ABSTRACT

Failure modes and effects analysis (FMEA) is a very powerful risk assessment tool widely used in a variety of manufacturing industries and business practices. Like many risk analysis procedures, FMEA provides a rigorous methodology for identifying, evaluating, and documenting potential modes of product or process failure [1,2,3]. In contrast to the other methods, an FMEA results in a numerical ranking of each potential failure, aiding the prioritization of follow-up investigations and implementation of corrections or controls to mitigate the failure [4]. FMEA is a useful tool in guiding and documenting the thinking process when operating parameters are evaluated for criticality or when a process is transferred to a different manufacturing site. It is a systematic, rigorous method for ranking parameters into (potentially) high-risk categories and for defining which variables need further process characterization [3].