FMEA defines how to see the individual impact of failures and how those failures affect customers and the supply chain. Any failure mode will cause a CAPA or non-compliance, which may include notification of the warranty to the customer. The impact is company-wide.
Like other processes, FMEA methodologies have evolved. There are currently seven steps defined in the AIAG-VDA standard.
1. Planning and preparation: Decide which processes, systems, metrics or aspects of your business you need to focus on.
2. Structural analysis: Identify and divide designs into system, subsystem, assembly, and component elements.
3. Functional analysis: Find out what the product does and how its functionality is facilitated.
4. Failure Analysis: Investigate elements that may not fulfill their intended function.
5. Risk analysis: Evaluate severity, occurrence, and detection of each failure chain.
6. Optimization: Develop actions that reduce risk and increase customer satisfaction by improving products.
7. Documentation of results: Document the results of each FMEA study.
Traditionally, planning and analysis of cause and effect of failure was planned manually on Excel spreadsheets. While still a primary tracking tool for many manufacturers and industries, this manual method has significant limitations, such as the inability to chart all processes and interrelationships between parts. How changes in one process affect another process. Or you might want to highlight common causes of failure across entire families of components, departments, or organizations, rather than just one individual part.
Due to the inherent need for enterprise-wide information, the integration of FMEA into quality management system workflows is supported by automated compliance, risk management, document management, and employee training capabilities. Tracking all possible points of failure in FMEA simplifies root cause analysis, ensures better planning decisions, and reduces the time required to consider failure impact and mitigation.
Mandatory use of FMEA as a critical methodology extends beyond the automotive market, giving manufacturers and their suppliers new ways to reduce risk and ultimately build safer, quality-focused products.
https://www.autonews.com/guest-commentary/why-fmea-crucial-auto-industrys-future Why FMEA is important to the future of the automotive industry