Step 12:

Implement Process Controls

Tools Included:
Introduction to Control
Statistical Process Control
Other Control Methods
Control Plan

Green Belt Training

1
Step 12: Purpose

• Implement Process Controls:

• Introduce the concepts for process control.
• Introduce the concepts of Statistical Process
Control strategies.
• Introduce other control strategies (e.g. mistake
proofing)
• Roadmap for development of an effective
Control Plan.

2
Six Sigma Breakthrough Steps
Step 1 - Select Output Characteristic
Define
- Identify Key Process Input/Output Variables
Step 2 - Define Performance Standards
Step 3 - Validate Measurement System
Measure Step 4 - Establish Process Capability
Step 5 - Define Performance Objectives
Step 6 - Identify Variation Sources
Analyze
Step 7 - Screen Potential Causes
Step 8 - Discover Variable Relationships
Step 9 - Establish Operating Tolerances
Improve
Step 10 - Validate Measurement System
Step 11 - Determine Process Capability
Control Step 12 - Implement Process Controls

3
 Step 12:
Introduction to Control

4
Discussion Topics

• Purpose
• Management Evolution
• Quality System
• Standardized Work
• The Control Plan

5
Step 12: Questions to Answer

Introduction to Control:
• Why is Control important?
• What is the Joiner Triangle?
• What is a Quality System?
• Why a Quality System?
• What is Standardized Work?
• What is a Control Plan?

6
Purpose

Introduction to Control
addresses the question:
“How can you walk away from
an improved process and be
confident that the gains will
continue?”

7
Management Evolution

• 1st Generation - Management by Doing:

– This is the simplest and most primitive approach.
– It’s an effective way to get something done, but its
capability is limited.

• 2nd Generation - Management by Directing:

– Expands your capacity by telling others exactly what
to do and how to do it.
– This approach allows experts to leverage their time by
getting others to do some of the work, and it maintains
strict compliance to the expert’s standards.
8
Management Evolution (continued)

• 3rd Generation - Management by Results:

– Let people do their job, just tell them what needs
to be done. Reward or punish based on the
results.
– A major flaw is, the possible means to achieve an
end may not have been completely honest or
legal. Employees may also feel they need to work
against each other to achieve their objectives.

9
Management Evolution (continued)

• 4th Generation - The Joiner Triangle:

– Quality: Understanding that quality is defined by
the customer and develop an obsession for
delighting customers. Understanding is no longer
the domain of special groups, it is shared with
everyone.

10
Management Evolution (continued)

• 4th Generation Style - The Joiner Triangle

(continued):
– Scientific Approach: Learning to manage the
organization as a system, developing process
thinking, basing decisions on data, and
understanding variation.
– All One Team: Believing in people; treat
everyone with dignity, trust and respect; work
toward win-win instead of win-lose for all
stakeholders.

11
Quality System

• A Quality System is an organization’s

agreed upon method of doing business.
• This is not to be confused with a set of
documents that are meant to satisfy an
outside auditing organization.
• A Quality System represents the actions, not
the written words of an organization.

12
Quality System (continued)

ACTIVITIES REQUIRED:
• Quality Policy
• Organization for Quality (not Quality
Department)
• Management Review of Quality
• Quality Planning (how to launch and control)
• Design Control
• Data Control
• Purchasing (approval of materials, evaluation of
suppliers, verification of purchased product)
13
Quality System (continued)

Quality System activities are

aimed primarily at achieving
Customer Satisfaction by
PREVENTING nonconformity at
all stages, from design through
servicing.

14
Quality System (continued)
• Quality System certifications are becoming a
customer requirement, as well as a requirement to
engage in new business opportunities.
• A solid Quality System can provide the means
through which your project will sustain its gains,
long-term.
• The control phase of this training requires that a
solid Quality System be employed in your
immediate project area.

15
Quality System (continued)

• The immediate GOAL during the Control

Phase of the Quality System Methodology:
• The TEAM should develop Standardized Work
instructions.
• The TEAM should understand and assist with
the implementation of process and product
control systems.
• The TEAM should document all of the above
and live by what they have documented.

