Product
and Process
Control Systems
Purpose
1. Assure that your company’s products are meeting the needs of
customers with regard to quality and that company suppliers are
meeting internal company requirements.
2. Validate and/or map the current processes for the selected products.
3. Evaluate whether the current product and process controls that are in
place are able to meet these needs.
4. Identify optimized or new “Critical to Quality – Critical to Customer”
requirements for the “vital few” needs and assure that an effective
“process control system control plan” is in place for the selected
products and sub-components to assure customer and company needs
are satisfied.
5. Understand the relationship of CCRs (Critical Customer Requirements)
to KPCs (Key Product/Process Characteristics) and the process to
identify KCCs (Key Control Characteristics).
6. Create small process control teams that will optimize existing or create
Product and Process Control Systems for the selected products.
7. Schedule time over the next few weeks to begin the process of
improving the process controls and metrics defined in the control
systems.
Product-Process Control 2 .PPT
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Agree on Common Definitions
The purpose of an organization is to meet the needs of its
customers at the lowest optimum cost. It creates products.
Products can be goods, services, or information. Products are
produced by processes.
A process is a sequence of events or tasks that create an
output: a product. A process includes everything involved at
each step: people, techniques, equipment, materials, energy,
facilities, etc.
A customer is one who receives the output of a process or any
step in a process.
External customers are a “cast of characters” located
beyond your organization.
Product-Process Control 3 .PPT
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Agree on Common Definitions
An internal customer is one who is located within your
organization.
Meeting the needs of internal customers is a prerequisite for
meeting the needs of external customers AS LONG AS IT DOES
NOT SUB-OPTIMIZE the external customers
 Management must meet both sets of needs.
Quality is measured by the extent to which the specific needs of
specific customers are met.
Process outputs embody both product features and deficiencies.
Process variation is any change to the process that negatively
impacts our ability to meet the needs of our customers.
Product-Process Control 4 .PPT
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How Do CCRs Relate to KPCs
All…
KPC
Are…
CCR
Not all…
CCR
Are…
KPC
Product-Process Control 5 .PPT
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What Is a Key Characteristic?
A KEY characteristic is a product characteristic for
which reasonably anticipated variation could
significantly affect a product’s safety, compliance to
government regulations, performance, or fit.
LSL
Std.
USL
LSL
KPC
USL
Taguchi Loss
Function
Product-Process Control 6 .PPT
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Key Characteristic Concepts
1. Two kinds of characteristics
a. Product
 Key Product Characteristic (KPC)
–
–
Safety / Compliance
Fit / Function
b. Process
 Key Control Characteristic (KCC)
2. Control of a process characteristic will ensure that
variation of a product characteristic is reduced
Product-Process Control 7 .PPT
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Fit/Function Key Product Characteristics
A product characteristic for which reasonably anticipated
variation could significantly affect:
 Customer outcomes other than safety/compliance such
as:
– Fit
– Function
– Performance
– Durability
– Mounting or appearance
Fit / Function
Symbol
– Ability to process or build
Fit / Function
the product
Standard
Product Characteristics
Product Characteristic
Pyramid
Product-Process Control 8 .PPT
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Safety/Compliance Characteristics
A product characteristic for which reasonably anticipated
variation could significantly affect:
 Product Safety
 Compliance with Governmental Standards and
Regulations
– Emissions
– Environmental
Safety/Compliance
Symbol
Fit / Function
Standard
Product Characteristics
Product Characteristic
Pyramid
Product-Process Control 9 .PPT
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Selecting KPCs and KCCs
Key Product Characteristics (KPCs) are outputs from a
process that are measurable on, within, or about the product
itself. They are the outputs perceived by the customer.
Examples of Key Product Characteristics (KPCs):
 KPCs "On" The Product - Width, Thickness, Coating
Adherence, Surface Cleanliness, Etc.
 KPCs "Within" The Product - Hardness, Density, Tensile
Strength, Mass, Etc.
 KPCs "About" The Product - Performance, Weight, Etc.
Key Control Characteristics (KCCs) are inputs that affect the
outputs (KPCs). They are unseen by the customer and are
measurable only when they occur.
Product-Process Control 10 .PPT
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Translate KPCs to Effective KCCs
1. Identify the exact step where each KPC is created
2. Determine what process characteristic(s) impact the KPC and
how they affect KPCs
a. May require studies (Design of Experiment, PFMEA)
b. These are your Key Control Characteristics (KCC)
3. Determine how to measure those KCCs
4. Determine how repeatable and reproducible those
measurements are (measurement system capability)
5. Determine your process capability
KCC
KCC
6. Develop your process control system
KPC
7. Implement your process control system
KCC
Product-Process Control 11 .PPT
KCC
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Tools to Identify KCCs








