CONTROL PLANS

Control Plans
Objectives
 Introduce the basic concepts of control plans

 Practice evaluating and developing control plans
What Is a Control Plan ?
 A document that provides critical elements that must

be controlled for satisfactory quality.
 A final list of the critical Xs and Ys
– Final capability data
– MSA information
– Control methods
Six Sigma Project Tracker
Project Tracker
Revision 7 Project Start Date: 1/1/2012 Project Type
Project Throughput Time (days): 180 Improvement
Review 6 Sigma Develop
Databases Data Collection Project
Project Hopper and Sponsor Role for like projects Plan for "Y" Schedule Launch Charter
Identify 'Y" and

Define draft charter
Charter Approved
Data Collection
C & E Matrix or 30 Day MBB Preliminary Plan for Key
Process Map FTA Review FMEA or FTA MSA "Xs" MBB Review
M easure
1/2/2012 1/16/2012 1/23/2012 2/6/2012 2/20/2012 2/20/2012 2/20/2012
Initial
Capability Improvements Contract
Study Multi-Vari Defined MBB Review Approval
Analyze
3/1/2012 3/26/2012 3/26/2012 3/26/2012 3/26/2012
Single or Multi Legend Completion
Factor Tests Improvements 2/3/2012 check
(DOE) Implemented MBB Review
Actual 2/1/2012
Improve completion date Planned
completion date
5/10/2012 5/10/2012 5/10/2012
Hand Off Final Project
Training/Process Final Capability Final FMEA Presentation & Project Sign-off
Control Plan Owner Sign-off Study Revised RPN MBB Review Report & Closure
Control
5/30/2012 6/11/2012 6/11/2012 6/14/2012 6/19/2012 6/19/2012 6/29/2012
Requirements Process Solution
Redesign map is calculated separately
(Use as required) VOC/VOB Analysis Redesign Design
with no dependencies on other block
Redesign dates
Enter Start Date Here

Six Sigma Project Tracker
Redesign Project Name
Project Tracker Revision 7 Project Start Date:
Project Throughput Time (days):
1/1/2012
180
Project Type
Redesign
Review 6 Sigma Develop
Project Hopper and Databases Determine Project
Sponsor Role for like projects Team Schedule Launch Charter Kickoff Meeting
Identify 'Y" and Charter

Define draft charter Approved
Cross Stakeholder
Functional Selection Discussion Stakeholder
Value Chain Process Map Matrix Guideline MBB Review Interviews MBB Review
M easure
(VOC/VOB)
1/9/2012 1/9/2012 1/16/2012 1/23/2012 1/23/2012 2/20/2012 2/20/2012
Requirements Concept Concept Contract

Image KJ KJ Survey / QFD Generation Selection MBB Review Approval
Analyze
3/5/2012 3/19/2012 3/26/2012 4/2/2012 4/9/2012 4/9/2012 4/16/2012
Lean Process Transition FMEA / Risk Improvements

Mapped Plans Assessment Trial Process Implemented MBB Review
Improve
(Redesign)
4/30/2012 4/30/2012 5/7/2012 1/2/2012 5/28/2012 5/28/2012
Hand Off Process Final Project Project Sign-off

Control Plan Training Owner Sign-off MBB Review Presentation & Closure
Control
6/4/2012 6/11/2012 6/11/2012 6/11/2012 6/18/2012 6/25/2012
Importance to Customer
 The only reason a control plan exists is to ensure

that we consistently operate our processes such that
the product or service meets customer requirements
ALL THE TIME!
Product/Part/ Production
Customer Process Process
Service Control
Requirements Characteristics Control
Characteristics Plan
Control Plan Strategy
 The intent of an effective control plan strategy is to:

– Operate processes consistently on target with minimum
variation
– Minimize process tampering (over-adjustment)
– Assure that the process improvements that have been
identified and implemented become institutionalized; ISO
9000 can assist here
– Provide for adequate training in all procedures
– Include required maintenance schedules
Control plans must

