The Failure Mode and Effects Analysis is a cross-industry established method to identify and eliminate potential failures, problems, errors and risks of a system, design or process before adverse consequences reach the internal/external customers. The basic idea of the FMEA is thus the preventive risk identification and error prevention instead of a subsequent correction.
Risk Analysis - Causes/Threats
Risk Analysis - Consequences
Risk Analysis - Likelihood
Risk Analysis - Severity
Since FMEA is a very complex method for identifying risks, a number of prerequisites should be met in order to justify the sometimes considerable effort involved. These include
The composition of the team is essential for success. Therefore, each team member should meet specific requirements. Some of the things to mention are:
A large number of software products are available as aids for carrying out an FMEA.
The performance of an FMEA essentially depends on which type of FMEA is used. The following three types can be distinguished, whereby the selection depends on which phase of the product or process development cycle one is in:
However, the operational process of an FMEA is essentially the same and can be described as follows. A team consisting of representatives from all affected areas (e.g. development, production, assembly, quality, customer service) - the involvement of external parties such as customers and suppliers can also be useful - defines possible errors within the framework of brainstorming. Accordingly, an experienced moderator should be available to make the brainstorming session efficient. This raises the following questions:
The possible consequences are then examined and the causes of the errors identified and evaluated. The causes of the errors are then assessed against three criteria: (1) A = probability of occurrence, (2) B = severity of the consequences, (3) E = probability of detection. Each dimension can have a value between one and ten. Finally, the risk priority figure RPN is determined from this, which results from multiplying the three variables described, i.e.: RPN = A * B * E
The significance of the rating numbers on the scale for the individual dimensions can easily be seen in the literature or on the Internet. On the basis of the RPN, it is then decided whether measures should be taken or not. Accordingly, communication with the responsible risk management team should be available in order to pass on identified risks directly.
• Enables early collaboration of different functional areas
• Preventive quality assurance before adversely affecting the supply chain
• Combines identification and evaluation and also provides measures to reduce risks
• Very high time and personnel expenditure
• Team members need a great deal of expertise and experience
• Little information is available in early design phases
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