Module-12 Failure Modes and Effects Analysis (FMEA)

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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 Use the Process FMEA to prioritise areas for attention Use the Process FMEA to support the generation of Control Plans

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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Leap day shuts down bank cash machines NASA probe lost due to Metric/Imperial units confusion Worldwide Perrier stocks withdrawn due to filter failure Pilot shuts down wrong aircraft engine Company emails confidential account information to analysts and has to suspend trading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 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. 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 (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

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Six Sigma Transactional Improvement Process

Define
Select Project Define Project Objective Form the Team

Measure
Define Measures (ys)

Analyse
Develop Detailed Process Maps
START PROCESS STEPS DECISION STOP

Improve
Brainstorm Potential Improvement Strategies Select Improvement Strategy
Criteria Time Cost Service Etc A + + s B s + s C + D + s + +
10.2 10.0

Control
Control Critical xs
Upper Control Limit

Check Data Integrity

9.8

Lower Control Limit

9.6 1 5 10 15 20

Monitor ys

Map the Process Identify Customer Requirements

Determine Process Stability Determine Process Capability

LSL USL

Identify Critical Process Steps (xs) 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

LSL USL

y
Validate Control Plan

15

20

25

30

35

15

20

25

30

35

Identify Priorities Update Project File

Set Targets for Measures

Implement Countermeasures

Identify further opportunities Close Project

Phase Review

Phase Review

Phase Review

Phase Review
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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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9.Assess Results

1.Describe Process

2.Define Functions

8.Take Action

Process FMEA Roadmap

3.Identify Potential Failure Modes

7.Calculate Risk

4.Describe Effects of Failure 6.Current Controls 5.Determine Causes

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Step 1: Describe Process

1.Describe Process

Process Flow Diagrams Error & Correction Data Internal Problem Data Customer Feedback

Process Knowledge

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Step 1: Describe Process- Order Fulfilment Receive order Check stock All available? No Notify Sales Order stock 1.Describe Process

Suppliers: Sales Stores Inputs: Order Product Packaging

Yes Pull product and check Package product Weigh product Correct weight? Yes No

Outputs: Packaged Product Shipping requisition Order fulfilment note

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Customers: Sales Shipping End customer

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Step 2: Define Function

2.Define Functions

List of Functions (Purposes)

Process Flow Diagram

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Examples of Functions

2.Define Functions

Action Verb
Process Check Contact Receive Deliver

Noun
Information Address Customer Stock Order

Action Verb
Publish Approve Release Gather Project Test

Noun
Report Credit Product Data Sales Part

Calculate Price
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Step 2: Define Function

2.Define Functions Functions Receive order Check stock All available? Yes Pull product and check No Notify Sales Order stock Check sufficient stock Notify sales Order stock Pull product Check product Etc. C o p y r ig h t 2 0 1 2B S I .A lr ig h ts
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Receive order

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Step 3: Identify Potential Failure Modes

3.Identify Potential Failure Modes

Function

Does Not Function?

List of Potential Failures Does not/Cannot Too much Too little Too early Too late Degraded Intermittent Incorrect Unwanted

Function

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Step 3: Identify Potential Failure Modes

Process Function Receive Order

Potential Failure Modes Does not receive order Receives incorrect order Receives too many orders Does not check sufficient stock Incorrect check (wrong conclusion) -Insufficient stock when sufficient -Sufficient stock when insufficient Does not notify sales Notifies sales too late Notifies sales with incorrect information

Check sufficient stock

Notify Sales

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Step 4: Describe Effects of Failure

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. There may be several potential effects for each failure, but these are listed together as Note: Be realistic. one overall effect. 4.Describe Effects of Failure

Copyright 2012 BSI. All rights reserved.

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Step 4: Describe Effects of Failure

Assume the failure could occur - what would be the effect? Potential Failure Modes Does not Receive Order

4.Describe Effects of Failure

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 insufficient when sufficient available) Incorrect stock check (Concludes sufficient stock when insufficient available) Notify Sales too late

Incomplete order, delay, customer dissatisfaction Customer not aware of delay, sales takes further orders
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Step 5: Determine Causes

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

5.Determine Causes
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Step 5: Determine Causes

What could cause the potential failure mode to occur ?

