FMEA A Complete Guide To Identifying and Preventing Risks in Your Company

FMEA:
A complete guide to
identifying and preventing
risks in your company
WHAT IS THE FMEA METHOD?
The acronym FMEA stands for Failure Mode and Effect Analysis.
FMEA is established as a method to identify potential failures of a product, project, process, system or
service, and the risks that may be caused, in order to minimize these failures. The objective is to reduce
the estimated probability of the failure as much as possible, eliminating its root causes.
For each of the failure modes identified, the probability of occurrence, severity and impact they cause on
customers/consumers and the detection capability of failure modes are evaluated so that the inherent risk
of failure can be calculated.
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WHAT IS THE FMEA METHOD?
FMEA is always used to improve a process, project, service or product, promoting a more preventive than
reactive stance in relation to failure modes and risks, either based on pre-existing failures or avoiding the
occurrence of potential failures.
The tool can also be integrated into continuous improvement systems and methodologies like Lean Six
Sigma and Kaizen. As such, it is a quality and continuous improvement tool that adds value to products or
services, making them more assertive, and the company has proper inputs to promote quality actions and
correction of failures and waste, in addition to having more satisfied customers.
IN SHORT
FMEA is also a way to tell the customer:
“I UNDERSTAND MY PRODUCT, I KNOW WHAT CAN GO WRONG, BUT I HAVE

A STRATEGY IN CASE FAILURE OCCURS”
WHY USE FMEA? WHAT ARE ITS BENEFITS?
Below are some of the advantages of using this method:
❑ Preventively detect and focus on eliminating or reducing potential failures and risks;
❑ Document failure modes, their effects, criticality, detection controls and improvement actions;
❑ Increase understanding and register the know-how that the company has about its product, process or service;
❑ Reduce the number of recalls and customer complaints;
❑ Calculate and assess the risk of each failure mode, which is essential to ensure decision making according to
the priority of corrective and preventive actions that will be implemented by the organization;
❑ Implement precise changes through preventive failure assessment;
❑ Reduce development time: optimizing efficiency, resulting in more flexible, targeted and accurate processes,
reducing possible rework and design errors;
❑ Reduce the cost of failures: with the application of FMEA, costs are often more preventive than corrective,
which means savings, better benefits for employees, investment in company growth and even lower sales
prices that make the company more competitive.
WHY USE FMEA? WHAT ARE ITS BENEFITS?
And in addition to all the benefits mentioned, in some cases, FMEA is required by customers or regulatory
standards.
An example of this is the market for automotive parts suppliers. The methodology is also widely used by the
pharmaceutical industries to assist in the analysis of their Risk Management Plan.
FMEA has proven to be an essential planning technique and is now widely used by all types of industries to
ensure the safety and efficiency of their products and processes.
Therefore, in addition to being used to improve internal processes, FMEA is a tool that demonstrates the
company's focus on quality, on improving reliability and on good relationships with business partners and
especially its customers and consumers.
WHEN SHOULD I USE THE TOOL?
There are many times that you need to
perform a failure mode and effects
analysis, for example:
✓ When designing new products,

processes, systems or services, or
implementing changes and
amendments to the existing ones;
✓ When setting quality improvement
goals for specific processes;
✓ When you need, in addition to
understanding, to improve process
failures;
✓ Before developing a control plan for a
new or modified process;
✓ To analyze failures in significant
changes and modifications in the
organization.
FMEA TYPES
Although the main objective of applying the FMEA tool is always the same: identifying failures and analyzing the
risks, there are several types of FMEAs that are differentiated by their specific action. The tool is extremely
flexible, and its methods can be applied in many ways and with different objectives, check out some examples:
PRODUCT (OR
PROCESS FMEA SYSTEM FMEA SOFTWARE FMEA
PROJECT) FMEA
To analyze potential Its objective is to identify Focusing on global system Used for software
product failures failures in process functions, it studies functions. In this model,
considered in view of planning and execution. systems and subsystems the objective is to
the specifics of the Thus, companies can from the early stages of the analyze the
project. ensure optimization of concept and design phase. development, function
their processes. The objective is to focus on and use of the software
potential failure modes to ensure its efficiency
related to system inside the organization.
functionality.
HOW CAN YOU USE FMEA
IN YOUR COMPANY?
Now that you know more about FMEA and its benefits,
let’s learn how to use this approach in your company?
Check out next the step-by-step guide that will guide

