What is Failure Mode and Effects Analysis (FMEA)?

At the start of a new project, process, or production run the last thing you think about is failure, but things do
go wrong! The only practical way of avoiding failure is stop and think about what could potentially go wrong
and why, then steps can be taken to minimise or eliminate the risk, this is the goal of an FMEA. It is a team
approach, the team analysis the process, product, or service to determine the potential failure modes, as well
as why they might occur.
An FMEA is a step-by-step method used for identifying and analysing possible process or product failures
and then designing a prioritised strategy to mitigate the biggest risks.
Therefore, an FMEA prompts us to ask and answer the following questions:

• What could go wrong?

• Why could the failure happen?
• How likely is this failure to happen?
• What are the potential consequences of each identified failure?
An FMEA, unlike a Root Cause Analysis which is used to determine what went wrong after the event, is used
to identify or determine preventable problems before they happen.
By analysing historic issues and evaluating processes for risks it is possible to make improvements to your
systems and minimise if not reduce the likelihood or impact of failures. It is always best to identify problems
as early as possible, the later it is that they are identified can cause pricey delays, if not harm to your
relationship with your client.
FMEA is a proactive team driven approach focusing on prevention rather than simply reacting after the
problem has been identified and therefore MUST be applied early in the development of processes, products
or services to help create, maintain and improve safety, quality, reliability and efficiency whilst also reducing
the costs associated with failures. Also important to note is that an FMEA is a live document that requires
reviewing on a regular basis and updating when or if new failures arise.

When to use an FMEA

• When a process, product, or service is being designed or redesigned, or following Quality Function
Deployment (QFD).
• When an existing process, product, or service is being applied in a new way.
• Before developing Control Plans for a new or modified process.
• When improvement goals are planned for an existing process, product, or service.
• When analysing failures of an existing process, product, or service.
• Periodically throughout the life of a process, product, or service.
Even though I am an advocate of using FMEAs the technique can be seen to be long and laborious as it
relies on a team representing every area of the process under review, but as a structured reliability
improvement method it is still an effective way to lower the possibility of failures.
Advantages of an FMEA are:

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 • Avoidance of potential failures: identifies and prevents possible failures in process, products, or
services.
• Increased functional safety & reliability: enhances safety and reliability for process, products, or
services.
• Cost reduction: reduces the costs of internal and external failures and minimises product
modifications.
• Legal protection: provides exoneration from product liability claims.
• Operational efficiency: eliminates disturbances during the startup of production.
• Communication improvement: improved communication between the customer and supply chain.
• Knowledge base development: supports the development of a valuable knowledge base within your
company.

Figure 1

FMEA Procedure
Note: this is a general procedure. Specific details may vary within the standards of your company or industry.
Before undertaking an FMEA it is advisable to learn more about any standards or specific methods relevant
to your company or industry through other references and training.
1. Assemble a cross functional team with a diverse knowledge of the process, product, or service and
customer needs. The team often includes representatives from the following areas design,
manufacturing, quality, technical, maintenance, purchasing, sales, marketing, and customer service.
It might also be beneficial to include the suppliers and customers.

2. Identify the scope of the FMEA. Will you be using the technique to analyse the risk for a concept,
system, design, process, or service? What are the boundaries? How detailed should it be? Using
your process map review and label the process steps and the intended input of those steps ensuring
that every team member clearly understands it in detail.
• Ask the following questions:
o What is the purpose of this system, design, process, or service?
o What do our customers expect it to do?
• Also consider doing the following:
o The process step should be named with a verb followed by a noun.
o Usually, the scop will be broken into separate subsystems, items, parts, assemblies,
or process steps. As part of this technique, you need to identify the process
step/input of each.

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 Figure 2

Process Potential
Potential Failure Potential
Step / Failure Current Controls
Effects Causes
Input Mode

OCCURENCE
RPN

DETECTION
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 3

3. For each process step identify all the possibilities of how a failure could occur. These are the potential
failure modes. If necessary, go back and rewrite the process step with additional detail to ensure the
failure modes show a loss of that process step/input.
• A potential failure mode represents any way the process, product, or service step could fail to
perform its intended function or functions.

Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode
OCCURENCE

RPN
DETECTION
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 4

4. Next, for each failure mode recognise all the consequences on the system, related systems, process,
related processes, product, service, customer requirements, or compliance to applicable regulations.
These are the Potential Failure Effects. The effect is related directly to the ability of the specific
component to perform its intended function.
• Ask, “What does the customer experience because of this failure? What happens when the
failure happens?”
• Describe the effect so it is significant to the product or system performance.
• Defining the effects in broad terms can make it difficult to identify and reduce the true potential
risks. Do not over complicate it by using terms that the whole team understands.
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 Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode

OCCURENCE

DETECTION
RPN

SEVERITY
What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 5

5. For each failure mode, determine the Potential Root Causes, please note that there could be more
than one. Use tools specific for root cause analysis as well as the knowledge and experience of the
team. List all possible causes for each failure mode on the FMEA form.

Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode

OCCURENCE
RPN

DETECTION
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 6

6. For each cause, identify Current Process Controls. These will consist of tests, procedures, or
mechanisms that your company have in place to keep failures form escaping to the customer. These
controls might prevent the cause from happening, reduce the likelihood that it will happen or detect
failure after the cause has already happened but before it can affect the customer.

Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode
OCCURENCE

DETECTION

RPN
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 7

7. Determine how serious each effect you have identified is by assign a Severity ranking, or S.
• The severity ranking is an estimate of how serious an effect would be if it occurred.
• To determine the severity, consider the impact the effect would have on the customer,
downstream operations, or on the workforce performing the process.
• The severity ranking is based on a relative scale ranging from 1 to 10. A 10 means that the
severity of the effect would have a dangerous outcome leading to a hazard without warning.

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 Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode

OCCURENCE
RPN

DETECTION
SEVERITY
What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 8

Effect Criteria: Severity of Effect Ranking

Hazardous – May endanger operator (machine or assembly). Failure will occur without warning.
10
without warning
Hazardous – with May endanger operator (machine or assembly). Failure will occur with warning.
9
warning
100% of product may have to be scrapped. Product is nonfunctional. Customer
Very High 8
very dissatisfied
A portion of the product, <100%, may have to be scrapped. Product is functional,
High but at reduced level (e.g., cosmetic defects), resulting in decreased line speed or 7
additional manpower. Customer dissatisfied.
A portion of the product, <100%, may have to be scrapped. Product is functional,
Moderate but at reduced level (e.g., cosmetic defects), resulting in decreased line speed or 6
additional manpower. Customer experiences discomfort.
<100% of the product might have to be reworked offline and accepted. Customer
Low 5
experiences some discomfort.
100% of the product might have to be reworked in station, resulting in decreased
Very Low 4
line speed or additional manpower. Cosmetic defects noticed by most customers.
<100% of the product might have to be reworked in station, resulting in decreased
Minor 3
line speed or additional manpower. Cosmetic defects noticed by most customers.
Minor impact resulting in slight inconvenience to process, operation, or operator.
Very Minor 2
No effect.
None 1
Figure 9

8. As for the Severity, for each cause assign an Occurrence ranking, or O, to each effect that you have
identified. The ranking estimates the probability of failure occurring for that reason during the lifetime
of your scope.
• Occurrence is usually rated on a scale of 1 to 10, where 1 is extremely unlikely and 10 is
inevitable.
• The Occurrence ranking is based on the likelihood, or frequency, that the cause (or
mechanism of failure) will occur.
• Once the cause is known, capture data on the frequency of causes. Sources of data may
include scrap and rework reports, customer complaints, and equipment maintenance records.

Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode
OCCURENCE

DETECTION

RPN
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
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 Figure 10

Probability of Failure Possible Failure Rates Cpk Ranking

> 1 in 2 <0.33 10
Very High
1 in 3 >.033 9
1 in 8 >0.51 8
High
1 in 20 >0.67 7
1 in 80 >0.83 6
Moderate 1 in 400 >1.00 5
1 in 2,000 >1.17 4
Low 1 in 15,000 >1.33 3
Very Low 1 in 150,000 >1.50 2
Remote <1 in 1,500,000 >1.67 1
Figure 11

9. The next step is to determine the Detection ranking, or D, to each control that you have identified.
• To assign detection rankings firstly identify the process or product related controls in place for
each failure mode and then assign a detection ranking to each control. Detection rankings
evaluate the current process controls in place.
• A control can relate to the failure mode itself, the cause (or mechanism) or failure, or the effects
of a failure mode.
• To make evaluating controls even more complex, controls can either present a failure mode
or cause from occurring or detect a failure mode, cause of failure, or effect of failure after it
has occurred.

