Module - 7 - Control Phase

Control Phase
Module 7
1
Agenda
– Introduction to Control Phase
– Lean Controls
– Statistical Quality Control
– Key learning
– Control Plan
2
Non-Business Use
Introduction to Control Phase
3
The Breakthrough Strategy Y=f(x)
Who is the customer?

Define What do they want? CTQ
Is the data clean or dirty?
Characterization Measure Y
What is the baseline performance?
What is the project objective?
Analyze What are the various x’s?
What are the Critical X’s?

Improve What solutions will control the x’s?
What are the specs for the x’s?
Optimization Control x
What is the data integrity of x’s?
What is the capability of the x’s?
What is the plan to control the x’s over time?
Non-Business Use
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Purpose Of Control Phase
❑ Document an approved control plan encompassing all activities and documentation

necessary to sustain project and process improvements
❑ Verify that all Quality System requirements have been satisfied (proper approvals,
revision controlled, distributed, trained on)
❑ Establish provisions to monitor process performance and thus verify that the project
improvements are maintained
❑ In an ideal project, monitor the KPOVs and control the KPIVs
❑ Hand off to a willing and prepared process owner, a completed, finished, done, tied
up, wrapped up project
Three Take-Aways
1) You need to have your controls documented
2) You need to make sure that ACTIONs back up the words
Non-Business Use 3) Project is DONE 5
The Funnel Effect
Measure:
Fishbones, C&E matrix, FMEA
Process Maps, etc
30 - 50 Inputs
Analyze:
Paretos, Multi-vari, 1-t, 2-t, paired t, ANOVA, 10 - 15 Xs
Chi-Sq, Test for equal var, proportions tests
8 - 10 PIVs
IMPROVE
Screening DOEs
DOEs
3-6 Key PIVs
Modeling DOEs CONTROL
Optimized Process
Non-Business Use
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What Is Six Sigma?
Project Management Deployment
- 12 Steps - Top driven, IC linked
- Focused on Customer - Champions, Strategic
- Data Driven 6s - Full time Black Belts
- Rigorous closure - Green Belts
- Metrics drive behavior
Statistically
Significant
- Are changes Six Sigma IS solid
statistically valid? Project Closure
- Hypothesis tests
- R2, p-values,etc
Non-Business Use
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Control Phase Roadmap
STATISTICAL PROCESS CONTROL FMEA
LONG TERM MSA PLAN CHANGE/REVISION CONTROL
REACTION PLAN Control PROCESS REDISGN

Plan
STANDARDIZED WORK; (words)
VISUAL WORK PLACE 5S AND MISTAKE PROOFING
PREVENTATIVE MAINTENCE
INTEGRATE WITH QUALITY SYSTEMS
ESPECIALLY AUDIT SYSTEMS AND CONTROLLED TRAINING PLAN BOTH FOR CURRENT
DOCUMEMTATION (SOPs and written instructions) AND FUTURE ACTIVITIES
Whatever actions it takes to sustain expectations.

Use your toolbox.
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Questions To Be Answered
❑ Who is the owner of the control plan?
▪ Who is the Process Owner?
▪ Who is responsible for ensuring process improvements are monitored and

sustained?
❑ What controls were developed to maintain process improvements?
▪ What vehicle ensures that the controls are followed at all times?
▪ What controls prevent the process from reverting back to the original, less
than optimum process?
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❑ Where in the process, is the data being collected?
▪ What type of data is being collected?
▪ What control charts are used to monitor the process?
▪ Is the process in control and how can it be verified?
❑ When should the new process be audited?
▪ When will the training schedule be communicated?
▪ When will the control plan, and all supporting documentation, be completed?
▪ When will the project be completed and transferred to the Process Owner?
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❑ Why will the transfer of the improvements to the Process Owner be successful?
▪ Why will the change control plan and reaction plan be successful?
❑ How will training of new process be scheduled?
▪ How will using new process be verified?
▪ How will the new process be transferred from the Green Belt to the Process
Owner?
▪ How will the control plan and change control plan be maintained?
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Tools
❑ Control Plans
▪ Reaction Plans
▪ FMEA
❑ Statistical Process Control (variable and attribute)

▪ Gage Control Plans
▪ Graphical Techniques
❑ Mistake Proofing
▪ Audits and Training Systems
▪ Quality System controlled documented systems (work instructions, policies & procedures,
controlled process instructions, etc.)
▪ Standardized work/visual work place

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Be end of control phase, you should be able to:
❑ Select the appropriate chart for types of data
❑ Create and interpret basic attribute and variable control charts
▪ Assess process stability
▪ Assess process control
▪ Differentiate between customer specification limits (VOC) and process control

limits (VOP)
❑ Recognize within and between group variation
Non-Business Use
13
Lean Controls
14
The Vision of Lean Supporting Your Project
Kanban
The Continuous Goal…
Sustaining Results Kaizen
 We cannot sustain
Kanban without Kaizen.
Standardized Work
 We cannot sustain Kaizen (Six
Sigma) without Standardized
Work.
Visual Factory  We cannot sustain Standardized

Work without a Visual Factory.
 We cannot sustain a visual

factory without 5S.
5S Workplace Organization
Lean tools add discipline required to further sustain gains realized with Six Sigma
Belt Projects 15
Non-Business Use
5S Translation - Workplace Organization
Step Japanese Literal Translation English
Step 1: Seiri Clearing Up Sorting
Step 2: Seiton Organizing Straightening
Step 3: Seiso Cleaning Shining
Step 4: Seketsu Standardizing Standardizing
Step 5: Shitsuke Training & Discipline Sustaining
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What is Kaizen?
Kaizen
❑ Definition*: The philosophy of continual
improvement, that every process can and should
be continually evaluated and improved in terms of Standardized Work
time required, resources used, resultant quality

and other aspects relevant to the process
Six Sigma projects are examples of Kaizens
❑ Kaikaku are breakthrough successes which are the Visual Factory

first focus of Six Sigma projects
.
5S - Workplace Organization
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Prerequisites for Kaizen
❑ Kaizen’s need the following cultural elements:

▪ Management Support: Consider the corporate support which is the reason why Six Sigma focus
is a success in your organization
▪ Measurable Process: Without standardized work, we really wouldn’t have a consistent process
to measure. Cycle times would vary, assembly methods would vary, batches of materials
would be mixed, etc…
▪ Analysis Tools: There are improvement projects in each organization which cannot be solved
by an operator. This is why we teach the analysis tools in Six Sigma
▪ Operator Support: The organization needs to understand that its future lies in the success of
the value-adding employees. Our roles as Belts are to convince operators that we are here for
.
them--they will then be there for us
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What is Kanban?
Kaizen
❑ Kanbans are the best inventory control method that
impacts some of the 7 elements of MUDA
Standardized Work
❑ Kanban provides production, conveyance, and delivery
information. In it’s purest form the system will not
allow any goods to be moved within the facility
without an appropriate Kanban (or signal) attached to
the goods
❑ The Japanese word for a communication signal Visual Factory

or card--typically a signal to begin work
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What is Kanban?
Kaizen
❑ Kanban is the technique used to “pull” products
and material through and into
the lean manufacturing system. Standardized Work
❑ The actual “Kanban” can be a physical signal such

as an empty container or a small card
Visual Factory
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Two Types of Kanban
Intra-process
There are two main categories of Kanbans
P.I.K.
❑ Type 1: Finished goods Kanbans Production
Instruction Kanban
▪ Signal Kanban: Should be posted at the end of the processing area to
signal for production to begin Signal
▪ P.I.K Kanban: Used for a much more refined level of inventory control.
Kanban is posted as inventory is depleted thus insuring only the minimum
allowable level of product is maintained Withdrawal
❑ Type 2: Incoming Material Kanbans Inter-Process
▪ Used to purchase materials from a supplying department either internal Between two
or external to the organization. Regulates the amount of WIP inventory
processes
.
located at a particular process Supplier
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Kanban – success criteria
These items support successful Kanbans: Kanbans should smooth out inventory
and keep product flowing but use them
❑ Improve changeover procedures cautiously. If you prematurely
implement a Kanban it WILL backfire
❑ Relatively stable demand cycle
❑ Number of parts per Kanban (card) MUST be standard and SHOULD be kept to as few as
possible parts per card
❑ Small amount of variation (or defects)
❑ Near zero defects should be sent to the assembly process (Result of earlier belt
projects)
❑ Consistent
. cycle times defined by Standardized Work
❑ Material handlers must be trained in the organization of the transportation system
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Warnings Regarding Kanban
❑ It is not possible to implement a viable Kanban system without a strong support

structure made up of the prerequisites if you do NOT have 5S, visual factory,
standardized work and ongoing Kaizen’s, Kanbans cannot succeed
❑ Kanban systems are not quick fixes to large inventory problems, workforce issues, poor
product planning, fluctuating demand cycles, etc...
❑ Benchmarks have organizations using up to seven years to implement a successful

Kanban System all the way through supplier and customer supply chain
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The Lean Tools and Sustained Project Success
The main lessons you should consider are:
❑ The TEAM should 5S the project area and begin integrating visual factory indicators
▪ Indications of the need for 5S are:
o Outliers in your project metric
o Loss of initial gains from project findings
❑ The TEAM should develop Standardized Work Instructions
▪ They are required to sustain your system benefits.
▪ However, remember without an organized work place with 5S standardized work

instructions won’t create consistency
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The Lean Tools and Sustained Project Success
❑ Kaizen’s and Kanban’s cannot be attempted without organized workplaces and

organized work instructions
▪ Remember the need for 5S and Standardized Work Instructions to support our
projects.
❑ Project Scope dictates how far up the Lean tools ladder you need to implement
measures to sustain any project success from your DMAIC efforts
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Statistical Process Control (SPC)
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April 2000
❑ Repair parts inventory is at an all time low
❑ Manager presents an award in honor of this achievement
❑ Ceremony conducted: Free breakfast for all techs!
❑ “Everyone should be proud of what you’ve accomplished”
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Inventory
20
10
J F M A
2000 2001
Non-Business Use Award given 27
July 2000
Three consecutive months of inventory increases : Manager wishes he could take back the
award
“Recognition seems to have been backfired” : Instead of holding the gains, techs seems to
have gotten complacent – Allowing inventory to creep back to where it was previously
Manager decides: “This group just needs tough management!
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Inventory
20
Manager regrets giving award

10
J F M A M J J
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2000 2001 28
Nov. 2000 Inventory Rises To A Value Of 26!
Manager decides to take tough action and take names
He calls everyone in and demands they do something to keep inventories down
Following this tantrum, everyone treads lightly. Short of hiding material in their homes, the
techs don’t know what to do ➔ So, they hold their breath and hope inventories drop
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Inventory
20 No more Mr. Nice Guy
10
J F M A M J J A S O N D
2000 29
Non-Business Use 2001
June 2001
Manager has seen reduced levels of inventory since the end of last year. “Things are looking-
up!”
(Although nothing had been done to change the system)
His learning: “Tough management style gets results!”
Manager concludes:
“Tough management style gets results!”
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Inventory
20
10
J F M A M J J A S O N D J F M A M J
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2000 2001 30
“My Decisions Were Based On Data! –
What Could Be Wrong With That?"
His decisions stemmed from interpreting the high and low points as signals
However, as the control chart below clearly reveals,
NONE OF THESE INDIVIDUAL POINTS WERE SIGNALS!
They all reflect the same underlying system – Each should be interpreted alike
30 UCL
Inventory
20
10 LCL
J F M A M J J A S O N D J F M M J J A S O
2000 2001
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A Process
10.5 10
9.5
Y = Referral Cycle Time

