So you need to create a Quality Control Plan...
Whether for Six Sigma, Quality Improvement, or day-to-day operation of the the business - looking from afar creating a QC Plan can seem like a daunting task.
What's A QC Plan - Where Do I Start - How Do I Do It?
Stress No More!
The key to creating an effective QC Plan is first understanding that you need to "eat the elephant one bite at a time".
First let's review some basics - then I'll show a "structure" that'll make creating Quality Control Plans a BREEZE...
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" world-
A 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.
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 (SOP’s) 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.
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.
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:
The benefits of developing and implementing a QC Plan include:
QC Plans Are Created To Control:
As Part Of The Total System:
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.
QC Plan Key Elements
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.
Enter the control plan document number usedfor tracking, if applicable. For multiple control pages, enter page number (page___of___).
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.
Enter the name and description of the product/process being controlled.
Enter the name of the company and the appropriate division, plant or department preparing the Quality Control Plan.
Enter any specific supplier or work center identification number necessary for tracking purposes.
Enter the name and telephone number of the primary contact responsible for the control plan.
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.
If required obtain approval.
Enter the data that the original QC Plan was created.
Enter the date that the plan was last updated.
If required obtain engineering authority approval.
If required obtain quality authority approval.
If required obtain additional authority approvals.
The item number, usually from the engineering specification. If multiple part numbers are used they should all be listed.
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.
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.
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 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 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.
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.
Specifications and tolerance are obtained from various engineering specifications and documents.
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.
When sampling will be used, list the sample size and frequency of sampling.
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:
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.
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.
May 10, 16 09:24 PM
A Quality Control Plan is a documented description of the activities needed to control a process or product. The objective of a QCP is to minimize variation.
May 10, 16 08:49 PM
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May 10, 16 07:28 PM
The Weibull distribution is applicable to make population predictions around a wide variety of patterns of variation.