It's More Than Just Locating a Contract Manufacturer
Believe it or not, locating a contract manufacturer for your new product, line extension or simply due to capacity constraints is the easy part. There are all kinds of consultants out there that specialize in just that. The hard part is finding a contract manufacturer that can meet ALL the criteria to manufacture a quality product that is compliant with all the latest regulations. And to do that you need a consultant that not only knows these criteria inside-out but also can build, from the ground up if needed, the processing, quality and regulatory compliance programs to ensure a smooth start-up.
Seeing how many small contract manufacturers are out there, and how many pop up on a regular basis, it surprised me to see how many of them do not have programs in place for quality and regulatory compliance that meet or exceed the current government standards. Don't get me wrong, it's not that these firms are *trying* to circumvent the regulations, they simply might not be aware of them. And that constitutes a huge problem for the entrepreneur, especially one who does not fully understand them as well. In fact, it is the Brand Owner, NOT the Contract Manufacturer, that is ultimately responsible for what goes in the package and out to the consumer. And that is why the entrepreneur needs to know, or have someone on their side that does know, the current regulations and how to work with the contract manufacturer to meet them.
This blog will center around what the Brand Owner needs to know, what their rights are when it comes to contract manufacturing batch records, quality test results and what they should expect when it comes to transparent communications and visibility with the contract manufacturer. When it boils right down to it, while the Brand Owner (entrepreneur) is accountable for product quality and compliance, it is the partnership that works together to make that happen. If you choose to work with me, I will look at the contract manufacturers regulatory compliance, their quality programs, testing, documentation and record keeping required to meet the current standards and will also look at how their production efficiency plays a role in compliance.
Navigating the contract manufacturing waters can be tricky but knowing what to look for and what you can do as the entrepreneur to help get them there is all part of a successful partnership.