What Is A Quality Control Plan

So What Is A Quality Control Plan Anyway?

A Quality Control Plan, or QC Plan, is a critically important document for any business.
It's a description of the activities, tools and procedures, needed to control a process that
delivers a service or product. Its overall objective is to minimize and control variation.
It pulls together and documents the actions necessary to maintain the acceptable or
steady state.
Its purpose is to help you produce quality products that meet or exceed customer
requirements. It's a structured approach for the design, selection and implementation of
value-added control activities for the total system.
Quality Control Plans provide a written high level description of the methods used to
minimize process and product variation.
QC Plan information must be documented in an efficient (cost effective) and effective
and consistent manner. There are many approaches used by companies to create a Quality
Control Plan, maybe even yours.
Alternate approaches are typically okay provided they contain the same key information.
The strategy below can be used for a wide range of business and manufacturing processes
and technologies.
In the "hard goods" worldA QC Plan documents how process and product characteristics and features are to be
managed and controlled throughout the production process.
Quality Control Plans are living documents and must be revised as changes in the
design, process or performance level occurs.
A new feature that has be added to a product through a design change will likely require
that the QC Plan be updated.
It's recommended that Design Change Documents, such as Engineering Change Orders
(ECO), have the QC Plan included in the ECO package. This will ensure that the QC Plan
is reviewed, revised and implemented in parallel with the implementation of the design or
change.

Conversely, when process improvements are made and process capability increases - less
inspection and monitoring may be appropriate. This change can also be reflected through
a revision to an existing QC Plan.
And if process and product conditions deteriorate, additional inspection and monitoring is
likely necessary in order to maintain customer satisfaction. Again, this change is reflected
through a revision to the QC Plan.

Quality Control Plan Use

Why Use A QC Plan?
A good QC Plan represents the single resource for documenting important process and
product requirements. Requirements are in the form of measurable specifications with
direct linkage to standard operating procedures (SOPs) such as detailed measurement
and/or testing work instructions for set-up, tool usage etc.
A Quality Control Plan "Ties Everything Together". It ensures that processes run as
smoothly as possible producing acceptable output. It also provides the specific instruction
on what to do when things don't run smoothly (reaction plan).
QC Plans are a core Six Sigma tool.

Quality Control Planning

The creation of a QC Plan is "THE KEY INGREDIENT" of the overall quality
planning process and therefore quality improvement tool. Without the plan all of the
those wonderful things discussed in the meeting rooms will not "stick" over time.
QC Plans are living documents and as such they should be revised as process and product
conditions warrant. They must always reflect the current methods of control and the
measurement systems being used.
QC Plans should be developed early in the products life-cycle in order to document and
communicate the initial plan for process control. Early production units are often the
"sales pieces" and as such they should be of optimum quality. The QC Plan will guide
manufacturing on how to control the process and ensure product quality. 99-22-g6
A Quality Control Plan is the written description of the system for controlling parts and
processes. A single QC Plan may be generated and applied to a group or family of
products that are produced by the same process at the same source. Engineering drawings

and other support documentation such as process monitoring instructions are attached or
linked to the QC Plan for continued use.

The Quality Control Plan describes the actions that are required at each key phase of the
process such as receiving, in-process, out-going, and periodic surveillance to assure that
all process outputs are meeting established standards and requirements.
During production runs or builds for example, the plan provides the monitoring and
control methods that are used to control the features and characteristics of the product or
process.
And since the goal is continuous quality improvement, the QC Plan encompasses this
strategy and is responsive to hanging process conditions. The plans should be controlled,
maintained and used throughout a products life cycle.
To create an effective QC Plan a basic understanding of the process must be obtained.
Therefore a multi-disciplined team should be used to develop the plans.
This ensures that all available information relevant to plan creation is available. This
information includes:

Process Flow Charts

Design Drawings

Equipment Capabilies

Available Measurement Equipment

Lessons Learned

Design Reviews

Risk Analysis

Etc

Quality Control Plan Benefits

The benefits of developing and implementing a QC Plan include:

Quality: The QC Plan reduces waste and improves the quality of products during design,
manufacturing, and assembly. It's structure and discipline provide a thorough evaluation
of the product and process. They control sources of variation (input variables) which
cause variation in product characteristics (output variables). QC Plans are key Six Sigma
and quality improvement tool.

Customer Satisfaction: Control Plans focus resources on process and product

characteristics that are important to the customer. The proper allocation of resources on
these major items helps to reduce costs without sacrificing quality.

Communication: As a living document the QC Plan identifies and communicates

changes in the product/process characteristics, control methods, and characteristic
measurement methods.

When To Create A Quality Control Plan

QC Plans Are Created To Control:

Incoming Materials: Controls the parts and materials that are purchased or otherwise
procured from sources external to the company. Ensures that these materials meet
requirements before they are allowed into the company'svalue-added process.

In-Process Manufacturing & Assembly: Controls the internal value-added operations

that exerted upon procured materials.

