10 Ssgb Amity Bsi Fmea

8/9/2019 10 Ssgb Amity Bsi Fmea

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Module-10

Failure Modes and Effects Analysis (FMEA)


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At the end of this section delegates will be able to:

Understand the role of Failure Mode and Effects

Analysis, FMEA within the DMAIC ImprovementProcess

Conduct a Process FMEA on an existing, new ormodified transactional process

Use the Process FMEA to prioritise areas forattention

Use the Process FMEA to support the generation ofControl Plans

Failure Mode and Effects Analysis Learning Objectives


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Failure Mode and Effects Analysis - Agenda

Introduction to Failure Mode and Effects Analysis

FMEA Within DMAIC

FMEA Roadmap

FMEA Form and Control Plans

Implementing FMEA

Summary


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Classic Failures

City trader buys 15,000,000 shares instead of 15,000

Leap day shuts down bank cash machines

NASA probe lost due to Metric/Imperial units

confusion

Worldwide Perrier stocks withdrawn due to filter

failure

Pilot shuts down wrong aircraft engine

Company emails confidential account information to

analysts and has to suspend trading


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Introduction to FMEA

Failure Mode and Effects Analysis, FMEA is:

A systematic method of identifying and investigating potential

design or process weaknesses. A means to evaluate and manage product risks.

A means of evolving organizational knowledge.

Developed in the aerospace industry in the mid 1960s Also sometimes referred to as Failure Mode Effect and

Criticality Analysis, FMECA


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FMEA Purpose

Purpose:

Recognise and evaluate the potential failuremodes and causes associated with the designand manufacture of a product or design and

operation of any process. Identify actions which could eliminate or

reduce the chance of the potential failure

occurring. Document the analysis and changes made.


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Application of FMEA in Six Sigma

In Design for Six Sigma - (Design FMEA) : to identify potential failure modes

to identify potential causes of failure to eliminate/minimise the potential failure modes within

the Design process

In Transactional/Operational Six Sigma (ProcessFMEA) : to analyse the existing processes (identify possible xs)

to improve the process (elimination/reduction of failure

modes) to select new process alternatives

to develop control plans


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15 20 25 30 35

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Define Measures (ys)

Check Data Integrity

Determine ProcessStability

Determine ProcessCapability

Set Targets forMeasures

Phase Review

Control Critical xs

Monitor ys

Validate ControlPlan

Identify furtheropportunities

Close Project

1 5 10 15 20

10.2

10.0

9.8

9.6

Upper Control Limit

Lower Control Limit

y

Phase Review

Develop DetailedProcess Maps

Identify CriticalProcess Steps (xs)by looking for:

Process Bottlenecks Rework / Repetition

Non-value AddedSteps

Sources of Error /Mistake

Map the Ideal

Process Identify gaps

between current andideal

START

PROCESS

STEPS

DECISION

STOP

Phase Review

Brainstorm PotentialImprovement Strategies

Select ImprovementStrategy

Plan and ImplementPilot

Verify Improvement

ImplementCountermeasures

Criteria A B C D

Time + s - +

Cost + - + s

Service - + - +

Etc s s - +

15 20 25 30 35

LSL USL

Phase Review

Analyse Improve ControlMeasureDefine Select Project

Define Project

Objective

Form the Team

Map the Process

Identify CustomerRequirements

Identify Priorities

Update Project File

Phase Review

Define

Six Sigma Transactional Improvement Process


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Application of PFMEA in DMAIC

Analyse: To analyse the existing processes and identify

possible xs (causes of failure)

Improve: To improve the process (elimination/reduction of

failure modes) To select new process alternatives

Control:

To develop control plans It is only necessary to conduct PFMEA on the

modified/changed areas of the process


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Force Field Analysis6Greenall

Barnard

Associates

Process FMEA

Roadmap

1.DescribeProcess 2.Define

Functions

3.Identify PotentialFailure Modes

4.Describe Effectsof Failure

5.DetermineCauses

6.CurrentControls

7.CalculateRisk

8.TakeAction

9.AssessResults


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Step 1: Describe Process

Process Flow Diagrams

Error & Correction Data Internal Problem Data

Customer Feedback

ProcessKnowledge

1.DescribeProcess


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Suppliers:Sales

Stores

Inputs:Order

ProductPackaging

Customers:Sales

ShippingEnd customer

Outputs:Packaged Product

Shipping requisitionOrder fulfilment note

Step 1: Describe Process- Order Fulfilment

Receive order

Check stock

Pull product and check

Package product

Weigh product

Correct

weight?

