Producing Quality Products with your Contract Manufacturer

The Trust Factor

Building a foundation of trust with your contract manufacturer early in the partnership is essential when it comes to maintaining the quality of the finished product. But what defines “quality?” Is it proper documentation traceability, good manufacturing practices, or Food and Drug Administration (FDA) Form 483s?

Defining Quality

A simplified definition of quality is every product released to be sold has met 100% of all the finished product specifications. While it's impossible for even the most reliable contract manufacturer to guarantee every product made has met the gold standard, it is ensured that every product released to be sold is acceptable and capable of being sold. In order to set ranges of acceptability, three things must be in place: Gold Standard, Release Specifications, and Control Limits.

Gold Standard: The Vision

The Gold Standard is your target product. It represents exactly what your customers will receive when they purchase the product. This isn't just a physical prototype, this is a technical data sheet. The product must be consumable, meet the label requirements, and be appealing to the customer. The brand owner is solely responsible for creating the Gold Standard and defining the specifications that are critical to producing it.

Release Specifications: The How

After defining the characteristics of your product, you can begin the Release Specifications. Release Specifications define the exact conditions and acceptance criteria of the product. The specification decisions ultimately land on the Brand Owner but setting these should be a collaborative effort between the Brand Owner and Contact Manufacturer to ensure that the product will meet them 100% of the time.

Control Limits: The Process

Following the Gold Standard and Release Specifications comes the Control Limits. Control Limits are based on collecting data from numerous production runs and performing a simple statistical analysis to determine how capable the system is at making quality products. Contract Manufacturers are sole responsibility for this stage.

Conclusion

Overall, there are several ways to define quality, but these three pillars will help ensure that the product is meeting the owners and customers expectations 100% of the time.