Welcome to the

AIAG VDA FMEA 1st Training

 Introduction

 Joint publication- OEM, Tier 1 members of AIAG & VDA.

 CSRs needs to be referred as well
 New Method: “Supplemental FMEA for Monitoring & System
Response(MSR) has been added
 Analysis of diagnostic detection and fault mitigation during customer
operation so as to maintain safe state or regulatory compliance
 The FMEA-MSR is a supplement to DFMEA to maintain Safety and
Regulatory requirements during customer operation.
 FMEA-MSR has been introduced to ensure safety goals as per ISO26262
which defines automotive functional safety related to electrical,
electronic and software systems. However FMEA-MSR is applicable for
any equipment and to be done involving the customer to understand the
interfaces. It is to be conducted in the same way as any FMEA
 Previous FMEA book has been superseded

3 October, 2024 2
 Types of FMEA and Applicability

DFMEA PFMEA FMEA-MSR

Product Design
Responsible
√ √ √
and
Manufacturing
Only
Manufacturing,
X √ X
Product Design
is excluded

3 October, 2024 3
 Major Changes

 New 7 Step Process

 PFMEA Terminology
 Breakdown of various components
 PFMEA new template
 Value added PFMEA.

3 October, 2024 4
 Purpose and Description

 Challenges: demands, costs, optimization, liability, complexity,

legislation……………..
 FMEA addresses the technical aspects of risks reduction
 FMEA is team-oriented, systematic, qualitative and analytical
method for:
 Evaluate the potential technical risk of failure of product or process
 Analyse cause and effects of these failures
 Document these P&D actions
 Recommend action to??..............reduce risks

3 October, 2024 5
 Scope – Risk Management Tool

Technical Risks(FMEA) Strategy Risks

Financial Risks Time Risks
Product & Process Improvements done
Product profitable after Improvements done
analysed for potential although product
counter measure? within time?
failures? unprofitable?
OUT SCOPE OUT SCOPE
IN SCOPE OUT SCOPE

Info about product Decisions for further improvement of

and process risk product and process

product and process with

reduced risk

3 October, 2024 6
 Objectives and Limitations

 Identify functions of product or steps of process- failure modes, effects,

causes
 Are the preventive and detection controls enough? Recommend actions.
 Prioritise on preventive product/process problems
 Others- quality, reliability, linkages, interfaces, CSat, improving
knowledge base………………………………, meeting regulations…..

Limitation
 Subjective, not measurable(FTA, FMEDA)
 Single point failure analysis
 Relies on team knowledge
 Relies lot on recording skills

3 October, 2024 7
 Integration

 Clear, True, Realistic, Complete

 Transition: Start with new projects, Changes in existing ones, then others. No
deadline for now, refer customer requirements
 Existing FMEAs conducted with an earlier version of the FMEA handbook may remain in their
original form for subsequent revisions.
 Optionally, the team may decide to transfer the data to the latest form and update the FMEA
in accordance with the latest FMEA procedure, in order to take advantage of improvements
associated with the latest FMEA procedure.
 FMEA that will be used as a starting point for new program applications should be converted
to comply with the new format.
 However, if the team determines that the new program is considered a minor change to the
existing product, they may decide to leave the FMEA in the existing format.
 New projects should follow this FMEA procedure if not otherwise defined unless company
procedure defines a different approach.
 Use the existing PFMEAs as Foundation or Family PFMEAs and create new ones
3 October, 2024 8
 Integration

 Foundation FMEA
 Recommended to be created for new analysis
 Generic, core, baseline, best practice FMEAs
 These contain knowledge from previous developments
 They are not program specific, so generalization is allowed
 Family FMEA
 Specialised Foundation FMEAs
 Contains common product/process boundaries
 Contains commonalities with these families
 Usability
 Focus on new process and existing applications
 Information's and ratings can be carried over and/or critically examined case to
case

3 October, 2024 9
 PFMEA- When??

 Case 1: New designs, new technology, or new process

 Complete design.. Process
 Case 2: New Application of existing design or process
 Existing product/process in new environment/location/application/usage
profile(duty cycle, regulatory..)
 Case 3:Engineering changes to an existing design or process
 Revised after start of production if:
 Changes to design or process
 Operating conditions
 Requirements(law, norms, state of art..)
 Quality issues
 HARA (Hazard Analysis..) / TARA(Threat Analysis…)
 Product monitoring findings and lessons learnt

3 October, 2024 10
 FMEA Timing Aligned with APQP
Process

APQP Plan & Define Product Process Product Feedback

Phases Program Design & Design & and Assessment
Development Development Production and
Verification Verification Validation Corrective
Action
DFMEA Start FMEA Start DFMEA when Complete DFMEA Complete Start again
Planning in concept the design concept analysis prior to DFMEA with DFMEA
phase before is well understood release of design actions prior and PFMEA
product specifications for to start of planning if
development
quotation production there are
begins.
tooling changes to an
Information flow
from DFMEA to existing
PFMEA PFMEA. The Start PFMEA when Complete PFMEA Complete design or
DFMEA & PFMEA the production analysis prior to PFMEA actions process
should be executed concept is well final process prior to PPAP
during the same understood decisions
time period to allow
optimization of
both product and
process designs
3 October, 2024 11
 PFMEA

