Welcome To Potential Failure Modes AND Effect Analysis Process FMEA-4 Edition

WELCOME TO
POTENTIAL
FAILURE MODES
AND
EFFECT ANALYSIS
Process FMEA- 4TH EDITION
1
PFMEA TRAINING PROGRAM
• Objective of this training:

• To understand the functions, requirements, and deliverable of the product or
processes being analyzed,
• Failure modes when functional requirements are not met,
• Effects and consequences of the failure mode,
• Potential causes of failure mode,
• Actions and controls to address the causes of failure mode,
• Actions to prevent recurrence of failure mode.
2
 PFMEA TRAINING PROGRAM
 Design- Conversion of customer

requirements to product specification.
 Process – Sequence of activities to convert

input into desired output.
3
What is FMEA?
• Failure modes and effects analysis (FMEA) is a step-by-step
approach for identifying all possible failures in a design, a
manufacturing or assembly process, or a product or service.
4
• What makes FMEA.
• Customer requirements
• Experience/ Knowledge
• Plan for improvement
• Lessons learned.
5
PFMEA- Potential Failure mode effect analysis
 Purpose: To recognize and evaluate
 The potential failure of process
 Product and its effects
 To identify preventive action
 Documentation of process
FMEA-LEARNING OBJECTIVES
• To understand the Failure Mode Effective Analysis
• To learn the steps in developing FMEA
• To summarize the different type of FMEAS
• To learn how to link the FMEAS to other process tools

Types of FMEA:
• Design FMEA
• Process FMEA
• System FMEA
• Service FMEA
8
It is an analytical methodology used to :
• Ensure that potential problems have been considered and

addressed through out the APQP processes
• Assess risk involved in each and every process ,system,

assembly, sub – assembly and component.
9
• Scope of FMEA : Scope defines the boundaries of the FMEA. What should
be included and excluded ,based on at what level the FMEA is developed,
system,sub-system,part/component level.
• Function model
• Block diagram
• Interface diagram
• Process flow diagram
• Interrelationship matrix
• Schematics
• Bill of materials.
10
• What is process FMEA?
• All process FMEA focuses on manufacturing process design,
• Manufacturing includes manufacturing processes, inspection,
testing,packaging,labelling,storing between processes and
transportation.
• PFMEA does not depend upon design changes to overcome process
failures.
• Further each process in PFMEA assumes that the incoming material is
OK
11
• PFMEA implementation :
• Success of PFMEA depends upon its timelines. It is a “Before the
event Action” and not “After the fact exercise”.
• To be done when the window opportunity is available. The window
opportunity for PFMEA starts from the preparation of process flow
chart and ends before the preparation of the Pre-launch control
plans.
12
• FMEA development ,either design or process, use a common
approach to address,
• Potential product or process to meet expectations,
• Potential consequences,
• Potential causes of the failure mode,
• Level of risk,
• Risk reduction.
13
• What level is PFMEA required ?
• a) New design, new technology, or new processes.
• b) Modifications to existing design or processes.
• c) Use of an existing design or processes in a new environment ,
location, application or usage profile..(inclusive of regulatory and duty
cycle )
14
• Purpose of PFMEA :
• To identify all process deliverable (DO’S and DON’TS)
• To identify all product and/or process failures to meet these
deliverables .( needs and requirements )
• To identify the potential consequences and their severity.
• To identify potential causes (or processes deficiencies )
• To focus on preventing these causes and or failure modes.
• To detect the causes and or failure modes should they occur.
• To evaluate the level of risk to develop a ranked list of priorities to
work on.
• To identify special characteristics for attention.
15
• PFMEA process sequences : ( Basic approach )
• Functions, requirements, deliverables of the products or process –
most important activity.
• What can go wrong – What are the failure modes ?
• What are the effects and their consequences?
• What are the causes - Can prevent the cause /failure modes
• If we can prevent, -can we reduce the occurrence ?
• How to detect causes and failure modes ?
• What remedial taken, when, who?
16
FMEA – A TEAM TOOL

