Towards a Risk Management Framework for Quality, Environmental and Health & Safety Management Systems in Regulated Environments

Abstract

Whilst large-scale manufacturing in Ireland has seen a general decline in recent years, exceptions to this rule have been the medical device and pharmaceutical sectors which have seen continual growth. These sectors differ from traditional manufacturing in that many of the products they produce are viewed not just as industrial goods, but also a tool of public health. Because of this, the Industries are highly regulated. In order for a company to receive product approval, it must undergo stringent auditing of its quality management system. In addition to their quality systems, companies are under increasing pressure to control, improve and maintain their environmental systems and their health & safety systems. Traditionally, manufacturing companies have been structured as a hierarchy of functional units. The difficulty with this type of structure is that problems that occur at the interfaces, or at function boundaries, are often given less priority than the short-term goals of the functional unit. Integrating quality, environmental, and health & safety management systems may provide a solution. However, because medical devices and pharmaceutical companies manufacture under strong regulatory oversight of their Quality Management System, this oversight has led many companies to reject integration in the belief that integrating their environmental and health & safety systems with their quality system will jeopardise approval by regulatory authorities. The difficulty is, that if these systems operate independently of each other, then the barriers between them will not be crossed. Corrective actions will be focused on the system concerned, and therefore will result in little benefit to the organisation as a whole. Moreover, as part of its risk control measures in one system, the organisation many actually create risk in another. This thesis details the development of a risk-based framework by which companies operating in such highly regulated environments can resolve this problem. Based on the evidence from a detailed literature review and the data gathered by means of survey and case studies, the corrective and preventive action (CAPA) component of the management system was found to be the most significant common element throughout the regulations and standards governing these companies. The proposed framework supports an integrated approach to the management of environmental, quality and health & safety systems, which is developed around this CAPA process. IDEFØ, (Integration Definition Function Modeling) is the functional modelling methodology used to describe the analysis and development of the framework. The framework was then validated via expert reviewers, representing some of the main end-users of the framework.