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A Process
5
4
3
2
1
0
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A Process Over Time
5
4
3
2
1
0
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A Process Over Time
5
What has changed? 4
Centering? ______ 3
Spread? ______
2
1
0 Time
4.0 3.0 2.0 35

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A Process Over Time
5
4
3
2
1
0 Time
What has changed?
Centering? ______
Spread? ______
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A Process Over Time
5
4
3
2
1
0 Time
What has changed?
Centering? ______
Spread? ______
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Control Charts Are A View Of The Process
Avg Spread Avg Spread Avg Spread Avg Spread

Stable?
Yes/No
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Stable?
Y N N N N Y Y Y
Yes/No
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Stable?
Y N N N N Y Y Y
Yes/No
Averages IN OUT OUT IN
Variation OUT OUT IN IN 40

Non-Business Use
❑ Statistical Process Control (SPC) involves the use of statistical techniques, to

interpret data, to control the variation in processes
❑ SPC is used primarily to act on out of control processes, but it is also used to
monitor the consistency of processes producing products and services.
❑ A primary SPC tool is the Control Chart - a graphical representation for specific
quantitative measurements of a process input or output
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❑ In the Control Chart, these quantitative measurements are compared to decision

rules calculated based on probabilities from the actual measurement of process
performance
❑ The comparison between the decision rules and the performance data detects any
unusual variation in the process, variation that could indicate a problem with the
process
❑ Several different descriptive statistics can be used in Control Charts
❑ There are several different types of Control Charts that can test for different
causes, such as how quickly major vs. minor shifts in process averages are detected
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❑ Control Charts, quite simply are Time Series Charts of all the data points with one
extra addition. The Standard Deviation for the data is calculated for the data and
two additional lines are added to the chart. These lines are placed +/- 3 Standard
Deviations away from the Mean and are called the Upper Control Limit (UCL) and
the Lower Control Limit (LCL)
❑ Control Charts graphically highlight data points that do not fit the normal level of
expected variation. This is mathematically defined as being more than +/- 3
Standard Deviations from the Mean
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Purpose of Statistical Process Control
❑ Every process has Causes of Variation known as:
▪ Common Cause: Natural variability
▪ Special Cause: Unnatural variability
o Assignable: Reason for detected Variability
o Pattern Change: Presence of trend or unusual pattern
❑ SPC is a basic tool to monitor and improve variation in a process.
❑ SPC is used to detect Special Cause variation telling us the process is “out of
control” but does NOT tell us why.
❑ SPC gives a glimpse of ongoing process capability AND is a visual management tool.
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Specification Focus
❑ Focusing on the performance will tell you where you are compared to where you
want to be
❑ Focusing on drivers of the process will guide you to process improvements
Let The Life Is Good Let The

Beatings Begin “Benign Neglect” Beatings Begin
LSL USL
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Simple Time Series Plot Of Cycle Time
❑ A simple Time Series Plot shows cycle time variation by day of the year, but does
not show if this is a normal pattern
65
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Cycle Time
45
35
Day of Year 10 20 30 40 50 60 70 80 90 100
Graph > Time Series Plot
Time series charts form the basis of control charts
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Understanding
.
the Power of SPC
❑ Control Charts indicate when a process is “out of control” or exhibiting Special

Cause variation but NOT why!
❑ SPC Charts incorporate upper and lower Control Limits. The limits are typically +/-
3 from the Center Line which represents 99.73% of natural variability for Normal
Distributions
❑ SPC Charts allow workers and supervision to maintain improved process

performance from Six Sigma projects
❑ Use of SPC Charts can be applied with all processes
❑ Services, manufacturing, and retail are just a few industries with SPC applications
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Understanding
.
the Power of SPC
❑ Caution must be taken with use of SPC for Non-normal processes
❑ Control Limits describe the process variability and are unrelated to customer
specifications (Voice of the Process instead of Voice of the Customer)
❑ An undesirable situation is having Control Limits wider than customer specification

limits. This will exist for poorly performing processes with a Cp less than 1.0
❑ Many SPC Charts exist and selection must be appropriate for effectiveness
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Focus .of Six Sigma and the Use of SPC
Y=F(x)
To get results, should we focus our behavior on the Y or X?
Y X1 . . . XN
Dependent Independent
Output Input
Effect Cause
Symptom Problem
Monitor Control
If we find the “vital few” X’s, consider using SPC on the X’s to
achieve a desired Y
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Control
.
Chart Anatomy
Special Cause
Variation Run Chart of
Process is data points
“Out of
Control”
Upper Control
Limit
+/- 3 sigma
Common
Cause
Variation
Process is “In
Control”
Lower Control
Limit
Mean
Special Cause
Variation
Process is
“Out of
Control” Process Sequence/Time Scale
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Control
.
Chart Anatomy
Special Cause
Variation Run Chart of
Process is data points
“Out of
Control”
Upper Control
Limit
Notice, we are not showing or considering specifications limits
+/- 3 sigma
Common
Cause on a Control Chart as the Control Charts and their limits are
Variation
Process is “In the Voice of the Process not the Voice of the Customer which
Control”
are the specification limits
Lower Control
Limit
Mean
Special Cause
Variation
Process is
“Out of
Control” Process Sequence/Time Scale
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Control
.
and Out of Control
Out of Control
3
2
1
99.7%
95%
68%
-1
-2
-3
Out of Control
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Common vs. Special Causes
Region of Special Cause Variation

UCL
Individual Value
LCL
Region of Special Cause Variation
TIME
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Where Control Charts Are Used
Who is the customer?

Define What do they want? CTQ
Characterization Is the data clean or dirty?
Measure
Y
What is the baseline performance?
What is the project objective?
What are the various x’s?
Analyze
What are the Critical X’s?
What solutions will control the x’s?
Improve What are the specs for the x’s?
Optimization x
Control What is the data integrity of x’s?
What is the capability of the x’s?
What is the plan to control the x’s over time?
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Two General Kinds Of Data
❑ ATTRIBUTE – The data is discrete (counted). Results from the inspection of

visual defects, visual problems, information, or from pass/fail or yes/no
decisions
❑ VARIABLES – The data is continuous (measured). Results from the actual

measuring of a characteristic such as cycle time, dollars, milliliters or cc’s,
milligrams, etc…
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SPC Selection Process
Choose Appropriate
Control Chart
ATTRIBUTE CONTINUOUS
type
of data
type of subgroup
attribute size
DEFECTS data DEFECTIVES
Sample size 1 2-5 10+

type
type of
of defect
subgroups
I – MR X–R X–S
Chart Chart Chart
CONSTANT VARIABLE CONSTANT VARIABLE
Individuals Mean & Mean &
& Moving Range Std. Dev.
Range
C Chart U Chart NP Chart P Chart SPECIAL CASES
Number of Incidences Number of Proportion

Incidences per Unit Defectives Defectives
CumSum EWMA
Chart Chart
Cumulative Exponentially
Sum Weighted Moving
Average
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Understanding Variable Control Chart Selection
Type of Chart When do you need it?
Average & Range  Production is higher volume; allows process Mean and variability to be
or S viewed and assessed together; more sampling than with Individuals Chart
(Xbar and R or (I) and Moving Range Charts (MR) but when subgroups are desired.
Xbar and S) Outliers can cause issues with Range (R) charts so Standard Deviation
charts (S) used instead if concerned
Most Common
Individual and  Production is low volume or cycle time to build product is long or
Moving Range homogeneous sample represents entire product (batch etc.); sampling
and testing is costly so subgroups are not desired. Control limits are
wider than Xbar Charts. Used for SPC on most inputs.
Exponentially  Small shift needs to be detected, often because of autocorrelation of the

Weighted output results. Used only for individuals or averages of Outputs.
Moving Average Infrequently used because of calculation complexity
Cumulative Sum  Same reasons as EWMA (Exponentially Weighted Moving Range) except
the past data is as important as present data
Less Common
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Understanding Attribute Control Chart Selection
Type of Chart When do you need it?
P  Need to track the fraction of defective units

Sample size is variable and usually > 50
nP  When you want to track the number of defective units per subgroup
Sample size is usually constant and usually > 50
C  When you want to track the number of defects per subgroup of units produced
Sample size is constant
 When you want to track the number of defects per unit

U
Sample size is variable
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Attribute data
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Control Charts For Attribute Data
❑ Attributes are individual quality characteristics reflects acceptable or unacceptable

outcomes
❑ Two primary types
▪ Defects: Individual non-conformance's
▪ Defectives: Units or parts failing to meet at least one conformance standard
❑ Goal: Be able to identify specific causes of variation and take action without over-
controlling (tampering) with the process
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Four Major Types Of Attribute Charts
❑ Defectives
▪ NP Charts – Plot of the number of nonconforming units; percentage of defective parts
o Constant sample size
▪ P Charts – Plot of the proportion of defectives per lot or sub-group
o Constant or non-constant sample size
❑ Defects
▪ C Charts – Plot of the number of defects sampled (not the percent defective)
o Constant sample size
▪ U Charts – Plot of the number of defects per unit sampled; not the percent defective
o Constant or non-constant sample size
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NP Chart
❑ Calculate the parameters of the nP Control Charts with the following:
Center Line Control Limits
Total number of defective items

np =
Total number of subgroups
Where:
np: Average number defective items per subgroup

LCLnp: Lower Control Limit on nP chart
UCLnp: Upper Control Limit on nP chart
Since the Control Limits AND Center Line are a function of sample size,
they will vary for each sample.
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NP Chart
❑ Assumptions of Attribute charts: np chart
▪ The probability of non-conformance is the same for each item
▪ There should be two events (pass or fail), and they are mutually exclusive
▪ Each unit is independent of the other
▪ The testing procedure should be the same for each lot
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NP Chart Example
Example: Smartbulbs Inc is a famous LED bulb manufacturer. The supervisor drew a randomly
constant sample size of 200 bulbs every hour and reported the number of defective bulbs for each
lot. Based on the given data, prepare the control chart for the number of defectives and determine
whether the process is in statistical control
No of lots k = 20 , Σnp = 105, Σn = 4000
Compute 𝑝 = # of defectives / # of samples

=Σnp/Σn =105/4000= 0.0263
Calculate centerline n𝑝 = Σnp/k =105/20 = 5.3
Calculate UCL and LCL
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NP Chart Example
Interpret the chart: If any of the points in the chart are outside of ± 3σ limit,
then consider the process is out of control. In the above example, all the points
or number of defective bulbs within each lot are between the UCL and LCL
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P Chart
❑ Calculate the parameters of the P Control Charts with the following:
Total number of defective items

p=
Total number of items inspected
Where:
Where np = number of defectives in the sample
k= number of lots
n= sample size
Since the Control Limits AND Center Line are a function of sample size,
they will vary for each sample.
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P Chart
❑ Assumptions of Attribute charts: p chart
▪ There should be two events (pass or fail), and they are mutually exclusive
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P Chart Example
Example: ABC Manufacturing produces thousands of tubes every day. A Quality inspector randomly
draws samples for 20 days and reports the defective tubes for each sample size. Based on the given
data, prepare the control chart for the fraction defective and determine the process in statistical
control
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P Chart Example
Calculate each subgroup’s non-conformities rate= np/n
No of lots k = 20
𝑛 =Σn/k = 23040 / 20 =1152
Compute 𝑝 = # of defectives / # of samples