 Analyses the potential failures of manufacturing, assembly, logistical

processes to produce products meeting design intent
 Considers potential failure modes which result from process variations…
establish actions
 Purpose is to take action prior to start of production and consequences of
these defects

3 October, 2024 12
 Collaboration between FMEA
(Customer and Supplier)
 Helps communicate effects and severities, a joint and agreed severity
evaluation can be done

Failure Effects & Severity

Customer Severity

Tier n Severity

Tier(n + 1) Severity Technical risk analysis &

proposed product and
process changes
3 October, 2024 13
 Collaboration between FMEA
(Customer and Supplier)

 Starting point:
 Ensure that severity in DFMEA and PFMEA are same when failure effects
are the same
 If product failure effects to the end user(vehicle level) are not there in
PFMEA, no correlation possible between DFMEA and PFMEA
 In reality, correlation is required between a failure feature of the design
that leads to failure effect that is captured in PFMEA( same
characteristic)

3 October, 2024 14
 PFMEA Team

 Facilitator
 Process/manufacturing engineer
 Quality Control/Assurance Team Engineer
 Purchase/Stores/Maintenance/Customer Rep…
 Customer Rep
 Supplier Team
 Operator
 Engineering/Project Management Team

3 October, 2024 15
 Project(FMEA) Planning – 5T’s

 InTent
 Why are we doing the FMEA?
 Team competent ie understand the intent and purpose, focus on goals and objectives
 Timing
 When is this due?
 Before the event action; before implementation of product/process where failure exits
 Timing as project plan/APQP milestones
 Team
 CFT, must facilitate expertise, knowledge; success depends on team participation
 Tasks
 7 Step framework
 Review and analyse with management and customer; cover in internal and customer audits
 Tools
 Software packages, spreadsheets, database & solutions..

3 October, 2024 16
 Exercise 1

 How would you define PFMEA boundaries?

 What is baseline PFMEA?
 Give two conditions when PFMEA can be revised?
 When do you start the PFMEA?
 Does your organization needs to have Foundation and/or
Family PFMEA

3 October, 2024 17
 7 Step Approach

Risk
System Analysis Failure Analysis and Risk Mitigation
Communication

1st Step Planning 2nd Step Structure 3rd Step Function 4th Step Failure 5th Step Risk 6th Step 7th Step Results
& Preparation Analysis Analysis Analysis Analysis Optimization Documentation

Project Identification Visualization of the Visualization of the Establishment of the Assignment of existing Identification of the Communication of the
Analysis scope function failure chain and/or planned controls actions to reduce risks results and conclusion
and rating of failures of the analysis

Project Plan – 5Ts Structure tree or Function tree or equivalent Potential failure effects, Assignment of prevention Assignments of Establishment of content
equivalent; PFD or PFD failure modes, failure controls to the failure responsibilities and of the documentation
causes for each process causes deadlines for action
function implementation

Analysis boundaries: what Identification of process Association of Identification of process Rating of SOD for each Implementation of actions Documentation of actions
is included and excluded steps and sub-steps requirements or failure causes using a failure chain taken including taken including
from the analysis characteristics to functions fishbone diagram(4M) or Evaluation of action confirmation of confirmation of
failure network priority effectiveness of the effectiveness of the
Cascade of implemented actions and implemented actions and
customer(internal & assessment of risk after assessment of risk after
external) functions with actions taken actions taken
associated requirements

Identification of baseline Collaboration between Collaboration between Collaboration between Collaboration between Collaboration between Communication of actions
FMEA with lessons customer and supplier customer and supplier customer and customer and supplier FMEA team, to reduce risks, within the
learned engineering engineering supplier(Failure Effects) (Severity) management, customers organization/customers/
teams(interface) teams(systems, safety and suppliers regarding suppliers as applicable
and components) potential failures

Basis for structure Basis for function analysis Basis for failure analysis Basis for documentation of Basis for process Basis for refinement of Records of risk analysis
analysis step step step failures in FMEA form and optimization step product requirements and and reduction to
the risk analysis steo prevention and detection acceptable levels
3 October, 2024 controls 18
 1st Step: Planning and Preparation

 Purpose: which processes is to be included/excluded

 All processes within the facility can be analysed or re-analysed
 Do a higher level review to finalise so that resources can be channelized
 Identify project
 5Ts
 Analysis boundaries
 Baseline FMEA with lessons learnt
 Basis for structure analysis step ie next one.
 Project identification and boundaries
 Clear on what needs to be evaluated
 Decision making on FMEAs needed for the customer program; include/exclude
 Processes can be: receiving, storage, delivery, manufacturing, assembly,
packaging, …….

