12 Ssgb Amity Bsi Fmea

Module-12

Copyright 2012 BSI. All rights reserved.

Module-12Failure Modes and Effects Analysis (FMEA)

Failure Mode and Effects Analysis Learning Objectives

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

Understand the role of Failure Mode and Effects Analysis, FMEA within the DMAIC Improvement

Process

Conduct a Process FMEA on an existing, new or modified transactional process


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Use the Process FMEA to prioritise areas for attention

Use the Process FMEA to support the generation of Control Plans

Failure Mode and Effects Analysis - Agenda

Introduction to Failure Mode and Effects Analysis

FMEA Within DMAIC

FMEA Roadmap

FMEA Form and Control Plans


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Implementing FMEA

Summary

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Worldwide Perrier stocks withdrawn due to filter failure


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Pilot shuts down wrong aircraft engine

Company emails confidential account information to analysts and has to suspend trading

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.


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Developed in the aerospace industry in the mid 1960s

Also sometimes referred to as Failure Mode Effect and Criticality Analysis, FMECA

FMEA Purpose

Purpose:

Recognise and evaluate the potential failure modes and causes associated with the design and

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.


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Document the analysis and changes made.

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


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In Transactional/Operational Six Sigma (Process FMEA) :

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

Define Measures (ys)

Check Data Integrity

Determine Process

Control Critical xs

Monitor ys1 5 10 15 20

10.2

10.0

9.8

9.6

Upper Control Limit

Lower Control Limit

Develop Detailed Process Maps

Identify Critical Process Steps (xs) by looking for:

START

PROCESSSTEPS

DECISION

STOP

Brainstorm Potential Improvement Strategies

Select Improvement Strategy

Criteria A B C DTime + s - +Cost + - + sService - + - +Etc s s - +

Analyse Improve ControlMeasureDefine Select Project Define Project

Objective Form the Team

Map the Process

Define

Six Sigma Transactional Improvement Process


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15 20 25 30 35

LSL USL

Determine Process Stability

Determine Process Capability

Set Targets for Measures

Phase Review

Validate Control Plan

Identify further opportunities

Close Project

y

Phase Review

by looking for: Process Bottlenecks Rework / Repetition Non-value Added

Steps Sources of Error /

Mistake Map the Ideal

Process Identify gaps

between current and ideal

Phase Review

Plan and Implement Pilot

Verify Improvement

Implement Countermeasures

15 20 25 30 35

LSL USL

Phase Review

Map the Process Identify Customer

Requirements

Identify Priorities Update Project File

Phase Review

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)


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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

Process FMEA Roadmap

1.Describe Process 2.Define

Functions

3.Identify Potential Failure Modes8.Take Action

9.Assess Results


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Failure Modes

4.Describe Effects of Failure

5.Determine Causes

6.Current Controls

7.Calculate Risk

Action

Step 1: Describe Process

Process Flow Diagrams Error & Correction Data Process

1.Describe Process


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Error & Correction Data Internal Problem Data Customer Feedback

Process Knowledge

Suppliers:SalesStores

Outputs:Packaged ProductShipping requisition

Step 1: Describe Process- Order Fulfilment

Receive order

Check stock

Pull product and check

All available?

Order stock

Notify Sales

Yes

No

1.Describe Process


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SalesStores

Inputs:OrderProductPackaging

Customers:Sales

ShippingEnd customer

Shipping requisitionOrder fulfilment note


Package product

Weigh product

Correct weight?

Transfer to Goods OutYes

No

List of Functions(Purposes)

Step 2: Define Function

2.Define Functions


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ProcessFlow

Diagram

Action Verb Noun

Publish Report

Action Verb NounProcess Information

Examples of Functions

2.Define Functions


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Gather

Approve

Release

Project

Credit

Product

Data

Sales

Test Part

Check

Contact

Receive

Deliver

Calculate

Address

Customer

Stock

Order

Price

Step 2: Define Function

Functions

Receive order

Check sufficient stock

2.Define Functions

Receive order

Check stock Order stock


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Check sufficient stock

Notify sales

Order stock

Pull product

Check product

Etc.


All available? Notify Sales

Yes

No

List of PotentialFailures

Does not/CannotToo muchToo little

Step 3: Identify Potential Failure Modes

3.Identify Potential Failure Modes


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Function Does Not Function?

