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FMEAFailure Mode And
Effective Analysis
All Rights Reserved
Trade marks and/or proprietry names indicated are the property of respective owners.
Process Failure Mode And Effects AnalysisDana Quality Assurance Services+91-80-6549970 Failure Mode Effective Analysis 1
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Low - High
Process
1 to 10
Primary Process Responsibility Outside Suppliers Affected Engineer
Model year /Vehicle(s) Part Number
Other Div or people involved Scheduled Production Released PMEA Date Rev
Approvals Quality Assurance Manager Quality Assurance Engineer
Operations Manager Senior Adivisor
Part Name Process Function Potential Failure Potential Effects of Potentail Cause OF Failure Current Control Recommended Actions
Operation Mode Failure Actions and Taken
Number Status
SIR Take TPPE Wrong Material Fragmented Container Insufficient Supplier Material Certif
Container Material Held in Unpredictable Control improper required with
1 Storage Area Deployement Handling each
Misidentified shipment
Material release
Verification
Out of Spec Fragmented Container Open Boxes Visual
Material Unpredictable Inspection
Deployement
Contaminated Fragmented Container Open Boxes
Material Unpredictable
Deployement
Material Fragmented Container Engineering Change Release
Occurred
Severity
Detection
RPN
Occurred
Severity
Detection
RPN
1 9 2 18
3 10 3 90
1 9 7 63
1 10 7 70
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Composition Unpredicatble Suppier Change verification
Change Deployement Green OK Tag
Release
Verification
2 Move To Unreleased Fragmentation Untrained LTO Check For OK
Approved Untrained Personnel Tag at press
Storage Trace Card
Check List
Training
5 10 1 50
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To understand the role and function of the FMEA
To understand the concepts and techniques of
Design FMEA and how to apply it.
To Understand the concepts and techniques of
Process FMEA and how to Apply it
To understand the role and function of FTA
To understand the concepts of Zero Quality
Control or Mistake - Proofing (e.g. Poke - Yoke) and
its implications for FMEA.
Course Goals
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Customer Requirements
Engineering Specifications
System And Components Specifications
Process and Supplier Requirements and
ControlDevelop System Design And Process FMEA
Eliminate Potential Failures
Improve Upon Design And Process
Design is the Critical element
How FMEA Fits With Elements Of TQM
What is An FMEADana Quality Assurance Services+91-80-6549970 Failure Mode Effective Analysis 5
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An Advanced Quality Planning tool used to
evaluate potential failure modes and their causes.Prioritizes Potential Failures according to their Risk
and drives actions to eliminate or reduce their
likehood of occurrence.
Provides a disciplinary /methodology for documenting
this analysis for future use and continuous process
improvement.
By its self ,and FMEA is not a problem solver .It is
used in Combination with other problem solving tools,
The FMEA presents the oppurtunity but does notSolve the Problem .
FMEAs Have Failure Modes
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The team developing the FMEA turns out to be one
individual.The FMEA is created to satisfy a customer or third
party requirement ,not to improve the process.
The FMEA is developed too late in the process and
does not improve the product /process development
cycle.The FMEA is not reviewed and revised during the life
of the product .It is not treated as a dynamic tool.
The FMEA is percieved either as too complicated or
as taking too much time.
FMECA
Failure Mode Effects And Critically Analysis
Origins
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1950's Origin - Aerospace & US Military
To categorize and rank for focusTargeted prevention as a critical issue
Addressed saftey issues
FMEA
Failure Mode And Effects Analysis - 1960's and 70's
First notices & used by reliability engineers
System of various group actvities provided through documentation
of potential failure modes of products and /or processes and its
effect on product performance .
The evaluation and documentation of potentail failure modes of a product & process
Actions are then identified which could eliminate or reduce the potential failure.
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Automotive
QS 9000 Paragraph 4.2
Cited in the AIAG APQP Manual
Process Saftey Management Act (PSM)
Where And Why
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CFR 1910.119999999 lists the process FMEA as one of about
6 methods to evaluate hazards
Example ICI Explosives - Hazardous Operability studiesFDA - GMPS
One of several methods that should be used to verify a new design (21 CFR
Part 820).Inspectors check list questions cover use of the Design FMEA.
ISO 9001
Requires Preventive Actions .The utilization Of FMEAs is one
Continuous iimprovement tool which can satisfy the requirement .
ISO 14000
Can be used to evaluate potential hazards and their accompanying risks.
Components
sub systems,
ain system
Subsystems
Main systems
Man power
Machine
Components
System Design Process
Material
Measurement
Types Of Automotive FMEAs
Method
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Focus Focus Focus
Minimize failure Minimize processMinimize Failure effects on the failures effects on
Effects on the system design the Total Process.
Objective /Goal Objective /Goal Objective /Goal
Maximize System Maximize Design Maximize Total
Quality,reliability Quality ,reliability Process Quality
Cost Cost and reliability,cost,
and maintainability. maintainability. Process,Gauges Productivity andmaintainability .
Syste
FME
Design
FME
The effect from the
The Ramifications of
the problem
The Problem The cause (s) of the
Problem
System FMEA with a
The cause (s) of the
problem from the
Effect CauseFailure Mode
New Root Causes for
the Design Failure
Machines
Tools ,Work
Stations
Production lines
Operator Training
Relationships Of Automotive FMEAs
Envirnoment
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Proces
FME
Design FMEA Process FMEA
Sign Off
Concept Design
Go - Ahead
Design
Completion
Modes
Production
Start
Automotive FMEA Time Line
Problem from the
Design FMEA
Prototype
Build
Eng/Mfg
system FMEA
The same effect as the
Design FMEA
The causes of the Specific Root Causes
For the Process Failure
ModesBetter Definition
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Design FMEA :
Start early in process.Complete by the time preliminary
drawings are done but before any tooling is initiated.
Process FMEA :
Start as soon as basic manufacturing methods have been
discussed .Complete prior to finalizing production plans
and releasing for production.
Customer Input
Team - Team Selection ( Cross - Functional)
Ranking - Ranking Of Decisions
Some Key FMEA Terms
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Risk Priority Assessment
Design Process
Production Process
AIAG Automotive Industry Action Group
APQP Advanced Product Quality Planning
DFMEA Design Failure Mode And effects analysis
DOE Design Of experiments
FMA Faiulure Modes Analysis
FMEA Failure Mode and Effects Analysis
KCC Key Control Characterstic
Automotive Acronyms
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KPC Key Product Characterstic
PFMEA Process Failure Mode and Effects Analysis
PPAP Production Part Approval Process
PSW Production Submission Warrant
QFD Quality Function Deployement
Characterstic : A distinguishing feature ,dimension or property of a process or its output ( Product) on
Which variable or attribute data can be collected .