you through the implementation of the tool:
1 DETERMINE THE STUDY BOUNDARIES
The first step to start the analysis using the FMEA method is to delimit the scope of the study, that is, to define
its objective. In this way, defining the study boundaries means:
✓ Clearly determine the organizational process under analysis: limits, interfaces, etc.
✓ Gather detailed information about the object of study, be it process, system, product,
project, service, etc.
✓ Identify and evaluate existing performance indicators;
✓ Establish who are the study stakeholders.
A tip for determining the study boundaries is to review your process through a process flowchart, from there,
identify each component/step that the process/product/service contains. Then, list each component identified
in a table. By doing this, you can have a good idea of the size of the analysis scope
1 DETERMINE THE STUDY BOUNDARIES
Note: The analysis to be conducted can be done in parts, where you can first look at a part of the study, and so
on and then evaluate the whole, this will enable a more comprehensive analysis and use of the tool.
Therefore, you can use the following tools to help you in the data collection for this initial analysis:
Turtle diagram Process flowchart Performance indicators
2 DEFINE YOUR TEAM
It is essential to set up a competent team with practical knowledge to assist you in the analysis. FMEA relies
heavily on an appropriate and well-prepared development team.
Therefore, form a team that:
✓ Should have at least 4 participants;

✓ Multidisciplinary, with experienced representatives from relevant areas and stakeholders, diversified
knowledge of the process, product or service and customer needs;
✓ With knowledge and experience regarding the process to be analyzed;
✓ Has the presence of someone who is knowledgeable and knows how to use the FMEA tool
to ensure proper use of the method.
✓ Has a person in charge. In other words, a leader must be defined for the study
THE FINAL QUALITY OF AN FMEA STUDY MAINLY DEPENDS ON HAVING A TEAM THAT IS QUALIFIED,
MOTIVATED AND GUIDED TO DO A GREAT JOB.
3 BUILD A STRUCTURE FOR USING FMEA
A framework or worksheet for process FMEA analysis should at least include the following fields:
✓ Name: name of component, process, system or service to be analyzed;

✓ Failure Mode: event that causes the product, process, service or system to lose its function;
✓ Effect of failure: result or consequence of failure, it is what the failure causes and the aspect that the
customer will notice;
✓ Severity Rating: how serious is the failure when it occurs?
✓ Cause: presentation of potential causes that may cause the failure;
✓ Occurrence rating: how often does the failure mode happen?
✓ Detection rating: can I identify the failure before it occurs or before it reaches my customer?
✓ Calculation of the RPN (Risk Priority Number): calculation of the risk that is associated
with the failure mode.
✓ Recommended Actions;
✓ Persons in charge;
✓ Deadlines;
✓ Action Implemented;
✓ Recalculation of RPN.
The FMEA form header should contain all important information like start date, revision number, name of
team participants, etc. That's because the FMEA is a dynamic document that goes through revisions and
improvements over time. That is why it is important that this document contains as much information as
possible so that no historical data is lost.
Therefore, during its development, elaboration and revision, some best practices cannot be ignored:
✓ Complete the FMEA document in a straightforward manner with objective and clear information;
✓ Be open and creative with the information you need in your worksheets, encouraging your team to participate;
✓ Get insights from all FMEA team members, don’t judge others when they are giving their opinions.
AND ONE OF THE MOST IMPORTANT ITEMS OF