3 October, 2024 19
 Demonstration of process for narrowing
the preparation

 When the scope of PFMEA is being defined, consider:

 Technology/degree of innovation
 Quality/reliability history(warranty, claims….)
 Safety of people and systems
 Cyber-physical systems
 Legal compliances
 Whether existing PFMEA should be included in final scope
 New development of product and processes
 Changes to product and processes, operating conditions
 Changed requirements(legal, standards, norms, customers..)
 Field issues/warranty
 Continuous improvement

3 October, 2024 20
 PFMEA

 Project Plan
 Develop plan for execution of PFMEA when the DFMEA project is known
 Use 5T method
 Consider CSRs
 This will help to be proactive, start early
 DFMEA(7 Step) should be incorporated into the overall project plan

 Identification of Baseline PFMEA

 To know what information is available, link this with CFT
 Use Foundation PFMEA(these are specialised PFMEAs for products that contain
common/consistent product boundaries and related functions)
 If no baseline is there, develop new PFMEA

3 October, 2024 21
 Earlier Version:
PFMEA, Edition 4 Complete Format has been thus
revised

Changed

Changed
Changed Changed Changed

Changed

Changed
Changed

Changed

3 October, 2024 22
 New
Template

Microsoft Excel
Worksheet

3 October, 2024 23
 PFMEA Header Changes
Gone: Key date,
Prepared by, Page
Number
 During this Step 1, the header is to be
filled Changes: FMEA
Date changed to
Planning and Preparation(Step 1) Start Date

Company Name Acme Subject Model K Steering

Automotive Assembly
Manufacturing PFMEA Start PFMEA ID No:
location Date:
Customer name PFMEA Revision Process
Date: Responsibility
Model Years(s) / CFT Confidentiality
program Level

Added
3 October, 2024 24
 PFMEA Header Changes
Five different formats are available
for the PFMEA(xls)

CONTINUOUS
IMPROVEMENT STRUCTURE ANALYSIS (STEP 2) FUNCTION ANALYSIS (STEP 3)
History/Change 1. Process Item 2. Process Step 3. Process Work 2. Function of the 3. Function of the
Authorisation Element Process Step and Process Work Element
(Optional) System, Subsystem, Station No and Name Product Characteristics and Process
Part Element or Name of Focus Element 4M Type Characteristic
of Process 1. Function of the
Process Item

Function of System,
Subsystem, Part
Issue # Element or Process

3 October, 2024 25
 PFMEA Header Changes

FAILURE ANALYSIS (STEP 4) RISK ANALYSIS (STEP 5)

1. Failure Effect(FE)
Severity(S) of FE

2. Failure Mode(FM) of 3. Failure Cause(FC) of Current Prevention

Occurrence(O) of FC
Current Detectio

Detection(D) of FC or FM

PFMEA AP

Special Characteristics

Filter Code (Optional)

the Process Step the Work Element Control(PC) of FC Control(DC) of FC or
FM

3 October, 2024 26
 PFMEA Header Changes
Changes: RPN
Changes: Recommendation Changes: TCD replaced by Action
Actions changed to Prevention Priority
Action and Detection Actions
OPTIMIZATION (STEP 6)

Severity(S)

Occurrence (O)

Detection(D)

PFMEA AP
Prevention Action Detection Action Responsible Person's Target Completion Status Action Taken with Completion Date
Name Date Pointer to Evidence

Changes: New Changes:

Column for Status Evidences

Remarks

3 October, 2024 27
 1st Step: Summary

 Foundation FMEAs
 Family FMEAs
 FMEA Project Plan
 5Ts
 Included/excluded
 Boundaries – available / not available
 System/Sub-system/component level
 Funnelling – novelty, complexity, safety, legal, new part/existing,
manufacturing experience, failures….
 Header is then ready.

3 October, 2024 28
 2nd Step: PFMEA Structure Analysis

 Purpose: identify and breakdown the manufacturing system into Process

items, Process steps and Process work elements
 Objectives:
 Visualization of the analysis scope
 Structure tree or PFD
 Identification of process steps and sub-steps
 Collaboration between customer and supplier engineering teams
 Basis for Function Analysis Step

3 October, 2024 29
 Structure Tree
Highest Structure Tree arranges system elements hierarchically &
Level of Focus; it’s a Process Work element is the lowest level of structure tree;
shows dependencies via structural connections. It allows to
Structure manufacturing each work element is a category of potential causes which
understand relationship between Process Items, Process
Tree operation/station could impact the process step; 4M 5M, 6M….
Steps and Process Work Elements

Process Step/Station 4M Elements

Product/process(item)
(Process Element) (Man, Machine, Material, EnvironMent)

OP 10 Operator

Heating Device
OP 20

Induction Heating

OP 30 Press Operations

Electrical Motor
OP 40 Fabrication
Assembly Line

3 October, 2024 OP …. 30
 2nd Step: PFMEA Structure Analysis

 Collaboration between Customer and Supplier engineering teams

 Output of structure Analysis leads to collaboration between customers
and suppliers
 Basis for Function Analysis
 The information from step 2 is used to develop Step 3 ie Function
Analysis
 If process elements are missing here then they will be also missing
from Function Analysis

3 October, 2024 31
Example

Microsoft Excel
Worksheet

3 October, 2024 32
 2nd Step: Summary

 Breakdown Process – Items , Steps, Work Elements

Focus of 4M, 5M, 6M

Analysis(Operation /
Station)

PFD

Causes that could impact the Process Step

3 October, 2024 33
 3rd Step: Function Analysis

 Purpose: intended functions/requirements of product/process are

appropriately allocated
 Objectives:
 Visualization
 Function tree/net or PFD
 Association of requirements or characterises to functions
 Collaboration
 Basis for Failure Step Analysis
 Function
 What process item or step is intended to do. Can be more than one process step
 Prior to analysis gather info – conditions, cycle time, safety/other requirements…
 Helpful to describe the positive functions; description to be clear
 Should be in present TENSE eg apply glue, drill hole, assemble…

