With the school year in full swing, we are reminded that, even as adults, we are always learning, sharing and growing. We are also challenged, tested, evaluated, even praised and rewarded for our efforts. Sometimes the reward is the sheer accomplishment and successful achievement due to the skills acquired and challenges overcome. One example is a medical device project that HARBEC ran since 2013 with 100% inspection.
Due to the tight tolerances for the medical product, the typical method of verifying the process could not be used. This endeavor took a great deal of teamwork (internally and with the customer), and lot of dedication. New inspection methods were created and verified, employees were trained, space was dedicated, and new machines purchased. In the medical world, mistakes are unacceptable. This requires an experienced team and companywide dedication.
As shown in the infographic, this project produced over 30 different medical parts for a total of 140,000+ machined pieces.
All these parts required 100% inspection and with an average of 30 dimensions per part. That is over 4,200,000 inspection points taken. A very daunting task indeed and with most dimensions having a tolerance of +/-.002” and some dimensions as tight as +/-.0005” the precision and processes of the toolmakers had to be spot on. Every part needed to be 100% inspected visually, and there could be no burrs, cutter marks and anodizing flaws. Quality manager Kevin Ralg reflects, “at times this seemed like it might be difficult, but at HARBEC we do not back down from challenges, we welcome them and figure out how to get it done. By purchasing the right inspection equipment, along with the correct software to record the results, we were not only delivering quality parts, we were also meeting the production requirements on time.”
With so much inspection needed on these parts, both dimensionally and visually, and tolerances being so tight, there would also be a greater risk for returned parts. Not only did HARBEC do a 100% inspection both dimensionally and visually but the customer was affirming the same task. “That’s quite an accomplishment. HARBEC shined bright on this project and it took a total team effort to make this happen” says Ralg. From kick off to send off, quality is the priority throughout the company.
To learn more about HARBEC’s Quality Department, visit our website.‹ Back To All Blog Posts
The Aviation Industry is highly regulated with demands and controls that ensure the safety and reliability of equipment and materials. Our aviation, space and defense customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our processes are monitored to improve efficiency, ensure product safety and reliability while continually improving.
More Information >
The Medical Industry is highly regulated with demands and controls that ensure regulatory requirements and customer expectations are met. Our medical device customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our ISO 13485 management system adopts a risk management approach which, while having these controls in place, eliminates hazardous situations throughout the product realization process.
More Information >
HARBEC is a registered ITAR company. International Traffic in Arms Regulations (ITAR) is a set of United States Government regulations on the export and import of defense related articles and services. Our Defense and Military customers can have complete confidence that HARBEC has an established and implemented ITAR compliance program and adhere to the strict guidelines set forth by ITAR and EAR statutes.
More Information >