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Six Sigma Green Belt Training

07 Failure Modes and Effects Analysis (FMEA)


2004 American Society for Quality. All Rights Reserved. Recognize Define Measure Analyze Improve Control

About This Module

An FMEA is a systematic method for identifying, analyzing, and documenting potential failure modes and their effects on the system, the product and process performance. The possible causes of failure can then be prioritized.

Six Sigma, A Quest for Process Perfection Attack Variation and Meet Goals
\DataFile\Fishbone.mtw \DataFile\FMEAform.xls \DataFile\CopyProc.ppt \DataFile\CopyFMEA.xls \DataFile\CpultPM.ppt \DataFile\CauseEff.ppt 2004 American Society for Quality.
All Rights Reserved.

Define

Measure

Analyze

Improve

Control

Page 2

FMEA Version 2.1

What We Will Learn

1. As a Team, how to construct an FMEA and associated Action Plan 2. How the FMEA process ties to process mapping 3. The relationship between Failure Mode, Cause and Effect 4. The different types of FMEAs

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Page 3

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Sample FMEA
Company: Copying Company
S Failure Failure E Mode Effects V Must redo copy Must redo copy Must redo copy O D R C E P C Controls T N

Project: Copying Process


Actual Compl. p p p Date S O D p r p n R i Risk s X k prpn

Part/ process

Causes

Action Recommended

Resp. Person

Schedule Date

Action Taken Ensured proper supplier used to provide copy paper

Retrieve No Copies Copies Copy is wrong size

Paper Jam 9

Periodic Maint. 7 441

Set Size Required

Set Light/ Copy Dark too light


Copy Place not Doc into aligned Position properly Copy Place not Doc into aligned Position properly Copy Place not Doc into aligned Position properly Select Copy on Paper wrong Tray paper Place Spots Doc into on Position copies

Must redo copy Must redo copy Must redo copy Must redo copy Must redo copy

Existing User notes on copier 5 245 7 misset size 7 User Existing misset notes on control copier 4 140 7 5 Used landscape instead of Tray portrait or 7 vice versa 8 Selection 2 112 align marking not clear Doc moved when lid closed Use Auto Feeder / 4 align ruler 3 84 Use Auto Feeder / 5 align ruler 2 70 Auto select function 3 63 Periodic Cleaning SOP 1 42

Ensure proper weight and type Key Opr paper avail for copiers Place sign over copier outlining standard size enlarge/reduce or reliable mach to clearly indicate standard reduce/enlarge Key Opr

3/1

2/15

7 3 7 147 3 441

2/20

Place sign over mach

2/15

7 3 2

42 1

42

Place sign to encourage user to utilize auto settings Key Opr

2/20

Place sign over mach

2/15

7 2 2

28 1

28

Place note on ruler re tray selection

Key Opr

1/20

Placed Note

1/15

8 2 1

16 1

16

Enlarge marks for 8.5 " paper on ruler Key Opr Place sign over copier re "Ensure align prior to copying or use auto Feeder" Key Opr Place sign over copier to encourage user to use auto tray select Key Opr Place cleaning material near copier

1/15

Enlarged marks

1/14

7 2 1

14 1

14

1/15

Displayed Sign

1/14

6 1 1

User selected wrong tray 3

2/25

Place sign over mach Placed Cleaning Matl

2/20

7 2 3

42 1

42

Dirty Glass 6

Maint.

1/15

1/15

6 1 1

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Page 4

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Why Use FMEAs?

Identify ... critical product characteristics and process variables Prioritize ... product and process deficiencies in support of downstream improvement actions

Help focus ... on prevention of product and process problems

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Page 5

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Benefits of FMEAs

Improves the quality, reliability and safety of products. Helps increase customer satisfaction.

Reduces product development timing and cost.


Reduces the amount of rework, repair and scrap. Documents and tracks actions taken.

Prioritizes deficiencies to focus improvement efforts.

