Failures Mode and Effect (FMEA)

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FMEA Overview

What is FMEA?

Why use FMEA?

When to use FMEA

Who do we invite

How it Works?
Steps

to complete an FMEA

The Rating Scale

Calculating

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the RPN

FMEA Tips

Review the FMEA Template

Failure Modes And Effects Analysis

FMEA (Failure Modes And Effects Analysis)

is a tool to identify and evaluate possible
process failures and the risks associated with
them
Use the FMEA to build a plan for reducing or
eliminating that risk

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What is FMEA?

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Prioritization tool

Considers three factors simultaneously

(Severity, Occurrence, Detectability)

Asks What could go wrong, and will I try to

avoid, prevent it, or fix it?

Helps build bridges with the disenfranchised

Why Use FMEA?

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To identify and prioritize parts of the product or

process that need further improvement

To ensure the quality, and reliability of products

and services

To increase customer satisfaction by preventing

or reducing impact of errors

To document and track actions taken to

reduce risk

To develop action plans to avoid risk/defects

When To Use FMEA

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When a service, product or process is created,

improved, or redesigned

When existing products, services, or processes are

used in new ways or in new environments

To expose potential problems in a process

Who Do We Invite?

Customer : Give us insight to their hidden needs and

our hidden mistakes

Suppliers : Provide insight to solutions we might not

have envisioned

Associates: Those who live with the process, give us

logic flaws and potential solutions

Process Owners: Provide the keys to empowering

change

Total count: 4 8 people, never alone!

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How It Works?

Failure modes - Under what conditions could something

go wrong?

Failure effects (Ys) - When things go wrong, what does

it look like?

Failure cause (Xs) - What makes the failure occur?

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Steps For Completing A FMEA

1.

Review the product, service, or process

2.

Brainstorm and group possible failure modes

3.

List one or more potential effects for each failure mode

Answer the question: If the failure occurs, what are

the consequences?
4.

Assign a severity rating for each effect

5.

Assign an occurrence rating for each failure cause

6.

Assign a detection rating for each failure mode

7.

Calculate risk priority number (RPN) for each effect

8.

Use the RPNs to select high priority failure modes (sort by RPN)

9. Plan to reduce or eliminate the risk associated with

high priority failure modes
10. Carry out the plans
11. Recompute RPN
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The Rating Scales

Can use a 1 5 Scale

Advantage: Few options to choose from, quick decisions

Disadvantages: Discrimination can be poor, everything looks the

same

Can use a 1 10 scale

Advantage: More range of choices, allows for averaging close misses

wit little hard feelings

Disadvantages: More tiring to read list repeatedly

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The Rating Scales

Example of a 1 5 Scale

Rating

Severity of Effect

Almost Certain Loss of

Customers

2
1

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Likelihood of
Occurrence
Ability to Detect
Very High:
Failure is almost Little to no chance
inevitable
of detection

High Probability of customer

High: Repeated Very low chance
dissatisfaction and lost business
Failures
of detection
Moderate:
Noticeable to customers resulting
Occasional
Moderate chance
in potential for lost business
Failures
of detection
Minor defected noted by some
customers. Minor defect noticed Low: Relatively
High chance of
by discriminating customers.
few failures
detection
Remote: Failure
Almost certain
No Effect
is unlikely
detection

11

The Rating Scales

Example of a 1 10 Scale

Score (High
is always
worst)

10
9

8
7

Severity of effect (Use highest number)

Cost Quality Schedule

Likelihood of
Occurrence
(Currently)

Guaranteed Loss of Customer

Almost certain loss of customer

Every time
Almost inevitable

Very High Probability of customer

dissatisfaction and lost business
High Probability of customer
dissatisfaction and lost business

Very High repeated

Failures
Repeated Failures

6
5
4

3
2
1

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Noticeable to customers resulting

in potential for lost business
Minor defected noted by some
customers. Minor defect noticed
by discriminating customers.
Almost no effect
No Effect

Ability to Detect
Will reach customer before anyone
knows
Caught in final audit
Detected in later steps, out of our
scope after more work invested in
process
Detected in later steps, out of our
scope, before more value added work
Detectable after our process only,
within our scope

Occasional Failures Caught in our end process audit

Caught in later process step
Relatively Few
Failures
Failure is unlikely
Never happens

Caught in process step by other

checks and balances
Stopped as the error occurs
Can't happen

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FMEA: Calculating Risk Priority Number (RPN)

RPN = Severity x Occurrence x Detection
Severity Scale
Rating

Bad

10
9
8
7
6
5

Criteria A Failure Could:

Guaranteed Loss of Customer

Noticeable for customers resulting in potential

for Loss business

Occurrence Scale

4
3

Good

Rating

Likelihood

10

Every time

No Effect

Detection Scale
Rating

8
7

10

9
8

Occasional Failures

7
6

2
1

Definition
Will reach customer before anyone knows

Never Happens

Caught in our end process audit

3
2
1

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Cant happen

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FMEA Tips

Use brainstorming to identify key failure modes

Critical process or project steps (High Level)
High cost and/or customer impact
High probability (problems we see often)

Brainstorm first before scoring (RPN)

