FMEA defines how to look at discrete effects of a failure and how those failures impact customers and the supply chain. When there is a failure mode, it drives a CAPA or a nonconformance, which may include a notice to customers about their warranties. Its impact reaches across the entire enterprise.
As with any process, the FMEA methodology has evolved. Today, there are seven steps as defined by AIAG-VDA standards.┬а
1. Planning and preparation: Determine which process, system, metrics or aspect of your business you need to focus on.
2. Structure analysis: Identify and break down the design into the system, subsystems, assemblies and component elements.
3. Function analysis: Explore what the product should be doing and how that functionality is facilitated.
4. Failure analysis: Explore any element that could fail to meet its intended function.
5. Risk analysis: Evaluate the severity, occurrence and detection of each failure chain.
6. Optimization: Develop actions that reduce risk and increase customer satisfaction by improving the product.
7. Results documentation: Document the results of each FMEA investigation.
Traditionally, the planning and analysis of cause and effect of failures were mapped out manually on Excel spreadsheets. While still the primary tracking tool for many manufacturers and industries, this manual method has significant limitations, such as the inability to illustrate the interrelation between all the processes and parts; how a change in one process can impact another process; or how to highlight the common causes of failure тАФ not just with one discrete part, but across a family of components or across a division or an organization.┬а
Because of its inherent need for information across the enterprise, when FMEA is integrated within a quality management systems workflow, it is supported with automated compliance, risk management, document control and employee training capabilities. By tracking all possible failure points with FMEA, root-cause analysis is simplified, ensuring better quality planning decisions and reducing the time required to study failure effects and their mitigation.
The mandated use of FMEA as a critical methodology is expanding beyond automotive markets, empowering manufacturers and their suppliers with new ways to mitigate risk and ultimately build safer, quality-driven products.