List of KPCs
FMEA (Failure Mode and Effects Analysis)
Process Capability Studies
Process Flow Diagrams
DOE (Design of Experiments)
Process Control Plans
Cause-Effect Diagrams
Pareto Analysis
Product-Process Control 12 .PPT
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KPCs May Be…









Dimensions
Attributes
Properties
Engineering Specifications/Tests
Usage
Function/System Function
Orientation
Fit and Finish
Feature for a Part
 A Sub-assembly
 A System
Product-Process Control 13 .PPT
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KCC Test
The following will determine if a process parameter is or
is not a key control characteristic.
A Key Control Characteristic (KCC) is:
 A process parameter for which variation must be controlled
around some target value to ensure that variation in a KPC is
maintained around its target values during manufacturing and
assembly.
 A process parameter for which reduction in variation will reduce
the variation of a KPC.
 Directly traceable to a KPC.
 Particularly significant in ensuring a KPC achieves target value.
 Not specified on product drawing or product documentation.
Product-Process Control 14 .PPT
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Product and Process Control Systems
CONTROL
SUBJECT
(Specific attribute
or variable to be
controlled)


SENSOR
(Device and/or
person
measuring the
control subject)

ACTUATOR
(Adjusts the
process)
NOT OK

UMPIRE
(Does control
subject meet the
standard?)
STANDARD
(Specification,
target value)


Purpose
OK
End of One
Cycle
Product-Process Control 15 .PPT
 To maintain a specific output
of a process at it’s standard;
 To assume consistent
production;
 To assure stability;
 To prevent/correct departure
from a specific standard
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Choose Control Subjects
Choose Control
Subjects
Establish
Measurement
Establish
Standards of
Performance
Measure Actual
Performance
Compare to
the Standards
OK?
 Identify major work
process
 Identify objective of the
process
 Describe the work
process
 Identify customers of the
process
 Discover customer needs
(Critical Customer
Requirements)
 Select control subjects
(KPCs and KCCs)
Not OK?
Take Action
on the Difference
Product-Process Control 16 .PPT
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Process Map
Go to
supermarket
Yes
Long list of
items?
No
Pick up
basket
No
Go to
express
lane
Yes
Get shopping
cart
Shop
More than
ten items?
Yes
Go to any
check-out
Put groceries
on conveyor
Pay for
groceries
Receipt
Leave store
Product-Process Control 17 .PPT
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Concept of Dominance
The number of control subjects can be overwhelming.
Operating processes are influenced by many variables:
 Input materials
 Physical facilities
 Human skills
 Environmental conditions
Often one variable is more important than all the rest
combined. Such a variable is said to be the “dominant
variable.”
Product-Process Control 18 .PPT
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Dominant Variables
Dominant
Variable
Example
Process
Description
Strategy
Setup
Sheet metal stamping
Stable, reproducible
over many cycles
Precise set up,
validation
Time
Metal cutting, visual
inspection
Change progressively
Periodic evaluation or
prediction of change,
convenient
adjustment
Worker
Pharmacist
dispensing
medication, carpenter
Dynamic, changing
according to the
situation and skill of
worker
Worker training, error
proofing, periodic
evaluation
Component
Electrical appliance
assembly, dispensing
meals at a fast food
restaurant
Input components to
retain identity
Control components
within supplier
organization
Information
Order entry, airline
scheduling
Dynamic
information/decision
stream
System design for
accurate, timely
information
Product-Process Control 19 .PPT
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Dominant Variables
Dominant Process Variables

Set-up dominant: Some processes are highly stable, and their
Cont’d.
results can be reproduced over many cycles of operation. The
design for control should provide the operating forces with the
means for precise set-up and the means to validate it before
operations begin. A common example is an operation or a printing
process.

Time-dominant: Here the process is known to change
progressively with time, e.g., depletion of consumable supplies,
heating up, length of an operation, wear of tools. The design for
control should provide means for periodic evaluation of the effect
of any progressive change, and for convenient readjustment.