Characterstic ,Critical ,Chrysler Definition: Characterstic applicable to a component ,
material assembly or vehicle assembly operation which are designated by Chrysler Corporation
Engineering as being critical to part function and having particular quality ,reliability and /or durability
significance .These include characterstic identified by the shield ,pentagon ,and diamond.
Characterstic , critical ( Inverted Delta) , Ford Definition: Those Product requirements
( Dimensions , performance tetst) or Process parameters that can affect compliance with government
regulations or safe vehicle/product function ,and which require specific supplier ,assembly ,shipping or
monitoring and included on Control Plans.
Characterstic ,Key Control ( KCCs): Those process parameters for which variations must be
Controlled around a target value to ensure that significant characterstic is maintained at its target value.
KCCs require ongoing monitoring per an approved Control Plan and Should be considered as candidates
Characterstics I
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For Process improvement .
Characterstic, Key Product ( KPC): those product feature that affect subsequent operations,
Product function ,or customer satisfaction .KPCs are established by the customer engineer ,Quality
representative ,and supplier personnel from a review of the Design and Process FMEAs and must beincluded in the Control Plan.Any KPC s included in Customer -released engineering requirements are
provided as a starting point and do not affect the suppliers responsibility to review all aspects of the design,
Manufacturing process,and customer application and to determine additional KPCs.
Characterstic , process : Core team Identified process variables ( Input variables) that have a
Cause and effect relationship with the identified Product Characterstic (s) which can only be measured at
the time of occurrence.
Characterstic , Product : Feature or properties of a part , Component or assembly that are
described on drawings or other primary engineering information
Characterstic , Product , Critical (D) Chrysler Definition : a defect which is critical to part Function and having particular qu
Characterstic , Product , Major , Chrysler Definition : a defect not critical to function ,but which could materially reduce the
Satisfaction , or reduce production Efficiency .
Characterstic , Product ,Saftey /Emmission /Noise (S), Chrysler Definition: A defect
Which will affect compliance with Chrysler Corporation and Government Vehicle Saftey /Emission /Noise
Characterstic II
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Requirements.
Characterstic ,Saftey ,Chrysler Definition : Specifications of a Component.
material ,assembly or vehicle assembly operation which require special manufacturing control to assureCompliance with Chrysler Corporation and Government vehicle safety requirements.
Characterstic saftey Chrysler Defnition : Specifications which require special
manufactruing control to assure compliance with Chrysler or Government vehicle saftey reqiirements.
Charactertsic ,Significant ,Chrysler Defnition : Special characterstics selected by the
supplier through knowledge of the product and process.
Characterstic , Special : Product and process charactertsic designated by the customer, including
governmental regulatory and saftey ,and /or selected by the supplier through knowledge of the product and process.
Charactertsic , Special ,Chrysler Definition : Specifications of a component ,material ,assembly or vehicle
assembly or vehicle assembly operation which are designated by Chrysler as being critical to functionand having particular quality ,reliability and durability significance .
Charactertsic Special Chrysler Definition : Specific Critical Characetrstic that are process
driven (controlled ) and therefore require SPC to measure process stability , Capability ,and
control for the life of the part.
Charactertsic ,Special Chrysler Definition : Limited to highlighting critical Characterstics on
Production ( Production) part drawings ,tools and fixture ,and tooling aid procedures where ongoing
process control is not automatically manadated.
Charactertsic , Special , Chrysler Definition: Engineering Designated specifications
Characterstics III
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or product requirements applicable to component material,assembly operations which require
special manufacturing control to assure complinace with governmental vehicle saftey,emissions
noise ,or theft prevention reuqirmenets .
Characterstic , Special , Ford Definition "Critical Charactertsic" : those productrequirements (Dimensions , Specifications ,Tests) or process parameters which can affect
compliance with government regulations or safe vehicle /Product Function and which require specific
producer ,assembly ,shipping or monitoring actions and inclusions on the control plan.
Characterstic ,Specification , Ford Definition "Significant charactertsic : those
Product ,process and test requirements that are important to Customer satisfaction and for which quality
planning actions shall be included in the Control Plan.
Charatcetrtic ,Special Ford Definition : Significant /Characterstic :
characterstic that are important to the customer and that must be included on the Control Plan.
Charactertsic ,Special , GM Definition "fit /Function : Product charactertic for which
reasonably anticipated variation is likely to significantly affect customer satisfaction with a product (other
than S/C) such as its fits , function,mounting or appearance ,or the ability to process or build the product.
Characterstic , Special ,GM Definition Saftey/Compliance : Product charcterstic for
which reasonably anticipated variation could significantly affect customer the products safety or its
compliance with government regulations (such as : Flammability ,occupant protection ,streering control,
braking etc..) Emmisions ,noise , radio frequency interference etc.
Characaterstic , special GM Definition " Saftey /Compliance : Product Charactertsic for
Characterstics IV
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Which reasonably anticipated variation could significantly affect customer the products saftey or its
complaince with government regulations ( such as : Flammibility ,occupant protection ,steering control,
braking etc) Emmissions ,noise ,radio frequency interference etc .
Characterstic , Special ,GM Definition " Standard : Product characterstic for which
reasonably anticipated variation is unikely to significantly affect a products saftey,compliance with
governmental regulations ,fit/function .
Charcterstic ,Special , Process (e.g.Critical ,Key Major , significant): A Process
characterstic for which variation must be controlled to some target value to ensure that variation in a
special product characterstic is maintained to its target value during manufacturing and assembly.
Characterstic ,Special ,Product : Core team compilation of important product characterstics
From all sources.All special characterstics must be listed on the control Plan.
Charactertic , Special Product (e.g Critical ,Key ,Major Significant ): a Product
characterstic for which reasonably anticipated variation could significantly affect a products saftey or
Compliance with governmental standards or regulations ,or is likely to significantly affect customer
satisfaction with a product.
Characterstic ,Special ,Tooling , Chrysler definition : Critical tooling
symbol used identitity special charactertic of fixtures ,gauges ,developmental parts,and initial product
parts.