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Page 6

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process and FMEA Hierarchies


Process - Level #1
Step #1 Step #2 Step #3

FMEA - Level #1

Process - Level #2
Step #1 Step #2 Step #3

FMEA - Level #2

Process - Level #3
Step #1 Step #2 Step #3

FMEA - Level #3

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Page 7

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process FMEA Steps


1. Identify Heavy Hitter Process Step 2. Identify Associated ys (Product Parameters) Prior to FMEA: Charter Team Develop and Characterize Process Map 3. Failure Mode 4. Identify Failure Effects/Rate Severity 5. Identify Causes/Rate Occurrence 6. Identify Controls (if any)/Rate Detection 7. Calculate RPN 8. Prioritize by RPN Order

9. Determine Actions/Plan
10. Recalculate RPN Based on Plan 11. Take Action
Define Measure Analyze Improve Control Page 8 FMEA Version 2.1 2004 American Society for Quality.
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FMEA Form

Header Accessible from View Header/Footer in Excel

Workbook in Excel

\DataFile\FMEAForm.xls
Define Measure Analyze Improve Control Page 9 FMEA Version 2.1 2004 American Society for Quality.
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Cause-Failure Mode-Effect Continuum

Effect (ys) Cause (xs) Failure Mode

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Page 10

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

The Cause and Effect Diagram Example


Admin/Service Example
Measurements Materials Personnel

First produced in 1950 by Professor Kaoru Ishikawa - Also called the: Ishikawa Diagram Fish Bone Diagram Developed to represent the relationship between some effect and all possible causes influencing the effect.

Failure Mode (Defect)

Failure Effect Environment Methods Machines

\DataFile\CausEff.ppt
Enter causes for each of the 6M branches. Expand or add text boxes as required.
Define Measure Analyze Improve Control 2004 American Society for Quality.
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Page 11 FMEA Version 2.1

Cause and Effect Diagram Example (cont.)

Measurements
Specimen not sufficient

Materials

Personnel

Plastic bags

Patient not in room

Analyzer out of cal Ice

Cant procure specimen

Lab Results Delays


Room too hot Courtesy visits Info desk delays Time of bag spec Room too cold Order slip delays Multiple Results Poor identification Centrifuge not avail Analyzers not avail Info link

Environment

Methods

Machines
The Memory JoggerTM

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Page 12

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Copy Machine Example

Our process is copying documents on a Xerox model XC1045 copy machine.

First, we will construct a process map


Then, we will construct a cause and effect diagram Finally, we will complete an FMEA

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Page 13

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process: Making a Copy \DataFile\CopyProc.ppt


INPUTS
Place Doc into Position in/on Copier Set Number of Copies Needed Set Size Required (xs) N Size display C Size buttons Set Light/Dark Settings (xs) C Darker Button C Lighter Button C Auto Button
.

Select Paper Tray/Source (xs) C 8.5 X 11: Landscape C 8.5 X 11 Portrait

Press Copy Button

Retrieve Copies

OUTPUT
OUTPUTS(Ys) Copies with: right number right contrast correct orientation right size on right paper

(xs) (xs) N Hinges on Lid C # Copies CR Auto Feeder Button N Glass Clean CR # Copies Required INPUTS (Xs) Operator Copy Machine Paper Power Instructions Document to Copy Product (ys) Doc set correctly Doc set incorrectly Upside Down Sideways

(xs) (xs) CRCopy Button C Output Tray N Leds

C 8.5 X 14 Landscape
C 8.5 X 14 Portrait C 11 X 14 C Trays with adequate supply of paper
.

Product (ys) Correct # of Copies Incorrect # of Copies

Product (ys) Right size selected Size too Small Size too Large

Product (ys) Right contrast Too Light Too Dark

Product (ys) Correct Tray Selected Incorrect Tray Selected

Product (ys) Machine producing copies Machine not producing copies

Product (ys) Copies available

KEY for (xs) Process Parameters


N Noise Parameters C Controllable Process Parameter S SOP Parameters CR Critical Parameters

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Page 14

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Step 1: Identify Heavy Hitter Process Step

From the Process Map, identify the process step with the most likelihood of having failure modes with significant effects. Use defect data and/or team knowledge about failure modes when selecting process steps. Significant impact to the business? (COPQ, cycle time, fill rate, ...) Use a Cause and Effect Diagram to capture brainstorming results. After completing FMEA Steps #2-7 for all failure modes associated with this process step, return to this step and select the next most likely Heavy Hitter process step. Not all process steps will need to be analyzed by the FMEA.
2004 American Society for Quality.
All Rights Reserved.

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Control

Page 15

FMEA Version 2.1

Step 2: Identify Associated ys

From the Process Map, identify the ys that are associated with the process step being investigated.

As the ys are the indications of a successful completion of the process step, they are crucial as a basis for determining failure modes.

