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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 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
Introduction to Failure Mode and Effects Analysis FMEA Within DMAIC FMEA Roadmap FMEA Form and Control Plans 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Leap day shuts down bank cash machines NASA probe lost due to Metric/Imperial units confusion Worldwide Perrier stocks withdrawn due to filter failure Pilot shuts down wrong aircraft engine Company emails confidential account information to analysts and has to suspend trading
Introduction to FMEA
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.
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
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
9.8
9.6 1 5 10 15 20
Monitor ys
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
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Validate Control Plan
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Implement Countermeasures
Phase Review
Phase Review
Phase Review
Phase Review
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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 the modified/changed areas of the process
9.Assess Results
1.Describe Process
2.Define Functions
8.Take Action
7.Calculate Risk
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
Yes Pull product and check Package product Weigh product Correct weight? Yes No
2.Define Functions
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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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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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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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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
Notify Sales
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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. 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
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Assume the failure could occur - what would be the effect? Potential Failure Modes Does not Receive Order
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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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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5.Determine Causes
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
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
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 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
No controls
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7.Calculate Risk
Probability of Occurrence
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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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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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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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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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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
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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
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Review corrective actions and modify RPN figure based on results. Before Improvement
Reduced Risk
9.Assess Results
RPN
After Improvement
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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
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9.Assess Results
1.Describe Process
2.Define Functions
8.Take 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. 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
Page Originators:
: of
SEV
OCC
DET
RPN
RECOMMENDED ACTIONS
ACTIONS TAKEN
RPN
No controls
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SCB
18.08.03
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FMEA Form
ITEM
PROCESS FUNCTION
SEV
OCC
CURRENT CONTROLS
DET
RPN
RECOMMENDED ACTIONS
ACTIONS TAKEN
RPN
No controls
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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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Implementing 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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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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Specific FMEA
Specific FMEA
General FMEA
Knowledge Base
Design Check-list
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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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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
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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
9.8
9.6 1 5 10 15 20
Monitor ys
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
y
Validate Control Plan
15
20
25
30
35
15
20
25
30
35
Implement Countermeasures
Phase Review
Phase Review
Phase Review
Phase Review
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