Control Item Part , Ford Definition:Product drawings /specifications containing Critical
Charactertics .Ford Design and Quality Engineering approval is required for changes to Control item
FMEAs and Control Plans.
Characterstic V
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Flow CHART , Preliminary Process
Description of anticipated manufacturing process
developed from preliminary bill of material and
product /process assumptions .
Flow DIAGRAM, PROCESS
Depicts the flow of materials through the process,
including any rework or repair operations .
Process Flow Document
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FMEA: Failure Mode and effects Analysis- systemized technique which identifies
and ranks the potential failure modes of a design or manufacturing of a design or manufacturing process in order to prioritiz
improvement actions.
Failure Cause Potential : How the Failure could occur,described in terms of somtheing that can be
corrected or can be controlled .
Failure Modes Analysis (FMA) : a Formal structered procedure used to analayse failure mode data
from both current and prior processes to prevent occurrence of those failure modes in the future.
Failure Mode Potential : The manner in which the process could potentially fail to meet the process
requirements and/or design intent a description of the non -conformance at that specific operation.
FMEA , Design : analytical technique used by a design responsible engineer /team as a means to assure,
to the extent possible ,that potential failure modes and their associated causes /mechanisms have been
considered and addressed.
FMEA , Machine /Equipment : Same as process FMEA , Except machine /equipment being designed is
considered the product.
FMEA , Process:Analytical technique used by a manufacturing responsible engineer /team as a means
to assure that , to the extent possible ,potential modes and their associated causes /mechanisms
have been considered and addressed.
FMEA & Failure Terms
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Control Plan: Written descriptions of the system for controlling production parts and
processes.They are written to address the important characterstics engineering
requirements of he product.Types of control Plans include "family" device or technology
Control Plans which apply to a number of parts produced using a common process.
Customer approval of control plans may be required prior to PSW submission.Refer to
Section III For customer -specific requirement .
Control Plan , Prelaunch : A description of the dimensional measurements and
material and performace tests that will occur after prototype and before full (normal)
production.
Control Plan Production: A Comprehensive documentation of product/process
characterstic ,process controls ,tests , and measurements systems occuring during mass
(normal) Production.
Control Plan , Prototype: A Description of the dimensional measurements and
material and performance tests that will occur during Prototype Build.
Control Plan Definitions
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Before Or after ?
Individual or Team Approach ?
FMEA Timing
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Process Flow Diagram(Includes All Proceses)
Process FMEA Critical Charactertsics
(On all Processes) & Failure Effects Issues
Process Control Plan( Critical Processes From FMEA)
Critical Charactertsics
& Charactertsic Control Issues
Design FMEA( On Intended Use)
Typical Automotive Triology Development
APQP Time Line
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Check For CustomerRequirements.
Give careful consideration
to that you consider a
Major Process.
Use the appropraite RPN
numbers and
considerations of other
appropraite information/
data to determine Critical
Give careful Charactertics.
consideration todefining Contro Develop Control
plan stages mechanisms appropriate
Prototype for critical
Pre-launch charactertsic
Production
Element for every
Process
Develop the
Control Plan with
Critical
Charactertsics
flow Listing
Enter Every
Major Process
from flow listing
into FMEA Form
Develop FMEA(s)
Automotive Document Development
Develop Process
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Advanced Product Quality Planning Timeline
Process Flow Listing Flow /Process Control Plan(Includes All Processes) (All Major Processes)
APQP Procedure should Process Flow Listing
Trigger this Process Becommes the
Process Control Plan
Some Elements may Process FMEAbe Included On ( All MAJOR Processes)
Use to Determine
Critical Charactertic
From RPN
Design FMEA( Intended Use)
Control Plan / Process Flow Combination Example
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Check for customer
requirements.
Give careful consideration
to what you consider a
Major process.
Use the appropriate RPN
numbers and
considerations of other
appropriate information/
data to determine critical
charactertics.
Develop Control
mechanisms appropriate
for critical
charactertsics.
One Document ? Or More ?
Process in the
Control Plan
Revise the
Control Plan with
Critical
Charactertsics
Major Process
Form Flow Listing
into Control Plan
Form
Develop FMEAs
Element for Every
Control Plan /Process Flow Combination ExampleDocument Development
Develop Process
Flow Listing
Entry Every
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Manufacturing Entity
Receiving Machine or Machine Pack
Cell 1 Or Cell 2
& Ship
Segmenetd + By machine or Cell Receiving
Pack
Device ,Technology or Family = a Flow of a technology or device & Ship
QS 9000 :1996 - FMEAs
Internal Or
External
Customer
Machine
or Cell 3
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4.2.3 - Quality Planning
Process Failure Mode And effects
analysis ( Process FMEAs)
Process FMEAs shall consider all special
Charactertsics.Efforts shall be taken to improve
the process to achieve defect prevention ratherthan defect detection.Certain customers have
FMEA review and approval requirements that shall
be met prior to production part approval ( See
Customer specific pages).Refer to the Potential
Failure Mode and effects Analyisis reference
manual.
4.2.3 - Quality Planning
QS 9000 :1996 - Control Plans
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The Control Plan
Suppliers shall develop ControlPlans at the system
subsystem,Component and /or material level,as apporiatefor the product supplied.
The Control Plan requirement encompasses processes
producing bulk material(e.g Steel , Plastic resin ,Paint ) as
well as those producing parts.
The output of the advanced quality planning process,beyond
the development of robust processes,is a control Plan.
control Plans may be ebased on existing plans ( for mature
Products and capable processes). New Plans are required
when products or processes differ significantly from those in
current production.
4.2.3 - Quality Planning
QS 9000 : 1996 - Control plans
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The Control Plan
The Control Paln shall cover three distinct phases as appropriate:
Prototype - a description of the dimensional meausrements and
material and performance test that will occur during Prototype build.
Note: Prototype Control Plans may not be required from all suppliers
Prelaunch - a description of the dimensional meausrements and
material and performance test that will occur after Protype and
before full Production.
Production - a Comprehensive documentation of product /process
characterstcis , process controls test and measurement systems that
will occur during mass production.
Suppliers shall establish cross - functional teams to develop Control Plans for
approval by the appropriate customer engineering and quality personnel
unless this approval requirement is waived by the customer .In Some cases,
the Customer will establish a cross functional team to develop the control Plan.
Quality Planning - 4.2.3 S
SemiConductor Supplement
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During the advanced quality planning processes,the supplier shall
include all processes from the incomming material through shipping
and warehousing.