Allavailable?

Order stock

Notify Sales

Transfer to Goods Out

Yes

Yes

No

No

1.DescribeProcess


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Process

Flow

Diagram

List of Functions

(Purposes)

Step 2: Define Function

2.DefineFunctions


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ActionVerb Noun

Gather

Publish

Approve

Release

Project

Report

Credit

Product

Data

Sales

Test Part

Check

Contact

Receive

Deliver

Calculate

Address

Customer

Stock

Order

Price

ActionVerb Noun

Process Information

Examples of Functions

2.DefineFunctions


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Step 2: Define Function

Functions Receive order

Check sufficient stock

Notify sales

Order stock

Pull product Check product

Etc.

2.DefineFunctions

Receive order

Check stock

Pull product and check

All

available?

Order stock

Notify Sales

Yes

No


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List of PotentialFailures

FunctionDoes Not

Function?

Does not/Cannot

Too much

Too littleToo early

Too late

Degraded

Intermittent

IncorrectUnwanted

Function

Step 3: Identify Potential Failure Modes



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Process Function Potential Failure Modes

Receive Order Does not receive orderReceives incorrect order

Receives too many orders

Check sufficient stock Does not check sufficient stock

Incorrect check (wrong conclusion)

-Insufficient stock when sufficient

-Sufficient stock when insufficient

Step 3: Identify Potential Failure Modes

Notify Sales Does not notify salesNotifies sales too late

Notifies sales with incorrect information


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Assume the failure could occur

- what would be the effect ?

Consider : How it affects the process (processor):

next operation

subsequent downstream operations

How it affects the end user (customer).

Immediate & delayed impact.

Be realistic.Note: There may be several potential effects for each failure, but

these are listed together as one overall effect.

Step 4: Describe Effects of Failure



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Does not Receive Order

Incorrect stock check(Concludes insufficient when

sufficient available)

Step 4: Describe Effects of Failure


Assume the failure could occur

- what would be the effect?

Potential Failure Modes Potential Effects

Order not fulfilled, customer has to

re-submit order

Delay in fulfilling order, excess

stock, possible loss of order

Incorrect stock check(Concludes sufficient stock

when insufficient available)

Incomplete order, delay, customer

dissatisfaction

Notify Sales too late Customer not aware of delay, sales

takes further orders


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What could cause the potential failure mode

to occur ?

Process / processor errors that could lead to the failure Be specific, processor error or equipment failure

are too vague Consider the working environment of the process,condition of equipment, IT systems

There will typically be several causes for each failure

mode Identify root causes for severe failures

Step 5: Determine Causes

5.DetermineCauses


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Step 5: Determine Causes

What could cause the potential failure mode to

occur ?

Potential CausesPotential Failure Modes

5.DetermineCauses

Incorrectly addressed

Delivered to wrong department Lost in post

Does not receive order

Incorrect stock check Error in inventory levels

Entered wrong part code

Entered wrong quantity

Multiple orders in process


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Force Field Analysis6GreenallBarnard

Associates

Process FMEA

Roadmap


Functions



5.DetermineCauses

6.CurrentControls

7.CalculateRisk

8.TakeAction

9.Assess

Results


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1. For the given example, describe the process using a process flowchart. Describeeach process step in terms of its function using a verb noun combination e.g.check stock, calculate profit , complete invoice, check form etc. (N.B. dependingon the detail of the flowchart there may be more than one function at eachstep).

