failure mode and effects analysis (fmea). 2 for internal use only module objectives by the end of...

Failure Mode And Effects Analysis (FMEA)

2FOR INTERNAL USE ONLY

Module Objectives

By the end of this module, the participant should be able to:

Construct a Product or process FMEA.

Use the FMEA to prioritize risks of the process.


• Identify potential failure modes and analyze risks

• Document/track actions taken to reduce risks of failures

• Prioritize deficiencies to focus improvement efforts

• Improve quality, reliability, and safety of product

• Increase customer satisfaction

Why Learn FMEA?

Helps to identify and prevent defects from occurring


When To Use FMEA?

FMEA is used throughout a project.

• Define/Measure phase – Project scoping

• Analyze phase – Identify potential Critical Xs

• Improve phase – Assess risks of improvements

• Control phase – Troubleshooting/reoccurrence prevention


Three Part Functionality

Actual Improve

ProposedImproveMeasure/Analyze

Measure/Analyze focuses on left side of form.


FMEA Header Definitions

1. Process or Product Name: Process being analyzed

2. Responsible: Person responsible for updating

3. Prepared By: Person who originally created FMEA

4. FMEA Date (Orig): Original FMEA release date

5. Rev.: Current revision level of FMEA

1

23

54

File: FMEA.xls

Complete header information first.


FMEA And Hierarchies

High - Level #1

Step #1 Step #2 Step #3

Input - Level #3

Input #1 Input #2 Input #3

FMEA – Level #1

FMEA – Level #2

FMEA – Level #3

Process - Level #2

Step #1 Step #2 Step #3

Like mapping, FMEA is performed at varying levels.


Utilize Process Maps, C and E Diagrams, C and E Matrices, and other pertinent information

Use core team and supporting members

Choose starting level

Focus on inputs first, not scores

Getting Started

Planning leads to useful FMEA.


FMEA Steps

Process Step/Input

Potential Failure Mode Potential Failure EffectsSEV

Potential CausesOCC

Current ControlsDET

RPN

Actions Recommended

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

1.

What Process Step?

2.

How could process step fail?

3.What effect to customer?

4.

What causes failure?

How Bad?

How Often?

5.

Can failure be detected?

7.

What can be done?

How well?

FMEA can be intimidating but easily broken into pieces

6. Calculate and prioritize risk


0

1000

2000

3000

4000

5000

6000

7000

Defect

Cou

nt

C&E Matrix, Pareto of Customer Requirements As They Relate To The Process

1. List Process Steps

Focus on C and E Matrix inputs that highly impact outputs

Complete Travel

Authorization

Contact Agency

Traveler Information Verification

Gather Customer Billing Info

Auth. Code?

Authorized TravelAuth. Code

ŸŸ

Authorization Form, S

DomesticInternationalTravelerApprover

Website, STravel Budget CCost Estimate SComputer Systems,NLocation Variation,N

Ÿ

ŸŸŸŸ

ŸŸŸŸ

Ÿ

Contact Service, SPhone/Web

Travel Information,STraveler/Designee, N Agency Resources

day time, SNafter hours, SN

Computer Systems, NMeasurement Systems, STime In Queue

Time in VRUCall VolumePeak Hours

ŸŸ

ŸŸŸ

ŸŸ

ŸŸ

ŸŸŸŸ

Agency Request Entered

Ÿ Correct Traveler Information

Ÿ

Traveler Info, SCompany Info, SRestrictions if applicable, SPreferences, S (seat, class)

Agent NTraveler NComputer Systems, NMeasurement Systems, S

ŸŸŸŸŸŸŸŸ

Customer name, SLocation, SAuth. Code, SOperator, SAgent NTraveler NComputer Systems, N

Measurement Systems, N

ŸŸŸŸŸŸŸŸ

Correct Traveler Billing

Info Into System

Ÿ

Y

NNeed For

Travel

Rationale, NViable Alternatives, N

Traveler NDestination Customer,N

ŸŸŸŸ

Complete Travel Request

Form

Request Form, SCharge No., STraveler NLocation Variation, NComputer Systems, NOther Personnel?Form Procedure

STravel Information N

ŸŸŸŸ

Ÿ

ŸŸ

Ÿ

InformationCorrect

Updated ProfileŸTravel RequestŸ

X Y

Detailed Process Map


1a. List Process Step Inputs

Lower level FMEA has additional details

Complete Travel

Authorization

Contact Agency

Traveler Information Verification

Gather Customer Billing Info

Auth. Code?

