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Failure Mode and Effects Analysis (FMEA) purpose is to minimize the risks associated with product defects before they hit the shelves. It’s primarily an analytical approach to quality management and risk development. Businesses use it to identify, reduce, and eliminate machine or product failures during all stages of the manufacturing process. Active failure prevention minimizes the impact on customers and saves costs along the product life cycle.
Defects are evaluated in terms of how often they occur, their significance to the customer, and the likelihood defects will be detected before delivery. Based on this assessment, a decision is made as to whether defect prevention measures are necessary.
Depending on the industry, a defect could be anything from corrosion of a critical machine component to a major medical center power outage. This preventive system analysis is found in all major industries and is just as important to maintain business operations as a Business Continuity Plan (BCP) or a Disaster Recovery Plan.
They are so important because they prevent potential lawsuits, recalls, and production delays that can cost hundreds of thousands to even millions of dollars worth of damages. For that reason, it’s necessary for any company looking to minimize potential financial impacts as a result of lost time, materials, or worse. And it’s especially important to industries where product defects can lead to severe injury or even death.
But what exactly constitutes active failure and what can be done to prevent it?
The rest of the article will be dedicated to discussing these points as well as providing an example on how to fill out the corresponding checklist. It will also provide an overview of the three most common types of FMEA checklists and the six steps on how to complete a final analysis.
“Quidquid latine dictum sit altum videtur,” meaning whatever you say in Latin sounds profound, can be used to describe the term, ‘failure modes.’ The grandiloquent language is needlessly complicated and overly technical for a concept that’s fairly straightforward.
Failure modes (FM) just means the early detection of defective machines, equipment, products, or any system processes that could lead to its eventual failure. For example, failure modes encompass any point in the system process in which breakdown occurs and can include physical or abstract causes, like prematurely starting or ending operations at the incorrect time.
Some of the most common failure modes are caused by the following outside forces:
There are three main parts of failure modes and sometimes you’ll hear them referred to as failure causes and failure effects. But what is the difference?
To better understand this concept, we can think of these three modes of failure in the pretense of a popped car tire.
Failure modes: What is causing the failure right now (present)?
Ex.The failure mode would, of course, be the deflated tire.
Failure Causes: What caused the failure to occur in the first place (past)?
Ex. The failure cause could be multiple things. For instance, neglecting to rotate or replace the tires after they reached their maximum mileage of wear and tear or overinflating caused it to burst when met with road hazards. Maybe it was a sheer fluke and the tire had the misfortune of coming in contact with a shard of glass.
Failure Effects: What will be the repercussions of this failure (future)?
Ex. The failure effect would then be anything resulting from the flat tire. That could be being late for work, bending the axel, or crashing the car.
After a failure has occurred, the natural next step would be to conduct a root cause analysis of the problem in order to prevent it from happening again. In this way, money, time, equipment, customers, and lives can be saved. That’s effects analysis in a nutshell.
But to give a more in-depth explanation, effects analysis can be further broken down into three components that factor into an equation which calculates the risk prioritization number, or RPN. This number rates the severity of the issue and also assigns it a priority level.
The equation looks like this:
Severity x Occurrence x Detection = Risk Priority Number
A number is assigned to each section: severity, occurrence, and detection. Usually, it’s a number on a scale from one to ten, however, this number can vary as different companies and organizations have their own risk assessment values.
Severity: How big of an impact will the failure have on finances, business operations, and supply chain?
Occurrence: How frequently is this problem anticipated to occur?
Detection: How quickly and easily can the failure be identified and restored?
For example, let's say the severity was assigned a numerical value of 5, the occurrence was given a 7, and detection a 10. If you multiple those values together, the resulting RPN is 350.
The RPN will be essential to performing a complete FMEA which, in turn, will evaluate risk and quality management and mechanical fatigue to mitigate human error and failure.
Failure modes analysis is done after a failure has occurred and been identified, but it’s more productive to anticipate faults to prevent them from happening in the first place. In this way, failure modes and effects analysis can be applied before a failure takes place, saving the company the thing that matters most: the bottom line.
