v Marandi - Validation & Process Improvement Engineeling Co. - IRAN
H.R Marandi - e-CxO Corporations - U.S.A
S Gordehie - Validation & Process Improvement Engineeling Co. - IRAN

Managing risk in the project development cycle presents an opportunity to optimize the time, resources, and cost of developing a project. This same opportunity extends to the establishment of our quality argument and all of its related systems. The challenge in embracing this new approach to quality is shifting from the traditional mindset based on blanket inspection and testing to one driven by control and monitoring. With this shift in philosophy, we fmd ourselves reinventing our approach and expectations to fundamental quality activities, such as root cause analysis (RCA). The lack of a disciplined approach to RCA has undermined the effectiveness of CAPA programs and often leads to recurring issues with deliverables. As a result, the focus of many risk investigations has been the quality and defensibility ofRCAs, which are often used to close out a CAPA. This article describes the application of one approach that is very ffective in integrating the basic tenets of Quality by Design and risk management. This paper is going to present a RCA roadmap consists of eight steps; based on a peer study done, which is presented previously. It is believed that establishing an objective, data-driven methodology is critical to the success of a RCA exercise.

Operation excellence, Quality by Design, Quality management, CAPA, Roadmap