Monthly Archives: July 2012

How to Manage Production Quality From Your Manufacturer

This is the last of three posts covering the steps that should be taken once a start-up company, entrepreneur, or inventor finds a  manufacturer for their product. 

• First, the company should put all manufacturers through a supplier selection process to identify the one supplier to move forward with into manufacturing.

• Next, the company should qualify the product manufactured by the manufacturer prior to moving onto the next step of starting volume production and managing the production quality.

Once production begins, there are many checks and balances throughout the manufacturing and production system that are implemented to ensure that the resulting product functions as expected and all parts meet their documented specifications. These checks and balances make up the product quality plan which must be put into place and properly executed when the product is in production. The field of quality management has been around for over a hundred years and managing production quality is a skill that requires years of experience and training. Experts in this field not only understand the function of the product but also have a background in statistics, probability, and the theory behind product sampling plans. It is recommended that those not trained in the field ask the manufacturer for their product quality plan and take it to a professional who can provide advise on the validity and effectiveness of the plan.

The quality plan consists of those checks and balances that occur at different frequencies throughout the part fabrication and product assembly processes. Some common aspects of a quality plan are described below.

• Incoming Quality Control The incoming quality control (IQC) occurs on parts and components that are used in the assembly process. Typically, this is done on an audit basis (inspect a sample of parts rather than 100% of the parts) and the complete lot is either accepted or rejected based on the results of the test.

• In-Process Quality Control After the parts are accepted in IQC, they are sent to the assembly process. During the assembly process, there are many checks and balances carried out by automation or by humans. These checks ensure that the product is being assembled properly. Also throughout the product assembly line, there are functional tests that are performed on the complete assembly or subassembly to ensure it functions as expected. These checks occur on 100% of the products.

• Outgoing Quality Control Prior to shipment of the final assembled product, a sample of the finished goods inventory (FGI) is passed through tests and checks to be sure that they meet the expected quality levels. If the sampled products pass all the required tests and quality checks, the complete lot of FGI is released for shipment. If a higher than allowed number of products from the sample do not pass the quality checks, the FGI lot is rejected with 100% inspection and rework/repair necessary.

• Process Audits During production, a set sample of products are typically taken from the production line and checked to be sure the assembly and test processes are being performed properly. This audit ensures that the processes are not drifting from the expected values.

• Functionality and Performance Audit Another audit that is done on the finished goods inventory (FGI) is a functional, life, and performance test of the product. These tests are done to be sure that the product is meeting its functional specifications throughout the operational life of the product.

• Regulatory and Safety Audit Since every product must meet country-specific regulatory and safety requirements, audits are performed on a periodic basis to be sure that the product still meets the regulations.

When a manufacturer has a well defined product quality plan and executes it diligently, the product quality will be maintained at the highest levels and product returns from customers will be minimized. Work with the manufacturing supplier and a quality engineer to implement the quality plan and avoid unnecessary headaches.

Need more information on new product development or or how to select a manufacturer? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com