AIAG-VDA_PFMEA_R1

AIAG-VDA PFMEA
Understanding for
Practitioners and Facilitators
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First Edition
March 2021
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Course Objectives
• Learn all the steps to developing an PFMEA and the pitfalls to
avoid it.
• Understand the definitions, scoring system and calculations
used in an PFMEA.
Contents
• Chapter 1 – Introduction to Failure Modes and Effects Analysis
• Chapter 2 – Developing an FMEA
• Chapter 3 – System Analysis
• Chapter 4 – Failure Analysis and Risk Mitigation
• Chapter 5 – Risk Communication
5
A BRIEF INTRODUCTION TO CUE-BIZ
Cue-Biz Introduction
• “Growing Together” is the motto followed by us at Cue-Biz
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India Pvt. Ltd.” with the aim of emphasizing on four verticals
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About Cue-Biz
• Specialities
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– Soft Skills
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Rulebook of the Classroom
 Start and end on time
 Return from breaks and lunch on time
 Do not monopolize discussion
 Respect yourself and others (share your viewpoint and allow others to
share theirs)
 Don’t interrupt others
 Ask for clarification if you are confused
 Listen – and respect others’ ideas
 Take responsibility for the quality of the discussion
 Cell phones are either off or silent mode
 No e-mails, texting or tweeting during class
 If you must take a phone call or answer a text please leave the room for as
short a period as possible
Class Introduction
• Course Presenter Information:
– Name
– Background
• Student/Participant Introductions:
– Name
– Position / Function / Work Age
– Responsibilities
– Involvement in PFMEA?
11
Chapter 1
Introduction to Failure Mode

and Effects Analysis
Chapter 1: Introduction to FMEA —
Section Content
Learning Outcomes Chapter Outline
At the end of this chapter, you will be • What is an FMEA?
able to: • Maintaining FMEAs
• Describe an FMEA • Types of FMEAs
• Describe the benefits of an FMEA • Reasons of FMEA failure
• Describe the types of FMEAs
• Describe why FMEA fails
PFMEA alignment with APQP Time plan
DFMEA
PFMEA
PPAP
WHAT IS AN FMEA?
Purpose and Benefits
FMEA - Definition
• FMEA is a structured approach in :-
– Identifying ways in which a product / process can fail to meet critical
customer requirements then plan to prevent those failures.
– Estimating the risk of causes with regard to these failures.
– Evaluating control plan for preventing these failures.
– Prioritizing the actions for improving the process.
• It is “Before-the-event” action and NOT an “After-the-fact”
exercise
• FMEA is a living document
• It is a technique of reducing or avoiding ‘RISK’
“Anything that can go wrong, will go wrong.”

- Edward A Murphy Jr.
Why Perform FMEA?
• Prevention is the only effective way to achieve zero defect
launch goals.
• To identify potential failure modes which may adversely affect
safety or compliance with Govt. Regulations
• To identify potential design deficiencies before releasing to
production
• To identify potential process deficiencies before production
begins
• To identify Special Characteristics
• FMEAs are integral in Problem Solving.
When to Perform FMEA?

• Design FMEA should be initiated before or at design concept
finalization
– Component Level
– Sub-system level, and
– System level
• Process FMEA should be initiated before or at feasibility stage,

prior to tooling for production
• When existing designs or processes are being changed
• When carry-over designs/processes will be used in new
applications or new environments
Benefits of FMEA
• The FMEA process is a structured approach to…
– Higher reliability
– Better quality
– Increased safety
– Enhanced customer satisfaction.
– Reduce development timing and cost.
– Enable knowledge management.
– Identifies potential problems with Customer point of view.
Scope of AIAG-VDA FMEA

Feasibility / Risk Analysis
source: AIAG-VDA FMEA Handbook 1st Edition
FMEA Advantage
The 1-10-100 Rule “Rule of Ten” Rs. 1 spent on
prevention will save
Rs. 10 on correction
and Rs. 100 on
1 Prevention Cost failure costs
10 Correction Cost
100 Failure Cost
FMEA Inter-relationships
• FMEA is part of APQP
• PPAP requires many components of FMEA:
– DFMEA (if design responsible)
– PFD (Process Flow Diagram showing special characteristics)
– PFMEA (Process FMEA)
– Control Plan (Showing special characteristics)
– Work Instructions (Special Characteristics)
• One of the tools for prevention of failures and continuous
improvement highlighted in 8D Problem Solving
• ISO 26262 requires FMEA
• IATF 16949 requires FMEA
• … and many others
TYPES OF FMEAS
Primary Types of FMEAs

• System FMEA: Used to analyze systems and subsystems in the
early concept and design stages.
• Design FMEA: Used to analyze products before they are
released to production.
– Focuses on potential failure modes associated with the functions of a
product inherent in the design.
– NOTE: VDA uses the term Product FMEA instead of Design FMEA
• Process FMEA: Used to analyze processes before they are

released for use in serial production.
– Focuses on potential failure modes associated with the deliverables of
a process due to design and operation.
Reasons – Why FMEA fails?
• One person is assigned to complete the FMEA
• Not customizing the scoring system with company
specific data, so they are meaningful to your
company
• The design or process expert is not included in the
FMEA team or is allowed to dominate the FMEA
team
• Members of the FMEA are not trained in
use/application of FMEA and becomes frustrated
with the process
Chapter 2
Developing an FMEA
Chapter 2: Developing an FMEA —

Section Content
At the end of this chapter, you will be • Conducting an FMEA
able to: • Basic Structure of an FMEA
• Describe the structure of an
FMEA
• Describe the steps to conduct an
FMEA
CONDUCTING AN FMEA
The intent is to provide consistent direction, guidance to all automotive

industry represented by these organizations.
“Red-Blue Book”
• The VDA-AIAG Handbook is not part of the “Core Tools” set,
but will be required by the major OEMs.
• The core tools belong to GM-Ford-FCA….
• The “Handbook” is co-owned by VDA and AIAG.
How to Construct an FMEA –

