Standard Operating Procedure: Failure Mode and Effects Analysis (FMEA)1.0 Purpose, Scope, and Foundational Principles1.1. IntroductionThis Standard Operating Procedure (SOP) provides a systematic, repeatable methodology for conducting Failure Mode and Effects Analysis (FMEA). The procedure is designed to align with the harmonized AIAG-VDA standards, ensuring a structured and globally recognized approach to risk identification and mitigation. By following this SOP, teams shall effectively analyze potential failures in products and processes, prioritize risks, and implement robust corrective actions.1.2. Strategic Importance of FMEAThe FMEA methodology is a cornerstone of modern quality and risk management. Its strategic value is derived from its ability to move an organization from a reactive to a proactive state, delivering significant benefits in quality, compliance, and financial performance.• Proactive Prevention FMEA is fundamentally a preventive tool. It enables the systematic identification of potential problems in design or manufacturing before they can manifest as costly defects or product recalls. This foresight reduces operational and financial risks, safeguarding brand reputation and customer trust.• Regulatory Compliance The application of FMEA is a mandatory requirement for achieving and maintaining compliance with key international quality standards. It is explicitly required by standards such as ISO 9001 and the automotive sector's IATF 16949, making it an indispensable process for market access and quality certification.• Cost Reduction By identifying risks at the earliest possible stage, FMEA directly contributes to the bottom line. It is a powerful tool for preventing the high costs associated with scrap, rework, warranty claims, and field failures. Early intervention is significantly more cost-effective than correcting defects after they have reached the customer.

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