Reduction in Dye Test Failures Incidence for Cartridges Manufacturing Process in the Medical Device Industry

Abstract

The medical device industry is known to be regulated by regulatory agencies across the world. Every year, a significant number of Non Conformances (NCs) and Corrective Actions Preventive Actions (CAPA’s) are generated to investigate the incidences where the product specifications are not aligned with company requirements. In coated cartridge manufacturing process, 63 Non-conformances were generated from January 2022 to October 2022 in where 22 non-conformances correspond to Dye Test Failures. This incidence of Dye Test Failures triggers the generation of one CAPA to investigate and identify actions to reduce the incidence of Dye Test Failures associated to human errors, equipment malfunctions and method. Kaizen Methodology and 6M’s Tool were applied for the investigation and implementation phases. A total of 5 actions were successfully implemented. An Effectiveness Monitoring (EM) was established for a 9-month period where a maximum of 9 Non conformances will be permitted to declare successful the reduction as part this Dye Test CAPA. Key Terms  Cartridges, Dye Test, Coating, Non-conformance.