•Team approach is necessary
•Team should be led by process owner

or responsible person
17
PFMEA TRAINING PROGRAM -
Team Members for a PFMEA
• Process engineer
• Manufacturing supervisor
• Operators
• Quality
• Safety
• Product engineer
• Customers
• Suppliers
The aim of PFMEA is to anticipate-
•What might fail ?
•What effects this failure would have?
•What might cause failure?
19
• Potential failure mode : One possible way that system or process can
fail.
• Potential effect of failure : The effect or impact of the system or
process failure .
• Potential cause :The cause of potential failure
• Severity rating : How severe the effect or outcome of the failure mode
.
• Occur : How likely it is that way the failure may occur.
20
 FAILURE- A component or system not meeting or not functioning to
the design intent
 FAILURE MODE - The manner in which a system or component
failure occurrences
21
• Potential functional failure
• Location failure
• Cause of failure
22
• Potential functional failure could be:
• Complete failure
• Partial failure
• Intermittent failure
• Failure over time
• Over performance
23
FAILURE MODE
Example- A PEN LIGHT – Used by an eye specialist
 No Light
 DIM LIGHT
 Erratic blinking light
 Gradual dimming light
 Over brightness
Example - A sheet metal part- Over bent

Cracked
Deformed
• Analyze the above and conclude the prevention from occurring
• The assumption is made the failure could occur , but may not
necessarily occur
• Process FMEA-Quality objectives :
• Improve the design or process as applicable,
• Address all high risk modes,
• Consider all major lessens learned in past as inputs ,
• Identify all key /special characteristics,
• Completed window of opportunity,
• Is the result of participation by right people,
• Is done with efficient and effective use of time,
• Documentation of the incidents,
• Control plan shall consider all identified failure modes ,
• PFMEA and DFMEA shall be aligned and integrated.
•
25
• How to develop and complete a PFMEA :
• Define customers :
• End user( Owner, driver, passenger, etc,.
• Next processes, (could be internal or external)
• Vehicle manufacturing /assembly plants ,
• Safety of personnel,equipment,tools,product.
• Statutory and regulatory requirements,
• Product and servicing activities.
26
• How to develop and complete a PFMEA:
• Identify Functions, Requirements, and specifications.
• Identify potential failure modes
• Identify potential effects
• Identify potential causes.
• Identify controls
• Identifying and assessing risks
• Recommended action and results.
27
• Ensuring the design requirements including reliability are achieved ,
• Reviewing engineering drawing and specifications,
• Conforming incorporation in assembly and manufacturing process
and,
• Reviewing related FMEAS and control plans, operating instructions
etc,.
• Record the results .
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• PFMEA is a living document and should
• Be initiated before or after feasibility stage,
• Be initiated prior to tooling for production,
• Take into account all manufacturing operations from individual components to
assemblies,
• Include all processes:
• Assembly operations,
• Shipping,
• Receiving.,
• Transporting of materials,
• Storage etc,.
29
• The following source of information are useful in defining the process design
intent:
• Purpose of the product and process ( Do’s And Don’ts )
• Safety requirements ,
• Regulatory requirements,
• QFD requirements ( customer voice )
• Manufacturing and assembly issues,
• Ergonomics solutions,
• Appearance requirements,
• Packaging and labelling requirements.
30
• Example of process intent /function = co2 welding of a upper fixing bracket
:
• Requirements - Do’s
• Specified weld strength
• Specified part/weld position and dimension,
• Good weld appearance
• Uniform weld bead size etc,.
• Requirements – Don’ts
• No cracks
• No excessive spatter,
• No deforming after welding
31
What tools are available to meet our objective?
• Benchmarking
• Customer warranty reports
• Design checklist or guidelines
• Field complaints
• Internal failure analysis
• Internal test standards
• lessons learned
• Returned material reports
• Expert knowledge
32
• Another example: Machining process:
• Process function = machining of a flange face

• Requirements
• a) Height of flange
• b) Surface finish
• c) No tool mark on face
• d) No damages and dents .
33
• Collect historic data of failures ,complaints,rework,etc.,
• Study TGR/TGW reports –Previous development records –Thing gone
Right, Things Gone wrong.
• Identify the potential failure modes for each process step and each
part characteristics under each process step.That is, what can go
wrong? Define the failure modes in technical /physical terms not as
symptoms notified .
•
34
• Failure modes are the opposite of functions/Feature/Requirements :
• Ex: welding:
S no Requirement Failure mode
1 Bracket position Position shifted
2 Weld strength Poor weld strength
3 No blow hole More blow holes
4 No crack Crack in length
5 No excess spatter Excess spatter
6 Uniform weld bead Gap in weld bead.
35
• Process flow diagram/ and linkage to PFMEA:
• A process flow diagram describes the flow of the product through the
process –from incoming to outgoing.
36
Identify all effects –For example :
Requirement Failure mode Customers Effects
• Weld strength Poor weld strength End user Vehicle vibration poor
ride
Vehicle manufacturer Rework , cost of poor

