As mentioned in the Make It Big book, Failure Modes and Effects Analysis (FMEA) is a great tool for identifying the critical to quality (CTQ) points that are tracked in the book's quality plan. This post presents the basics and provides a template for use.
FMEA can be targeted at product and processes (Product FMEA and Process FMEA). Entrepreneurial designers use these tools together to help anticipate problems in product design and process design.
The attached template provides the major FMEA elements discussed in the book. An FMEA template is provided on the first Excel tab followed by tabs for severity, occurrence, and detection scales. These are presented as examples and guides. Users of the template should feel free to adjust these to meet the unique needs of the product and production environment. An Ishikawa fishbone cause and effect analysis tab is also provided should the need arise to troubleshoot. Lastly, a detailed Process Control template is also presented to control processes once up and running. This template can be used to list the processes, CTQ and specification characteristics, and measurement method, sample size, and frequency.
"FMEA analysis is a comprehensive but simple tool that really helps identify problem areas before they happen," say Marc Theeuwes, former Director of Engineering and Operations, and now Consulting Associate Professor at Stanford University, "They are a great collaborative tool that highlight CTQ points which directly flow into quality design and production. I've used similar templates for products manufactured across Asia."
This template is comprehensive and can be customized, broadened, and shortened to meet the unique needs of the entrepreneur's product.
The FMEA template is included as a reference here: FMEA Template.
The book "Make It Big Crossing the Entrepreneur's Gap" describes a number of product and process design tools and templates. Combined these help entrepreneurs cross the gap and get to market quickly.