May PDM – FMEA: Failure Modes and Effects Analysis

Signup on our partner site by Monday May, 8.  The sign up is down the page, so be sure to keep scrolling!

Glenn Tanzman, MBA, MSIE, CQE, CMfgE, President of Tanzco Management Consulting, LLC

Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a final product or service. “Failure modes” means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual. “Effects analysis” refers to studying the consequences, or effects, of those failures.

FMEA is used during design to prevent failures. Later it is used for control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of
design and continues throughout the life of the product or service.

ISO 9001:2015 introduced risk based thinking into the standard. FMEA is one of the tools that can be used to determine the factors that could cause a company’s processes and quality management system to deviate from its planned results. It can be used to create preventive controls to minimize negative effects. Many of my clients are using it to demonstrate their compliance with the risk assessment requirements of the ISO standards.

FMEA began in the 1940s by the United States military, FMEA was further developed by the aerospace and automotive industries. Several industries have formalized FMEA standards. This is an opportunity for you to familiarize yourself with tool and how it might apply at your company.