Use FMEA Templates To Minimize Business Risk

What Are FMEA Templates?

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.

This article addresses the following topics:

1. What failure modes is

2. What effects analysis is

3. History of FMEA

4. Benefits and goals of an FMEA analysis

5. Three Most cCommon FMEA Types

6. Six steps of an FMEA analysis

7. Using a digital tool for FMEA analysis

What Does Failure Modes Actually Mean?

“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:

• Mechanical
• Thermal
• Humidity
• Electrical
• Gas
• Saltwater
• Light
• Dust

What Is the Difference Between Failure Modes, Causes, and Effects?

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.

What Does Effects Analysis Really Mean?

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 Applications of FMEA Throughout History

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:

• Software Development
• Agriculture
• Transportation
• Healthcare
• Manufacturing

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 Benefits and Objectives of an FMEA Analysis

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.

The three most common FMEA types

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:

1. System FMEA
   Here, the focus is on the functionally correct interaction of the individual components of a complex system. An attempt is made to avoid errors as early as the system design stage. In addition, the functionality and safety of the system is tested.
2. Construction FMEA
   Here the focus is specifically on the product. Potential errors and failures that can occur in system parts or assemblies are considered to avoid delays. As a cause of failure, the design and the manufacturing type are examined in more detail.
3. Process FMEA
   Here, basically, all factors and conditions that can affect a defect-free process are examined. The focus for this is the manufacturing and assembly process.

Failure Modes and Effect Analysis Inspection Example

Name the precise function (process step or input)

Function
Front Axle of ForkLift

Potential Mode or Failure
Corrosion    Torque fatigue    Deformation    Cracking    Other

Potential Effect
Injury    Interoperability of Product    Improper Appearance of Product    Degraded Performance    Other

Severity Rating
5

Potential Cause
Erroneous Algorithm    Improper Torque Applied   Excessive Loading    Contamination Other

Severity Rating
10

Current Controls
Operator Training    Quality Audit    Testing    Analysis    Other

Detection Rating
7

RPN (Risk Priority Number)
350

Corrective Action
Selection of Different Materials    Redesign of the Product    Limiting Operating Range    Preventative Maintenance    Other

Completion
Name and Signature of the Inspector
Rebecca Smith

FMEA Team

Name and Signature of Team Member
John Smith

In 6 Steps to a Completed FMEA

It takes six steps to complete an FMEA. In this process, the design FMEA, process FMEA, and system FMEA follow the same principle:

1. Preparation
   First, a team must be assembled to perform an FMEA. Then, the task and the objectives of the FMEA are defined. In addition, all necessary documents, FMEA forms, and checklists must be prepared
2. Structural analysis
   To get an overall picture, the first thing to do is to describe the structure of a product or process. For this purpose, all system elements are recorded. Each system element can be composed of further system elements. These elements are then combined into a structure and displayed graphically to show dependencies.
3. Functional analysis
   All system elements have different functions or tasks. These are collected and assigned to the individual elements. In a function network, relationships can be represented among themselves.
4. Function analysis
   The list of functions is the basis for identifying possible defects. In the FMEA form, all potential errors are documented with their error consequences and error causes. This is done initially without an evaluation of their severity or probability. In a defect network, errors that stand in a relationship to each other as well as error causes and consequences can be represented.
5. Risk assessment
   Each individual potential failure of the FMEA must be evaluated in order to assess whether action is necessary. The RPN is used to evaluate and prioritize the elimination of the causes of defects. For each defect, a risk priority number must be defined in the FMEA form. The higher the RPN, the sooner action should be taken. The risk priority number is determined as the product of three factors: Significance of the failure sequence, probability of occurrence, and probability of detection. The evaluation standard must be self-defined with measurable and binding criteria.
6. Optimization
   At the conclusion of the FMEA, actions are defined for the potential defects according to the risk priority number. After their implementation, the RPN is calculated again. The success of the FMEA is measured by the difference in the scores. If the risk priority number after the execution is significantly smaller than before, the FMEA was successful.

Improve FMEA Analysis With Digital Tool

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:

1. Develop and track corrective actions
   Once risks are identified, FMEA teams can instruct corrective actions within the app. The respective recipient receives a notification with details about the corrective action, due date, and priority. When an action is completed or changes, FMEA teams also receive a notification. This makes it easier and more efficient to track the implementation of corrective actions with Lumiform.
2. Complete and update FMEA checklists anywhere, anytime
   The team can access an FMEA form at any time via smartphone or tablet. Using the form builder, they edit ready-made templates for a future FMEA checklist. All data is automatically saved and can be retrieved immediately.
3. Perform analyses of systems, processes and designs faster
   Data collected using the FMEA checklists is captured under the Analysis tab. Here, team members can access all data and view reports broken down by time, location and department. This helps to quickly identify the defects and their causes so that they can be fixed as soon as possible.
4. Automatically generate and release FMEA reports
   Once the team has completed an FMEA form, a report is immediately and automatically generated, which can be sent to management, quality management teams, and suppliers with just one click!