Quality Management

A Guide to Failure Mode and Effects Analysis

Written byContributing Writer
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Updated onJanuary 15, 2024

With most Fortune 500 companies using Six Sigma methodology, quality improvement is in the limelight today like never before. Organizations are constantly searching for methods to enhance product quality and prevent failures that may result in huge economic losses.

Failure mode and effects analysis (FMEA) is a popular technique used in Six Sigma for this very purpose. This article will dive deeper into this technique, its types, examples, and when and how to use it. Further, we will also delve into the specifics of a reputed Six Sigma program that will put you on the path to becoming an expert in this field.

What is FMEA?

FMEA stands for Failure Mode and Effects Analysis. It is a practice to conduct a risk assessment of a process or product to identify potential failures. FMEA is an approach structured to reduce failures by assessing the product or an existing or proposed process during the design stage for possible errors. It was first used by the U.S. military and aerospace sectors in the 1940s and 50s for the evaluation of equipment and vehicles.

It consists of two modes.

Failure mode refers to the various modes in which a product or process could experience defects or errors
Effects analysis, which is the assessment of the consequences of the failures

To understand the concept better, let’s dive deeper into some examples.

Also read: A Guide to Six Sigma Projects

Examples of FMEA

Let’s begin with the example of using lithium-ion batteries in electric vehicles. In recent months, there have been instances of such vehicles catching fire with loss of human life in some cases. Hence, a factory manufacturing the batteries merits an FMEA.

Design FMEA (DFMEA) may be used to assess the design of the battery. Here are some questions to ask.

Which areas have experienced the blast?
Which parts are likely to get damaged?
Which parts interact with each other to cause the failure?

One may implement the Process FMEA (PFMEA) to understand the defects during the production process, such as assessing each step to see if any dimensional variation is introduced, any incompatible joining process, or any missed inspection of dimensions.

These steps, when performed from the point of view of preventing catastrophic failures, will enable early detection and remediation of the failure areas.

In a second instance, let’s suppose a company will produce a new health drink. They will conduct a DFMEA to assess the regulatory compliance of the ingredients of the health drink. The drink’s packaging will also require an FMEA to ensure that it does not contaminate the product.

Further, a PFMEA will be carried out to evaluate the various processes, the associated hygiene, supplier quality, testing, and final product quality. As it is a product for human consumption, this health drink will require a detailed FMEA for production to ensure that it is not exposed to any external contamination.

Types of FMEA

FMEA is applied in a myriad of ways as per the industry’s requirements. Let’s take a look at some of the major types of FMEA:

Design FMEA (DFMEA)

Design FMEA refers to the application of FMEA during the design stage of the product. It aims to root out the possible areas of failure and defect in the design of the product.

Process FMEA (PFMEA)

Process FMEA is typically a requirement to obtain approval as a supplier for OEM parts. The goal is to identify the possible causes of failure during production. This is crucial to detect any missing instances of dimensional inspection during each step of production.

Functional FMEA (FFMEA)

Functional FMEA is also called System FMEA (SFMEA). This FMEA encompasses all the systems and processes of an organization to evaluate and prioritize the possibilities of failure, including the design, use, wear-out, and aging. It also involves assessing the cost associated with each failure, relevant corrective actions, and the corresponding customer satisfaction.

Software FMEA

Software FMEA aims to ascertain and concentrate on the possible errors and risks during software development. It is an exercise for the enhancement of quality, safety, and reliability of the software by preventing failures before their occurrence.

Also Read: Why Choose Six Sigma Methodology for Project Management?

When to Use FMEA?

While the FMEA types may vary, the primary motive remains the same—to detect and prepare for potential defects. It is typically used when:

A new product, service, or process must be designed, or an existing one must be modified
A current product or process has to be used and implemented for a new application
A product has to be qualified for sale to OEMs
A root cause analysis is required to investigate failures
There have been too many failures, and corrective actions require new integrations in the production line
New equipment has to be added to, or an old one has to be replaced on the production line
Control plans have to be developed for new or existing processes
There has to be regular analysis of the efficacy of the process
It is a requirement to ensure regulatory compliance
An organization needs to assess risks and modes for its mitigation to frame its risk management strategy
There are multiple components in a system or product, and the potential failures due to their interactions must be explored
An organization decides to use alternative suppliers, equipment, or materials in a cost-cutting endeavor
The process has to be scaled up for higher production volumes, requiring an examination of the potential errors
The process has to be revamped for quality improvement

How to Use Failure Mode and Effects Analysis?

