KEP Loves Solving Customer Challenges

Our cross-functional teams work with our customers to solve problems and reach goals—from designing the perfect prototype to changing and updating our processes and procedures in order to deliver the highest-quality products that meet ALL our customer’s requirements. We are up for any challenge. This enables us to put our wisdom and experience to work and the result is the smart creative solution that adds high quality to your product.

How KEP Does It: Implementing Processes to Meet Customer Needs

High-quality products are the end goal, but it doesn’t just happen by accident: KEP has implemented many processes and procedures in our facilities to ensure our customers’ satisfaction.

Example: KEP designed a new assembly jig for mistake proofing the assembly process. For our largest customer, we also built a gowning hallway with stations to increase cleanliness by reducing the chances for potential contaminants to enter the room. We even have a cross-functional team working with a customer on a continuing basis to determine the processes that must be put in place to ensure the purity and improve the surface condition of their product.

That’s just the one of KEP’s many customer satisfaction stories.

KEP Customer Case Study:

One of our customers needed a special solution to ensure their products met FDA requirements. In order for their product to meet these requirements, the product had to be able to pass the FDA’s Bacterial Endotoxins Test.

Bacterial endotoxins are found in the outer membrane of gram-negative bacteria. Affecting both product purity and safety, the effects of endotoxin are related to the amount of endotoxin in the product. Endotoxins limits are dependent on the intended use of the device and what the device contacts—with contamination being an important concern for the food and beverage as well as the medical and dental industries.

How KEP Does It: Ensuring Requirements Are Met

KEP’s quality systems at our Kent, Mogadore and Winesburg facilities are tailored to comply with ISO 9001:2015 and are FDA registered.

Since FDA review is needed prior to marketing a food or medical device, FDA will either “clear” the device or send products back to the drawing board—which can be a major loss for our customers.

Currently, the FDA has implemented more stringent guidelines for endotoxins. According to the FDA, “the strategy for endotoxins testing should be based upon product and process understanding in combination with risk management to ensure consistent final product quality.”

KEP knows we have to stay ahead of continuous improvements and updates to our processes to ensure our customers’ products are high quality and meet evolving FDA standards.

How KEP Does It: Taking Steps to Guarantee Product Quality

Endotoxin contamination has many sources including water, contaminated glassware, plasticware, and other equipment, contamination from ungloved hands, and other chemicals, raw materials, and contaminates during the manufacturing process.

Since it is difficult to remove endotoxins from products once present, KEP implements procedures and protocols to reduce the potential for endotoxins in our processes.

KEP has always had a focus on cleanliness and processes in place to ensure product purity while handling raw materials and products. We also specified and installed endotoxin filters to ensure endotoxins are eliminated prior to the final product stage.

Our customer’s products met the FDA requirements and have reliably gone to market ever since.

KEP has the processes in place to ensure future FDA requirements are met for our customers, no matter how stringent they become in future years—Have a challenge? Tell us the details so we can find the perfect solution for your business.

FDA.gov. (2017). Bacterial Endotoxins/Pyrogens. [online] Available at:
https://www.fda.gov/iceci/inspections/inspectionguides/inspectiontechnicalguides/ucm072918.htm.