3 October, 2024 34
 3rd Step: Function Analysis

 Requirement(Characteristic):
 distinguishing feature of a product. PFMEA requirements are described in terms of
product/process characteristics.
 Negative of this will be the failure mode and the failure cause
 Characteristics: product/process/legal/Industry norms/Standard/Customer
requirements/internal requirement
 Eg Pin diameter, hole thickness, PCD, surface roughness….
 Mention measurable product characteristics
 Visualization of Functional Relationships
 Interaction of process item functions, process step functions and process work
element functions may be visualized as a function network, function structure,
function tree and/or function analysis

3 October, 2024 35
 3rd Step: Function Analysis

Operator
Process Function
Operator presses the button of
machine for releasing the press-in
process when loading is completed

Operator
Operator Function:
Operator takes sintered bearing
from shut and push it onto the press
in shaft until the upper stop

Electrical Motor/Assembly Line (OP 30) Sintered Bearing Press-In Press Machine
Process Function: Process Process Function
Assembly of shaft into pole Process Function: Machine aligns sintered bearing to
housing assembly Press in sintered bearing to achieve the bearing seat in pole housing
axial position into pole housing
to max gap per print Press Machine
Process Function
Machine centers the sintered bearing
to the bearing seat in pole housing

What does it do? How Press Machine

Process Function:
Machine presses in the sintered bearing
into the bearing seat in pole housing until
the defined axial position.

3 October, 2024 Press Machine 36

……
 3rd Step: Function Analysis

1. Function of the process item, 2.Function of Process Step and 3. Function of the Process
Function of the system, sub- Product Characteristics Work Element and Process
system, part element or process Characterises
Your Plant: Press in sintered bearing to Machine presses sintered
Assembly of shaft into pole housing achieve axial position in pole bearing into the pole
assembly housing to max gap housing seat until the
Ship to Plant: defined axial position
Assembly of motor to vehicle door
End User:
Window raises and lowers

In this section you work from left to right

answering the question “How is the higher
level function enabled by the lower functions”

3 October, 2024 37
 3rd Step: Function Analysis

 Collaboration between Engineering teams(Safety, systems and

components)
 Especially when multiple PFMEAs teams are working simultaneously
 This collaboration can be verbal or written as a summary
 Basis for Function Analysis
 Comprehensive completion will lead to Step 4 Failure Analysis

3 October, 2024 38
Example

Microsoft Excel
Worksheet

3 October, 2024 39
 3rd Step: Summary

Function: Process Item; Maybe more functions

(-ve of this is FE)

Function of Process Step; Maybe more functions

(-ve of this is FM)

Function of Process Work Elements;

(-ve of this is FC)

3 October, 2024 40
 Exercise 2

 What is a Structure Tree?

 Process Flow diagram is not to be used as an input for Structure analysis. (T/F)
 Process work element has categories of:
 4M
 5T
 4C
 All of the above

 The output of Function Analysis does not lead to Failure Analysis… (T/F)

 A “Characteristic” can be”

 Diameter
 Coating Thickness
 (a) and (b)
 All of the above

 If there are “legal/safety” requirements related to the product, there are to be identified in which column of the PFMEA format?
 Failure mode
 Detection controls
 Special characteristic
 All of the above

 Can the PFMEA Header be customized to your own organizational requirement?

3 October, 2024 41
 PFMEA

3 October, 2024 QACA/PFMEA/V2 42

 4th Step: PFMEA Failure Analysis

 Purpose: identify failure causes, modes and effects and show their
relationship to enable risk assessment
 Objectives:
 Establish failure chain
 Using fishbone diagram or other tool, identify failure causes
 Documentation in FMEA and the risk analysis step
 Note: Failure analysis is performed for each element/step in the process
description

3 October, 2024 43
Failure Chain Model
Failures from where? NCs; tasks
Focus Element incomplete; unintentional; unnecessary

What happens

Failure Effect Failure Mode Failure Cause

Why

Related to functions of process items Process could cause product not to deliver Why? Consequence of cause is a failure
System, Sub-system, Part intended function mode
Element/Process name
Assume: basic design is correct Concise, complete to channelize efforts
Customer might notice or experience
Failure mode could occur; technical terms,
Customers: Assume – incoming parts are ok
not as a symptom
internal/External/Legislative/End user or
operator Review TGW/reject/scrap/claims Thought Provoking Simulation Questions
3 October, 2024 Rating
Given a Severity 44
 4th Step: Failure Analysis Structure Tree

Press Machine
Process Characteristics
Machine press in the sintered bearing into the
Electrical Motor/Assembly Line (OP 30) Sintered Bearing Press-In bearing seat in pole housing until the defined
Process Requirement: Process axial position
Assembly of shaft into pole Product characteristics Failure:
housing assembly Axial position sintered bearing in pole Machine stops before reaching final
housing(max gap < 0.3 mm) position

Effect on Process: Failure:

Clearance too small to Axial Position of sintered bearing is not
assemble shaft Press Machine
reached ……

