Safety Risk Assesment
Risk assessment is an overall process comprising of risk analysis, risk estimation, hazard identification and relevant risk reduction measures.
Risk assessment is a key parameter into any product compliance measure that allows manufacturers to identify any potential hazards that the user may become exposed to and thereby, introduce relevant reduction measures to prevent any harm to the user.
There are various methodologies to conduct risk assessments outlined by organizations such as ISO, IEC, SEMI. Industries adapt to various risk assessment methodologies which allows manufacturers to extensively evaluate and deep dive into critical technical aspects of the product design. Some techniques for performing Risk assessment are:
- Fault Tree Analysis (FTA);
- Event Tree Analysis (ETA);
- Hazard and Operability Studies (HAZOP);
- Failure Mode Effect Analysis (FMEA):
The key goal of any risk assessment is to ensure critical design aspects are evaluated in initial stages of the product design. Each identified risk is granted a rating, which is calculated by means of severity of the hazard, frequency of exposure of hazard, probability of occurrence of that hazard and possibility of avoidance of that hazard. The limits for all these values are derived from different applicable standards, which vary from industry to industry. The best approach to conduct this process is at the initial stages of product design.
A simple flowchart below shows the step-by-step procedure on conducting a safety risk assessment.
During the risk assessment process, the risk reduction measure may not be sufficient and has to go thorough further assessment. This stage is known as 3-step method. The protective measures that shall be implemented for risk reduction, shall be applied in the sequence of 3-step method.

Stealth compliance has extensive experience in conducting safety risk assessment based on a customized safety risk assessment template. Contact us to get started with Safety risk assessment.