General Approach
1. Identify and list all the requirements
2. For each requirement identify potential failure modes
3. For each failure mode
– Assess potential effects of failures
– Identify the cause(s)
4. For each cause identify level of controls
5. Identify and implement continual improvement
actions
AIAG-VDA FMEA Handbook – 7 Step Approach
5Ts Link To
Process Flow Process
Action
Diagram, Type and Control
Actual planning,
Tree Diagram Level of Plan And
application Checking
Failure controls, Work
of Focus effectiveness
Effect, Risk Instruction
Element
Mode, Evaluation
Cause
analysis
Transition Strategy
• Existing FMEAs conducted with an earlier version of the FMEA
handbook may remain in their original form for subsequent revisions.
• When practical, existing FMEAs used as a starting point for new

programs 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 can follow the FMEA method presented in this

guidebook unless company procedure defines a different approach.
The transition date and project milestone after which new projects
follow this method should be defined by the company taking into
consideration any customer specific requirements and standards.
AIAG-VDA FMEA Handbook 1st Edition
FMEA STRUCTURE
AIAG-VDA FMEA Handbook Form

This process requires the identification / analysis for at least three levels of
product flow-down
AIAG-VDA FMEA Handbook Form
This process requires the identification / analysis for at least three levels of
product flow-down
Higher Higher Higher

Level Level Level
Focus Focus Focus
Level Level Level
Lower Lower Lower
Level Level Level
Chapter 3
System Analysis
Chapter 3: System Analysis —

Section Content
At the end of this chapter, you will be • Step 1: Planning and Preparation
able to: – Scope of Analysis
• Describe Planning and • Process Flow Diagram
Preparation • Step 2: Structure Analysis
• Describe the scope of analysis • Step 3: Function Analysis
• Explain Structure analysis and
Function Analysis
System Analysis: Steps 1-3
System Analysis (Prerequisites)

1st Step 2nd Step 3rd Step
Planning & Preparation Structure Analysis Function Analysis
PROJECT PLANNING AND

PREPARATION
Before anything else, preparation is the key to success.

- Alexander Graham Bell
Step 1: Project Planning and Preparation
The purpose of the Process FMEA Preparation Step is to define
what product/processes are to be included and excluded for
review in the PFMEA project.
The main objectives of Process FMEA Preparation are:

– Project identification and boundaries
– Project plan: InTent, Timing, Team, Tasks, Tools (5T)
– What is included and excluded from the analysis
– Identification of baseline FMEA with lessons
learned
– Basis for the Structure Analysis step
Step 1: Project Planning and Preparation

Project Planning
5Ts Key Aspects:
• FMEA InTent • The Five T's are five topics
– Why are we here? that should be discussed at
• FMEA Team the beginning of a FMEA in
– Who needs to be on the team?
order to achieve the best
results on time and avoid
• FMEA Timing FMEA rework. These topics
– When is this due? can be used as part of a
• FMEA Task project kick-off.
– What work needs to be done?
• FMEA Tool
– How do we conduct the analysis?
5Ts — 1. FMEA InTent
• It is recommended that members of the FMEA team are
competent in the method, based on their role on the team.
• When members of the team understand the purpose and
intent of the FMEA, they will be more prepared to contribute
to the goals and objectives of the project.
5Ts — 2. FMEA Timing

Senior Management Commitment to Timing:
• The FMEA workshop needs to start on time and should be
part of the Design Timing Schedule.
• Companies have more success with FMEAs when allotted time
is built into the schedule.
• Senior Management interest is shown by:
– Participating in FMEA reviews
– Being educated in FMEA
– Promoting FMEA culture in the organization
– Providing adequate resources
– Acceptance of the risks and risk minimization actions identified in the
FMEA.
5Ts — 3. FMEA Team
• The FMEA team consists of multi-disciplinary (cross-
functional) members who encompass the necessary subject
matter knowledge.
• This should include facilitation expertise and knowledge of
the FMEA process.
• The success of the FMEA depends on active participation of
the cross-functional team as necessary to focus on the topics
of discussion.
FMEA Team
The Core Team may consist of the following people:
• Facilitator
• Design Engineer
• System Engineer
• Component Engineers
• Test Engineer
• Quality/Reliability Engineer
• Others responsible for the development of the product
FMEA Team
The Extended Team may consist of the following people:
• Technical Experts
• Process/Manufacturing Engineer
• Service Engineer
• Project Manager
• Functional Safety Engineer
• Purchasing
• Supplier
• Customer Representative
• Others that may have specialized knowledge which will help
the core team analyze specific aspects of the product
FMEA Team
Skills and Tools:
– Members who understand product and process
relationships
– Members who understand tools used in process
management
– Skilled group facilitator
– Members who are familiar with error proofing techniques
– Scriber/Recorder or Document control coordinator to
create, control and maintain the outputs
– Follow a well-defined process
– Time is allotted for analysis and improvement
Management Responsibility
“Ultimately, management has the responsibility and

ownership for development and maintenance of the
FMEAs”
FMEA 4th Edition
“Management carries the responsibility for the

application of FMEA. Ultimately, management is
responsible for acceptance of the risks and risk
minimization actions identified in the FMEA”
Senior Management Commitment