What happens? Why

3 October, 2024 45
 4th Step: Failure Analysis Sheet

1. FE to next higher level element 2. FM of Focus Element 3. FC of Work Element

and/or End User
Your Plant: Axial position of sintered bearing Machine stops before
Clearance too small to assemble is not reached reaching final position
shaft without potential damage
Ship to Plant:
Assembly of motor to vehicle door
requires additional insertion force
with potential damage
End User:
Comfort closing time too long

Effect associated Mode associated Cause of failure

FM
FE

FC
with next higher with Focus associate with
level element Element work element or
process
characteristics

3 October, 2024 46
 4th Step: Failure Analysis
Documentation- Several Views

Item-Function-Failure
1. Process item, system, sub-system, part 2. Function of Process Item, System, Sub- 3. FE to next higher level element and/or End
element or name of process system, Part element or process User

Electrical Motor Assembly Line Your Plant: Your Plant:

Assembly of shaft into pole housing assembly Clearance too small to assemble shaft without
Ship to Plant: potential damage
Assembly of motor to vehicle door Ship to Plant:
End User: Assembly of motor to vehicle door requires
Window raises and lowers additional insertion force with potential damage
End User:
Comfort closing time too long

1. Process Step Station No and name of 2. Function of Process Step and Product 3. FM of process step

Step-Function-Failure
focus Element Characteristics

OP-30 Press in sintered bearing to achieve axial Axial position of sintered bearing is not reached
Sintered Bearing Press-In Process position in pole housing to max gap per print

1. Process work element 4M 2. Function of Process work element and 3. FC of work element

Function-Failure
Work Element-
process characteristics

Press Machine Machine press in the sintered bearing into the Machine stops before reaching final position
bearing seat in pole housing until the defined
axial position

3 October, 2024 47
Example

Microsoft Excel
Worksheet

3 October, 2024 48
 4th Step: Failure Analysis

 Collaboration between Customer and Supplier(FE)

 Basis for Function Analysis
 Comprehensive completion will lead to Step 5 Risk Analysis

3 October, 2024 49
 4th Step: Summary

 FC, FM, FE & show relationships

 Severity – Your plant, Ship to plant, End User
 4M Analysis/5M…
 Process Item – Function Failure
 Process Step – Function Failure
 Process Work Element

3 October, 2024 50
 Exercise 3

 Purpose of Failure Analysis is to:

 Identify Failure Mode
 Identify Failure Causes
 Identify Failure Effects
 Show their relationships
 All of the Above

 Which is the focus element in Failure Analysis?

 Failure effects are given severity rating accounting to 3 aspects, mention these.

 Define Failure Mode?

 Typical Failure cause could include:

 4M
 5T
 4C
 None

3 October, 2024 51
 5th Step: Risk Analysis

 Purpose: estimate risks by SOD, prioritise

 Objectives:
 Ratings
 Prevention controls to be assigned
 Detection controls to be assigned
 Action Priority
 Basis for Optimization Step
 Current Prevention Controls(PC)
 Facilitate optimal process planning to minimise possibility of failure occurrence
 Production Process: eliminate the failure cause or reduce its rate of occurrence
 Measures which are defined in Design process are verified during prototype, machine qualifications
and process verification prior to start of production
 Current Detection Controls(DC)
 Detects the existence of the failure cause or the failure mode either by automated or manual
method, before the item leaves the process or is shipped.

3 October, 2024 52
 5th Step: Risk Analysis

Prevention 100% Detection

Process Quality

Time
0 Product Characteristics

Operator Instructions Visual Inspection

Machine capability Sensory inspection

Process Monitoring Inspection

3 October, 2024 53
PC Vs DC
Detect
existence

Curr. Prevention Controls

of FC or
FM(Auto/
Manual)
Poka Yoke Visual Insp.
Equipment Mntn. Optical Insp.
Operator Mntn. Attributive Test

Curr. Detection Controls

WI’s; Op. Instr. Dimensional Check
Visual Aids Monitoring
Machine Controls Function Check
Set Up Approval
Minimize
possibility of
failure
occurrence PC: can be implemented in the Design
process & verified at Prototype, Machine
qualifications, process verification before
start of production; can help to
formulate WI’s, Set Ups, PMs,
3 October, 2024 Calibrations, Error Proofing verification 54
Evaluation

•Most serious Failure Effect

•Determined without O, D
•One Table; 1 to 10
Severity •Effect considers 3 Options
•Failure mode is Your Plant/ next
mfg/asly plant or End User

•Failure Cause
•Determined without D Time Based
•3 Tables, Options; 1 to 10
Occurrence •Consider- Equipment history/ Prediction IPTV
field experience /process
carryover/ new process/
Standardized WI’s exist /PM/

•Occurred Failure Cause or Mode

•Most Effective Detection Detection
Detection •Determined without S & O Detection
Opportunity
•One Table; 1 to 10 Maturity
•Duty Cycle? Sample Size? Test
Procedure?

