There are several different types of risk management tools and techniques, for example:
Risk management for medical devices (ISO 14971)
FMEA/FMECA (IEC 60812)
P-FMEA (IEC 60812)
Fault tree analysis (IEC 61025)
Below is a short summary of each of the listed processes/techniques and how they are related.
Risk management for medical devices according to ISO 14971
Risk management for medical devices is a comprehensive approach, from the requirements for planning the development of a device to the requirements for a device which is no longer on the market. ISO 14971 is based on the hazards that may exist in the product, e.g. virus, gas at high pressure, radiation, or sharp edges. Based on these hazards, a number of events can be identified, which can lead to hazardous situations and harm to people, property, or the environment.
Failure mode effects analysis (FMEA)
FMEA stands for “Failure mode and effects analysis”. The method is based on how failure of components or sub-systems may malfunction (local effect), such as break apart, fall out, or change shape, and then analyzes what kind of system effect this results in. This means that you cannot successfully work with FMEA until relatively late in the process of product development, because you need to have designed most components and sub-systems in order to determine how the components can fail and the consequences of that failure. Until they are designed, it is difficult or all but impossible to do the analysis.
In FMEcA, the term “Criticality” has been added to the abbreviation, i.e. one also studies the severity of harm to a patient/user due to a faulty component. With this addition, the method is more similar to risk management according to ISO 14971 as it identifies the harm. However, the method still emanates from component failures, and not hazards, unlike ISO 14971.
P-FMEA is a tool based on FMEA, but instead of analyzing a component failure, it refers to a process failure, e.g. in manufacturing or service. For each step in the process a product goes through in manufacturing and shipment, one asks how such a process step can go wrong, and what it may lead to.
Fault tree analysis (FTA)
Fault tree analysis is a method that is well suited to analyzing combinations of events leading to harm or to so-called top events. The method uses a structure which includes AND and OR gates, which allows analysis of what must happen for harm to occur.
ISO 14971 involves identifying reasonably foreseeable sequences or combinations of events that may lead to a hazardous situation and harm. FTA is a possible approach that can support the analysis of the combination of events and the calculated probability of harm occurring.
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