16
Standardized Work
• The “one best way” to perform each operation is
identified and agreed upon through general
consensus.
• This becomes the “Standard” work procedure
(SOP, Standard Operating Procedures). Once the
standard has been defined, all will be expected to
perform the job according to that standard.
• We must understand that variation equals defects
and Standardized Work leads to reduced variation.

17
The Control Plan

• A “living document” which is used to

document all your process control methods.
• The control plan is a written description of the
systems for controlling parts and processes
or services.
• The control plan should be updated regularly
to reflect the addition or revision of controls
based on experience gained.

18
Step 12: Questions to Answer

Introduction to Control:
• Why is Control important?
• What is the Joiner Triangle?
• What is a Quality System?
• Why a Quality System?
• What is Standardized Work?
• What is a Control Plan?

19
Step 12: Answers Summary

Introduction to Control:
• Control is important because it allows us to
walk away from an improved process and be
confident that the gains will continue.
• The Joiner Triangle is a development of the
4th generation management style that:
– recognizes Quality as defined by the Customer;
– takes a Scientific Approach for managing the
organization as a process;
– treats everyone in the organization with respect to
ensure a team mentality.
20
Step 12: Answers Summary (continued)
Introduction to Control:
• A Quality System is the organizations agreed
method of doing business, the actions, not the
written words.
• Quality Systems are important because they
provide a means through which your project will
sustain its gains.
• Standardized Work is the “one best way” to
perform each operation of a process.

21
Step 12: Answers Summary (continued)
Introduction to Control:
• A Control Plan is a “living document” which is
used to document all your process control methods.
It includes a written description of the systems for
controlling parts and processes or services.
It must be updated to reflect the revised controls
and any process changes that occur after project
completion.

22
Step 12: Lessons Learned
Introduction to Control:
• Understanding the philosophy of process control
is a must.
• Process control makes it very clear that the
focus of the Six Sigma Breakthrough Strategy is
the Customer! Now and next month and next
year…..

23
 Step 12:
Statistical Process Control

24
Step 12: Questions to Answer

Statistical Process Control:

• What is SPC?
• What is the purpose of SPC?
• Why use Control Charts?
• What are the advantages and disadvantages of
SPC?

25
Definition & Purpose
• SPC is the basic tool for studying variation and
using statistical signals to monitor and/or improve
process performance.
• Most companies perform SPC on finished goods
(Y’s), rather than process characteristics (X’s)
• It is not until we focus our efforts on control of those
inputs (X’s) rather than control of our outputs (Y’s)
that we realize the full gain of our efforts to increase
quality, productivity, and lower costs.
• If you truly understand and control your (X’s),
you don’t even have to measure your (Y).
26
Application
• All processes have natural variability (due to
common causes) and unnatural variability (due to
special causes). Use of SPC allows us to detect
special cause variation through out-of-control
signals.
• Control Charts are the means through which
process and product parameters are tracked
statistically over time, incorporating upper and
lower control limits that reflect the natural limits of
random variability in the process.
27
Application (continued)

• Control charts allow for the identification of

unnatural (nonrandom) patterns in process
variables. The actions we take to correct
nonrandom patterns in control charts are the
key to successful SPC usage.
• Control limits are based on establishing ± 3
sigma limits for the Y or X being measured.

28
SPC Control Methods
• SPC on (X’s) or (Y’s) without proper Worst
training = WALL PAPER

– Warning Signal used to attempt to detect

defects. Operators will learn to ignore or
disconnect the warning signals once
production becomes #1 priority. PEOPLE
ACT ON WHAT THEY ARE MEASURED
ON!!!
– S.O.P is implemented to attempt to detect
defects. If action is not taken, the SPC is not
sustainable short-term or long-term.