be revised as needed
Control Plan Roadmap
1. Collect existing Six Sigma 7. Pay particular attention to adequacy
documentation for process of training, maintenance, operating
and reaction plans
2. Determine scope of process for
current control plan 8. Assign tasks to team members to
complete missing plan elements
3. Form teams to update 9. Verify compliance with plant
documentation more than one documentation requirements
quarter old
10. Retrain operations and maintenance
4. Replace short term capability studies personnel
with long term capability results  Collect sign-off signatures from
5. Fill in Control Plan Summary (046 11 safety and environmental,
Control Plan Worksheet maintenance, operations and
012203.XLS) based on review of process engineering
updated Six Sigma documentation  Verify control plan effectiveness in
six months with long term capability
6. Identify missing or inadequate 12 study
components — gaps
Link to Six Sigma
The Measurement Phase
Process Map Cause and FMEA
Effects Matrix Process/Product
Failure Modes and Effects Analysis
(FMEA)
1 2 3 4 5 6 7 8 9 10 11
Process or
Prepared by:
Product Name:
OUTPUTS
Low Capacity
INPUTS
Poor Reactor
Performance
Corrosion of
Heavies in
Moisture in
Downtime
Excessive
Equipment
Responsible: FMEA Date (Orig) ______________ (Rev) ____________
From Unit
Acidity in
Lights in
Material
Product
Product
Product
Product
Losses
Process Step Process Inputs Total
Process S O D R
Step/Part E C E P
139 Day Tanks Analysis 10 10 9 9 335 Number Potential Failure Mode Potential Failure Effects V Potential Causes C Current Controls T N
9 Reactor Cat./HF Ratio 5 8 7 157 Spin Draw Fiber Breakouts Undersized package, High SD Dirty Spinneret Visual Detection of Wraps and
7 Reactor Rxr Temperature 6 5 4 7 149 Process panel-hours lost 2 8 broken Filaments 9 144
73 Lights Removal Condenser Leak 4 8 2 4 1 148 Filament motion Visual Sight-glass
74 Lights Removal Reboiler Leak 4 8 2 4 1 148 5 2 8 80
131 Purification Low Stages 8 8 144
Polymer defects Fuzzball Light
144 Final Storage Containers 3 2 6 6 140 8 2 9 144
100 Neutralization pH Value 6 6 3 138
16 Catalyst Stripper Pluggage 3 6 5 3 137
0
111 Drying Decomposition 2 6 3 2 2 134
39 Drier Water Carryover 4 6 5 1 132
34 Drier Molecular Sieve 3 3 2 7 2 125
Key Inputs are explored and prioritized
Control Plan
Operational Excellence
Control Plan
Product: Core Team: Date (Orig):
Key Contact:
Phone: Date (Rev):
Process
Measurement %R&R Sample Sample Control
Process Process Step Input Output Specification (LSL, Cpk /Date Reaction Plan
Technique P/T Size Frequency Method
USL, Target)
DICY Turn Steam on Scales

Accuracy
DMF Load DMF DMF Load

Accuracy
DMF Load DMF DMF

Cleanliness
DICY Load DICY DICY Envir.

Factors
DICY Load DICY DICY Load

Accuracy
DICY Load DICY DICY Raw

Materials
DICY Load DICY DICY Mixer

Speecd
DMF Load DMF DMF Raw

Materials
DICY Turn Steam on Preheating

DICY TK
Key Inputs are evaluated for control

FMEA Versus Control Plan
 The FMEA should be a primary source for the identification of key
variables to control and for an initial evaluation of current control plan.
C
POTENTIAL CURRENT CURRENT
S L O
POTENTIAL FAILURE POTENTIAL EFFECT(S) CAUSE(S) / PROCESS PROCESS
PROCESS FUNCTION REQUIREMENTS E A C
MODE OF FAILURE MECHANISM(S) OF CONTROLS - CONTROLS -
V S C
FAILURE PREVENTION DETECTION
S
Characteristics Methods
Machine, Speci
Part / Process Name
Device, Jig, al Product / Evaluation / Sample
Process / Operation
Tools, For Char. Process Measureme Control
Number Description No. Product Process
Mfg. Class. Specification / nt Size Freq. Method
Tolerance Technique
Cummins Control Plan Form
Prototype Pre-launch Production Key Contact / Phone: Date (Orig.): Date (Rev):
Control Plan Number:

Part Number / Latest Change Level: Core Team: Customer Engineering Approval / Date (if Req'd):
Part Name / Description: Supplier / Plant Approval / Date: Customer Quality Approval / Date (if Req'd):
Supplier / Plant: Supplier Code: Other Approval / Date (if Req'd): Other Approval / Date (if Req'd):
Process Name / Machine, Special
Part / Process
Operation Device, Jig, Char.
Number Product / Process Evaluation / Sample
Description Tools, For Mfg. Class.
No. Product Process Specification / Measurement Control Method
Size Freq.
Tolerance Technique
CFM-01-01-02-00
Control Plan Example
Manufacturing
Machine, Speci
Part / Process Name
Device, Jig, al Product / Sample
Process / Operation Evaluation / Reaction Plan
Tools, For Char. Process Control
Number Description
Mfg. No. Product Process Class. Specification / Measurement Size Freq. Method
Technique
Tolerance
USL = 1.8 Mills Dupont Meter,
Final Coat - Air spray guy 5 random Shutdown Assembly Line
Painting LSL = 2.0 Mills Ppk = 1.5 / April 2003 R&R = 25%, P/T = Every Hood Xbar R Chart
Thickness (Y) P/N: LAM8912 spots until resolved - John
Target = 1.9 Mills 9%
Final Coat - Air Shutdown Assembly Line