Component-dominant: Here the main variable is the quality of
the input materials, sub-assemblies, and components. An example
is the assembly of complex electronic or mechanical equipment,
such as a computer. For the short run, it may be necessary to
resort to inspection of materials from a supplier. For the long run,
the design for control should be directed at supplier relations,
including joint planning with suppliers to upgrade their inputs.
Product-Process Control 20 .PPT
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Dominant Variables
Worker-dominant: In these processes, quality dependsCont’d.
mainly
on the skill and knack possessed by the workers. The skill
trades and specialists are well-known examples. The design for
control should emphasize aptitude testing of workers; training
and certification; quality rating of workers; error-proofing to
reduce worker errors.
Information-dominant: Here the processes are of a “job-shop”
nature, so that there is frequent change in what product is to be
produced. As a result, the job information changes frequently, as
in the case of a service department. The design for control
should concentrate on providing an information system that can
deliver accurate, up-to-date information on just how this job
differs from its predecessors.
Product-Process Control 21 .PPT
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Establish Measurement
Choose Control
Subjects
 Develop unit of measure
 Develop sensor
Establish
Measurement
Establish
Standards of
Performance
Measure Actual
Performance
Compare to
the Standards
OK?
Not OK?
Take Action
on the Difference
Product-Process Control 22 .PPT
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Measurement
98.6
Unit of Measure
A defined amount through which one can
evaluate a quality feature in numbers
Sensor
A method or instrument that can make the
measurement
Product-Process Control 23 .PPT
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Ideal Unit of Measure
 Is understandable
 Provides an agreed-upon basis for
decision-making
 Is customer focused
 Applies broadly
Product-Process Control 24 .PPT
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Types of Sensors
Technical
Human
Product-Process Control 25 .PPT
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Establish Standards of Performance
Choose Control
Subjects
Establish
Measurement
 Set targets
 Develop control methods
 Set checking criteria
Establish
Standards of
Performance
Measure Actual
Performance
Compare to
the Standards
OK?
Not OK?
Take Action
on the Difference
Product-Process Control 26 .PPT
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Criteria for Targets
 Customer focused
 Aggressive and realistic
 Help control the process
Product-Process Control 27 .PPT
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Develop Checking Methods
What will be checked
How the checking will be done
When it will be checked
Who is responsible
Product-Process Control 28 .PPT
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Example: Baking a Cake
Process Indicator: Oven Temperature
Temperature
(What)
Gauges read
(How)
Time
(When)
Checked by
(Who)
300 degrees
Thermometer
11:40 a.m.
A. Smith
325 degrees
Thermometer
12:20 p.m.
B. Jones
Product-Process Control 29 .PPT
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Measure Actual Performance
Choose Control
Subjects
Establish
Measurement
Establish
Standards of
Performance
 Charter indicators
 Develop detailed work
 Instructions
Measure Actual
Performance
Compare to
the Standards
OK?
Not OK?
Take Action
on the Difference
Product-Process Control 30 .PPT
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Compare to the Standards
Choose Control
Subjects
Establish
Measurement
Establish
Standards of
Performance
Measure Actual
Performance
Compare to
the Standards
OK?
 Quality Goals
 Quality Manual
Not OK?
Take Action
on the Difference
Product-Process Control 31 .PPT
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Take Action on the Difference
Choose Control
Subjects
Establish
Measurement
Establish
Standards of
Performance
Measure Actual
Performance
Compare to
the Standards
Not OK?
Take Action
on the Difference
Product-Process Control 32 .PPT
OK?
 Analyze process
 Make contingency plans
 Troubleshoot
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Three Types of Actions
Troubleshooting
Quality
Improvement
Quality Planning
Product-Process Control 33 .PPT
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Next Steps
Work in assigned teams to:
 Map assigned processes
 Analyze processes for accuracy
 Review the key processes to define CCRs, KPCs, and
KCCs
 Utilize a Process Control System Six Sigma Template to
document Product and Process Control Systems for the
assigned processes
 Identify a plan to close the gaps if company and
customer requirements are not met
Product-Process Control 34 .PPT
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Process Control System (Business Process Framework)
Process Owner:
Direct Process Customer:
Process Description:
Date:
CCR:
Flowchart
Measuring and Monitoring
Key
Measurements
Product-Process Control 35 .PPT
Specs
&/or Targets
Measures
(Tools)
Where &
Frequency
Responsibility
(Who)
Contingency
(Quick Fix)
Remarks
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