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  • Bhargav replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 7 months ago

    There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failure Mode and Effect Analysis (FMEA) helps predict and prevent problems through proper control or detection methods. Mistake proofing emphasizes detection and correction of mistakes before they become defects. Poka Yoke helps people and processes work correctly the first time. It refers to techniques that make mistakes impossible to commit. These techniques eliminate defects from products and processes as well as substantially improve their quality and reliability.