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Failure Mode and Effect Analysis

TOTAL QUALITY MANAGEMENT

F.M.E.A.
Power Solutions ABSL STM Quality Limited 2007

Introduction

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What is an F.M.E.A.?
Why do we need it? When do we do it? What do we do when its finished?
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What is a Failure Mode and Effect Analysis?

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F.M.E.A. is a simple way of predicting what

might go wrong. By using a structured method, results can be quantified and hence compared.

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How Does It Work?

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Identifies critical and significant characteristics

Helps engineers prioritise and focus on

eliminating product and process concerns and help prevent problems from occurring.

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Purpose
Utilise individuals

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knowledge and skills within a team environment Identify potential failures at the earliest possible stage of new design/process

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Failure Mode and Effect Analysis

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F.M.E.A.s can be done for any design,

manufacturing or in-service activity F.M.E.A.s are modular and can be carried out for single parts or large assemblies

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F.M.E.A. - Types
System
Design FMEA

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Sub-System Component
System

Process FMEA

Assembly

Sub-System Component System

Manufacturing

Sub-System Component
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Benefits Design F.M.E. A.

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Aids in evaluating requirements and

alternatives Aids in initial Design for Manufacture Increases probability of detecting failure modes and their effects Provides additional information for testing requirements Helps identify critical and significant characteristics Helps validate test methods
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Benefits Process F.M.E. A.

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Identifies potential process related failure

modes which will effect internal/external customers Reduces costs of repairs due to faulty process methodology Increases efficiency Establishes a priority system for considering corrective actions Identifies confirmed critical and significant characteristics
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F.M.E. A. and Control Plans

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F.M.E.A

Identifies Risks

Control Plan

How Risks are Controlled

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F.M.E.A. Model
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Why Do A Failure Mode and Effect Analysis?

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To meet Customer Requirements A.P.Q.P.

To keep up with competition To retain current business Help obtain new business
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Generating F.M.E.A.s
Who initiates?
Who prepares? Who updates? Who is FMEA customer?

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When started and updated?

How is FMEA documented?

Failure Mode and Effects Analysis

When is FMEA complete?

When to discard?

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Managing F.M.E.A.s

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FM.E.A.s are living documents and are

updated when: Modification to a component, process or system is planned; Component is to be used in new environment; Customer concern arises.

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Process F.M.E.A.s

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Process Flow Chart

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Firstly, create a flow chart of operations

Then identify boundary for analysis Next, create a flow chart for one operation

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Process Flow Chart of Operations

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Transport raw materials

Op.10 Preparation

Op.20 Mould

Op.30 Weld

Op.40 assemble

Store/Pack

Op.60 Inspect & Pack

Op.50 Trim to size

Boundary for analysis

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Boundary For Analysis

Op.50 Trim
Place part on trim machine fixture

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Op.50.1

Press Start button

Op.50.2

Remove from fixture when cycle complete

Op.50.3
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Process/Function Requirements
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Process/Function Requirements
From Process flow:

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Enter a simple description of the process being

analysed i.e. Place part on trim machine fixture; Indicate the purpose of the process being analysed i.e. Fully seat part in correct orientation; List separately other operations involved with that process; Process function contains both product and process characteristics.
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Define the Process Purpose

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What does the process do at this operation?

What is the process purpose? What is its function?

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Process Purpose
Op.50 Trim

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Locate part on fixture - correct Place part on trim machine fixture Op.50.1 orientation - fully seated

Press Start button

Op.50.2 Start trimming

programme Position in checking fixture - fully seated

Remove from fixture when cycle complete

Op.50.3 Remove waste

before packing
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Determine What Can Go Wrong

Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Failure Mode

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Definition: Potential failure mode is the manner in which the process could potentially fail to meet the process requirements and/or design intent. It is a description of the non-conformance at that specific operation.

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Failure Mode

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Examine process flow using:

No function Partial function Intermittent function

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Effects Of Failure Mode

Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Effects of Failure Mode

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Definition: The effects of the failure mode on the customer. The customer could be the next operation, subsequent operations or the final customer / user.

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Effects of Failure Mode

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Identify potential effects on: next user downstream user ultimate customer vehicle operation operator safety Compliance with government regulations machines / equipment
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Effects of Failure

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Failure mode

Next user

Downstream Ultimate Vehicle Operator Government users customer operation safety regulations

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Effects of Failure
Failure mode: Incorrect Trim Programme

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Failure mode

Next user
Incorrect to checking fixture

Downstream Ultimate Vehicle Operator Government users customer operation safety regulations
Packaged in wrong stillage Cannot fit to vehicle. Stop Production line Cannot fit to vehicle None None

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Severity
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Severity

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Definition: An assessment of the seriousness of the effect of the potential failure mode on the customer.

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Suggested Severity Scoring

Effect
Hazardous without warning Hazardous with warning Low

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Ranking
10

Criteria: Severity of Effect

May endanger machine or assembly operatornon compliance government regulation without warning May endanger machine or assembly operatornon compliance government regulation without warning Minor disruption to production line 100% of product may have to be reworked

None

No Effect

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Critical or Special Characteristic

Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Identify Special Characteristics

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CRITICAL: Requirements that affect compliance with government regulations or safe vehicle / product function and require special controls (Score = 9 or 10)
SIGNIFICANT: Product and/or test requirements important for customer satisfaction, summarized on Control Plan and require special controls (Score = 5 to 8,)

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Cause
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Cause

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Definition: Potential cause of a failure is defined as how the failure could occur in terms of something that can be corrected or controlled.

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Cause

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Only specific errors or malfunctions (eg.

Operator fails to remove waste) should be listed.

Ambiguous phrases (e.g. Operator error,

machine malfunction) should not be used.