29
SPC Control Methods (continued)
• SPC on (X’s) or (Y’s) with fully trained Better
operators. The operators have been
trained and understand the rules of
SPC, but management will not
empower them to stop or investigate.
– Operators using SPC without
management support are essentially doing
inspection. They are looking for defects,
not the causes.

30
Control Methods (continued)
• SPC on (X’s) or (Y’s) with fully trained Best
operators and staff who respects the rules.
Once a chart signals a problem everyone
understands and agrees to shut down for
special cause identification/elimination.
– Properly applied SPC that detects an error
condition will act as a flag and shut down the
equipment so defect will not move forward.
– In the best situation, SPC will predict an error
before it occurs, defect will never be created.

31
SPC Flow
Input Output
Process

X’s (SPC)/Measurement Y
System

4. Verify and Monitor 1. Detect Special

Cause

3. Implement 2. Identify Root Cause

Corrective Action

32
Control Chart Method
Step 1: Select the appropriate variable to control.
Step 2: Select the data collection point (note: if
variable cannot be measured directly, a surrogate
variable can be identified).
Step 3: Select type of control chart(s).
Step 4: Establish basis for rational sub-grouping.
Step 5: Determine appropriate sample size and
frequency.
Step 6: Determine measurement method/criteria.

33
Control Chart Method (continued)
Step 7: Determine gage capability.
Step 8: Perform initial capability study to establish
trial control limits.
Step 9: Set up forms for collecting and charting
data.
Step 10: Develop procedures for collection,
charting, analyzing and acting on information.
Step 11: Train personnel.
Step 12: Institutionalize the charting process.

34
Control Charts - Variables Data

• X-bar & R Chart

– X-bar charts measure the central tendency or mean of (Y) or (X)
over time.
– R charts measure the gain or loss of uniformity within subgroups,
which represents the random cause variability in the (Y) or (X) over
time.
– R charts are based on the range of values within each sub-group.
• Individual (I) & MR Charts:
– Also known as an individuals and moving range chart.
– Similar to the X-bar & R chart.
– Instead of charting the sub-group average and range over time,
this chart plots each individual reading and a moving range.
– An extremely simple tool for operators to use.

35
X Bar R Chart
Xbar/R Chart for Value X1-Value X3 X bar R Chart
57 UCL=56.72
56 Continuous
55
Mean=54.57 Data
54
53
LCL=52.42
52 High Volume
51
50
1 Manufacturing
Subgroup 0 1 2 3 4 5 6 7 8 9 10

6
Each subgroup
5
UCL=5.406 is an average of
4 3-5 parts
3
2 R=2.1
1 R Chart
0 LCL=0 measures
variation
X bar measures
location 36
I MR Chart
I and MR Chart for Measured Val
I MR Chart
UCL=86.00
85 Continuous Data
Mean=80.85
80 Low Volume
Manufacturing
LCL=75.69
75
Subgroup 0 5 10
Each plot point
8
UCL=7.489
represents one
7
6 part
5
4
3 R=2.909
2 MR Chart
1
0 LCL=0 measures
variation
I Chart measures
location
37
Control Charts - Attribute Data

• Attributes are individual quality characteristics.

• Attribute data reflects acceptable or unacceptable
outcomes with regard to these attributes.
• Two primary types
– Defects: individual non-conformances
– Defectives: units or parts failing to meet at least one
conformance standard
• The goal is the same, to be able to identify
specific causes of variation and take action
without over-controlling (tampering) with the
process.
38
Control Charts - Attribute Data (continued)

• Defects:
– c Charts - Simple chart used to track the
number of defects per units produced (not
the percent defective) assuming the
sample size is constant.
– u Charts - Simple chart used to track the
number of defects per units produced (not
the percent defective) assuming the
sample size is NOT constant.

39
Control Charts - Attribute Data (continued)

• Defectives:
– np Charts - Simple chart used to track the
number of nonconforming units
(percentage of defective parts) assuming
the sample size is constant.
– p Charts - Simple chart used to track the
number of non-conforming units
(percentage of defective parts) assuming
the sample size is NOT constant.