quality
Next process Rework, rejection
Safety accident
Servicing Frequent repairs.
37
• Assess how bad the effects care on a 1 to 10 scale.(severity )
• The higher the effect ,the highest the “s” ranking and vice-versa.
• Severity ranking of 7 to 10 generally indicates a special characteristics.
• The assumption is made that a failure could occur but may not be
necessarily occur.
• A large number of failure modes for the same requirements indicates
that the requirements are not preciously defined.
38
• Give individual severity ranking to each effect.
• Then the column for severity ,write the highest of the individual
severity ranking numbers.
• That is, each failure mode will have the only one (the highest) severity
ranking number for RPN calculation.
39
• Identify all potentials underlying one mechanisms/root causes for
each failure mode .define the causes in terms of something that can
be corrected or controlled.
• Vague terms – improper process, operator error etc. not to be used .
• Investigating of causes need to focus on the failure modes and not on
effects.
40
• Examples of Effects :
Requirement Failure mode Effect
Four screws - for seat Fewer than four End user :Loose seat cushion and noise
tightening screws Assembly :Stop shipment and additional sort
and rework due to affected portion .
Specified screws Wrong screw used – Manufacturing and assembly : Unable to install
Larger dia or thread . screw in position .
Assy sequence : first Screw placed in any Manufacturing and assembly :difficult to install
screw in right front other hole remaining screws in position.
hole
Screws torqued to Screw torque too high End user : loose seat cushion ,screw may
dynamic torque cracked.
position. ….and so on.
41
RANKING OF FAILURE MODES
 SEVERITY
 OCCURRENCE
 DETECTION
 Failure – severity First quantify the severity of effects

 Most serious effects – first
 Design and process changes
42
RISK PRIORITY NUMBER :
RPN= S x O x D
Higher the PRN the team must attend first and

implement recommended action immediately.
43
ACTION PLAN TO REDUCE
Severity :
 Modify the product to reduce severity grade
Detection :
 Improve control plans –Additional verification
Occurrence:
 Improving design specification Improving process methods
44
45
PFMEA TRAINING PROGRAM :
Pressure Cooker Safety Features
• 1. Safety valve relieves pressure before it reaches dangerous levels.
• 2. Thermostat opens circuit through heating coil when the
temperature rises above 250° C.
• 3. Pressure gage is divided into green and red sections. "Danger" is
indicated when the pointer is in the red section.
46
Pressure Cooker FMEA
• Define Scope:
• 1. Resolution - The analysis will be restricted to the four major
subsystems (electrical system, safety valve, thermostat, and pressure
gage).
• 2. Focus - Safety
47
Pressure cooker block diagram
48
SUGGESTED EVALUATION CRITERIA.
S no Probapality of failure Likely failure mode Ranking
1 Very high : Persistent _>100per 1000 Pieces 10
failure 50 pierces per 1000 pieces 09
2 Frequent high failure 20 pieces per 1000 pieces 08
10 pieces per 1000 pieces 07
3 Moderate –Occasional failure 5 pieces per 1000 pieces 06
2 pieces per 1000 pieces 05
1 piece per 1000 pieces 04
4 Low: Relatively failure 0.5 piece per 1000 pieces 03
0.1- piece per 1000 pieces 02
5 Remote failure is unlikely <1 piece per 1000 pieces 01
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10 STEPS TO CONDUCT FMEA
S no STEP Action plan
1. Review each part or process 1.Use process flow chart to identify each
process of the component
2. Brainstorm to identify the potential 2.Review existing document and data for
failure clues
3. Identify and list out the potential failure 3.There may be more than one for each
failure
4. Assign severity ranking 4.Based on the severity of the
consequence of the failure
5. Assign occurrence rating 5.List out every potential cause and or
failure mechanisms likely to occur
6. Assign detection rating 6. .Based on the chances the failure will

be detected prior to customer finding it
continued….
50
10 STEPS TO CONDUCT FMEA
S no Step Action plan
7. List your current control 7.List prevention and detection act ivies to
assure design adequacy and prevent or
reduce occurrence
8. Calculate RPN to each part 8.RPN =Severity X Occurrence X Detection
or process
9. Develop the action plan 9. Brainstorm with CFT members
10. Assign the responsibility 10. Define who what , when will do
11. Take action appropriate 11.Implement the improvement plan
identified by your PFMEA team
12. Monitor action taken and 12.Record the details .
effects on RPN
51
CRITERIA OCCURRENCE SEVERITY DETECTION
Very high 10/9 10/9 1/2
High 8/7 8/7 3/4
Moderate 6/5 6/5 5/6
Low 4/3 4/3 7/8
Very low 2/1 2/1 9/10
The suggested evaluation criteria and ranking system
 occurrence of the failure cause - O
 Severity of the effect of failure - S
 Detection of the failure cause - D
52
RISK PRIORITY NUMBER :
RPN= S x O x D
Higher the PRN the team must attend first and

implement recommended action immediately.
53
PREVENTION IS BETTER THAN CURE.