Painting 60 =/- 2 psi Ppk = 2.0 / April 2003 Visual, R&R = 5% 1 reading 1 per day I Chart
Pressure (X1) until resolved - Mary
Final Coat - Oven Shutdown Assembly Line

Painting 120 +/- 1 Degrees Ppk = 3.0 / April 2003 Visual, R&R = 5% 1 reading 1 per day I Chart
Temp until resolved - Elizabeth
Control Plan Example
Non-Manufacturing
Machine, Speci
Part / Process Name
Process / Operation Evaluation / Reaction Plan
Mfg. Class. Specification / Measurement Size Freq. Method
Technique
Tolerance
Customer Visual Read in
XYZ Loan
Response - 02 Hours Loan Form Contact Sales Manager -
Loan Apps Processing Ppk = 1.3 / April 2003 Every Loan Every Loan I-MR Chart
Turnaround Time Manimum Kappa = 1.0 / April John
System
(Y) 2003
Customer Completion of
All operators HR Employee File All involved Employee File
Loan Apps Response - Course 101 for all Quarterly Contact HR Manager - Mary
completed 100% Agreement Operators Inspection
Operator (X1) operators
Customer
Daily Computer
Response - Contact IT Manager -
Loan Apps LSL = 100% Ppk = 3.0 / April 2003 Print out. One Report Once a day I-MR Chart
Computer Uptime Elizabeth
100% Agreement
(X2)
Control Plan Development
 Identify key output variables and specifications, based on customer
requirements (May use Quality Function Deployment process (QFD))
– Cause & Effect Matrix
– FMEA
 Determine key/critical input variables
– Process Map
– Cause & Effect Matrix
– FMEA
– Multi-vari studies
– DOE
 For each key/critical input variable determine:
– Appropriate measurement systems
– Relationship to output variables
Process
 One control plan may cover several processes or

parts.
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Process Step
 Each process step with critical Xs and Ys should be

listed on the control plan
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Output Variables
 Key Process Output Variables (KPOVs) should include big ―Y‖.
 Critical Ys (KPOVs) may come from:
– C&E Matrix,
– FTA
– FMEA.
 May contain important constraint variables
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Input Variables
 Critical Key Process Input Variables (KPIVs), Xs may come
from the Process Map, C&E Matrix, FMEA, FTA, Multi-Vari
studies, DOEs, including any uncontrollable noise variable
inputs.
 For each line identify as either an input (KPIV) or output
(KPOV).
 Not both!
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Machine Devices
 Describe, identify the processing equipment needed

for this step.
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Characteristics
 Number – A cross reference number from all applicable
documents (Process Map, FMEA)
 Product – Features of the part, component or assembly that
are described on drawings
 Process – Variables that have a Cause and Effect relationship
with the Product. (Can only be measured at the time it occurs.)
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Special Characteristics
 Used to highlight Major / Minor features from a

drawing or items marked Critical on Prints.
 NOTE: This field can be left blank for undesignated
characteristics.
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Specifications and Capability
 Targets and specification limits for KPIVs and KPOVs

are recorded.
 For continuous variables, Cp/Cpk indexes should be
calculated.
 Record short and long term data where available.
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Measurement Technique and MSA
Capability
 Measurement technique and measurement system
capability should be indicated.
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Sample Size and Frequency
 Specifics of sampling plan:

 How big is your sample size?
– Example: Every unit, left hand corner
 How often do you sample?
– Example: Every day, 1 of 10 parts
Machine, Speci
Part / Process Name
Process / Operation
Tolerance Technique
Control Methods
 Inspection and test methods
Better
 Standard Operating Procedures

(SOPs), Checklists
 Mistake-proofing systems and
devices
– Color tags Methods
Product / Sample Reaction Plan

– Single use devices
Evaluation /
Process Control
Measurement
Specification / Size Freq. Method
Technique
Tolerance
 Statistical Process Control