Failure Mode And Effects Analaysis and Control Plan Documents
Shall include these processes.
The Intent :
The supplier Shall " Consider " All Processes .But does it mean that
all process shall be included In the FMEA and Control Plan?
6.2 Overview
APQP Manual : 1995
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A Control Plan is written description of the
system for controlling parts and processes "
"In effects, the Control Plan describes the actions
that are required at each phase of the process
including receiving , in - process , out going , and
periodic requirements to assure that all process
outputs will be in taste of control"
" Process Potential FMEA"
IS " aSummary of engineer's /teams thoughts
FMEA Manual : 1995
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( Including an analysis of items that could go wrong
based upon experience and past concerns ) as a
Process is developed".
" A process FMEA should begin with a flow chart/
risk assessment of the general process.This flow
chart should identify the products charactertsics
associated with each operation."
Prevention Planning
Identifies Change requirements
Benifits Of FMEAs
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Cost reduction
Increased through-put
Decreased Waste
Decreased warranty costs
Reduce non-value added operations
Select proper team and organize members effectively
Select teams for each product /Service , process/system.
Create a ranking system
FMEA Pre Requisites
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Agree on format for FMEA matrix ( Typically set by AIAG)
Define the customer and customer needs/
expectations
Design /Process requirements
Develop a process flow Chart
What is a team
Two or more individuals who coordinate actvities
to accomplish a common task or goal.
The Team
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Maintaining Focus
A sepearte team for each product or projects.
Brainstorm
Brainstorming ( The Team ) is necessary as the
intent is to discover many possible possibilities.
Two Types Structures
Natural Work Group Task Team
Work area or unit Representatives who have key
representatives from support information or are stakeholders.
groups on as - needed basis.
Participation is mandatory. Assigned by steering committee
Team Structures
Membership
Member SelectionDana Quality Assurance Services
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or upper management
Assigned by management or Assigned by or negoiated with
identified by team and within its steering committee or upper
authority. management.Ongoing Disbands when task is finished .
Leader appointed by management. Leadership shared or delegated by
members.
Are management directed and foccussed
Build their own identity
Are accountable and use
Measurements
roject Identificatio
Team Life Span
Leadership
Succesful Teams
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Have corporate champions
Fir into the organization
Some Teams Just " Do not
Are cross - functional Work"
Determine if there should be a meeting
Decide who should attend
Provide advance notices
Maintain meeting minutes or records
Basic Team Rules
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Establish ground rules
Provide and follow an agenda
Evaluate meetings
allow NO interruptions
Ground Rules are an aid to "self -
management"
Team must develop their own ground rules
Once deveolped,everyone must live by them
They can modify or enhance the rules as they
Team Ground Rules
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continue to meet
Clarify
Participate
Listen
Summarize
Stay on Track
Team Meeting Responsibility
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Manage time
Test For Consensus
Evaluate meeting process
One Person makes the decision
One person consults the group,then
makes the final decision
Team or group makes decision based
upon majority rule or consensus
Decision Criteria /Model
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Start During Prototype stage
Design Engineer - Generally the Team Leader
Test Engineer
Reliability Engineer How do you Currently
Material Engineer prevent problmes from
Field Service Engineer occuring?
Component Process Engineer
Vehicle Process Engineer
Styling Engineer
Project Manager or Rep.
Design FMEA Team
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Quality Engineer
Customer Contact Person
Others ,including Mfg., Sales , Mkting ,QA / QC, Process ,Pacakaging
Process Engineer - Generally the Team MembersProcess Operator
Industrial Engineer
Design Engineer How do you presently
Reliability Engineer prevent problems?
Tooling EngineerMaintenance Engineer
Styling Engineer
Project Manager or Rep.
Quality Engineer
Process FMEA Team Members
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Others including supplier , Sales ,QA/QC, MFG.
Design FMEA Customer
End User : person who uses the product
Use Failure
This can help in Repair manuals & Filed Service
More in the DFMEA section herein.
Process FMEA Customer
Subsequent operations
Defining the Customer
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End users : person who uses the product
More in the DFMEA section herein
Do not mix up :
Design Failures & Causes
With
Process Failures & Causes
Design Failures Process Failures
Insufficient lubrication capabilitry Insufficient lubrication applied
Incorrect specified Incorrect material used
CAUTION
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RPN = (S) x (O) x(D)
S = Severity
O = Likehood of Occurrence
D = Likelihood Of Detection
Prevention vs Detection- Automotive Expectations:
1000 is the Maximum and 75 is considered "OK"
High and low numbers are the important ones to consider
Input Concept
Risk Assessment (RPN) Factors
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From Experience From
& Data Guess
Design FMEAItem- Function Potential Failure Potential Effects Potential Current Design Recommended Responsible
Mode Of Failure Cuases /Mechanisms Of controls Actions Activity and
Failure and status target completion
date
Process FMEAProcess Function Potential Failure Potential Effects Potential Current Design Recommended Responsible
Requirements Mode Of Failure Cuases /Mechanisms Of controls Actions Activity and
Failure and status target completion
date
Device /
Process
Failure Mode Chance OF Severity Chance Not
Occurrence Detected
RPN Flow
Effect ControlCause
Severity
Occurenc
Detection
RPN
Occured
Severity
Severity
Occurenc
Detection
RPN
Occured
Severity
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Design FMEADana Quality Assurance Services
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A Design FMEA is an analytical
Techniques utilized primarily by a Design
FMEA team to ensure potential Failure
modes and their associated causes are
identified , Considered and addressed.
Reference page 8 in the AIAG FMEA Reference Manual
This systematic approach parrels,Formalizes and documents the
mental discipline that an Engineer normally goes through in any
Design process.
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Customers include
End userRepair functions
Dealership or other Sales Outlet
Designer of the next level system or product
Process Engineers
Assembly Engineers
Test Engineers
Product Analysis
Start with a list of :
Typical Design Considerationms
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What the design is expected to do
What the design is expected NOT to do
Design Intent
Customer Needs
Customer Wants
Product Requirement
Manufactring assembly requirements
Think about what Quality Function Deployement
documents in your customer Contacts
company Competative Analysis
define these Known Product Quality
Reliability Requirements
Manufactruring Requirements
Aids in the objective evaluation of design requirements and
Design FMEA Benefits
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alternatives.
Increases the probablity that potentail modes and their
effects on the system/product have been considered.