Authorized TravelAuth. Code

ŸŸ

Authorization Form, S

DomesticInternationalTravelerApprover

Website, STravel Budget CCost Estimate SComputer Systems,NLocation Variation,N

Ÿ

ŸŸŸŸ

ŸŸŸŸ

Ÿ

Contact Service, SPhone/Web

Travel Information,STraveler/Designee, N Agency Resources

day time, SNafter hours, SN

Computer Systems, NMeasurement Systems, STime In Queue

Time in VRUCall VolumePeak Hours

ŸŸ

ŸŸŸ

ŸŸ

ŸŸ

ŸŸŸŸ

Agency Request Entered

Ÿ Correct Traveler Information

Ÿ

Traveler Info, SCompany Info, SRestrictions if applicable, SPreferences, S (seat, class)

Agent NTraveler NComputer Systems, NMeasurement Systems, S

ŸŸŸŸŸŸŸŸ

Customer name, SLocation, SAuth. Code, SOperator, SAgent NTraveler NComputer Systems, N

Measurement Systems, N

ŸŸŸŸŸŸŸŸ

Correct Traveler Billing

Info Into System

Ÿ

Y

NNeed For

Travel

Rationale, NViable Alternatives, N

Traveler NDestination Customer,N

ŸŸŸŸ

Complete Travel Request

Form

Request Form, SCharge No., STraveler NLocation Variation, NComputer Systems, NOther Personnel?Form Procedure

STravel Information N

ŸŸŸŸ

Ÿ

ŸŸ

Ÿ

InformationCorrect

Updated ProfileŸTravel RequestŸ

X Y

Detailed Process Map


2. How Could Process Input Fail?

Describe what could go wrong to Ys

• Delayed• Missing• Wrong information• Misunderstood

• Wrong quantity• Excess information• Not available• Etc.

Exa

mp

les

Mo

des


3. What Effect To Customer?

• Unable to proceed• Lost data• Dissatisfaction• Poor performance

• Lost income• Confusion• Annoyed• Etc.

Describe consequence to next process or customer

Exa

mp

les

Eff

ects


4. What Are Potential Causes?

For each mode, list major causes

Delivery Defects

PEOPLE

ENVIRONMENT

MATERIALS

METHODS

MEASUREMENTS

MACHINES

Maintenance

Servers

Resources/Shift

Ticket Types

Times

Training

Freq of Updates

Experience Level

Postal Service

Co. Profiles

Traveler Profiles

Terminals

Call Volume

Self

systems

internet

Zabar Volume

Process

Queue

Hol

ida

yTim

e of

D

ay

Phone Service

T-1

Line

s

Credit card

addressem

ail

Computer Prog

PO Damage

PO DamageCall Routings

Carrier Updates

Time Zones

Comp Downtime


Avoid Confusion

Relate back to mode, not effect

Failure Mode

Effect

Cause

Could result in

Due to


5. Can Failure Be Detected?

For each cause, list how it is detected

• Training• Audits• Procedure• Inspection

• “Buddy Checks”• Screen pop-up• Etc.• None

Exa

mp

les

Co

ntr

ols


6. Rate Severity, Occurrence,and Detection

Characteristics to evaluate which improvement actions will have greatest positive impact to customer:

• Severity – Impact to customer of failure mode

• Occurrence – Rating of frequency of failure cause

• Detection – Likelihood that cause will not be detected

Always use project team to establish ratings.

The scale of the rating will depend on the Ratings Definition Grid


Rating Definitions Grid

Almost certain detection

Failure unlikelyMinimal effect

Moderate detection probability

Occasional failures

Minor defect

Low detection probability

Moderate failures

Loss of secondary function

Remote chance of detection

High repeated failures

Loss of primary function

Cannot detectVery high and almost inevitable

Extreme without warning

Detection Probability

OccurrenceSeverity

High 10

Low 1

Rating

The key to effectively rating severity, occurrence, and detection is a detailed ratings definition grid


6a. Calculate Risk

Risk Priority Number (RPN) is product of rankings for:

Severity (SEV)

Probability of Occurrence (OCC)

Difficulty to Detect (DET)

RPN = SEV x OCC x DET

Effects Causes Controls

Special attention given to high RPN and high SEV


Prepare Pareto Chart Of RPNs

Actions recommended for high RPNs

Key is FOCUS!

Separate the vital few from the trivial many!


