Implantação de um sistema de gestão de qualidade em uma planta de produção de frutooligossacarídeos

Abstract

In a global modernization context, the development of emerging technologies needs to be aligned with quality standards and competitiveness scenario, in order to facilitate the entry in the market by these new companies and their quality management. Quality Management Standards implementation, such as ISO 9001:2015, supports on meeting regulatory requirements, increasing customer satisfaction, delivering products of higher quality and safer, in addition to structuring internal processes within the organization. Specially in pharmaceutical and food industries the consumption of fructooligosaccharides (FOS), which are prebiotic sugars, soluble fibres and non-cariogenic, has been increasing in recent years. Its production has been developed by the Enzymatic Technology and Bioprocesses group at UNIFAL-MG with the use of continuous processes with stable biocatalysts produced from immobilised cells of Aspergillus oryzae IPT-301 in polyurethane foam. Their research has motivated technological and economical studies towards the future implementation of a production plant in Brazil. In this context, this work shows a 7-step method for the implementation of a Quality Management System based on ISO 9001:2015 addressing topics that will allow the group to meet the minimum requirements to obtain a certification in the future, when operating the plant. The evaluation of the internal and external context encompasses the regulatory requirements considering two types of finished product (a sweetener and a nutritional supplement with functional properties allegations), description of the processes, iterations, risk and opportunities identification in addition to a SWOT matrix to direct strategic management. Advantages highlighted were related to the innovative process with national technology, multidisciplinary and experienced team, low cost of raw material (white sugar), lack of competition in Brazillian market, high public and private interest and possibility of patenting the technology. Nevertheless, lack of investment for the site structure, long period to meet regulatory requirements, high coadjutants costs and uncertainty on FOS purification process may be risks to the site implementation. The content of this work is not exhaustive, and a review is needed when, in fact, the production site is operating, however this piece allowed the group leadership to understand future demands and challenges so that future activities can be planned in a strategic way.