2. Working from the process flowchart, identify potential failure modes by addingthe key words: does not/cannot/incorrect function, too much/too little function,too early/late function etc. Each function should have at least one failure mode.

3. For each of the failure modes identify the potential effects of the failure on theprocess, processor and/or the customer. If there are several effects then group

these together as the overall effect for the failure mode. Each failure modeshould have one effect.

4. For each failure mode, identify the possible causes of the failure. Be specific,processor error" is too vague. There will typically be more than one cause perfailure mode.

5. Prepare a short presentation on your team's findings.Workshop 1

Time:

Workshop 1:Identify Potential Failures Modes


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Force Field Analysis6GreenallBarnard

Associates

Process FMEA

Roadmap


Functions



5.DetermineCauses

6.CurrentControls

7.CalculateRisk

8.TakeAction

9.AssessResults


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In order of preference there are three types of currentcontrols :

1. Prevent the cause2. Detect the cause, leading to corrective action

3. Detect the failure (defect)

These might include: Control Charts Check Sheets Mistake Proofing Training Information Technology

Identify the current controls to prevent / detect the

failure before it reaches the customer

Step 6: Current Controls

6.CurrentControls


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Step 6: Current Controls

Incorrect stock check Error in inventorylevels

Entered wrong partcode

Entered wrong quantity

Multiple orders inprocess

Stock take (annual),Stock control system

Double entry required

No controls

Potential

Causes Current Controls

Potential

Failure Modes

Identify the current controls to prevent / detect

the failure before it reaches the customer6.CurrentControls

Double entry required


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Severity ofthe Effect

Probability

ofOccurrence

Detection

(Capability ofCurrent Controls)

Risk

PriorityNumber

X X =

Step 7: Calculate Risk

7.CalculateRisk


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Process FMEA Severity Rating

How serious is the effect ?

Note : Many organisations choose to modify the descriptions to best describe their industry.

Sev Effect Customer Effect Processor Effect

5 Hazardous Safety compromised or non-

compliance with legal issue

May endanger processor or

process equipment4 High Loss of service Process stops, 100%

transactions incorrect

3 Moderate Very dissatisfied, service

provided but much degraded

Significant process disruption,

many transactions requirecorrecting

2 Low Inconvenient, service provided

but not up to expectations

Some process disruption, some

transactions require reworking

1 Veryminor/none

Not noticed by mostcustomers

Minor disruption to processor no effect


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Process FMEA Occurrence Rating

How likely is the cause ?

Note : Many organisations choose to modify the descriptions to best describe their industry.

Occ Probability Likely failure rates

5 Very high, persistent failures 1 in 10 transactions (opportunities)

4 High, frequent failures 1 in 100 transactions (opportunities)

3 Moderate, occasional failures 1 in 1,000 transactions (opportunities)

2 Low, relatively few failures 1 in 10,000 transactions (opportunities)

1 Remote, failure is unlikely 1 in 100,000 transactions (opportunities)


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Process FMEA Detection Rating

How effective are the Current Controls?

Det Criteria Typical Detection/Control Method Type

5 No Controls Cannot detect or is not checked ?

4 Controls detect failure Inspection, checking 3

3 Controls detect cause Control charts (focused on outputs) 3/2

2 Controls prevent failure Control charts (focused on inputs) 2/1

1 Controls prevent cause Mistake Proofing, training 1


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Effect


dissatisfaction

Cause

Multiple orders in process

Current Controls

No Controls

Severity = 3

Occurrence = 3

Detection = 5

RPN = 3 x 3 x 5 = 45

Step 7: Calculate Risk

Failure Mode

Incorrect Stock Check

7.CalculateRisk


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Corrective Action Effects On RPN Rating

Note : Do not modify RPN until corrective action is completed (Step 9)

Step 8: Take Action

Corrective Action Severity Occurrence Detection1. Process change Maybe Yes Yes

2. Improve Current Control No Maybe Yes

3. Improve Employee training No Yes Yes

4. Mistake proofing No Yes Yes

5. Increased inspection No No Maybe

8.TakeAction


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Stock is temporarily reserved

against enquiry

Step 8: Take Action

RPN = 3 x 3 x 5 = 45

8.TakeAction

Effect


dissatisfaction

Cause Multiple orders in process

Current Controls

No Controls

Severity = 3

Occurrence = 3

Detection = 5

Failure Mode



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Review corrective actions and modify

RPN figure based on results.