40
C Chart

C Chart for Defects C Chart

35
UCL=31.54
Counts number of
defects per lot
Sample Count

25
inspected.
C=18.6
15
All subgroups are
the same size.
5 LCL=5.662

0 1 2 3 4 5 6 7 8 9 10 Parts can have

Sample Number
more than one
defect.

41
U Chart
U Chart
U Chart for Defects

Counts
2 UCL=2.039
Numbers of
defects per unit
Sample Count

U=1.232 of production.
1

LCL=0.4242
Can handle
subgroups of
0
0 1 2 3 4 5 6 7 8 9 10
differing sizes.
Sample Number

Parts can have

more than one
defect.
42
NP Chart

NP Chart for Paycheck

NP Chart
Sample Count = mumber of defective

15 UCL=15.29

Counts number of
defective units of
paychecks PER SAMPLE

10
production for a
NP=7.3
constant lot size.
5

A part is either good

0 LCL=0 or it is defective.

0 10Sample Number 20
Each of the 20 samples measured how many defective
paychecks were in a sample of 250
43
P Chart

P Chart for Paycheck P Chart

Proportion (percent) of checks bad

0.07

0.06 UCL=0.06115 Measures percent

0.05 of defective
0.04 Production.
0.03 P=0.0292

0.02
Can handle either
constant or variable
0.01
subgroup sizes.
0.00 LCL=0

0 Sample Number 10 20 A part is either good

Each of the 20 samples measured how many defective or it is defective.
paychecks were in a sample of 250

44
Control Chart Advantages

• Proven technique for improving

productivity.
• Effective in defect prevention.
• Prevent unnecessary process
adjustments.
• Provide diagnostic information.
• Provide information about process
capability.
• Can be used for both attribute and
variable data types.
45
Control Chart Disadvantages

• Everyone must be WELL trained and

periodically retrained.
• Data must be gathered correctly.
• Mean and Range / Standard Deviation
must be calculated correctly.
• Data must be charted correctly.
• Charts must be analyzed correctly.
• Reactions to patterns in charts must be
appropriate - every time!

46
Catapult Exercise
• Break up into groups of 5 or more.
• Use measurement system of carbon paper or aluminum
foil.
• Choose an angle (no positive stops allowed)
• Keeping the angle and all other settings constant, 5
team members will each fire 5 shots. After each
operator, stop and label by operator and trial number.
Repeat the process and each fire 5 more shots.
• The rational subgroups are the groups of 5 shots per
operator.
• Enter this data into Minitab and generate and Xbar and
R chart.

47
Catapult Data Collection
OPERATOR FIRE 1 FIRE 2 FIRE 3 FIRE 4 FIRE 5

OP A TRIAL 1
1st operator fires
five shots, which
OP B TRIAL 1
are immediately
OP C TRIAL 1 recorded in top
row.
OP D TRIAL 1

OP E TRIAL 1 Be sure to identify

OP A TRIAL 2 or cross out hits
from one
OP B TRIAL 2
operator before
OP C TRIAL 2 the next operator
OP D TRIAL 2 fires.
OP E TRIAL 2

48
Catapult Exercise Discussion

• After data has been collected, we will enter

into Minitab and create a Xbar-R chart using
the “Stat>Control Charts>Xbar-R” command.
– Which chart do we evaluate first?
– Are we in control?
– What are are control limits for Xbar? For R?
– Do any operators exhibit more variation then
others?
– What else do you see?
– If there is an out of control point, what do we do?

49
Selection of Proper Chart
• Case A • C Chart
• Case B • U Chart
• Case C • P Chart
• Case D • X Bar R Chart
• Case E • Np Chart
• Case F • I MR Chart

Connect Data Set to Appropriate Chart

Case explanations will be handed out

50
Step 12: Questions to Answer

Statistical Process Control:

• What is SPC?
• What is the purpose of SPC?
• Why use Control Charts?
• What are the advantages and disadvantages of
SPC?