3 October, 2024 55
Action
Priority

Action Priority Prioritize- SOD; 1 to 1000 combinations; Same for DFMEA

and PFMEA but not for FMEA-MSR
Priority – High(H) Highest; Team needs to:
1. Identify appropriate action to improve prevention and /
or detection controls
2. Justify and document why current controls are adequate
Priority – Medium(M) Team should:
1. Identify appropriate action to improve prevention and /
or detection controls or
2. At the discretion of the company, justify and document
why controls are adequate
Priority – Low(L) Team could:
Identify appropriate action to improve prevention and / or
detection controls
Note: Severity ranks 9-10 with AP H or M to be
3 October, 2024 reviewed by Management including any actions. 56
 Process General Evaluation Criteria Severity (S)
Potential Failure Effects rated according to the criteria below.

Impact to Ship-to Plant Impact to End User

S Effect Impact to Your Plant
(when known) (when known)

Affects safe operation of the vehicle

Failure may result in an acute health Failure may result in an acute health and/or
and/or other vehicles, the health of
10 and/or safety risk for the safety risk for the manufacturing or
driver or passenger(s) or road users or
manufacturing or assembly worker assembly worker
High pedestrians.

Failure may result in in-plant Failure may result in in-plant regulatory

9 regulatory noncompliance noncompliance
Noncompliance with regulations

Line shutdown greater than full production

100% of production run affected shift; field repair or replacement required
may have to be scrapped. Failure (Assembly to End User) other than for
Loss of primary vehicle function
may result in in-plant regulatory regulatory noncompliance. Failure may
8 noncompliance or may have chronic result in in-plant regulatory noncompliance
necessary for normal driving during
expected service life.
health and/or safety risk for the or may have chronic health and/or safety
manufacturing or assembly worker risk for the manufacturing or assembly
Moderately worker.
high

Product may have to be sorted and a Line shutdown from 1 hour up to full
portion (less than 100%) scrapped; production shift; stop shipment possible; Degradation of primary vehicle
7 deviation from primary process; field repair or replacement required function necessary for normal driving
decreased line speed or added (Assembly to End User) other than for during expected service life.
manpower regulator noncompliance
 Process General Evaluation Criteria Severity (S)
Potential Failure Effects rated according to the criteria below.

Impact to Ship-to Plant Impact to End User

S Effect Impact to Your Plant
(when known) (when known)

100% of production run may have to be

6 reworked off line and accepted
Line shutdown up to one hour Loss of secondary vehicle function.
Moderately low

Less than 100% of product affected;

A portion of the production run may have to strong possibility for additional Degradation of secondary vehicle
5 be reworked off line and accepted defective product; sort required; no function.
line shutdown

Defective product triggers significant Very objectionable appearance,

100% of production run may have to be
4 reworked in station before it is processed
reaction plan; additional defective sound, vibration, harshness, or
products not likely; sort not required haptics.

A portion of the production run may have to Defective product triggers minor Moderately objectionable
3 be reworked in-station before it is reaction plan; additional defective appearance, sound, vibration,
processed products not likely; sort not required harshness, or haptics.
Low

Defective product triggers no reaction

Slightly objectionable appearance,
Slight inconvenience to process, operation, plan; additional defective products
2 or operator not likely; sort not required; requires
sound, vibration, harshness, or
haptics
feedback to supplier

1 Very Low No discernible effect No discernible efffect or no effect No discernible effect.

 Occurrence Potential (O) for the Process
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining the best Occurrence
estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and may not reflect the actual occurrence. The
occurrence rating number is a relative rating within the scope of the FMEA (process being evaluated). For Prevention Controls with
multiple Occurrence Ratings, use the rating that best reflects the robustness of the control.

Prediction of Failure Cause

O Type of Control Prevention Controls
Occurring

10 Extremely high None No prevention controls.

9
Very High Behavioral Prevention controls will have little effect in preventing failure cause.
8
7
High Prevention controls somewhat effective in preventing failure cause.
6 Behavioral or Technical
5
Moderate Prevention controls are effective in preventing failure cause.
4
3 Low
Best Practices: Behavioral or
Prevention controls are highly effective in preventing failure cause.
Technical
2 Very low

Prevention controls are extremely effective in preventing failure

cause from occurring due to design (e.g. part geometry) or process
1 Extremely low Technical (e.g. fixture or tooling design). Intent of prevention controls -
Failure Mode cannot be physically produced due to the Failure
Cause.
 Occurrence Potential (O) for the Process (Incidents per Thousand Values)
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining the best
Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and may not reflect
the actual occurrence. The occurrence rating number is a relative rating within the scope of the FMEA (process being
evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that best reflects the robustness of
the control.
O Incidents per 1000 items/Vehicles Type of Control Prevention Control
>=100 per thousand
10 None No prevention controls
>/= 1 in 10

50 per thousand
9
1 in 20 Prevention controls will have little
Behavioral
effect in preventing failure cause.
20 per thousand
8
1 in 50
10 per thousand
7
1 in 100 Prevention controls somewhat effective in
2 per thousand preventing failure cause .
6
1 in 500 Behavioral or
5 per thousand Technical
5
1 in 2000 Prevention controls are effective inpreventing
1 per thousand failure cause.
4
1 in 10,000
.01 per thousand
3
1 in 1,00,000 Best practices Prevention controls are highly effective in
<.001 per thousand Behavioral or Techinal preventing failure cause.
2
1 in 1,000,000
Prevention controls are extremely effective in
preventing failure cause from occuring due to
Failure is eliminated through
1 Technical design (e.g.fixture or tooling design). Intent of
prevention control
prevention controls _Failure Mode cannot be
physically produced due to the Failure cause.
3 October, 2024 60
 Occurrence Potential (O) for the Process
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining the best
Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and may not reflect
the actual occurrence. The occurrence rating number is a relative rating within the scope of the FMEA (process being
evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that best reflects the robustness of
the control.
O Time Based Failure Cause Prediction Type of Control Prevention Controls
10 Everytime None No prevention controls

9 Almost every time Prevention controls will have little

Behavioral
effect in preventing failure cause.

