FMEA Overview

What is FMEA?

Failure Mode and Effect Analysis (FMEA) is a

technique that provides three distinct functions.

1. FMEA is a tool for preventing problem.

2. FMEA is a procedure for developing and
implementing new or revised design, process or
services.
3. FMEA is a diary of design, process or service.

How does FMEA work?

This tool is most effective when applied as a team.

 Types of FMEA
Two distinct types of FMEA have emerged since its
development in the mid sixties.

1. The Design FMEA (DFMEA).

2. The Process FMEA (PFMEA).

Two basic questions that are asked:

• How could this design or process fail to do what

it is supposed to do?
• What should we do to prevent these potential
design or process failures?

FMEA belongs to the world class tool kit.

 Basic Elements of all FMEAs
All FMEAs must include five basic elements to
guarantee their effectiveness or success.

Planning the FMEA

Failure Mode Cause Effect

Occurrence Severity Detection

Interpretation

Follow – Through

FMEA as a universal quality program requirements.

 Measurable Benefits of FMEA
Organization can assign all expenditures associated
to the business in one of the following three
categories.
1. Prevention Cost
2. Appraisal Cost
3. Failure Cost
Developing and maintaining FMEA is a prevention
cost.

Examples of Prevention Cost Tools: QFD, FTA,

FMEA, DOE, Taguchi Methods, Robust Design, etc.

Examples of Failure Cost: Engineering changes

based on failures that have occurred, sorting, scrap,
rework and all other cost initiated by a failure.
 Benefits from Developing and Maintaining
Effective FMEA

1. Saves on development cost and time.

2. Saves as a guide to more efficient test planning.
3. Assists in the development of cost effective
preventive maintenance system.
4. Provides insight for designing built in test.
5. Minimizes the unforeseen events when planning
a process.
6. Provides quick reference for problem solving.
 Benefits from Developing and Maintaining
Effective FMEA (Contd…)

7. Reduces engineering changes.

8. Improves customer satisfaction.
9. Serves as a key for tracking the design and
providing updates through organization.
10. Minimizes unnecessary costly controls in
production.
11. Identifies safety concerns to be addressed.
12. Provides insight for robust designs against
customer habits.
 Words of Caution
1. FMEA is not designed to supercede the engineer’s
work.
2. FMEA is not the tool for selecting the optimum
design concept.
3. The severity occurrence and detection scales
should be tailored to reflect the organization’s
products and processes.
4. If you are not sure what number to assign to any
of the ranking scales, DO NOT assign the
highest number.
5. The RPN can be misleading.
6. Applying the Pareto principle to the RPN is a
misapplication of the Pareto principle.
7. Very small RPN may justify corrective action.
8. Majority of the FMEA should not be developed in
a meeting.
Prerequisites to FMEA
 Planning the FMEA

• Who should be responsible for FMEA?

• Who should participate and how should they
participate?
• Should we assess the system, the subsystem or
the individual components (top down)? or
should we start with components (bottom up)?
• When should we begin the FMEA?
• Can we start the process FMEA during the
development of the design FMEA?
• Should we consider this as a failure mode?
 Planning the FMEA

• Is this the failure mode, is it the effect or is it the

cause?
• Should we rate the occurrence and detection of
the failure mode or should we rate the
occurrence and detection of the cause?
• What rating should we assign to the scales?
• How can we efficiently and accurately assign
numbers when the team is in disagreement?
• Should we construct the FMEA by assessing
each failure mode from left to right or is there
any advantage to constructing each column in
its entirety before proceeding to the next
sequential column?
There are three basic cases for which FMEAs are
generated.

Case 1 New design, new technology or new

process
Case 2 Modification to existing design or
process. Here the scope should focus on the
modification to design or process, possible
interactions due to the modification.
Case 3 Use of existing design or process in a
new environment, locatoin or applicatoin. Here,
scope of the FMEA is the impact of the new
environment or location on the existing design
or process.
FMEA Process Sequence
 DFMEA

This is done to ensure that to the extent possible,

potential failure modes and their associated causes /
mechanisms have been considered and addressed.
Customer:

The DFMEA is a living document and should:

• Be initiated before or at design concept finalization.
• Be continually updated as changes occur or
additional information is obtained throughout the
phase of the product development.
• Be fundamentally completed before the production
drawings are released for tooling.
• Begin with a block diagram for the system,
subsystem and/or component being analyzed.
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1. FMEA Number