FMEA ANALYSIS IS TO BE HONEST WITH YOUR
PROCESS.
Do not try to soften the analysis and classification

indices of potential failures to try to make the
process look perfect or better than it is.
Be critical and have your team evaluate the indices

against the suggested metrics in a way that
matches the reality of your organization.
TO CORRECTLY IMPLEMENT FMEA, ALL ITEMS EXEMPLIFIED IN THIS WORKSHEET MUST BE COMPLETED:
4 IDENTIFY POTENTIAL FAILURE MODES
With all available information gathered about the objective of the study, it must be analyzed step by step,
starting the process of filling in the worksheet. So now it's time to review existing documentation and other
collected information to gain insights into how and what processes or procedures can fail.
As we have seen in the tool's structure, it has a column "Failure Mode", this field must be filled in with the
description of the type of failure that the process can produce.Thus, it is necessary to predict which failures
may occur, causing customer dissatisfaction. Define the most likely failures and those that have already
occurred that the team is aware, based on the organization's history and the data collected.
You can search your organization's history for data on non-conformities, customer complaints, quality
deviations, returns, out-of-spec results, rejections, etc.The team can also identify potential failure modes and
risk events through a variety of techniques, and the most popular tools are Brainstorming and Ishikawa
Diagram.
LIST THE POTENTIAL EFFECTS OF
5 EACH FAILURE MODE
All failures identified have consequences. We can then define the effect as the impact and consequences that
a failure can have on the product, process, service or system and, mainly, on the customer.
Then, evaluate the following questions:

✓ If such a failure occurs, what could happen?
✓ What is the impact and effect that the failure has on the customer? Be it internal or external.
In this case, it is important to determine what kind of experience the customer has or may have as a result of
the failure and what happens when the failure occurs. Even the impact of the failure on subsequent steps in the
process.
Please note that each failure can cause more than one effect, but that’s ok, include all the identified effects,
because the list must be thorough!
6 RATE THE SEVERITY
In this step, you need to define and evaluate the severity rating indices:
SEVERITY - S: IT IS THE VALUE ASSOCIATED WITH THE EFFECT ASSIGNED TO A FAILURE MODE RELATED
TO THE CUSTOMER.
the severity level is related to how serious is the failure mode if it happens.
In this evaluation we must ask ourselves: How bad will it be if the failure reaches the customer?
For the severity index, a score from 1 to 10 is graded according to the severity of the failure effect, the greater
the severity, the higher its score. A higher severity (S) score means that customers are more likely to identify or
be more harmed by the failure. For this reason, a high severity index is usually the primary focus of measures
aimed at preventing and reducing failures.
6 RATE THE SEVERITY
Here's an example of a severity rating that you can use or adapt to your business reality:
Index Severity Criterion
1 Minimum Effect not detectable by the customer
2e3 Low severity Lightly annoys the customer
4, 5 e 6 Moderate severity Customer dissatisfied with noticeable performance loss
7e8 High severity High customer dissatisfaction
Potential security risk and serious non-compliance

9 e 10 Extreme severity
issues.
ESTABLISH POTENTIAL CAUSES
7 OF FAILURE MODE
Defining why a failure occurred is
just as important as assessing its
consequences, isn't it?
There is a reason for every failure

and identifying the source of the
problem is an essential part of the
process of trying to prevent it from
happening again.
In this step, you should highlight all

the possible causes of the failure
mode in the “Potential Causes”
column.
8 RATE THE OCCURRENCE
In addition to severity, another significant variable to be monitored is occurrence (O):
OCCURRENCE – O: IT IS AN ESTIMATE OF PROBABILITY/FREQUENCY THAT A FAILURE MODE WILL OCCUR

AND RESULT IN A FAILURE.
Therefore, the “Occurrence” column should be filled with information about the probability of frequency that a
type of failure will occur.
Please note that an effect can occur with low severity, that is, it does not have a big impact in isolation, but an
effect with a high occurrence rate means that it is quite harmful in the long term.
8 RATE THE OCCURRENCE
Here's an example of Occurrence rating:
Index Criterion
1 Remote chance of failure
2 Very low frequency (once every 5 years)
3 Infrequent (once every 2 years)
4 Low frequency (once a year)
5 Occasional frequency (once per semester)
6 Moderate frequency (once a month)
7 High frequency (once a week)
8 Substantial frequency (a few times a week)
9 Very high frequency (once a day)
10 Maximum frequency (several times a day)
IDENTIFY CURRENT FAILURE
9 MODE CONTROLS
For each failure mode, identify the current detection controls:
CONTROL: ACTIVITIES CAPABLE OF PREVENTING THE CAUSE OF A FAILURE OR DETECTING IT WHEN IT