51
Step 12: Answers Summary
Statistical Process Control:
• SPC is a tool for studying process variation and the
statistical signals that can be used to monitor and/or improve
process performance.
• The purpose of SPC is to measure and plot the inputs
and/or the output so we can see signals indicating how the
process is running and react accordingly.
• Control Charts are the means through which process and
product parameters are tracked statistically over time. They
are predictive tools. Control Charts also allow for
identification of unnatural patterns in process variables.

52
Step 12: Answers Summary (continued)

Statistical Process Control:

• Advantages of SPC include:
– it’s a proven technique for improving productivity
– effective in defect prevention
– prevents unnecessary process adjustments
– provides diagnostic information
– can be used for both Attribute and Variable data
types.

53
Step 12: Answers Summary (continued)

Statistical Process Control

• Disadvantages of SPC include:
– everyone must be well trained and periodically
retrained
– data must be gathered correctly
– the mean, range and standard deviation must be
calculated correctly
– data must be charted correctly and then analyzed
correctly
– reactions to patterns in the charts must be
appropriate every time
54
Step 12: Lessons Learned
Statistical Process Control:
• Sufficient training is a must!
• Must use the correct chart.
• Appropriate actions must be taken.
• If charting is redundant or not being used, then
stop doing it.

55
 Step 12:
Other Control Methods

56
Other Control Methods
For continuous / discrete variables:
• Inspection and Test Methods
• Standard Operating Procedures (“SOPs”)
• Checklists
• Audits
• Mistake-proofing systems and devices
• Automated process control
• Training Systems
• Controlled Documentation
• Trouble Shooting Guides
• Reaction Plans
FMEA can be a Control Method or a key part of one of the above
57
Control Methods (continued)

Inspection and Test Methods:

• End of the line inspection or testing is the
worst type of control.
• Adding extra inspection as a solution is not a
valid six sigma approach.
Standard Operating Procedures:
• Written description of the “one best way” to
perform the operation. Can include visual
standards.

58
Control Methods (continued)

Checklists:
• Itemized list of steps or activities that must
be completed in order to assure successful
operation of process (e.g. airline pilots use
checklists prior to takeoff)
Audits:
• Independent verification that the process is
following SOP’s, checklists, etc.

59
Control Methods (continued)

Mistake Proofing:
• Levels
– Good: Detects the defects before they continue
to the next operation or the customer
– Better: Allows for the detection of errors during
processing
– Best: Makes occurrence of errors impossible!
• Examples: asymmetric parts, sensors, light
beams, alarms, color coding, others?????

60
Control Methods (continued)

Automated Process Control:

• Use of a feedback loop within a PLC
controlled system to monitor and
automatically adjust key process parameters
Training Systems:
• Developing, documenting, deploying, and
enforcing the use of training to assure that
all employees in the future (including
substitutes) receive appropriate training.

61
Control Methods (continued)

Controlled Documentation:
• Information that is critical to successful
production of quality products must be
maintained and stored in such a way that
inadvertent or unauthorized changes cannot
occur. Any changes must be done through
properly authorized channels.
• Examples: blueprints, work standards and
instructions, safety policies, other?????

62
Control Methods (continued)

Trouble Shooting Guides:

• A systematic guide of what to look for during
upset conditions.
Reaction Plan:
• A systematic guide of what to do given a
specific upset condition.
• Also assigns responsibility for actions.

63
 Step 12:
Control Plan

64
Step 12: Questions to Answer

Control Plan:
• What is the importance of a Control Plan?
• What is the Control Plan strategy?
• What is key for Control Plan evaluation?

65
 Importance of Control Plan
The only reason a control plan exists is to ensure that we
consistently operate our processes such that product
meets customer requirements ALL THE TIME!