=Σnp/Σn = 346 / 23040 = 0.01502
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P Chart Example
Calculate the upper control limit (UCL) and low control limit (LCL). Since the sample sizes are
unequal, the control limits vary from sample interval to sample interval
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P Chart Example
Interpret the chart: The proportion of defectives on day 13 is higher than the
upper control limit (UCL). Therefore, the process is out of control. The role of
belt or statistician to identify the root cause for the cause and take appropriate
corrective action to bring the process under control
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U Chart
❑ Calculate the parameters of the U Control Charts with the following

Total number of defects Identified Constant Variable
u= sample sample
Total number of Units Inspected
Where:
c = number of defects
K= number of lots
n= sample size
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U Chart
❑ Assumptions of Attribute charts: u chart
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U Chart Example (Constant Sample)
Example: The following data shows the number of defects per lot in 20 consecutive lots of 100
motorbikes each. Plot the average number of defects per unit based on the data and determine the
process in statistical control
no of lots k = 20
Sum of defects Σc = 937
Sum of sample size n = 100
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Calculate the u value for each lot; u= number of defects in each lot/ lot size
Compute 𝑢 = Σc/nk =937/(20*100) = 0.4685
Then calculate the upper control limit (UCL) and low

control limit (LCL)
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Interpret the chart: If any of the points in the chart are outside of ± 3σ limit, then
consider the process is out of control. In the above example, all the samples are
within the control limit. Hence, we assume the process is in control
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U Chart Example (Variable Sample)
Example: A motorbike manufacturer collected the number of defects identified in the final
inspection stage for 20 days. Based on the given data, the supervisor wants to know the quality level
using a control chart for defects per motorbike and determine the process in statistical control
no of lots k = 20
Sum of defects Σc = 934
Sum of sample size Σn = 2240
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Calculate the u value for each lot; u= number of defects in each lot/ lot size
Compute 𝑢 = # of defects / number of samples
=Σc/Σn =934/2240= 0.417
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Then calculate the upper control limit (UCL) and low control limit (LCL). Since the sample sizes are
unequal, the control limits vary from sample interval to sample interval
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Interpret the chart: If any of the points in the chart are outside of ± 3σ limit, then
consider the process is out of control. In the above example, Sample 8 is outside
of the control limit. Hence the process is not in control. Thus, the team needs to
identify the root cause for the special cause variation
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C Chart
❑ Calculate the parameters of the C Control Charts with the following:
Total number of defects

c=
Total number of subgroups
Where:
c: Total number of defects divided by the total number of subgroups

LCLc: Lower Control Limit on C Chart
UCLc: Upper Control Limit on C Chart
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C Chart
❑ Assumptions of Attribute charts: u chart
▪ The probability of defect is the same for each item
Non-Business Use
82
C Chart Example
Example: Mobile charger supplier drawn randomly constant sample size of 500 chargers every day
for quality control test. Defects in each charger are recorded during testing. Based on the given
data, draw the appropriate control chart and comment on the state of control
no of lots k = 20
Σc = 326
Compute c̅ = # of defects / # of lots
=Σc/k =326/20= 16.3
Then calculate UCL and LCL
Non-Business Use
83
C Chart Example
Interpret the chart: if any of the points in the chart is outside of ± 3σ limit, then
consider the process is out of control. In the above example, the average number
of defects per lot is 16.3. Sample 9 is outside of the control limit. Hence the
process is out of control. Thus team needs to identify the root cause for the
special cause variation
Non-Business Use
84
Continuous Data
85
Two Commonly Used Variables Or Continuous
Data Control Charts
❑ Xbar Charts
▪ Individual-Moving Range Chart (I-MR) - for a subgroup size of one only
▪ Xbar-Range Chart (X-R) - used when rationally collecting measurements in a subgroup

size between two and ten observations.
▪ Xbar-S Chart (X-S) - when the subgroup size is more than 10
❑ Exponentially Weighted Moving Average (EWMA)
❑ Cumulative Sum (CUSUM)
Non-Business Use
86
Individual-Moving Range Chart (I-MR)
❑ Calculate the parameters of the Individual and MR Control Charts with the following:

k
R
k
x i i
UCL x = X + E 2 MR UCL MR = D 4 MR
X= i =1 MR = i
k k LCL x = X − E 2 MR LCL MR = D 3 MR
Where:
Xbar: Average of the individuals, becomes the Center Line on the Individuals Chart
Xi: Individual data points
k: Number of individual data points
Ri : Moving range between individuals, generally calculated using the difference between
each successive pair of readings
MRbar: The average moving range, the Center Line on the Range Chart
UCLX: Upper Control Limit on Individuals Chart
LCLX: Lower Control Limit on Individuals Chart
UCLMR: Upper Control Limit on moving range
LCLMR : Lower Control Limit on moving range (does not apply for sample sizes below 7)
E2, D3, D4: Constants that vary according to the sample size used in obtaining the moving range 87
Non-Business Use
I-MR chart also called an X-MR chart is a combination of two
charts (Individual and Moving Range)
❑ I-Chart: Individual chart displays the individual data points and monitors the mean
and shifts in the process when the data points are collected at regular intervals of
time (help to identify the common and assignable causes in the process if any)
❑ MR Chart: While the Individual chart monitors the process mean, the Moving Range
chart monitors the process variation when the data points are collected at regular
intervals of time (i.e., tracking the absolute difference between each measurement
to its previous measurement)
❑ Assumptions of Variable charts: I-MR chart

▪ Data is assumed to be normally distributed
▪ Subgroup size is one observations
▪ When the collected data is continuous (ie Length, Weight), etc. and captures data in
time order 88
Non-Business Use
I-MR chart are used
❑ There are certain situations when opportunities to collect data are limited or when
grouping the data into subgroups simply doesn't make practical sense
❑ Perhaps the most obvious of these cases is when each individual measurement is
already a rational subgroup. This might happen when each measurement represents
one batch, when the measurements are widely spaced in time or when only one
measurement is available in evaluating the process
❑ Such situations include destructive testing, inventory turns, monthly revenue

figures and chemical tests of a characteristic in a large container of material. All of
these situations indicate a subgroup size of one. Because this chart is dealing with
individual measurements it, is not as sensitive as the X-Bar Chart in detecting
process changes
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89
I-MR chart are used
❑ To check any indications of assignable causes in the process which may lead to
process out of control
❑ To monitor the process performance before and after the implementation of

process improvements
❑ When the production rate is very slow on the shop floor and difficult to wait for
more samples
❑ The measurement systems are too expensive (like destructive testing)
❑ Mostly used for batch process
Non-Business Use
90
I-MR Chart Example
Example: A salesperson travels to various shops in the city to deliver the sample products. Below is
the distance traveled data (in miles) for the last 11 months. Calculate the control limits for the I-MR
chart
First, calculate Moving Range Calculate the 𝑋̅ and 𝑀𝑅
k=11
𝑋 = 880/11= 80
𝑀𝑅 =32/10 =3.2
n=2 (comparing the current

state with the previous
state)
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91
I-MR Chart Example
Example: A salesperson travels to various shops in the city to deliver the sample products. Below is
the distance traveled data (in miles) for the last 11 months. Calculate the control limits for the I-MR
chart
Calculate the Control limits for the Individual Chart
Calculate the Control limits for the Moving Average Chart
E2 = A2 𝑛 = 1.88* 2 = 2.66
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I-MR Chart Example
Interpret the chart: If any of the points in the chart is outside of ± 3σ limit, then consider
the process is out of control. In the above example, In the above example, all the samples
are within the control limit. Hence, we assume the process is in control
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Using an I-MR Chart in a DMAIC Project
❑ Usually, for any process, assignable causes will be taken care of during Analyze and
Improve phases of DMAIC using different types of statistical tools like Regression,
Design of Experiments, etc
❑ The variation of the process due to common causes still exists while the process is
under control. And I-MR control chart will help to identify the process abnormality
due to assignable causes in a timely manner in the Control Phase of DMAIC. These
charts will only signal that there is a problem in the process
❑ Let’s say that the Project was chartered to run a DMAIC process with the stated goal
of increasing customer satisfaction via Net Promoter Scores
❑ Throughout the Measure Phase, customer complaints were measured to get a

baseline. An I-MR Chart could be used to show trends in customer complaints
Non-Business Use
94
❑ The Analyze Phase could have determined ways to remove several causes of
variation. In the Improve phase, changes could have then been made to the process
and piloted. You could use an I-MR chart, then see what the effects of the pilot
were
❑ Also, in the Control Phase, you might make continual monitoring of the I-MR Chart
part of your control plan
❑ The Six Sigma team has to identify the cause of the problem and appropriate
corrective action to be initiated. This is an iterative procedure for continuous
improvement of the process
Non-Business Use
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❑ Let’s say that the Project was chartered to run a DMAIC process with the stated goal
of increasing customer satisfaction via Net Promoter Scores. Throughout the
Measure Phase, customer complaints were measured to get a baseline. An I-MR
Chart could be used to show trends in customer complaints
❑ Later, the Analyze Phase could have determined ways to remove several causes of
variation. In the Improve phase, changes could have then been made to the process
and piloted. You could use an I-MR chart, then see what the effects of the pilot
were. Also, in the Control Phase, you might make continual monitoring of the I-MR
Chart part of your control plan.
❑ The Six Sigma team has to identify the cause of the problem and appropriate
corrective action to be initiated. This is an iterative procedure for continuous
improvement of the process. 96
Non-Business Use
Xbar Moving Range Chart (X-R)
❑ Calculate the parameters of the Xbar and R Control Charts with the following:

k
R
k
x i i UCL x = X + A 2 R UCL R = D 4 R
X= i =1
R = i
LCL x = X − A 2 R LCL R = D 3 R
k k
Where:
𝑿: Average of the subgroup averages, it becomes the Center Line of the Control Chart
𝑿𝒊 : Average of each subgroup
k: Number of subgroups
𝑹𝒊 : Range of each subgroup (Maximum observation – Minimum observation)
Rbar: The average range of the subgroups, the Center Line on the Range Chart
UCLX: Upper Control Limit on Average Chart
LCLX: Lower Control Limit on Average Chart
UCLR: Upper Control Limit on Range Chart
LCLR : Lower Control Limit Range Chart
A2, D3, D4: Constants that vary according to the subgroup sample size
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97
Xbar-Range Chart (X-R)
❑ X-bar chart: The mean or average change in a process over time from subgroup
values (measures between sub-group variation). The control limits on the X-Bar
bring the sample’s mean and center into consideration
❑ R-chart: The range of the process over time from subgroups values (measures
within sub-group variation). This monitors the spread of the process over time
❑ Assumptions of Variable charts: X-R chart