The FMEA process can take considerable time to complete!
Important to FMEA development are the active participation of
the product and process owners and commitment from senior
management. Senior Management carries the responsibility for
the application of FMEA:
– Ultimately, senior management is responsible for acceptance of the
risks and risk minimization actions identified in the FMEA.
– Senior management needs to make FMEAs a critical topic during
Design Reviews.
– Senior management needs to take an active interest in the results of
an FMEA and support the mitigation of the risk, whatever time and
resources are required
• Senior management is responsible for the “FMEA” culture in
the company.
5Ts — 4. FMEA Tasks
• The 7-Step Overview provides the framework for
the tasks and deliverables of the FMEA. In addition,
the FMEA team should be prepared to review the
results of their analysis with management and the
customer, upon request.
• The FMEA may also be audited by an internal
auditor, customer auditor, or third-party registrar to
ensure each task has been fulfilled.
5Ts — 5. FMEA Tools

• There are numerous FMEA tools i.e., software
packages that can be used to develop a DFMEA and
PFMEA as well as follow up on actions.
• Customized standard spreadsheets can be used for
development of FMEA. Companies may develop their
own in-house database solution or purchase
commercial software.
• In any case, the FMEA team needs to have
knowledge of how to use the FMEA tool selected for
their project as required by the company.
PFMEA HEADER INFORMATION
Header Information
During Preparation, the header of the PFMEA document should
be filled out. The header may be modified to meet the needs of
the organization and includes some of the basic PFMEA
Preparation information as follows:
Header Information
• Company Name: Name of Company Responsible of PFMEA
• Manufacturing Location: Geographical Location
• Customer Name: Name of customer(s) or Product Family
• Model Year / Program(s): Customer Application or Company Model /
Style
• Subject: Name of PFMEA project
• PFMEA Start Date: Start date
• PFMEA Revision Date: Latest revision date
• Cross-Functional Team: PFMEA development team members
• PFMEA ID Number: A unique identification number for the PFMEA
document
• Process Responsibility: Name of PFMEA owner
• Confidentiality Level: The level of confidentiality determined by the
PFMEA owner, e.g. Business Use, Proprietary, Confidential
STRUCTURE ANALYSIS
Step 2: Structure Analysis
Purpose:
• The purpose of Process Structure Analysis is to identify and
breakdown the manufacturing system into Process items,
Process steps, and Process Work Elements.
• The main objectives of a Process Structure Analysis are:
– Visualization of the analysis scope
– Structure tree or equivalent: process flow diagram
– Identification of process steps and sub-steps
– Collaboration between customer and supplier engineering teams
(interface responsibilities)
– Basis for the Function Analysis step
PROCESS FLOW DIAGRAM
Process Flow Diagram
Objectives
– Diagram the entire process graphically from receiving to shipping
– Map requirements to operations / steps
– Identify potential sources of variation
• A comprehensive Process Flow Diagram provides the

foundation for the development of an effective Process FMEA,
Control Plan and Work Instructions.
• Note: in the AIAG-VDA FMEA Handbook, the Process Flow
contains information from Steps 1-3
– It defines the scope of the activities
– It contains the overall structure of the process
– It identifies the requirements (functions) for each step
Preparing a Process Flow

Process Flow Graphics
• Each process step should be represented by a symbol (icon).
• Some customers have specified a specific format or graphics
but there is no single approach – be consistent.
• Example symbols:
Process Flow
Diagram
Manufacturing Process Flow

Process Flow
Item Process Responsibility Process Identification
Product Prepared By
Core Team Key Date Start Date Revision Date
Step. No. / Experienced

Product Process
Brief Sources of Process Flow Diagram ID Characteristics Characteristics
SC
Description Variation
Preparing a Process Flow
Characteristics
• List all Product and Process Characteristics (requirements) for
each process step.
– “what is this step in the process supposed to do or produce?”
• It is recommended that each requirement be identified by a

unique ID.
– This should be consistent with the PPAP dimensional report IDs
(Ballooned Drawing).
Ballooned Print
The PC
identifications
should match the
IDs on the
“ballooned” print
used with PPAP
Step 2: Structure Analysis
Goal of Structure Analysis
– An overview of the system structure of the
product
– Visual indication of the interaction between
process steps and its work elements, i.e. 4M
– Allows for the reuse of process elements
– Allows for the Function Analysis and Failure
Analysis steps that follow
Step 2: Structure Analysis-Structure Tree

The structure tree arranges system elements
hierarchically and illustrates the dependency via the
structural connections.
• This pictorial structure allows for an understanding of
the relationships between the Process Item, Process
Steps and Process Work Elements.
• Each of these is a building block that will have
functions and failures added in subsequent steps.
The Process Step is the focus of the analysis.

Process Step is a manufacturing operation or station.

Influencing
Process Step
Factors
Man
Machine
Product / Process Step
Process Item Material
The Process Item of the Method

PFMEA is the highest
level of the structure Other
tree or process flow
diagram and PFMEA. Environment
“End result of all of the Process Step
successfully completed Measurement
Process Steps”
From Process
From PFD Characteristics
Adapted From AIAG – VDA FMEA presentation
Step 2: Structure Analysis- Structure Tree in
Excel
The system structure can be created in the Structure Analysis
section of the Spreadsheet:
FUNCTION ANALYSIS
Step 3: Function Analysis
Goal of Function Analysis
– Overview of the product functionality
– Flows down the functional requirements of the
item to the lower level elements
– Answers the question “What is the
Function/Requirements of the specific level
element?”
– Verification against the customer requirements /
specifications
– Overview of cause and effect relationships
– Creating the basis for the failure analysis

The results of this activity should be…
At the Item Level: a list of all the functional requirements of
the product being assembled or manufactured as well as any
process or logistical requirements in the process.
At the Focused (Process Step) Level: a list of all
requirements/deliverables for each step of the process (from
the Process Flow Diagram)
• List each requirement separately

– Provide a name and number for each deliverable to be evaluated
– Show process design level per engineering drawing
• Requirements should be described by an action verb followed by a noun
– Describe the requirement in terms that can be measured
A function describes what the process item or process step is
intended to do. There may be more than one function for
each process item or process step.

