Product

and Process
Control Systems

Purpose
1. Assure that your companys 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 subcomponents 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.

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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.

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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.

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How Do CCRs Relate to KPCs

All
KPC

Are
CCR

Not all
CCR

Are

KPC

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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 products safety, compliance to
government regulations, performance, or fit.

LSL

Std.

USL

LSL

KPC

USL

Taguchi Loss
Function

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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

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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
Fit / Function
Ability to process or build
Standard
the product
Product Characteristics

Product Characteristic
Pyramid
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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

Fit / Function

Safety/Compliance
Symbol

Standard
Product Characteristics

Product Characteristic
Pyramid
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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.

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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

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

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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

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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.

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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

STANDARD
(Specification,
target value)

UMPIRE
(Does control
subject meet the
standard?)

Purpose

OK

End of One
Cycle

To maintain a specific output

of a process at its 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

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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
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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.

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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
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Dominant Variables
Dominant Process Variables

Set-up dominant: Some processes are highly stable, and their

Contd.
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.
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Dominant Variables
Worker-dominant: In these processes, quality dependsContd.
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.

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Establish Measurement
Choose Control
Subjects

Establish
Measurement

Develop unit of measure

Develop sensor

Establish
Standards of
Performance

Measure Actual
Performance

Compare to
the Standards

OK?

Not OK?
Take Action
on the Difference

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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

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Ideal Unit of Measure

Is understandable
Provides an agreed-upon basis for
decision-making
Is customer focused
Applies broadly

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Types of Sensors

Technical

Human

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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

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Criteria for Targets

Customer focused
Aggressive and realistic
Help control the process

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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

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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

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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

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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

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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

OK?

Analyze process
Make contingency plans
Troubleshoot

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Three Types of Actions

Troubleshooting

Quality
Improvement

Quality Planning

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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

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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

Specs
&/or Targets

Measures
(Tools)
Where &
Frequency

Responsibility
(Who)

Contingency
(Quick Fix)

Remarks

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