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The Failure Mode and Effects Analysis (FMEA) is the tool used to identify and minimise possible risks in the design of products and processes while in the development phase. As per the definition, FMEA (Failure Mode and Effects Analysis) is an analytical method of risk management. Within the framework of an FMEA, possible design or manufacturing errors are assessed according to their significance, their probability of occurrence and their probability of detection with one key figure each. (Source/Link: Wikipedia)
- System delimitation
- Project plan
- Block diagram
- Lessons learned
- Basis for structure analysis
- System & process visualisation
- Identification of the design interfaces
- Basis for function analysis
- Functions of the system elements (design & process) and their interaction (functional networks)
- Basis for failure analysis
- Failure modes & failure chain (design & process) (correlation between failure effects, failure modes, failure causes)
- Assignment of actions (prevention & detection)
- Evaluation of the significance, occurrence and detection for each failure chain
- Identification, documentation, implementation of further actions necessary to reduce risk
- Confirmation of effectiveness
FMEA is used on precautionary basis in quality management (QM) and safety management, especially during the design or development phase of new products or processes. The method is widely used in the automotive and aerospace industries. Glossary. These days, FMEA is also being sought after by other sectors: Medical Technology, Mechanical Engineering, Food and Packaging Industry, Chemical Industry, Railway Industry and Wind Energy.
The aim of the FMEA is to steer clear of errors right from the outset, instead of having to discover and rectify them afterwards. In addition, it should also help to increase technical reliability. Potential causes of errors are identified and evaluated as early as the design phase. The findings gathered in the process also serve to avoid the repetition of design defects in new products and processes. In this way, the FMEA makes a major contribution to avoiding inspection and error-tracking costs.
For good and robust results, it is essential that the FMEA methodology is applied in the early phase of product development (planning and development) within the product life cycle. This is because the cost/benefit optimisation associated with FMEA is most economical in the development phase (preventive error avoidance). The later an error is discovered, the more difficult and cost-intensive the correction becomes.
FMEA has established itself in many economic sectors as the leading tool for cost optimisation and error avoidance. FMEA first appeared in a military standard in the USA in the 1950s. However, it is also associated in particular with NASA's Apollo project. In the context of ambitious space projects, the identification and minimisation of risks is crucial for success.
FMEA became widespread through its application in the automotive industry. Pioneering work in this area can be attributed in particular to the US and German automotive industries.
The objectives of the FMEA are fascinating: During development, long before the planning results are realised, potential root cause-error-consequential relationships are identified and their occurrence is minimised! It is therefore always a matter of anticipating potential risks or errors. The next step is to minimise the occurrence probabilities of these potential root cause-error-consequence relationships. For this purpose, measures supportive to development are defined.
By assigning parameters for occurrence and detection probabilities as well as their consequences, risk parameters are developed in the FMEA for each root cause-error relationship. In this way, it is ultimately possible to make risk-oriented use of resources, which are always limited, within the framework of development projects.
New challenges, innovative solutions – 2nd Medical Devices Risk Management Forum
FMEA was and is the object of committee and standardisation work and industry-related method descriptions. For the automotive industry, the method descriptions of the international AIAG (Automotive Industry Action Group) and the national VDA (Association of the Automotive Industry) are particularly worth mentioning:
Factors for success of the application are:
- The specialist know-how of the experts involved
- A proficient process model for development
- Leadership to ensure the implementation of the results
- A suitable modelling tool (software tool)
Being familiar with and accepting the limits of FMEA is an important factor of acceptance. For instance, social interactions cannot be anticipated with the method.