QM-085-Design Andd Process Fmea

Design & Process FMEA

Grow &
Innovate

Eliminate Reduce
Waste Variability

© 2005 Textron Inc. Design & Process FMEA V5.0 [1/2005] 1

Module Objectives

• By end of this module participants will:

- Review Failure Mode & Effects Analysis to analyze and
communicate risk and plans to manage it

- Understand how to construct a complete FMEA to analyze,
communicate, and manage design risk and process risk

© 2005 Textron Inc. Design FMEA V5.0 [1/2005] 2

Key Concepts/Tool Road Map
Phase 1
Gate 0

Gate 1
Customer and Define Customer CTS
Validate Business Case
Business Requirements
Requirements Assess Technology
Definition CTS Risk

Phase 2

Gate 2
Functional
Conceptual Generate Ideas Evaluate Concepts
Requirements (FR)
Design and

Segment Specific Deliverables
Feasibility

Phase 3 N

Gate 3
Requirement Map FR to Design Interface Y
Preliminary Req Met? DFx*

Textron Deliverables
Flow Down Parameters (DP) Management
Design

Simulation Map
Phase 4 Y Design
Transfer Noise Y

Gate 4
Detail Simulation FRs 6σ DP to
Function Management
Design Viable? Capable? Process
DP
Variables
N Model DOE Return to Phases 1 or 2 N

Build Pilot / Prototype DOE - Function Verification

Gate 5
Phase 5
Pilot/ Test OK? Y
Prototype Improve Pilot / Prototype N

Phase 6
Product & Implement Design Process capable?
Y
Waste Elimination

Gate 6
Process Solution at Production N
Validation / Service Environment Focus/Error Proof
DFSS/Improve Process

Phase 7

Gate 7
Supply Chain Implement Design
Transition Readiness & Process Controls

DFx* = Design For (Manufacturability, Assembly, Reliability, etc.)


Key Concepts/Tool Road Map


Design & Process FMEA Summary

What is it? Why Used?
• A systematic approach to KEY PRINCIPLE:
prioritize risks associated with Risk Management
specific causes, identify ways • Enhance probability of success
of eliminating or reducing the in realizing product and service
specific causes, and document goals
a plan to prevent the possible • Avoid costly rework, defects
failures of a product or service. and failure by proactively
focusing on potential risky
areas early in the project

NP&SI Deliverable(s)
• Risk Assessment / Management


Types Of FMEA

• Types of FMEA
- Project/Program: Identifies what can go wrong with a
major project
- Design: Identifies what can go wrong with the design
of a product or service. Consideration for System,
Subsystem, Component.
- Process: Identifies what can go wrong with a process
- Service: Identifies what can go wrong with a service
function
- Application: Identifies what can go wrong with
customers using your product or service


FMEA Steps


Blank FMEA Form

1 2 3
4 5

6

1. System/Component: process being analyzed
2. Design Responsibility: function updating FMEA over time
3. Prepared By: person currently responsible for FMEA
4. FMEA Date (Orig): original FMEA release date
5. (Rev.): date of latest revision of FMEA
6. Item/Process/Function: specific part of program being analyzed
and function


Blank FMEA Form

7 9 11 12
8 10

7. Potential Failure Mode: how component can fail to function
8. Potential Effects: customer impact of failure mode
9. Severity (Sev): magnitude of effect of failure mode
10. Potential Causes: failure point
11. Occurrence (Occur): rates frequency of failure mode
12. Detection (Detec): how well can failure be detected


Blank FMEA Form

13 15 16 17
14

13. Detection (Detec): how well can failure be detected
14. Risk Priority Number: Severity x Occurrence x Detection; (RPN)
15. Recommended Actions: actions which will lower RPN rating
16. Responsibility: individual taking recommended action
17. Actions Taken: system changes lowering RPN


Risk Priority Numbers, RPN

• The risk priority number (RPN) is the product of the rankings for:
- Severity (SEV)
- Probability of Occurrence (OCC)
- Difficulty to Detect (DET)
• High RPN’s are flags to take effort to reduce the calculated risk
• High severity ratings should be given special attention
(regardless of RPN)

