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10/20/22, 11:17 AM Control Plan | Control Plan Development | Quality-One

Control Plan Development


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Control Plans
– Control Plan Development –
⇓  Introduction to Control Plans
⇓  What is a Control Plan
⇓  Why Develop a Control Plan
⇓  How to Develop a Control Plan
⇓  Learn More About Control Plans

Introduction to Control Plans


Most companies are looking for methods to reduce cost and
eliminate waste in their processes. In the business world today
controlling waste and maintaining a high level of quality is
imperative for a company to succeed. The cost of doing
business is ever increasing. Rising costs of raw materials
combined with labor and equipment costs have brought scrap
reduction into the critical to business category. The cost of
steel alone has more than doubled in the last two years.
Therefore, it has become increasingly important to assure that
parts are being produced that conform to customer
requirements every time. In addition, we must have the ability
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to detect a non-conforming part or assembly as well as a plan


for responding to changing process conditions.  The majority
of manufacturing companies are experienced at detecting
initial problems and developing corrective actions to correct
the problem. But many fall short when it comes to sustaining
those corrective actions or process improvements over a long
period of time. In many cases the process gradually returns to
its previous state and the problems eventually resurface. The
purpose of a Control Plan is to monitor processes and assure
that any improvements are maintained over the life cycle of
the part or product. Control Plans are currently being utilized
to ensure product quality in the Automotive, Aerospace,
Agricultural Equipment, Heavy Equipment and many other
industries throughout the world.  A Control Plan is often a
Production Part Approval Process (PPAP) requirement for
suppliers of parts to companies in these industries. The
primary resource for information regarding Control Plan
Methodology in the automotive industry is the Advanced
Product Quality Planning and Control Plan manual published
by the Automotive Industry Action Group (AIAG).

What is a Control Plan


The Control Plan is a document that describes the actions
(measurements, inspections, quality checks or monitoring of
process parameters) required at each phase of a process to
assure the process outputs will conform to pre-determined
requirements. In simpler terms, the Control Plan provides the
operator or inspector with the information required to
properly control the process and produce quality parts or
assemblies. It should also include instructions regarding
actions taken if a non-conformance is detected. The Control
Plan does not replace detailed operator instructions. In some
cases the Control Plan is used in conjunction with an
inspection sheet or checklist. The Control Plan helps assure
quality is maintained in a process in the event of employee
turnover by establishing a standard for quality inspection and
process monitoring.  Control Plans are living documents that
should be periodically updated as the measurement methods
and controls are improved throughout the life cycle of the
product.

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Control Plan Template

Why Develop a Control Plan


Developing and implementing Control Plan Methodology has
several benefits. The use of Control Plans helps reduce or
eliminate waste in a process. Businesses today must reduce
waste everywhere possible. The Control Plan improves
product quality by identifying the sources of variation in a
process and establishing controls to monitor them. Control
Plans focus on the product characteristics most important to
the customer and the business. By focusing on what is critical
to quality during the process, you can reduce scrap, eliminate
costly reworks and prevent defective product from reaching
the customer. When scrap and reworks are reduced,
throughput of the process is inherently improved.
Manufacturing efficiency is improved and your company’s
bottom line is impacted in a positive manner.

How to Develop a Control Plan


The Control Plan should be developed by a Cross Functional
Team (CFT) that has an understanding of the process being
controlled or improved. By utilizing a CFT, you are likely to
identify more opportunities for improvement of the process.
The Control Plan is more than just a form to fill out.  It is a
plan developed by the team to control the process and ensure
the process produces quality parts that meet the customer

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requirements. The information contained in the control plan


can originate from several sources, including but not limited
to the following:

Process Flow Diagram


Design Failure Mode and Effects Analysis (DFMEA)
Process Failure Mode and Effects Analysis (PFMEA)
Special Characteristics Matrix
Lessons Learned from similar parts
Design Reviews
Team knowledge about the process
Field or warranty issues

Throughout the life cycle of a product, the information


contained in the list above frequently changes or the content
grows. Therefore the Control Plan must be a living document,
continuously updated as new information is added. The
Control Plan therefore is an integral part of an effective
product quality system.

The Three Levels of Control Plans


Prior to completing the Control Plan development, the team
must determine the proper level appropriate for the process
being controlled. There are three designations for a Control
Plan level based upon what point the product is at in the New
Product Introduction (NPI) process. They are as follows:

1. Prototype – This level Control Plan should include


descriptions of the dimensions to be measured and the
material and performance tests to be completed during
the prototype build
2. Pre-Launch – This level of Control Plan should contain
descriptions of the dimensions to be measured and the
material and performance tests to be completed after
prototype but prior to product launch and regular
production
3. Production – This level of Control Plan should contain a
comprehensive listing of the product and process special
characteristics, the process controls, measurement
methods and tests that will be performed during regular
production

The Control Plan Format


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There are many variations of the form used to document the


Control Plan.  Most of the forms used are in the Excel format
although there are custom software packages available for
many quality tools, including Control Plans. The following
section will provide descriptions of what general information
should be populated in each of the blocks. The types of
control plans vary depending upon the process being
controlled.