Requirement(s) (Characteristics)
• A Characteristic is a distinguishing feature (or quantifiable
attribute) of a product. For example, a diameter or surface
finishes. For PFMEA, Requirements are described in terms of
Product Characteristics and Process Characteristics.
• A Product Characteristic (Requirement) is related to the
performance of a process function and can be judged or
measured. A product characteristic is shown on a product
drawing or specification document e.g., Geometry, Material,
Surface Finish, Coatings, etc. Process functions create Product
characteristics.
Note: The negative of these will be the Failure Mode and the Failure
Cause resp.
1st Level 2nd Level 3rd Level
• Whole Process • Process Steps • Influencing Factors
• Process Element • Sub-processes • 4M’s
Functions are: Functions are: Functions are:
• Technical product • Results after • Activities to be
specifications process step executed
• Process results • Product state to be • Tasks to be
• Health and safety achieved completed
• Logistical results • Product • Process
characteristics to characteristics to
be achieved be achieved
These are nominees

for causes
Step 3: Function Analysis – Example
Press Machine
Function
Process Function
Press Machine
Function
Press Machine
Function
Extracted - AIAG-VDA FMEA Handbook 1st Edition
Matrix – Higher, Focus & Lower Levels
When using a spreadsheet approach, the following three
templates should be used (see handout)
Higher Level
Focused Level
Lower Level
Chapter 4
Failure Analysis and

Risk Mitigation
Chapter 4: Failure Analysis & Risk Mitigation

— Section Content
At the end of this chapter, you will be • Potential Process Failure Modes
able to: • Step 4: Failure Analysis
• Explain failure modes • Step 5: Risk Analysis
• Identify failure modes from • Step 6: Optimization
requirements
• Distinguish between prevention
and detection controls
• Explain the key elements of the
risk mitigation
Failure Analysis & Risk Mitigation: Steps 4-6
Failure Analysis & Risk Mitigation

4th Step 5th Step 6th Step
Failure Analysis Risk Analysis Optimisation
FAILURE ANALYSIS
Step 4: Failure Analysis
Goal of Failure Analysis
– Establishment of the Failure Chain
– Potential Failure Effects, Failure Modes, Failure
Causes for each process function.
– Identification of process failure causes using a
fishbone diagram (4M) or failure network
– Collaboration between customer and supplier
(Failure Effects)
– Basis for the documentation of failures

Failures
Failures of a process step are deduced from product and process
characteristics. Examples include:
• non-conformities
• inconsistently or partially executed tasks
• unintentional or unnecessary activity
The Failure Chain
For a specific failure, there are three aspects to be considered in an FMEA:
• Failure Effect (FE): the consequences of a failure mode
• Failure Mode (FM): manner in which an item could fail to meet or deliver
the intended function
• Failure Cause (FC): indication of why the failure mode could occur

General Approach
2. For each requirement identify potential failure
modes
Step 4: Failure Analysis – Failure Mode
Failure Mode
A (Process) Failure Mode is defined as the manner in which the process could
cause the product not to deliver or provide the intended function.
The team should assume that the basic design of the product is correct;
however, if there are design issues which result in process concerns, those
issues should be communicated to the design team for resolution.
There are several categories of potential failure modes including:

– Loss of process function/operation not performed
– Partial function - Incomplete operation
– Overachieving process function - Too much too high
– Intermittent process function - operation not consistent
– Unintended process function - wrong operation
– Wrong part installed
– Delayed process function - operation too late
Step 4: Failure Analysis – Failure Mode

The Failure Chain
General Approach
modes
Step 4: Failure Analysis – Failure Effects

Failure Effects
Failure Effects are related to functions of the process item
(System, Subsystem, Part Element or Name of Process). Failure
Effects are described in terms of what the customer might notice
or experience.
Customers could be:
– Internal customer (next operation/subsequent operation)
– External customer (Next Tier Level/OEM/Dealer)
– Legislative bodies
– Product end user/Operator
Failure Effects
Failure Effects are given a Severity rating according to:
1. Your Plant: the effect of the failure mode assuming the
defect is detected in the plant (what action will the plant
take, e.g., scrap)
2. Ship-to plant: the effect of the failure mode assuming the
defect is not detected before shipping to the next plant
(what action will the next plant take, e.g., sort)
3. End user: the effect of the process item effect {what will the
end user notice, feel, hear, smell, etc., e.g., window raises
too slow)

Your Plant Effect – Examples could include
– Unable to assemble at operation x
– Unable to attach at customer facility
– Unable to connect at customer facility
– Cannot bore at operation x
– Causes excessive tool wear at operation x
– Damages equipment at operation x
– Endangers operator at customer facility
Note: When parts cannot be assembled there is no impact to the End User
and question for End User does not apply.
Ship-to-Plant Effect – Examples could include
– Line shutdown
– Stop shipment
– Yard hold
– 100% of product scrapped
– Decreased line speed
– Added manpower to maintain required line rate
– Rework and repair

End User Effect – Examples could include
– Noise
– High effort
– Unpleasant odor
– Water leak
– Unable to adjust
– Difficult to control
– Poor appearance
– Safety effect on end user
Note: In some cases, the team conducting the analysis may not know the end user
effect (e.g., catalogue parts, tier 3 components). When this information is not known,
the effects should be defined in terms of the part function and/or process specification.
The Failure Chain

General Approach
modes
Step 4: Failure Analysis – Failure Cause
Failure Cause
A failure cause is an indication of why a failure mode could
occur. The consequence of a cause is the failure mode.
– The cause should be listed as concisely and completely as possible so
that efforts (controls and actions) can be aimed at appropriate
causes.
– If there are several causes for a failure mode, this should result in
multiple lines (cause branches) for the failure mode.
– Investigation of causes needs to focus on the failure mode and NOT
on the effect(s).
Potential cause of failure is defined as how the failure mode could

occur, described in terms of something that can be corrected or
controlled.