▪ Subgroup size is between two and ten observations.
▪ When the collected data is continuous (ie Length, Weight), etc. and captures data in
time order
Non-Business Use
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How to Interpret the X Bar R Control Charts
❑ To correctly interpret an X bar R chart, always examine the R chart first since the X
bar chart controls limits that are derived from the R bar (average range) values
❑ If the values are out of control in the R chart, that X bar chart is not accurate
❑ Identify the special cause and address the issue. Remove those subgroups from the
calculations. Once the R bar chart is in control, then review the X bar chart and
interpret the points against the control limits
❑ All the points need to be interpreted against the control limits but not specification
limits
❑ Process capability studies can be performed only after both the X bar and R chart
values are within the control limits. There is no need to perform process capability
studies for an unstable process
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X-R Chart Example
Example: In a manufacturing industry, plate thickness is one of the important CTQ factors. During
the Measure phase, the project team performed the process capability study and identified that the
process is not capable (less than 2 sigmas). In Analyze phase, they collected 20 sets of plate
thickness samples with a subgroup size of 4.
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X-R Chart Example
Compute X bar and R values

▪ Measure the average of each subgroup i.e
X bar, then compute the grand average of
all X bar values. This will be the center
line for the X bar chart
▪ Compute the range of each subgroup i.e

Range, then measure grand averages of
all range values i.e R bar and this will be
the center line for the R chart
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X-R Chart Example
In the previous example n=4
Non-Business Use
102
X-R Chart Example
From both X bar and R charts, most of the values are out of control, hence the process
is not stable
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X-R Chart Example
❑ Monitor the process after improvement

▪ Once the process stabilizes and control limits are in place, monitor the process performance
over a set time period
▪ Once the process is improved and matured, the team identifies the X bar R chart as one of the
control methods in the Control plan, which are used to monitor the process performance over
the time period
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X-R Chart Example
The following are the measurement values in the

Control phase of the project
Non-Business Use
105
X-R Chart Example
Calculate the Control limits
Non-Business Use
106
X-R Chart Example
From the both X bar and R charts, it is clearly evident that the process is almost stable.
During the initial phase, one value is out of control. The team has to perform a root
cause analysis for the special cause. It also seems that the process is smoothing out
from the data set number 16. If that continued, the chart would need new control limits
from that point
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X-R Chart Example
After the process is stabilized, even if any point goes out of the control limits, it
indicates an assignable cause exists in the process that needs to be addressed. This is an
ongoing process to monitor the process performance
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X-R Chart - Important notes
❑ A process that is “in control” means that the process is stable, and it is predictable
❑ Just because a process is stable does not mean it has a zero-defect process
❑ Remember to NEVER put specifications on any kind of control chart
❑ The points on the chart are comprised of averages, not individuals. Specification limits
are based on individuals, not averages
❑ The operator might have the tendency to not react to a point that is out of control when
the point is within the specification limits
❑ X bar R chart helps to avoid unnecessary adjustments in the process
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109
X Bar S Control Chart (X-S)
❑ Calculate the parameters of the Xbar and S Control Charts with the following:

k k
x i s i UCL x = X + A 3 S UCLS = B4 S
X= i =1
S= i =1
k k LCL x = X − A 3 S LCLS = B3 S
Where:
Xi : Average of the subgroup averages, it becomes the Center Line of the Control Chart
Xi: Average of each subgroup
k: Number of subgroups
si : Standard Deviation of each subgroup
Sbar: The average S. D. of the subgroups, the Center Line on the S chart
UCLX: Upper Control Limit on Average Chart
LCLX: Lower Control Limit on Average Chart
UCLS: Upper Control Limit on S Chart
LCLS : Lower Control Limit S Chart
A3, B3, B4: Constants that vary according to the subgroup sample size 110
Non-Business Use
Xbar-S Chart (X-S)
❑ X-bar chart: The mean or average change in the process over time from subgroup
values. The control limits on the X-Bar bring the sample’s mean and center into
consideration
❑ S-chart: The standard deviation of the process over time from subgroups values.
This monitors the process standard deviation (as approximated by the sample
moving range)
❑ Assumptions of Variable charts: X-S chart

▪ The X bar S chart is to be used when rationally collecting measurements in a subgroup

size is more than 10
▪ When the collected data is continuous (ie Length, Weight), etc. and captures in time
order 111
Non-Business Use
How to Interpret the X Bar S Control Charts
❑ To correctly interpret the X bar S chart, always examine the S chart first since X bar
chart control limits are derived from the S bar (average standard deviation) values
❑ If the values are out of control in S chart, that means X bar chart is not accurate
❑ Identify the special cause and address the issue. Remove those subgroups from the
calculations. Once the S chart is in control, then review the X bar chart. Afterward,
you should interpret the points against the control limits
❑ All the points are to be interpreted against the control limits but not specification
limits
❑ If any point out of control in X bar chat. Identify the special cause and address the
issue
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X-S Chart Example
Example: A packing organization monitoring the performance of a packing machine, each container
should weigh 35 lb, during the Measure phase, the project team performed the process capability
study and identified that the process is not capable(less than one sigma). In Analyze phase collected
12 sets of container weights with a subgroup size of 4
Note: To demonstrate an example, we just took

subgroup size 4 in this example. But, it is always
recommended to take 10 and above for the X bar S
chart
Non-Business Use
113
X-S Chart Example
Compute X bar and S values

▪ Measure the average of each
subgroup i.e X bar, then
compute the grand average of
all X bar values, this will be
the center line for the X bar
chart
▪ Compute the standard

deviation of each subgroup,
then measure grand averages
of all standard values ie S bar
and this will be the center
line for the S chart
Non-Business Use
114
X-S Chart Example
In the previous example n=4
Non-Business Use
115
X-S Chart Example
From the both X bar and S charts it is clearly evident that most of the values are out of
control, hence the process is not stable
Non-Business Use
116
X-S Chart Example
Control Phase – Once the process is improved and matured, the team identified the X
bar S chart as one of the control methods in the Control plan to monitor the process
performance over the time period.
The following are the measurement values in the Control phase of the project:
Non-Business Use
117
X-S Chart Example
Compute X bar and Sigma
Find the control limits
Non-Business Use
118
X-S Chart Example
From the both X bar and S charts it is clearly evident that the process is almost stable.
During the initial setup of 2nd data set both the S chart and X bar chart values are out
of control, the team has to perform the root cause analysis for the special cause and
also the process smoothing out from data set number 4. If that continued, the chart
would need new control limits from that point
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119
X-S Chart Example
Since the S chart is in statistical control, calculate the process standard deviation
After the process is stabilized, if any point still goes out of control limits, it indicates an
assignable cause exists in the process that needs to be addressed. This is an ongoing
process to monitor the process performance
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X-S Chart - Important notes
❑ A process is “in control” that indicates means of the process is stable and it can be
predictable
❑ A process is stable that does not mean it’s a zero-defect process
❑ Remember to NEVER put specifications on any kind of control chart
❑ The points on the chart are comprised of averages, not individuals. Specification limits
are based on individuals, not averages
❑ The operator might have the tendency to not react to a point out control when the point
is within the specification limits
❑ X bar S chart helps to avoid unnecessary adjustments in the process
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121
Exponentially Weighted Moving Average Control
Chart (EWMA)
❑ Calculate the parameters of the EWMA Control Charts with the following:

σ λ
Z t = λ X t + (1 − λ) Z t −1 UCL = X + 3 ( )[1 − (1 − λ) 2t ]
n 2−λ
σ λ
LCL = X − 3 ( )[1 − (1 − λ) 2t ]
Where: n 2−λ
Zt: EWMA statistic plotted on Control Chart at time t
Zt-1: EWMA statistic plotted on Control Chart at time t-1
: The weighting factor between 0 and 1 – suggest using 0.2
s: Standard Deviation of historical data (pooled Standard Deviation for subgroups
– MRbar/d2 for individual observations)
Xt: Individual data point or sample averages at time t
UCL: Upper Control Limit on EWMA Chart
LCL: Lower Control Limit on EWMA Chart
Non-Business Use n: Subgroup sample size 122
Chart (EWMA)
❑ The EWMA – Exponentially Weighted Moving Average chart is used in statistical
process control to monitor variables (or attributes that act like variables) that make
use of the entire history of a given output. This is different from other control
charts that tend to treat each data point individually
❑ The user gives each output (previous sample mean) a weighting. The most recent
samples are weighted the highest. This means you give the oldest data the least
amount of weight. The chart displays the data geometrically. This gives the
advantage of the chart not being greatly affected when a small or large value
enters the calculation
❑ The EWMA chart will detect shifts of .5 sigma to 2 sigmas much faster than
Shewhart charts with the same sample size
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Chart (EWMA)
❑ Another advantage is that each data point plotted on the chart represents a moving
average of points. Thus you can use the Central Limit Theorem to say that the
plotted points (the moving average of the subgroups) is normally distributed and
the control limits are clearly defined
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Chart (EWMA)
❑ When you have continuous data from the entire life of a process.
❑ You want to detect small shifts in the process. For larger shifts, use Shewart style
charts like the X Bar R and the X Bar S charts.
❑ When you want to measure the mean. Monitoring the process variability requires
the use of some other technique
❑ The subgroup sample size should be > 1. If the sample size in the subgroup is 1, try
using an Individual X chart
❑ When you want to smooth out the effect of uncontrollable noise in the data
Non-Business Use
125
Examples of Uses of EWMA Control Charts
❑ Detecting drift that is caused by tool wear

▪ Ex. Manufacturer produces a widget of a certain diameter. If the diameters of the widget
are off, there are consequences. Measuring using an EWMA Chart helps understand the
manufacturing machine wear and its impact on the creation of the widgets
❑ Accounting processes
▪ Ex. Day-to-day fluctuations in accounting processes may be large but may not necessarily
mean the process is unstable. The choice of lambda can be determined to make the
chart more or less sensitive to these daily fluctuations
❑ Website visitors that fluctuate depending on the day of the week.

