Risk management is the fundamental activity that guarantees safety of products and that permits to obtain any type of certification.
In the development cycle of our designs, a fundamental place is taken by risk management, that is carried out according to the following steps. Moreover, we can execute risk management for your designs that have not been subjected to this important activity.
Risk management is carried out in conformity with harmonized standards, such as ISO 14971 for medical devices, ISO 12100 for machinery, etc.
An example of steps we use to execute risk management is the following:
- Identification of product specifications
- Identification of potential hazards connected with product
- Risk analysis and estimation for each hazard
- For each hazard, the events related to the equipment are identified Such events will be called “Top events”.
- For each Top Event it is executed a FTA, Fault Tree Analysis (IEC 1025)
- For each leaf of the FTA, that corresponds to a device component at the level of detail chosen for the FTA, it is executed a Failure Mode and Effect Analysis (IEC 812)
- Risk estimation
- Risk acceptability
- Risk reduction
- Generation of other hazards
- Estimation of all the identified hazards
- Result of risk management – product safety