A Smart Manufacturing Conceptual Framework for Digitalising Data Collection of the Quality Management System for Regulatory Compliance in the Medical Device Industry

The medical device manufacturing industry is driven by stringent regulatory compliances and faces challenges in implementing quality management systems. One such challenge is the preparation of the paper-based documentation of all the documents as evidence for certification audits. With the advent of Industry 4.0, the increasing amount of data from the shop floor, with variety and veracity, poses additional challenges to the organization. Various technological interventions have made quality systems suffer from categorizing the incoming data and presenting it in suitable formats. A smart manufacturing conceptual framework with elements of intelligent manufacturing, quality control and smart manufacturing has been developed and proposed. The activities and outcomes of the framework enable the organization to capture data from the shop floor according to the various entities. The TOPSIS decision modeling technique is used to perform the structural validation of the framework. The TOPSIS scores reveal the influence of the framework compared to a conventional process. A statistical test was also performed to emphasize the claim.