▪ Ex. This website gets far more visitors when people are at work Monday through Thursday
compared to even Friday, the weekends, or during holidays
Non-Business Use
126
EWMA Control Charts – Important notes
❑ Your data must be time-ordered
❑ Consecutive points have the highest chance of being alike – so default to a range of
2 when possible
❑ Created for normal data but is robust enough for non-normal data sets
Non-Business Use
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Cumulative Sum chart (CUSUM)
❑ A cumulative sum chart (CUSUM) is a type of control chart used to detect the
deviation of the individual values or subgroup mean from the adjusted target value
❑ CUSUM chart is an alternative to Shewhart control charts.
❑ The basic advantage of the CUSUM chart is that it is more sensitive to the small
shift of the process mean when compared to the Shewhart charts (Individuals I-MR
or Xbar charts)
❑ The cumulative sum chart and the exponentially weighted moving average (EWMA)
charts also monitor the mean of the process, but the basic difference is unlike Xbar
charts. They consider the previous value means at each point. Moreover, these
charts are considered a reliable estimate when the correct standard deviation
exists
Non-Business Use
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When Would you Use a Cumulative Sum Chart
❑ The purpose of the cumulative sum chart (CUSUM) is to monitor the small shift in
the process mean of the samples collected at time intervals. These measurements
of samples at a given time interval represent the subgroups
❑ Instead of calculating the subgroup’s mean independently, the CUSUM chart

represents the information from current and previous samples
❑ CUSUM chart is always better than the Xbar charts to detect the small shifts of
process mean
❑ The CUSUM chart is more effective when the sample size is one. These charts are
basically used in process industries and in manufacturing
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Comparison between CUSUM and Shewhart chart
❑ CUSUM chart considers all the samples up to a current point and also considers the
current sample for measurement, whereas the Shewhart chart is based on the
single subgroup measurement
❑ CUSUM chart determination of out-of-control limit is based on decision interval

whereas, the Shewhart chart is based on control limits (upper and lower control
limits)
❑ CUSUM chart the control limits are computed from average run length spec,
whereas the Shewhart chart control limits are generally at the three-sigma limits
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Advantages & disadvantages of the CUSUM chart
❑ Advantages of the CUSUM chart
▪ CUSUM chart is the best way to detect the small shifts of process mean
especially 0.5 to 2 SD from the target mean
▪ It is easy to identify visually the shifts in the process mean
❑ Disadvantages of the CUSUM chart
▪ Establishing and maintaining CUSUM charts are more difficult
▪ CUSUM charts are slower in detecting large process mean shift
▪ Since CUSUMs are correlated, it is tough to interpret the patterns
Non-Business Use
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Control Methods/Effectiveness for SPC
132
11/13
Non-Business Use /2023
SPC Overview: Control Methods/Effectiveness
Type 1 Corrective Action = Countermeasure: improvement made to the process which
will eliminate the error condition from occurring. The defect will never be created. This is
also referred to as a long-term corrective action in the form of mistake proofing or design
Best
changes.
Type 2 Corrective Action = Flag: improvement made to the process which will detect
when the error condition has occurred. This flag will shut down the equipment so that the
defect will not move forward.
SPC on X’s or Y’s with fully trained operators and staff who respect the rules. Once a
chart signals a problem everyone understands the rules of SPC and agrees to shut down
for Special Cause identification. (Cpk > certain level).
Type 3 Corrective Action = Inspection: implementation of a short-term containment

which is likely to detect the defect caused by the error condition. Containments are
typically audits or 100% inspection.
SPC on X’s or Y’s with fully trained operators. The operators have been trained and
understand the rules of SPC, but management will not empower them to stop for
investigation.
S.O.P. is implemented to attempt to detect the defects. This action is not sustainable
short-term or long-term.
SPC on X’s or Y’s without proper usage = WALL PAPER.

Worst
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❑ The most effective form of control is called a type 1 corrective action. This is a
control applied to the process which will eliminate the error condition from
occurring. The defect can never happen. This is the “prevention” application of the
Poka-Yoke method
❑ The second most effective control is called a type 2 corrective action. This a
control applied to the process which will detect when an error condition has
occurred and will stop the process or shut down the equipment so that the defect
will not move forward. This is the “detection” application of the Poka-Yoke method
Non-Business Use
135
❑ The third most effective form of control is to use SPC on the X’s with appropriate
monitoring on the Ys. To be effective, employees must be fully trained, they must
respect the rules and management must empower the employees to take action.
Once a chart signals a problem, everyone understands the rules of SPC and agrees
to take emergency action for special cause identification and elimination
❑ The fourth most effective correction action is the implementation of a short-term

containment which is likely to detect the defect caused by the error condition.
Containments are typically audits or 100% inspection
❑ Finally you can prepare and implement an S.O.P. (standard operating procedure) to
attempt to manage the process activities and to detect process defects. This
action is not sustainable, either short-term or long-term
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Detection of Assignable Causes or Patterns
❑ Control Charts indicate Special Causes being either assignable causes or patterns.
❑ The following rules are applicable for both variable and Attribute Data to detect
Special Causes
❑ These four rules are the only applicable tests for Range (R), Moving Range (MR) or
Standard Deviation (S) charts
▪ One point more than 3 Standard Deviations from the Center Line
▪ 6 points in a row all either increasing or all decreasing
▪ 14 points in a row alternating up and down
▪ 9 points in a row on the same side of the center line
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Detection of Assignable Causes or Patterns
❑ These remaining four rules are only for variable data to detect Special Causes
▪ 2 out of 3 points greater than 2 Standard Deviations from the Center Line on the same
side
▪ 4 out of 5 points greater than 1 Standard Deviation from the Center Line on the same
side.
▪ 15 points in a row all within one Standard Deviation of either side of the Center Line.
▪ 8 points in a row all greater than one Standard Deviation of either side of the Center
Line.
❑ VERY few organizations use all 8 rules for detecting Special Causes
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Recommended Special Cause Detection Rules
❑ These 3 rules are visually the most easily detected by personnel

▪ One point more than 3 Standard Deviations from the Center Line
▪ 6 points in a row all either increasing or all decreasing
▪ 15 points in a row all within one Standard Deviation of either side of the Center Line
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WECO Rules for all charts
❑ Western Electric Rules are the original set of four control chart rules used to
conduct stability analysis. Western Electric Rules can be used with all control charts
and are sometimes referred to as WECO Rules
❑ Western Electric rules are triggered when:
▪ One point above UCL or below LCL
▪ Two out of the three points either above or below 2 sigma
▪ Four out of five points above/below 1 sigma
▪ Eight points in a row above/below the center line
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Special Cause Rule Default in MINITAB
❑ If a Belt is using MINITAB, you must be aware of what default settings for the rules.
You can alter your program defaults with:
Tools>Options>Control Charts and Quality Tools> Tests
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Special Cause Rule – Rule 1
❑ This is the MOST common Special Cause test used in SPC charts
Test 1 One point beyond zone A

1
A
B
C
C
B
A
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142
❑ This test is an indication of a shift in the process Mean
Test 2 Nine points in a row on

same side of center line
A
B
C
C
B 2
The amount away from the Center Line does not matter as long as the
consecutive points are all on the same side of the Center Line
Non-Business Use
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❑ This test is indicating a trend or gradual shift in the Mean
Test 3 Six points in a row, all

increasing or decreasing
A 3
B
C
C
B
A
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144
❑ This test is indicating a non-random pattern
Test 4 Fourteen points in a

row, alternating up and down
A
B
C
C 4
B
A
This rule does not depend on the points being in any particular zone of the
chart. Also note the process is not considered to be out of control until after
the 14th point has followed the alternating up and down pattern.
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145
❑ This test is indicating a shift in the Mean or a worsening of variation
Test 5 Two out of three points in

a row in zone A (one side of center
line)
5
A
B
C
C
B
A 5
It is not required that the points more than 2 sigma away be in consecutive order,
they just have to be within a group of 3 consecutive points on the same side
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146
❑ This test is indicating a shift in the Mean or degradation of variation
Test 6 Four out of five points in

zone B or beyond (one side of
center line)
6
A
B
C
C
B 6
Only the 4 points that were more than one sigma need to be on the same side
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147
❑ This test is indicating a dramatic improvement of the variation in the process
Test 7 Fifteen points in a row in

zone C (both sides of center line)
A
B
C
C 7
B
A
You might think this is a good thing but you need to investigate to find the Special
Cause so the improvement can be sustained in the future
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148
.
❑ This test is indicating a severe worsening of variation
Test 8 Eight points in a row

beyond zone C (both sides of
center line)
A
B
C
C
B 8
The eight consecutive points can be any number of sigma away from the Center Line
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Responding to Out of Control Indications
❑ The power of SPC is not to find out what the Center Line and Control Limits are
❑ The power is to react to the Out of Control (OOC) indications with your Out of
Control Action Plans (OCAP) for the process involved. These actions are your
corrective actions to correct the output or input to achieve proper conditions
❑ SPC requires immediate response to a Special Cause indication
❑ Variability will increase if operators always adjust on every point if not at the
Center Line. ONLY respond when an Out of Control or Special Cause is detected
❑ Training is required to interpret the charts and response to the charts
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Size of Subgroups
❑ Typical subgroup sizes are 3-12 for variable data where the subgroup size for
Attribute Data is often 50 – 200
❑ Size of subgroups aid in detection of shifts of Mean indicating Special Cause exists.
The larger the subgroup size, the greater chance of detecting a Special Cause
Lot 1 Lot 5
Lot 3
Lot 2
Lot 4
Short-term studies
Long-term study
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151
Size of Subgroups
Sources of Variation
- Natural Process - Natural Process Variation - Natural Process Variation
Variation as defined by - Different Operators - Different Operators
subgroup selection - Supplier Source
You really want to

-UCL have subgroups
with only Common
-LCL Cause variation so
if other sources of
variation are
detected
First select the spread that
we will declare as the
“Natural Process
Variation”, so whenever So, when a second And, of course, if two additional
any point lands outside source of variation sources of variation arrive we will
these “Control Limits”, an appears, we will know! detect that too!
alarm will sound
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Sampling Frequency
❑ Sampling Frequency is a balance between cost of sampling and testing versus cost
of not detecting shifts in Mean or variation.
❑ Process knowledge is an input to frequency of samples after the subgroup size has
been decided.
▪ If a process shifts but cannot be detected because of too infrequent sampling, the
customer suffers
▪ If choice is given of large subgroup samples infrequently or smaller subgroups more

frequently, most choose to get information more frequently.
▪ In some processes, with automated sampling and testing frequent sampling is easy.
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153
Sampling Frequency
❑ If undecided as to sample frequency, sample more frequently to confirm detection

of process shifts and reduce frequency if process variation is still detectable.
❑ A rule of thumb also states “sample a process at least 10X more frequent than the
frequency of ‘out of control’ conditions”
❑ You do NOT want to under sample and not have the ability to find Special Cause
variation easily
❑ Also do not be afraid to sample more frequently and then reduce the frequency if it
is clear Special Causes are found frequently
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154
Sampling Frequency
I Chart of Sample_3
Output
Sampling too
7.5
UCL=7.385
All possible samples 7.0

