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A brief analysis of the changes in FMEA: This article helps us understand what exactly has changed in the new version of FMEA, and how it can be used more effectively. What is FMEA used for? Of these five tools, FMEA is by far the one with the highest level of technical expertise involved in product development. APQP is merely a model, PPAP represents the requirements for submitting samples from pilot production, while SPC and MSA involve only basic statistical concepts, similar to tossing a coin over and over again. And FMEA is the cornerstone that serves as a link between the previous and subsequent elements. This article only discusses DFMEA (Design) and PFMEA (Process), and does not cover MFMEA (Equipment), LFMEA (Logistics), etc. FMEA, in simple terms, is an analysis of potential failure modes and their consequences; it involves identifying potential failure modes that may arise during the design and manufacturing processes. The initial draft of such an analysis is prepared before the design is finalized and pilot production begins. However, our understanding of design and production is something that is continuously improved, so DFMEA/PFMEA also need to be updated on an ongoing basis. We are fully committed to identifying as many failure modes as possible at an early stage, and using objective evaluation tools to assess the risk of those failures. Thus, two things become clear here: one is identifying risks, and the other is assessing them. But that’s not important; the most common problem in the automotive manufacturing industry is that companies focus only on these two aspects and ignore what measures should be taken for high-risk projects in order to reduce those risks. There are even many who deliberately lower the RPN value through incorrect scoring in order to avoid taking any action. If the direction is wrong, everything else is wrong. FMEA is the risk analysis method for our products and manufacturing processes; it involves identifying problems, analyzing the risks associated with those problems, and taking effective risk control measures to reduce those risks – that is what FMEA entails. What are the key changes in the new version of FMEA? 1. A completely new six-step approach to FMEA analysis is used ; 2. A new FMEA form was used (including the FMEA report view and analysis table) ; 3. Added structural and functional decomposition from system-subsystem-component levels ; 4. The failure mode column was moved behind the failure consequences, resulting in a complete structure of Failure Consequences FE (what impact it has on the customer) – Failure Mode FM (where the problem lies) – Failure Cause FC (what are the root causes of the problem). 5. Use the RMR risk matrix and AP rating in place of RPN values. The new risk assessment method for FMEA: evolving from the previous RPN-based approach to the SOD, SO, and SD methods, with a constant focus on identifying which high-risk items require improvement. As for the RMR (Risk Matrix Assessment Method) that may be used in this version, it directly determines the AP level (high, medium, low) through the matrix; indeed, conducting a scientific risk assessment is a task that requires great effort from FMEA experts. Regarding FMEA risk optimization and improvement: As for how to make improvements, it is well known that severity levels can only be reduced by modifying the design. What’s left then is to modify the preventive or detection measures. The new table separates these two types of measures, and of course we encourage the use of preventive measures, unless your production process is limited.