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For years, customers and auditors have been preaching to suppliers the need for the FMEA (failure mode and effects analysis) to be a “living” document. There are probably several interpretations of what it means to have a living FMEA, but one thing is for sure—the FMEA must be updated whenever real problems occur. This fails to happen because people don’t recognize the value of the FMEA document to prevent problems and so, in reality, the document is as dead as a doorknob. In many organizations, the FMEA document is mostly used as a “file stuffer” to satisfy the customer’s demands or to achieve compliance with the QS-9000 or ISO/TS 16949 requirements. Because of these motivations, the credibility of the FMEA as a useful tool has diminished, and most organizations are missing out on the tool’s true value. To bring the FMEA to life, it needs to be intimately connected to the corrective action report (CAR) system. When the FMEA becomes visible throughout the organization and is directly connected to chronic real problems and chronic real problem prevention, then people start to care. This is when the FMEA becomes truly alive.
The table below shows the process breakdowns (presented in FMEA style) that occur if the corrective action system isn’t tightly linked to the FMEA system:
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