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Page 16

FMEA Version 2.1

2004 American Society for Quality.


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Step 3: Identify Failure Mode

Brainstorm failure modes for the selected process step Identify the ways in which the process could fail to generate each of the expected ys.

Eliminate duplicates from brainstorm list. Are the failure modes from the same level of the process? Are the failure modes specific? Are the failure modes the most likely? Do the failure modes provide good coverage of the process step? Have all ys been considered?

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Page 17

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Step 4: Identify Failure Effects/Rate Severity

Pick the most likely failure mode and brainstorm the most important effects:

FAILURE EFFECTS are the outcome of the occurrence of the failure mode in the process.
The impact on the customer is what the customer experiences as a result of the Failure Mode.

Identify each effect as being Attribute or Variable.


Severity doesnt change unless the design changes.

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Page 18

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Step 5: Identify Causes/Rate Occurrence

Identify the most likely causes for each failure mode using a Cause and Effect Diagram :

CAUSES are the conditions that bring about the Failure Mode.

Transfer the resulting information to the FMEA form. Assign an occurrence value (1-10) to the likelihood that each particular cause will happen and result in the failure mode. The occurrence score for each cause should be related to the likelihood of that cause resulting in the failure mode and producing the specific associated effect.

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Page 19

FMEA Version 2.1

2004 American Society for Quality.


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Organize Brainstorming Ideas

Copy Process Fishbone


Measurements Materials Personnel

Out of cal

Wrong size paper

Select wrong orientation

Copy Misaligned

Humidity

Doc moved when Align marking not clear lid closed

Environment
Define Measure Analyze

Methods
Improve

Machines
Control

What other causes should we add?


2004 American Society for Quality.
All Rights Reserved.

Page 20

FMEA Version 2.1

Creating a Fish Bone Diagram in Minitab

Lets create the fish bone diagram on the previous page using Minitab

Minitab will allow you up to six bones on your fish


For manufacturing, the bones are typically Measurements Materials Personnel Environment Methods Machines

Give the bones any name you wish Identify a measurable undesirable effect for the head

Define

Brainstorm causes and assign each cause to a bone


Measure Analyze Improve Control Page 21 FMEA Version 2.1 2004 American Society for Quality.
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Fish Bone Diagram in Minitab (cont.)


Approach:

Open Data File FISHBONE The data have been entered in columns C1 through C6 (normally, you would enter your own data) Go to Stat > Quality Tools > Cause-andEffect The dialog box Cause and Effect Diagram will appear as shown

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Page 22

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Fish Bone Diagram in Minitab (cont.)

3
4

1. Highlight Personnel 2. Push Select 3. Personnel will appear in the Causes window next to the Label for Personnel 4. Repeat for all Labels

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Page 23

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Fish Bone Diagram in Minitab (cont.)

1. Type Effect: MISALIGNED COPY 2. Type Title: COPY PROCESS FISHBONE 3. Push OK

1 2

3
Define Measure Analyze Improve Control Page 24 FMEA Version 2.1 2004 American Society for Quality.
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Fish Bone Diagram in Minitab (cont.)

Copy Process Fishbone


Measurements Material Personnel

O ut of calibration

Wrong size paper

S elected w rong orientation

Misaligned C opy

H umidty

D oc mov ed w hen lid closed

A lign marking not clear

Env ironment

Methods

Machines

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Page 25

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Step 6: Identify Controls (if any)/Rate Detection


Identify the current mechanisms in place which prevent the cause from occurring, or detect it before the product reaches the customer. Some examples of controls are SPC, training, maintenance, inspection, SOP etc.

Assign a detection value (1-10) based on an assessment of the likelihood that the current control mechanisms will detect the cause of the failure mode before it reaches the customer.

Dont agonize over detectability.

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Page 26

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Step 7: Calculate Risk Priority Number (RPN)

The product of the estimates of severity


occurrence and detection.

The RPN provides a relative priority for taking action; the bigger the RPN, the more important to address.

RPN = SEVERITY x OCCURRENCE x DETECTION

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Page 27

FMEA Version 2.1

2004 American Society for Quality.


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Steps 8 and 9

8: Prioritize by RPN Order Use the Sort command in Excel to order the spreadsheet in descending order of Risk Priority Number (RPN).

9: Determine Actions/Plan Based on the causes found, determine actions that will minimize the effect of each cause, in priority order.

