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Introduction

- FMEA -

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FMEA
Failure Modes & Effects Analysis

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FMEA - Introduction
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1. Introduction

FMEA development (design or process) uses a common approach to


address:

• Potential product or process failure to meet expectation


• Potential consequences
• Potential cause of failure mode
• Application of current control
• Level of risk
• Risk reduction

Before the FMEA document is started, the team must define the scope of
the project and collect all necessary information for an efficient & effective
FMEA

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What is an FMEA (from research)
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This is not a one man job !!!

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FMEA definitions
It is a systemised group of activities intended to:-
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• Recognise and evaluate the potential failure of a product or


process and its effects
• Identify actions which could eliminate or reduce the chance
of a potential failure occurring.
• Focuses on prevention of a failure
• Results in a coordinated/ document team effort of the process

Defines what a design or process must do to satisfy a customer :-


• Allows the team to evaluate controls and the need to mitigate
risk by changes to design or the manufacturing control plan.
• A method to determine the need for and a priority of actions
• The deliverable is to prevent failures from reaching customers,
improving customer satisfaction.

FMEA’s identify or confirm potential critical and significant characteristics to be


addressed by, design changes, process changes or to be included in the process
Control Plan

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Basic Structure

Fundamentally, the format utilized should address:

• Functions, requirements, and deliverables of the product or process being


analyzed
• Failure modes when functional requirements are not met
• Effects and consequences of the failure mode
• Potential cause of the failure mode
• Actions & Control for causes of the failure mode
• Actions to prevent recurrence of the failure mode

Specific formats may vary based on the need of the organization and
the requirements of the customer

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Identify the Team

A team approach is recommended to benefit the FMEA


development process to ensure input and collaboration
from all affected areas

The FMEA team leader should select team members


with the relevant experience and necessary authority.

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TEAM STRUCTURE
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• As a minimum, the team should include:-


include:-
• Design or process owner
• Devils advocate or contrarian
• Peer or expert who challenges the current
Design process
• Data owner
• Quality expert
• Other subject matter experts as necessary
• Testing
• Metrology
•Optional
• Expert facilitator
• Recorder
• Key supplier Implementing roles
Establish the roles - particular attention to the team formation and
• Services functions by:
•Purchasing •Getting to know each other, including individual strengths/ weaknesses
and preferences for working.
•Identifying roles and responsibilities
•Establishing ground rules for behaviour
•Clarifying the team's goals and tasks
•Scheduling tasks, meetings and deadlines
•Learning to use different group methods at meetings

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Define the Scope

The following may assist the team in defining the SCOPE


of the FMEA:

• Functional model •Process Flow diagrams


• Block diagrams (Boundary) •Interrelationship matrices
• Parameter diagrams (P) •Schematics
•Bill of Materials (BOM)
• Interface diagrams

Scope establishes the boundary of the FMEA analysis and defines what is
included or not
The scope needs to be established at the start of the process to assure
consistent direction and focus

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Preparation tool
5
Assembly Process
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4 Supplier

0
Fuite Corps Bracket
carter etranger tordu suite
central dans a chute
actuator OP20

Ppm Pareto

before

Boundery / Interface diagram

after

Check Lists

Visual Management tool


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Structure of FMEA

System FMEA

Subsystem FMEA

Component FMEA

A system FMEA is made up of various subsystems. Examples: Chassis


System, Power-train System etc

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System FMEA

The focus of the System FMEA is to address all interfaces and interaction
among systems, subsystems, the environment and the customer

Subsystem FMEA

The focus of the Subsystem FMEA is to address all interfaces and


interactions among the subsystem components and interactions with other
subsystems or systems. Example – front suspension subsystem, which is a
subset of the chassis system

Component FMEA

Component FMEA is a subset of a Subsystem FMEA. Example – a brake


pad is a component of the brake assembly, which is a subsystem of the
chassis system

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Define the Customer

There are four major customers to be considered in


the FMEA process:

• END USER – the person or organization that will utilize the product.
Example – durability

•OEM Assembly & Manufacturing Centers (Plants)


•Supply Chain Manufacturing – including fabricating production, service
parts, assemblies and processes as welding, painting or other finishing
services

•Regulators – government agencies that define requirements and monitor


compliance to safety and environmental specifications which can impact the
product or process

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Identify Functions, Requirements and Specifications

● The purpose of this activity is to clarify the item design intent or process
purpose.

● This assists in the determination of the potential failure mode for each
attribute or aspect of the function.

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Identify Potential Failure Modes

● Defined as the way or manner in which a product or process could fail


to meet design intent or process requirements.

● A concise and understandable failure definition is important since it


properly focuses the analysis.

● Potential failure modes should be described in technical terms and


not as a symptom necessarily noticeable by the customer.

● A large number of failure modes identified for a single requirement


may indicate that the defined requirement is not concise.

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Identify Potential Effects

● Potential Effects = Effects of the failure mode as


perceived by the customer

● The customer can be internal as well as End User

● Potential Effects includes the analysis of the consequences of the


failures and the severity or seriousness of those consequences

The effects or impact of the failure are described in terms of what the
customer might notice or experience

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Identify Potential Causes

● Potential Causes = indication of how the failure could


occur ( in terms of something that
can be corrected or controlled)

● Identifying the root causes of the failure mode enables the


identification of appropriate controls and action plans

A separate potential causes analysis is performed for each cause if


there are multiple causes

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Identify Controls

● Control are those activities that prevent or detect the cause of the
failure or failure mode.

● In developing controls it is important to identify what is going wrong,


why, and how to prevent or detect it

● Controls are applicable to product design or manufacturing


processes

Controls focused on prevention will provide the greatest return

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Identifying and Assessing Risk

One of the important steps in the FMEA process in the assessment of


risk. This is evaluated in three ways:

● Severity – level of impact in of a failure on the customer.

● Occurrence – how often the cause of a failure may occur.

● Detection – how well the product or process controls detect the cause
of the failure or the failure mode.

Organizations need to understand their customer requirements for


risk assessment.

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Recommended Actions & Results

The following can be used to assure that the appropriate actions are
taken, including but not limited to:

● Ensuring design requirements including reliability are achieved

● Reviewing engineering drawing & specifications

● Confirming incorporation in assembly / manufacturing processes

● Reviewing related FMEAs, control plans and operations instructions

Once actions are completed and result captured, the updated rating
for severity, occurrence and detection should be recorded

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Management Responsibility

● Management owns the FMEA process.

● Management has the ultimate responsibility of selecting and applying


resources and ensuring an effective risk management process
including time

● Management responsibility also includes providing direct support to


the team through on-going reviews, eliminating roadblocks and
incorporating lessons learned

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