Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA)
This FMEA Standard describes Potential Failure Mode and Effects Analysis in Design (DFMEA) and Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (PFMEA). It assists users in the identification and mitigation of risk by providing appropriate terms, requirements, ranking charts, and worksheets. As a Standard, this document contains requirements “must” and recommendations “should” to guide the user through the FMEA process. The FMEA process and documentation must comply with this Standard as well as any corporate policy concerning this Standard. Documented rationale and agreement with the customer is necessary for deviations in order to justify new work or changed methods during customer or third-party audit reviews.
Widespread use of design and process FMEA is a benefit to consumers and manufacturers. The application of FMEA has been in place in the automotive industry since the late 1960’s with emphasis on standard ranking criteria and forms since the early 1990’s. The FMEA methodology has proven itself useful in the prevention and mitigation of potential failure modes. However, a growing need developed for improved failure mode ranking criteria and a change in thinking about the use of the Risk Priority Number (RPN). This standard includes updated ranking charts and de-emphasizes the use of an RPN threshold as the primary factor in determining preventive or corrective action efforts. It also includes a Boundary Diagram and Process Flow Diagram example as use of these tools has increased. The section for Potential Failure Mode and Effects Analysis for Machinery (Machinery FMEA) is a form of Design FMEA and has been removed. Machinery FMEA is a type of Design FMEA for equipment. There are numerous books, reference manuals and training references on the subject of FMEA. This standard serves as a common starting point for the development of an effective DFMEA and PFMEA.
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