Year: 2022-23

Company: Medtronic

Liaison(s): Jordan Dietz, Niall Kelly, Maureen Kinsella, Mark Nelson, Doug Wheeler

Medtronic is a global company with more than 60 years of medical device experience. The company currently has over 49,000 patents and treats over 70 different conditions. One department that has aided Medtronic’s success through the years is Global Calibration Services (GCS). GCS is tasked with maintaining the accuracy and traceability of measurements used to produce high-quality products. These calibration services are based on national standards, international standards, and their own quality management standard (QMS) documents. Currently, GCS is managing multiple QMS procedures across the many sites it supports. Medtronic aims to define and create a one best way calibration procedure that will apply to all sites. Our Team Master’s Project aims to develop the one best way procedure that takes the best of the various site procedures and ensures compliance with business and regulatory requirements. Alongside the one best way procedure, the team will redline Medtronic’s Global Policy to ensure the global policy includes all the work elements proposed in the one best way procedure. Through the partnership with Medtronic, the KGI team has identified 25 key work elements showcased in seven different site-specific procedures, has recommended best practices for each work element, and has compiled them into a draft of the one best way procedure. The new one best way procedure will optimize how GCS maintains the accuracy and traceability of measurements across Medtronic.