As our customers’ needs change, we are quick to react and provide solutions. One of the ways we have recently demonstrated this commitment to customer solutions was with an immediate reaction to a customer’s request for new materials and tighter tolerances.
This KEP customer came to us with a problem. New regulatory requirements associated with their medical device required the tubing we make for them to be changed on multiple levels.
The new regulatory requirements for this tubing product included:
- A dull matte surface appearance
- Very tight dimensional tolerances
- Inside dimension +/-.004” (roughly the thickness of a strand of human hair)
- Wall dimension +/-.004”
- Length dimension +/-.200” (80% tighter than normal)
Phase 1: Reassuring the Customer
We began a Zoom meeting with the customer to clarify their needs and expectations to our team. Their team was made up of representatives from Quality, Engineering, Manufacturing as well as Sales. Our team was made up similarly. Initially the customer was very concerned that what they were requesting was unrealistic, especially in the short time frame they had to provide product to the regulatory department for validations.
We assured them that we were capable of making this product for them and that we would do everything in our power to expedite this project in order to meet their stringent timeline.
Phase 2: Getting to Work
The first hurdle that we had to overcome was material. The current material used to produce their product was not meant to produce a dull matte finish; in fact it leaves the product slightly glossy and tacky. We worked with our material supplier to identify a replacement material that would meet those requirements and placed an order for the material.
The second hurdle, and probably most critical to success, was to determine if we could actually run a product with a new material that we had never run before – under the tightest of tolerances – and still maintain a qualified process capability result.
The unknowns were many but the efforts were great. KEP’s manufacturing and quality team work hand in hand to identify risk, eliminate variations, develop solutions and in the end produce a product meeting all capability and process control requirements.
Phase 3: Delivering Quality Products on a Tight Timeline
Parts were manufactured, measured for capability and shipped to the customer with all the associated documentation needed to pass the customer’s validation protocols. The first request for a Zoom meeting was on July 29, 2020. Following this, the new material was determined, ordered and received. Parts were then manufactured, inspected for capability and shipped by September 18, 2020. It took only thirty-seven days from project start to completion – a timeline that is unheard of as most standard validations take months to complete.
“They told us what they needed, we delivered, their problem solved!” – Greg Graham
The customer was very happy with our efforts and stated that our team made an excellent impression on decision-makers within their organization.
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