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Copyright 2012 BSI. All rights
reserved.
Control Plans
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Control Plans Learning Objectives
At the end of this section delegates will:
Understand the role of Control Plans in ensuring that improvements to processes are
sustained.
Copyright 2012BSI. All rightsreserved.
2
ecogn se a e con ro s ou e ocuse on e r ca x s
Understand that Control Plans utilise a number of tools including FMEA, SOPS, Mistake
Proofing and Control Charts.
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Control Plans - Agenda
Control Plans within DMAIC
Overview of Control Plans
Review Key Control Tools
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3
Summary
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Define ImproveMeasure Control Control Critical xs
Monitor ys
1 5 10 15 20
10.2
10.0
9.8
9.6
Upper Control Limit
Lower Control Limit
Analyse Characterise xs
Optimise xs
y=f(x1,x2,..)
y
x
. . .. . .
. .
. . .
. . .
Identify Potential xs
Analyse xs
Run 1 2 3 4 5 6 7
Effect
C1 C2
C4
C3
C6C5
Select Project
Define ProjectObjective
Form the Team
Map the Process
Define Measures (ys)
Evaluate Measurement
System
DMAIC Improvement Process
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4
Validate ControlPlan
Close Project
y
Phase Review
Set Tolerances for xs
Verify Improvement
15 20 25 30 35
LSL USL
Phase Review
Select Critical xs
Phase Review
2 1 1 1 2 2 2 2
3 1 2 2 1 1 2 24 1 2 2 2 2 1 15 2 1 2 1 2 1 26 2 1 2 2 1 2 17 2 2 1 1 2 2 18 2 2 1 2 1 1 2
x
xx
xx
xx
xx
x
x
Identify CustomerRequirements
Identify Priorities
Update Project File
Phase Review
Stability Determine Process
Capability
Set Targets forMeasures
15 20 25 30 35
LSL USL
Phase Review
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Control Plan
Control Plans are intended to ensure consistent performance of a process
Control Plans define:
What needs to be controlled to ensure consistent performance of a process
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How frequently control activities take place
Actions to be taken when an out of control condition is detected
Control should be focused on the Critical xs
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Control Plan
Control Methods include:
Failure Mode and Effects Analysis, FMEA
Control Charts
Check Sheets
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Mistake Proofing
SOPs
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Control Plan
Key ys
Critical xs
SOPS
FMEA controls
Mistake Proofing
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Checksheets
Process
Step
Process
description
Characteristic Specification Measurement
Method
Accuracy/
Gauge
R&R
Control
Method
Frequency Sample
size
Reaction
Plan
2x Bonding TensileStrength
> 2.5 N Instron 20% R&R IMR-chart
1/shift 1 Quarantinebatch
21 Bonding Adhesive Visc. 18 +/- 2 Pas Viscometer
V1
7% R&R IMR-
chart
1/shift 1 Replace
adhesive
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Control Plan Example
Y
x
Process
Step
Process
description
Characteristic Specification
2x Bonding TensileStrength
> 2.5 N
21 Bonding Adhesive Visc. 18 +/- 2 Pas
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Measurement
Method
Accuracy/
Gauge
R&R
Control
Method
Frequency Sample
size
Reaction
Plan
Instron 20% R&R IMR-
chart
1/shift 1 Quarantine
batchViscometer
V1
7% R&R IMR-
chart
1/shift 1 Replace
adhesive
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Process FMEA Roadma
1.DescribeProcess 2.Define
Functions
3.Identif Potential
9.AssessResults
Failure Modes
4.Describe Effectsof Failure
5.DetermineCauses
6.CurrentControls
7.CalculateRisk
.
Action
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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 RESULTSFUNCTION FAILURE MODE EFFECTS OF
FAILURESEV CLA CAUSE(S) OF FAILURE OCC CONTROLS DET RPN ACTIONS FOR
ACTIONACTIONSTAKEN
SEV OCC DET RPN
3 Apply
Adhesive
Apply too
little
Insufficient
bond
strength
8 Adhesive viscosity 2 Shift Check 3 48 None
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FMEA Form
ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL
FUNCTION FAILURE MODE EFFECTS OFFAILURE
SEV CLA CAUSE(S) OF FAILURE OCC
3 Apply
Adhesive
Apply too
little
Insufficient
bond
strength
8 Adhesive viscosity 2
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11
CURRENT RECOMMENDED RESP. ACTION RESULTSOCC CONTROLS DET RPN ACTIONS FOR
ACTIONACTIONSTAKEN
SEV OCC DET RPN
2 Shift Check 3 48 None
Control Plan
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Control Charts
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Control Charts
Variable
Data
NoSubgroups
Subgroupsn = 2-9
Subgroupsn > 9
Individuals & X Bar & R X Bar & s
Attribute
Data
Defect Data(Poisson)
Defective Data(Binomial)
Varying Constant Varying Constant
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Moving RangeChart Chart Chart SubgroupSize SubgroupSize SubgroupSize SubgroupSize
u Chart c Chart p Chart np Chart
CUSUM Chart
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What do Control Charts tell us?