RPN Scales should be relevant to the process

Remember: Numbers are judgments

Identify proactive/preventive steps to reduce likelihood of

failure

Part of the value of the FMEA is the discussion that is

generated as a result of its use

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Failure Modes And Effects Analysis

Worksheet
Process/Product:
FMEA Team:
Black Belt:

FMEA Date: (Original)

(Revised)
Page:

of

Total Risk Priority Number

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RPN

Detection

Action
Taken

Occurrence

Responsibility
Recommended And Target
Completion
Action
Date

Severity

RPN

Current
Controls

Detection

Potential
Failure Mode

Potential
Cause(s)
Of
Failure

Action Results
Occurrence

Item/Process
Step

Potential
Effect(s) Of
Failure

Severity

FMEA Process

Resulting Risk Priority Number

15

GB Project Example
Business Case: Credit cards issued at the 2 oz postage weight is costing Card Issuance
approximately $975K YTD. Therefore, improving the postage performance of credit card
issued will result in significant cost savings for the Card Issuance budget plan.

Problem Statement: Our 1st quarter 2004 2 oz postage trend for Credit Card Issuance is
increasing 55% to 69% of total credit card volume issued. There is no existing process to
monitor and validate postage trends for credit cards, which has resulted in missed revenue
reduction opportunities.

Project Goal: The goal is to reduce the 2 oz postage volume by 30% and increase the 1 oz
package volume to an optimized level of 60%, by 4th quarter 2004.

Scope: This project focuses on credit card postage performance, utilizing our Credit Card
Production vendor - TSYS.

Customers & VOC: The project focuses on improving the SVA. The shareholders voice
demands that we error proof our processes to drive best in class performance. However,
our card carrying customers are not impacted by the weight of the card package, and
therefore not impacted by this initiative.

Primary Metric: 2 oz. Postage trend for Credit Card

Secondary Metric: Card Issuance Package Unit Cost
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Recalibrate Scales to Fit Project

Rating

Severity of Effect

Almost Certain Loss of

Customers

2
1

Rating

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Likelihood of
Occurrence
Ability to Detect
Very High:
Failure is almost Little to no chance
inevitable
of detection

High Probability of customer

High: Repeated Very low chance
dissatisfaction and lost business
Failures
of detection
Moderate:
Noticeable to customers resulting
Occasional
Moderate chance
in potential for lost business
Failures
of detection
Minor defected noted by some
customers. Minor defect noticed Low: Relatively
High chance of
by discriminating customers.
few failures
detection
Remote: Failure
Almost certain
No Effect
is unlikely
detection

Likelihood of
Severity of Effect
Occurrence
Ability to Detect
Very High:
Almost certain to make package Failure is almost Little to no chance
weight 2 Oz.
inevitable
of detection
High probability that the defect
will cause package to approach High: Repeated Very low chance
2 Oz threshold
Failures
of detection
Effect independent of other
Moderate:
changes does not cause postage
Occasional
Moderate chance
change
Failures
of detection
Neglible weight change/weight
change does not significantly
Low: Relatively
High chance of
impact overall package
few failures
detection
Remote: Failure
Almost certain
No effect on package weight
is unlikely
detection

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GB Project Example
#

2a

2b

Process
Function (Step)
B of A Materials
Mgm t s ubm its
reques t to
collate ral ve ndor
for cre ation of
m aterials
B of A Materials
Mgm t s ubm its
reques t to
collate ral ve ndor
for cre ation of
m aterials

Potential
Failure Modes
(process
defects)

Potential
Failure Effects
(Y's)

S Potential
E Causes of
V Failure (X's)

O Current
C Process
C Controls

D
E
T

R
P
N

Provide wrong
collateral
specifications

Vendor creates
the collateral
out of spec

Materials Mgmt
does not have
3
updated
Visa/MC specs

4 No Control

60

Provide no
collateral
specifications

Vendor creates
the collateral
out of spec

2 No Control

40

Same cause as
vendor creates
4
collateral out of
spec - 2b

2 No Control

40

Same cause as
vendor creates
4
collateral out of
spec - 2b

2 No Control

40

Produce

3a1

Vendor creates

Collate ral ve ndor

the new
collateral based
create s collate ral
collateral out of

on wrong specs

spec

Vendor uses
previous specs
from similar
order

3a2

Vendor creates
Produce
the BAU
Collate ral ve ndor
collateral based existing
create s collate ral
on wrong specs collateral out of
spec

3b

Collate ral ve ndor Identify weight

create s collate ral incorrectly

Incorrect weight
loaded identified
Scales not
4
by collateral
calibrated
vendor

1 No Control

20

3c1

Collate ral ve ndor Identify weight

create s collate ral incorrectly

Incorrect weight
loaded (for new)
Assume weight
4
identified by
are the same
collateral vendor

Current
1 Process
Procedures

12

1a

Card Is suance BA
Request wrong
reques ts a new
collateral
collate ral ite m

Wrong
collateral is
created

Receive
incorrect
3 request from
business
partners

Verification by
2 Card Issuance
BA

1b

Card Is suance BA
Request wrong
reques ts a new
collateral
collate ral ite m

Wrong
collateral is
created

3 BA error

Verification by
2 Card Issuance
BA

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Responsible
Recommend
Taken
Person &
Actions
Actions
Target Date

S
E
V

O
C
C

D
E
T

R
P
N

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