RPN = SEV x OCC x DET

Effects Causes Controls


Rating Definitions

Severity Occurrence Detection
Rating
Hazardous
Hazardous Very high and
Very high and Cannot detect
Cannot detect
High 10 without almost or detection
without almost or detection
warning
warning inevitable
inevitable with very low
with very low
probability
probability
Loss of primary
Loss of primary High repeated
High repeated Remote or low
Remote or low
function
function failures
failures chance of
chance of
detection
detection
Loss of
Loss of Moderate
Moderate Low detection
Low detection
secondary
secondary failures
failures probability
probability
function
function
Minor defect
Minor defect Occasional
Occasional Moderate
Moderate
failures
failures detection
detection
probability
probability
No effect
No effect Failure unlikely
Failure unlikely Almost certain
Almost certain
Low 1 detection
detection


Getting Started

• Utilize Concept Design, Process Maps, Quality Function
Deployment, and any other pertinent information
• Select people from functions directly upstream and
downstream from system under analysis
- Engineering
- Manufacturing
- Quality Assurance
- Marketing
- Suppliers and other required business functions


Method To Complete Design FMEA

1. For each Risk Item, determine the ways in which the
Design can go wrong (These are Failure Modes)
2. For each Failure Mode associated with the item, determine
Effects
3. Identify potential Causes of each Failure Mode
4. List the Current Controls for each Cause
5. Assign Severity, Occurrence and Detection ratings to each
Cause
6. Calculate RPN
7. Determine Recommended Actions to reduce High RPN’s
8. Take appropriate Actions and Document
9. Recalculate RPN’s


DFMEA Example
E-mail Response

How could design inputs fail and cause outputs not to meet
customer requirements?

Process Map
Inputs Outputs

Customer E-mail Answer with
E-mailed Response
Question E-mail
Responses

We will review a portion of DFMEA together using
hypothetical E-mail Response process and file DFMEA.xls.


Internet E-mail Response
MEASUREMENTS SUPPLIES PEOPLE

Backlog Transfers to Right Team
Phone Support Unit
Cycle Time
Available Marketing Training
Volume
Materials
PC Delays

Quality

Customer Satisfaction
Respond to
E-mail within
48 hours

Service Centers

Research Facilities

Archives

ENVIRONMENT PLACES POLICIES & PROCEDURES


DFMEA Example
E-mail Response
Failure Mode and Effects Analysis
(Design FMEA)

Determine the ways in which the Design can go wrong


DFMEA Example
E-mail Response
(Design FMEA)

Item /
Process Potential Failure
Mode
Function

Receive customer
Respond with
question and determine
wrong/incorrect answer
appropriate answer

For each Failure Mode associated with the item, determine Effects


DFMEA Example
E-mail Response
(Design FMEA)

Item /
Process Potential Failure Potential Effect(s) of
Mode Failure
Function

Receive customer
Respond with Customer receives mis-
wrong/incorrect answer information
appropriate answer

Identify potential Causes of each Failure Mode


DFMEA Example
E-mail Response
(Design FMEA)

Item /
Potential Cause(s)/
Mechanism(s) of
Mode Failure
Failure
Function

Unfamiliar question--
Receive customer
Respond with Customer receives mis- inexperience of
wrong/incorrect answer information technical response
appropriate answer
staff

Data entry error for
response choice

Unknown - Different
language

List the Current Controls for each Cause


DFMEA Example
E-mail Response
(Design FMEA)

Item /
Mode
Function

Receive customer
Respond with
wrong/incorrect answer
appropriate answer

Assign Severity, Occurrence and Detection ratings to each Cause


DFMEA Example
E-mail Response
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e
Process Potential Failure Potential Effect(s) of Current Design Current Design
e Mechanism(s) of c t
Mode Failure Controls Prevention Controls Detection
v Failure u e
Function
r c

Receive customer Manual supervisor
question and determine 7 8 New hire training review during OJT 6
appropriate answer phase
staff

7 7 none 10
response choice

Six languages currently
Unknown - Different
7 5 represented in 5
language
response team