Aids in the planning of design test and development programs
Aids in analyzing field concerns ,design changes and in
developing advanced designs.
Ranks potential failure modes according to their effect on the
customer ,thus prioritizing improvements and development
testing.
Provides an open issue format for recommending and tracking
risk reducing actions.
Can reduce product development timming ,Production startup
problems ,reduce costs and enhance product quality,reliabiity
and saftey.
The Design FMEA is a living document and should be initiated
More Design FMEA Considerations
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at ,or by ,design concept completion.
The design FMEA should be continually updated as changes
occur throughout all phases of product development.The Design FMEA should be fundamentally complete along with
the final product drawings.
The design FMEA addressess the design intent and assures
the design will be manufacturers /asembled to this intent.
The Potentail Failure Mode /Causes which can Covered by the Process
FMEA ad therefore should NOT be included in a design
FMEA.
Causes of design failure modes are
Design Failure Causes
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those things that ,from a designer 's
prespective ,would , by ommission or
improper use ,result in the failure mode.
Improper Tolerancing
Design Failure Cause Examples
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Incorrect Stress Calculations
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Incorrect Stress Calculations
Wrong Assumptions
Wrong Material Call outLower Grade Component
Lack of design Standards
Improper Heat Treatment
Improper Torque Call out.
Design Block diagram ExampleIf the product is complex ,break it
down into smaller sub -systems .Identify
System Primary vs Secondary Fuctions.Body
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Subsystem
Exterior Window Interior
Glass Sealing Latch/
Component with Lock
Strip
Doors
Door
Inner
Panel
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Effect Critreria: Severity of Effect Ranking
Hazardous Very high ranking when a potentail failure mode affects safe 10
without vehicle operation and/or involves noncomplaince with government
warning regulation without warning
Hazardous Very high seviriaty ranking when a potential mode affects safe 9
with vehicle operation and/or involves non compliance with government
warning regulation with warning.
Very High Vehicle /item inoperable ,with loss of primary function 8
Generic Design FMEA Severity
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High Vehicle /Item operable ,but at a reduced level of performance 7
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Customer dissatisfied.
Moderate Vehicle /Item operable ,but comfort convinence items inoperable 6
Customer experiences discomfort.
Low Vehicle /Item operable but comfort /convenience items (s) operable at 5reduced level of performance .Customer experiences some
dissatisfaction.
Very Low Fit & Finish /Squeak & Rattle item does not conform .Defect noticed 4
by most customers.
Minor Fit & Finish /Squeak &rattle item does not conform .Defect noticed 3
by average customers.
Very Fit & Finsih /Squeak & rattle item does not conform .Defect noticed 2
Minor by discriminating customers.None No effect 1
Possible Failure Rates Ranking
Very High : Failure is almost inevitable > 1 in 2 10
1 in 3 9
High : Repeated Failures 1 in 8 8
1 in 20 7
Moderate : Occasional Failures 1 in 80 6
1 in 400 5
1 in 2000 4
Generic DFMEA Occurrence
Probability Of Failure
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Low : Relatively Few Failures 1 in 15000 3
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1 in 150000 2
Remote : Fialure Unlikely < 1 in 1,500,000 1
Detection Criteria : Likelyhood of detection by Design Control Ranking
Absoulete Design Control will not and /or can not detect potential 10
Uncertainity cause /mechanism and subsequest failure mode: or there is no
Design Control.
Very Very remote chance the design Control will detect a potential 9
Remote causes/mechanism and subsequent failure mode.
Remote Remote chance the design Control will detect a potential 8
cause /mechanism and subsequent failure mode.
Very Low Very low chance the design Control will detect a potential 7
cause /mechanism and subsequent failure mode.
Generic DFEMA Detection
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Low Low chance the design control will detect a potential 6
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g p
cause /mechanism and subsequent failure mode.
Moderate Moderate chance the design Control will detect a potential 5
cause /mechanism and subsequent failure mode.
Moderately Moderatly high chance the design Control will detect a potential 4
High cause /mechanism and subsequent failure mode.
High High chance the design Control will detect a potentail 3
cause /mechanism and subsequent failure mode.
Very High Very high chance the design Control will detect a potential 2
cause /mechanism and subsequent failure mode
Almost Design Control will almost certainly defect a potential 1
Certain cause /mechanism and subsequent failure mode.
Design Controls are those actions taken as
a normal part of the development process
that are designed into the process to
minimize the occurrence of failure or to
detect specific failure modes.
Design Controls
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Design controls should directly relate to the
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Design controls should directly relate to the
Prevention and/or detection of specific
causes of failures.
Reliability Tests/Prototype Testing
Design Reviews
Worst Case stress Analysis
Robust Design
Envirnomental Stress Testing
Designed Experiments
Design Control Examples
Consider
Interpretation of
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Finite Element Analysi
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Finite Element Analysi
Variation Simulation
FT AnalysisComponent Derating ( 60% to 80 %)
100,000 Mile Pilot Test
When the failure modes have been ranked by their RPN,
corrective actions should be first directed at the highest ranked
concerns and critical items identified .
The intent of any recommended action is to reduce one or more
(or all) of the occurrence ,severity and/or detectioin rankings.Only a design revision can bring about a reduction in the
severity ranking .If no actions are recommneded for a specific
cause ,this should be indicated.
A reduction in the occurrence ranking can only be effected by
Recommended Actions
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removing or controlling one or more of the causes of the failure
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g g
mode through a design revision.
An increase in design verification actions will result in a
reduction in the detection ranking ONLY.
Design FMEA doesnt rely on process controls to overcome
potentail weakness in the design: however ,it does take
technical and physical limitations of a process into consideration (Design rules)
Sample Sizes
Evaluation
For the Control Plan Frequency
Method of
characterstics
and is therefore the
Starting Point
The Process FMEA
Identifies
Critical and Significant
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Evaluation
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Evaluation
Out-of-Control
Action Plan
(OCAP)
You want to understand your current process
You are looking for oppurtunities to improve
You want to illustrate a potential solutionYou have improved a process and want to
document the new process
Use a Process Flow ChartBecause:
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Lets Try A Process Flow Chart
1 Identify the process or task you want to analyze.Defining the
scope of the process is improtant because it will keep the
improvement effort from becoming manageable.
2 Ask the people most familiar with the process to help construct
the chart.
3 Agree on the starting point and ending point.Defining the scope
of the proces to be charted is very important ,otherwise the
Creating a Process Flow Chart
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task can become unwieldly.