Potential Failure Modes Does not receive order Potential Causes Incorrectly addressed Delivered to wrong department Lost in post

5.Determine Causes

Incorrect stock check

Error in inventory levels Entered wrong part code Entered wrong quantity Multiple orders in process

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9.Assess Results

1.Describe Process

2.Define Functions

8.Take Action

Process FMEA Roadmap

3.Identify Potential Failure Modes

7.Calculate Risk 6.Current Controls C o p y rig h t 2 0 1 2 B S I.A llrig h ts

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4.Describe Effects of Failure 5.Determine Causes

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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. 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.

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

Time:
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9.Assess Results

1.Describe Process

2.Define Functions

8.Take Action

Process FMEA Roadmap

3.Identify Potential Failure Modes

7.Calculate Risk 6.Current Controls C o p y rig h t 2 0 1 2 B S I.A llrig h ts

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4.Describe Effects of Failure 5.Determine Causes

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Step 6: Current Controls Identify the current controls to prevent / detect the failure before it reaches the customer
In order of preference there are three types of current controls : 1. 2. 3. Prevent the cause Detect the cause, leading to corrective action Detect the failure (defect)

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

6.Current Controls

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Step 6: Current Controls Identify the current controls to prevent / detect the failure before it reaches the customer

Potential Failure Modes Incorrect stock check

Potential Causes Error in inventory levels Entered wrong part code Entered wrong quantity Multiple orders in process

Current Controls Stock take (annual), Stock control system Double entry required

Double entry required 6.Current Controls C o p y r ig h t 2 0 1 2 B S I .A llr ig h ts

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No controls

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Step 7: Calculate Risk

7.Calculate Risk

Severity of the Effect

Probability of Occurrence

Detection (Capability of Current Controls)

Risk Priority Number

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Process FMEA Severity Rating

How serious is the effect ? Sev 5 Effect Hazardous Customer Effect Safety compromised or noncompliance with legal issue Loss of service Processor Effect May endanger processor or process equipment Process stops, 100% transactions incorrect Significant process disruption, many transactions require correcting Some process disruption, some transactions require reworking Minor disruption to process or no effect

High

Moderate

Very dissatisfied, service provided but much degraded Inconvenient, service provided but not up to expectations Not noticed by most customers

Low

Very minor/none

Note : Many organisations choose to modify the descriptions to best describe their industry.
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Process FMEA Occurrence Rating

How likely is the cause ? Occ 5 4 3 2 1 Probability Very high, persistent failures High, frequent failures Moderate, occasional failures Low, relatively few failures Remote, failure is unlikely Likely failure rates 1 in 10 transactions (opportunities) 1 in 100 transactions (opportunities) 1 in 1,000 transactions (opportunities) 1 in 10,000 transactions (opportunities) 1 in 100,000 transactions (opportunities)

Note : Many organisations choose to modify the descriptions to best describe their industry. C o p y rig h t 2 0 1 2B S I.A llrig h ts
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Process FMEA Detection Rating

How effective are the Current Controls? Det 5 4 3 2 1 Criteria No Controls Controls detect failure Controls detect cause Controls prevent failure Controls prevent cause Typical Detection/Control Method Cannot detect or is not checked Inspection, checking Control charts (focused on outputs) Control charts (focused on inputs) Mistake Proofing, training Type ? 3 3/2 2/1 1

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Step 7: Calculate Risk

Failure Mode Incorrect Stock Check Effect Incomplete order, delay, customer dissatisfaction Cause Multiple orders in process Current Controls No Controls

7.Calculate Risk

Severity = 3

Occurrence = 3

Detection = 5 RPN = 3 x 3 x 5 = 45

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Step 8: Take Action

Corrective Action Effects On RPN Rating

8.Take Action

Corrective Action
1. Process change 2. Improve Current Control 3. Improve Employee training 4. Mistake proofing 5. Increased inspection

Severity
Maybe No No No No

Occurrence
Yes Maybe Yes Yes No

Detection
Yes Yes Yes Yes Maybe

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

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Step 8: Take Action

Failure Mode Incorrect Stock Check Effect Incomplete order, delay, customer dissatisfaction Cause Multiple orders in process Current Controls No Controls RPN = 3 x 3 x 5 = 45