7. Improvement Selection

General Rules:

• Detection: Usually easiest to fix – Creation ofmeasurement system

• Occurrence: Next easiest to fix – Change processto reduce or eliminate cause

• Severity: Cannot be reduced – Must be eliminatedwith Mistake Proof improvement or redesign

Immediately improve what can be improved, collect data on all others


Exercise

Inputs Outputs

Projector has bright light

Projector is quiet

Colors correct

Power On

Bulb life

Instructor Training

Computer Interface

Projector

Process Map

Let’s build an FMEA together using the projector example and Excel file “FMEA.xls.”


Example One


Example Two

Process or Product Name:

Root Causes of Insurance Complaints

Prepared by: Banani Das

Responsible: Banani Das/Blackbelt FMEA Date (Orig) June 11, 2003 (Rev) _____________

Process StepKey Process

InputPotential Failure Mode Potential Failure Effects

SEV

Potential CausesOCC

Current ControlsDET

RPN

What is the process step

What is the Key Process Input?

In what ways does the Key Input go wrong?

What is the impact on the Key Output Variables (Customer Requirements) or internal requirements?

How

Sev

ere

is t

he e

ffec

t to

the

cus

tom

er? What causes the Key Input to

go wrong?

How

oft

en d

oes

caus

e or

F

M o

ccur

? What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP number.

How

wel

l can

you

det

ect

caus

e or

FM

?

FA gathers client information

Client Suitability/Risk Factor

Incorrect suitability or risk factor taken by the FA

Insurance Complaints

9

Misunderstanding between FA and client 4

License requirements, Admin Supervision, Continuing Education 9 324

FA recommends insurance product

FA advice Lack of knowledge Insurance Complaints

9

Lack of knowledge

9



FA experience Lack of experience with the insurance product


4

Minimal experience with insurance product 9



FA knowledge Unfamiliarity with product Insurance Complaints

9

Incorrect information provided by insurance wholesaler

4

Admin Supervision

4 144

Client purchases insurance product

Various insurance offerings

Incorrect product choice is provided to client


4

FA does not fully understand the insurance product 9

Admin Supervision

4 144

Administrative Manager reviews complaint

Understanding of complaint

Lack of knowledge Insurance Complaints

4

Infrequency of insurance complaints (experience) 9

License requirements, Continuing Education 4 144

MLIG reviews complaint

MLIG expertise Not enough information provided to MLIG by branch


9

Lack of documentation

1

Compliance documentation requirements 9 81

MLIG researches FA profile and business

FA business structure

FA does minimal insurance business


4

Infrequency of insurance transactions 4


MLIG researches FA profile and business

FA LOS FA inexperienced Insurance Complaints

1

Lack of experience

1


Process/Product Failure Modes and Effects Analysis

(FMEA)

RPN

EOC

Actions Recommended

Resp. Actions Taken

What are the actions for reducing the

occurrence of the Cause, or improving detection? Should

have actions only on high RPN's or easy

fixes.

Whose Responsible

for the recommende

d action?

What are the completed actions taken with the recalculated RPN? Be

sure to include completion month/year

324 4

Training MLIG/Admin Mgr

TBD

324 7


TBD

144 4


TBD

144 1

Record of when specialist is involved, track complaints by insurance company

MLIG Compliance

TBD

144 6


TBD

144 2


TBD

81 2

16 1

1 1


• Break into teams

• Prepare FMEA for:

- Project kick-off meeting- Team Member selection- Presentation preparation and delivery

• Debrief

Exercise

Use Excel file “FMEA.xls” to perform exercise


• Break into teams

• Consider the catapult

• Build FMEA for:

- Fail to hit target- Hurt someone during launch- Not easy to use

• Debrief

Exercise (Optional)


Advice

• Do not try alone, use cross-functional group

• Include suppliers and customers

• Activities are required for completion

• Train team

• Ask many questions; summarize often

• Look at process as objectively as possible

• Link to other tools

• Continually update

FMEA requires much planning and follow-up


Meeting Best Practices

• Proper preparation for meetings

• Prepare “draft” or “shell” prior to meeting

• Initial focus on FMEA text

• Secondary focus on scoring

• Independent voting – Build consensus

• Gather inputs, revise, send for comments

Refrain from starting and expecting to finish in one meeting


Linkages

Inputs from:

–Process Map–C and E Diagram–C and E Matrix

Results to:

–Pareto Chart–Control Plan

Key tool in Six Sigma projects


Session Summary

FMEA can and should be used on all projects

Excellent tool to identify risk

Team based activity

Built in action planning

Living document

FMEA is an excellent tool used throughout a project

failure mode and effects analysis (fmea). 2 for internal use only module objectives by the end of...

Documents

process fmea

fmea level

internal use

fmea steps

useful fmea

s customer

s time

s location