7.5
little will not
Individual Value
6.5
7
_
6.5
6
6.0
X=6.1
allow for
5.5
5.5
sufficient
5 5.0
Sample every half hour
detection of
LCL=4.815
1 7 13 19 25 31 37
1 2 3 4 5 6 7 8 9 10 11 12 13
Observation
I Chart of Sample_6 I Chart of Sample_12

shifts in the
6.6
UCL=8.168 UCL=6.559
8
6.4 process because
6.2
7
of Special
Individual Value
Individual Value
6.0
_ _
X=6.129 X=5.85
6 5.8
5.6 Causes
5
Sample every hour 5.4 Sample 4x per shift
5.2
LCL=5.141
4 LCL=4.090
5.0
1 2 3 4 5 6 7 1 2 3 4
Observation Observation
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155
Sub-grouping And Sampling Guidelines
❑ Control Charts are usually derived from samples taken from the larger population
❑ Sampling must be collected in such a way that it does not bias or distort the
interpretation of the Control Charts
❑ If there is any special treatment or bias given to the process over the period the
data is collected, the Control Chart interpretation will be invalid
❑ The frequency of sampling depends on the volume of activity and the ability to
detect trends and patterns in the data
❑ At the onset, you should error on the side of taking extra samples, and then, if the
process demonstrates its ability to stay in control you can reduce the sampling rate
❑ Using rational subgroups is a common way to assure that this does not happen
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156
❑ A rational subgroup is a sample of a process characteristic in which all the items in

the sample were produced under very similar conditions and in a relatively short
time period
❑ Rational subgroups are usually small in size, typically consisting of 3 to 5 units to

make up the sample
❑ It is important that rational subgroups consist of units that were produced as closely
as possible to each other, especially if you want to detect patterns, shifts and drifts
▪ If a machine is drilling 30 holes a minute and you wanted to collect a sample of

hole sizes, a good rational subgroup would consist of 4 consecutively drilled
holes. The selection of rational subgroups enables you to accurately distinguish
Special Cause variation from Common Cause variation
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❑ Make sure that your samples are not biased in any way, meaning that they are
randomly selected
❑ For example, do not plot only the first shift’s data if you are running multiple shifts.
Don’t look at only one vendor’s material if you want to know how the overall
process is really running
❑ Finally, don’t concentrate on a specific time to collect your samples; like just
before the lunch break
❑ If your process consists of multiple machines, operators or other process activities

that produce streams of the same output characteristic you want to control it
would be best to use separate Control Charts for each of the output streams
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❑ If the process is stable and in control, the sample observations will be randomly
distributed around the average
❑ Observations will not show any trends or shifts and will not have any significant
outliers from the random distribution around the average
❑ This type of behavior is to be expected from a normally operating process and that
is why it is called Common Cause variation
❑ Unless you are intentionally trying to optimize the performance of a process to

reduce variation or change the average, as in a typical Six Sigma project, you
should not make any adjustments or alterations to the process if is it demonstrating
only Common Cause variation. That can be a big time saver since it prevents “wild
goose chases.”
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159
❑ If Special Cause variation occurs, you must investigate what created it and find a
way to prevent it from happening again
❑ Some form of action is always required to make a correction and to prevent future
occurrences
❑ Specification limits are not evaluated when using a Control Chart
❑ A process in control does not necessarily mean it is capable of meeting the

requirements. It only states that it is stable, consistent and predictable. The ability
to meet requirements is called Process Capability, as previously discussed
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160
Caution!
❑ Do not sort data (need original time order)
❑ Range charts out of control results in loss of ‘signal’
❑ Control limits not same as specification limits
❑ Control limits are determined by listening to the process
❑ Specification limits are determined by listening to the customer
❑ Special cause variation may occur within control limits
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161
Key Learning Points
Wk 2-Pg 162
Aspects Of Control
Operational Method
Written Instructions
Verbal Instructions
(Mistake Proofing)
Sheets (OMS)
Poka - Yoke
DFSS
SPC
AMOUNT OF CONTROL
Amount of Effort
Employ the Control Technique that ensures the Greatest Control

with the Least Amount of On-Going Effort from the Process
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Mistake Proofing Origins
❑ Poka-Yoke
❑ Shigeo Shingo developed it to achieve zero defects
❑ Translated into “mistake proofing” (“fool-proofing”)
❑ Used to avoid inadvertent errors
❑ Immediate action – Worker oriented
Poka-Yoke: To avoid (yokeru) inadvertent errors (poka)
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Why Is Mistake Proofing Important?
❑ Improved quality and customer satisfaction
❑ Prevents defect occurrence
❑ If defects occur, ensures effective action
❑ Little or no formal training
❑ Cost effective
❑ Easy to implement
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165
What Is Mistake Proofing (Poka-Yoke)?
❑ Japanese phrase: Yokeru (to avoid), Poka (errors)
❑ A strategy for preventing errors in processes
❑ Makes it impossible for defects to pass unnoticed
❑ Corrects problems as soon as they are detected
❑ Technique detects defects
❑ Prevents defects from moving into next area
❑ Developed by Dr. Shigeo Shingo to achieve zero defects
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Basics To Poka-Yoke
❑ Effective mistake proofing requires two basic concepts
❑ A focus on controlling the factors which cause errors – Not fixing the resulting defective
output
❑ Inspection which is effective and tireless
Can not do it wrong. Can only do it one way. If wrong, detected

100%. Can not be passed into next area
Non-Business Use
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Every Day Examples Of Mistake Proofing
❑ Guide Pins of Different Sizes ❑ Error Alarms
❑ Optical Magnification ❑ Counters
❑ Different Colored Tags for Pressure Ranges ❑ Checklists
❑ Look Up Tables for Data Base Entry ❑ Asymmetric Parts
❑ Spell Check ❑ Build Error Checking Into Control Logic
❑ Limit Switches ❑ Exact Part Count
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168
Mistake Proofing Business Processes
Mistake Proofing is the primary

means of control for many business
processes
- Check digits
- Pull down menus
- Check sheets
- One over One
- Required fields
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Evolution Of Defectives
This is what we want

to control/monitor ERRORS
Critical x’s
(Misspelling)
DEFECTS
Opportunities
(Name Field)
DEFECTIVES
Units
(Enrollment Application)
Errors are the cause of defects…an error occurs when the

Non-Business Use
conditions for successful processing are either incorrect or absent 170
Root Cause Further Evolved
RED
FLAGS
Conditions
(Illegible Handwriting)
Causes ERRORS
Critical x’s
(Misspelling)
Failure Mode DEFECTS

Opportunities
( Name Field)
DEFECTIVES
Failure Effects
Units
(Enrollment Application)
Can we prevent illegible handwriting?

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Red Flag Condition
❑ What is a Red Flag condition?
❑ You will find that in some projects, after you have identified the KPIVs and their optimal
settings, one or more of them may be extremely difficult to control. The control plan
should attempt to provide robust control mechanisms, however it may be difficult to do
so without mistake proofing. Some examples:
▪ Training was found to be critical, but the operation has 150% turnover
▪ Cycle times are very long, so the operators tend to lose concentration and KPIV
breakdowns may not be observed even though gages/process measurements show
the issue
Mistake proofing is a good control application

for conditions such as these
Non-Business Use
172
Improvement Phase Principles Red Flag
Conditions
❑ Frequent changes to a job
❑ Complex processes
❑ Lack of standards
❑ Lack of measurement systems
❑ Lack of training
❑ Long cycle times
❑ Infrequent jobs
❑ High output
❑ Environmental conditions
❑ Attitude (Motivation)
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173
Strategies For Errors
Ten Most Common Use the Highest Solution

Process Errors Principle Possible
1. Processing omissions Elimination/Prevention

2. Processing errors
3. Error in setting up job Replacement
4. Assembly omissions
5. Inclusion of incorrect component
6. Incorrect job Facilitation – hidden factory
7. Operation error
8. Measurement error Detection
9. Tool or equipment error
10. Defects in job components Mitigation – moderate
or lessen the impact
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Mistake Proofing Strategies
Detect defects
before they move
to next step
Detect errors during

processing
Prevent errors
from occurring
Good Best
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175
Mistake Proofing Human Errors
1. Forgetfulness (not concentrating)
2. Errors due to misunderstanding
(jump to conclusions)
3. Errors in identification (view
incorrectly… too far away)
4. Errors made by untrained workers
5. Willful errors (ignore rules)
6. Inadvertent errors (distraction, fatigue)

7. Errors due to delay in decision-making
8. Errors due to lack of standards
(written & visual)
9. Surprise errors (machine not
capable, malfunctions)
10. Intentional errors (sabotage - least
common)
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176
Selecting Solutions
❑ Selecting improvements to implement:

▪ High-level objective evaluation of all potential improvements
▪ Impact of each improvement
▪ Cost to implement each improvement
▪ Time to implement each improvement
▪ Balance desire with quantifiable evaluation
▪ Engineering always wants the gold standard
▪ Sales always wants inventory
▪ Production always wants more capacity
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177
Selecting Solutions
❑ The tool for selecting defect prevention methods is unnecessary for just a few changes to
the process. Many projects with smaller scopes have few, but vital control methods put into
the process
❑ Selecting solutions comes down to a business decision. The impact, cost and timeliness of
the improvement are all important. These improvement possibilities must be balanced
against the business needs. A cost benefit analysis is always a good tool to use to assist in
determining the priorities
❑ Recall the progression of a Six Sigma project? Practical Problem – Statistical Problem –
Statistical Solution – Practical Solution. Consider the Practical Solutions from a business
decision point of view
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Impact of the improvement
❑ Time frame of improvements

▪ Long-term vs. Short-term effectiveness: if a supplier will lose a major customer because of
defects, the short term benefit will prevail first
❑ Effectiveness of the improvement types

▪ Removing the Root Cause of the defect
▪ Monitoring/flagging for the condition that produces a defect
▪ Inspecting to determine if the defect occurred
▪ Training people not to produce defects
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Cost to implement improvement
❑ Initial cost to implement improvement

▪ Cost to train existing work force
▪ Cost to purchase any new materials necessary for improvement
▪ Cost of resources used to build improvement
▪ Any capital investments required
❑ On-going costs to sustain improvement

▪ Future training, inspection, monitoring and material costs
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180
Time to implement improvement
❑ Technical time constraints

▪ What is the minimum time it would take to implement?
▪ Time to build/create improvement, time to implement improvement
❑ Political time constraints

▪ What other priorities are competing for the technical time to build the improvement?
❑ Cultural time constraints

▪ How long will it take to gain support from necessary stakeholders?
Non-Business Use
181
Improvement Selection Matrix
Implementing this familiar tool to prioritize proposed improvements is based on the three
selection criteria of time, cost and impact
❑ All the process outputs are rated in terms of their relative importance to the process
❑ The outputs of interest will be the same as those in your X-Y Matrix
❑ The relative ranking of importance of the outputs are the same numbers from the updated
X-Y Matrix
❑ Each potential improvement is rated against the three criteria of time, cost, and impact
using a standardized rating scale
❑ Highest overall rated improvements are best choices for implementation
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183
❑ The significance rating is the relative ranking of outputs. If one output is rated a 10, and it
is twice the importance of a second output, the rating for the second output would be a 5.
❑ Items on the left having more impacts on multiple outputs will have a higher overall impact
rating. The cost and timing ratings are multiplied against the overall impact rating
❑ The improvements listed with the highest overall ratings are the first to get consideration.
❑ The range of impact ratings can be zero to seven
❑ An impact of zero means no impact
❑ The cost and timing ratings are rated zero to seven. With zero being prohibitive in the cost
or timing category
Non-Business Use
184
Improvement Selection Matrix Project Outputs
❑ Primary and Secondary Metrics of your Project
▪ List each of the Y’s across the horizontal axis
▪ Rate the importance of the process Y’s on a scale of 1 to 10 where 1 is not very
important, 10 is critical
▪ The Significance rankings must match your updated X-Y Matrix rankings
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185
Impact Ratings
7 X's are removed from impacting the process output.
Continual control and adjustment of critical X's impacting the
6
process output.
Continual control of critical X's prevents defects in the process
5
output from X.
Defect detection of the process output prevents unknown defects
4
from leaving the process.
3 Process inspection or testing is improved to find defects better.
Process is improved with easier control of a critical X impacting the
2
process output.
1 Personnel are trained about X's impact on the process output.
0 X's have no impact on the process output.
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186
Cost to Implement Ratings
Improvement Costs are minimal with upfront and ongoing
7
expenses.
Improvement Costs are low and can be expensed with no capital
6
authorization and recurring expenses are low.
Improvement Costs are low and can be expensed with no capital
5
authorization and recurring expenses are higher.
Medium capital priority because of relative ranking of return on
4
investment.
Low capital priority because of relative ranking of return on
3
investment.
High capital and ongoing expenses make a low priority for capital
2
investment.
High capital and/or expenses without acceptable return on
1
investment.
Significant capital and ongoing expenses without alignment with
0
business priorities. 187
Non-Business Use
Time to Implement Ratings