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Page 28

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Steps 10 and 11
10: Recalculate RPN Based on Plan Assuming the actions are carried out successfully, reassign severity, occurrence and detectability.

Place these new ratings in the predicted columns (ps, po & pd). Assign a rating from 1 to 5 for each action that will show the risk associated with each action (5 being the greatest risk). Place the rating in the risk column.

11: Take Action Based on the risk mitigation column (Risk * prpn), take the actions indicated or reassign actions.

Complete the actions indicated by the times stated!

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Page 29

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Steps 1-11:
Step 1 Step 2 ID ys Step 4
Company: Your Company Project: Copying Process
S Part/ Failure Failure E process Mode Effects V Retrieve No Copies Copies Copy is wrong size Must redo copy Must redo copy Must redo copy O D R C E P C Controls T N

\DataFile\CopyFMEA.xls
Step 6 Step 9 Step 11
Page 1 of 1 Printed on 4/5/00 2:37 PM Owner__Key Operator__ p R Actual r i Risk Resp. Schedule Compl. p p p p s X Person Date Action Taken Date S O D n k prpn Ensured proper supplier used to provide copy Key Opr 3/1 2/15 7 3 7 147 3 441 paper

FMEA
Action Recommended

Causes

Set Size Required

Set Light/ Copy Dark too light Copy Place not Doc into aligned Position properly

Must redo copy

Periodic Ensure proper weight and type Maint. 7 441 paper avail for copiers Place sign over copier outlining Existing standard size enlarge/reduce or User notes on reliable mach to clearly indicate standard reduce/enlarge 7 misset size 7 copier 5 245 User Existing misset notes on Place sign to encourage user to control utilize auto settings 7 5 copier 4 140 Used landscape instead of Tray Place note on ruler re tray portrait or selection 7 vice versa 8 Selection 2 112 7 Paper Jam 9

Key Opr

2/20

Place sign over mach Place sign over mach

2/15

7 3 2 42 1

42

Key Opr

2/20

2/15

7 2 2 28 1

28

Key Opr

1/20

Placed Note

1/15

8 2 1 16 1

16

Step 3

Step 5

Step 7 & 8

Step 10

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Page 30

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process FMEA

Helps analyze manufacturing and assembly processes to reduce the occurrence and improve detection of defects. Assists in the development of process control plans. Establishes a priority for improvement activities. Documents the rationale behind process changes and helps guide future process improvement plans. IS PROACTIVE! Should be started when new processes are designed or when old processes are changed.

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Measure

Analyze

Improve

Control

Page 31

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process FMEA Scoring Definition

Score
10 9 8 7 6 5 4 3 2 1

SEVERITY CRITERIA
Hazardous Without Warning Hazardous With Warning Very High High Moderate Low Very Low Minor Very Minor None

OCCURENCE
>=1 in 2 1 in 3 1 in 8 1 in 20 1 in 80 1 in 400 1 in 2,000 1 in 15,000 1 in 150,000 <1 in 1,500,000 Very High Very High High High Moderate Moderate Moderate Low Low Remote

DETECTION
Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain

Note: When completing a Process FMEA, first assume the material is good and the process is bad. Then assume that the process is good and the material is bad. Lastly, review the process for safety considerations.
Define Measure Analyze Improve Control 2004 American Society for Quality.
All Rights Reserved.