Final Goods: Controls the measurement and testing exerted upon the final product to
discern its readiness for customer use.
As Part Of The Total System:

System Level: The Refrigerator

Sub-system Level: The Refrigerator Door

Component Level: The Refrigerator Door Handle

How To Create A Quality Control Plan

Below is a generic QC Plan Template. You can download it for free here. Let's go through
an example of how the Quality Control Plan gets created.
Quality Control Plan Template

QC Plan
Key
Elements

QC Plan
Instruction - Template Header

Prototype, Pre-Launch, Production

Prototype: A description of the dimensional measurements, material and performance
tests occurring during Prototype build.
Pre-Launch: A description of the dimensional measurements, material and performance
tests that will occur after Prototype and before normal Production.
Production: A comprehensive documentation of product and process characteristics,
process controls,tests, and measurement occurring during normal production.
Control Plan Number
Enter the control plan document number usedfor tracking, if applicable. For multiple
control pages, enter page number (page___of___).
Part Number & Latest Change Level
Enter the number of the system, subsystem or component being controlled. When
applicable, enter the latest engineering change level and/or issue date from the drawing
specification.
Part Description
Enter the name and description of the product/process being controlled.
Supplier/Plant
Enter the name of the company and the appropriate division, plant or department
preparing the Quality Control Plan.
Supplier Code
Enter any specific supplier or work center identification number necessary for tracking
purposes.
Key Contact & Phone Number
Enter the name and telephone number of the primary contact responsible for the control
plan.
Core Team

Enter the name(s) and telephone number(s) of the individual(s) responsible for preparing
the Quality Control Plan to the latest revision. It is recommended that all of the team
members names, phone numbers,and locations be included on an attached distribution
list.
Supplier/Plant - Approval/Date
If required obtain approval.
Origination Date
Enter the data that the original QC Plan was created.
Revision Date
Enter the date that the plan was last updated.
Engineering Approval Date
If required obtain engineering authority approval.
Quality Approval Date
If required obtain quality authority approval.
Other/Additional Approvals
If required obtain additional authority approvals.

QC Plan Instruction - Template Body

Part / Process Number

The item number, usually from the engineering specification. If multiple part numbers are
used they should all be listed.
Process Name / Operation Description
Where possible, all of the steps in the production of the system, subsystem, or component
should be described. These steps can be identified from a process flow chart or traveler or
router.
Machine, Device, Tools For Manufacturing

For each operation that is described, identify the processing equipment, e.g., machine,
device, jig, or other tools for manufacturing, as appropriate.
CHARACTERISTICS - The distinguishing feature, dimension or property of a process
or product on which variable or attribute data can be collected. Use visual aids where
applicable.
Number
Simple Use: Enter a sequential tracking number.
Advanced Use: Enter a cross reference number from other applicable documents such as
a Process Map or FMEA etc.
Product
Product Characteristics are the features or properties of the part, component or assembly
that are described on engineering drawings or other primary engineering information. The
Quality Control Plan Team should identify the Special Product Characteristics which are
a compilation of important Product Characteristics from all sources.
All Special Characteristics must be accounted for in QC Plans - they must be listed. Other
product characteristics and features for which process controls are required during normal
operations should also be listed. Wherever possible use visual aids for appearance related
features.
Process
Process Characteristics are the process variables (input variables) that have a cause and
effect relationship with the identified Product Characteristic.
A Process Characteristic can only be measured at the time it occurs.The team should
identify Process Characteristics for which variation must be controlled to minimize
product variation.
There could be one or more Process Characteristics listed for each product characteristic.
In some processes one Process Characteristic may affect several Product Characteristics.
Special Characteristic Classification
Where and when required apply any special characteristic designation. Example
designations include "safety", "critical", "key", "major", etc.
METHODS - The systematic plan deploying procedures, instructions and tools to control
the process.

Product / Process / Specification Tolerance

Specifications and tolerance are obtained from various engineering specifications and
documents.
Evaluation / Measurement Technique
This column identifies the measurement system to be used. This could include gages,
fixtures, tools, and/or test equipment required to measure the part, process or
manufacturing equipment.
Sample Size & Frequency
When sampling will be used, list the sample size and frequency of sampling.
Control Method
This column contains a brief description of how the operation will be controlled. Include
procedure numbers where applicable. The control method utilized should be based on
knowledge and analysis of the process. The control method is determined by the type of
process that exists.
Example control methods include:

Statistical Process Control

Inspection, Variable or Attribute Data

Mistake-Proofing (automated/non-automated)

Sampling Plans
Control Plan descriptions should reflect the planning and strategy being implemented in
the manufacturing process. If procedures are used, the plan will typically reference the
procedure document by a specific identification name and/or number.
The method of control should be continually evaluated for effectiveness of process
control. For example, significant changes in the process or process capability should lead
to an evaluation of the control method.
Reaction Plan
The reaction plan specifies the corrective actions necessary to avoid producing
nonconforming products or operating out of control. The actions should normally be the
responsibility of the people closest to the process, the operator or supervisor, and be
clearly designated in the plan.

In all cases, suspect and nonconforming products must be clearly identified and
quarantined, and disposition made by the responsible person designated. This column
may also refer to a specific reaction plan number and identify the person responsible for
the reaction plan.

Quality Control Plan Example