Calculate RPN


DFMEA Example
E-mail Response
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e R.
e Mechanism(s) of c t P.
v Failure u e N.
Function
r c

question and determine 7 8 New hire training review during OJT 6 336
staff

7 7 none 10 490
response choice

Unknown - Different
7 5 represented in 5 175
language
response team

Determine Recommended Actions to reduce High RPN’s


DFMEA Example
E-mail Response
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e R. Responsibility &
Process Potential Failure Potential Effect(s) of Current Design Current Design Recommended
e Mechanism(s) of c t P. Target Completion
Mode Failure Controls Prevention Controls Detection Action(s)
v Failure u e N. Date
Function
r c

Respond with Customer receives mis- inexperience of Build automated Response team:
question and determine 7 8 New hire training review during OJT 6 336
wrong/incorrect answer information technical response response database 6/1/01
staff

Data entry error for Build automated Response team:
7 7 none 10 490
response choice response database 6/1/01

Add four additional
Unknown - Different language capabilities:
7 5 represented in 5 175 Chris P. Owner: 4/1/01
language Dutch, Japanese,
response team
Hindi, Swahili

Take appropriate Actions and Document
Recalculate RPN’s

Design FMEA Used Throughout Design
Process

Design FMEA is living document and should be:
• Initiated before or at design concept finalization
• Continually updated as changes occur
• Fundamentally completed before product/service is released
to production (production drawings are released for tooling)
• Revisited during pre-production and production (Process
FMEA)


Relationship To Other Tools
• Metrics Identification
• Process Map
• C & E Diagrams
• C & E Matrix/QFD
• Kano Diagram
• Pugh Matrices
Design FMEA (Product or Service)
Process FMEA (Product or Service)
• Multivariate analysis
• Identification of vital few
inputs
• Design reviews
• Quality Control Plan


Team Exercise

• Pick an item from your project or an example from
every day life and build a simple FMEA around it

• Flipchart a Pareto of rpn’s versus PIV’s


Lessons Learned / Pitfalls to Avoid

• Do not try alone, use a group
• Time consuming process
• Activities are required for completion
• Train team
• Proper preparation for meetings
• Summarize often
• Independent voting
• Negotiate issues


Example Report Page


Key Module Learning Points

•
•
•
•
•


Module Objectives Revisited

• By end of this module participants will:
- Review Failure Mode & Effects Analysis to analyze and
communicate risk and plans to manage it
- Understand how to construct a complete FMEA to analyze,
communicate, and manage design risk and process risk


Appendix

Grow &
Innovate

Eliminate Reduce
Waste Variability


One Page Pullout

Design & Process FMEA
• Utilize Concept Design, Process
Maps, Quality Function
Deployment, and any other
pertinent information
• Select people from functions
directly upstream and downstream
from system under analysis
- Engineering
- Manufacturing
- Quality Assurance
- Marketing
- Suppliers and other
required business
functions


Transactional Process FMEA Example
Item Process Step Key Process Input Potential Failure Mode Potential Failure Effects SEV Potential Causes OCC Current Controls DET RPN EOC

cause or FM occur?

detect cause or FM?
customer?
What is the What is the Function How can this process What are the effects of A w hat causes the What are the existing

How Severe is the
effect to the

How often does

How well can you
process step of the Process Step step go w rong? this step going w rong? process step to go controls and procedures
(Key Process w rong? (inspection and test) that
Input)? prevent either the cause
or the Failure Mode?
Should include an SOP
number.

1 Annually Establish Clear expectations Customers and Lack of training Sales Training
establish annualized of the customer are Salespeople will not
Customer forecasting by not established have a foundation of
Business Plan model during the discussion related 9 9 1 81 9
development of the to forecasting
Customer Business accuracy.
Plan
Manage the Monthly review Regular follow up Forecast data will Priority and time to Sales Training
forecasting to analyze and questioning not be accurate meet with all the
element of the performance to does not happen 9 dealers. (face to 9 9 729 9
Customer estimated face or by phone)
Business Plan forecast
Customer does not Dealer termination Lack of training Sales/Dealer
cooperate Training to improve
3 3 1 9 9
expectations of
dealers
Gather Data Collect a rolling Inaccurate Inaccurate forecast Economic changes None
from customers 12 month information given to during the month.
forecast by the salesperson 9 3 1 27 9
customer, by
model
Customer does not None
9 analyze his needs. 3 1 27 9