Page 32

FMEA Version 2.1

Sample Process FMEA


S O C

Failure

Failure

Part/process
OBTAIN PARTS

Mode
NO PARTS

Effects

Causes
FAILED TO ORDER < LEAD TIME SUPPLIER DIDN'T DELIVER PART FORECAST CHANGED

C 8 8 4

Controls
SOP (MRP) AD-HOCK EXPEDITING SALES

D E T
2 8 10

R P N
160 640 400

Actions
UPDATE LEAD TIMES CABS, Re-Source

P P P P S O D r P n Plans 5 2 1 5 2 2 20 40

CAN'T BUILD 10 PARTS

WRONG PARTS

CAN'T BUILD PARTS

8 8

WRONG PART ORDERED SUPPLIER ERROR WRONG PARAMETER WRONG PARAMETER TESTER MALFUNCTION INADEQUATE TEST PROCEDURE

2 4 4 2 2 4

SOP UNCONTROLLED TEST COMPLETED TEST COMPLETED CAL LAB CERTIFICATION DESIGN SPECIFICATION

8 6 10 10 10 10

128 192 400 80 80 160


Part Pick Process

0 0 5 1 2 20 0 0 0

FAILS TEST 10 DEFECTIVE 4 PART SHIPPED 4 4

BAD PART

FAILS TEST STOP ASSEMBLY OF UNIT

10 10

WRONG PARAMETER WRONG PARAMETER

2 2

TEST COMPLETED OPERATOR

4 4

80 80

0 0

LATE PART

PARTIAL BUILD 8 8 8

FAILED TO ORDER < LEAD TIME SUPPLIER LATE DELIVERY FORECAST CHANGE GROUND PIN LOCATION EXCESSIVE PRESSURE MISSREGISTRATION INCOMPLETE INSERTION

10 10 4 4 2 2 2

SOP (MRB) AD-HOCK EXPEDITING SALES DRAWING / PROCEDURE OPERATOR OPERATOR OPERATOR

2 8

160 640
CABS, Re-Source

0 4 2 2 32 0 0 0 0

10 320 6 6 4 4 144 72 64 64

LOAD FLEX

DAMAGED MISS INSTALLED CONNECT PINS FAILS TEST

6 6 8 8

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Page 33

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Transactional Process FMEA


Quality Data System
Part/ Process S E Failure Mode Failure Effects V
Not all defect data entered into system Not all defect data entered into system

Causes

O C C

Controls

D R E P T N

Completion

Action Plan
One input form to eliminate redundant data entry.

Who

Date

p p p SOD

p r p n

DPU DPU

Data integrity is suspect Data integrity is suspect

Data entry is repetitive (same info in several docs) Tst Process Sheet, Nonconforming Tag, SPC, 8 spcl reporting reqs 10 None

4 320

Team

Date

2 1 2

Risk (1-5)
1

DPU

Codes confuse assoc

Assocs don't see need for 8 entering PASS info 6 Training Too many codes. Teams Use wrong codes - untrained to limit codes to Training & difficult to extract those meaningful for their Document for 8 area 6 QDB meaningful info Assocs don't see benefits: Crystal Rpts Reports not giving assocs & Point & what's needed to manage Shoot 8 production within Cell 8

Get supervisory buy-in for QDS. Automate test routers.


6 288 Limit # of codes that Cells see to those that affect or are pertinent for their process/product. 6 288

Names

Date

1 1 1

Teams

Date

3 1 2

DPU

Not all defect data entered into Data integrity is suspect system

Provide canned reports. Train Assocs how to obtain info & what reports mean.
4 256

DPU

Scrap Tub Make uninformed No link from CABS to requires no data decisions re 10 Supplier Qual DB to be fed to RI Suppliers Not all defect data entered into Data integrity is suspect system Initial setup of Key Characteristic not Takes longer to implement intuitive

10 Policy

DPU

8 Assocs not trained

Training 6 Manpower

SPC
Test RTY

Infinity SW not user 4 friendly Defect data captured on paper then input into 6 computer.

Data not entered RTY data to be in sequence suspect

8 SW Design Training & # of computers on floor for data 4 192 8 entry

Name Print non-conformance tags from data entered in computer (real time). Eliminate scrap tubs (non-conf on all parts). Link QDB to PQS - await disposition till root cause of part failure is determined. 2 200 Names Plan comprehensive training for QDB: Train the trainer for 2 locations. Make system intuitive to require less less training. 6 288 Names Investigate alternate SPC pkgs and methods to make existing system easier to use. 6 192 Team
Establish real time data entry. Provide adequate computers on floor.

Date

2 1 2

Date

3 1 1

Date

2 2 2

Date

2 4 3 24

120

Names

Date

1 1 2

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Page 34

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Risk X prpn
4

18

16

40

Design/Product FMEA

Helps to identify potential product failure modes early in the product development cycle. Increases the likelihood that all potential failure modes and their effects on assemblies will be considered. Assists in evaluating product design requirements and test methods. Establishes a priority for design improvement. Documents the rationale behind design changes and helps guide future development projects. IS PROACTIVE! Should be done when new products are designed or existing products are changed.

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Page 35

FMEA Version 2.1

2004 American Society for Quality.


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Sample Product FMEA

Does the test really guarantee a failure wont reach the customer?