Now that you know when to use FMEA, here’s how you can use it:

Establish the process to be evaluated
Assemble a team of knowledgeable individuals familiar with the intricacies of the process to be assessed
Identify the sections and parameters of the process that are the most critical or have faced failures before
Examine the selected aspects for potential failures, human errors, defects due to improper use, etc
Quantify the risks associated with the failures
Investigate the workable solutions and check if they can be integrated into the process
Make a note of the failures from the process history and customer complaints
Verify the implementation of the recommended changes

Also Read: Quality Management Process: A Beginner’s Guide

How to Create an FMEA?

Creating an FMEA requires you to delve into the specifics of how to use an FMEA. It entails quantifying the failures to prioritize them depending on their severity.

Here’s how you can create an FMEA:

Determine the specific function to be evaluated, e.g., a pipeline coating process
Assess each step of the process for potential failures or dimensional variations
Examine the consequences of each failure
Assign a severity (S) ranking to each failure as per the consequences on a scale from 1 to 10, with 10 being the most severe
Assign the likelihood of failure on a scale from 1 to 10, with 10 being the most likely Here, you will anticipate how many times a particular failure may occur depending on the process variables. This is also referred to as occurrence (O)
Establish the corrective actions and their implementation. Allocate the likelihood of each failure depending on how frequently the failure will be detected immediately on a scale of 1 to 10, with 10 indicating that the defect will pass undetected to the customer, which is undesirable. This is called detection (D).
Calculate the risk priority number (RPN) based on severity (S), occurrence (O), and detection (D). The formula used for RPN is:

RPN = S × O × D

Evaluate the failures with respect to their RPNs. The failures with the highest RPN point to the parts of the process that are the most vulnerable and will be the cause of future defects. These have to be the focus of improvement.

Applications for Failure Mode and Effects Analysis

FMEA has applications in almost every industry in today’s competitive market. Let’s look at how some of the major industries use it.

Manufacturing

The manufacturing industry utilizes FFMEA to detect and eliminate product and assembly failures to avoid recall and scrapping of the parts at the customer end. Aerospace, defense, and automotive parts manufacturers use PFMEA to ensure regulatory compliance and obtain approval for their parts. They use DFMEA to analyze the design of the products, especially in case of critical parts that cannot be reworked.

Medical

The medical industry employs FMEA because they have to adhere to stringent regulations as the products have to be used for or within the human body. Hence, they implement FMEA at the design and process stages to root out potential defects. It is crucial as any defect that goes unnoticed may severely damage human life.

Electronics

The electronics industry works with critical circuitry. Hence, any small defect may go undetected due to the size and assembly of the components. Hence, this industry implements FMEA to assess the potential failures during the design and process stages. They may also utilize FFMEA if they are looking at cutting costs and making the electronics viable.

Fast Moving Consumer Goods (FMCG)

The FMCG industry has to adhere to specific regulations, especially if they deal with perishable items. Hence, an FMEA will enable them to identify potential failures and implement corrective actions quickly without affecting production rates.

Also Read: Six Sigma Books Worth Reading

Dive into FMEA and Other Six Sigma Fundamentals

FMEA is integral to quality management and an essential tool in Six Sigma.

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Frequently Asked Questions

What is the FMEA process in Six Sigma?

The FMEA (Failure Mode and Effects Analysis) process in Six Sigma is a method to identify and prioritize the possible failures in the process that is being evaluated using Six Sigma.

What are the steps of the FMEA process?

The major steps of the FMEA process include:

Determine the process for evaluation
Create a team with knowledge about the process
Establish process steps and parameters
Ascertain the possibilities of failure in each step and parameter
Quantify the associated risks
Prioritize them and study the effect of the failures
Recommend corrective actions and assess their implementation

What is an example of FMEA?

If a factory makes instant noodles, they will implement FMEA to evaluate the errors in the production line that may lead to improper packaging volume, contamination of the food, inaccurate measurements of ingredients, missed inspections and samplings, etc. This will ensure they are prepared for any possible customer complaint about the product.

How is FMEA calculated?

FMEA is calculated based on three parameters—severity (S), occurrence (O), and detection (D). The risk priority number (RPN) is obtained by multiplying these parameters—

RPN = S × O × D