6Sigma - Failure Modes and Effects Analysis

8/6/2019 6Sigma - Failure Modes and Effects Analysis

1/32

Copyright 2005. Confidential and proprietary property of Sykes Enterprises, Incorporated.

Failure Modes and Effects Analysis (FMEA)


2/32


3/32

Optimize &Refine

Solutions

Control Xs

& Monitor Ys

Close & Hand-Off Project

ControlRefine the

Project

Process Maps &Simplification

C&E for Variable

Reduction

ProcessCapability

Measure

Failure Modes &Effects Analysis

ID Variation:

GraphicalAnalysis

Plan for DOE

AnalyzeDesign &

Execute AnExperiment

Define Y=f(x)

RecommendedChanges

ImproveProject Scope &

ProblemValidation

ProblemStatement

Project Metrics

Team Members

Define

MeasurementCapability

ID Variation:StatisticalAnalysis

Objective

Statement(s)Data Collection

Systems

D MAIC Roadmap for Breakthrough


4/32

P rocess Analysis

1) Describe Project O bjective statement Metrics.xls charts Initial validated forecast

2) Apply FMEA3) ID Variation: Graphical Methods

4) ID Variation: Statistical Methods Correlation & Regression Means testing Sigma testing Proportions testing Contingency tables

5) Planning for D O E

6)

Complete Phase Summary Conclusions, Issues, & Next Steps

Failure Modes& EffectsAnalysis

ID Variation:

GraphicalAnalysis

Plan for DOE

Analyze

ID Variation:StatisticalAnalysis


5/32

Background

Failure Modes and Effects Analysis (FMEA) First developed in the 19 50 s Appropriated by NASA in the 19 60 s for the space program Ford Motor Company was the first North American company to widely implement the

use of FMEAs.

T ypes of FMEA S ystem T op-level, early stage analysis of complex systems D esign Systems, subsystems, parts & components early in design stage P rocess Focuses on process flow, sequence, equipment, tooling, gauges, inputs,

outputs, set points, etc

The Process FMEA is the Six Sigma FMEA.


6/32

W ho? W hen?

Who constructs the FMEA? T he Black Belt is the team leader. T he process owner inherits the finished FMEA. Use the process mapping, C&E matrix team. May need to add a rep from quality, a supplier, reliability

When should the FMEA be constructed? After the process map & the C&E matrix Before or after the control plan, depending on the maturity of the

process


7/32

W hy?

Warm up exercise: You have 60 seconds to document: What would you want to know about a defect ?For the process: FMEA improves the reliability of the process. An FMEA identifies problems before they occur.

FMEA serves as a record of improvement & knowledge.

For the future: FMEA helps evaluate the risk of process changes. FMEA identifies areas for other studies

multi-vari, AN O VA, D O E

A completed FMEA is a Six Sigma project deliverable.


8/32


9/32

6 W P rocess FMEA -- T erminology

FMEA: A systematic analysis of a process used to identify potentialfailures and to prevent their occurrence.Pot en tial F ailur e m od e : T he manner in which the process couldpotentially fail to meet the process requirements.Pot en tial F ailur e Eff ec t : The effects of the failure mode on thecustomer.S eve rity : An assessment of the seriousness of a failure mode.Severity applies to the effects only.C aus e : H ow the failure could occur, described in terms of somethingthat can be corrected or controlled.Occ urr en c e : T he likelihood that a specific failure mode is projectedto occur.

D e t e c tion : T he effectiveness of current process controls to identifythe failure mode (or the failure effect ) prior to occurring, prior torelease to production, or prior to shipment to the customer.R PN -- R isk P riority N umber: T he product of Severity, O ccurrence& Detection


10/32

Initial Assessment Actions and HistoryActions Taken

SEV

CC

DET

RPN

What are the actions for reducing the occurrence, or improving detection, or for identifying the root cause if itis unknown? l e c i s ly i RPN's re sy i es.

Who isresponsible for therecommendedaction?

List the completed actionsthat are included in therecalculated RPN.Include t he implementationdate for any changes.

W h a t i s

t h e n e w

s e v e r i t y ?

W h a t i s

t h e n e w p r o c e s s

c a p a

b i l i t y ?

A r e

t h e

d e t e c t

i o n

l i m i t s

i m p r o v e d

?

R e c o m

k p u t e

R P N a f

t e r

a c t i o n s a r e c o m p l e t e .

0

0

0

0

0

0

A

ion R ul

R o nd dA

ion

R pon ibili

! nd

Co pl

ionD!

The highest value process stepsf romthe C&E

matrix.

In what ways might the process potentially f ail tomeet the processrequirements and/or designintent?

What is the e ff ect o f eachf ailure mode on the outputsand/or customer requirements?The customer could be the nextoperation, subsequentoperations, another division or the end user.

H o w

S e v e r e

i s t h e e f

f e c t

t o t h e c u s o

t m e r

?