S Part/ E Process Failure Mode Failure Effects V


SC TST SC TST SC TST SC TST SC TST SC TST SC TST SC TST SC TST Short Travel Short Travel Short Travel Short Travel Short Travel Short Travel Short Travel Short Travel Short Travel Saturation Oscillaion Non linearity Saturation Saturation Saturation SF Stability Oscillation Incorrect output 5 4 3 5 5 5 4 4 4

Causes
Particle in gap Particle in gap Particle in gap Film on parts Particle on coil Particle on magnet Film on parts Film on parts Film on parts

O D R C Controls E P C Detection T N
4 4 4 3 2 2 3 3 3 Sweep Sweep Sweep Sweep Sweep Sweep Sweep Sweep Sweep 4 4 4 3 4 4 3 3 3 80 64 48 45 40 40 36 36 36

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Page 36

FMEA Version 2.1

2004 American Society for Quality.


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Product FMEA Form

Part/ Process Failure Mode


Unit Level I/O, Inputs Failure Receiver Low Receiver Test Sens MTL Variation Unit Level Out of Tolerance

Failure Effects
INOP Target loss & Limited Range

S E V
4 2 2

Causes

O D R C E P Controls C T N

Actions

p p p Plans S O D

p r p n

Current # Defects
1 7 2

TSO Failure Target not in RF Fnt End 1090 Rcvr Brg, correct location (SW Brd) Beamform, Align on Display Limited Range No Noticeable RF Fnt End Return Loss Fails Effect Unit Level 1090 Sens Low

4
2 1

Interconnect cable Vendor Improved open 2 Vendor issue 4 32 conn & process Whitmore 4 1 4 16 Dsn Eval to remove Lo Gain 4 IF Fil Adj 4 32 RF hot spot In Work 2 1 4 8 RF Signal Low, Restrict ability of Cables w/poor RF 4 M&TE, Temp 3 24 cables to move DOE? 2 2 3 12 P-Shifter out of SOP, DOE to improve align due to wire 3 Handling 2 24 process DOE? 4 2 1 8 line couplers RF Front End, Addl Equip needed Lease/ Rcvr, Xmission 4 M&TE, Temp 3 24 to determine cause borrow 2 4 1 8 M&TE Capability/ Mod TE repeatability 5 M&TE 4 20 MSE SW 1 2 4 8

32

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Control

Page 37

FMEA Version 2.1

2004 American Society for Quality.


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Defect FMEA

Helps identify the root causes of defects. Establishes a priority for improvement activities. Documents plan of action. Provides methodology to battle initial ground swell of defects. Focuses effort on defects with highest $ impact. IS NOT PROACTIVE!

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FMEA Version 2.1

2004 American Society for Quality.


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Scoring Criteria
Use actual defect quantities

Score 10 9 8 7 6 5 4 3 2 1

SEVERITY CRITERIA
Hazardous Without Warning Hazardous With Warning Very High High Moderate
Low

OCCURENCE
Very High Very High High High Moderate Moderate Moderate Low Low Remote

DETECTION
Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain

Very Low Minor Very Minor None

Note : To change header information, click on "View" then "Header."


RISK : Optional field used to reflect the probability of completing actions.

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Page 39

FMEA Version 2.1

2004 American Society for Quality.


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Defect FMEA Form


C O S T

Part/ Process

Defect

Causes

Q T Y

D E Controls T

R P N

Actions

p p p Plans S O D
4/23

p r p n

Unit Level Dewetting Solder No/Insufficient Solder (mostly JUnit Level Lead parts) No/Insufficient Soler (mostly JUnit Level Lead parts) Incorrect Unit Level Installation Incorrect Unit Level Installation Unit Level

Solderability of 4 Parts

Component 56 age & storage 4

DOE on part 896 solderability DOE on paste 684 process

4 6 4 96

Screen Thick 4 ATA Paste Process 57 & consistency 3 ATA IR Reflow Process Part Installation Instructions ATA Board Handling GAA Drawings and ECO's Speed and 57 pre-heat 50 SOP 50 SOP 50 SOP

5\7

4 6 3 72

4 4 4 4

3 2 2 2

684 DOE on IR reflow Call ATA re problem 400 Send marked dwg Process flow 400 characterization Dwg Stds & ECO 400 procss improvmnt

4/10 3/30

4 6 3 72 4 5 2 40 0

10/15

4 5 2 40

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Control

Page 40

FMEA Version 2.1

2004 American Society for Quality.


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Catapult Exercise
Analyze the Catapult process using the FMEA tool.
(Remember we want to get the most bang for the buck.)