Production
Customer Product/Part Process Process
Control
Requirements Characteristics Characteristics Control
Plan

Quality Function Deployment (QFD) process

66
Control Plan Method
(1) Collect existing operations documentation for
the process. Identify key output variables and
specifications, based on customer requirements.
Determine the key and critical input variables and
their relationship to the output variables. Identify the
appropriate measurement system.
(2) Determine the scope of the process for the
current Control Plan.
(3) Replace short term capability studies with long
term capability studies. Your control plan should
reflect the long term variation felt by the customer.
67
Control Plan Method (continued)
(4) Fill in the Control Plan Summary based on
review of updated operations documentation.
(5) Identify missing or inadequate components, the
“gaps”.
(6) Pay particular attention to adequacy of training,
maintenance, operating and reaction plans.
(7) Verify compliance with plant documentation
requirements.
(8) Train or retrain operations and maintenance
personnel.
68
Control Plan Method (continued)
(9) Collect sign-off signatures from safety,
environmental, maintenance, operations and
process engineering.
(10) Verify Control Plan effectiveness in six months
with a long term capability study.

69
Factors Impacting Control Plan
These need to be
M easurement Preliminary
updated before
System Analysis
proceeding

Measurement
Process
System Analysis
Maps Short Term
%R&R, %P/T
Capability
Calibration C&E
Requirements Matrix Initial Control
Plan Assessment
Sampling &
FMEA
Testing Plans
Customer
Requirements
Control Plan
Long Term
Capability Maintenance
SPC Plans
Schedules Trouble
Noise Variable Shooting
Operating Compensation Training Aids
Windows Materials
Reaction
Plans
DOE's SOP's

Might already
Improvement have some of
Procedures these
Activities

70
Control Plan Strategy
The intent of an effective control plan strategy is to:
• Operate our processes consistently on target
with minimum variation.
• Minimize process tampering (over-adjustment).
• Assure that the process improvements that
have been identified and implemented become
institutionalized.
• Provide for adequate training in all procedures.
• Include required maintenance schedules.

71
Control Plan Components
• Process map steps.
• Key process output variables, targets & specifications.
• Key and critical process input variables with appropriate
working tolerances and control limits.
• Important noise variables (uncontrollable inputs).
• Short and long term capability analysis results.

• Designated control methods, tools and systems:

» SPC » Sampling & Testing
» Automated process control » Measurement System Analysis
» Checklists » Training Materials
» Mistake proofing systems » Maintenance schedules
» Standard Operating Procedures » Reaction Plan and Procedures
» Workmanship Standards
72
Documenting the Control Plan

Process Current
Cpk /Date Measurement %R&R Sample Sample
Process Process Step Input Output Specification (LSL, Control Reaction Plan
(Sample Size) System %P/T Size Frequency
USL, Target) Method

For Key Process Input and Key Process Output Variables, the measurement
system and measurement system capability should be identified.
Targets and specification limits for Key Process Input Variables and Key Process
Output Variables are recorded.
For continuous inputs and outputs, the Cp/Cpk indexes should be calculated.
Record short & long term data where available.
The specifics of the sampling plan with associated reaction plan for out-of-spec
conditions should be listed.
This document is an extension of the Current Controls column of the FMEA.

73
FMEA Vs. Control Plan
The FMEA is the primary source for identification of key variables to
control and for initial evaluation of current control plan.

S O
Key Process
Process Step Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls
Input
V C

Process Current
Cpk /Date Measurement %R&R Sample Sample
Process Process Step Input Output Specification (LSL, Control Reaction Plan
(Sample Size) System %P/T Size Frequency
USL, Target) Method

74
Catapult Exercise

• Let’s develop a control plan for our catapult

process.
• Key inputs include: pull back angle, cup
location, etc.
• The instructor will bring up the worksheet in
Excel and we will do as a class exercise.

75
Considerations for Control Methods

For noise (uncontrollable input) variables:

• Compensate with changes to (X’s) based on known
relationships, not tweaking or opinion!
• Define shutdown conditions.
• Use alternative quality control procedures (inspection,
sorting, rework, etc.).

Changes in the process require

changes to the control method.

76
Considerations (continued)

COMPENSATE This type of control involves making a process

adjustment to bring the variable back into
control without identifying or correcting the
factor which caused the situation.