7 Less than a week to get in place and workable.
6 7 - 14 days to get in place and workable.
5 2 - 8 weeks to get the improvement in place and workable.
4 2 - 3 months to get the improvement in place and workable.
Over a year to get the improvement in place and workable. All
0
above times include time for approvals process.
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188
Example of Completed Solution Selection
Matrix
Plenty of bottled water

Outside noises do not
interfer with speakers
Food choices include

Coffee is hot and rich
"healthy choices"
OVERALL
COST TIME OVERALL
IMPACT
RATING RATING RATING
available
RATING
tasting
Significance Rating 10 9 8 9
Impact Impact Impact Impact
Potential Improvements Rating Rating Rating Rating
1 Hotel staff monitors room 2 2 6 0 86 7 7 4214
2 Mgmt visits/leaves ph # 2 0 4 0 52 7 7 2548
3 Replace old coffee makers/coffee 0 7 0 0 63 3 6 1134
4 Menus provided with nutrition info 0 0 0 4 36 5 5 900
5 Comp. gen. "quiet time" scheduled 6 0 0 0 60 3 3 540
6 Dietician approves menus 0 0 0 7 63 5 2 630
Improvements with the higher overall rating should be given first priority.
Keep in mind that long time frame capital investments, etc. should have
parallel efforts to keep delays from further occurring.
Improvement Selection Matrix Output
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189
Implementing Solutions in Your Organization
❑ Implementation plans should emphasize the need to:
▪ Organize the tasks and resources

Once you’ve decided on your selection
▪ Establish realistic time frames and deadlines of defect reduction solutions, you need
to plan those solutions
▪ Identify actions necessary to ensure success
A plan should include timelines, critical
❑ Components of an implementation plan include: milestones, project review dates and
specific actions noted for success in
▪ Work breakdown structure
your solution implementation
▪ Influence strategy for priorities and resourcing
▪ Risk management plan
▪ Audit results for completion and risks
❑ All solutions must be part of Control Plan Document

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190
Control Plan
Wk 2-Pg 191
End of Control: Your Objectives
❑ You’ve already decided on the some defect reduction methodology
❑ Final decisions need to clarify which defect reduction tools to use
❑ Capital expenditures may be required
❑ Training hurdles to overcome
❑ Management buy-in not completed
❑ This module will help select solutions with a familiar tool
❑ The Control Phase allows the Belt and its team to tackle other processes in the future
❑ The elements of a Control Phase aid to document how to maintain the process
❑ This module identifies the elements of strong Control Plans
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What is a Control Plan?
❑ Written summary describing systems used for monitoring/controlling process or product

variation
❑ Document allowing team to formally document all control methods used to meet
project goal
❑ Living document to be updated as new measurement systems and control methods are
added for continuous improvement
❑ ESSENTIAL portion of final project report

▪ Final projects are organizationally dependent (Informal or formal)
▪ Filed as part of project tracking mechanism for organization
o Track benefits
o Reference for sustained results

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WHO Should Create a Control Plan
❑ The team working on the project!!!!
❑ ANYONE who has a role in defining, executing or changing the process:
▪ Associates
▪ Technical Experts
▪ Supervisors
▪ Managers
▪ Site Manager
▪ Human Resources
Non-Business Use
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Why Do We Need a Control Plan?
❑ Project results need to be sustained
❑ Control Plan requires operators/engineers, managers, etc. to follow designated control

methods to guarantee product quality throughout system
❑ Allows a Belt to move onto other projects!
❑ Prevents need for constant heroes in an organization who repeatedly solve the same
problems
❑ Control Plans are becoming more of a customer requirement
Non-Business Use
195
Control/Feedback Logic
❑ If the error has not occurred we might be able to prevent the error using
control/feedback logic
Error about to occur Error has occurred
Defect about to Defect has

occur (Prediction) occurred
(detection)
Warning signal Warning signal
Control/feedback Mistake Proof Control/feedback
Shutdown Shutdown
Look At Mistake Proofing In Conjunction With The FMEA

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196
Control Phase - Breakthrough Methodology
Live & Breathe the Principles of Six Sigma

Leader Champion Belt

1. Who is the Customer X X X
DM 2. Determine the Project Y (Need + Measure + Spec) X X X
3. Validate Data Integrity of Y (Dirty Data Until Proven Clean) X X X
Y

4. Establish the Baseline/Current Capability (Sigma/DPMO) X
A 5. Define the Performance Objectives (DPMO Reduction, $$ Opportunity) X X X
6. Identify the Sources of Variation ( Possible Xs) X

7. Determine Critical Xs (Trivial Many vs. Critical Few) X
I 8. Discover Viable Solutions (Identify the Function/Confirm the Xs) X
9. Establish Specs of Xs (How much/little X do we need?) X X X
X

10. Validate Data Integrity For The Xs (GRR) X
C 11. Determine Process Capability of the Xs X
12. Prove Process Can Sustain Improvements?) X X X
You Know That Six Sigma Is Baked-In When You Can’t Tell The
Difference Between an Operations or a Quality Review!
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Control Phase Deliverables
❑ Validate the Data Integrity for the Xs (GRR)
▪ Long Term Gauge Control Plan
❑ Determine Process Capability of the Xs
▪ Continuous vs. Attribute
❑ Prove the Process Can Sustain Improvements (How will we maintain the change?)
▪ Control Plan
We Have Changed The Process Performance –

Can We Maintain It?
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Control Phase - Long Term Gauge Control Plan
❑ Long term gauge control is the management of the data collection process
❑ Remember, the quality of our process cannot be understood or controlled without

understanding of the quality of our measurements
Long term process control is dependent on the control of the data

collection process
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Control Phase - Long Term Gauge Control Plan
GRR
Y X
CTQ Measure Spec Baseline Critical X Solution
On Time Order To 10 Days 2.3 Zst Shipper Not Notify Shipper
Delivery Receipt DPMO Notified In 5 days out
Time
❑ What was your initial baseline GRR(Y)? Is this data collection method still
appropriate for the long term?
❑ Who will/does own the data collection process?
❑ How often will the data collection process need to be checked?
This is where an FMEA can help as one document for the entire control
plan. What we hand-over to people of the process should be considered
and thought through very clearly. Remember, it’s behavioural issues that
will cause the process to regress to where it started 200
Non-Business Use
Control Phase Capability Of Xs
CTQ Measure Spec Baseline Critical X Solution

On Time Order To 10 Days 2.3 Zst Shipper Not Notify Shipper
Delivery Receipt DPMO Notified In 5 days out
Time
Y
Zst 3.2
Step 4 in Breakthrough applies to the capability of the Y.

Step 11 applies to the capability of the Xs
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The Control Plan - Manufacturing Example
Manufacturing Control Plans

Part Name/Family: Prepared by: D Summer Page: of 1 of 2
Part Number: BR400 Approved by: AJ Kiefer Document No.: TBD
Plant Corona Approved by: Rev. Date: NEW
(Shop Area): Line 9 Finishing Approved by: Supercedes:
Mach/Oper. Characteristic/ Specification/ Measurement Sample Who Where Decision Rule/ Reference
Check Parameter CTQ Requirement Method Size Frequency Measures Recorded Corrective Action Number
Aging Contaminated Y No oxidized 30 minute 1 lamp/ Each shift Aging Aging No part oxidation after MV-671
Head Atmosphere parts burn head/ start-up Oper. Chart 30 min. burn. Contact
Check mach. MA
Vacuum Manifold Y 2 torrmax Hastings 1 reading Once/4 MA Vacuum See troubleshooting MV-672
Check vacuum pres. analog meter hours Chart map
Exhaust Machine PM
Vacuum traps Must be clean Replace felts Each trap Once/week MA Log Clean lines and elbows MV-675
minimum
Compression No cracks Visual Each head Once/week MA Log Replace as required MV-675
rubber/chuck No leaks
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Control Plan Business Process Example
Specification
Sub Sub Process CTQ Measurement Who Where Decision Rule/
Specification Requirement Sample Size Frequency
Process Step Method Measures Recorded Corrective Action
KPOV/KPIV Characteristic USL LSL
Order Line item ordered X price SAP field every line every Order entry
/X no difference SAP Auto e-mail CSR
entry check = extended check item/order order DB
Special
Order Ord # includes SPA field not every CSR Hold order Auto E-
pricing X/ Visual 1 / order CSR
entry SPA # blank order database mail CSR
agreement
Also, include references to SOP documents

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Control/Response Plan - Elements
Business Process
❑ Business Process teams may use an FMEA ▪ Process Owner & procedures
as their control plan document ▪ Sampling Method and frequencies
❑ Control Plans may contain the following ▪ Contingency Plans
elements: ▪ Early warning indicators
▪ CTQ ▪ Consistency documents
▪ Process Name ▪ Process Flow Diagrams
▪ Spec ▪ FMEAs
▪ Baseline and Improvement Sigma's &

DPMOs
▪ Critical To Process specs (x’s)
The control plan will keep defects low by keeping processes centered
and providing timely information when the Xs begin to shift 204
Non-Business Use
Control Plan Elements
Control Plan
Documentation Response
Plan Plan Process owners
accountable to
Aligning maintain new
Systems Training level of
Monitoring process
& Structures Plan Plan performance
Implemented Verified Financial Impact

Improvements
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205
Control Plan Information
❑ The team develops the Control Plan by utilizing all available information from the
following:
▪ Results from the Measure and Analyze Phases
▪ Lessons learned from similar products and processes
▪ Team’s knowledge of the process
▪ Design FMEAs
▪ Design reviews
▪ Defect Prevention Methods selected
❑ Control Plans use all of the information from the previous phases of your project and
the Defect Prevention methods selected. Control Plans may not be exciting because you
are not doing anything new to the process but stabilizing in for the future
Non-Business Use
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Training Plan
Who/What organizations require training?
❑ Those impacted by the improvements

Training
▪ People who are involved in the process/Impacted by the improvement
Plan
▪ People who support the process
❑ Those impacted by the Control Plan

▪ Process owners/managers
▪ People who support the processes involved in the Control Plan
▪ People who will make changes to the process in the future
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Training Plan
Who will complete the training?
❑ Immediate training
Training
▪ The planning, development and execution is a responsibility of the project team
Plan
▪ Typically some of the training is conducted by the project team
❑ Qualified trainers
▪ Typically owned by a training department or process owner
▪ Those who are responsible for conducting the on-going training must be identified
❑ Specific training materials need developing

▪ PowerPoint, On the Job Checklist, Exercises, etc
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Training Plan
❑ When will training be conducted?
❑ What is the timeline to train everyone on the new process(es)?