Failure Cause
Typical failure causes categories may include the classic Ishikawa's
4Ms, but are not limited to:
– Man: set-up worker, machine operator / associate, material associate,
maintenance technician etc.
– Machine/Equipment: robot, hopper reservoir tank, injection molding
machine, spiral conveyor, inspection devices, fixtures, etc.
– Indirect Material: machining oil, installation grease, washer
concentration, (aid for operation), etc.
– Milieu/Environment: ambient conditions such as heat, dust,
contamination, lighting, noise, etc.
Note: In preparing the FMEA, assume that the incoming part(s) /
material(s) are correct. Exceptions can be made by the FMEA team where
historical data indicate deficiencies in incoming part quality.
The Failure Chain

1. Failure Effects (FE):
The effect of failure associated with "Next Higher Level Element and/or End
User" in the Function Analysis.
Note for spreadsheet users: A potential failure mode may have more than one failure effect.
Failure effects are grouped in the spreadsheet in order to avoid excessive duplication of the same
failure modes and causes.
2. Failure Mode (FM):

The mode (or type) of failure associated with the "Focus Element" in the
Function Analysis.
Note for spreadsheet users: It is recommended that users start with the failure mode and then
identify related failure effects using the information in the #1 Function of the Process Item
column of the Function Analysis section because some or all categories may apply.
3. Failure Cause (FC):

The cause of failure associated with the "Work Element and Process
Characteristic" in the Function Analysis.
RISK ANALYSIS

General Approach
modes
4. For each cause identify level of controls
Step 5: Risk Analysis
Goal of Risk Analysis
– Assignment of existing and/or planned controls
and rating of failures
– Assignment of Prevention Controls to the Failure
Causes
– Assignment of Detection Controls to the Failure
Causes and/or Failure Modes
– Rating of Severity, Occurrence and Detection for
each failure chain
– Evaluation of Action Priority
– Basis for the Optimization step

Process Controls
Process Controls are descriptions of actions or activities that
are (or will be) in place to:
– Prevent the cause of failure mode; thereby preventing the
failure mode
– Detect the cause of the failure mode
– Detect the failure mode
There are two different Control Groups:

– Current Prevention Controls, and;
– Current Detection Controls
Process Controls
Current Prevention Controls - Current Prevention Controls
facilitate optimal process planning to minimize the possibility of
failure occurrence.
Eliminate (prevent) the failure cause or reduce its rate of occurrence.
Current PC Examples could include:

– Two-handed operation of machines
– Form-dependent position
– Equipment maintenance
– Operator maintenance
– Work instructions I Visual aids
– Machine controls
– First part release

Process Controls
Current Detection Controls - Current Detection controls detect the
existence of a failure cause or the failure mode, either by automated
or manual methods, before the item leaves the process or is shipped
to the customer.
Current DC Examples could include:

– Visual inspection
– Optical inspection with camera system
– Optical test with limit sample
– Attributive test
– Dimensional check with a caliper gauge
– Random inspection
– Torque monitoring
EVALUATIONS
Indices and Action Plans

Evaluations
Each Failure Mode, Cause and Effect relationship (failure chain
or net) is assessed for its independent risk.
There are three rating criteria for the evaluation of risk:
Severity (S): stands for the Severity of the Failure Effect
Occurrence (O): stands for the Occurrence of the Failure Cause
Detection (D): stands for the Detection of the occurred Failure
Cause and/or Failure Mode
Evaluation numbers from 1 to 10 are used for S, O, and D

respectively, in which 10 stands for the highest risk
contribution.
Step 5: Risk Analysis – Severity (S)
Severity of Effect
Severity is a rating number associated with the most serious
effect for a given failure mode for the process step being
evaluated.
– It is a relative rating within the scope of the individual FMEA and is
determined without regard for Occurrence or Detection.
– The evaluations of the Failure Effects should be mutually agreed to
by the customer and the organization.
Step 5: Risk Analysis – Severity (S) AIAG 4th Edition
Step 5: Risk Analysis – Severity (S) AIAG VDA
Corporate or
Impact to Ship-to Plant Impact to End User
S Effect Impact to Your Plant Product Line
(when known) (when known)
Examples
Affects safe operation of the
Failure may result in an Failure may result in an acute
vehicle and/or other vehicles,
acute health and/or safety health and/or safety risk for the
10 the health of the driver or
risk for the manufacturing or manufacturing or assembly
passenger(s) or road users or
High assembly worker worker
pedestrians.
Failure may result in in-
Failure may result in in-plant Noncompliance with
9 plant regulatory
regulatory noncompliance. regulations.
noncompliance.
Line shutdown greater than full
production shift; stop shipment
100% of production run
possible; field repair or
affected may have to be
replacement required
scrapped. Failure may
(Assembly to End User) other Loss of primary vehicle
result in in-plant regulatory
than for regulatory function necessary for normal
8 noncompliance or may have
noncompliance. Failure may driving during expected service
a chronic health and/or
result in in-plant regulatory life.
safety risk for the
noncompliance or may have a
Moderately manufacturing or assembly
chronic health and/or safety
High worker.
risk for the manufacturing or
assembly worker
Line shutdown from 1 hour to
Product may have to be
full production shift; stop
sorted and a portion (less Degradation of primary
shipment possible; field repair
than 100%) scrapped; vehicle function necessary for
7 or replacement required
deviation from primary normal driving during expected
(Assembly to End User) other
process; decreased line service life.
than for regulatory
speed or added manpower.
noncompliance.
Step 5: Risk Analysis – Severity (S) AIAG VDA

