Module-14 Control Plans

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. • Recognise that the control should be focused on the Critical x’s • Understand that Control Plans utilise a number of tools including FMEA, SOPS, Mistake Proofing and Control Charts.

Control Plans - Agenda

1. 2. 3. 4.

Control Plans within DMAIC Overview of Control Plans Review Key Control Tools Summary

DMAIC Improvement Process
Define
Select Project Define Project Objective Form the Team

Measure
Define Measures (y’s)

Analyse
Identify Potential x’s
C1 C2 C3

Improve
Characterise x’s

Control
Control Critical x’s
10.2 Upper Control Limit

y
Effect

Evaluate Measurement System
C4 C5 C6

y=f(x1,x2,..)
Optimise x’s
5 1 2 1 2 2 1 2 1 6 1 2 2 1 1 2 2 1 7 1 2 2 1 2 1 1 2 4 1 2 1 2 1 2 1 2

.. .. . .. . . .. x

10.0

9.8

Lower Control Limit

9.6 1 5 10 15 20

Analyse x’s Map the Process Identify Customer Requirements
Run 1 2 1 1 2 2 1 1 2 2 3 1 1 2 2 2 2 1 1

Monitor y’s

Determine Process Stability Determine Process Capability
LSL USL

1 2 3 4 5 6 7 8

1 1 1 1 2 2 2 2

y
Set Tolerances for x’s Verify Improvement Validate Control Plan

Select Critical x’s x x x x x x x x x xx

15

20

25

30

35

LSL

USL

Identify Priorities Update Project File

Set Targets for Measures

Close Project
15 20 25 30 35

Phase Review

Phase Review

Phase Review

Phase Review

Phase Review

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 • What control methods will be used • 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 x’s

Control Plan • Control Methods include:
• • • • • Failure Mode and Effects Analysis, FMEA Control Charts Check Sheets Mistake Proofing SOPs

Control Plan
• • • • • • Key y’s Critical x’s SOPS FMEA controls Mistake Proofing Checksheets

Process Process Characteristic Specification Measurement Accuracy/ Control Frequency Sample Reaction Step description Method Gauge Method size Plan R&R 2x Bonding Tensile > 2.5 N Instron 20% R&R IMR1/shift 1 Quarantine batch Strength chart 21 Bonding Adhesive Visc. 18 +/- 2 Pas Viscometer 7% R&R IMR1/shift 1 Replace V1 chart adhesive

Control Plan Example
Process Process Characteristic Specification Step description

Y x

2x 21

Bonding Bonding

Tensile Strength Adhesive Visc.

> 2.5 N 18 +/- 2 Pas

Measurement Accuracy/ Control Frequency Sample Reaction Method Gauge Method size Plan R&R Instron 20% R&R IMR1/shift 1 Quarantine chart batch Viscometer 7% R&R IMR1/shift 1 Replace V1 chart adhesive

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

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

CLA

OCC

DET

RPN

RECOMMENDED ACTIONS

RESP. FOR ACTION

ACTIONS TAKEN

ACTION RESULTS SEV OCC DET

RPN

3

Apply Adhesive

Apply too little

Insufficient bond strength

8

Adhesive viscosity

2

Shift Check

3

48

None

FMEA Form
ITEM PROCESS FUNCTION POTENTIAL FAILURE MODE POTENTIAL EFFECTS OF FAILURE POTENTIAL CAUSE(S) OF FAILURE

SEV

CLA

OCC

3

Apply Adhesive

Apply too little

Insufficient bond strength

8

Adhesive viscosity

2

Expand detail in Control Plan
OCC CURRENT CONTROLS DET RPN RECOMMENDED ACTIONS RESP. FOR ACTION ACTIONS TAKEN ACTION RESULTS SEV OCC DET RPN

2

Shift Check

3

48

None

Control Charts

Control Charts
Variable Data No Subgroups Individuals & Moving Range Chart Subgroups n = 2-9 X Bar & R Chart Subgroups n>9 X Bar & s Chart Defect Data (Poisson) Varying Subgroup Size u Chart CUSUM Chart Constant Subgroup Size c Chart Attribute Data Defective Data (Binomial) Varying Subgroup Size p Chart Constant Subgroup Size np Chart

What do Control Charts tell us?
1.3

Individual value

1.29 1.28 1.27 1.26 0 5 10 15 20 25

Subgroup

• • • • •

Is the process stable? Should we be taking action? Are there any special causes? What is the average process output? What is the variability?

Mistake Proofing (Poka Yoke)

Process for Poka Yoke
Identify Potential Mistake Generate Poka Yoke ideas Select “best” method Implement Challenge Test •Potential mistake identified e.g. by Process FMEA, or Root Cause of problem that has occurred •Team (including operators) generate possible Poka Yoke concepts •Select method for implementation based on effectiveness, simplicity, and cost •Challenge Mistake Proofing system by introducing error and seeing if defect is prevented / detected as expected

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 through design (Design for Manufacture, Design for Six Sigma) 5. General Industrial Housekeeping

Common Poka Yoke Devices

• Guide Pins/Jig Modification • Error Detection Alarms • Counters
9 9 9 8

• Checklist • Detectors

Standard Operating Procedures SOPs

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 predictable time and with minimum risk of error or defects

Standard Operating Procedures

SOPs, Standard Operations, are:
• Part of the process documentation • Part of the training and qualification requirements for operators to work on the process

DMAIC Improvement Process
Define
Select Project Define Project Objective Form the Team

Measure
Define Measures (y’s)

Analyse
Identify Potential x’s
C1 C2 C3

Improve
Characterise x’s

Control
Control Critical x’s
10.2 Upper Control Limit

y
Effect

Evaluate Measurement System
C4 C5 C6

y=f(x1,x2,..)
Optimise x’s
5 1 2 1 2 2 1 2 1 6 1 2 2 1 1 2 2 1 7 1 2 2 1 2 1 1 2 4 1 2 1 2 1 2 1 2

.. .. . .. . . .. x

10.0

9.8

Lower Control Limit

9.6 1 5 10 15 20

Analyse x’s Map the Process Identify Customer Requirements
Run 1 2 1 1 2 2 1 1 2 2 3 1 1 2 2 2 2 1 1

Monitor y’s

Determine Process Stability Determine Process Capability
LSL USL

1 2 3 4 5 6 7 8

1 1 1 1 2 2 2 2

y
Set Tolerances for x’s Verify Improvement Validate Control Plan

Select Critical x’s
x x x x x x x x x x x

15

20

25

30

35

LSL

USL

Identify Priorities Update Project File

Set Targets for Measures

Close Project
15 20 25 30 35

Phase Review

Phase Review

Phase Review

Phase Review

Phase Review

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 and Control Charts.

Module Take-Away
Spend 2 minutes identifying how you will apply the learning from this module to your project and record your thoughts here: __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ Status: Completed? ________________________________

Control Plan Form

Process Process Characteristic Specification Measurement Accuracy/ Control Frequency Sample Reaction Step description Method Gauge Method size Plan R&R

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