WELCOME

FMEA Training
Before we start
 Course duration & breaks
 Facilities
 Food & refreshments
 Use of mobile phones
 Punctuality (9.00 – 17.00)
 Materials, stationeries & handouts
 Assessment
 Attendance & approval certificates
 Satisfaction survey & training effectiveness
 Most Importantly – ENJOY !!!
Contents
 Introduction
 FMEA
Fundamentals
 PFMEA
 PFMEA tools
• Control plan
• Flowchart
 Example Review
 Implementation
 Assessment.
 Activity
FMEA Fundamentals
Failure Modes & Effects Analysis
 Failure Modes & Effects Analysis (FMEA)
dates back to the 1940’s with the US military
 Formal application began in 1960’s with the
Aerospace industry as pioneers
 Today it is widely used in the Automotive
industry
 It is a systematic tool for identifying:
• Effects of a potential product or process failure
• Methods to eliminate or reduce the chance of a
failure occurring.
FMEA Benefits
 Prevention focus
 Improves the quality, reliability and safety of
evaluated products and processes
 Recognizes and evaluates the potential failure and
the effects of that failure
 Identifies actions that could eliminate or reduce the
chances of the potential failure occurring
 Assists in the development of robust development
plans
 Assists in the development of robust control plans
 Improves customer / consumer satisfaction.
Main Reasons for Using FMEA
 To identify potential failures and the effects
so that action may be taken to reduce or
eliminate the failure modes
 To improve design, reliability, maintainability,
safety, and manufacturing of a product
 To ensure ‘right first time’
 To keep the know-how in the company
 To provide a formal record of analysis.
Other reasons for using FMEA
 FMEAs are part of TS16949 requirements
• Multidisciplinary approach ([Link])
• SC’s identification ([Link])
• Product design outputs ([Link])
• Manufacturing process design ([Link])
• Control plan development ([Link])

 FMEAs are part of customer PPAP

requirements.
 APQP Elements
PRODUCT DESIGN & DEVELOPMENT
PROCESS DESIGN & DEVELOPMENT
Form Team
Facilities Tools PRODUCT & PROCESS
Design FMEA
Concern Log Team Manufacturing Measurement VALIDATION
& Gages Prototype System Packaging
Preliminary Lists Feasibility System
 Customer Inputs Requirements Prototype Build Builds Analysis Specifications Production Quality
of Special Commitment Analysis Plan Plan Production
 Program Timing Control Plan Control Planning
Products Trial Run Sign off
 Design Goals Plant
& Process Drawings & Process to Preliminary and Mgmnt.
 Reliability & Quality Goals Product Process Packaging Support
Characteristics Specifications Preliminary Process
 Affordable Cost Targets Characteristic Capability Standards
Design Reviews Study Plan Capability Study Production
 Capacity Planning Volumes Linkage
Part
 Key Contact Personnel Design Verification Plan Design Verification Floor Plan Measurement
Product/ Approval
& Sign-off Report Layout Systems Production Validation
Product Quality Timing Plan Design Verification Process (PSW)
Evaluation Quality Testing
Characteristic PSW
Budget Approval Subcontractor System
Matrix Part
Pre-Launch Review
Preliminary Bill of Materials APQP Status Delivery at
Process Control
Product Assurance Plan Packaging MRD
FMEA Plan
Evaluation Functional
Program Metrics Tracking/Trends Special
Design for Manufacturing Operator Management Check
Assembly & Service Product & Review Report
Management Support Process
Process
Characteristic Instructions
Sourcing Decision Customer
Satisfaction
Lessons
Reduced
Feedback Assessment/Corrective Action Learned
Variation Delivery Process
and Service
Leverage of FMEA
 The earlier in the APQP process FMEA’s are
started the higher the leverage in quality

QFD
Quality
Concept
(system)
FMEA Design
FMEA
Process Ongoing
Flowchart
Process
FMEA
production
Control
Plan

Quality planning
Process Control
(Pre-production) (SPC, DOE,
audits, etc.) Problem
solving
Types of FMEA

System
Design
FMEA Sub System

Component

Process Assembly
FMEA
Manufacturing
Design FMEA

Design Special
Characteristics

CFT
WORK
DFMEA DVP Validation

Design FM due to
design deficiencies
DVP – Design Validation Plan
Process FMEA
Treatment of special
characteristics

Manufacturing
Process Definition

CFT
WORK
PFMEA Control Plans

Process FM due to
process deficiencies
COFFEE BREAK
Process FMEA
(PFMEA)
PFMEA Definition