Too littleToo early Too lateDegradedIntermittentIncorrectUnwanted

Function

Process Function Potential Failure Modes

Receive Order Does not receive orderReceives incorrect orderReceives too many orders

Check sufficient stock Does not check sufficient stock

Step 3: Identify Potential Failure Modes


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Check sufficient stock Does not check sufficient stockIncorrect check (wrong conclusion)

-Insufficient stock when sufficient-Sufficient stock when insufficient

Notify Sales Does not notify salesNotifies sales too lateNotifies sales with incorrect information

Assume the failure could occur

- what would be the effect ?

Consider :

How it affects the process (processor):

next operation

Step 4: Describe Effects of Failure


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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.


Does not Receive Order

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


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Incorrect stock check (Concludes insufficient when sufficient available)

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

What could cause the potential failure mode to occur ?

Step 5: Determine Causes

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


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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

5.Determine Causes

Step 5: Determine Causes

What could cause the potential failure mode to occur ?

Potential CausesPotential Failure Modes

5.Determine Causes

Incorrectly addressed

Delivered to wrong department

Does not receive order


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Delivered to wrong department

Lost in post

Incorrect stock check Error in inventory levels

Entered wrong part code

Entered wrong quantity

Multiple orders in process



Functions


8.Take Action

9.Assess Results


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5.Determine Causes

6.Current Controls

7.Calculate Risk

Action

Workshop 1:Identify Potential Failures Modes

For the given example, describe the process using a process flowchart. Describe each 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. depending on the detail of the flowchart there may be more than one function at each step).

Working from the process flowchart, identify potential failure modes by adding the 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.


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Each function should have at least one failure mode.

For each of the failure modes identify the potential effects of the failure on the process, processor and/or the customer. If there are several effects then group these together as the overall effect for the failure mode. Each failure mode should have one effect.

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 per failure mode.

Prepare a short presentation on your team's findings.

Workshop 1

Time:



Functions


8.Take Action

9.Assess Results


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Failure Modes


5.Determine Causes

6.Current Controls

7.Calculate Risk

Action

In order of preference there are three types of current

controls :

1. Prevent the cause

2. Detect the cause, leading to corrective action

3. Detect the failure (defect)

Identify the current controls to prevent / detect the failure before it reaches the customer

Step 6: Current Controls


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3. Detect the failure (defect)

These might include:

Control Charts

Check Sheets

Mistake Proofing

Training

Information Technology

6.Current Controls

Step 6: Current Controls

Error in inventory levels

Potential Causes Current Controls

Potential Failure Modes

Identify the current controls to prevent / detect the failure before it reaches the customer


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Incorrect stock check Error in inventory levels

Entered wrong part code

Entered wrong quantity

Multiple orders in process

Stock take (annual), Stock control system

Double entry required

No controls6.Current Controls

Double entry required

Severity ofProbability

ofDetection Risk

Step 7: Calculate Risk

7.Calculate Risk


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Severity ofthe Effect

Probabilityof

Occurrence

Detection(Capability of

Current Controls)

RiskPriorityNumber

X X =

Process FMEA Severity Rating

How serious is the effect ?

Sev Effect Customer Effect Processor Effect

5 Hazardous Safety compromised or non-compliance with legal issue

May endanger processor or process equipment

4 High Loss of service Process stops, 100% transactions incorrect

3 Moderate Very dissatisfied, service provided Significant process disruption, many


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

3 Moderate Very dissatisfied, service provided but much degraded

Significant process disruption, many transactions require correcting

2 Low Inconvenient, service provided but not up to expectations

Some process disruption, some transactions require reworking

1 Very minor/none

Not noticed by most customers Minor disruption to process or no effect

Process FMEA Occurrence Rating

How likely is the cause ?

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)


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

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)

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


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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

Effect Incomplete order, delay, customer dissatisfaction

Severity = 3

Step 7: Calculate Risk

Failure ModeIncorrect Stock Check

7.Calculate Risk


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Cause Multiple orders in process

Current Controls No Controls

Occurrence = 3

Detection = 5

RPN = 3 x 3 x 5 = 45

Corrective Action Effects On RPN Rating

Step 8: Take Action

Corrective Action Severity Occurrence Detection 1. Process change Maybe Yes Yes

8.Take Action


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

1. 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

Step 8: Take Action

8.Take Action

Effect Incomplete order, delay, customerdissatisfaction

Severity = 3



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Stock is temporarily reserved against enquiry

RPN = 3 x 3 x 5 = 45


Current Controls No Controls

Occurrence = 3

Detection = 5

Review corrective actions and modify RPN figure based on results.

