Quality

Did you know the FDA roughly defines ‘adulterated product’ as having any ingredient present that wasn’t supposed to be there. For example, if a batch of someone else’s product was manufactured on the same equipment used to make your product, and the equipment wasn’t properly cleaned prior to your batch, your product could have some residual trace ingredients from that previous batch in it. If your product is deemed adulterated by the FDA, they can react in a number of ways, from inspections up to and including shutting your business down.

Besides being a state, federal and even international requirement, strong quality regulation helps businesses like yours produce market-safe products and helps build a safe work environment for your employees. Avoid product recalls, improper documentation, cross-contamination and all the costs associated with those by being proactive about your quality regulation.

Any small to medium-size business that produces a food or nutraceutical product must have a quality prevention and control program. With extensive experience in this industry, Kurt, is uniquely qualified to help your business thrive.

One example of thorough quality prevention and control program is verifying and documenting the ingredients used in your product perform the function you intend with no negative consequences. Do all your ingredients play nice when combined in their final form? Does an increase in one additive have an unforeseen impact on another? Kurt knows what questions to ask and what common pitfalls to avoid.

Typically, developing, installing, and training your operations staff on a complete quality prevention and control program will cost anywhere from $10,000 to $50,000.

Unfortunately, a thorough quality prevention and control program is typically the last thing a small or start-up company thinks of when trying to get on the ground floor of selling product. That is not to say they ignore it, far from that. What typically happens is they do not understand that these programs are a government requirement, and not meeting that requirement can have significant impact on your business, up to and including shutting it down. The cost of installing and maintaining these programs is not necessarily high when compared to the cost of non-compliance, but it does need to be addressed as a separate budget line item in your business. Most small and start-up businesses view these as ‘sunk dollars’ since they don’t actively help sell more product. If viewed as a preventative cost, however, any upfront investment will more than pay for itself if it stops a shipment of contaminated product before it reaches your customers.