Corporate or
Impact to Ship-to Plant Impact to End User
S Effect Impact to Your Plant Product Line
(when known) (when known)
Examples
100% of product run may
Loss of secondary vehicles
6 have to be reworked off-line Line shutdown up to one hour.
function.
and accepted.
A portion of the production Less than 100% of product
run may have to be affected; strong possibility for Degradation of secondary
5 Moderately
reworked off-line and additional defective product; vehicle function.
Low
accepted. sort required; no line shutdown.
100% of production run may Defective product triggers
Very objectionable
have to be reworked in- significant reaction plan;
4 appearance, sound, vibration,
station before it is additional defective products
harshness, or haptics.
processed. not likely; sort not required.
A portion of the production Defective product triggers
Moderately objectionable
run may have to be minor reaction plan; additional
3 appearance, sound, vibration,
reworked in-station before it defective products not likely;
harshness, or haptics.
is processed. sort not required.
Low Defective product triggers
Slight inconvenience to minor reaction plan; additional Slightly objectionable
2 process, operation, or defective products not likely; appearance, sound, vibration,
operator. sort not required; requires harshness, or haptics.
feedback to supplier.
No discernible effect or no
1 Very Low No discernible effect. No discernible effect.
effect.
Step 5: Risk Analysis – Occurrence (O)
Occurrence
• The Occurrence rating (O) describes the occurrence of
Failure Cause in the process, taking into account the
associated current prevention controls.
• The Occurrence rating describes the potential of the failure
cause to occur, according to the rating table, without regard
to the detection controls.
• Identify whether the index is based on…
– Consensus
– Historical data on the same or similar processes
– Statistical study (e.g. DOE) on the process
.
Step 5: Risk Analysis – Occurrence (O)

Consider if prevention controls are
• Technical (rely on machines, tool life, tool material, etc.), or
use best practices (fixtures, tool design, calibration
procedures, error proofing, preventive maintenance, work
instructions, statistical process control charting, process
monitoring, product design, etc.),
— or —
• Behavioral (rely on certified or non-certified operators, skilled
trades, team leaders, etc.)
when determining how effective the prevention

controls will be.
Step 5: Risk Analysis – Occurrence (O) AIAG 4th
Edition
Likelihood of Criteria: Occurrence of Cause – PFMEA
Rank
Failure (Incidents per items/vehicles)
Very High ≥ 100 per thousand | ≥ 1 in 10 10
50 per thousand | 1 in 20 9
High 20 per thousand | 1 in 50 8
Moderate .5 per thousand | 1 in 2,000 5
.1 per thousand | 1 in 10,000 4
.01 per thousand | 1 in 100,000 3

Low
≤ .001 per thousand | 1 in 1,000,000 2
Very Low Failure is eliminated through preventive control 1
Step 5: Risk Analysis – Occurrence (O) AIAG VDA

Prediction of Corporate or
O Failure Cause Type of Control Prevention Controls Product Line
Occurring Examples
10 Extremely High None No prevention controls.
9
Prevention controls will have little effect in preventing
Very High Behavioral
failure cause.
8
7
Prevention controls somewhat effective in preventing
High
failure cause.
6
Behavioral or
Technical
5
Prevention controls are effective in preventing failure
Moderate
cause.
4
3 Low Best Practices: Prevention controls are highly effective in preventing

Behavioral or failure cause.
2 Very Low Technical
Prevention controls are extremely effective in preventing

failure cause from occurring due to design (e.g. part
1 Extremely Low Technical geometry) or process (e.g. fixture or tooling design). Intent
of prevention controls – Failure Mode cannot be
physically produced due to the Failure Cause.
Step 5: Risk Analysis – Detection (D)
Detection
• Detection is the rating associated with a prediction of the
most effective process control from the listed detection-type
process controls.
• The intent of the term "control discrepant product" used in
Table Ranks 3 and 4 is to have controls/systems/procedures
in place that controls the discrepant product in such a
manner, that the probability of the product escaping the
facility is very low.
– When more than one control is identified, it is recommended that
the detection ranking of each control be included as part of the
description of the control.
– Record the value with the lowest (most effective) ranking.
– Only detection controls are ranked and recorded.
Step 5: Risk Analysis – Detection (D) AIAG 4th

Edition
Opportunity for Criteria: Likelihood of
Rank
Detection Likelihood of Detection by Process Control Detection
No detection No current process control; Cannot detect or is no Almost

10
opportunity analyzed. Impossible
Not likely to detect Failure Mode and/or Error (Cause) is not easily
9 Very Remote
at any stage detected (e.g. random audits).
Problem Detection Failure Mode detection post-processing by operator

8 Remote
Post-Processing through visual/tactile/audible means.
Failure Mode detection in-station by operator through

Problem Detection visual/tactile/audible means or post-processing through
7 Very Low
at Source use of attribute gauging (go/no-go, manual torque
check/clicker wrench, etc.)
Failure Mode detection post-processing by operator
Problem Detection through use of variable gauging or in-station by operator
6 Low
Post-Processing through use of attribute gauging (go/no-go, manual
torque check/clicker wrench, etc.)
Step 5: Risk Analysis – Detection (D) AIAG 4th
Edition
Opportunity for Criteria: Likelihood of
Rank
Detection Likelihood of Detection by Process Control Detection
Failure Mode or Error (Cause) detection in-station by

operator through use of variable gauging or by
Problem Detection automated controls in-station that will detect discrepant
5 Moderate
at Source part and notify operator (light, buzzer, etc.). Gauging
performed on setup and first-piece check (for set-up
causes only).
Failure Mode detection post-processing by automated
Problem Detection Moderately
controls that will detect discrepant part and lock part to 4
Post-Processing High
prevent further processing.
Failure Mode detection in-station by automated controls
Problem Detection
that will detect discrepant part and automatically lock 3 High
at Source
part in station to prevent further processing.
Error Detection Error (Cause) detection in-station by automated controls
and/or Problem that will detect error and prevent discrepant part from 2 Very High
Prevention being made.
Error (Cause) prevention as a result of fixture design,
Detection not
machine design or part design. Discrepant parts cannot Almost
Applicable; Error 1
be made because item has been error-proofed by Certain
Prevention
process/product design.
Step 5: Risk Analysis – Detection (D) AIAG VDA