A Process FMEA is an analytical

technique used by a Manufacturing
Engineering Responsible as a means to
ensure that potential failure modes and
their associated causes/mechanisms
have been considered and addressed
PFMEA Benefits
 The Process FMEA:
• Identifies the process functions and requirements
• Identifies potential product and process-related failure
modes
• Assesses the effects of the potential failures on the
customer
• Identifies the potential manufacturing process causes and
identifies process variables on which to focus controls
• Develops a ranked list of potential failure modes, thus
establishing a priority system for preventive/corrective
action considerations
• Documents the results of the manufacturing process
analysis.
PFMEA Assumptions
 The Process FMEA assumes the product as
designed will meet the design intent
 The Process FMEA does not rely on product
design changes to overcome weaknesses in
the process.
 APQP Elements
PRODUCT DESIGN & DEVELOPMENT
PROCESS DESIGN & DEVELOPMENT
Form Team
Facilities Tools PRODUCT & PROCESS
Design FMEA
Concern Log Team Manufacturing Measurement VALIDATION
& Gages Prototype System Packaging
Preliminary Lists Feasibility System
 Customer Inputs Requirements Prototype Build Builds Analysis Specifications Production Quality
of Special Commitment Analysis Plan Plan Production
 Program Timing Control Plan Control Planning
Products Trial Run Sign off
 Design Goals Plant
& Process Drawings & Process to Preliminary and Mgmnt.
 Reliability & Quality Goals Product Process Packaging Support
Characteristics Specifications Preliminary Process
 Affordable Cost Targets Characteristic Capability Standards
Design Reviews Study Plan Capability Study Production
 Capacity Planning Volumes Linkage
Part
 Key Contact Personnel Design Verification Plan Design Verification Floor Plan Measurement
Product/ Approval
& Sign-off Report Layout Systems Production Validation
Product Quality Timing Plan Design Verification Process (PSW)
Evaluation Quality Testing
Characteristic PSW
Budget Approval Subcontractor System
Matrix Part
Pre-Launch Review
Preliminary Bill of Materials APQP Status Delivery at
Process Control
Product Assurance Plan Packaging MRD
FMEA Plan
Evaluation Functional
Program Metrics Tracking/Trends Special
Design for Manufacturing Operator Management Check
Assembly & Service Product & Review Report
Management Support Process
Process
Characteristic Instructions
Sourcing Decision Customer
Satisfaction
Lessons
Reduced
Feedback Assessment/Corrective Action Learned
Variation Delivery Process
and Service
PFMEA & APQP
Program
Approval Prototype Pilot Launch

PFMEA
TIMEFRAME
Planning Planning

Product Design and Dev.

Process Design and Development

Product and Process Validation

Production

Feedback Assessment and Corrective Action

Plan & Product Process Product & Feedback Assessment &

Define Design & Design & Process Corrective Action
Program Development Development Validation
Verification Verification
PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .
Item: . Process Responsibility: . Prepared By .
.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .
Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

ANALYZE PREVENTION/ TAKE THE

DETECTION ACTION RESULTS
CONTROL
Inputs to PFMEA

Process
Flowchart
PFMEA
PFMEA Team
 Not set number of people
 People with the specific know how about
similar products and processes
 Recommended compositions:

Facilitator
Representatives from:
Support • Suppliers
Team • Customer Representative
• Process Engineer (Leader) • Gov. Regulations Expert
Core
• Manufacturing/Process Engineer
Team
• Quality Engineer
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Process Function/Requirements:
 Simple description of the process or operation being
analyzed (e.g., turning, drilling, tapping, welding,
assembling)
 Indicates the purpose of the process or operation being
analyzed.
Process Function Requirement
VERB + NOUN + MEASURABLE
Weld Weight x kg
Control Speed y rpm
Dispense Fuel cm3/sec
Attach Rust z bar
Drill Noise X Decibel

Examples:
 Operation #10: Drill hole size X mm, through depth
 Operation #20: Weld part A to part B forming subassembly X
 Operation #30: Attach subassembly X to assembly Y.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

ANALYZE

Potential Failure Mode:

 The manner in which the process could potentially fail to
meet the process requirements and/or design intent
description of the nonconformance at that specific
operation.
Potential Failure Modes
CHALLENGE THE FUNCTION
 No Function: Process operation is totally non-
functional or inoperative.
 Partial/Over Function/Degraded Over Time:
Meets some of the specifications or some
combination of the specifications but does not fully
comply with all attributes or characteristics
 Intermittent Function: Complies but loses some
functionality or becomes inoperative often due to
external impacts such as temperature, moisture and
environmental
 Unintended Function: This means that the
interaction of several elements adversely impacts
the product or process.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

ANALYZE

Potential Effect(s) of Failure:

 The effects of the failure mode on the customer
 The customer could be the next operation, subsequent operations
or locations, the dealer, and/or the vehicle owner
 In terms of what the customer might notice or experience
 Effects should be considered at several levels:
• Next sub assembly
• Customer
• Vehicle buyer
• Compliance with government regulations.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Severity:
 Severity of the effect is a relative ranking associated with the most
serious effect identified
 Assessment of the seriousness of the effect of the potential failure
mode on customers
 Only a design change can reduce (or increase) the severity
ranking
 Only consider the severity of the worst effect.
Severity Table
Criteria: Severity of Effect Criteria: Severity of Effect
This ranking results when a potential failure This ranking results when a potential failure
mode results in a final customer and/or a mode results in a final customer and/or a
manufacturing/assembly plant defect. The manufacturing/assembly plant defect. The
final customer should always be final customer should always be
considered first. If both occur, use the considered first. If both occur, use the
higher of the two severities. higher of the two severities.
Effect (Customer Effect) (Manufacturing/ Assembly Effect) Ranking
Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 10
without failure mode affects safe vehicle operation assembly) without warning.
warning and/or involves noncompliance with
government regulation without warning.

Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 9
with warning failure mode affects safe vehicle operation assembly) with warning.
and/or involves noncompliance with
government regulation with warning.
Very High Vehicle/item inoperable (loss of primary Or 100% of product may have to be 8
function). scrapped, or vehicle/item repaired in repair
department with a repair time greater than
one hour.
High Vehicle/Item operable but at a reduced Or product may have to be sorted and a 7
level of performance. Customer very portion (less than 100%) scrapped, or
dissatisfied. vehicle/item repaired in repair department
with a repair time between a half-hour and
an hour.
Moderate Vehicle/Item operable but Or a portion (less than 100%) of the 6
Comfort/Convenience item(s) inoperable. product may have to scrapped with no
Customer dissatisfied. sorting, or vehicle/item repaired in repair
department with a repair time less than a
half-hour.
Low Vehicle/Item operable but Or 100% of product may have to be 5
Comfort/Convenience item(s) operable at a reworked, or vehicle/item repaired offline
reduced level of performance. but does not go to repair department.
Very Low Fit and Finish/Squeak and Rattle item Or the product may have to be sorted, with 4
does not conform. Defect noticed by most no scrap, and a portion (less than 100%)
customers (greater than 75%). reworked.
Minor Fit and Finish/Squeak and Rattle item Or a portion (less than 100%) of the 3
does not conform. Defect noticed by 50% product may have to be reworked, with no
of customers. scrap, on-line but out-of-station.
Very Minor Fit and Finish/Squeak and Rattle item Or a portion (less than 100%) of the 2
does not conform. Defect noticed by product may have to be reworked, with no
discriminating customers (less than 25%). scrap, on-line but in-station.

None No discernible effect. Or slight inconvenience to operation or 1

operator, or no effect.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Classification:
 Used to define any special product or process characteristics (e.g.,
critical, key, major, significant) that may require additional process
controls.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Potential Cause(s)/Mechanism of Failure:

 How the failure could occur
 Something that can be corrected or can be controlled
 Only specific errors or malfunctions should be listed; ambiguous
phrases should not be used.

Design Process
Insufficient lubrication Insufficient lubrication
capability applied
Incorrect material specified Incorrect material used
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Occurrences:
 Is the likelihood that a specific cause / mechanism of failure will
occur
 The likelihood of occurrence ranking number
• Has a relative meaning rather than an absolute value.
Occurrence Table
Probability Likely Failure Rates Ranking
Very High: Persistent Failures > 100 per thousand pieces 10
50 per thousand pieces 9
High: Frequent Failures 20 per thousand pieces 8
10 per thousand pieces 7
Moderate: Occasional Failures 5 per thousand pieces 6
2 per thousand pieces 5
1 per thousand pieces 4
Low: Relatively Few Failures 0.5 per thousand pieces 3
0.1 per thousand pieces 2
Remote: Failure is Unlikely < 0.01 per thousand pieces 1
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

PREVENTION/
DETECTION
CONTROL

Current Process Control (Prevention/Detection):