Before Improvement

R

e

d

u

c

e

d

R

i

s

k

Step 9: Assess Results

9.Assess Results


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After Improvement

R

P

N

R

e

d

u

c

e

d

R

i

s

k

Step 9: Assess Results

8.Take Action

Effect Incomplete order, delay, customer dissatisfaction

Severity = 3



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Stock is temporarily reserved against enquiry

RPN = 3 x 3 x 2 = 18


Current ControlsNo Controls

Occurrence = 3

Detection = 5 2x



Functions


8.Take Action

9.Assess Results


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Failure Modes


5.Determine Causes

6.Current Controls

7.Calculate Risk

Action

FMEA Purpose

Purpose:

Recognise and evaluate the potential failure modes and causes associated with the design and

manufacture of a product or any process.

Identify actions which could eliminate or reduce the chance of the potential failure occurring.


37

Document the analysis and changes made.

FMEA Form

FAILURE 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 RESULTS FUNCTION FAILURE MODE EFFECTS OF

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

ACTION ACTIONS TAKEN

SEV OCC DET RPN

3 Checks sufficient stock

Incorrect Stock Check (Concludes sufficient

stock when insufficient available)

Incomplete order, delay,

customer dissatisfacti

on

3 Multiple orders in process 3 No controls 5 45 Stock reserved against enquiry

SCB 18.08.03 3 3 2 18


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FMEA Form

ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL FUNCTION FAILURE MODE EFFECTS OF

FAILURE SEV CAUSE(S) OF FAILURE OCC

3 Checks sufficient stock

Incorrect Stock Check (Concludes sufficient

stock when insufficient available)

Incomplete order, delay,

customer dissatisfacti

on

3 Multiple orders in process 3

Expand detail in Control Plan


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CURRENT RECOMMENDED RESP. ACTION RESULTS CONTROLS DET RPN ACTIONS FOR

ACTION ACTIONS TAKEN

SEV OCC DET RPN

No controls 5 45 Stock reserved against enquiry

SCB 18.08.03 3 3 2 18

Control Plan

Control Plan

Detail of the Current Controls are held in an additional 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 Control Plan


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Workshop 2: Risk Assessment

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

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

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.


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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.

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

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

Implementing FMEA


Implementing FMEA

Who Should Do FMEA ?

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


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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


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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

Applied too late

Poor team working, wrong team members or no team

Over dependence upon the numbers

Inconsistency in numbers


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Solving all problems in meetings

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.


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During the Improve/Control phases a PFMEA should be updated/completed for the areas of

the process that have changed.

Improving Organisational Capability

SpecificFMEA

SpecificFMEA

GeneralFMEA


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KnowledgeBase

DesignCheck-list

Failure Mode and Effects Analysis


Failure Mode and Effects Analysis Summary

Failure Mode and Effects Analysis Summary

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

Improvement Process

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

The Process FMEA prioritises areas for attention


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The Process FMEA prioritises areas for attention

The Process FMEA can be used to support the generation of Control Plans

Application of PFMEA in DMAIC

Analyse:

To analyse the existing processes and identify possible xs (causes of failure)

Improve:



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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

Define Measures (ys)

Check Data Integrity

Determine Process

Control Critical xs

Monitor ys1 5 10 15 20

10.2

10.0

9.8

9.6

Upper Control Limit

Lower Control Limit

Develop Detailed Process Maps

Identify Critical Process Steps (xs) by looking for:

START

PROCESSSTEPS

DECISION

STOP

Brainstorm Potential Improvement Strategies

Select Improvement Strategy

Criteria A B C DTime + s - +Cost + - + sService - + - +Etc s s - +

Analyse Improve ControlMeasureDefine Select Project Define Project

Objective Form the Team

Map the Process

Define

Six Sigma Transactional Improvement Process


51

15 20 25 30 35

LSL USL

Determine Process Stability

Determine Process Capability

Set Targets for Measures

Phase Review

Validate Control Plan

Identify further opportunities

Close Project

y

Phase Review

by looking for: Process Bottlenecks Rework / Repetition Non-value Added

Steps Sources of Error /

Mistake Map the Ideal

Process Identify gaps

between current and ideal

Phase Review

Plan and Implement Pilot

Verify Improvement

Implement Countermeasures

15 20 25 30 35

LSL USL

Phase Review

Map the Process Identify Customer

Requirements

Identify Priorities Update Project File

Phase Review

12 Ssgb Amity Bsi Fmea

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