Break into the Catapult teams. We have already constructed a process map. First, we will construct a cause and effect diagram. Then, we will complete at least two failure modes for the most critical step(s) of our process. Appoint a spokesman for your team to debrief the class on your progress, questions, etc. Complete the FMEA (Datafile/FMEAform.xls) for the Catapult process before the second session (We will use this information for our DOE competition).
Measure Analyze Improve Control Page 41 FMEA Version 2.1
1

25 minutes!

2 3 4 5

Define

2004 American Society for Quality.


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Process Map Catapult

\DataFile\CpultPM.ppt
INPUTS
INPUTS (Xs) Operator Catapult Ball Rubber Bands Instruction Manual Target Target Location Environment C C C C

Set up Launcher
Process (xs) Cup Position Tension Pin Arm Stop Setting Rubber Band Hook Position C Angle Pin Setting C Safety considerations

Select Ball
Process (xs) C Type C Weight N Size N Color

Select Rubber Band


Process (xs) C Number of Rubber Bands N Elasticity of Rubber Band

Final Setting For Shot


Process (xs) C Final Settings C Rubber Band Tension S SOP

Line up and Shoot!


Process (xs) C Operator N Side to side movement S SOP

Measure Distance
Process (xs) C Length C Latteral N Observer N Tape measure

Record Distance
Process (xs) N Paper N Pen C Recorder

OUTPUT
OUTPUTS (Ys ) Ball hits target

. (ys) Product Product (ys) Product. (ys) Product (ys) Right size selected Launcher Setup Right settings Correct Ball Selected Correctly for Desired Incorrect Ball Selected Size too Small Incorrect Setting Distance Size too Large Launcher set Not enough tension incorrectly Wrong Cup Position Stop Wrong Tension Pin Wrong Wrong # Rubber Bands Accident/Injury

Product (ys) Product (ys) Product (ys) Ball successfully Distance Correct Data Recorded away Distance Incorrect Data Errors Ball not successfully away Injury

KEY for (xs) Process Parameters N Noise Parameters C Controllable Process Parameters S SOP Parameters CR Critical Parameters

Define

Measure

Analyze

Improve

Control

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FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Catapult Cause and Effect Diagram


Measurements Materials Personnel
Ball Ty pe

\DataFile\CausEff.ppt
Ball Set or Pressed

Consistent Measuring

Ball W eight Ball Material Rubberband Strength Rubberband Texture Rubberband Tension

Consistent Release T

Pressing Down when r Rubberband New Rubberband Used

Distance
Rubberband Configura Inc line or Level Sec uring to Floor at Fric tion pegs Start Angle Height off Floor Plac ement of Rubberb Stop Angle Top or Bottom of Peg Floor Covering Smooth Release Top or Bottom of Hoo Length of Arm

Environment

Methods

Machines

Use this info or your own to create a C&E Diagram


Define Measure Analyze Improve Control Page 43 FMEA Version 2.1 2004 American Society for Quality.
All Rights Reserved.

When to Update an FMEA?


An FMEA should be updated whenever a change is being considered to a products:

design

application
environment material

products manufacturing or assembly process

Define

Measure

Analyze

Improve

Control

Page 44

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Summary of Product/Process FMEAs


What is the tool? - Spreadsheet What will the tool identify/ show?
All

product/process failure modes, related effects, causes, & methods of control. Risk Priority Number (RPN) for action based on failure severity, probability of occurrence and detection capability. Actions/plans to reduce elements of RPN.

When to apply this tool?


When evaluating product for robustness (functionality, produceability, reliability). During early stages of defect reduction efforts to identify causes. When identifying key process/product parameters and evaluating methods for control.

What results can you expect?


Learn

to identify critical product/ process parameters. Achieve consensus on solutions and methods of implementation. Detailed product/process understanding.
Define Measure Analyze Improve Control

Page 45

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Keys to Success

Identify purpose...BE SPECIFIC! Understand effects...INVOLVE CUSTOMERS & SUPPLIERS! Link to the process map. Use to prioritize efforts, allocate resources. Use as a risk assessment/prioritization tool based on predicted impact. Use to build consensus on prioritization. Encourage creativity...TEAMWORK! PLAN! ASK QUESTIONS!

