13 SSGB Amity BSI Control Plans

7/27/2019 13 SSGB Amity BSI Control Plans

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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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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


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


5

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


6

Mistake Proofing

SOPs


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Control Plan

Key ys

Critical xs

SOPS

FMEA controls

Mistake Proofing

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7

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


reserved.8

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


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


reserved.


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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


reserved.

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


reserved.


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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


21

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


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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:

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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


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13 SSGB Amity BSI Control Plans