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4 Agree on the level of detaiul you will use .Its betetr to start out
with less detail ,increasing the detail only as needed to
accomplish your purpose.
5 Look for areas for improvement
Is the process standardized ,or are the people doing the work in different ways?
Are steps repeated or out of sequence ?
Are there steps that do not ad value to the output?
Are there steps where errors occur frequently?
Are there rework loops?
6 Identify the sequence and the steps taken to carry out the
Process.
7 Construct the proces flow chart either from left to right or from
Creating A Process Flow Chart
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top to bottom ,using the standard symbols and connecting the
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steps with arrows.
8 Analyze the results.
Where are the rework loops?
Are there process steps that dont add value to the output?
Where are the differences between the current and the desired situation?
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TTOOOOOOOOOO makeeeeeeeee
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Use to help determine who should be involved by
identify all the work areas in a process
Use as a job aid to remind people about processs
standards
Use as a check list to collect data on where problems
occur
Use to investigate why rework is occurring at a
certain place in the process
Use the ideal process flow chart data to
communicate your proposed solution
How To Use The Flow Chart
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If a process step or box has two output
arrows ,consider whether a decision box is
needed
Remember that the people closest to the work it best .Make sure pe
involved in developing the flow chart
Software packages make flow chartproduction easy.
Flow Chart Tips
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Identifies potential product-related failure modes
Assesses the potential customer effects of the
failures
Identifies the potential internal and externalmanufacturing or assembly process causes and
identifies process variables on which to focus
controls for occurence reduction and/or detection of
the failure conditions
Develops ranked list of potential failure modes,thru
establishing a priority system for corrective action
considerations
Documents the results of the manufacturing or
The Process Potentail FMEA
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assembly process
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A process potential FMEA is an analytical tool utilized by a process
FMEA team as a means to ensure potential failure modes and their
associated causes are identified ,considered and addressed.
Teams should be run by the owner of the process or someone who
understands the process well.Defines reasons for rejection at specific operations.
In preparation for the FMEA ,the assumption should be made that
the incomming parts and materials are correct.
A comparision of similar components is a recomended starting point.A
knowledge of the purpose of the design necessary.It can be cause -associated with a potential failure mode in a
subsequent operation or an effect associated with a potential failure
in a previous operation.
Each potential mode for the particular operation should be
Process Potential FMEA
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listed in terms of a part or process characterstic.
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Process FMEA Foci
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Customer include:End user
Next Manufacturing or Process step
Process Engineers
Assembly Engineers
Repair FunctionsTest Engineers
Product Analysis
Dealership or other Sales Outlet
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Process FMEA Beneifts
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As a systematic approach ,the process potentail FMEA
parrallels and formalizes the mental discipline that an engineer
goes through in any manufacturing planning process.
The Process Potential FMEA identifies potential product related
process failure modes.
The process potential FMEA assesses the potential customer
effects of the failures.The process potential FMEA identifies potential manufacturing
and/or assembly process causes.
The process potential FMEA identifies significant process
variables to focus controls for occurrence reduction and
detection of failure conditions.
The process potential FMEA develops a list of potential failuremodes ranked according to their affect on the customer,thus
establishing a priority system for corrective and preventive
action considerations.
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More Process FMEA Considerations
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The process FMEA is a living document.
The Process FMEA should be continually updated as changes
occur throughout all phases of product development and on into
and through to the end of production.
The process FMEA should begin with a flow chart of the
processes - from receiving through shipping and warehousing.
The potential Failure Modes /Cause which can occur during
manufacturing or assembly process are covered by the Process
FMEA but some information (severity rankings,identification of
some effects ) may come from the Design FMEA.
A reduction in occurrence ranking can on by be achieved by
implementing a proces change that controls and eliminates
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RPN
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Effect Criteria Sevrity Of effect Rankingazar ou ay en angere mac ne or assem y operator . ery g sever ty
Generic PFMEA Severity
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t out ran ng w en a potenta a ure mo e a ects sa e ve c e operat onarn ng an or nvo ves noncomp ance w t government regua t on. a ure
w occur w ou warn ng.azar ous ay en angere mac ne or assem y operator . ery g sever ty
w t ran ng w en a potent a a ure mo e a ects sa e ve c e operat onwarn ng an or nvo ves noncomp nace w t government regu at on. a ure
w occur w warn ng.
ery g a or srupt on to pro uct on ne . o pro uct may ave toe scrappe . e c e tem n opera e , oss o pr mary unct onus omer very ssa s e .
g nor srupt on to pro uct on ne . ro uct may ave to e sortean a port on ( ess t an ) c rappe . e c e t em opera e , uta a re uce eve o per ormance . us omer ssa s e .
o erate nor srupt on to pro uct on ne . port on ( ess t an ) o
t e pro uct may ave to e scrappe (no sort ng) . e c e temopera e , ut some mcom ort conv en ence tem (s) nopera e
us omers exper ences scom or .
ow nor srupt on to pro uct on ne . o pro uct may ave toe rewor e . e c e tem opera e , ut some com ort conv en encetems opera e at re uce eve o per romance . utsomer
exper ences some ssa s ac on.
ery ow nor srupt on to pro uct on ne . e pro uct may a ve to esorte an a port on( ess t an )rewor e . t
n s quea ratt e tem oes not con rm . e ect not ce ymos cus omers.
nor nor crupt on to pro uct on ne. e pro uct may ave too e
sorte an port on ( ess t an ) rewor e on- ne ut out ostat on. t n s squea ratt e tems oes not con orm . e ectno ce y a scr m na ng cus omers.
ery nor srupt on to pro uct on ne . e pro uct may ave to enor sorte an port on ( ess t an ) rewor e on- ne ut n-
stat on . t n s squea ratt e tem oes not con orm . e ectno ce y a scr m na ng cus omers
one o e ect
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CpK Ranking
Very High : Failure is almost inevit > 1 in 2 < 0.33 10
i
Probablity OF Failure Possible Failure Rates
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1 in 3 > 0.33 9
High : Generally Associated with processessimilar to previous processes which 1 in 8 > 0.51 8
often failed
1 in 20 > 0.67 7
Moderate : Generally associated with
processes similar to previous proces 1 in 80 > 0.83 6
which have experienced occasional
failures ,but not in major proportion 1 in 400 > 1.00 5
1 in 2000 > 1.17 4
Low: Isolated failures associated wi 1 in 15000 > 1.33 3
similar processes.
