Control Plan
The
Quality
Improvement
Model
Define
Process
Select
Measures
Collect &
Interpret
Data
Maintain Current Process
Purpose:
•Develop a control plan to
maintain the improvements
for the process
•Document control plan
Is
Process
Stable
?
No
Investigate &
Fix Special
Causes
Yes
Improve
Process
Capability
No
Is
Process
Capable
?
Yes
Develop Control
Plan to Maintain
Current Process
10-1
Objectives
Control Plan
• 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
10-2
Control Plan
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)
A Control Plan to:
“Sustain The Gains”
10-3
Three Ways to Control Key Variables in
a Process
Control Plan
Control to a
Standard
Statistical
Process
Control
Engineering
Process
Control
10-4
Control Strategy Roadmap
Control Plan
1) Monitor variables for
out of control conditions
Major Focus on
KPIV’S to
2) Develop alarm and
recording strategy
3) Finalize process
sampling plan
Minimize
Production of
Defects
4) Document control
plan for each key
variable
5) Identify Opportunities
for Mistake Proofing
10-5
Control Strategy Roadmap
Control Plan
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?
10-6
Control Strategy Roadmap
Control Plan
Step 1 - Monitor Variables For Out Of Control Conditions
Strength Seems To Be In Control
10-7
Control Strategy Roadmap
Control Plan
Step 1 - Monitor Variables For Out Of Control Conditions
Looks Like a Problem With Yield – What Now ??
10-8
Control Strategy Implementation
Control Plan
Step 1 - Monitor Variables For Out Of Control Conditions
Experimental Results Indicated Yield Is A
Function Of Pressure And Temperature
Remember
Yield = - 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
10-9
Control Strategy Roadmap
Control Plan
Step 1 - Monitor Variables For Out Of Control Conditions
Pressure seems to be in good control, though
the pattern should be investigated.
10-10
Control Strategy Roadmap
Control Plan
Step 1 - Monitor Variables For Out Of Control Conditions
Big Trouble on Temperature !!
Historic Mean 124
Historic StdDev 2.7
10-11
Control Strategy Roadmap
Control Plan
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
10-12
Control Strategy Roadmap
Control Plan
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
10-13
Control Plan Purpose
Control Plan
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
10-14
Control Plan
Factors Impacting a Good Control Plan
Step 4 - Document Control Plan For Each Key Variable…
Measurement
System
Preliminary
Analysis
Measurement
System Analysis
%R&R, %P/T
These need to be
updated before
proceeding
Process
Maps
Calibration
Requirements
C&E
Matrix
Sampling &
Testing Plans
SPC Plans
Operating
Windows
DOE's
Improvement
Activities
Short Term
Capability
Initial Control
Plan Assessment
FMEA
Customer
Requirements
Long Term
Capability
Control Plan
Maintenance
Schedules
Noise Variable
Compensation
Trouble
Shooting
Aids
Training
Materials
SOP's
Reaction
Plans
Procedures
10-15
Control Plan
Control Plan Summary Sheet
Step 4 - Document Control Plan For Each Key Variable…
Product:
Key Contact:
Phone:
Date (Orig):
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
X
Process Step LSL Target USL Cp Cpk
Pp
Ppk
Measurement
Technique
%Variation
%R&R
P/T
Sample Frequency
Control Method
Reaction Plan
INPUTS
Control Plan.XLS
10-16
Control Plan
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
10-17
Control Plan
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
Step 1
Project
New
Process
Step 2
Step 3
Step 4
10-18
Auditing Procedures
Control Plan
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

By Observation

When was the last time the instruction was revised?
10-19
Control Plan
Documentation Package
Trouble
Shooting
Reaction
Plans
Capability
Maps
Scope
Maint.
Training
Critical
Parameters
FMEA’s
MSA
Customer
SOP’s
Summary
Control Plan
10-20
Summary
Control Plan
 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
10-21
Control Plan
Exercise
1.) Your Catapult Team should complete page 13 of the
blue “Catapult Process” handout.
Limit yourselves to 15 minutes for this exercise.
10-22