2. System, subsystem or component name and

number

A system can be considered to be made up of

various subsystems. eg. chasis system or
interior system, etc.
A subsystem FMEA is generally a subset of a
larger system. eg. front suspension system is a
subset of the chasis system.
A component FMEA is generally an FMEA
focused on the subset of a subsystem. For eg. a
strut is a component of the front suspension.
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3. Design Responsibility: Enter the OEM,

department and group. Also include the supplier
name, if applicable.
4. Prepared by: Enter the name, telephone number
and company of the engineer responsible for
preparing the FMEA.
5. Model Year/Program: Enter the intended model
year, programs that will use and/or be affected
by the design being analyzed (if known).
6. Key Date: Enter the initial FMEA due date which
should not exceed the scheduled production
design release date.
7. FMEA Date: Enter the date the original FMEA
was compiled and the latest revision date.
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8. Core team: First the name of the responsible
individuals and departments that have the
authority to identify and/or perform tasks.
9. Item/Function: Enter the name and other
pertinent information, eg. the number, the part
class, etc.
10. What are all the things that this design/process
or service is supposed to do to satisfy the
customers?

Some of the common problems observed in

practice are:
a) All functions are not identified.
b) The description of the function is not concise.
c) The description is not exact.
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11. The Failure Modes:

The question to be answered in this column is:

Could this failure occur?… not, how often will it
occur?
A recommended starting point is a review of past
things gone wrong, concerns, reports and group
brain storming.
Examples:
Cracked, loosened, fractured, slips, deformed,
leaking, oxidized, no support (structural),
inadequate signal, no signal, drift.
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12. The Effects of Failures: Describes the

consequences of the failure mode.

What do the customers experience should this

potential failure mode occur?

Three common practices that can mask the true

consequences are:

a) Not from the customer’s perspective.

b) Confusion between ‘local’, ‘global’ or next
higher effects.
c) Technical description does not capture the
experience.
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• Market surveys
• Benchmarking studies
• Quality function studies
• Warranty reports
• Customer complaint reports

Examples of effect:

Noise, erratic operation, unstable, leaks, rough,

inoperative, unpleasant odor, regulatory
noncompliance.
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13. Severity: It is the rank associated with the most
serious effect for a given failure mode.

How serious is the effect of the failure mode?

This assessment of severity is typically
measured on a scale from 1 to 10.
A high severity number suggests:
• the safety of the customer is at risk.
• the failure cost will be extremely high as to
jeopardize the financial welfare of the
organization.
The definitions in this scale should reflect the
nature of the products that are designed and
produced by the organization.
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14. Classification: This column may be used to
classify any special product characteristic (eg.
Critical, key, major, significant) for components,
subsystem or system that may require additional
design or process controls.
15. Potential Causes / Mechanisms of Failure:
Potential cause of failure mode is defined as an
indication of a design weakness, the
consequence of which is the failure mode.
Some common mistakes made when identifying
the causes are:

a) Some FMEA procedures restrict the search for

causes.
b) All causes are inserted into the FMEA form.
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When developing DFMEA, causes contributing to a

failure mode can originate from:

• the design
• the supplier
• the process
• the customer
• the environment
• any place between the design and the customer
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Typical failure causes may include:

• Incorrect material specified

• Inadequate design life assumption
• Overstressing
• Inadequate maintenance instructions
• Improper surface finish specification
• Excessive heat
• Improper tolerance specified
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The two strategies that must be considered for
effective problem solving or problem prevention
are:
1. The ‘forgiving downstream’ principle
2. The ‘controlling upstream’ principle
Some common examples of controlling upstream
strategies commonly found in the FMEA
recommendations column are:
• recommending a material upgrade
• tightening the tolerances
All causes do not contribute equally to a potential
failure mode. Only a few causes, referred to as
‘root causes’ are likely to contribute to the majority
of the failure mode.
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Step 1: Write down the failure mode.

