Walter Andrew Shewhart is regarded as the founder of Statistical Quality Control (SQC), an approach to production inspection based on the application of statistical theory. He developed SQC in the 1920s while working at Bell Telephone Laboratories. During this period, he was tasked with training...

This study investigates how strategic innovation influences operational quality, focusing on the mediating effects of transformational and transactional leadership, as well as process innovation, within manufacturing organizations in Colombia. It employs structural equation modeling to analyze...

This study aims to investigate the application of risk analysis techniques in the medical device industry and the techniques most utilised to address compliance with ISO 14971:2019 with a view to assessing the challenges of risk management. Failure Mode Effect Analysis (FMEA) and its limitations...