2 No contact made Inaccurate forecast Salesperson None
with the customer managing time and
9 priorities 3 3 81 9

4 National account Understatement of Salesperson input None
does not include all forecast to the quot;national
inputs 9 account 9 9 729 3
salespersonquot;

6 Electronically To accumulate Saleperson enters Lack of or Salesperson Submit and review
Summarize and summarize wrong data in wrong excessive inventory selecting the wrong reports. Double
data data in a month, customer, of Finished Goods, item. check entry before
3 1 3 9 0
standard format model, etc. Raw, WIP submission
that is tied to
Oracle
8 Customer is not set Customer forecast Credit process Credit approval
up with credit cannot be entered. 3 holds up entry of 1 process and Pending 1 3 0
approval new customers report.
9 Summarize Acccumulate Missing information Poor understanding Changing priority None
Demand information that of the and schedule by
Planning supports the recommendation 3 new development 1 3 9 0
Cookbook recommendation team
of the forecast
10 Poor correlation Incorrect Communication to None
data used recommendation 3 salespeople not 3 3 27 0
© 2005 Textron Inc. clear or, not done.
Design FMEA V5.0 [1/2005] 34

Manufacturing Process FMEA Example
S O D R
Key Process
Item # Process Step Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P
Input
V C T N

How Severe is the
effect to the

How often does cause
cusotmer?

or FM occur?

How well can you
detect cause or FM?
What is the What is the Key In what ways does the Key What is the impact on the What causes the Key Input to What are the existing controls
process step Process Input? Input go wrong? Key Output Variables go wrong? and procedures (inspection and
(Customer Requirements) or test) that prevent either the cause
internal requirements? or the Failure Mode? Should
include an SOP number.

1 Basecoat Paint Supplier Customer specifies difficult Lower yeilds, lower transfer Specification of only one none
Supplier as single source efficiency, higher costs, poor 9 approved source. Inability to 10 10 900
service (frieght and material) qualify additional sources.
2 Basecoat Paint Supplier Customer specifies difficult Transfer Efficiency and % Solids and/or viscosity? none
Supplier as single source Yeilds vary by supplier 8 10 10 800

3 Topcoat Paint Supplier Customer specifies difficult Transfer Efficiency and % Solids and/or viscosity? none
Supplier as single source Yeilds vary by supplier 8 10 36 key process inputs
10 800

4 Basecoat Consistent Fluid Too much high thickness, out of spec Improper set up or monitoring Process check sheet
were reduced to 13.
Flow color, appearance 10 10 Lessons learned,
8 800

5 Basecoat Consistent Fluid tool little low thickness, out of spec Improper set up or monitoring Process check however = tried to fix too
sheet
Flow color, appearance 10 10 8 800
much with this first
6 Gun Setup Booth Dynamics Improper Fan settings Create particulates, te Poor discipline or adherence to none
8 procedures 10
FMEA. 10 800 Performed a
7 Gun Setup Fluid Flowrate excess variation in fluid inconsistent film thickness unknown?
second, more focused,
fluid flow meter, visual inspection
flow 7 10
FMEA
10 700

8 Receiving % Solids too low lower transfer efficiecies Manufacturer specifications none
Inspection 6 10 10 600

9 Load Operators improperly loaded paint thickness consistency condition of six up or plastic none
from painting at two different 8 fixtures 7 10 560
heights and parts fall off too
10 Load Operators improperly loaded easily
paint thickness consistency poor plastic fixture design none
from painting at two different 8 7 10 560
heights and parts fall off too
11 Basecoat Cap and Tip Cap and tip either plug or easily
Low fluid flow, low thickness, Operator error none
Cleanliness greatly reduce flow and fan offspec color 10 5 10 500

12 Basecoat Stress in plastic Chemical attack of high color variation, high stress Improperly developed and Receiving Inspection
stress areas. areas etched by solvent 10 defined molding process 8 5 400
(gating?).