Process Potential
Potential Failure
Step / Failure Potential Causes Current Controls
Effects
Input Mode
OCCURENCE

RPN

DETECTION
SEVERITY

What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
0
Figure 12

Criteria: Likelihood the existence if a defect will be detected by

Detection process controls before next or subsequent process, or before Ranking
product leaves the processing location.
Almost impossible No known control(s) available to detect failure mode. 10
Very remote Very remote likelihood current control(s) will detect failure mode. 9
Remote Remote likelihood current control(s) will detect failure mode. 8
Very low Very low likelihood current controls(s) will detect failure mode. 7
Low Low likelihood current controls(s) will detect failure mode. 6
Moderate Moderate likelihood current controls(s) will detect failure mode. 5
Moderately high Moderately high likelihood current controls(s) will detect failure mode. 4
High High likelihood current controls(s) will detect failure mode. 3
Very high Very high likelihood current controls(s) will detect failure mode. 2
Current control(s) almost certain to detect failure mode. Reliable
Almost certain 1
detection controls are known with similar processes.
Figure 13

10. Calculate the Risk Priority Number (RPN) for each effect that has been identified.
• The RPN gives us a relative risk ranking. The higher the RPN, the higher the potential risk.

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 • The RPN is calculated by multiplying the three rankings together. Severity x Occurrence x
Detection = RPN.
• Calculate the RPN for each failure mode and effect.
• Prioritise the risks by sorting the RPN from highest to lowest score. This will help the team
determine the most critical inputs and the causes of their failure.

Process Potential
Potential Failure Potential
Step / Failure Current Controls
Effects Causes
Input Mode

OCCURENCE

DETECTION
RPN

SEVERITY
What is the In what way What is the impact What causes the What are the existing
process step does the on the Key Output Key Input to go controls and procedures
and input Key Input Variables (Customer wrong? (inspection and test) that
under go wrong? Requirements)? prevent either the cause
investigation? or Failure Mode?
0
0
Figure 14

11. Develop the action plan and reduce the RPN.

• The RPN can be reduced by lowering any of the three rankings (severity, occurrence, or
detection) individually or in a combination with one another.

Actions Recommended Responsibility Actions Taken

OCCURRENCE
What are the actions for What are the

DETECTION
SEVERITY
reducing the occurrence of completed actions
the cause, or improving taken with the RPN
detection? recalculated RPN?

Figure 15

12. Now assign responsibilities.

• This is step is especially crucial in Acting.
• Be sure to include the person(s) responsible for the action and the date of the deadline.

Actions Recommended Responsibility Actions Taken

OCCURRENCE

What are the actions for What are the

DETECTION
SEVERITY

reducing the occurrence of completed actions

the cause, or improving taken with the RPN
detection? recalculated RPN?

Figure 16

13. As actions are completed, record the results and the completion date on the FMEA form.
• The Action Plan specifies the steps taken to implement the solution, assigns who will complete
them, and sets deadlines for their completion.
• Most Action Plans identified during an FMEA will be simple “who, what, and when” categories.
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 • Identify who is responsible for specific actions and set target completion dates.

Actions Recommended Responsibility Actions Taken

OCCURRENCE
What are the actions for What are the

DETECTION
SEVERITY
reducing the occurrence of completed actions
the cause, or improving taken with the RPN
detection? recalculated RPN?

Figure 17

14. Recalculate the resulting RPN, note the new Severity, Occurrence, or Detection ratings and the new
RPNS.
• This step in an FMEA confirms the action plan had the desired results by calculating the
resulting RPN.
• Recalculate the RPN by reassessing the severity, occurrence, and detection rankings for the
failure modes after completing the action plan.

Actions Recommended Responsibility Actions Taken

OCCURRENCE
What are the actions for What are the

DETECTION
SEVERITY
reducing the occurrence of completed actions
the cause, or improving taken with the RPN
detection? recalculated RPN?

Figure 18

And finally
FMEAs are an important tool in the mitigation of risk, simply because they prioritise actions that
theoretically will prevent failures or reduce the severity and frequency of them occurring. They also aid in
the selection of remedial actions which reduce the impact and consequence of failures.

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