Failure mode effect analysis (FMEA) & Root cause analysis (RCA) | Fundamental Differentiation

Failure Mode and Effect Analysis (FMEA): A failure modes and effects analysis (FMEA) is a procedure in product development and operations management for analysis of potential failure modes within a system for classification of the severity and likelihood of the failures. A successful FMEA activity helps a team to identify potential failure modes based on past experience with similar products or processes, enabling the team to design those failures out of the system with the minimum of effort and resource expenditure, thereby reducing development time and costs. Effects analysis refers to studying the consequences of those failures.

FIG: FMEA

Root cause analysis (RCA): A systematic process of investigating a critical incident or an adverse outcome to determine the multiple, underlying contributing factors. The analysis focuses on identifying the latent conditions that underlie variation in performance and, if applicable, developing recommendations for improvements to decrease the likelihood of a similar incident in the future.

Comparison between Failure mode and effect analysis (FMEA) & Root cause analysis (RCA)

Sl. No.	FMEA	RCA
1	Prospective, Proactive Focus: Failure prevention	Reactive Focus: Failure detection
2	Used for changes or modification in equipment, process	Used for product complaints, OOS, Unplanned deviation, product recalls.
3	Choose topic for evolution of failure modes prior to its implementation	Analyses underlying cause on occurrence of a failure through a series of ‘WHY’questions
4	‘Contributory factors’ for potential failure modes are evaluated What could go wrong?	Causes of problems are investigated What went wrong?
5	Goal: Evaluate impact of changes and decrease the ‘RPN’	Goal: Preventing recurrence of problem
6	Includes delectability in evaluation	Develop way to detect and fix a problem