Journal of Product Design, Quality Engineering & Technology

Abstract

Quality by Design (QbD) is a proactive approach that emphasizes designing quality into products and processes from the earliest stages of development rather than relying solely on post-production inspection. Originating in the pharmaceutical industry, QbD frameworks are now widely applied across multiple engineering domains, including manufacturing, software, automotive, and electronics. This paper presents a comprehensive review of QbD frameworks in engineering, highlighting their principles, methodologies, implementation strategies, and impact on product quality, process efficiency, and regulatory compliance. The paper also explores challenges, future trends, and case studies demonstrating successful QbD applications. By integrating QbD into engineering workflows, organizations can enhance reliability, reduce defects, and optimize resources, aligning with the goals of modern engineering excellence.

Keywords: Quality by Design, Engineering, Risk Assessment, Process Optimization, Design of Experiments, Quality Management, Reliability, Regulatory Compliance.