OCCURS.
These controls are tests, procedures, or mechanisms that you have in place to prevent failures from occurring
or being detected.
Therefore, controls can prevent a cause from occurring, reduce the probability of occurrence, or detect a
failure before it happens, or if it happens, detect it before the customer is affected.
10 RATE THE DETECTION
In this step, we must evaluate the detection rate (D):
DETECTION - D: METHODS OR TECHNIQUES THAT CAN DETECT A FAILURE/RISK MODE WITH SUFFICIENT
TIME TO DEVELOP A CONTINGENCY PLAN OR ACT IMMEDIATELY, THUS PREVENTING THE FAILURE FROM
REACHING THE CUSTOMER.
Detection levels indicate the probability that failures will be detected early, before the project is completed or
the product reaches the end customer. When assuming that the failure has occurred, one must analyze how
effective the current controls are for detection.
The detection indicator must be inverted to severity and occurrence, so the lower the detection index, the easier
it will be to identify the failure, and the higher the value assigned to the detection index, it means that the
greater the difficulty of detecting the failure.
10 RATE THE DETECTION
We present an example of detection classification:
Index Detection Criterion
1 Very high Failure mode is always detected
2e3 High Effective detection method
4, 5 e 6 Moderate Moderate probability of detection, medium effectiveness
7e8 Low Lower probability of failure mode detection
9 Very low Detection method is not effective
10 Remote Failure that could be overlooked, undetected
11 CALCULATE THE RPN
Now that you have the values for the severity (S), occurrence (O), and detection (D) indices, you can calculate
the Risk Prioritization Level.
RPN stands for “Risk Priority Number”. The calculation of the Risk Index is the product of multiplying the
severity, occurrence and detection indices:
RPN = Severity X Occurrence X Detection
With the RPN index calculated, failures can be classified as low, medium and high risk. And the treatment that
each failure mode will receive should be prioritized based on this value. Briefly, the purpose of the RPN index
is to assess the risks that need to be prioritized and urgently addressed, and what improvements can be
made to reduce or eliminate these risks.
12 PRIORITIZATION OF ACTIONS BY RPN
Now you might be asking yourself: what to do with the RPN results?
With the RPN indexes calculated and defined in the previous step, it's time to define priorities, for this you need
to analyze what are the priority risks of your process and study what actions can be taken.
The criteria for prioritizing risk treatments may vary according to the particularities of each organization, so the
prioritization of RPN results will not necessarily be the same in all cases.
Depending on the business type and environment, as well as its own activity profile, each organization will have
a specific reaction and approach to its risks.And FMEA shows us that we can take calculated risks as long as
we know what those risks are and prioritize the most important risks.
For this, we must use the RPN result to help us in this prioritization assessment. The result can vary between
1 and 1000, according to this example of risk rating described below:
RPN Priority
1 - 125 Low Risk
Medium Risk (improvement actions are

126 - 500
recommended)
501 - 1000 High risk (immediate action recommended)
Therefore, the RPN index enables to:

✓ Prioritize the highest level of risk, the most important risk to be addressed at this time;
✓ Define the general level of risk for the process and the organization;
✓ Evaluate the improvement in risk levels after the action is implemented.
To prioritize actions by the RPN index, each company can make decisions in different ways:
Accept the risk and decide not to eliminate or reduce the risk at this time, knowing its impact and
consequences.
Reduce the risk through actions to:

✓ Mitigate high risk failures;
✓ Reduce the severity of consequences and probability of occurrences;
✓ Add controls to increase failure detection
Therefore, it is recommended to improve RPN rates by taking measures for:

