NG BB 32 Failure Modes and Effects Analysis

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National GuardBlack Belt Training

Module 32

Failure Modes and Effects Analysis (FMEA)

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UNCLASSIFIED / FOUO

CPI Roadmap – Analyze

Note: Activities and tools vary by project. Lists provided here are not necessarily all-inclusive.

TOOLS•Value Stream Analysis•Process Constraint ID •Takt Time Analysis•Cause and Effect Analysis •Brainstorming•5 Whys•Affinity Diagram•Pareto •Cause and Effect Matrix •FMEA•Hypothesis Tests•ANOVA•Chi Square •Simple and Multiple Regression

ACTIVITIES

• Identify Potential Root Causes

• Reduce List of Potential Root Causes

• Confirm Root Cause to Output Relationship

• Estimate Impact of Root Causes on Key Outputs

• Prioritize Root Causes

• Complete Analyze Tollgate

1.Validate the

Problem

4. Determine Root

Cause

3. Set Improvement

Targets

5. Develop Counter-

Measures

6. See Counter-MeasuresThrough

2. IdentifyPerformance

Gaps

7. Confirm Results

& Process

8. StandardizeSuccessfulProcesses

Define Measure Analyze ControlImprove

8-STEP PROCESS

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3Failure Modes and Effects Analysis

Learning Objectives

Understand why we use Failure Modes and Effects Analysis (FMEA)

Summarize the different types of FMEAs

Learn how to link the FMEA to other LSS tools

Learn the steps necessary to work through an FMEA

Complete an exercise to create an FMEA

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Unintended Consequences

For any new or redesigned process…

Your solution has to be aligned with your organization’s strategic and tactical goals in order to yield benefits that will be judged significant

You want to know about any unintended consequences or problems related to your solution before you implement or promote it

Awareness of potential difficulties will allow you to prevent or mitigate the effects of any failure

You want to minimize any “start up” problems and move to full implementation in the shortest possible time

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Risk Management

Any significant issues identified in the FMEA must then beaddressed by taking:

Preventive Action

Steps that reduce the likelihood of a problem occurring at all

Focused on reducing/eliminating root causes prior to occurrence

Contingent Action

Measures implemented to limit the damage caused by a potential problem should it occur

Focused on achieving the goal in spite of difficulties

We can mistake proof our new or revised processes by proactively focusing on the “meaningful many”….

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Example: Risk Management

Pizza Delivery Process

Task – Assign a van to each delivery driver

Potential Problem – Not enough drivers with vehicles to meet order demand (due to less flexibility in moving drivers to vehicles)

Preventive Action – Review volume patterns and match staff/vehicle schedules to ensure adequate coverage/capacity

Contingent Action – Identify “on-call” delivery staff and short-term vehicle rentals for expected or unexpected demand spikes (e.g., Super bowl)

Alarm – Delivery times >28 minutes and/or driver/vehicle shortages

Use FMEA in Analyze to find potential

causes of a problem and evaluate from a

risk perspective

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FMEA

Stands for Failure Modes and Effects Analysis.

FMEA is a structured approach to: Identifying the areas and ways in which a process or system can

fail (failure mode)

Identifying potential root causes and estimating the risk associated with theses causes

Identifying and prioritizing the actions that should be taken to reduce those risks

Evaluating and documenting proposed improvement plans or current control plans

FMEA is used to identify and reduce risk, and therefore unintended consequences, in the problem solving process

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When to Conduct an FMEA

When existing designs or processes are being changed

When new systems, products and processes are being designed.

When carry-over designs are used in new applications

After system, product or process functions are defined, but before beginning detailed final design

When the improvement idea has been decided

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Types of FMEAs

System

Analyzes systems and subsystems in early concept and design stages

Design

Analyzes new process, product or service design before rollout

Process

Used to improve existing transactional and operational processes

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FMEA

FMEA

SIPOCSupplier-Input-Process-

Output-Customer

Process Map

C & EMatrix

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FMEA Procedure

1. For each process step (start with steps that give highest value from C&E Matrix) determine the ways in which the input to the step or the function of the step can go wrong (failure mode)

2. For each failure mode, determine effects

Select a severity rating for each effect (1-10 scale)

Any failure with a severity rating of 9 or 10 should be worked immediately

3. Identify potential causes of each failure mode

Select an occurrence rating for each cause (1-10 scale)

4. List current monitoring and controls for each cause

Select a detection rating for each cause (1-10 scale)

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FMEA Procedure (Cont.)