Step 2: Review the appropriate block diagram
(DFMEA) or the process flow diagram (PFMEA).
Step 3: Brainstorm all the possible causes.
Step 4: Structure the brainstorming output using a
fishbone diagram.
Step 5: Construct a fault tree if the fishbone
diagram appears to be incomplete.
Step 6: Review the fishbone diagram, screen out
and circle the root causes.
Step 7: Transfer the root causes to FMEA form.
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Root cause screening process flow

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16. Occurrence: Occurrence is the likelihood that a

specific cause/mechanism will occur during the
design life. How often the failure mode or the
cause will occur is answered in this column.

Estimate the likelihood of occurrence of

potential failure causes/mechanism on a 1 to 10
scale.
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In determining this estimate, questions such as

the following should be considered:
 What is the service history / field experience
with similar components?
 Is the component completely new?
 Has the component application changed?
 What are the environmental changes?
 Has an engineering analysis (eg. reliability)
been used to estimate the expected
comparable occurrence rate for the
application?
 Have the preventive controls been put in
place?
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17. Current Design Controls: What types of controls
are planned or in place to assure that all the
failure modes are identified and removed?
For example, the design review is commonly
used as a control in DFMEA.
List the prevention, design validation/verification
or other activities that will assure the design
adequacy for the failure mode and/or
cause/mechanism under consideration.
Examples of control:
Design control: design review, fail/safe designs,
such as a pressure relief valve, mathematical
studies, rig/lab testing, feasibility review,
prototype test, road test.
Process control: control plans, inspection
plans, audits, SPC.
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Types of Design:

Review Objective Specific Tools

Preliminary Concept To evaluate and •QFD
Design Review (PCDR) preliminary concept •(PUGH) Concept selection
Detail Design Review To evaluate and approve •Statistical Comparisons
(DDR) the prototype •DOE
•Statistical Tolerencing
•Simulation modeling
Final Production Design To evaluate and approve •Preliminary cap. studies
Review (PRDR) the design for •Initial SPC
manufacturing •Initial Sample submission

The DFMEA form of the AIAG manual has two

columns for design control:
 Prevention control
 Detection control
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18. Detection (D): What is the chance of chatching

this failure mode or the causes leading to this
failure mode?
Detection is the rank associated with the best
detection control listed in the design control.
Actually, there are two distinct definitions of
detection that apply to FMEA.
1. What is the chance of catching the problem
before we give it to the customer?
2. What is the chance of the customer catching
the problem before the problem results in a
catastrophic failure?
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The first question is what answered in this

column in a 1-10 scale.
It is best to have detection controls in place as
early as possible in the design development
process.
i..e, provide early warning (detection) for the
customer that will allow the customer to take
action to avoid a catastrophic failure. Examples
of this type are:
 Warning labels
 Built-in noise alerts to detect system
deterioration.
 Automatic system shut off switches, such as
fuse protectors.
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Table: Detection Scale
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19. Risk Priority Number (RPN): This is the product

of severity (s), occurrence (o) and detection (D)
rankings.

(S) x (O) x (D) = RPN

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20. Recommended actions: The intent of any
recommended action is to reduce the rankings in
the following order:
 Severity
 Occurrence
 Detection
Actions such as the following should be
considered:
 Revised design geometry and/or tolerances
 Revised material specifications
 DOE or other problem solving techniques
 Revised test plan
If engineering assessment leads to no
recommended action for a specific failure mode,
indicate this by entering ‘none’.
Process FMEA
 Process FMEA

A process potential FMEA is an analytical

technique used by a manufacturing/assembly
engineer/team as a means to ensure that to the
extent possible, potential failure modes and their
associated causes/mechanisms have been
considered and addressed.
 Process FMEA

The Process FMEA:

 identifies the process functions and

requirements
 identifies potential product and process
related failure modes
 assesses the effect of the failures on the
customer
 Process FMEA

 identifies the potential manufacturing or

assembly process causes and identifies
process variables on which to focus controls
for occurrence reduction or detection of the
failure conditions
 identifies process variable on which to focus
process controls
 develops a rank list of potential failure modes
thus establishing a priority system for
preventive/corrective action consideration
 Documents the results of the manufacturing
or assembly process.
 Process FMEA