✓ Improved Detection (D): introduce new error-proofing methods, improve current detection mechanisms, as
well as change the process to increase detection probability.
✓ Occurrence Reduction (O): take actions to increase the process robustness and control the cause or
mechanism of one or more failure modes, reducing the probability of affecting the organization's processes.
✓ Severity Reduction (S): review the process to make it more immune to risks or at least mitigate the impact of
potential failure modes and risk events, thus reducing its rating.
13 PLAN THE IMPROVEMENTS
In this step, the team responsible for executing the FMEA will determine which corrective actions are
recommended. Focusing on the items with the worst RPN indicators, and the most urgent needs to be met, as
well as developing an action plan to prevent failures from reoccurring or dramatically reduce them.
The action plan should indicate what needs to be done, who will be responsible and the expected time for
completion. The team leader is responsible for ensuring that all recommended actions are performed correctly.
Therefore, to ensure that everything goes according to plan, and to assess if something needs to be changed, it
is necessary to control and monitor the execution of actions, and after meeting the deadline for completion,
schedule the next revision of this FMEA.
EVALUATE THE RESULTING NPR AFTER
14 IMPLEMENTING THE ACTIONS
Do you think it's over? Calm down, not yet...
The final step is to return to the FMEA to evaluate the failures that led to the improvement actions
implemented in the previous step.
After implementing the actions, the status and results must be recorded on the FMEA form, and to ensure the
effective implementation of actions, it is essential to verify their effectiveness. For that, in the FMEA worksheet,
there is a space used to evaluate the new severity, occurrence and detection indices after the actions are
concluded.
Hence, the form must be filled in with information about the defined actions, their results and the new RPN
index, in case the severity, occurrence or detection index has been changed. If the RPN index has not yet
reached a satisfactory value according to the standards of your organization, new improvement actions must
be proposed and implemented.
15 CONSTANTLY REVISE THE FMEA
Finally, we should always be aware that, over time, a
low risk can become a high risk, and the high risk
being addressed can turn into a less critical risk.
Therefore, it is important to continuously monitor all
failure modes. For this reason, the FMEA is a dynamic
and living document and must be constantly revised
whenever:
✓ Processes, products, systems, or services are

changed;
✓ Significant changes in the business environment;
✓ When a risk event occurs that had not been
assessed;
✓ Within a period predetermined by the organization.
15 CONSTANTLY REVISE THE FMEA
The team responsible for revising the FMEA should re-evaluate all failure modes and add new failures as
necessary, in addition to examining the severity, occurrence and detection of each failure mode to assess
whether there are significant changes.
Finally, the team should revise the RPN ratings, and if necessary, list which failure modes should be addressed
and propose new remedial actions if necessary.
Keep in mind that a revision of the FMEA does not necessarily mean that new failure modes are selected for
treatment if the RPN scores are judged to be satisfactory for the organization.
In conclusion, there is no beginning, middle and end to the analysis of failure modes and their effects. This is
an ongoing analysis, as potential failures and impacts and indicators should always be monitored. And
improvement actions should not be forgotten.
FMEA APPLICATION EXAMPLE
Now, let’s see a practical example of the tool?
We can observe in this example, that although the failure mode has an effect with high severity, its low
occurrence and effective detection control methods make the risk low, that is, we have the risk, but we manage
to control it with our preventive control measures.
Now that you know what FMEA is and how to
DISCOVER SOFTEXPERT FMEA implement it in your company, I invite you to
learn more about SoftExpert FMEA.
The solution helps organizations increase

productivity and reduce costs, while meeting the
requirements set by international standards and
regulations such as IATF 16949 and ISO 9000
and supporting the new AIAG and VDA FMEA
standards.
The solution continuously monitors the failures