How can the f ailure occur?Describe in terms o f somethingthat can be corrected or controlled. Be speci f ic. Tryidenti f y the causes that directlyimpacts the f ailure mode, i.e., rootcauses.

o w o

t e n o e s

t e

c a u s e o r

f a i l u r e m o d e

o c c u r ?

What are the existing controls and procedures (inspection and test) thateither prevent f ailure mode f romoccurring or detect the f ailure shouldit occur? Shouldi nclude an SOPnumber.

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x

O C C x D

E T

0

0

0

0

0

0

RPN

Potential Cause(s)/Mechanism(s) of Failure

OCC

CurrentProcessControls

DET

ProcessFunction Potential Failure Mode

Potential Effectsof Failure

SEV

P arts of the FMEA Form

The first section of the FMEA form, initial assessment , is used to

evaluate initial conditions of the process.

After completing the initial assessment, the team then generates alist of actions to reduce the occurrence or increase the detection.

FMEA & CP Form.xls


11/32

FMEA Examples

Documentation ExampleT he H uman Resources Department for a particular organization maintains official filesfor all personnel. Included is personal data, benefits, current organizational status, andperformance evaluation packages. Many within the organization both contribute and querythese files, relying on their accuracy. Queries from external entities also rely on theiraccuracy. T he H R Department is receiving many complaints both from internal and external

customers regarding the inaccuracy of the information forwarded to them by H R.Service T ime Example

A Customer Service Department for a particular organization handles all customerinquiries, either directly or by channeling cases to other departments as appropriate. Auditsto determine timeliness and completeness of each case is periodically conducted. Resultsfrom the last three month s audits show a trend veering from annual objectives.

In the following examples, a single line from the FMEA is used as anillustration for each of the above examples.

R emember! The purpose of the FMEA is to drive improvement!


12/32

T he Form P art I: Initial Assessment

The highest value process stepsfrom the C&E

matrix.

In what ways mightthe process

potentially fail tomeet the process

requirements and/or design intent?

What is the effect of each failure mode onthe outputs and/or customer

requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?

How can the failureoccur?Describe in terms of something that can be

corrected or controlled.Be specific.

H o w o

t e n d o e s

t h e c a u s e

o r f a i l u r e m o

d e o c c u r ?

What are the existingcontrols and procedures(inspection and test) thateither prevent or detect

occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T

Manager completion of change form

Not filled outcorrectly

Outdated employeeinformation incurrent profile

6

No incentive for Manager to complycompletely withrequirement

3

HR checklist for tasksto be completed uponchange in employeestatus

2 36

Communicationfrom CustService toSupporting DeptRepresentative

No directcommunication

Delayed transfer of customer case

9

No formal liaison

4

Customer complaints

8 288

ProcessFunction

Potential FailureMode


SEV

Potential Cause(s)/Mechanism(s) of

Failure

OCC


DET

RPN


13/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e


d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form P rocess Function

The p rocess ste p s to b eanal yz ed in the FME A, should b e the to p three or four that were identified inin the C &E Matri x.


14/32


15/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e


d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form P otential Effects of Failure

Effects are theim p act on customer

re q uirements .


16/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e


d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form S everity

Se verit y is a rankin g ona 1 -10 scale , 10 b ein g the most se vere . Low

se verities are those thatare unnoticea b le or

locall y reworka b le . Ver y hi g h se verities areusuall y reser ved for

safet y or lia b ilit y issues .


17/32


18/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e


d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form P otential Causes of Failure

To the e xtent p ossi b le , list e ver y concei va b lecause of each failure

mode . Remem b er the6Ms -- man , machine , method , measurement ,

materials , mother nature .

W hat are all of the possible causes for a particular failure?


19/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e


d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form Occurrence

Occurrence is the likelihoodthat a s p ecific cause will occur

and will result in a s p ecificfailure mode . Rank on a scale

from 1 -10 . If the cause is either unknown or it s fre q uenc y is not

tracked , then the occurrencerefers to the failure mode .


20/32


21/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e

o r f a i l u r e m o d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M ?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form Current P rocess Controls

Controls are methodsthat either p re vent the

failure mode fromoccurrin g or detectthe a failure mode

when it occurs .

W hat happens if this box is blank? W hat is the DET value?


22/32


23/32


24/32


matrix.





requirements?

o w

e v e r e

s t e e e c

t t o

t h e c u s o

t m e r ?



H o w o

t e n d o e s

t h e c a u s e

o r f a i l u r e m o d e o c c u r ?


occurrence?

H o w w e l

l c a n y o u

d e t e c t

c a u s e o r

F M

?

S E V x O

C C x

D E T




6


3


2 36




9

No formal liaison

4

Customer complaints

8 288

ProcessFunction



SEV


Failure

OCC


DET

RPN

T he Form Risk P riority Number

The risk p riorit y num b er (RPN) is the p roduct of

the se verit y, occurrence ,

and detection . DET OCC SEV RPN vv!

R PNs help to determine Six Sigma project priorities.