5. Calculate the Risk Priority Number (RPN) by multiplying the 3 ratings together (Max Score = 1000)

6. In the Improve phase, develop recommended actions, assign responsible persons, and note actions taken.

Prioritize so the highest RPNs are addressed first

Some level of risk may be accepted and no action is taken on RPNs below an established limit

7. Implement solutions from the first round of actions, create a re-prioritized FMEA and analyze for further necessary action

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FMEA Inputs and Outputs

Determine by utilizing the following CPI tools as needed:

FMEA

BrainstormingC&E MatrixProcess Map

Process HistoryProceduresKnowledgeExperience

List of actions to prevent causes or

detect failure modes

History of actions taken

Inputs Outputs

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Failure Modes and Effects

The relationship between failure modes and effects is not always 1 to 1.

Failure Mode 1

Failure Mode 2

Effect 1

Effect 2

Failure Mode 1

Failure Mode 2Effect 1

Failure Mode 1Effect 1

Effect 2

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Severity, Occurrence, and Detection

Severity

Importance of the effect on customer requirements

Often can’t do anything about this without fundamentally changing the system or design

Occurrence

Frequency with which a given cause occurs and creates failure modes (or probability it will occur)

Detection

The ability of the current monitoring and control method to detect before or after occurrence of a given cause

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Rating Scales and RPN

Rating formats can be quantitative or qualitative

The rating scales provided in this module were adopted from the Automotive Industry Action Group, AIAG – may need to be adjusted for transactional or service CPI projects

Typically:

1 = Not severe, not likely to occur or likely to detect

10 = Very severe, very likely to occur or not likely to detect

RPN is a product of the severity, occurrence and detection ratings:(Severity) x (Occurrence) x (Detection) = RPN (maximum of 1000)

A customized rating scale may be created or the RPN level at which action is taken may be adjusted for your particular organization

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Severity Scale 1 of 2

Effect Criteria: Severity of Effect Defined Ranking

Hazardous:

Without

Warning

May endanger operator or others. Failure mode affects safe

product operation and / or involves noncompliance with

government regulation. Failure will occur WITHOUT warning.

10

Hazardous:

With

Warning

May endanger operator or others. Failure mode affects safe

product operation and / or involves noncompliance with

government regulation. Failure will occur WITH warning.

9

Very High

Major disruption to production line. 100% of product may have to

be scrapped. Product inoperable, loss of primary function.

Customer very dissatisfied.

8

High

Minor disruption to production line. Product may have to be sorted

and a portion (less than 100%) scrapped. Product operable, but at

a reduced level of performance. Customer dissatisfied.

7

Moderate

Minor disruption to production line. A portion (less than 100%)

may have to be scrapped (no sorting). Product operable, but

some comfort / convenience item(s) inoperable. Customers

experience discomfort.

6

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Effect Criteria: Severity of Effect Defined Ranking

Low

Minor disruption to production line. 100% of product may have to

be reworked. Item operable, but some comfort / convenience

item(s) operable at reduced level of performance. Customer

experiences some dissatisfaction.

5

Very Low

Minor disruption to production line. The product may have to be

sorted and a portion (less than 100%) reworked. Fit / finish /

squeak / rattle item does not conform. Defect noticed by most

customers.

4

Minor

Minor disruption to production line. A portion (less than 100%) of

the product may have to be reworked on-line but out-of-station. Fit

/ finish / squeak / rattle item does not conform. Defect noticed by

average customers.

3

Very Minor

Minor disruption to production line. A portion (less than 100%) of

the product may have to be reworked on-line but in-station. Fit /

finish / squeak / rattle item does not conform. Defect noticed by

discriminating customers.

2

None No effect. 1

Severity Scale 2 of 2

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Likelihood of Occurrence Scale

Probability of Failure Possible Failure Rates Cpk Ranking

Very High: > 1 in 2 < 0.33 10

Failure is almost inevitable 1 in 3 > 0.33 9

High: Generally associated with

processes similar to previous1 in 8 > 0.51 8

processes that have often failed 1 in 20 > 0.67 7

Moderate: Generally associated

with processes similar to1 in 80 > 0.83 6

previous processes which have 1 in 400 > 1.00 5

experienced occasional failures,

but not in major proportions1 in 2,000 > 1.17 4

Low: Isolated failures associated

with similar processes1 in 15,000 > 1.33 3

Very Low: Only isolated failures

associated with almost identical

processes

1 in 150,000 > 1.5 2

Remote: Failure is unlikely. No

failures ever associated with

almost identical processes< 1 in 1,500,000 > 1.67 1

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Detection Criteria: Likelihood the existence of a defect

will be detected by test content before product

advances to next or subsequent process

Ranking

Almost

Impossible

Test content detects < 80 % of failures 10

Very Remote Test content must detect 80 % of failures 9

Remote Test content must detect 82.5 % of failures 8

Very Low Test content must detect 85 % of failures 7

Low Test content must detect 87.5 % of failures 6

Moderate Test content must detect 90 % of failures 5

Moderately High Test content must detect 92.5 % of failures 4

High Test content must detect 95 % of failures 3

Very High Test content must detect 97.5 % of failures 2

Almost Certain Test content must detect 99.5 % of failures 1

Detection Scale

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FMEA Example

We will conduct an FMEA on the All Ranks Club coffee example

A Black Belt wants to improve customer satisfaction with the coffee served at the All Ranks Club