Very Low: Only isolated failures 1 in 150000 > 1.50 2
associated with almost identical
Processes.
Remote : failure Unlikely .No Failu < 1 in 1500000 >/1.67 1
associated with almost identical
processes
If a process is under SPC or is similar to previous process process under SPC ,then the Statisticaldata should be used to determine Occurrence ranking.
Assessment of occurrence ranking can be made using the word descriptions in the evaluation
creteria if statistical data is not available.
Detection Criteria : Liklyhood the existence of a defect will be Ranking
Generic PFMEA Detection
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detected by process controls before next or subsequent
process, or before part or component leaves
manufacturing or assembly location
Al t N K C t l il bl t d t t f ili d 10
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Almost No Known Controls available to detect failiure mode 10
ImpossibleVery Very remote likelyhood current controls will detect failure mode 9
Remote
Remote Remote likehood current controls will detect failure mode 8
Very Low Very low .likelyhood current controls will detect failure mode. 7
Low Low likelyhood current current controls will detect failure mode. 6
Moderate Moderate likelyhood current controls will detect failure mode 5
Moderately Moderately likelyhood current controls will detect failure 4
High mode
High High Likelyhood current controls will detect failure mode. 3
Very High Very high likelyhood current controls will detect failure mode. 2
Almost Current Controls almost certain to detect the failure mode 1
Certain reliable detection controls are known with similar processes.
Assume the failure has occurred and then assess the capabilities of all current controls to prevent
shipment of the part having this failure mode or defect.
Random quality control checks would be unlikely to detect the existence of an isolated defect and
therefore would result in low to remote detection ranking.
Sampling done on an statistical basis is a valid detection control.
A reduction in detection ranking can only be achieved by improving process control system(s).
Process Failure Causes
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1 Omitted processing 11 Poor control procedures
2 Processing errors 12 Improper equipment
3 E i k i i
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3 Errors setting up work pieces maintenance
4 Missing parts 13 Bad recipe
5 Wrong parts 14 Fatigue
6 Processing wrong work p 15 Lack of saftey
7 Mis-operation 16 Hardware failure
8 Adjustment error 17 Failure to enforce controls
9 Equipment not set proper 18 Envirnoment
10 Tools and /or fixtures 19 Stress connections
improperly prepared 20 Poor FMEA(s).
1 Standardized work instructions /procedures
Process Control Examples
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2 Fixtures and jigs
3 Mechanical interference interfaces Controls can be
4 Mechanical counters process controls fool
5 M h i l fi PSC
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5 Mechanical sensors proofing or PSC ,or
6 electrical /Electronic sensors can be post -process7 Job sheets or process pacakages inspection/testing.
8 Bar coding withj software integartion and
control Inspection /testing
9 Marking may occur at the
10 Training and related educational safegaurds subject operation or
11 Visual Checks at subsequent
12 Gauge studies operations that can
13 Preventive Maintenance detect the subject
14 Automation (Real Time Control ) failure mode.
SPC records
Typical Process Documents
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Visual aides
Work instructions
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Inspection instructions /recordsEquipment operating instructions
Training records
Traceability records
Corrective Action should be first directed at the highest
concerns as rank ordered by RPN.
Recommended Actions
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The intent of any recommended action is to reduce the
occurrence ,severity and/or detection rankings.
If ti d d f ifi th thi
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If no actions are recommended for a specific cause ,then this
should be indicated.
Only a design revision can bring about a reduction in the
severity ranking.
To reduce the probability of occurrence ,process and/or
specification revisions are required.
To increase the probability of detection ,process control and /or
inspection changes are required .Improving detection controls is
typically costly.The emphasis should be placed on preventing,
rather than detecting ,defects.
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FTA
Inductive logic (bottom up) Deductive (top Down)
Determines all possible way gdbgbndgnbd
equipment can fail .Determines the Assumes a system failure and
effect of such failures on the system. determines the possible causes
FMEA
FMEA vs FTA
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Focus is on the parts of which the Focus is on the total system
system is comprised
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The ellipseThe top event ,the ellipse contains the descrption of the system-level fault or
undesired event.The symbol appears at the head or top of the the tree and is
included on by once I any tree.The input to the ellipse is from a logic gate.
The Rectangle
Fault Tree Symbols
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The fault event ,the rectangle , contains a brief descriptiuon of a lower level fault
This decriptiom should be short without being vague.Fault events appear
throughout the tree and have both their input and output from a logic gate.
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Logic Gates
Logic Gate inputs and outputs ,except for the inhinitgate,which is addresses
below ,have similar connections. The out put from a logic gate is to any fault
event block or to a transfer out function.The input is from any fault event block
or from a transfer in function.The AND Gate is the logic gate in which the
output occurs only if all inputs exist.
The or is thelogic gate in which the output occurs only if one or more of
the input events occur.
1 Defining the Undesired Events (Major Faults)
a) The undesired event is often the fault which ,upon occurrence ,results incomplete failure of the system,the failure of a back -up system ,degradation or
an undetected failure .This is considered catasophic failure.The major fault is
a failure which causes loss of availability through the degradation or system
shut down and/or poses a saftey hazard to operators and/or maintanence
personnel .The undesired event however ,may be unusual failure at a sub-
Fault Tree Fundamentals
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system level ,the root caue of which is unknown .Any observable event may be
chosen as the "undesired event" .The analayst must recognise that the FTA will
not identify failures unrelated to the chosen event.
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b. To define the undesired event ,the normal system operation and envirnomentmust be known in order to allow the analysis to show the undesired event as a
failure .When defining the undesired event,are must be taken to prevent the
range of the faults from becoming too broad .For example ,Failure to complete
trip " for an automobile, is not specific enough to allow for ease of analysis .This
is because failure could vary from an air conditioning fault ,which caused
discomfort ,to loss of engine power ,which caused loss of mobility .Both faults
could be considered failure : however ,loss of mobility is obiviously a much more
severe fault than losing air conditioning.
2 Defining Types of Faults
Faults fall into two basic categories : operational and Component
Operation Fault
The operational fault is one which occurs when a component is operating as it
was designed to ,but at an inappropriate time or place .An example is a failure of
a control valve to close or to interruypt the introdiuction of a reactant into a
chemical process due to an inappropriate signal from another device.