25/32


26/32

Rating S ummary

Ratin S it f E ff t ik lih d f u n D t t i n Ab ili t10 Hazardou s it out arning Canno t detect

Hazardou s it arningVer y remote chance

of detection

8 Loss of r imar y func tionRemote chance

of detection

7Reduced r imar y

func tion erfor mance

Ver y low chance

of detection6

Loss of secondar yfunc tion erfor mance

Low chance of detection

5Reduced secondar y

func tion erfor mance Modera te chance

of detection

4Minor defec t noticed by most customer s

Modera tely high chance of detection

3 Minor defec t noticed by some customer s High chance of detection

2Minor defec t noticed

by ob servan t customer sVer y high chance

or detection

1 o effec tRemote:

Failure is unli elyAlmost cer tain detection

Low:Relatively few failures

Modera te:Occa sional Failures

Ver y High:Failure is almost inevitable

High:Repea ted Failures


27/32

T he Form P art II: Actions and History

Actions TakenSEV

OCC

DET

RPN

What are the actions for reducing the occurrence,or improving detection,or for identifying the rootcause if it is unknown?Should have actionsonly on high RPN's oreasy fixes.

Who is responsiblefor therecommendedaction?

List the completedactions that areincluded in therecalculated RPN.Include theimplementation datefor any changes.

W h a t i s t h e n e w s e v

W h a t i s t h e n e w p r o

c a p a b

i l i t y ?

r e e e e c o n m

i m p r o v e d ?

e c o m

p u e

a

a c t i o n s a r e c o m p l e t e

Issue delinquencyreport

C.C. Largelist5/1/00

Procedurechanged toincludedelinquencyreport 7/15/00

5 2 3 30

ID Dept liaison for allsupportingDepartments

Slim Pickins8/3/00

Procedurechanged, Deptliaisons identified8/31/00

9 2 4 72

Action ResultsRecommended

Action(s)Responsibilityand Completion

Date

The actions in Part II are directed at solving the project issues.


28/32

Actions TakenSEV

OCC

DET

RPN






c a p a b

i l i t y ?

r e e e e c o n m

i m p r o v e d ?

e c o m

p u e

a





5 2 3 30


Slim Pickins8/3/00


9 2 4 72


Action(s)Responsibilityand Completion

Date

T he Form Recommended Actions

Corrective actions are thepoint of the FMEA. If no

actions are generated for aparticular cause this should

be noted. Correctionactions should first bedirected to the highest

priority items.


29/32


30/32

Actions TakenSEV

OCC

DET

RPN






c a p a

b i l i t y ?

r e e e e c o n m

i m p r o v e

d ?

e c o m p u e

a





5 2 3 30


Slim Pickins8/3/00


9 2 4 72


Action(s)

Responsibilityand Completion

Date

T he Form Actions T aken

Include a brief description of the actual action completed. Manytimes an action changes

during theimplementation. Include

the actual completiondate for the action.


31/32

Actions TakenSEV

OCC

DET

RPN






c a p a b

i l i t y ?

r e e e e c o n m

i m p r o v e

d ?

e c o m

p u e

a





5 2 3 30


Slim Pickins8/3/00


9 2 4 72

Action Results

RecommendedAction(s)

Responsibilityand CompletionDate

T he Form Recalculation

Generate ne w ratings for severity, occurrence anddetection based on the

results of the actions. Thene w values of the RPN w ill

determine if ne w actionsare re q uired for those

causes

Actions should be designed to reduce the occurrence or increase detection.


32/32

Introduction to Control P lans

A control plan is: A summary of all of the control activities for the process. A method of identifying holes in the control system. A list of control activities yet to be implemented.

An input to the FMEA (mature processes ). An output of the FMEA (new processes ).

Pro cess"

#

epW

$

a#

's% ontroll e & ?

In p'

t or Out p ut ?

"

pec. Lim its /R eq uir eme nt s

Meas ur eme ntMe thod

S amp le Siz e ( r eq u e n cy Who/ Wh a tMeas ur es

Wh e r e R ec ord e d

Dec is ion Rul e /Corr ec tiv e Ac tion

SOP 's

StatusChangeindicator

X List SelectMgr Review

HR Inspection100% A s Needed

Mgr, HRClerk

HR Checklist Return to Mgr for Correction 9.3 0 12

New Dept Y List Select Mgr ReviewHR Inspection

100% A s Needed Mgr, HRClerk


New Grade Y List Select Mgr ReviewHR Inspection

100% A s Needed Mgr, HRClerk


New Salary Y rade Guideline Mgr Review 1 00% A s Needed Mgr 9.3 0 12

New Mgr Y Org Chart Mgr Review 1 00% A s Needed Mgr 9.3 0 12

Change

Effect DateY None Mgr Review

HR Inspection100% A s Needed Mgr, HR

ClerkHR Checklist Return to Mgr for Correction 9.3 0 12

) mp lo yee St a tu s

Ch a ng e For m

6Sigma - Failure Modes and Effects Analysis

Documents

Transcript of 6Sigma - Failure Modes and Effects Analysis