional requirements.

The main activities in risk analysis are the following:

• Assessment – known failures in and (expert) users of similar products are studied and interviewed to identify potential system failures and human errors. All failures and errors are then prioritized, e.g. according to the FMEA method. Two risk factors are important in the prioritization: the magnitude of potential loss and the probability that loss will occur. This prioritization enables to focus the design on the unacceptable and/or most important risks.
• Management – identified risks are reduced as far as possible in the product design by specifying a risk management strategy for each risk to be tackled. Several formal approaches or standards can be followed to effectively manage risks, e.g. IEC, MOD, EN, ISO…
• Documenting – a safety case is written to prove that the designed product is acceptably safe. A safety case communicates clear, comprehensible, and defensible arguments to prove that a product in a given context can be operated in an acceptably safe way. Arguments for the case are gained throughout the design process, from the design rationale or by means of techniques such as the goal-structured notation (GSN).