Training
❑ What will trigger ongoing training? Plan
▪ New employee orientation?
▪ Refresher training?
▪ Part of the response plan when monitoring shows performance degrading?
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Training Plan Outline
Integration into
Schedule for Ongoing New Final Location of
Who Will Create Training Modules Who Will be Schedule for Employee Employee
Training Module Modules Completion Trained Training Trainer(s) Training Manuals
Training
Plan
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Documentation Plan
Documentation
❑ Documentation is necessary to ensure that what has been learned from the
Plan
project is shared and institutionalized:
▪ Used to aid implementation of solutions
▪ Used for on-going training
❑ This is often the actual Final Report some organizations use
Documentation must be kept current to be useful
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Documentation Plan
Documentation
Items to be included in the Documentation Plan:
Plan
❑ Process documentation
▪ Updated Process Maps/flowcharts
▪ Procedures (SOP’s)
▪ FMEA
❑ Control Plan documentation
▪ Training manuals
▪ Monitoring plan—process management charts, reports, sops
▪ Response plan—FMEA
▪ Systems and structures—job descriptions, performance management objectives

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Documentation Plan
Documentation
Assigning responsibility for Documentation Plan:
Plan
❑ Responsibility at implementation
▪ Belt ensures all documents are current at hand off
▪ Belt ensures there is a process to modify documentation as the process changes in place
▪ Belt ensures there is a process in place to review documentation on regular basis for
currency/accuracy
❑ Responsibility for ongoing process (organizationally based)

▪ Plan must outline who is responsible for making updates/modifications to documentation as
they occur
▪ Plan must outline who is responsible to review documents—ensuring currency/accuracy of

documentation
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Documentation Plan Outline
Documentation
Plan
Update/
Items Immediate Review
Document Modification
Necessary Responsibility Responsibility
Responsibility
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Monitoring Plan
❑ Purpose of a Monitoring Plan:

▪ Assures gains are achieved and sustained
Monitoring
▪ Provides insight for future process improvement activities
Plan
❑ Development of a Monitoring Plan:
▪ Belt is responsible for the development of the monitoring plan
▪ Team members will help to develop the plan
▪ Stakeholders must be consulted
▪ Organizations with financial tracking would monitor results
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Monitoring Plan
❑ Sustaining the Monitoring Plan:

▪ Functional managers will be responsible for adherence to the monitoring plan
Monitoring
▪ They must be trained on how to do this
Plan
▪ They must be made accountable for adherence
❑ Knowledge Tests:
▪ When to Sample : After training, Regular intervals, Random intervals (often in auditing sense)
▪ How to Sample
▪ How to Measure
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216
Monitoring Plan
Statistical Process Control:
❑ Control Charts
Monitoring
▪ Posted in area where data collected
Plan
▪ Plot data points real time
▪ Act on Out of Control Response with guidelines from the Out of Control Action Plan (OCAP)
▪ Record actions taken to achieve in-control results
▪ Notes impacting performance on chart should be encouraged
❑ Establishing new limits

▪ Based on signals that process performance has changed
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Monitoring Plan
❑ FMEA is a great tool to use for the Monitoring Plan
Potential C
Process Potential S Potential O Current D R Responsible S O D R
# Function
Failure Modes
(process
Failure Effects E
l
a
Causes of C Process E P
Recommend
Actions
Person &
Taken
Actions
E C E P Monitoring
(Step) (Y's) V Failure (X's) C Controls T N Target Date V C T N
defects) s
1
Plan
2
❑ Allows process manager and those involved in the process to see the entire process and
how everyone contributes to a defect free product/service.
❑ Provides the means to keep the document current—reassessing RPNs as the process
changes
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Monitoring Plan
❑ Check Lists/Matrices
▪ Key items to check
Monitoring
▪ Decision criteria; decision road map
Plan
▪ Multi-variable tables
❑ Visual Management
▪ Alerts or signals to trigger action.
o Empty bins being returned to when need stock replenished
o Red/yellow/green reports to signal process performance
▪ Can be audible also
▪ 5S is necessary for Visual Management
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Response Plan
Response
❑ Response Plans — outline process(es) to follow when there is a defect or
Plan
Out of Control from monitoring:
▪ Out of control point on Control Chart
▪ Non random behavior within Control Limits in
▪ Control Chart
▪ Condition/variable proven to produce defects present in process
▪ Check sheet failure
▪ Automation failure
❑ Response to poor process results are a must in training.
Response Plans are living documents updated with new information as it

becomes available
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Response Plan
Response
Components of Response Plan:
Plan
❑ The triggers for a response
▪ What are the Failure Modes to check for?
▪ Usually monitor the highest risk X's in the process
❑ The recommended response for the Failure Mode
❑ The responsibilities for responding to the Failure Mode
❑ Documentation of response plan being followed in a Failure Mode
❑ Detailed information on the conditions surrounding the Failure Mode
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Response Plan – Abnormality Report
Process Response
❑ Detailed documentation when failure
Metric Plan
modes occur
Current Situation
Signal
❑ Provide a method for on-going continuous Situation Code
improvement Detailed Situation
❑ Reinforce commitment to eliminating Date
Investigation of Cause
defects Code of Cause
❑ Fits with ISO 9000 standard of having a Corrective Action
CAR or Corrective Action Request Who To Be Involved
Root Cause Analysis

❑ Method to collect frequency of corrective What To Be Done
actions Date for completion of analysis
Date for implementation of permanent prevention
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Aligning Systems and Structures
❑ Systems and structures are the basis for allowing people to change their behaviors
permanently: Aligning
Systems
▪ Performance goals/objectives
& Structures
▪ Policies/procedures
▪ Job descriptions
▪ Incentive compensation
▪ Incentive programs, contests, etc
There are long- and short-term strategies for alignment of systems

and structures
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Aligning Systems and Structures
❑ Get rid of measurements that do not align with desired behaviors

Aligning
❑ Get rid of multiple measures for the same desired behaviors
Systems
❑ Implement measures that align with desired behaviors currently not & Structures
motivated by incentives
❑ Change management must consider your process changes and how the process will
respond?
❑ Are the hourly incentives hurting your chance of success?
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Aligning Systems and Structures - Project Sign
Off
❑ Best method to assure acceptance of Control Plan is having supervisors and
management for the area involved Aligning
Systems
▪ Meeting for a summary report
& Structures
▪ Specific changes to the process highlighted
▪ Information where Control Plan is filed
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Control Phase Overview—The Goal
❑ The goal of the Control Phase is to:
❑ Assess the final Process Capability
❑ Revisit Lean with an eye for sustaining the project
❑ Evaluate methods for Defect Prevention
❑ Explore various methods to monitor process using SPC
❑ Implement a Control Plan
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Organizational Change
Each “player” in the process has a role

in SUSTAINING project success achieved
❑ Accept responsibility
❑ Monitoring
❑ Responding
❑ Managing
❑ Embracing change & continuous learning
❑ Sharing best practices
❑ Potential for horizontal replication or expansion of results
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Control Phase—The Roadblocks
❑ Look for the potential roadblocks and plan to address them before they become
problems:
▪ Lack of project sign off
▪ Team members are not involved in Control Plan design
▪ Management does not have knowledge on monitoring and reacting needs
▪ Financial benefits are not tracked and integrated into business
▪ Lack of buy in of process operators or staff
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228
Control Phase Checklist
Control Questions
Step One: Process Enhancement And Control
Results
• How do the results of the improvement(s) match the requirements of the business
case and improvement goals?
• What are the vital few X’s?
• How will you control or redesign these X’s?
• Is there a process Control Plan in place?
• Has the Control Plan been handed off to the process owner?
Step Two: Capability Analysis for X and Y Process Capability
• How are you monitoring the Y’s?
Step Three: Standardization And Continuous Improvement

• How are yougoing to ensure that this problem does not return?
• Is the learning transferable across the business?
• What is the action plan for spreading the best practice?
• Is there a project documentation file?
• How is this referenced in process procedures and product drawings?
• What is the mechanism to ensure this is not reinvented in the future?
Step Four: Document what you have learned
• Is there an updated FMEA?
• Is theControl Plan fully documented and implemented?
• What are the financial implications?
• Are there any spin-off projects?
• What lessons have you learned?
General Questions
• Are there any issues/barriers preventing the completion of the project?
• Do the Champion, the Belt and Finance all agree that this projectis complete?
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Planning for Action
Non-Business Use
230
It’s a Wrap
Congratulations you
have completed Lean
Six Sigma Green Belt
Training!!!
11/13
Non-Business Use /2023

Module - 7 - Control Phase

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Module - 7 - Control Phase

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Control Phase

– Introduction to Control Phase

– Statistical Quality Control

Who is the customer?

What are the Critical X’s?

❑ Document an approved control plan encompassing all activities and documentation

❑ In an ideal project, monitor the KPOVs and control the KPIVs

STATISTICAL PROCESS CONTROL FMEA

LONG TERM MSA PLAN CHANGE/REVISION CONTROL

REACTION PLAN Control PROCESS REDISGN

Whatever actions it takes to sustain expectations.

❑ Who is the owner of the control plan?

▪ Who is the Process Owner?

▪ Who is responsible for ensuring process improvements are monitored and

❑ What controls were developed to maintain process improvements?

❑ Where in the process, is the data being collected?

▪ What type of data is being collected?

▪ What control charts are used to monitor the process?

▪ Is the process in control and how can it be verified?

❑ When should the new process be audited?

▪ When will the training schedule be communicated?

❑ How will training of new process be scheduled?

▪ How will using new process be verified?

❑ Statistical Process Control (variable and attribute)

▪ Standardized work/visual work place

❑ Select the appropriate chart for types of data

❑ Create and interpret basic attribute and variable control charts

▪ Assess process stability

▪ Assess process control

▪ Differentiate between customer specification limits (VOC) and process control

❑ Recognize within and between group variation

Visual Factory  We cannot sustain Standardized

 We cannot sustain a visual

Step Japanese Literal Translation English

Step 1: Seiri Clearing Up Sorting

Step 2: Seiton Organizing Straightening

Step 3: Seiso Cleaning Shining

Step 4: Seketsu Standardizing Standardizing

Step 5: Shitsuke Training & Discipline Sustaining

time required, resources used, resultant quality

Six Sigma projects are examples of Kaizens

❑ Kaikaku are breakthrough successes which are the Visual Factory

❑ Kaizen’s need the following cultural elements:

❑ The Japanese word for a communication signal Visual Factory

❑ The actual “Kanban” can be a physical signal such

❑ Small amount of variation (or defects)

❑ Material handlers must be trained in the organization of the transportation system

❑ It is not possible to implement a viable Kanban system without a strong support

❑ Benchmarks have organizations using up to seven years to implement a successful

The main lessons you should consider are:

▪ Indications of the need for 5S are:

o Outliers in your project metric

o Loss of initial gains from project findings

❑ The TEAM should develop Standardized Work Instructions

▪ They are required to sustain your system benefits.

▪ However, remember without an organized work place with 5S standardized work

❑ Kaizen’s and Kanban’s cannot be attempted without organized workplaces and

❑ Repair parts inventory is at an all time low

❑ Manager presents an award in honor of this achievement

❑ Ceremony conducted: Free breakfast for all techs!

❑ “Everyone should be proud of what you’ve accomplished”

Manager decides: “This group just needs tough management!