Control Plan

10-1

TheQualityImprovementModel

Develop Control Plan to

Maintain Current Process

Collect & Interpret

Data

Select Measures

IsProcessCapable

?

Improve Process

Capability

IsProcessStable

?

Investigate & Fix

Special Causes

No

Yes

No

Yes

Maintain Current Process

Purpose:•Develop a control plan to

maintain the improvements for the process

•Document control plan

Define Process

Control Plan

10-2

• Explore the steps for setting up controls for your project

• Review Control Plan elements

• Review the need for well documented control plans to “sustain the gains”

• Introduce the concept of Mistake Proofing

Objectives

Control Plan

10-3

3 to 6Critical Input Variables

Process Maps• Identify Outputs• Identify Inputs

C&E Matrix

Failure Modes and Effects Analysis

Exploratory Data Analysis (EDA)

Design of Experiments (ASM / DOE)

A Control Plan to:

“Sustain The Gains”

The Funneling Effect

Control Charts (SPC)

Control Plan

10-4

StatisticalProcessControl

Control to a Standard

EngineeringProcessControl

Three Ways to Control Key Variables in a Process

Control Plan

10-5

1) Monitor variables for out of control conditions

2) Develop alarm and recording strategy

3) Finalize process sampling plan

4) Document control plan for each key variable

Major Focus on

KPIV’S to

Minimize

Production of

Defects 5) Identify Opportunities for Mistake Proofing

Control Strategy Roadmap

Control Plan

10-6

Step 1 - Monitor Variables For Out Of Control Conditions

Key Relationships Identified After DOE Completion

Strength = 6.6444 + 1.4466 Press

Yield = - 1690 + 15.7 Temp + 41.7 Press - 0.0338 TempSqr - 0.281 PressSqr

- 0.169 TempPress

What Should We Monitor?

Control Strategy Roadmap

Control Plan

10-7Strength Seems To Be In Control

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions

Control Plan

10-8

Looks Like a Problem With Yield – What Now ??

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions

Control Plan

10-9

Experimental Results Indicated Yield Is A Function Of Pressure And Temperature

RememberYield = - 1690 + 15.7 Temp + 41.7 Press - 0.0338 TempSqr - 0.281 PressSqr - 0.169 TempPress

Let’s Take A Look At The KPIV’s Pressure and Temperature

Control Strategy ImplementationStep 1 - Monitor Variables For Out Of Control Conditions

Control Plan

10-10

Pressure seems to be in good control, though the pattern should be investigated.

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions

Control Plan

10-11

Historic Mean 124Historic StdDev 2.7Big Trouble on Temperature !!

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions

Control Plan

10-12

Step 2 - Develop Alarm and Recording Strategy

Process Alarms• Online alarms key to process waste reduction• Identify key alarm points throughout the process• Do not alarm too many points – they will be ignored• SPC - Control Charts are effective alarm mechanisms

Data Recording• Record alarms to identify patterns of out of control conditions• Online data trending assists in monitoring process shifts • Record and analyze KPIV’s to prevent waste production

Developing an Effective Process Alarm Strategy is Key To Reducing Waste and Defects

Control Strategy Roadmap

Control Plan

10-13

Step 3 - Finalize Process Sampling Plan

• Use KPOV = f(KPIV1, KPIV2, …) predictive relationships to minimize routine process sampling

• Take product samples when SPC and on-line alarms indicate out of control conditions (In theory not practice)

• Be sure sample size is adequate through use of sample size calculations

• Document sampling plan and communicate to production, lab, technical, order processing and other key groups

Control Strategy Roadmap

Control Plan

10-14

Revise QuarterlyRevise Quarterly

The Purpose Of An Effective Control Plan Is To:

• Operate processes on target with minimum variation

• Minimize process tampering (over-adjustment)

• Assure that process improvements become institutionalized (ISO 9000 can assist here)

• Provide for adequate training in all procedures

• Identify required maintenance schedules

Control Plan PurposeStep 4 - Document Control Plan For Each Key Variable…

Control Plan

10-15

Control Plan

ProceduresImprovement

Activities

Preliminary Analysis

Measurement System

Process Maps

C&E Matrix

FMEA

Measurement System Analysis %R&R, %P/T

Calibration Requirements

Sampling & Testing Plans

SPC Plans

Operating Windows

DOE's

Maintenance Schedules

Training Materials

SOP's

Customer Requirements

Short Term Capability

Long Term Capability

Noise Variable Compensation

Reaction Plans

Trouble Shooting

Aids

Initial Control Plan Assessment

These need to be updated before proceeding

Factors Impacting a Good Control Plan

Step 4 - Document Control Plan For Each Key Variable…

Control Plan

10-16

Control Plan.XLSControl Plan.XLS

Product: Date (Orig):Key Contact:Phone: Date (Rev):

OUTPUTS

Y Process Step LSL Target USL Cp Cpk Pp Ppk Measurement

Technique%Variation %R&R P/T Sample Frequency Control Method Reaction Plan

INPUTS

X Process Step LSL Target USL Cp Cpk Pp Ppk Measurement

Technique%Variation %R&R P/T Sample Frequency Control Method Reaction Plan

Control Plan Summary Sheet

Step 4 - Document Control Plan For Each Key Variable…

Control Plan

10-17

• Process map steps

• Key process output variables, targets & specs

• Key process input variables with control limits

• Important noise variables (uncontrollable inputs)

• Short and long term capability analysis results

• Designated control methods including:

Sampling & Testing Meas. Sys. Analysis Training Materials Maintenance schedules Reaction Plan and

Procedures

SPC Automated process control Checklists Mistake proofing systems Standard Operating

Procedures

Control Plan Components

Step 4 - Document Control Plan For Each Key Variable…

Control Plan

10-18

New Process

Step 1

Step 2

Step 3

Step 4

Project

• Utilize your team and / or affected individuals

• Test the procedure exactly as it is documented

• Outline a method for updating procedures

• Date your procedures

• Destroy obsolete procedures

• Have an audit plan to verify compliance

• Responsibility for documenting control plan and updates

Other Tips in Documenting Improvements

Step 4 - Document Control Plan For Each Key Variable…

Control Plan

10-19

• Directly

By Observation

Are people actually doing what the procedure says?

Are all the steps being followed?

Are people referring to the procedure?

By asking those using the procedure

Is each step in the procedure clear?

Are you having difficulty in following the procedure?

Could we improve the procedure and still get results?

• Indirectly

By Observation

When was the last time the instruction was revised?

Auditing ProceduresStep 4 - Document Control Plan For Each Key Variable…

Control Plan

10-20

Control PlanControl Plan

Scope CustomerSummary

MapsMSA FMEA’s

Capability

Critical Parameters

SOP’s

TrainingMaint.

TroubleShooting

ReactionPlans

Documentation Package

Control Plan

10-21

Explored the steps for setting up controls for your project

Reviewed Control Plan elements

Reviewed the need for well documented control plans to “sustain the gains”

Control plan derived from tools and learning's in implementing model discussed in this course

Identify person who will be accountable for control plan documentation and updates

Summary

Control Plan

10-22

1.)Your Catapult Team should complete page 13 of the blue “Catapult Process” handout.

Limit yourselves to 15 minutes for this exercise.

Exercise