The Failure Mode and Effect Analysis found its origins in a United States Armed Forces Military Procedures document as early as 1949. During the war, the US military was looking for ways to abate the heavy loss of life and equipment being expended overseas. It was especially critical during wartime to isolate needless errors that disrupted the supply chain because of the severe shortages of food, steel, clothing, rubber, gasoline, and more that were already going on at the time.
Another organization closely linked to the US military—National Aeronautics and Space Administration (NASA)—employed the use of FMEA to identify potential defects or issues arising during the course of production, most notably in famous projects such as Apollo and Skylab as well as other well-known space programs.
In addition to the military and NASA, the aviation industry was a foreleader in the implementation and early development of Failure Modes and Effects Analysis.
Next on the list was the automotive industry, the most notable of which was Ford Motor Company who took advantage of the procedure to catch mistakes prior to launching production.
From there, it has been adapted to fit the needs of businesses and manufacturers since the 1970s to reduce the amount and frequency of costly mistakes.
These are some of the industries that use FMEA today:
As is clear from its history, the FMEA form and checklists were adopted by numerous industries whose main currency involves high-risk behaviors, activities, and products where safety is a major concern. However, it’s true that this methodology has also been applied to industries where human safety is less of a concern and instead focuses on mitigating human error and mechanical failure to maximize profits. As it is a highly efficient means of early detection and reaction, it has found a home in almost every large-scale industry in the world.
The FMEA analysis is used by companies in various industries for the improvement of processes, products, or systems. More specifically, benefits are to be derived from the following 3 advantages:
1. Ensure security
An FMEA team will analyze a company's products, processes, and systems in order to reveal any abnormalities. A key part of this analysis is risk assessment. Once a cause or effect is identified for a failure mechanism, a root cause analysis is performed to determine the underlying problem.
The first goal of an FMEA template, therefore, is to determine where improvement can be made through a precise analysis. This safety-oriented process has the advantage of establishing quality productivity within the company.
2. Develop brand reputation
A thorough analysis is of great importance when it comes to improving complex processes or products. The key is to work with the data obtained not only from one perspective, but by also assigning corrective actions to it.
There cannot be just one implemented change to improve a process over the long term. Therefore, the FMEA team should create a plan for regular reviews and corrections. This will ensure sustainable quality that customers expect. Therefore, the second goal and benefit of FMEA are to ensure long-term quality by repeating processes and constantly questioning their suitability.
3. Save time and costs
A thorough analysis of internal processes helps to rethink a company's strategy and, thus, to handle day-to-day business more quickly and effectively. Saving time means saving money. At the same time, it minimizes the risk of incurring costs due to failure mechanisms for a particular product and associated warranty costs.
Another factor to consider here is your reputation as a high-performing company. Always being on time also strengthens the company's reputation as a high performer and reliable. Average performance does not lead to positive customer feedback, so the third goal and benefit of an FMEA analysis are to save time and money to satisfy customers and strengthen the company's reputation.
Before any FMEA analysis, it is necessary to determine what type of FMEA it is. The following three types of failure mode and effects analysis are the most common:
Front Axle of ForkLift
Potential Mode or Failure
Corrosion Torque fatigue Deformation Cracking Other
Injury Interoperability of Product Improper Appearance of Product Degraded Performance Other
Erroneous Algorithm Improper Torque Applied Excessive Loading Contamination Other
Operator Training Quality Audit Testing Analysis Other
RPN (Risk Priority Number)
Selection of Different Materials Redesign of the Product Limiting Operating Range Preventative Maintenance Other
Name and Signature of the Inspector
Name and Signature of Team Member
It takes six steps to complete an FMEA. In this process, the design FMEA, process FMEA, and system FMEA follow the same principle:
Implementing an FMEA template process is a great success in itself. However, product development and process optimization teams usually find it difficult to track the resulting corrective actions. By using Lumiform, the powerful and flexible checklist app, processes can be improved and optimal results achieved.
With convenient digital forms from the tool, FMEA teams can: