Risk Reduction Through
Characteristic Management and FMEA
R. Dan Reid
M.B.S., M.A., ASQ Fellow, ASQ CQE
ASQ Automotive, Healthcare and Quality Management Divisions
FMEA
Failure Modes Effects Analysis is a tool used to list
possible failure modes of a product, service or
process and provide a rating so the focus of any
improvement effort is placed on the most important
Failure Mode is a manner in which the product or
service does not meet the customer requirements
Effect Analysis is the study of the effects of failure
on fit for usefulness
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FMEA Benefits
Quantifies risk to improve risk management as the right
thing to do is not always intuitive
Drives preventive action to avoid adverse events
Drives corrective action across similar processes
Improves quality, safety and profit margin
Provides documentation for organizational memory
Can be used to track progress over time
Improves customer satisfaction
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Applications
Design
analyze products or services before they are released
Process
analyze service, manufacturing & assembly processes
Concept
analyze systems or subsystems in the early design
concept stages
Equipment
analyze machinery and equipment design before they
are purchased
Facilities
analyze facility layout before construction to minimize
waste associated with the floor layout
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Design vs. Process FMEA
Design FMEA
Main focus is on design of the product or service and
specifications which enable the product or service to
meet the intended use
Process FMEA
Main focus is on the process which will allow the service
to be made repeatable to the requirements or design
specifications
Utilizes process knowledge and historical process data
to identify and help eliminate potential process failure
modes
The thought pattern for development is identical
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FMEA Scopes
System
All applicable interfaces and
interactions should be addressed
Subsystem
Component
Component
Component
Component
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Subsystem
Component
Component
Component
Component
Subsystem
Component
Component
Component
Component
Subsystem
Component
Component
Component
Component
For Each Potential Problem Listed
(S) - Rate the severity of the problem on a scale from one
to 10 (1 being very low and 10 being major)
(O) - Rate the likelihood of the problem occurring again
on a scale from one to 10. (1 being almost never
and 10 very likely)
(D) - If the problem occurs what is the likelihood we
would detect it, again one to 10. (1 means we would
detect it for sure and 10 means we probably
wouldnt be able to detect it
Each Should Be Rated Independently!
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Risk Priority Number (RPN)
For each problem on the list calculate an RPN or
Risk Priority Number
To do this multiply the Severity number by the
Occurrence Number by the Detection Number
RPN = S x O x D
This number will be between one and 1000; The
higher the number the greater the potential
problem
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Failure Modes
There Are 3 Main Types Of Design Failure Modes
Materials
Processes
Costs
There Are 4 Main Types Of Process Failure Modes
Too Much
Too Little
Missing
Wrong
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FMEA Acceptance Criteria:
A good FMEA should:
be completed across to the right side which is the
area for re-computing the Risk after initial efforts
have been taken to reduce the initial high risk
rating, e.g. RPN;
list multiple effects for each mode and multiple
causes for each effect. Generally there is not a 1:1
relationship as any given failure mode could have
many effects;
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FMEA Acceptance Criteria:
A good FMEA should:
list actions taken on high severity and high RPN,
or other risk ratings, aimed at preventing the
occurrence of a potential failure
Responsibility for the actions taken should be assigned
and tracked to completion
include efforts to error-proof the design and/or
mistake-proof the process
ensure that measurement uncertainty is known
and adequate for applicable metrics;
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FMEA Acceptance Criteria:
A good FMEA should:
identify characteristics which should be designated as
special or critical on the Control Plan so actions can be
planned and implemented to mitigate the effects of the
potential failure
This should include reference to a contingency plan to protect your
customer from receiving non-compliant product
carefully consider all the risk, e.g. safety, quality,
equipment and resource as well as efficiency of methods
used, actions taken and contingency planning;
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FMEA Acceptance Criteria:
A good FMEA should:
consider the major types of design failures:
materials,
processes,
costs or
consider the major types of process failures:
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too much,
too little,
missing or
wrong
Severity Rankings
FMEA Analysis
10
9
8
7
6
5
4
3
2
1
Critical Characteristic
(Error-Proofing)
Continuous
Improvement
(RPN Reduction)
Minor issues
Occurrence Ratings
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10
Risk Priority Number Reduction
FOR EACH BUSINESS UNIT OR SERVICE TYPE
PFMEAs
PROCESS
LIST ALL
RPNs
RPN
LESS THAN
TARGET
PARETO'S
OF RPNs
MANAGEMENT
REVIEWS
RPN
OVER
TARGET
*
PRIORITY ACTION PLAN
BY NATURAL OWNER
PERIODIC
REVIEWS
* Or any with
high severity
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TOP 5"
LIST
ACTION
PLANS
TRACK
PROGRESS
FMEA Tracking
Top Five RPN (can be Top 10 or Top n)
OP
No. No.
1
2
3
4
Master
5
RPN
Value
Function & Failure Mode
Who
Completion Revised
Date
RPN
Recommended Actions
Dot Tracking
STATUS HISTORY
ITEM
ACTION ITEM
ACTION
LEADER
DATE
OPENED
TARGET
CLOSE
DATE
ACTUAL
CLOSE
DATE
LAST
UPDATE
Most Recent
Oldest
1
#
1
G
G
2
3
4
5
"Color Codes"
General Motors
Source:
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Green - Task Completed on Time
Yellow - Task May Be Late
Red - Task is Late
White - Task Re-Timed, No Status
Blue - Task Status is Incorrect;
Not Updated
On Track (Bold Box/No Color)
COUNTER MEASURES
Remember
The idea behind a FMEA is to define
important product, service or process
characteristics so you can focus on these
areas to remove, control or improve the
product or service, insuring that risk and/or
harm is not passed on to your customers!
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Managing Quality Characteristics
Definition of Terms
What is a Quality Characteristic?
It is the basic building block on which quality is built
regardless of the definition
It is any feature, e.g. property, attribute, of the product /
service or process which is needed to achieve quality
There are several types:
technological (hardness, acidity, wavelengths)
psychological (taste, beauty, status, mental state)
time-oriented (promptness, reliability, maintainability)
contractual (guarantee, provisions)
ethical (courtesy, honesty, pride)
Contrasted with assigned characteristics, e.g. price
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Quality Control Handbook, 3rd Ed., Juran, McGraw Hill
Interrelation of Quality Parameters
Quality
of Design*
Quality of Market Research
Quality of Concept
Quality of Specification
Technology
Quality
Characteristic
* higher quality
costs more
** higher quality
costs less
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Quality of
Conformance**
Manpower
Management
Availability
(time-related)
Field
Service
Quality Control Handbook, 3rd Ed., Juran, McGraw Hill
Reliability
Maintainability
Logistical Support
Promptness
Competence
Integrity
Design Stage Is The Best Time
To Impact Quality & Cost
CHANCES FOR
QUALITY & COST
IMPROVEMENTS
COST TO
IMPLEMENT
Cost
START OF PRODUCTION
Time
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Source: General Motors
Characteristics In Design Process
Tools include:
Customer
Requirements
planning
change control
system design
Product Design
Requirements
customer-designated and
supplier-designated
parameter design (target)
tolerance design
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Product
Characteristics
QFD
APQP
FMEA
Statistical Engineering
Characteristics In Design Process
Tools include:
Customer
Requirements
planning
change control
system design
QFD
APQP
FMEA
Statistical Engineering
Product Design
Requirements
customer-designated and
supplier-designated
parameter design (target)
tolerance design
Product
Characteristics
manufacturing feasibility
system design
Process Design
Requirements
customer-designated and
supplier-designated
parameter design (target)
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Process
Characteristics
Design Requirements & PPAP
The design record is the part drawing, specifications, and/or electronic
(CAD) data used to convey information necessary to produce a product
PPAPs purpose is to provide the evidence that all customer engineering design
record and specification requirements are properly understood by the organization
and that the manufacturing process has the potential to produce product
consistently meeting these requirements during an actual production run at the
quoted production rate
The organization shall have the design record for the saleable product/part,
including design records for components or details
The organization shall record the actual results: all dimensions, characteristics,
and specifications as noted on the design record and Control Plan
Over-specifying increases the cost and may restrict competition
Under-specifying may compromise the quality level you need
A poor specification adversely affects quality and cost!
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Quality Characteristics
...a common thread
Design Record
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Includes Initial Critical
Characteristic Identification
Design Failure Mode and
Effects Analysis (FMEA)
Quantifies Risk of Potential Failures
Due To Design to Identify Other
Critical Characteristics
Process FMEA
Quantifies Risk of Potential Failures
Due To Process to Identify Other
Critical Characteristics
Quality Characteristics
...a common thread
Design Record
Design Failure Mode and
Effects Analysis (FMEA)
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Includes Initial Critical
Characteristic Identification
Quantifies Risk of Potential Failures
Due To Design to Identify Other
Critical Characteristics
Process FMEA
Quantifies Risk of Potential Failures
Due To Process to Identify Other
Critical Characteristics
Control Plan
Lists the Controls Needed to
Mitigate Potential Failures
Standard operating
procedures
Describes Work That Flows
Across Functions
Work instructions
Describes Work Done at
a Work Station
Chrysler, Ford, GM PFMEA
Source: APQP, DCX, Ford, GM
Control Plan
Form adapted from General Motors
Control Plan - APQP example
Set Up Dominant Process
Be sure to use a Control Plan based on the critical process variable
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Work Instruction
2003 The Bishop Company. (www.explainers.com) Used with permission
Characteristic Classification
Standard Characteristics
require due care
Key, Critical, Significant
ISO 9001:1994 used the term crucial
QS-9000 & ISO TS 16949 uses special
TS16949 definition: a product characteristic or
manufacturing process parameter which can affect safety
or compliance with regulations, fit, function, performance
or subsequent processing of product (clause 3.1.12)
require extra care to mitigate the effects of a potential
problem
types of controls necessary are customer-specific
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Characteristic Identification
Sources:
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QFD
APQP
Warranty
FMEA Analysis
recall data
customer complaints
Simulation
Modeling studies
Group consensus
Designed experiments
SPC data
Loss Function
Characteristic Identification
Requires input from multiple functions:
ISO TS 16949, clause 7.3.1.1
The organization shall use a multi-disciplinary approach to
prepare for product realization, including
Development / finalization and monitoring of
special characteristics
Development and review of FMEAs,
including actions to reduce potential risks, and
Development and review of Control Plans
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Characteristic Identification
Suppliers are also required to identify and
include all special characteristics in the control plan
comply with customer-specified definitions and symbols,
and
identify process control documents including drawings,
FMEAs, control plans and operator instructions with the
customers special characteristic symbol or the
organizations equivalent symbol or notation to include
those process steps that affect special characteristics
(ISO TS 16949, clause 7.3.2.3)
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Characteristic Identification
ISO 9001:2008, Clause 7.3.3.d)
Design and development outputs shall specify the
characteristics of the product that are essential for its
safe and proper use
ISO/TS 16949:2009, Clause 7.3.3.1
The product design output shall include
design FMEA, reliability results
product special characteristics and
specifications
product error-proofing, as appropriate
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Characteristic Management
Should consider BOTH variable
and attribute characteristics!
0.15
Series1Xbar
0.1
Control Chart
Series2
0.05
0
0
10
20
Subgroup
Averages
Fraction defective
P Control Chart
130
Series3
110
UCLxbar
Series4
90
70
30
40
Lot number
Averages
Xbarbar
11
16
LCLxbar
21
Subgroup Number
Subgroup Ranges
Range Control Chart
60
UCLr
40
Ranges
20
Rbar
0
0
10
15
Subgroup Number
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20
25
30
LCLr
Series5
APQP Special Characteristics Worksheet
The Description/Rationale column includes all special process and product
characteristics agreed upon by the cross functional team
Develop a rationale for each special characteristic and add this information
to the list for clarification
A sequential number (No.) is assigned to each characteristics listed to
ensure none are overlooked by the supplier when the Control Plan is
completed.
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Identify Pass-Through Characteristics (PTC)
PTCs Part characteristics which are not controlled or
functionally tested anywhere downstream in the supply chain and
would have a significant impact on customer satisfaction and/or
warranty
PTCs are ultimately supplied to an OEM customer (i.e. it will pass
through)
A PTC may or may not be a Special Characteristic
Develop a potential PTC list from various sources, e.g. engineers, reliability
practitioners, customers, historical data and/or market research
Examples of PTCs
Include engine thermostat function, torque converter studs
Threaded hole supplied by an external supplier not used by the next
downstream organization
Incorrect chemistry for bulk material
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Source: AIAG CQI-19
PTCs (Contd)
Determine if each potential PTC is controlled or functionally tested in
subsequent operations in the supply chain
If the potential PTC is not controlled in subsequent operations either in
sub-tier supplier operations, determine with your customer if the
potential PTC would have significant impact on customer satisfaction or
warranty
Agree with your customer on the appropriate action, e.g. error-proofing or
other controls to ensure that no defects reach the customer
Implement the action and verify that it is effective
Ensure that applicable procedures, e.g. FMEAs, Control Plans and/or Work
Instructions and documents include all PTCs and Special Characteristics
Design-responsible organizations should identify PTCs on the design
records
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Source: AIAG CQI-19
PASS THROUGH CHARACTERISTIC TOOL
Special Characteristics and PTCs are to be included on the
AIAG Potential Failure Mode and Effects Analysis (PFMEA)
documents to determine relative risk.
Supplier Name:
Customer Part No:
Part Description:
Drawing No / Revision:
Date:
Phone/Email:
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Inspection
Frequency
10
Process Capability
Gage Type
Sev. Occ. Det.
Control Plan
Containment
Product / Process
Characteristic
Specification
Characteristic
Classification
Control
Method
Detection
Operation #
PFMEA Risk
Prevention
Supplier Contact:
GRR
%
Pp
Ppk Cp Cpk
11 12
Source: AIAG CQI-19
PTC /
Feature?
18
Action Plans
19
PPAP Fourth Edition
2.2.11 Initial Process Studies
2.2.11.1 General
The level of initial process capability or
performance shall be determined to be
acceptable prior to submission for all Special
Characteristics designated by the customer or
the organization
This assumes that special characteristics
have been properly identified and designated
by the customer and supplier
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PPAP Fourth Edition
2.2.11
Initial Process Studies
2.2.11.1 General
NOTE 1: Where no special characteristics have
been identified, the customer reserves the right
to require demonstration of initial process
capability on other characteristics
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Joint Responsibility
If the supplier takes a minimalist approach,
the customer stands to lose much of the
power of the TS-specified quality tools!
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Part Qualification Process
v2.1
----- Process FMEA -----
System
Subsystem
Component
Incomplete
FMEAs
compromise
the system...
Potential Failure Mode and Effects Analysis
#REF! Desc.
FMEA Number #REF!
Model Year(s) #REF!
Process Responsibility #REF!
Prepared By #REF!
Vehicle #REF!
Key Date #REF!
FMEA Date #REF!
Core Team #REF!
Revision Date #REF!
Manual:
incorrectly
selected
20 Correct
Assembly piston and
rod ass'y
Machine
Vision ID
Incorrect
Incorrect
Piston or
reversed
piston
Loss of
Engine
Power;
Tight
Engine;
Engine
Failure
2 In-line
Audits
D
E
T
R
P
N
Recommended
Action (s)
Responsibility
Projected
Actions
Completion
Taken
Date
12/1/03
84 New Piston
NA
Laser Station.
...and adversely
impact ongoing
quality
Ideal State
4 No
10 280 Sensor to
Shadid,
detection
detect bearing Basel
type
10 Correct Part Incorrect Misbuild
- pilot
part
bearing
installed
Current
Process
Controls
New RPN
O
C
C
New DET
S
E
V
New OCC
Potential
Effect(s)
of Failure
New SEV
Potential
Failure
Mode(s)
Process
Function/Req.
Class
Zone / Op
Action Results
Potential
Cause(s)
/
Mechanism(s)
of Failure
7 4 4 112 40
7 2 3 42 40
Key Contact/Phone
Date (Orig.)
Part Number/Latest Change Level
Core Team
Cust. Engineering Approval/Date
Part Name/Description
Supplier/Plant Approval/Date
Cust. QA Approval/Date
Other Approval/Date (if required)
Other Approval/Date (if required)
Prototype
Pre-Launch
Production
Date (Rev.)
Control Plan Number
Supplier/Plant
Part/
Process
Number
Process Machine,
Name/
Device,
Operation Jig, Tools
Description for Mfg.
Supplier Code
Characteristics
No.
Special
Char.
Product Process Class.
Methods
Specification/
Tolerance
Evaluation
Measurement
Technique
Sample
Size
Freq
Control
Method
Efforts should be taken to reduce the RPNs!
If they remain high, the characteristic should be
designated as special by the supplier!
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Reaction
Plan
AIAG FMEA Training
PFMEA In Context class
Look what they are saying:
The class was excellent. It really showed how the PFMEA, Process Flow, and Control
Plan are connected and should be utilized to ensure the quality throughout the
process, and therefore ensure the part quality. The booklet we received as part of the
training has been a great reference in my normal job activities. Jared Peacock, Toyota
As a supplier to automobile manufacturers, I found it very valuable to combine the
content of the APQP and FMEA manuals into a single training course... the training
triggered many ideas which I plan to incorporate into my companys current practices
in order to improve the effectiveness of our FMEAs by highlighting the linkages
between our PFMEAs and PCPs. Clark Johns, Timken
"If you've got defects, your team needs this class." Jim Carter, General Motors
The workshop is the best approach to cover all process risks and their prevention /
detection while minimizing the repetitive work. I would encourage our suppliers to
take the training if they have not implemented this approach. Stanley Zhou, Chrysler
Group LLC
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Questions?
Contact Info
For a complete description of AIAGs services and
product offerings, or to register for an event or place
an order, please visit www.aiag.org or contact AIAG
Customer Service at 248.358.3003
R. Dan Reid
Program Manager, Quality
o. 248-358-9774
e. [email protected]
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