Use the process map and completed C&E matrix follow

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All Ranks Club Coffee Process Map

Inputs OutputsInputs Outputs

Hot Water

Soap

Scrubber

Clean Carafe

Cold Water

Measuring Mark

Full Carafe

Filter

Maker w/Filter

Fresh Coffee

Dosing Scoop

Maker w/Filter &

Coffee

Brewing Coffee

Cleaned Carafe

Dirty Water

Wet Scrubber

Full Carafe

Filled Maker

Empty Carafe

Maker w/Filter

Maker w/Filter &

Coffee

Operating Maker

Heat

Brewed Coffee

Hot Coffee

Customer

Order

Size Specification

Complete Order

Hot Coffee

Cup

Filled Cup

Customer

Cream

Sugar

Amount Desired

Complete Order

Money

Coffee Delivery

Complete Order

Filled Cup

Customer Reply

Amount Specified

Complete Order

Make Change

Temperature

Taste

Strength

Smile

Happy Customer

Pour Coffee

into Cup

Offer

Cream &

Sugar

Complete

Transaction

Say Thank You

Receive

Coffee OrderClean Carafe

Fill Carafe

w/Water

Pour Water into

Maker

Place Filter in Maker

Put Coffee in

Filter

Select Temperature

Setting

Turn Maker On

Primary Y = TasteSelect process steps with biggest impact on taste

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Step 1. Determine Potential Failure Modes

Process Step/

InputPotential

Failure

Mode

Potential

Failure EffectsS

E

V

E

R

I

T

Y

Potential

CausesO

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

TakenS

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?

What are the existing

controls and

procedures

(inspection and test)

that prevent either the

cause or the Failure

Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe

with water

Wrong

amount of

water

Water too

warm

Carafe not

clean

Process or

Product Name:

Responsible:

Prepared by: Page ___ of ___

FMEA Date (Orig) _____________ (Rev) ______________

Process/ProductFMEA Form

A FMEA is a vertical process. Each step should be completed for the entire process before

proceeding to the next step.

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Step 2. Identify Failure Effects and Severity

Process Step/

Input

Potential

Failure ModePotential

Failure

Effects

S

E

V

E

R

I

T

Y

Potential

CausesO

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

TakenS

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe

with water

Wrong

amount of

water

Coffee too

strong or too

weak

Water too

warm

Coffee too

strong

Carafe not

clean

Foreign

objects in

coffee

Bad taste

Process or

Product Name:

Responsible:




UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Process Step/

Input

Potential

Failure ModePotential

Failure

Effects

S

E

V

E

R

I

T

Y

Potential

CausesO

C

C

U

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

TakenS

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe

with water

Wrong

amount of

water

Coffee too

strong or too

weak

5

Water too

warm

Coffee too

strong

5

Carafe not

clean

Foreign

objects in

coffee

6

Bad taste 6

Process or

Product Name:

Responsible:




Step 2. Identify Failure Effects and Severity

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Step 3. Identify Potential Causes/Occurrence

Process Step/

Input

Potential

Failure Mode

Potential

Failure EffectsS

E

V

E

R

I

T

Y

Potential

Causes

O

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

Taken

S

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?

What are the

existing controls

and procedures


that prevent either

the cause or the

Failure Mode?

What are the

actions for

reducing the

occurrence of

the cause, or

improving

detection?

What are the

completed

actions taken

with the

recalculated

RPN?

Fill carafe with

water

Wrong amount of

water

Coffee too strong or

too weak

5 Faded level

marks on

carafe

4

5 Water spilled

from carafe

5

Water too

warm

Coffee too strong 5 Faucet not

allowed to run

and cool

8

5 Employee not

aware of new

need for cool

water

7

Carafe not clean Foreign objects in

coffee

6 Carafe not

washed

4

Bad taste 6 Carafe stored

improperly

7

Process or

Product Name:

Responsible:




UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Step 4. List Current Controls and Score

Process Step/

Input

Potential

Failure Mode

Potential

Failure Effects

S

E

V

E

R

I

T

Y

Potential

Causes

O

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

TakenS

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

NWhat is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe with

water

Wrong amount of

water


too weak

5 Faded level

marks on carafe 4 Visual inspection 4

5 Water spilled

from carafe

5 None 10

Water too

warm


allowed to run

and cool

8 Finger 4

5 Employee not

aware of new

need for cool

water

7 None 10


coffee

6 Carafe not

washed

4 Visual inspection 4


improperly

7 Visual Aid 5

Process or

Product Name:

Responsible:




UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Step 5. Calculate RPNs

Process Step/

Input

Potential

Failure Mode

Potential

Failure Effects

S

E

V

E

R

I

T

Y

Potential

Causes

O

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

Taken

S

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe with

water

Wrong amount of

water


too weak

5 Faded level

marks on carafe

4 Visual inspection 4 80

5 Water spilled

from carafe

5 None 10 250

Water too

warm


allowed to run

and cool

8 Finger 4 160

5 Employee not

aware of need

for cool water

7 None 10 350


coffee

6 Carafe not

washed



improperly

7 Visual Aid 5 210

Process or

Product Name:

Responsible:




In the Analyze phase, FMEA is used to help

identify potential causes of process

problems related to the Primary Y. Sort by RPN to find most

critical Xs for further analysis.

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Step 6. Develop Recommended Actions

Process Step/

Input

Potential

Failure Mode

Potential

Failure Effects

S

E

V

E

R

I

T

Y

Potential

Causes

O

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

Taken

S

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

N

What is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the actions

for reducing the

occurrence of the

cause, or improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe with

water

Wrong amount of

water


too weak

5 Faded level

marks on carafe


5 Water spilled

from carafe

5 None 10 250 Train employees Flo Employees trained

Water too

warm


allowed to run

and cool

8 Finger 4 160

5 Employee not

aware of new

need for cool

water

7 None 10 350 Train employees Mel Employees trained


coffee

6 Carafe not

washed



improperly

7 Training 5 210 Create storage bin &

train employees

Alice New storage bin &

employees trained

Process or

Product Name:

Responsible:




Complete this section of the FMEA

in the Improvephase.

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Step 7. Compare RPN Before and After

Process Step/

Input

Potential

Failure Mode

Potential

Failure Effects

S

E

V

E

R

I

T

Y

Potential

Causes

O

C

C

U

R

R

E

N

C

E

Current Controls D

E

T

E

C

T

I

O

N

R

P

N

Actions

Recommended

Resp. Actions

TakenS

E

V

E

R

I

T

Y

O

C

C

U

R

A

N

C

E

D

E

T

E

C

T

I

O

N

R

P

NWhat is the

process step

and input

under

investiga-

tion?

In what ways

does the Key

Input go

wrong?

What is the impact

on the Key Output

Variables

(Customer

Requirements)?

What causes

the Key Input

to go wrong?


controls and

procedures




Mode?

What are the

actions for

reducing the

occurrence of the

cause, or

improving

detection?

What are the

completed actions

taken with the

recalculated RPN?

Fill carafe with

water

Wrong amount of

water


too weak

5 Faded level

marks on carafe


5 Water spilled

from carafe

5 None 10 250 Train employees Flo Employees trained 5 2 7 70

Water too

warm


allowed to run

and cool

8 Finger 4 160

5 Employee not

aware of new

need for cool

water

7 None 10 350 Train employees Mel Employees trained 5 1 8 40


coffee

6 Carafe not

washed



improperly

7 Training 5 210 Create storage bin &

train employees

Alice New storage bin &

employees trained

6 2 3 36

Process or

Product Name:

Responsible:




UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO

31

Exercise: Prepare an FMEA

Objective

Create an FMEA for the GGA's Budget Department

Instructions

Select one process step critical to improving the Primary Y

Complete the FMEA through the first RPN calculation

Sort by RPN to determine critical Xs for further analysis

Be prepared to report results to the group

Time = 20 Minutes

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO

Process or

Product Name:Prepared by:

Pag

e

____

Responsible: FMEA Date (Orig) ______________ (Rev) _____________

Process

Step / Input

Potential Failure

Mode

Potential Failure

EffectsPotential Causes Current Controls

What is the

process

step and

Input under

investiga-

tion?

In what ways does

the Key Input go

wrong?

What is the impact

on the Key Output

Variables (Customer

Requirements)?

What causes the Key

Input to go wrong?


controls and procedures

(inspection and test) that

prevent either the cause

or the Failure Mode?

0

0

0

0

0

0

0

0

0

0

0

0

S

E

V

E

R

I

T

Y

O

C

C

U

R

R

E

N

C

E

D

E

T

E

C

T

I

O

N

RP

N

Process/Product

Failure Modes and Effects Analysis Form

(FMEA)

FMEA Template

Required Deliverable

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO


Takeaways

Use FMEA in the Analyze phase to determine potential and significant Xs impacting Y from a risk perspective

Include significant Xs identified here in the improvement plan

Show impact of improvements using before and after RPN calculations

UNCLASSIFIED / FOUO

UNCLASSIFIED / FOUO

What other comments or questions

do you have?

NG BB 32 Failure Modes and Effects Analysis

Education

warningmay

clean foreign

storage bin

key output

identify failure

cleanforeign

failure modes

filter amp