0 5 10 15 20 251.26
1.27
1.28
1.29
1.3
Individu
alvalue
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Is the process stable?
Should we be taking action?
Are there any special causes?
What is the average process output?
What is the variability?
Subgroup
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Mistake Proofing
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Po a Yo e
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Process for Poka Yoke
IdentifyPotentialMistake
Potential mistake identified e.g. by Process FMEA, or RootCause of problem that has occurred
Generate PokaYoke ideas
Team (including operators) generate possible Poka Yokeconcepts
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Select bestmethod
Select method for implementation based on effectiveness,simplicity, and cost
Implement
Challenge Test
Challenge Mistake Proofing system by introducing error andseeing if defect is prevented / detected as expected
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Poka Yoke Methods
1. Identify items by their characteristics
2. Detect/Prevent deviation from process or omitted process
3. Detect/Prevent deviations from Fixed Values
4. Prevent defect throu h desi n Desi n for Manufacture Desi n for Six Si ma
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5. General Industrial Housekeeping
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Common Poka Yoke Devices
Guide Pins/Jig Modification
Error Detection Alarms
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Detectors
Checklist
Counters9 9 9 8
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Standard Operating Procedures SOPs
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Standard Operating Procedures
SOPs, Standard Operations, are:
Detailed methods of working at operator
level in a process
The best, current way of carrying out an
operation in
a redictable time and with minimum
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risk of error or defects
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Standard Operating Procedures
SOPs, Standard Operations, are:
Part of the process documentation
Part of the training and qualification
requirements for operators to work on
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the process
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Define ImproveMeasure Control Control Critical xs
Monitor ys
1 5 10 15 20
10.2
10.0
9.8
9.6
Upper Control Limit
Lower Control Limit
Analyse Characterise xs
Optimise xs
y=f(x1,x2,..)
y
x
. . .
. . .
. .. . .. . .
Identify Potential xs
Analyse xs
Run 1 2 3 4 5 6 7
Effect
C1 C2
C4
C3
C6C5
Select Project
Define ProjectObjective
Form the Team
Map the Process
Define Measures (ys)
Evaluate Measurement
System
DMAIC Improvement Process
Copyright 2012BSI. All rightsreserved.
22
Validate ControlPlan
Close Project
y
Phase Review
Set Tolerances for xs
Verify Improvement
15 20 25 30 35
LSL USL
Phase Review
Select Critical xs
Phase Review
2 1 1 1 2 2 2 23 1 2 2 1 1 2 2
4 1 2 2 2 2 1 15 2 1 2 1 2 1 26 2 1 2 2 1 2 17 2 2 1 1 2 2 18 2 2 1 2 1 1 2
x
x
xx
x
xx
x
xx
x
Identify Customer
Requirements
Identify Priorities
Update Project File
Phase Review
Stability
Determine ProcessCapability
Set Targets forMeasures
15 20 25 30 35
LSL USL
Phase Review
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Control Plans Summary
When we have improved our process, and verified that the improvements generate
significant benefits, we need to ensure that the gains are sustained Control Plans, together with other appropriate tools are used to achieve this
Other useful tools for control include SOPs, FMEA, Checksheets, Mistake Proofing andControl Charts.
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Spend 2 minutes identifying how you will apply the learning from this module to your projectand record your thoughts here:
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
__________________________________________________________________________________________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Module Take-Away
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_________________________________________________________________________________
__________________________________________________________________________________________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Status: Completed? ________________________________
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Control Plan Form
Process
Step
Process
description
Characteristic Specification Measurement
Method
Accuracy/
Gauge
R&R
Control
Method
Frequency Sample
size
Reaction
Plan
Copyright 2012 BSI. All rights
reserved.25
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