FOUND TO BE CHEAPER
54
• Detection rating : If the failure occurs ,how certain is that the failure
will be detected .
• RPN – The product of S x D x O
• Current controls : Any exits preventive process that are in place to

lessen the chance of the failure occurring .
55
• Potential failure mode : One possible way that system or process can
fail.
• Potential effect of failure : The effect or impact of the system or
process failure .
• Potential cause :The cause of potential failure
• Severity rating : How severe the effect or outcome of the failure mode
.
• Occur : How likely it is that way the failure may occur.
56
Effect Criteria : Rank Effect Criteria :
Severity of Effect on Product (Customer Severity of Effect on Process
Effect) (Manufacturing / Assembly Effect)
Potential failure mode affects safe vehicle 10 May endanger operator (machine or
operation and / or involves non compliance assembly) without warning.
with Government regulation without warning
Failure to Meet Safety and Failure to Meet Safety

/ or Regulatory and / or Regulatory
Requirements Potential failure mode affects safe vehicle 9 Requirements May endanger operator (machine or
operation and / or involves non compliance assembly) with warning.
with Government regulation with warning
Loss of primary function (vehicle inoperable, 8 Major Disruption 10% of product may have to be
does not affect safe vehicle operation) scrapped. Line shutdown or stop ship.
Loss or Degradation of Degradation of primary function ( vehicle 7 Significance Disruption A portion of the production run may
Primary Function operable , but at reduced level of have to be scrapped. Deviation from
performance) primary process including decreased
line speed or added manpower.
57
Effect Criteria : Rank Effect Criteria :
Severity of Effect on Product Severity of Effect on Process
(Customer Effect) (Manufacturing / Assembly
Effect)
Loss of secondary function (vehicle operable, 6 100% of production run may have to be
but comfort / convenience functions reworked off line and accepted.
inoperable)
Loss or Degradation of
Secondary Function Degradation of secondary function (vehicle 5 Moderate Disruption A portion of the production run may
operable, but comfort / convenience have to be reworked off line and
functions at reduced level of performance) accepted.
Appearance or Audible Noise, vehicle 4 100% of production run may have to be

operable, item does not conform and noticed reworked in station before it is
by most customers (<75%) processed.
Moderate Disruption
Appearance or Audible Noise , vehicle 3 A portion of the production run may
operable, item does not conform and have to be reworked in station before it
Annoyance
noticed by many customers (50%) is processed.
Appearance or Audible Noise , vehicle 2 Slight inconvenience to process,

operable, item does not conform and operation , or operator.
Minor Disruption
noticed by discriminating customers (<25%)
1 No effect No discernible effect.

No effect No discernible effect.
58
Opportunity for Likelihood of
Criteria : Likelihood of Detection by Process control Rank
Detection Detection
No detection
No current process control ; Cannot detect or is not analyzed. 10 Almost Impossible
opportunity
Not likely to detect at Failure Mode and / or Error (Cause) is not easily detected ( eg., ransom
9 Very Remote
any stage audits)
Problem Detection Failure Mode detection post-processing by operator through visual /
8 Remote
Post Processing tactile / audible means
Failure Mode detection in-station by operator through visual /
Problem Detection at
tactile/audible means or post –processing through use of attribute 7 Very Low
Source
gauging ( go/ no-go, manual torque check / clicker wrench, etc.,)
Failure Mode detection post-processing by operator through use of
Problem Detection
variable gauging or in-station by operator through use of attribute 6 Low
Post Processing
gauging ( go /no-go, manual torque check / clicker wrench ,etc).
Failure Mode or Error (Cause) detection in-station by operator through
Problem Detection at use of variable gauging or by automated controls in-station that will
5 Moderate
Source detect discrepant part and notify operator (light, buzzer,etc.,). Gauging
performed on setup and first-piece check ( for set-up causes only).
59
Opportunity for Likelihood of
Criteria : Likelihood of Detection by Process control Rank
Detection Detection
Problem Detection Failure Mode detection post-processing by automated controls that will
4 Moderately High
Post Processing detect discrepant part and lock part to prevent further processing.
Failure Mode detection in-station by automated controls that will detect

