East West Manufacturing Blog

What's In A Quality Plan and How To Create One

Written by Patty Rasmussen | March 23, 2020

Quality and cost are two of the top criteria most companies look at when seeking a contract manufacturer. The reasons are obvious. If your product doesn’t meet the definition of quality — defined by industry standards or the consumer — your product is doomed to failure. Every product development project — whether a new product or changes to an existing one — has a quality plan. Your manufacturer has a quality plan, or they should.

According to the American Society for Quality (ASQ) a quality plan is defined as:

“A document or set of documents that describe the standards, quality practices, resources and processes pertinent to a specific product, service or project.”

The reasons for creating a quality plan and insisting on seeing your contract manufacturer's quality plan are many. The quality plan: 

  • Directs conformance to the customer’s requirements.
  • Verifies your own external and internal standards and procedures.
  • Provides traceability.
  • Provides objective evidence.
  • Indicates where training is needed.
  • Offers insight into the effectiveness of the organization’s quality management system.

A quality plan, rightly applied, protects the project, the product, the customer and the contract manufacturer/supplier because it lays out all the expectations in writing beforehand. The components of the quality plan are discussed and agreed upon before anything else happens. The goal is no surprises of the negative kind.

But what's in a quality plan and how do you create it? There are templates available on the Internet, some for free, some with a price. You should look at them to see how they're organized. However, you'll find most quality plans are comprised of basic information across industries. 

What to Include in Your Quality Plan

  • Goals/objectives - This should include the product specifications, use, aesthetics, cycle time, materials, and cost.
  • Process steps or procedures
  • Distribution of responsibilities - Who does what and when?
  • Standards - What are the practices and procedures that need to be applied?
  • Testing requirements - When does testing take place? Who performs it, and where?
  • Change/modifications documentation procedure - Gives you a way to track changes to the project or process.
  • Quality process measurement - A way to measure the value of the quality document itself.
  • Other actions as needed to meet the objectives.

In most cases, the engineering and quality teams at your contract manufacturer will develop the quality plan for your project.

>>Want to learn more about quality processes? Click here for ASQ resources<<

How to Create A Quality Plan

Step One | The plan typically begins with initial audits of the suppliers that the manufacturer intends to use for the project. These audits ensure that the supplier’s capabilities match the project and meet up with the quality standards. The audit thoroughly scrutinizes a factory’s:

  • equipment
  • materials
  • processes
  • workforce including management
  • quality plan.

Step 2 | The next step in the quality plan is confirming that the suppliers can produce the goods in conformance to the exact specifications and standards. This is accomplished through formal first article and process capability studies, usually performed by engineers on-site. If you’re working with an overseas contract manufacturer, there is typically a layer of U.S.-based oversight.

Step 3 | Finally, the quality plan includes a lot-level quality inspection of every production run of every product before it’s loaded for shipment. This is done by quality inspectors on-site. While at the supplier, the quality inspector confirms the quality control data including key process data and raw material certifications. The inspector uses calibrated gauges and test equipment to perform the required inspections as outlined in the quality plan.

Inspection criteria normally includes:

  • Order/shipment quantities
  • Packaging and aesthetics
  • Dimensional and mounting specifications
  • Final performance attributes

An inspection report is written up and submitted to the quality manager before any goods would be authorized to ship. The inspection report is also a critical document in maintaining ongoing quality metrics which measure supplier performance. Typically, if a supplier doesn’t meet the standard quality requirements, they may attempt to make improvement using a Corrective Action Process (CAP).

The quality plan is part of the continuous improvement process. The aim is to make your product correctly the first time, and every time. The quality plan is one way you can know that your manufacturer and your suppliers have your project’s best interests at heart.

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