ABSTRACT
Risk assessment is the overall process of risk identification, risk analysis and risk evaluation and is one of the processes carried out when planning for the QMS. Whether one is using methods of risk assessment where a risk is identified, analysed and evaluated in a few seconds or a few weeks, the steps are the same, the difference is in the rigour of the assessment and the magnitude of the decisions it informs. This chapter examines the four requirements of clause 6.1, namely: risks and opportunities that need to be addressed; planning actions to address risks and opportunities; integrating actions into QMS processes; evaluating the effectiveness of actions that address risks and opportunities. A catastrophic situation can arise when random and systematic events cause multiple devices, systems, or layers to fail simultaneously. This is referred to as common cause failure (CCF).
