FMEA Failure Mode and Effects Analysis, is a methodology used during the development of the product and the process, to ensure that the problems that could potentially occur have been considered and that may affect the quality of the product and / or its performance. As such, there is a need to elaborate the FMEAs during the Advanced Quality Planning process (APQP), and provide input for the development of the Control Plan. This tool is also known to be part of the Core Tools of the automotive sector and a requirement of the technical specification IATF 16949. It should be mentioned that this tool is also known by its acronym in English as FMEA Failure Mode and Effects Analysis.
There are two types of FMEA: Design and Process. The FMEA is a tool to improve the reliability of the product, and can be described generally as a method to identify the severity of the potential effects of failures and to estimate the probability of occurrence of the causes of the failures. It provides a basis for implementing measures that reduce risks.
The changes from the third edition to the fourth of the AMEF are the following:
- The format is intended to offer an easier reading.
- An index is included.
- Icons are used to indicate key paragraphs and visual inputs
- Additional examples and text are offered to improve the usefulness of the manual and provide more tight control within the FMEAs process as it develops.
- The need for support and support from the administration is reinforced.
- The understanding of the links between FMEA of design and FMEA of the process is defined and emphasized, as well as the definition of links with other tools.
- Improvements in the tables of ranges of severity, occurrence and detection, so that they are of more sense in the analysis and use in the real world.
- Alternative methods are introduced that are currently applied in the industry.
- Appendices are added, which have example formats and applications of more special cases of FMEAs.
- The “standard format” approach has been replaced with several options representing current applications of AMEFs in the industry.
- The suggestion that the NPR is not used as the primary means to assess risks.
- The need for improvement has been revised to include an additional method, and the use of the threshold for NPRs is clarified as a practice that is not recommended.
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