HOW TO USE THE FAILURE MODES AND

EFFECTS ANALYSIS TEMPLATE

With highly technical processes, systems and technologies have multiple failure modes. How can
it fail? What can go wrong with it? Have you ever looked at that systems view of the process to
determine, if those things happen, what do you do about it? In risk analysis, organizations
typically don’t go to that system mode. This system view of failure and what you do about it
could be likened to process risk analysis “on steroids.”

Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible
failures in a design, a manufacturing or assembly process, or a product or service. Please access
the FMEA Template for a fillable tool.

OPER A TI ON AL D EFI NI TI ON S:
 Failure modes—the ways, or modes, in which something might fail. Failures are any errors
or defects, especially ones that affect the customer, and can be potential or actual.
 Effects analysis—studying the consequences of those failures. Failures are prioritized
according to how serious their consequences are, how frequently they occur and how easily
they can be detected.

The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the
highest-priority ones. FMEA also documents current knowledge and actions about the risks of
failures, for use in continuous improvement. FMEA is used during design to prevent failures.
Later it’s used for control, before and during ongoing operation of the process. Ideally, FMEA
begins during the earliest conceptual stages of design and continues throughout the life of the
product or service.

W H EN T O U SE F M EA
 When a process, product or service is being designed or redesigned, after quality function
deployment.
 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 analyzing failures of an existing process, product or service.
 Periodically throughout the life of the process, product or service

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 F M EA PR OC ED UR E
Note: this is a general procedure. Specific details may vary with standards of your organization
or industry.
1. Assemble a cross-functional team of people with diverse knowledge about the process,
product, or service and customer needs. Functions often included are: design,
manufacturing, quality, testing, reliability, maintenance, purchasing (and suppliers), sales,
marketing (and customers) and customer service.
2. Identify the scope of the FMEA. Is it for concept, system, design, process or service? What
are the boundaries? How detailed should we be? Use flowcharts to identify the scope (i.e.,
the system, design, process, or service that is the subject of your FMEA) and to make sure
every team member understands it in detail.
3. Fill in the identifying information at the top of your FMEA template. Figure 1 shows a typical
format. The remaining steps ask for information that will go into the columns of the
template.

Example Failure Modes and Effects Analysis Template

Figure 1

4. Identify the functions of your scope. Ask, “What is the purpose of this system, design,
process or service? What do our customers expect it to do?” Name it with a verb followed
by a noun. Usually you will break the scope into separate subsystems, items, parts,
assemblies, or process steps and identify the function of each.
5. For each function, identify all the ways failure could happen. These are potential failure
modes. If necessary, go back and rewrite the function with more detail to be sure the failure
modes show a loss of that function.
6. For each failure mode, identify all the consequences on the system, related systems,
process, related processes, product, service, customer or regulations. These are potential

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 effects of failure. Ask, “What does the customer experience because of this failure? What
happens when this failure occurs?”
7. Determine how serious each effect is. This is the severity rating, or S. Severity is usually
rated on a scale from 1 to 10, where 1 is insignificant and 10 is catastrophic. If a failure
mode has more than one effect, write on the FMEA table only the highest severity rating for
that failure mode.
8. For each failure mode, determine all the potential root causes. Use tools classified as cause
analysis tool, as well as the best knowledge and experience of the team. List all possible
causes for each failure mode on the FMEA form.
9. For each cause, determine the occurrence rating, or O. This rating estimates the probability
of failure occurring for that reason during the lifetime of your scope. Occurrence is usually
rated on a scale from 1 to 10, where 1 is extremely unlikely and 10 is inevitable. On the
FMEA table, list the occurrence rating for each cause.
10. For each cause, identify current process controls. These are tests, procedures, or
mechanisms that you now have in place to keep failures from reaching 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 the customer is affected.
11. For each control, determine the detection rating, or D. This rating estimates how well the
controls can detect either the cause or its failure mode after they have happened but before
the customer is affected. Detection is usually rated on a scale from 1 to 10, where 1 means
the control is absolutely certain to detect the problem and 10 means the control is certain
not to detect the problem (or no control exists). On the FMEA table, list the detection rating
for each cause.
12. (Optional for most industries) Is this failure mode associated with a critical characteristic?
(Critical characteristics are measurements or indicators that reflect safety or compliance
with government regulations and need special controls.) If so, a column labeled
“Classification” receives a Y or N to show whether special controls are needed. Usually,
critical characteristics have a severity of 9 or 10 and occurrence and detection ratings above
13. Calculate the risk priority number, or RPN, which equals S × O × D. Also calculate Criticality
by multiplying severity by occurrence, S × O. These numbers provide guidance for ranking
potential failures in the order they should be addressed.
14. Identify recommended actions. These actions may be design or process changes to lower
severity or occurrence. They may be additional controls to improve detection. Also note
who is responsible for the actions and target completion dates.
15. Actions are completed, note results and the date on the FMEA form. Also, note new S, O or
D ratings and new RPNs.

For additional support, access the Excel-based FMEA template.

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 A B OUT A PQC
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