– Choice of control chart(s) and
sampling plan
– Procedures for identifying and
responding to out-of-control points
and undesirable trends
– Procedures for preventing
recurrence of special causes
 Automated process control
Reaction Plan and Procedures
 Reaction plan for out-of-specification conditions

should be listed along with responsible for leading
the activities.
Machine, Speci
Evaluation / Reaction Plan
Mfg. No. Product Process Class. Specification / Measurement
Size Freq. Method
Technique
Tolerance
Factors Impacting a Good Control Plan
These need to be
Measurement Preliminary
updated before
System Analysis
proceeding
Measurement Process
System Analysis Maps Short Term
%R&R, %P/T Capability
C&E
Calibration Matrix Initial Control
Requirements Plan Assessment
FMEA
Sampling and
Testing Plans Customer
Requirements
Control Plan
Long Term
Capability Maintenance
SPC Plans
Schedules Trouble
Noise Variable Shooting
Operating Compensation Training Aids
Windows Materials
Reaction
Plans
DOEs SOPs
May already
have some of
Improvement these
Procedures
Activities
Questions for Control Plan Evaluation
 Key Process Input Variables (KPIVs):
– How are they monitored?
– How often are they verified?
– Are optimum target values and specifications known?
– How much variation is there around the target value?
– What causes the variation in the KPIV?
– How often is the KPIV out of control?
– Which KPIVs should have control charts?
 Uncontrollable (Noise) inputs
– What are they?
– Are they impossible or impractical to control?
– Do we know how to compensate for changes in them?
– How robust is the system to noise?
(continued)
 Standard Operating Procedures (SOPs)
– Do they exist?
– Are they simple and understood?
– Are they being followed?
– Are they current?
– Is operator training performed and documented?
– Is there a process audit schedule?
 Maintenance procedures
– Have critical components been identified?
– Does the schedule specify who, what and when?
– Where are the manufacturer’s instructions?
– Do we have a troubleshooting guide?
– What are the training requirements for maintenance?
(continued)
 Measurement procedures
– What special equipment is needed for measurement?
– What is the measurement capability?
– Who does the measurement?
– How often is a measurement taken? How is routine data
recorded?
– What key procedures are required to maintain control?
– What is done with a product that is out of spec?
– How is the process routinely audited?
– Who makes the audit?
• How often?
• How is it recorded?
Control Plan Check List
Process maps detail manufacturing Sampling, inspection and testing plans
steps, material flow and important include how often, where and to whom
variables results reported
 Key product variables identified with Operating procedures identify actions,
importance to customer, desired target responsibilities, maintenance schedules
value and specification range defined and product segregation requirements
Long and short term capability trend Training materials describe all aspects
charts track variation reduction progress
of process operation and responsibilities
Key and critical input variables identified
Applicable version of TS16949,
with targets, statistically determined ISO9001, ISO14000 met if required
control limits and control strategies Process improvement efforts fully
defined documented and available for reference
Reaction plan in place for out-of-spec Control plan is reviewed and updated
material quarterly and resides in the operating
Measurement systems are capable with area
calibration requirements specified
Exercise #1 - Part 1
Exercise #1 - Part 2
Exercise-
Develop a Control Plan
 Break into groups
 Select a process from one group member´s project
 Develop a control plan for this process within 15
minutes
 Record output on flipchart
 Two groups will be randomly chosen to report
Control Plan Hints
 A control plan works with all types of data

 This tool works with all types of projects
 It should be a key document in your Control phase
_________________________________________
_________________________________________
_________________________________________
Objectives
 Introduced the basic concepts of control plans

 Practiced evaluating and developing control plans

CONTROL PLANS - June2012

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 Introduce the basic concepts of control plans

 A document that provides critical elements that must

Identify 'Y" and

Enter Start Date Here

Identify 'Y" and Charter

Requirements Concept Concept Contract

Lean Process Transition FMEA / Risk Improvements

Hand Off Process Final Project Project Sign-off

 The only reason a control plan exists is to ensure

ALL THE TIME!

 The intent of an effective control plan strategy is to:

Control plans must

Key Inputs are explored and prioritized

DICY Turn Steam on Scales

DMF Load DMF DMF Load

DMF Load DMF DMF

DICY Load DICY DICY Envir.

DICY Load DICY DICY Load

DICY Load DICY DICY Raw

DICY Load DICY DICY Mixer

DMF Load DMF DMF Raw

DICY Turn Steam on Preheating

Key Inputs are evaluated for control

Control Plan Number:

Final Coat - Air Shutdown Assembly Line

Final Coat - Oven Shutdown Assembly Line

 One control plan may cover several processes or

 Each process step with critical Xs and Ys should be

 Describe, identify the processing equipment needed

 Used to highlight Major / Minor features from a

 Targets and specification limits for KPIVs and KPOVs

 Specifics of sampling plan:

 Standard Operating Procedures

Product / Sample Reaction Plan

 Statistical Process Control

 Reaction plan for out-of-specification conditions

 A control plan works with all types of data

 Introduced the basic concepts of control plans

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