identified in FMEA, displaying reports and
graphs with metrics such as risk severity and
priority, and highlighting the causes considered
priorities at any given time, helping to improve
product safety and reliability, and make
customers more satisfied.
DISCOVER SOFTEXPERT FMEA
Here are some of the important features of SoftExpert FMEA:
✓ Automatic calculation of the risk priority number (RPN) and the criticality of the analyzed items.
✓ Stratification and ranking of failures in various worksheets and graphs - Pareto, bar, pie, area, etc. - over a
single FMEA or a set of them.
✓ Tracking of action deadlines and notification to the person responsible for the FMEA in case of delays.
✓ Visualization of FMEA data in traditional spreadsheet format, in an intuitive hierarchical tree view, or in filtered
lists.
✓ Automatic storage of FMEA processes for all revisions completed on them, and identification of changes
made in each revision.
✓ Allows you to attach electronic files of different types, such as texts, spreadsheets, drawings, diagrams to the
FMEA process.
✓ Management reports with information on the most common failures in products and processes, volume and
effectiveness of preventive/corrective actions, etc.
CONHEÇA O SOFTEXPERT FMEA
Aqui estão alguns dos importantes recursos do SoftExpert FMEA:
✓ Cálculo automático do número de prioridade de risco (NPR) e da criticidade dos pontos analisados.
✓ Estratificação e ranking das falhas em diversas planilhas e gráficos - Pareto, barra, pizza, área, etc. - sobre um
único FMEA ou um conjunto deles.
✓ Monitoramento dos prazos das ações e notificação ao responsável pelo FMEA em caso de atrasos.
✓ Visualização dos dados do FMEA no formato tradicional de planilha, em exibição de árvore hierárquica
intuitiva, ou em listas filtradas.
✓ Armazenamento automático dos processos de FMEA para todas as revisões ocorridas sobre estes, e
identificação das alterações realizadas em cada revisão.
✓ Permite anexar arquivos eletrônicos dos mais variados tipos, como textos, planilhas, desenhos, diagramas ao
processo de FMEA.
✓ Relatórios gerenciais com informações sobre as falhas mais encontradas nos produtos e processos, volume
e eficácia das ações preventivas/corretivas, etc.
Take your business to the next level.
www.softexpert.com | sales@softexpert.com
These materials are subject to change without notice. These materials are provided by SoftExpert and its affiliated companies for informational purposes only, without representation or warranty of any kind, and SoftExpert
shall not be liable for errors or omissions with respect to the materials. The only warranties for SoftExpert products and services are those that are set forth in the express warranty statements accompanying such products
and services, if any. Nothing herein should be construed as constituting an additional warranty. Some product features and functionalities presented herein may be optional or dependent on the composition of the offer
acquired.

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FMEA:

“I UNDERSTAND MY PRODUCT, I KNOW WHAT CAN GO WRONG, BUT I HAVE

✓ When designing new products,

Check out next the step-by-step guide that will guide

Turtle diagram Process flowchart Performance indicators

Therefore, form a team that:

✓ Should have at least 4 participants;

✓ Name: name of component, process, system or service to be analyzed;

AND ONE OF THE MOST IMPORTANT ITEMS OF

Do not try to soften the analysis and classification

Be critical and have your team evaluate the indices

Then, evaluate the following questions:

Index Severity Criterion

1 Minimum Effect not detectable by the customer

2e3 Low severity Lightly annoys the customer

4, 5 e 6 Moderate severity Customer dissatisfied with noticeable performance loss

7e8 High severity High customer dissatisfaction

Potential security risk and serious non-compliance

There is a reason for every failure

In this step, you should highlight all

In addition to severity, another significant variable to be monitored is occurrence (O):

OCCURRENCE – O: IT IS AN ESTIMATE OF PROBABILITY/FREQUENCY THAT A FAILURE MODE WILL OCCUR

1 Remote chance of failure

2 Very low frequency (once every 5 years)

3 Infrequent (once every 2 years)

4 Low frequency (once a year)

5 Occasional frequency (once per semester)

6 Moderate frequency (once a month)

7 High frequency (once a week)

8 Substantial frequency (a few times a week)

9 Very high frequency (once a day)

10 Maximum frequency (several times a day)

For each failure mode, identify the current detection controls:

CONTROL: ACTIVITIES CAPABLE OF PREVENTING THE CAUSE OF A FAILURE OR DETECTING IT WHEN IT

Index Detection Criterion

1 Very high Failure mode is always detected

2e3 High Effective detection method

4, 5 e 6 Moderate Moderate probability of detection, medium effectiveness

7e8 Low Lower probability of failure mode detection

9 Very low Detection method is not effective

10 Remote Failure that could be overlooked, undetected

RPN = Severity X Occurrence X Detection

1 - 125 Low Risk

Medium Risk (improvement actions are

501 - 1000 High risk (immediate action recommended)

Therefore, the RPN index enables to:

Reduce the risk through actions to:

Therefore, it is recommended to improve RPN rates by taking measures for:

✓ Processes, products, systems, or services are

The solution helps organizations increase

The solution continuously monitors the failures

Here are some of the important features of SoftExpert FMEA:

Aqui estão alguns dos importantes recursos do SoftExpert FMEA:

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