Corporate or
Ability to Detection Maturity
D Opportunity for Detection Product Line
Detect Method
Examples
No testing or inspection
The failure mode will not or cannot be
10 method has been
detected.
established or is known.
Very Low It is unlikely that the
The failure mode is not easily
testing or inspection
9 detected through random or sporadic
method will detect the
audits.
failure mode.
Human inspection (visual, tactile,
Test or inspection method audible), or use of manual gauging
8 has not been proven to (attribute or variable) that should
be effective and reliable detect the failure mode or failure
(e.g. plant has little or no cause.
Low experience with method, Machine-based detection (automated
gauge R&R results, or semi-automated with notification by
marginal on comparable light, buzzer, etc.) or use of inspection
7 process or this application, equipment such as a coordinate
etc.) measuring machine that should
detect failure mode or failure cause.
Corporate or
Detect Method
Examples
Human inspection (visual, tactile,
audible), or use of manual gauging
6 Test or inspection method (attribute or variable) that will detect
has been proven to be the failure mode or failure cause
effective and reliable (e.g. (including product sample checks).
plant has experience with Machine-based detection (semi-
Moderate
method, gauge R&R automated with notification by light,
results are acceptable on buzzer, etc.) or use of inspection
5 comparable process or equipment such as a coordinate
this application, etc.) measuring machine that will detect
failure mode or failure cause
(including product sample checks).

Corporate or
Detect Method
Examples
Machine-based automated detection
method that will detect failure mode
downstream, prevent further
processing or system will identify the
product as discrepant and allow it to
4 automatically move forward in the
process until the designated reject
System has been proven unload area. Discrepant product will
to be effective and reliable be controlled by a robust system that
(e.g. plant has experience will prevent outflow of the product
with method on identical from the facility.
High
process or this Machine-based automated detection
application), gauge R&R method that will detect failure mode
results are acceptable, in-station, prevent further processing
etc. or system will identify the product as
discrepant and allow it to
3 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.
Corporate or
Detect Method
Examples
Detection method has
been proven to be Machine-based detection method that
effective and reliable (e.g. will detect the cause and prevent the
2 High
plant has experience with failure mode (discrepant part) from
method, error-proofing being produced.
verifications, etc.)
Failure mode cannot be physically produced as-designed or
Very
1 processed, or detection methods proven to always detect the
High
failure mode or failure cause.
Step 5: Risk Analysis – Action Priority (AP)

• Once the team has completed the initial identification of
failure modes and effects, causes and controls, including
ratings for severity, occurrence, and detection, they must
decide if further efforts are needed to reduce the risk
• Due to the inherent limitations on resources, time, technology,
and other factors, the team needs to choose how to best
prioritize these efforts.
• The initial focus of the team should be oriented towards
failure modes with more emphasis on severity first, then
occurrence, then detection.
• The priority of an action should be based on the discussions
among the team considering the concerns and
product/process knowledge as well as based on information
captured by the FMEA process.
Step 5: Risk Analysis – RPN AIAG 4th Edition
• Risk Priority Number (RPN)
– RPN is calculated as:
RPN = Severity x Occurrence x Detection
– RPN is used to rank relative risk associated with specific

failure modes.
– The use of a Risk Priority Number (RPN) threshold is not a
recommended practice for determining the need for actions.
– RPN alone is not an adequate method to determine the need
for more actions since RPN gives equal weight to S, O, and D.

• If the organization chooses to modify the S,O,D tables for
specific products, processes, or projects, the AP table should
also be carefully reviewed and modified if necessary.
• It is recommended that potential Severity 9-10 failure effects
and Action Priority High and Medium, at a minimum, be
reviewed by management including any recommended
actions that were taken.
• This is not a prioritization of High, Medium, or Low risk, it is
the prioritization of the need for actions to reduce risk.
• Priority High (H): Highest priority for review and action
– The team needs to either identify an appropriate action to improve
prevention and / or detection controls or justify and document why
current controls are adequate.
• Priority Medium (M): Medium priority for review and action
– The team should identify appropriate actions to improve prevention
and / or detection controls, or, at the discretion of the company, justify
and document why controls are adequate.
• Priority Low (L): Low priority for review and action
– The team could identify actions to improve prevention or detection
controls.
Note: It may be helpful to include a statement such as
"No further action is needed" in the Remarks field as appropriate.

AIAG VDA Handbook
AIAG VDA Handbook

AIAG VDA Handbook
AIAG VDA Handbook

AIAG VDA Handbook
Example – Failure Analysis and Risk Evaluation
OPTIMIZATION
Step 6: Optimization
Goal of Optimization
– Identification of the actions necessary to reduce
risks
– Assignment of responsibilities and deadlines for
action implementation
– Implementation and documentation of actions
taken including confirmation of the effectiveness
of the implemented actions and assessment of
risk after actions taken
– Collaboration between the FMEA team,
management, customers, and suppliers regarding
potential failures`
Recommended Actions
The optimization is most effective in the following order:
– Process modifications to eliminate or mitigate a Failure
Effect (FE)
– Process modifications to reduce the Occurrence (O) of the
Failure Cause (FC).
– Increase the Detection (D) ability for the Failure Cause (FC)
or Failure Mode (FM).
– In the case of process modifications, all impacted process
steps are evaluated again.
Recommended Actions
Recommended actions are split into prevention and detection
actions.
New! New!
Action Effectiveness
• When an action has been completed, Occurrence and
Detection values are reassessed as a prediction of
effectiveness, and a new Action Priority may be
determined.
• However, the status of the action remains

