FMEA (Failure Mode and Effects Analysis) - A Quick Guide

By AMREP | Posted on February 21, 2024

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Failure Mode and Effects Analysis (FMEA) is an essential tool used for ensuring product quality and reliability. It offers a method for identifying, analyzing, and preventing potential failures in a product or manufacturing process. This guide gives you an overview of how the tool is used.

What is FMEA?
When to Perform Failure Mode and Effects Analysis (FMEA)?
The FMEA Process
Benefits of FMEA

What is FMEA?

FMEA is a quality assurance tool that proactively identifies potential failure modes, assesses their severity and likelihood of occurrence, and evaluates the effectiveness of existing controls in preventing or detecting failures. By proactively addressing potential failures early in the design or process development phase, FMEA helps reduce the risk of costly rework, delays, and customer dissatisfaction.

When to Perform Failure Mode and Effects Analysis (FMEA)?

A Failure Mode and Effects Analysis (FMEA) can be performed at different stages of a product, process, or service life cycle. Some of the situations that may require an FMEA are:

When you are creating a new system or modifying an existing one
When you are changing the way you execute a certain process
When you have a specific goal to improve the quality of a process
When you want to understand and reduce the failures of a process. Moreover, it is recommended to conduct an FMEA periodically to ensure the continuous improvement of quality and reliability. A well-performed FMEA can help you achieve a high level of customer satisfaction and stakeholder confidence.

The FMEA Process

The FMEA process typically involves the following steps:

Step	Description
Define the Scope	Clearly define the product, process, or system to be analyzed, establishing boundaries and outlining specific components or steps.
Assemble the FMEA Team	Form a cross-functional team of experts with diverse knowledge and experience in the product, process, or system under review.
Identify Functions	Identify the intended functions or objectives of each component or step within the scope.
Identify Potential Failure Modes	Brainstorm and list potential ways in which each component or step could fail to fulfill its intended function.
Analyze Effects of Failure	For each potential failure mode, describe the potential consequences or effects on the product, process, or system, considering safety, performance, and customer satisfaction.
Assess Severity	Assign a severity rating (typically on a scale of 1 to 10) to each failure mode, reflecting the seriousness of its potential impact.
Identify Potential Causes	Identify the potential root causes or mechanisms that could lead to each failure mode.
Assess Occurrence	Assign an occurrence rating (typically on a scale of 1 to 10) to each potential cause, reflecting the likelihood of its occurrence.
Identify Current Controls	Identify existing controls or measures in place to prevent or detect each failure mode.
Assess Detection	Assign a detection rating (typically on a scale of 1 to 10) to each control, reflecting its effectiveness in preventing or detecting the associated failure mode.
Calculate Risk Priority Number (RPN)	Multiply the severity, occurrence, and detection ratings to obtain the RPN, a numerical representation of the overall risk associated with each failure mode.
Prioritize Actions	Prioritize actions based on the RPN, focusing on addressing failure modes with high risk scores.
Develop Recommended Actions	Propose actions to eliminate or reduce the likelihood of high-risk failure modes.
Implement Actions	Implement the recommended actions and monitor their effectiveness in reducing risk.
Review and Update	Regularly review and update the FMEA as the product, process, or system evolves.

Benefits of FMEA

FMEA offers numerous benefits, including:

Reduced Risk of Product and Process Failures: By identifying and addressing potential failures early in the development cycle, FMEA helps prevent costly rework, delays, and customer dissatisfaction.
Enhanced Product and Process Quality: FMEA promotes a proactive approach to quality assurance, ensuring that products and processes meet the highest standards of reliability and performance.
Improved Customer Satisfaction: By minimizing product defects and ensuring consistent performance, FMEA contributes to increased customer satisfaction and loyalty.
Reduced Costs: FMEA helps avoid costly rework, delays, and field failures, leading to significant cost savings.
Continuous Improvement: FMEA fosters a culture of continuous improvement by encouraging regular assessment and optimization of products and processes.

In AMREP’s quality manufacturing world FMEA is typically used by our manufacturing engineers, quality engineers, process engineers, design engineers, and product engineers to analyze the reliability and quality of the products being manufactured. We use it at production sites to help prevent product failures and manufacturing problems before the issues escalate through the product manufacturing and supply chain.