Problem Detection at
discrepant part and automatically lock part in station to prevent further 3 High
Source
processing
Error Detection and / Error ( Cause ) detection in-station by automated controls that will detect
or Problem error and prevent discrepant part from being made 2 Very High
Prevention
Detection not Error (Cause) prevention as a result of fixture design, machine design or
applicable ; Error part design. Discrepant parts cannot be made because item has been error 1 Almost Certain
Prevention – proofed by process / product design.
60
ACTION NEEDED
• 1. All Design factors should be considered, even the design owner is
customer .
• 2. The product to meet the objectives of the customer .
• 3. feasibility design must permit meeting production volume and
schedule
• 4. Ability to meet Engg. Requirements along with Quality, Reliability,
Investment Cost weight , Unit cost and objectives .
61
Summary
• FMEA
• 1.Identifies the way in which process/product can fail,
• 2. Estimates the risk associated with special causes,
• 3. Priority wise the action that should be taken to reduce risk.
62
IN CONCLUSION
• Come Prepared
• Keep it simple
• Keep it focused
• Keep it short
• Keep it moving
• Follow up on action items
• Practice your team leader skills
• Collect Lessons Learned
Customer Requirements
Deign Specifications
Key Product Characteristics
Machine Process Capability
Process Process Operator

Flow Process FMEA Control Job
Diagram Plan Instructions
Conforming Product
Reduced Variation
Customer Satisfaction
64
BENEFITS BY PFMEA :
 Minimize late changes and associated cost
 Improves product/process reliability and quality
 Capture engineering /organization/knowledge
 Increases customer satisfaction
 Emphasize problem prevention of product /process
 Helps as a case history for analyzing the failures
Drives to zero defect
 Focus on error/mistake proofing

65
Benefits by PFMEA :
• Improves productivity and reliability
• Focus on customer concerns
• Focus on error/mistake proofing
• Capture lessons learnt
• Drives to zero defect.
• Retain technical knowledge in organization
• Improves customer satisfaction.
66
Exercise by candidates from their unit
problem and discussion.
67
THANK YOU
68

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Welcome To Potential Failure Modes AND Effect Analysis Process FMEA-4 Edition

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WELCOME TO

• Objective of this training:

 Design- Conversion of customer

 Process – Sequence of activities to convert

approach for identifying all possible failures in a design, a

manufacturing or assembly process, or a product or service.

PFMEA- Potential Failure mode effect analysis

 Purpose: To recognize and evaluate

 The potential failure of process

 Product and its effects

 To identify preventive action

• To learn the steps in developing FMEA

• To summarize the different type of FMEAS

• To learn how to link the FMEAS to other process tools

• Ensure that potential problems have been considered and

• Assess risk involved in each and every process ,system,

FMEA – A TEAM TOOL

•Team should be led by process owner

•What effects this failure would have?

•What might cause failure?

 FAILURE- A component or system not meeting or not functioning to

the design intent

 FAILURE MODE - The manner in which a system or component

• Potential functional failure

Example - A sheet metal part- Over bent

• Process function = machining of a flange face

Vehicle manufacturer Rework , cost of poor

Next process Rework, rejection

Servicing Frequent repairs.

 Failure – severity First quantify the severity of effects

Higher the PRN the team must attend first and

5 Remote failure is unlikely <1 piece per 1000 pieces 01

6. Assign detection rating 6. .Based on the chances the failure will

RISK PRIORITY NUMBER :

Higher the PRN the team must attend first and

PREVENTION IS BETTER THAN CURE.

• RPN – The product of S x D x O

• Current controls : Any exits preventive process that are in place to

Failure to Meet Safety and Failure to Meet Safety

Appearance or Audible Noise, vehicle 4 100% of production run may have to be

Appearance or Audible Noise , vehicle 2 Slight inconvenience to process,

1 No effect No discernible effect.

Failure Mode detection in-station by automated controls that will detect

Process Process Operator

 Minimize late changes and associated cost

 Improves product/process reliability and quality

 Capture engineering /organization/knowledge

 Increases customer satisfaction

 Emphasize problem prevention of product /process

 Helps as a case history for analyzing the failures

Drives to zero defect

 Focus on error/mistake proofing

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