"implementation pending" until the effectiveness has
been verified. Only then should it be changed to
"completed."
Continual Improvement
• The PFMEA serves as a historical record for the process.
Therefore, the original Severity, Occurrence, and
Detection (S, O, D) numbers need to be visible or, at a
minimum, available and accessible as part of version
history.
• However, original S, O, D ratings may be modified for
foundation, family or generic PFMEAs because the
information is used as a starting point for a process
specific analysis.
Example – Optimization
Chapter 5
Risk Communication
Chapter 5: Risk Communication —

Section Content
At the end of this chapter, you will be • Step 7: Risk Communication
able to:
• Describe Risk Communication
• Communicate result of FMEA
activity
Risk Communication: Step 7
Risk Communication
7th Step
Results Documentation
RESULTS DOCUMENTATION
Step 7: Risk Communication
Goal of Risk Communication
– Communication of results and conclusions of the
analysis
– Documentation of actions taken including
confirmation of the effectiveness of the
implemented actions and assessment of risk after
actions taken
– Communication of actions taken within the
organization, and with customers and/or suppliers
as appropriate
– Record of risk analysis and risk reduction to
acceptable levels

FMEA Report
• The scope and results of an FMEA should be summarized in a
report.
• The report is not meant to replace reviews of the PFMEA
details when requested by management, customers, or
suppliers.
• This report can be used for communication purposes within a
company, or between companies. In this way, it is also
ensured that all details of the analysis and the intellectual
property remain at the developing company.
FMEA Report
• The content of the documentation must fulfill the
requirements of the organization, the intended reader and
details may be agreed between the relevant parties.
The layout of the document may be company specific. The
content may include the following:
A. A statement of final status compared to original goals
established in the Project Plan
a. FMEA InTent: Purpose of this FMEA?
b. FMEA Timing: FMEA due date?
c. FMEA Team: List of participants?
d. FMEA Task: Scope of this FMEA?
e. FMEA Tool: How do we conduct the analysis Method used?

content may include the following: (cont’d…)
B. A summary of the scope of the analysis and identify what is
new.
C. A summary of how the functions were developed.
D. A summary of at least the high-risk failures as determined by
the team and provide a copy of the specific S/O/D rating
tables and method of action prioritization (i.e. Action Priority
table).
E. A summary of the actions taken and/or planned to address
the high-risk failures including status of those actions.
content may include the following: (cont’d…)
F. A plan and commitment of timing for ongoing FMEA
improvement actions.
a. Commitment and timing to close open actions.
b. Commitment to review and revise the PFMEA during mass
production to ensure the accuracy and completeness of the analysis
as compared with the production design (e.g. revisions triggered
from design changes, corrective actions, etc., based on company
procedures.)
c. Commitment to capture "things gone wrong" in foundation PFMEAs
for the benefit of future analysis reuse, when applicable.
Thank You!
Any Questions?

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AIAG-VDA PFMEA

© 2021, Cue-Biz India Pvt. Ltd.

A BRIEF INTRODUCTION TO CUE-BIZ

Introduction to Failure Mode

PFMEA alignment with APQP Time plan

Purpose and Benefits

“Anything that can go wrong, will go wrong.”

When to Perform FMEA?

• Process FMEA should be initiated before or at feasibility stage,

Scope of AIAG-VDA FMEA

source: AIAG-VDA FMEA Handbook 1st Edition

100 Failure Cost

Primary Types of FMEAs

• Process FMEA: Used to analyze processes before they are

Chapter 2: Developing an FMEA —

The intent is to provide consistent direction, guidance to all automotive

How to Construct an FMEA –

• When practical, existing FMEAs used as a starting point for new

• New projects can follow the FMEA method presented in this

AIAG-VDA FMEA Handbook Form

Higher Higher Higher

Chapter 3: System Analysis —

System Analysis (Prerequisites)

PROJECT PLANNING AND

Before anything else, preparation is the key to success.

The main objectives of Process FMEA Preparation are:

Step 1: Project Planning and Preparation

5Ts — 2. FMEA Timing

“Ultimately, management has the responsibility and

“Management carries the responsibility for the

Senior Management Commitment

5Ts — 5. FMEA Tools

AIAG-VDA FMEA Handbook 1st Edition

PROCESS FLOW DIAGRAM

• A comprehensive Process Flow Diagram provides the

Preparing a Process Flow

Manufacturing Process Flow

Core Team Key Date Start Date Revision Date

Step. No. / Experienced

• It is recommended that each requirement be identified by a

Step 2: Structure Analysis-Structure Tree

The Process Step is the focus of the analysis.

Step 2: Structure Analysis-Structure Tree

The Process Item of the Method

Step 3: Function Analysis

• List each requirement separately

Step 3: Function Analysis

These are nominees

Step 3: Function Analysis – Example

Extracted - AIAG-VDA FMEA Handbook 1st Edition

Failure Analysis and

Chapter 4: Failure Analysis & Risk Mitigation

Failure Analysis & Risk Mitigation

Step 4: Failure Analysis

How to Construct an FMEA –

There are several categories of potential failure modes including:

Step 4: Failure Analysis – Failure Mode

Step 4: Failure Analysis – Failure Effects

Step 4: Failure Analysis – Failure Effects

Step 4: Failure Analysis – Failure Effects

How to Construct an FMEA –

Potential cause of failure is defined as how the failure mode could

Step 4: Failure Analysis – Failure Cause

Step 4: Failure Analysis