Fault Tree Fundamentals
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Component Fault
The component fault can be further decided into two sub categories primary and
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The component fault can be further decided into two sub categories , primary and
secondary .a primary component fault occurs when a component fails to
function in its intended envirnoment .Example : A radar unit designed for use in
aircraft which fails due to vibration .a Secondary component failure occurs when
a componnet fails to function in an envirnoment other than the envirnoment for
Which it is intended ,Example : A radar unit designed for a cargo aircraft fails in a further aircraft
3 Comparision of Fault Occurrence and Faulty Existence
The term Fault Occurrence refers to the fact that an undesired event has taken
place and may or may not still exist .Fault Existence ,however implies that the
place and may or may not still exist .Fault Existence ,however implies that the
fault has occurred and continues to exist .Therefore the fualt can be describeas being either transient or permanent.
During the construction of the fault tree ,all systems analyst should use Fault
Occurence ,rather than Fault Existence as the focus of interest.
Fault Tree Fundamentals
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4 Comparison Of Failure Causes and Fault Effects
A failure is considered to be an ability to perform a normal fucntion Example:
Valve does not open .A Fault is a higher Occurrence which is usually
preceded by a lower -level failure such as a casing cracking due to overheating
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preceded by a lower -level failure,such as a casing cracking due to overheating
because of a lack of coolant induction due to an inoperable valve (lower level ogf
Failure ),However , a fualt may also occur when no failure is present .Example :
Coolant valve operates properly,but the signal to operate it encounters a delay
A Fault has occurred ,but there is no valve failure .Becuase of this ,it can be
stated that any failure causes a faulktr ,but not every fault is caused by a failure.
Failure Categories : a Component B.Envirnoment c.Human .D Software
Determine the level to which the examination should
be constructed
Begin with the system-level fault
Fully describe all events which immediately cause
this event
Fault Tree construction Steps Summary
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With each lower -level; fault , continue describing its
immediate causes until a component level failure or
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immediate causes until a component level failure or
human error can be attributed to the fault
Fully define each branch of the tree before begining
another branch
During the construction of the tree ,it is advisable touse a block diagram of the system to simply
determining the main branches
Fault Tree Construction Steps Summary
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If the results of the FMECA on the system are
available at the time of the FTA it is advisable to use
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the results in defining the top events
1 Determine the minimal cut-sets to simplify the tree
(Qualitative analysis ).
2 Determine the probability of each input event
3 Combine the probability inputs to logic gates asfollows :
a. AND Gate - The probability of output is the product of the
Analyzing the Fault Tree
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probabilities of the inputs (Po=PI1Pi2..Pin)
b. OR Gate - The probability of output is the sum of the
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probablities of the inputs (Po=Pi1+Pi2.Pin)
4 Combine the gate input probablities until the
probablity of the top event is determined.
Identify the system or equipment level
fault state (s) (Undersed event(S))
Construct the fault tree
Perform the analysis to the component
level
Fault -Tree Analysis Procedures
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The top event must be measurable and
definable
The top event must be inclusive of the lowerevents
The top event is the result of the lower
Criteria for Identifying the undesired Event
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events
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Can any equipment failures contribute to this effect?
Materials faults ?
Human errors?
Methods and Procedures?Software performance ?
Maintenance errors or the absence of maintenance ?
Inaccuracies or malfunctions of measurement
Clues About Causes
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devices(s)?
Envirnoments such as chemicals ,duct ,vibration,
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shock and /or temprature?
Almost all errors are caused by human errors
Forgetfulness- Sometimes we forget things when we are not
concentrating .Example : A person forgets to set his /her alarm
close at night .Safegaurd establish a routine which include
checking before going to bed.
Errors due to misunderstanding - Sometimes we make
mistakes when we jump to wrong conclusion before we are
familiar with the situation .Example : A person used to a stick
Errors 1
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shift pushes the brake petal in an automatic thinking it is the
clutch .Safegaurds : Training , checking in advance ,
standardizing work procedures .
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Errors in identification - Someties we misjudje a situation
because we view it too quickly or too far away to see it
clearly .
Safegaurds : Training ,attentiveness ,vigilane.
Errors made by amateurs - Some times we make mistakes
through lack of experience .Example : A new worker does not
know the operation or is just barely familiar with it .Safe gaurds :
Training ,Skill buliding work standerdization.
Willfull errors - Sometimes errors occur when we decide that
we can ignore the rules under certain circumstances .Examples "
Crossing a street against a red light because we no cars
Safe gaurds : Basic eductaion \Experience.
Inadverant errors- Sometimes we are absent minded and
Errors 2
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make mistakes without knowing how they happened .Example:
Someone lost in thought tries is red or not .Safegaurds:
Attentiveness ,discipline Work standardization.
E d t l S i k i k h
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Errors due to slowness - Sometimes we make mistakes whenour actions are slowed down by delays in judjement .Example
A person learning to drive is slow to step on the brake .
Safegaurds : Skill buliding ,Work standardization.
Errors due to lack standards- some errors occur when
there are suitable instructions or standards .Example :
A measurement may be left to an individuals disdretion.
Safegaurds : Work standardization , Work instructions.
Surpirse errors- errors sometimes occur when equipment runs
differently than inspected .Example : A machine malfunction
without warning ,Safe gaurds : Total Productive MaintenanceWork Standardisation.
Surprise errors- Errors sometimes occur when equipment runs
differently than expected .Example : A machine malfunction
without warning .Safe gaurds : Total Productive Maintenance
work Standardization.
Errors 3
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Intentional errors- Some People make mistakes deliberately
crimes and sobtage are examples Safe gaurds : Fundamentals
eductaion , Disiclipilne .
Mistakes happen for many reasons , but almost all
b t d if t k ti id tif h d
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can be prevented if we take tie identify when and
why they happen and then take steps to prevent
them, by using Poka -Yoke methods with
consideration to another available safe gaurds.
Variation control using assembly aidsIdentification by visual techniques
Standaredization work and work placce
organisation
Self - Check (In- process)Poke - Yoke
Five /methods of Mistake - proofing
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Emphasizes Prevention
Principles
Build into processes
Eliminate inadverant errors
Stop doing inadverant errors
Stop doing it wrong - Do it Right
Work TogetherFind Together
Find True Cause
Examples
Guide for part (Fixtures)
Mistake - Proofing
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Error detection alarm
Limit switchCounter
Check List
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Responsibility Responsibility activity
actvity
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lity,reliability and durability significance .
expected performance of a product , unfavorably affect customer.
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e 4.
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