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Occurrence
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Occurrence

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How frequently the cause is projected to

occur. Based on:

Historical manufacturing/assembly failure rates with similar parts Statistical data from similar process Existing process controls Customer concern data Rejects, PPM, Warranty data
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Suggested Occurrence Scoring

Probability
Very high

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Ranking
10 9

Possible Failure Rates

About 1 in 2 About 1 in 3

Moderate

About 1 in 80 About 1 in 400 About 1 in 2000

6 5 4

Remote

Less than 1 in 500,000

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Controls
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Controls

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Increasing inspection is only a temporary

measure. Permanent Corrective Action is required.

Emphasis must be placed on preventing

defects rather than detecting them (e.g. S.P.C.)

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Controls

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In Process Control column on FMEA: Prevention Controls Place a P before each prevention control listed Detection Controls Place a D before each detection control listed
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Prevention Controls

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Prevention: (Preferred option) Prevent the cause / mechanism of failure or

the failure mode occurring, or reduce their rate of occurrence

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Detection Controls

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Detection: Detect the cause / mechanism of failure or the

failure mode and lead to corrective actions

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Process Control Examples

Engineering specification tests
Poka-yoke or error proofing Audible or visual warning devices In Process / Final inspection S.P.C.

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Process / Parameter audits

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Detection
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Detection

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Definition: Detection is an assessment of the probability that: The process controls listed will detect a potential cause /mechanism (process weakness) , or The process controls listed will detect a subsequent failure mode.
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Suggested Detection Scoring

Detection
Certain

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Ranking
10

Likelihood of Detection
Process control will not and/or cannot detect a potential cause or there is no process control Moderately high chance the process control will detect potential cause

Moderate

Almost certain

Process control will almost certainly detect a potential cause

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Select and Manage Actions

To Reduce
Severity

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To Accomplish
Eliminate failure modes

Consider This Action

Change the design ... or the process if operator safety is involved Change the design or process

Occurrence

Prevent cause(s), or reduce their rate of occurrence

Detection

Add to or improve the control methods

Improve ability to detect a failure mode

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Risk Priority Number (R.P.N.)

Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Failure Mode and Effect Analysis

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We have seen that the F.M.E.A. asks three

questions:
What might go wrong?
What effect would this have?

What caused the problem?

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Failure Mode and Effect Analysis

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From the answers to the three questions

we can work out a risk priority number:

Risk Priority Number

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Failure Mode and Effect Analysis

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How do we calculate the R.P.N.? We simply use the scoring criteria easily

remembered by:

Severity of the problem Occurrence of the problem Detection of the problem

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Failure Mode and Effect Analysis

Each is given a value from 1 to 10
Lets try this out for S, O & D For Example,

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Severity = 1 2 3 4 5 6 7 8 9 10 Occurrence = 1 2 3 4 5 6 7 8 9 10 Detection = 1 2 3 4 5 6 7 8 9 10 Each of these could be assessed in a rating from 1 to 10.
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Failure Mode and Effect Analysis

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How can we use these values to give an

overall risk?

We multiply the three figures together:

e.g. 7 x 4 x 3 = 84. So the R.P.N. is 84.
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Failure Mode and Effect Analysis

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From the R.P.N. we can now see the

areas of greatest concern

i.e. Those failures with the highest risk

priority numbers

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Failure Mode and Effect Analysis

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We can now focus our attention on the

worst problems those with the highest R.P.N. With limited resources, this must be a good idea We can now eliminate or reduce the potential failure

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Recommended Actions
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Recommended Actions

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The intent of any Recommended Action is to reduce rankings in the following order:
Severity Occurrence Detection

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Responsibility & Target Date

Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Responsibility

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Each action must be assigned to a specific

individual and not a dept. / organisation

If the individual is not in the team a team

member should be assigned responsibility for communication and feedback of action with a target date.

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Actions Taken
Potential Failure Mode and Effects Analysis
___ System ___ Subsystem ___ Component Model Year / Vehicle(s): Core Team: Item Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms Failure O c c u r Design Responsibility: Key Date:

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FMEA Number: Page 1 of 1 Prepared by: FMEA Date (

Orig):

(Rev) Action Results

Current Design Controls

Function

D e t e c

R P N

Recommended Action(s)

Responsibility & Target Completion Date

Actions Taken

S e v

O c c

D R e P t N

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Actions Taken

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After the corrective action has been identified,

estimate and record the resulting severity, occurrence and detection rankings Calculate and record the resulting R.P.N. P.F.M.E.A. team must review the revised R.P.N.s to determine if further action is necessary. If no action write None.

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Actions Taken

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Once the actions have been implemented, the

estimated values, the future, becomes the present and can be incorporated into the LHS of the form on the next F.M.E.A.

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Failure Mode and Effect Analysis

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Advantages of F.M.E.A.s

Customer confidence
Improved quality & efficiency

Improved participation across traditional

boundaries

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Failure Mode and Effect Analysis

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More advantages of F.M.E.A.s

Uses extensive & untapped

personnel/process knowledge to improve new & existing work Provides a vehicle for continuous improvement Supports product liability
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Failure Mode and Effect Analysis

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There are drawbacks for F.M.E.A.s:

Must be adequate time & resources for

F.M.E.A.s Product Liability Need for in-depth product & process or design knowledge

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Failure Mode and Effect Analysis

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Remember - F.M.E.A. is a practical activity and

there will be differing interpretations regarding to the failure modes and rankings - this does not matter, provided that the team does not get bogged down in this way!

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Failure Mode and Effect Analysis

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Keep the meetings short and the tempo

sharp!
Design F.M.E.A. team - Chairman,

Production, Service, Quality Personnel

Process F.M.E.A. team - YOU CHOOSE!

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