8 More than once per shift

7 More than once per day Prevention controls somewhat effective in
6 More than once per week Behavioral or preventing failure cause .
5 More than once per month Technical Prevention controls are effective inpreventing
4 More than once per year failure cause.
3 Once per year Best practices Prevention controls are highly effective in
2 Less than once per year Behavioral or Techinal preventing failure cause.
Prevention controls are extremely effective in
preventing failure cause from occuring due to
1 Never Technical design (e.g.fixture or tooling design). Intent of
prevention controls _Failure Mode cannot be
physically produced due to the Failure cause.
3 October, 2024 61
 Detection Potential (D) for the Validation of the Process Design

Detection Controls rated according to the Detection Method Maturity and Opportunity for Detection

Ability to
D Detection Method Maturity Opportunity for Detection
Detect

No testing or inspection method has been

10 The failure mode will not or cannot be detected.
established or is known.

Very Low

It is unlikely that the testing or inspection The failure mode is not easily detected through random or
9
method will detect the failure mode. sporadic audits.

Human inspection (visual, tactile, audible), or use of

manual gauging (attribute or variable) that should detect
8 the failure mode or failure cause.
Test or inspection method has not been proven
to be effective and reliable (e.g. plant has little
Low or no experience with method, gauge R&R
results marginal on comparable process or this Machine-based detection (automated or semi-automated
application, etc.) with notification by light, buzzer, etc.) or use of inspection
equipment such as coordinate measuring machine that
7
should detect failure mode or failure cause.
 Detection Potential (D) for the Validation of the Process Design
Detection Controls rated according to the Detection Method Maturity and Opportunity for Detection

Ability to
D Detection Method Maturity Opportunity for Detection
Detect
Human inspection (visual, tactile, audible), or use of manual gauging (attribute or
6 Test or inspection method has been proven variable) that will detect the failure mode or failure cause (including product sample
Moderate

to be effective and reliable (e.g. plant has checks).

experience with method; gauge R&R results
are acceptable on comparable process or Machine-based detection (semi-automated with notification by light, buzzer, etc.),
5 this application, etc.). or use of inspection equipment such as a coordinate measuring machine that will
detect failure mode or failure cause (including product sample checks).

Machine-based automated detection method that will detect the failure mode
downstream, prevent further processing or system will identify the product as
4 discrepant and allow it to automatically move forward in the process until the
System has been proven to be effective and designated reject unload area. Discrepant product will be controlled by a robust
reliable (e.g. plant has experience with system that will prevent outflow of the product from the facility.
method on identical process or this
application), gauge R&R results are Machine-based automated detection method that will detect the failure mode in-
High

acceptable, etc. station, prevent further processing or system will identify the product as discrepant
3 and allow it to automatically move forward in the process until the designated reject
unload area. Discrepant product will be controlled by a robust system that will
prevent outflow of the product from the facility.

Detection method has been proven to be

effective and reliable (e.g. plant has Machine-based detection method that will detect the cause and prevent the failure
2
experience with method, error-proofing mode (discrepant part) from being produced.
verifications, etc.).
Very
high

Failure mode cannot be physically produced as-designed or processed, or detection methods proved to always detect the failure
1
mode or failure cause.
 Action Priority (AP) for DFMEA and PFMEA
Action Priority is based on combinations of Severity, Occurrence, and Detection ratings in order to prioritize actions for risk reduction.
Prediction of Failure Cause
Effect S O Ability to Detect D ACTION PRIORITY (AP)
Occurring
Low - Very Low 7-10 H
Moderate 5-6 H
Very high 8-10
High 2-4 H
Very high 1 H
Low - Very Low 7-10 H
Moderate 5-6 H
High 7-6
High 2-4 H
Product or Very high 1 H
Plant Effect 10-9 Low - Very Low 7-10 H
Very high Moderate 5-6 H
Moderate 5-4
High 2-4 H
Very high 1 M
Low - Very Low 7-10 H
Moderate 5-6 M
Low 3-2
High 2-4 L
Very high 1 L
Very Low 1 Very high - Very Low 1-10 L
Low - Very Low 7-10 H
Moderate 5-6 H
Very high 8-10
High 2-4 H
Very high 1 H
Low - Very Low 7-10 H
Moderate 5-6 H
High 7-6
High 2-4 H
Product or Very high 1 M
Plant Effect 8-7 Low - Very Low 7-10 H
High Moderate 5-6 M
Moderate 5-4
High 2-4 M
Very high 1 M
Low - Very Low 7-10 M
Moderate 5-6 M
Low 3-2
High 2-4 L
Very high 1 L
Very Low 1 Very high - Very Low 1-10 L
 Prediction of Failure Cause
Effect S O Ability to Detect D ACTION PRIORITY (AP)
Occurring
Low - Very Low 7-10 H
Moderate 5-6 H
Very high 8-10
High 2-4 M
Very high 1 M
Low - Very Low 7-10 M
Moderate 5-6 M
High 6-7
High 2-4 M
Very high 1 L
Product or Plant Low - Very Low 7-10 M
4-6
Effect Very high Moderate 5-6 L
Moderate 4-5
High 2-4 L
Very high 1 L
Low - Very Low 7-10 L
Moderate 5-6 L
Low 2-3
High 2-4 L
Very high 1 L
Very Low 1 Very high - Very Low 1-10 L
Low - Very Low 7-10 M
Moderate 5-6 M
Very high 8-10
High 2-4 L
Very high 1 L
Low - Very Low 7-10 L
Moderate 5-6 L
High 6-7
High 2-4 L
Very high 1 L
Product or Plant Low - Very Low 7-10 L
2-3
Effect High Moderate 5-6 L
Moderate 4-5
High 2-4 L
Very high 1 L
Low - Very Low 7-10 L
Moderate 5-6 L
Low 2-3
High 2-4 L
Very high 1 L
Very Low 1 Very high - Very Low 1-10 L
No discernible
1 Very Low - Very High 1-10 Very high - Very Low 1-10 L
Effect
 5th Step: Risk Analysis