1. Control Plan Level – The appropriate box should be


checked to indicate the level or type of Control Plan that
is being developed
2. Control Plan Number – Enter the appropriate number
that the Control Plan will be listed as in your document
control system
3. Part Number/Latest Change – The part number listed on
the drawing should be entered in this box
In addition the appropriate change or revision level
should be indicated. The control plan should be
reviewed and updated with each level change or
revision of the part or assembly. The control plan
should be a living document.
4. Part Name/Description – The name and description of
the part or process being controlled should be entered in
this box
The process name is preferred if the Control Plan is
covering a family of parts produced on the same
process
5. Supplier/Plant – Enter name of the company and
plant/division developing the Control Plan
6. Supplier Code – Your designated supplier code should be
entered if the part is being produced for an external
customer
7. Key Contact/Phone – The Name and contact information
(phone number, email) of the primary contact
responsible for the Control Plan
8. Core Team – Enter the names of the CFT that prepared
the Control Plan
9. Supplier/Plant Approval Date – Once the approval is
received from the customer, enter the date approval was
received

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10. Other Approval/Date – Enter any additional approval


information and date if required
11. Date Original – The date the Control Plan was initially
completed should be entered here
12. Date/Rev – Insert the latest revision date of the Control
Plan released in this box
13. Customer Engineering Approval/Date – If required,
obtain the customer engineering approval information
and enter in this location
14. Customer Quality Approval/Date – If required, obtain the
customer quality representative approval information
and enter in this location
15. Other Approval/Date – Enter any additional approval
information and date if required
16. Part/Process Number – The information for this column is
referenced from the process flow
Part numbers may be entered for an assembly and
in some applications the process step number from
the Process flow is entered
17. Process Name/Operation Description – Enter information
from the process flow diagram that describes the
operation being performed in this column
18. Machine/Device/Jigs/Tool for Manufacturing – In this
column, identify the equipment, machines, fixtures, jigs
and other tools required to accomplish the particular
process operation listed in the corresponding row

Characteristics Section
This section of the Control Plan describes the particular
characteristics of the product or process that may need to be
controlled and documented. The characteristic could be
product or process related and the data could be variable or
attribute data. The difference between product and process
characteristics is often confused when completing a Control
Plan.

19. Number – This column is used for assigning a number


corresponding to information in the process flow, work
instructions or a numbered print
20. Product – Product characteristics are physical features or
properties of an assembly or component part usually

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described on the drawing that can be measured when


the process is completed. Not all the dimensions or
features on the print should be listed on the Control
Plan. The team should determine the key or critical
characteristics and compile them from their various
sources. Special, Key or Critical characteristics come from
the DFMEA exercise, print reviews, product or process
historical information and customer feedback. If there are
no key product characteristics for the particular
operation, leave this space blank.
21. Process – In this column, the team should identify the
Key characteristics relating to the process. Examples
would be the setting on a torque tool or the orientation
of parts in a fixture. If there are no key process
characteristics for the particular operation, leave this
space blank. There could be multiple process
characteristics listed for a single product characteristic.
Key process characteristics can originate from the PFMEA
or team knowledge of the process performance.
22. Special Characteristic Classification – Enter the letter
representing the appropriate classification for any special
characteristics. The list of designations is below:
D – Design
P – Process
R – Regulatory
OS – Operator Safety

Methods Section
The information contained in the methods section includes
the specification to be measured and a plan for collecting the
data and controlling the process. The data could be variable
or attribute data.

23. Product/Process Specification / Tolerance – List the


specification and tolerance as defined on the drawing,
material specification, 3D model or in the manufacturing
or assembly documentation
24. Evaluation/Measurement Technique – Identify the
measurement tools, gages, fixtures and / or test
equipment used to evaluate the part or process
specification listed in the previous column. A
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Measurement Systems Analysis (MSA) is


recommended to assure that correct, consistent usable
data is being collected.
25. Sample Size – If sampling is required, list the
corresponding sample size or number of parts or
assemblies that should be measured /evaluated during
the process
26. Sample Frequency – If sampling is required, list the
frequency at which the samples will be taken during the
process. As an example, the frequency could be 1st, 25th
and final, or it could be continuous.
27. Control Method / Prevention – This column should list
the prevention controls and / or documents the operator
will need to complete the process step. This should
include work instructions, drawings, visual aids, etc.
28. Control Method / Detection – The information in this
column is critical for the effectiveness of the Control Plan.
This column should list any detection controls
determined by the team during the previous quality plan
activities, including the DFMEA and PFMEA. The methods
could include but are not limited to Statistical Process
Control (SPC), visual inspection, attribute data
collection, error proofing, etc. A document or procedure
number may also be populated in this space. The
effectiveness of the control selected should be evaluated
on a regular basis.
29. Reaction Plan – This column should specify the actions
required to prevent production of non-conforming
products. The actions should be the responsibility of the
operator and / or their immediate supervisor. They
should include at the very least how to label, identify and
quarantine the non-conforming material and the proper
disposition of the suspect material, parts or assemblies.
In addition, the reaction plan should include directions
for properly documenting the incident and who should
be notified of the non-conformance.

Control Plans can vary depending upon what type of process


is being controlled. There are many different applications

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where the Control Plan can add value to the process. Below
are a few examples of the different applications:

Equipment set-up process where the major contributor


to process variation is proper set-up of the equipment
prior to the production run
Equipment tooling dominant process where the major
influence on variation is the impact of tool life on the
part or product design characteristics
Operator dominant process where the variation in the
process is a result of the knowledge or training of the
operator and the proper controls

The Control Plan can be a very effective tool for reducing the
amount of scrap generated by a process. It can be very useful
at improving quality and helping contain any non-conforming
product prior to it leaving the work cell. It is most effective
when incorporated into a larger quality plan. The Control Plan
is the same as any other tool, in that to get the most value
you must know how to use it properly. Your teams will require
training and coaching in order to implement an effective
Control Plan system. If you are interested in learning more
about Control Plan Methodology, please contact one of our
experienced professionals at Quality-One.

Learn More About Control Plan


Development
Quality-One offers Quality and Reliability Support for Product
and Process Development through Consulting, Training and
Project Support. Quality-One provides Knowledge, Guidance
and Direction in Quality and Reliability activities, tailored to
your unique wants, needs and desires. Let us help you
Discover the Value of Control Plan Consulting, Control
Plan Training or Control Plan Project Support.

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