Quality Improvement Process for Software Controls in Regulated Industry using Six Sigma Methodology

Abstract

A regulated industry at medical devices company, Software Control practices on Automated Processes are weak and not systematized. Several findings were found in past internal audits related to software revision changes. In order to achieve the compliance with Food and Drugs Administration, this project, the focus was in the areas related to software validation after a change, maintenance and software changes on automated processes. The principal interest is establishing a quality improvement process for the existing software control structure using DMAIC tool. DMAIC is the methodology used in this research as Define, Measure, Analyze, Improve and Control. DMAIC is a popularized continuous improvement method. The goal of this project is standardize and simplify the Software Control system while eliminating the probability of future observations. In this project were used different techniques to maintain a continuous improvement, demonstrating that the DMAIC methodology is a useful one to have an incremental improvement. Key Terms ⎯ DMAIC, Finding, Six Sigma and Software Control.