Manufacturing Process FMEA Example
D R
S O
Key Process E P
Process Step Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls
Input T N
V C

How well can you
detect cause or FM?
How Severe is the
effect to the

How often does cause
cusotmer?

or FM occur?
What is the What is the Key In what ways does the Key What is the impact on the What causes the Key Input to What are the existing controls
process step Process Input? Input go wrong? Key Output Variables go wrong? and procedures (inspection and
(Customer Requirements) or test) that prevent either the cause
internal requirements? or the Failure Mode? Should
include an SOP number.

Loading Fixture Sixups dirty High particulates, lower Not cleaned often enough None
• Second pass FMEA;
Cleanliness yeilds 10 10 10 1000

Gun Set Gun Orientation Overspray from bottom gun High particulates, lower Bottom gun first instead of last none
focused on #1 source
settling on unpainted parts yeilds 10 10 10 1000
of scrap; particulates
Paint Application Paint Supplier Customer specifies difficult Lower yeilds, lower transfer Specification of only one none
Supplier as single source efficiency, higher costs, poor
service (frieght and material)
9 approved source. Inability to
qualify additional sources.
10 10 900
• 6 Key Process Inputs
Gun Set Gun Orientation Overspray from bottom gun High particulates, lower
settling on unpainted parts yeilds 10
Improper gun setup creating
dryer spray and particulate
contamination
8
setup sheet or none
10 800 identified, fixture
Paint Application Booth Dynamics Increase airborne
and cleanliness contamination
higher than normal
particulate scrap at the start 8
Unstable process. Needs to
reach equilibrium 10
none
10 800
cleanliness, gun
Loading/Unloading Fixture
Cleanliness
Sixups dirty High particulates, lower
yeilds
Not cleaned well enough None
10 700
orientation, paint
10 7

Gun Set Gun Orientation Spraying walls of booth High particulates, lower Improperly defined process none
supplier,
yeilds 10 700
10 7
booth dynamics,
Paint Application Booth Dynamics Doors to booth open Create particulates, te Poor discipline or adherence to none
8 procedures 8 10 640
operator and paint
Gun Setup Operator Inadequate preventive
maintenance
High particulates, lower
yeilds 9
Inadequate cleaning of the
booth 7
None
10 630 removal filter.
Basecoat Paint Removal Improperly Sized High particulates, lower Improper Specification none
Filter yeilds 8 7 10 560

Basecoat Paint Removal Filter dirty High particulates, lower Operator error. Filter not none
Filter yeilds 8 changed enough. 7 10 560

Gun Setup Booth Dynamics unbalanced or improper Create particulates, te improperly setup, poor booth none
airflow (turbulence, wrap 8 design 7 10 560
back)
Gun Setup Booth Dynamics Improper Fan settings Create particulates, te Poor discipline or adherence to none

Gun Setup Booth Dynamics Air filter plugging Create particulates, te Poor discipline or adherence to maintenance log


Industrial Example

Grow &
Innovate

Eliminate Reduce
Waste Variability


DFMEA Example
Wireless E-mail Device
How could design fail and cause outputs not to meet
customer requirements?

Case

Thumb Answer with
Screen
“keyboard” E-mail
Responses
Electrical
“components”

We will review a portion of DFMEA together using
hypothetical E-mail Response process and file DFMEA.xls.


DFMEA Example
(Design FMEA)

Determine the ways in which the Design can go wrong


DFMEA Example
(Design FMEA)

Item /
Mode
Function

Thumb quot;keyboardquot; --
Plastic key hinges
provides input device
break
for composing e-mail

For each Failure Mode associated with the item, determine Effects


DFMEA Example
(Design FMEA)

Item /
Mode Failure
Function

Plastic key hinges Keys fall off --
break preventing input

Identify potential Causes of each Failure Mode


DFMEA Example
(Design FMEA)

Item /
Potential Cause(s)/
Mechanism(s) of
Mode Failure
Failure
Function

Plastic key hinges Keys fall off -- Device used beyond
break preventing input design life

Chemical attack of
plastic by solvents

Plastic molding done
with incorrect material

List the Current Controls for each Cause


DFMEA Example
(Design FMEA)

Item /
Mode
Function

Plastic key hinges
break

Assign Severity, Occurrence and Detection ratings to each Cause


DFMEA Example
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e
e Mechanism(s) of c t
v Failure u e
Function
r c

Thumb quot;keyboardquot; -- Design life established
provides input device 7 6 at 99.5% of focus 4
for composing e-mail group usage

Cleaning
Chemical attack of recommendations
7 7 5
plastic by solvents printed in owners
manual

7 3 none 10

Calculate RPN


DFMEA Example
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e R.
e Mechanism(s) of c t P.
v Failure u e N.
Function
r c

provides input device 7 6 at 99.5% of focus 4 168

Cleaning
Chemical attack of recommendations
7 7 5 245
plastic by solvents printed in owners
manual

7 3 none 10 210

Determine Recommended Actions to reduce High RPN’s


DFMEA Example
(Design FMEA)

O D
Item /
S Potential Cause(s)/ c e R. Responsibility &
Process Potential Failure Potential Effect(s) of Current Design Current Design Recommended
e Mechanism(s) of c t P. Target Completion
Mode Failure Controls Prevention Controls Detection Action(s)
v Failure u e N. Date
Function
r c

Plastic key hinges Keys fall off -- Device used beyond Extend design life to Design Team:
provides input device 7 6 at 99.5% of focus 4 168
break preventing input design life include 99.9% of usage 4/1/01

Cleaning
Change material
Chemical attack of recommendations Casey T. Member:
7 7 5 245 specification to improve
plastic by solvents printed in owners 3/1/01
chemical resistance
manual

Plastic molding done Require supplier's
7 3 none 10 210 Jo T. Member: 6/1/01
with incorrect material control plan

Take appropriate Actions and Document
Recalculate RPN’s

General Scoring Designs

Grow &
Innovate

Eliminate Reduce
Waste Variability


General Rating Scales
RATING DEGREE OF SEVERITY LIKELIHOOD OF OCCURRENCE ABILITY TO DETECT
1 Customer will not notice the adverse effect or Likelihood of occurrence is remote Sure that the potential failure will be
it is insignificant found or prevented before reaching
the next customer
2 Customer will probably experience slight Low failure rate with supporting Almost certain that the potential
annoyance documentation failure will be found or prevented
before reaching the next customer
3 Customer will experience annoyance due to Low failure rate without supporting Low likelihood that the potential
the slight degradation of performance documentation failure will reach the next customer
undetected
4 Customer dissatisfaction due to reduced Occasional failures Controls may detect or prevent the
performance potential failure from reaching the
next customer
5 Customer is made uncomfortable or their Relatively moderate failure rate Moderate likelihood that the potential
productivity is reduced by the continued with supporting documentation failure will reach the next customer
degradation of the effect
6 W arranty repair or significant manufacturing Moderate failure rate without Controls are unlikely to detect or
or assembly complaint supporting documentation prevent the potential failure from
reaching the next customer
7 High degree of customer dissatisfaction due Relatively high failure rate with Poor likelihood that the potential
to component failure without complete loss of supporting documentation failure will be detected or prevented
function. Productivity impacted by high scrap before reaching the next customer
or rework levels.
8 Very high degree of dissatisfaction due to the High failure rate without supporting Very poor likelihood that the potential
loss of function without a negative impact on documentation failure will be detected or prevented
safety or governmental regulations before reaching the next customer
9 Customer endangered due to the adverse Failure is almost certain based on Current controls probably will not
effect on safe system performance with warranty data or significant DV even detect the potential failure
warning before failure or violation of testing
governmental regulations
10 Customer endangered due to the adverse Assured of failure based on Absolute certainty that the current
effect on safe system performance without warranty data or significant DV controls will not detect the potential
warning before failure or violation of testing failure
governmental regulations


Detection Criteria For Design FMEA
RANK EXAMPLE

1-2 Will be detected prior to releasing for production

3-4 Will be detected after release but prior to mass
production is started
5-6 Will be detected prior to shipping out the finished
product or service
7-8 The failure mode will be detected prior to a
catastrophe in application
9-10 Undetectable until catastrophic occurrence in
application


QM-085-Design Andd Process Fmea

QM-085-Design Andd Process Fmea

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (20)

Similar to QM-085-Design Andd Process Fmea

Similar to QM-085-Design Andd Process Fmea (20)

More from handbook

More from handbook (20)

Recently uploaded

Recently uploaded (20)

QM-085-Design Andd Process Fmea