Development of a quality framework to monitor, evaluate and control broad-based engineered nanomaterials

Abstract

Predictions of new technologies are often difficult to make, however Engineered Nano Materials (ENMs) is undoubtedly a novel technology and a revolutionary science that has the potential to bring substantial change to society. Scientists and researchers have demonstrated the ability to manipulate atoms and convert them to be lighter, more resilient, durable, high precision with superior strength qualities. Studies have indicated that although ENMs have been used in many products for several years, a formal, practical, systematic and robust system of assessment of risks with validated quality protocols are absent globally and are urgently required. There are inherent risks relating to ENMs which include environmental, toxicity, societal impacts and economic uncertainty. Very often all it takes is one incident, one oversight or one mistake (such as the recent listeriosis outbreak) to put an entire community and industry at risk. The volatility, mobility and increased reactivity of the ENMs is what presents risks for users and they need to be aware of such risks. Hence, it would be prudent for researchers, scientists and manufacturers to find and implement measures to mitigate and eliminate these risks. Globally, products that contain ENMs are not subject to any special legislation or regulations relating to research, production, handling and disposal of these materials which compels users to take precautionary measures. In the absence of compulsory regulation, voluntary or self-implemented measures may be effective in reducing risks. Thus the aim of this study was to develop an integrated quality framework that will assist in understanding, predicting and managing the risks associated with ENMs. The methodology comprised of an empirical study using a mixed method research approach. Questionnaires were administered and interviews were conducted with experts in the field of nanotechnology. The literature review and the results of this study confirmed the areas of risks that required to be addressed. The findings from the study were then used to develop a first generic or broad-based framework to ensure compliance with safety, health, environment, quality and nanotechnology risk standards. This

framework combined and integrated several management systems which allows an organisation to work such systems as a single unit with unified objectives. The integrated management framework that was developed included international standards for safety, health, environment, quality and nanotechnology (which included ISO 9001-2015; ISO 14000-2015; OHSAS 18001; ISO 17025; ISO TR 13121: 2011 and ISO TR 12885: 2008). The framework was designed to guide an organisation in improving efficiencies and reducing costs as duplication of management systems are avoided.

The proposed name for the new framework is Safety, Health, Environment, Quality and Nanotechnology (SHEQN) which incorporated technical reports with international standards.

Further, as part of this study, a computer programme was developed to classify the human risk exposure to ENMs. This computer application would assist the organisation in establishing and implementing their “Risk Management Strategy” at an accelerated pace.

It is hoped that the SHEQN Framework presented in this study will serve as a theoretical platform for organisations wanting to formalise their management of ENMs to facilitate commercialisation and ultimately promote the use of safer nanotechnology.