 Current Process Controls are descriptions of the controls that
• prevent to the extent possible the failure mode or the cause of
the failure from occurring
• or detect the failure mode cause of failure should it occur
 There are two types of Process Controls
• Preventive
• Detective.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Detection:
 Is a relative ranking associated with the best control established in
the process control
 In order to achieve a lower ranking, generally the planned process
control has to be improved.
Detection Table
Detection Criteria Inspection Types Suggested Range of Detection Methods Ranking
A B C
Almost Impossible Absolute certainty of X Cannot detect or is not checked. 10
nondetection.
Very Remote Controls will probably not X Control is achieved with indirect or random 9
detect. checks only.
Remote Controls have poor X Control is achieved with visual inspection only. 8
chance of detection.
Very Low Controls have poor X Control is achieved with double visual 7
chance of detection. inspection only.
Low. Controls may detect X X Control is achieved with charting methods, 6
such as SPC {Statistical Process Control}.
Moderate Controls may detect. X Control is based on variable gauging after parts 5
have left the station, or Go/No Go gauging
performed on 100% of the parts after parts have
left the station.
Moderately High Controls have a good X X Error detection in subsequent operations, OR 4
chance to detect. gauging performed on setup and first-piece
check (for set-up causes only).
High Controls have a good X X Error detection in-station, or error detection in 3
chance to detect. subsequent operations by multiple layers of
acceptance: supply, select, install, verify.
Cannot accept discrepant part.
Very High Controls almost certain to X X Error detection in-station (automatic gauging 2
detect. with automatic stop feature). Cannot pass
discrepant part.
Very High Controls certain to detect. X Discrepant parts cannot be made because item 1
has been error-proofed by process/product
design.

A: Error-Proofed // B: Gauging // C: Manual Inspection

 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

Risk Priority Number (RPN):

 The Risk Priority Number is a measurement of risk
 The RPN is a calculation based upon.
Prioritization criteria
Severity

10
HIGH SEVERITY CONFIRMED CRITICAL
9 CHARACTERISTIC

7 CONFIRMED
SIGNIFICANT
MEDIUM SEVERITY AND 6 CHARACTERISTIC
HIGH OCCURRENCE
5

HIGH RPN BASED ON RPN

2
CRITERIA
1

1 2 3 4 5 6 7 8 9 10 Occurrence
Special Characteristics

Criteria

Examples

Consequences in the process control

Special Characteristics
 Special characteristics require special
treatment and effort to ensure compliance
 FMEA is the tool to identify special
characteristics
 Most common classes of special
characteristics are Critical and Significant
 Special characteristics are those which may
affect:
• Safety
• Compliance with government regulations
• Customer satisfaction.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

TAKE
ACTION

Recommended Action(s):
 List of actions to
• Make the process more robust
• Mitigate the effect of the failure mode
• Reduce the occurrence or improve the detection
 The prioritization is based on
• High severity
• High severity x occurrence
• High RPN.
Where can you take actions?
 Discuss whether severity could be acted
upon or not
Recommended actions
 List of actions to
• Make the process more robust
• Reduce the occurrence or improve the detection
 The prioritization is based on
• High severity
• High severity x occurrence
• High RPN.
 PFMEA Template
POTENTIAL FAILURE MODE AND EFFECTS
FMEA Number .
ANALYSIS
(Process FMEA) Page of .

Item: . Process Responsibility: . Prepared By .

.
Model Year . Key Dates . FMEA Date (orig.) (Rev.) .

Core Team .
Process S C O D Action Results
Function Potential Current Current Responsibility
Potential Potential e l c e R O
Cause(s) / Process Process Recommended & Target S D R
Failure Effect(s) v a c t P Actions c
Mechanism Controls Controls Action(s) Completion e e P
Mode Of Failure e s u e N Taken u
Of Failure Prevention Detection Date v t N
Requirements r s r c r

THE
RESULTS

Action Results:
 There must be a responsible person for each action
 Team leader has to follow up the implementation status
 Calculate and record the resulting RPN
 If no actions are taken, leave the related ranking
columns blank.
Feedback loop
 What can be changed as a consequence of
learning from an error? (I.e. 8D)
• Item?
• Failure mode?
• Effect?
• Severity?
• Etc.
Example Review
Implementation Process
 Include the practice into your quality system
 Appoint a leader for the FMEA development
 Appoint team members related to the chosen
product or process
 Gather related information
• Warranty claims history
• Customer rejections & complaints
• Internal rejections and non conformities
• Vendors rejections
• Related products and process information
 Conduct FMEA Sessions.
Conducting FMEA sessions
 Formal scheduling: set frequency and
duration of meetings
 Set agenda and define team members that
need to be present
 Resources: room, time to dedicate,
stationeries, etc
 Have information and material available:
• Warranty and production PPM data
• Sample parts/component
 Monitor consistency of FMEA with flow chart
and control plan.
FMEA Management
 FMEA must be used as a tool and not as a
form to be submitted to the customer
 Project leaders must allocate enough time in
the overall schedules to conduct FMEAs
 All needed resources should be available
 Team leader is responsible to:
• Prepare the activity and form the team
• Identify additional necessary resources
• Determine the scope of each session
• Facilitate the activity to achieve the objective
• Record the results.
Questions?
Assessment

Not participant evaluative

Core concepts understanding
20 minutes (approx)
Activity
 Define the process flowchart
 Develop the PFMEA.
END OF PRESENTATION