1. The Quality Improvement Model
Define Process
The Quality Improvement Model
Select Measures
Collect & Interpret Data
Maintain Current Process
Is Process Stable ? No
Investigate & Fix Special Causes
Purpose:
Develop a control plan to maintain the improvements for the process
Document control plan
Yes
Is Process Capable ? No
Improve Process Capability
Yes
Develop Control Plan to Maintain Current Process

2. Objectives 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

3. Critical Input Variables
The Funneling Effect
Process Maps
Identify Outputs
Identify Inputs
3 to 6
Critical Input Variables
C&E Matrix
Failure Modes
and Effects Analysis
Control Charts (SPC)
Exploratory Data Analysis (EDA)
Design of Experiments
(ASM / DOE)
Now What ?
A Control Plan to:
“Sustain The Gains”

4. Three Ways to Control Key Variables in a Process
Statistical Process
Control
Control to a Standard
Engineering
Process

5. Control Strategy Roadmap
KPIV's
1) Monitor variables for out of control conditions
KPOV's
Major Focus on
KPIV’S to
Minimize
Production of
Defects
2) Develop alarm and recording strategy
3) Finalize process sampling plan
4) Document control plan for each key variable
5) Identify Opportunities for Mistake Proofing

6. Control Strategy Roadmap
Step 1 - Monitor Variables For Out Of Control Conditions
Key Relationships Identified After DOE Completion
Strength = Press
Yield = Temp Press TempSqr PressSqr
TempPress
What Should We Monitor?

7. Control Strategy Roadmap
Step 1 - Monitor Variables For Out Of Control Conditions
Strength Seems To Be In Control

8. Control Strategy Roadmap
Step 1 - Monitor Variables For Out Of Control Conditions
Looks Like a Problem With Yield – What Now ??

9. Control Strategy Implementation
Step 1 - Monitor Variables For Out Of Control Conditions
Experimental Results Indicated Yield Is A Function Of Pressure And Temperature
Remember
Yield = Temp Press TempSqr PressSqr
TempPress
Let’s Take A Look At The KPIV’s Pressure and Temperature

10. Control Strategy Roadmap
Step 1 - Monitor Variables For Out Of Control Conditions
Pressure seems to be in good control, though the pattern should be investigated.

11. Control Strategy Roadmap
Step 1 - Monitor Variables For Out Of Control Conditions
Historic Mean 124
Historic StdDev 2.7
Big Trouble on Temperature !!

12. Control Strategy Roadmap
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

13. Control Strategy Roadmap
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

14. Step 4 - Document Control Plan For Each Key Variable…
Control Plan Purpose
Step 4 - Document Control Plan For Each Key Variable…
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
Revise Quarterly

15. Factors Impacting a Good Control Plan
Step 4 - Document Control Plan For Each Key Variable…
These need to be
Measurement
Preliminary
updated before
System
Analysis
proceeding
Measurement
Process
System Analysis
Maps
Short Term
%R&R, %P/T
Capability
Calibration
C&E
Requirements
Matrix
Initial Control
Plan Assessment
Sampling &
FMEA
Testing Plans
Customer
Control Plan
Requirements
Long Term
Capability
Maintenance
SPC Plans
Schedules
Trouble
Noise Variable
Shooting
Operating
Compensation
Training
Aids
Windows
Materials
Reaction
Plans
DOE's
SOP's
Improvement
Procedures
Activities

16. Control Plan Summary Sheet
Step 4 - Document Control Plan For Each Key Variable…
Control Plan.XLS

17. Control Plan Components
Step 4 - Document Control Plan For Each Key Variable…
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:
SPC
Automated process control
Checklists
Mistake proofing systems
Standard Operating Procedures
Sampling & Testing
Meas. Sys. Analysis
Training Materials
Maintenance schedules
Reaction Plan and Procedures

18. Other Tips in Documenting Improvements
Step 4 - Document Control Plan For Each Key Variable…
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
New
Process
Step 1
Step 2
Step 3
Step 4
Project

19. Step 4 - Document Control Plan For Each Key Variable…
Auditing Procedures
Step 4 - Document Control Plan For Each Key Variable…
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
When was the last time the instruction was revised?

20. Documentation Package
Control Plan
Scope
Customer
Summary
Maps
MSA
FMEA’s
Capability
Critical
Parameters
SOP’s
Training
Maint.
Trouble
Shooting
Reaction
Plans

21. Summary 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

22. Exercise
1.) Your Catapult Team should complete page 13 of the blue “Catapult Process” handout.
Limit yourselves to 15 minutes for this exercise.