8.Take Action

Severity = 3

Occurrence = 3

Detection = 5 Stock is temporarily reserved against enquiry

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Step 9: Assess Results

Review corrective actions and modify RPN figure based on results. Before Improvement
Reduced Risk

9.Assess Results

RPN

After Improvement

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Step 9: Assess Results

Failure Mode Incorrect Stock Check Effect Incomplete order, delay, customer dissatisfaction Cause Multiple orders in process Current Controls No Controls RPN = 3 x 3 x 2 = 18

8.Take Action
Severity = 3

Occurrence = 3

x2 Detection = 5 Stock is temporarily reserved against enquiry

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9.Assess Results

1.Describe Process

2.Define Functions

8.Take Action

Process FMEA Roadmap

3.Identify Potential Failure Modes

7.Calculate Risk 6.Current Controls C o p y rig h t 2 0 1 2 B S I.A llrig h ts

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4.Describe Effects of Failure 5.Determine Causes

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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. Document the analysis and changes made.

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FMEA Form
FAILURE MODE & EFFECTS ANALYSIS PROCESS FMEA
Product: Application: Customer:
ITEM PROCESS FUNCTION POTENTIAL FAILURE MODE POTENTIAL EFFECTS OF FAILURE

PROCESS FMEA No. Issue No. Date:

POTENTIAL CAUSE(S) OF FAILURE CURRENT CONTROLS

Page Originators:

: of

SEV

OCC

DET

RPN

RECOMMENDED ACTIONS

RESP. FOR ACTION

ACTIONS TAKEN

ACTION RESULTS SEV OCC DET

RPN

Checks sufficient stock

Incorrect Stock Check (Concludes sufficient stock when insufficient available)

Incomplete order, delay, customer dissatisfacti on

Multiple orders in process

No controls

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Stock reserved against enquiry

SCB

18.08.03

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Copyright 2012 BSI. All rights reserved.

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FMEA Form

ITEM

PROCESS FUNCTION

POTENTIAL FAILURE MODE

POTENTIAL EFFECTS OF FAILURE

SEV

POTENTIAL CAUSE(S) OF FAILURE

OCC

Checks sufficient stock

Incorrect Stock Check (Concludes sufficient stock when insufficient available)

Incomplete order, delay, customer dissatisfacti on

Multiple orders in process

Expand detail in Control Plan

CURRENT CONTROLS

DET

RPN

RECOMMENDED ACTIONS

RESP. FOR ACTION

ACTIONS TAKEN

ACTION RESULTS SEV OCC DET

RPN

No controls

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Stock reserved against enquiry

SCB

18.08.03

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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. 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. C o p y rig h t 2 0 1 2B S I.A llrig h ts
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Implementing FMEA

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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 Execute recommended actions Integration into your development process Generate & use a library of generic FMEAs Follow the spirit, not the form

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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

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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 have changed.

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Improving Organisational Capability

Specific FMEA

Specific FMEA

General FMEA

Knowledge Base
Design Check-list

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Failure Mode and Effects Analysis Summary

Copyright 2012 BSI. All rights reserved.

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

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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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Six Sigma Transactional Improvement Process

Define
Select Project Define Project Objective Form the Team

Measure
Define Measures (ys)

Analyse
Develop Detailed Process Maps
START PROCESS STEPS DECISION STOP

Improve
Brainstorm Potential Improvement Strategies Select Improvement Strategy
Criteria Time Cost Service Etc A + + s B s + s C + D + s + +
10.2 10.0

Control
Control Critical xs
Upper Control Limit

Check Data Integrity

9.8

Lower Control Limit

9.6 1 5 10 15 20

Monitor ys

Map the Process Identify Customer Requirements

Determine Process Stability Determine Process Capability

LSL USL

Identify Critical Process Steps (xs) 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

LSL USL

y
Validate Control Plan

15

20

25

30

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15

20

25

30

35

Identify Priorities Update Project File

Set Targets for Measures

Implement Countermeasures

Identify further opportunities Close Project

Phase Review

Phase Review

Phase Review

Phase Review
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