Before Improvement

After ImprovementRPN

Reduced

Risk

Step 9: Assess Results

9.AssessResults


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Stock is temporarily reserved

against enquiry

Step 9: Assess Results

RPN = 3 x 3 x 2 = 18

8.TakeAction

Effect


dissatisfaction

Cause Multiple orders in process

Current Controls

No Controls

Severity = 3

Occurrence = 3

Detection = 5 2

Failure Mode


x


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Force Field Analysis6Greenall

Barnard

Associates

Process FMEA

Roadmap


Functions



5.DetermineCauses

6.CurrentControls

7.CalculateRisk

8.TakeAction

9.AssessResults

FMEA P


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FMEA Purpose

Purpose:

Recognise and evaluate the potential failure

modes and causes associated with the design andmanufacture of a product or any process.

Identify actions which could eliminate or reduce

the chance of the potential failure occurring. Document the analysis and changes made.

FMEA F


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FMEA FormFAILURE MODE & EFFECTS ANALYSIS PROCESS FMEA

Product: PROCESS FMEA No. Page : of

Application: Issue No. Originators:

Customer: Date:

ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL CURRENT RECOMMENDED RESP. ACTION RESULTSFUNCTION FAILURE MODE EFFECTS OF

FAILURESEV CAUSE(S) OF FAILURE OCC CONTROLS DET RPN ACTIONS FOR

ACTIONACTIONSTAKEN

SEV OCC DET RPN

3 Checkssufficient stock

IncorrectStock Check

(Concludessufficient

stock when

insufficientavailable)

Incompleteorder,

delay,customer

dissatisfacti

on

3 Multiple orders in process 3 No controls 5 45 Stock reservedagainst enquiry

SCB 18.08.03 3 3 2 18

FMEA F


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FMEA Form

ITEM PROCESS POTENTIAL POTENTIAL POTENTIALFUNCTION FAILURE MODE EFFECTS OF

FAILURESEV CAUSE(S) OF FAILURE OCC

3 Checks

sufficient stock

Incorrect

Stock Check

(Concludessufficient

stock when

insufficient

available)

Incomplete

order,

delay,customer

dissatisfacti

on

3 Multiple orders in process 3

CURRENT RECOMMENDED RESP. ACTION RESULTSCONTROLS DET RPN ACTIONS FOR

ACTIONACTIONSTAKEN

SEV OCC DET RPN

No controls 5 45 Stock reserved

against enquiry

SCB 18.08.03 3 3 2 18

Expand detail in

Control Plan

C t l Pl


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Control Plan

Detail of the Current Controls are held in anadditional form the Control Plan

Control Plan (and Current Controls) may need to

change based on recommended actions The effectiveness of the Control Plan is tested during

the Control phase of DMAIC

All Critical xs should be included in the ControlPlan

W k h 2 Ri k A t


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Workshop 2: Risk Assessment

1. Transfer the failure modes, effects and causes identified in workshop 1 to the largeFMEA form.

2. Using the Severity rating scale, rate each of the failure mode effects and record thenumber in the appropriate column. Where there are several possible effects for afailure mode, take the worst case for the rating. There should be only one severity

rating for each failure mode.3. Using the Occurrence rating scale and your team's expertise, rate each of the

potential causes of failure and record the numbers in the appropriate column.

4. For the purpose of the exercise, assume there are no Current Controls (Detection

rating = 5), calculate the Risk Priority Numbers (RPN) and record on the chart.There should be one RPN score for each cause listed on the FMEA form.