 Collaboration between Customer and Supplier(Severity)

 Compare failure modes and relate them
 Basis for Optimization
 Steps 1 to 5 is used to determine additional design or testing action is
needed.
 Customer reviews, management reviews, CFT reviews.

3 October, 2024 66
Example

Microsoft Excel
Worksheet

3 October, 2024 67
 5th Step: Summary

 Risk Analysis
 PC
 DC
 SOD
 AP

3 October, 2024 68
 Exercise 4

 Is a Structure Analysis required during Failure Analysis Step?

 Failure Analysis has:
 FE
 FM
 FC
 PM
 (a), (b), (c)
 Risk Analysis Step has:
 a) PC
 b) DC
 c) AC
 d) (a) & b)

3 October, 2024 69
 Exercise 4 Contd

 Place under Correct Category:

SPC, Work Instruction, In process Inspection, Layout Inspection, CMM Inspection, Set up
approval, Manufacture process monitoring.

Current Prevent Control Current Detection Control

 Define S, O, D, Action Priority

3 October, 2024 70
 6th Step: Optimization

 Purpose: determine actions and mitigate risks, assess the effectiveness

of those actions.
 Objectives:
 Identify actions that reduce risks
 Responsibilities, deadlines
 Implementation of documentation of actions
 Collaboration – CFT, Customer, Suppliers…
 Optimization effectiveness
 Process modifications to eliminate or mitigate a FE
 Process modifications to reduce Occurrence of FC
 Increase Detection ability for FC or FM
 Process modifications/concept modifications, all process steps of FMEA needs to
be reviewed.

3 October, 2024 71
 6th Step: Optimization

 Most Effective Optimization:

 Process changes to eliminate/mitigate FE
 Process modifications to reduce Occurrence(O) of FC
 Increase Detection(D) ability for FC or FM
 (Actual) Completion Date / Target Completion Date
 Status:
 Open: No Actions defined
 Decision Pending
 Implementation Pending
 Completed
 Not Implemented

3 October, 2024 72
 6th Step: Optimization

 Continual Improvement:
 Original SOD numbers needs to be available to demonstrate
improvements and can be part of version history
 This then becomes a repository to capture progression
 Family and Foundation FMEAs SOD Rating can be revised as
these become as a starting point for new FMEAs.
 Remarks:
 If team decides no further actions are necessary, you can
write in this column “no further actions is needed”

3 October, 2024 73
 6th Step : Summary

 Mitigate Risks and Optimise Actions

 Attack S – O – D
 Status of Actions and updates

3 October, 2024 74
 Exercise 5

 What is the purpose of Optimization Step?

 What is TCD stands for…
 What is the “Status” Column for?
 What are the “Action taken with Pointers to Evidence”
columns for?
 Can you make your own SOD & AP Tables?
 Is AP to be changed if SOD Changes…

3 October, 2024 75
 7th Step: Results Documentation

 Purpose: Summarise and communicate

 Objectives:
 Communication of results and conclusions
 Documentation and confirmation of effectiveness of actions
 Communication of actions to reduce risks
 Records

 FMEA Report:
 Scope and results summarised
 Communicate within company or between companies including
Management
 Report layout/format is to be decided by you

3 October, 2024 76
 7th Step: FMEA Report Contents

 5Ts
 Summary(Scope, How functions were developed, High Failures, SOD
Tables, Method of Action Prioritization, Actual Actions Taken for high risk
failures)
 Update on AP’s, H/M/L, as applicable
 Plan and commitment for timings and ongoing review of
improvement actions, revise
 Capture TGW in Foundation FMEAs for better future analysis

3 October, 2024 77
 DFMEA

3 October, 2024 78
 DFMEA

3 October, 2024 79
 DFMEA

3 October, 2024 80