Explained: What Is FMEA and How to Implement It?
FMEA is an analytical tool used in the design phase to help mitigate risk and failures during processes. Failure mode and effects analysis (FMEA) is a step-by-step process for anticipating things that could go wrong during the design stage by identifying all possible failures in the design, manufacturing and assembly processes. In other words, it’s a structured approach to discover ways in which a process can fail (failures) and ways those failures lead to waste, defects or dangerous outcomes (effects). As part of the root cause analysis process, FMEA helps to minimize and limit these failures, explains Jonathan Trout in reliableplant.com.
Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.
FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure. There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA).
One of the most important steps in preparing for an FMEA is selecting the right team because FMEA is a cross-functional team activity. Doing an FMEA by one person, or with an inadequate or incomplete team, is unacceptable and inevitably results in poor quality.
There are three primary reasons for the necessity to have the correct team when doing an FMEA. People have “blind spots.” A well-defined cross-functional team minimizes the errors inherent with “blind spots.” The FMEA analysis requires subject-matter experts from a variety of disciplines to ensure incorporation of all necessary inputs into the exercise, and that the proper expertise is applied to the design or process being analyzed. One of the indispensable values of an FMEA is the cross talk and synergy between subject-matter experts that occurs during the meetings. Well-defined groups can discover things that individuals often miss, points out Carl Carlson from Accendo Reliability.
FMEA Training explains that there are key differences between the DFMEA ir PFMEA. Primary Objectives of Design FMEA are to uncover potential failures associated with the product that could cause product malfunctions, shortened product life, safety hazards while using the product.
Though the objectives of Process FMEA are to uncover potential process failures that can impact product quality, reduce process reliability, cause customer dissatisfaction, create safety or environmental hazards.