5. For the top five RPN's, identify possible actions to reduce the RPN scores. Identifywhich of the categories (Severity, Occurrence, and Detection) would be reducedonce the action has been completed.

6. Prepare a short presentation to summarise your team's findings. Workshop 2

Time


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Implementing FMEA

Who Should Do FMEA ?


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Team not an individual

Cross functional opportunity to improve

communication and understanding

Include the processors (people who work in the process)

Consider including the customer where appropriate

Who Should Do FMEA ?

10 Keys To FMEA Success


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10 Keys To FMEA Success

Support by top & middle management

Motivated team members

Cross functional representation on the team

Treat as before the event not after the fact

Generate company specific rating scales

Treat as a living document-reflect latest revisions

Execute recommended actions Integration into your development process

Generate & use a library of generic FMEAs

Follow the spirit, not the form

Common Mistakes


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Common Mistakes

Applied too late

Poor team working, wrong team members or no

team

Over dependence upon the numbers

Inconsistency in numbers Solving all problems in meetings

When Do You Start PFMEA ?


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When Do You Start PFMEA ?

Within Six Sigma DMAIC:

If there is a Process FMEA available this should be

reviewed during the Measure/Analyse phases. If there is

no FMEA then consider completing one for the part of the

process of interest.

During the Improve/Control phases a PFMEA should be

updated/completed for the areas of the process that havechanged.

Improving Organisational Capability


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Improving Organisational Capability

Specific

FMEA

Knowledge

Base

DesignCheck-list

Specific

FMEA

General

FMEA


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Failure Mode and Effects Analysis Summary



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Process Failure Mode and Effects Analysis,PFMEA, can be applied within the DMAICImprovement Process

A Process FMEA can be conducted on an existing,new or modified process

The Process FMEA prioritises areas for attention The Process FMEA can be used to support the

generation of Control Plans



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Analyse: To analyse the existing processes and identify possible xs

(causes of failure)

Improve: To improve the process (elimination/reduction of failure

modes)

To select new process alternatives

Control To develop control plans

It is only necessary to conduct PFMEA on themodified/changed areas of the process

Six Sigma Transactional Improvement Process


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15 20 25 30 35

LSL USL

Define Measures (ys)

Check Data Integrity

Determine ProcessStability

Determine ProcessCapability

Set Targets forMeasures

Phase Review

Control Critical xs

Monitor ys

Validate ControlPlan

Identify further

opportunities Close Project

1 5 10 15 20

10.2

10.0

9.8

9.6

Upper Control Limit

Lower Control Limit

y

Phase Review

Develop DetailedProcess Maps

Identify CriticalProcess Steps (xs)by looking for:

Process Bottlenecks

Rework / Repetition

Non-value AddedSteps

Sources of Error /Mistake

Map the IdealProcess

Identify gapsbetween current andideal

START

PROCESSSTEPS

DECISION

STOP

Phase Review

Brainstorm PotentialImprovement Strategies

Select ImprovementStrategy

Plan and ImplementPilot

Verify Improvement

ImplementCountermeasures

Criteria A B C D

Time + s - +

Cost + - + s

Service - + - +

Etc s s - +

15 20 25 30 35

LSL USL

Phase Review

Analyse Improve ControlMeasureDefine Select Project

Define Project

Objective

Form the Team

Map the Process

Identify CustomerRequirements

Identify Priorities

Update Project File

Phase Review

Define

S S g a a sact o a p ove e t ocess

FMEA References


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References:

AIAG QS9000 - Potential Failure Mode and Effects Analysis 3rd Edition July 2001 , Automotive Industry

SAE J 1739: Potential Failure Mode and Effects Analysis inDesign and Potential Failure Mode and Effects Analysis inManufacturing and Assembly Processes Reference Manual

Mil Standard - 1629 , Military, aerospace applications

Failure Mode and Effect Analysis, Stamatis, D. H. (2003),ISBN: 0-87389-598-3, ASQ Quality Press, Milwaukee, WI

10 Ssgb Amity Bsi Fmea

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