Customer: For a process FMEA customer

should normally be the end user. However,
customer can also be a subsequent or
downstream manufacturing or assembly
operation.
The process FMEA is a living document and
should be initiated:
 before or at the feasibility stage
 prior to tooling for production and
 take into account all manufacturing
operations, from individual components to
assemblies.
 Construction of PFMEA
The PFMEA begins by developing a list of what
the process is expected to do and what it is
expected not to do, i.e., process intent.
The PFMEA should begin with a flowchart of the
general process. This flowchart should identify
the product/process characteristics associated
with each operation.
1. FMEA Number: Enter the document number
which may be used for tracking.
2. Item: Enter the name and number of the
system, subsystem or component for which
the process being analyzed.
3. Process Responsibility: Enter the OEM,
department and group. Include the supplier
name if known.
 Construction of PFMEA
4. Prepared by: Enter the name, telephone
number and company of the engineer
responsible for preparing the FMEA.
5. Model Year/Programs: Enter the intended
model year/programs that will use and/or be
affected by the design/process being analyzed
6. Key Date: Enter the initial FMEA due date
which should not exceed the scheduled start
of production date.
7. FMEA Date: Enter the date the original FMEA
was compiled and the latest revision date.
8. Core Team: List the names, department.
9. Process Function/Requirements: Enter a
simple description of the process being
analyzed (eg. turning, drilling, welding,
assembling).
 Construction of PFMEA
10. Potential Failure Mode: It is defined as the
manner in which the process could potentially
fail to meet the process requirements and/or
the design intent as described in the process
function/requirement column.
It is the description of the non-conformance of
that specific operation.
Pose and answer the following questions:
• How can the process/part fail to meet the
requirements?
• Regardless of engineering specifications,
what would a customer consider
objectionable?
Typical failure modes could be:
bent, cracked, handling damage, surface too
rough, burred, dirty, deformed, hole off
location.
 Construction of PFMEA

11. Effects of Failure: It is defined as the effects

of the failure mode on the customer. Describe
the effects of the failure mode in terms of
what the customer might notice or experience.

For the end user, the effect should always be

stated in terms of product or system
performance.

eg. noise, erratic operation, unpleasant odor,

leak, rework, scrap, inoperative, unstable,
poor appearance, rough, customer
dissatisfaction.
 Construction of PFMEA

If the customer is the next operation or

subsequent operation the effect should be
stated in terms of process/operation
performance.

cannot fasten, cannot mount, cannot face,

damages eqmt, doesn’t fit, doesn’t connect,
doesn’t match, causes excessive tool wear,
endanger operator.
 Construction of PFMEA

12. Severity: It is the rank associated with the

most serious effect for a given failure.

The final customer should always be

considered first.

13. Classification: This column may be used to

classify any special product or process
characteristic that may require additional
process controls.
 Construction of PFMEA

14. Potential Causes: It is defined as how the

failure could occur, described in terms of
something that can be corrected or can be
controlled.

Typical failure causes may be:

• Improper torque – over, under
• Improper weld – current, time, pressure
• Improper heat treat – time, temperature
• Inadequate or no lubrication
• Part missing
• Improper machine set up.
 Construction of PFMEA
15. Occurrence (O): It is the likelihood that a
specific cause/mechanism of failure will occur
16. Current Process Control: There are
descriptions of the controls that either
prevent to the extent possible the failure
mode or cause/mechanism of failure from
occurring, or detect the failure mode or
cause / mechanism of the failure should it
occur.
These controls can be process controls such
as mistake proofing, SPC or can be post
process evaluation.

There are two types of controls:

a) Prevention
b) Detection
 Construction of PFMEA

17. Detection (D): Detection is the rank associated

with the best detection control listed in the
process control column. In order to achieve a
lower ranking, generally the planned process
control has to be improved.

18. RPN: The risk priority number is the product

of the severity (S), occurrence (O) and
detection (D) ranking.

RPN = S x O x D
 Construction of PFMEA

19. Recommended Action: Engineering

assessment for preventive/corrective action
should be first directed at high severity, high
RPN and other items designated by the team.

In general practice, when the severity is 9 or

10 special attention must be given to ensure
that the risk is addressed through existing
design actions/controls or process
preventive/corrective actions regardless of
RPN.
 Construction of PFMEA

Actions such as the following should be

considered:
• Only a design and/or process revision can
bring about a reduction in the severity
ranking.
• To reduce the probability of occurrence,
process and/or design revisions are
required. An action oriented study of the
process using statistical methods could be
implemented.
• The preferred method to accomplish a
reduction in the detection ranking is the
use of mistake proofing methods.