CORRECT In this type of control action, the cause of the

variation is identified and corrected temporarily.
The problem may reappear on the next shift.

PREVENT In this type of action, the cause of the variation

is identified and permanently corrected. The
cause will not happen again or at least will not
occur as often.

Typically, unsuccessful control programs utilize only compensating

actions, focus should be implementation of preventive action.

77
Considerations (continued)
When an undocumented out-of-control condition occurs, a cross-
functional team consisting mainly of plant operators, process
engineers, and production supervision identifies the variable to be
controlled and follows these steps (Preventive Action):

1. Prepare or update a process flow diagram of the system.

2. Prepare a cause/effect (fishbone) diagram illustrating
possible causes of variation in the process. Four basic areas
to center on are: people, materials, methods and machinery.
3. The team selects the most likely causes from the list.
4. Starting with the most likely causes, “ROOT CAUSES” of the
variation are identified. Ask “WHY?” five times! FIND ROOT
CAUSES, NOT LIKELY CAUSES!

78
Considerations (continued)
Root
Why?
Cause Likely Root Cause
Cause Analysis
Why? Likely
Why? Cause Why?
For each Root
Out of
Cause
cause Control
Why?
Likely
Cause
Why?

Why? Likely
Root
Cause
Cause

79
Considerations (continued)
5. Prepare a Reaction Plan for each out-of-control condition.
• Causes are placed in the order that they should be
checked, the most likely or easiest to check first.
• The team determines compensating actions to take
should no cause be identified.
6. The Reaction Plan is reviewed by the team and the
technical department for modifications. The team
determines how the plan will be documented and how to
train the work force.
7. Corrective action (Permanent Ones!) assignments are
made and followed up to Prevent Recurrence!
8. Define a plan to collect data on how often the reaction plan
is used and how well it works. Review results quarterly.

80
Control Plan Check List
 Process maps detail manufacturing steps, material flow and
important variables.
 Key product variables identified with importance to customer,
desired target value and specification range defined.
 Long and short term capability trend charts track variation
reduction progress.
 Key and critical input variables identified with targets,
statistically determined control limits & control strategies
defined.
 Reaction plan in place for out-of-spec material.
 Measurement systems are capable with calibration
requirements specified.
81
Control Plan Check List (continued)
 Sampling, inspection and testing plans include how
often, where, and to who results are reported.
 Operating procedures identify actions, responsibilities,
maintenance schedules, and product segregation
requirements.
 Training materials describe all aspects of process
operation and responsibilities.
 ISO 9000 documentation standards met, if required.
 Process improvement efforts fully documented and
available for reference.
 Control plan is reviewed and updated regularly and
resides in the operating area.

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Step 12: Questions to Answer

Control Plan:
• What is the importance of a Control Plan?
• What is the Control Plan strategy?
• What is key for Control Plan evaluation?

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Step 12: Answers Summary
Control Plan:
• The reason a Control Plan exists is to ensure that
we consistently operate our processes so that our
product meets or exceeds customer requirements
all the time.

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Step 12: Answers Summary
Control Plan:
• An effective Control Plan strategy is to:
-operate our processes consistently on target with
minimum variation
-minimize tampering
-assure improvements become institutionalized
-provide adequate training in all process procedures
-include required maintenance schedules.

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Step 12: Answers Summary (continued)

Control Plan:
• Key inputs for Control Plan evaluation
include:
– input variables,
– uncontrollable noise inputs,
– standard operating procedures,
– maintenance procedures,
– measurement systems, and
– control charting.

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Step 12: Lessons Learned
Control Plan:
• Must be understood by all personnel involved.
• Must consider development of reaction plan or
trouble shooting guide.
• Must start with an adequate measurement
system.
• Control Plan must be linked to the Process Map
and FMEA.

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Step 12: Deliverables
Control Plan:
• Controls developed and implemented for all vital
(X’s).
• Institutionalized process improvements.
• Project completion when the documentation
package is completed and project closure can take
place.

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