FMEA Basics

“Up front time spent in doing a comprehensive FMEA well, when product/process changes can be most easily and inexpensively implemented, will alleviate late change crises. An FMEA can reduce or eliminate the chance of implementing a corrective change which could create an even larger concern.” (AIAG, Potential Failure Mode and Effects Analysis, Third Edition, 2001, p. 1)

To compete in today’s marketplace, manufacturers must eliminate all severe malfunctions and possible failures from their products and manufacturing processes. Failure Mode and Effects Analysis (FMEA) is a systematic set of activities intended to identify and help eliminate potential concern.

To yield the most valuable results, an FMEA must be performed before a design or process failure has been unknowingly incorporated into the product. Moreover, modern standards and regulations require designers and manufacturers to formally prove that all potential malfunctions have been eliminated or put under control.

Up-front time spent in doing a comprehensive FMEA, at the stage when products/processes changes can be easily and inexpensively implemented, will obviate late change crises.

An FMEA can be described as a systematic group of activities intended to: (a) recognize and evaluate the potential failure of a product/process and the effects of that failure; (b) identify actions that could eliminate or reduce the chance of the potential failure occurring; and (c) document the entire process. FMEA is an integral part of any QS 9000 compliant quality system.

FMEA Process

The FMEA process involves the following activities:

•	Identification of functions/elements of your process/product;

•	Identification of possible Failures for a function/element;

•	Identification of possible Effects of the Failure;

•	Determination of Severity of the Failure;

•	Identification of possible Causes of the Failure;

•	Determination of Occurrence of the Cause;

•	Identification of control methods used to inspect function/element for failures;

•	Determination of Detection;

•	Calculation of RPN - Risk Priority Number;

•	Prioritization of failures, selection of Critical and Important failures as candidates for Corrective Actions;

•	Identification of corrective actions to reduce the Risk. (Corrective Actions (CA) are actions aimed at the process/product improvement by reducing risk and increasing responsibility);

•	Determination of improved rates of Occurrence, Detection and calculation of the resulting RPN;

•	Process repetition to achieve better results.

At every step, results should be documented in a standard tabular FMEA Form.

The fundamental purpose of the FMEA is to recommend and take actions that reduce risk. Actions taken should result in a lower Occurrence or Detection rating. Adding validation or verification controls can reduce Detection. Design or process revision may result in lower Severity and Occurrence ratings. The revised ratings are documented with the originals on the tabular FMEA form. If no action is recommended, the decision not to act should also be noted.