Define

Measure

Analyze

Improve

Control

Page 46

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Process FMEA Steps


1. Identify Heavy Hitter Process Step 2. Identify Associated ys (Product Parameters) Prior to FMEA: Charter Team Develop and Characterize Process Map 3. Failure Mode 4. Identify Failure Effects/Rate Severity 5. Identify Causes/Rate Occurrence 6. Identify Controls (if any)/Rate Detection 7. Calculate RPN 8. Prioritize by RPN Order

9. Determine Actions/Plan
10. Recalculate RPN Based on Plan 11. Take Action
Define Measure Analyze Improve Control Page 47 FMEA Version 2.1 2004 American Society for Quality.
All Rights Reserved.

What We Have Learned ...

1. As a Team, how to construct an FMEA and associated Action Plan 2. How the FMEA process ties to process mapping 3. The relationship between Failure Mode, Cause and Effect 4. The different types of FMEAs

Define

Measure

Analyze

Improve

Control

Page 48

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

FMEA Scoring Criteria & Terminology


FMEA Appendix

\DataFile\FMEAform.xls

Define

Measure

Analyze

Improve

Control

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FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Scoring Criteria

Score
10 9 8 7 6 5 4 3 2 1

SEVERITY CRITERIA
Hazardous Without Warning Hazardous With Warning Very High High Moderate Low Very Low Minor Very Minor None

OCCURENCE
>=1 in 2 1 in 3 1 in 8 1 in 20 1 in 80 1 in 400 1 in 2,000 1 in 15,000 1 in 150,000 <1 in 1,500,000 Very High Very High High High Moderate Moderate Moderate Low Low Remote

DETECTION
Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain

Define

Measure

Analyze

Improve

Control

Page 50

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Key Definitions for FMEA


Severity is an assessment of how serious the effect of the potential failure mode is on the customer.
The customer in this case could be the next operation, subsequent operations, or the end user.

Occurrence is an assessment of the likelihood that a particular cause will happen and result in the
failure mode.

Detection is an assessment of the likelihood that the current controls (design and process) will detect
the cause of the failure mode, should it occur, thus preventing it from reaching your customer. The customer in this case could be the next operation, subsequent operations, or the end user.

Current Controls (for both design and process) are the mechanisms which prevent the cause of the
failure mode from occurring, or detect the failure mode, should it occur, before the product reaches your customer. For example, current controls include SPC, inspections, written procedures, training, preventive maintenance and all other activities that ensure a smooth running process.

Critical Characteristics are those items which affect customer safety and/or could result in noncompliance to regulations and thus require controls to ensure 100% compliance. These are usually processsettings such as temperature, time, speed, etc.

Significant Characteristics are those items which require SPC and quality planning to ensure
acceptable levels of capability.

Define

Measure

Analyze

Improve

Control

Page 51

FMEA Version 2.1

2004 American Society for Quality.


All Rights Reserved.

Terminology
A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T.
Define

Process or Product Name Description of Process or Product being analyzed. Responsible Name of Process Owner. Prepared By - Name of Agent coordinating FMEA study. FMEA Date Dates of Initial and subsequent FMEA Revisions. Process Step/Part Number Description of individual item being analyzed. Potential Failure Mode Description of how the process could potentially fail to meet the process requirements and/or design intent, i.e. a description of a non-conformance at that Potential Failure Effects Description of the effects of the Failure Mode upon the customer, i.e. what the next user of the process or product would experience or notice. SEV (Severity) An assessment of the seriousness of the effect of the potential failure mode Potential Causes Description of how the failure could occur, described in terms of something OCC (Occurrence) Description of how frequently the specific failure cause is expected to Current Controls Description of process controls that either prevent, to the extent possible, DET (Detection) An assessment of the probability that the current controls will detect the potential cause, or the subsequent failure mode. RPN (Risk Priority Number) The product of the Severity, Occurrence, and Detection Rankings i.e. RPN = SEV * OCC * DET. Actions Recommended Actions to reduce any or all of the Occurrence, Severity or Detection rankings. Responsibility Person or group responsible for the Recommended Action. Actions Taken Brief description of actual action and effective date. New SEVERITY Rating after corrective action. New OCCURENCE Rating after corrective action. New DETECTION Rating after corrective action. Resulting new RPN after corrective action.
Measure Analyze Improve Control Page 52 FMEA Version 2.1 2004 American Society for Quality.
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