ANALYSIS AND PREVENTION OF RISKS IN THE MANUFACTURE OF LABORATORY MICROBIOLOGICAL CULTURE MEDIA BY FMEA METHOD

Abstract

At all stages of the production of microbiological nutrient media (MNM), the manufacturer, and in particular, the microbiological laboratories that manufacture the media on site, face many operational risks. The presence of such risks, in almost every critical point of production and further operation of the MNM, is due to the presence of common basic requirements for all MNM, which must be taken into account and respected during their development and preparation; as well as the complexity and laboriousness of the very process of manufacturing high-quality differential-diagnostic and other nutrient media, requiring the availability of all the components necessary for preparing these media, equipment, sterile conditions and qualified personnel. In this regard, there is a need to search for effective methods to identify and prevent undesirable situations associated with the production and use of MNM. The aim of this work was to adapt the risk assessment methodology based on the expert method for analyzing the types and consequences of FMEA failures (Failure Mode Effect Analysis) set out in GOST R ISO 31010-2011 for the needs of microbiological laboratories, including those for veterinary and sanitary expertise, producing microbiological nutrient environments and using them. As part of this work, a comparative analysis of risk assessment methods was carried out in order to select the optimal one; adaptation of the QMS principle - risk-oriented thinking and the FMEA method for risk assessment in the implementation of MNM manufacturing processes in a microbiological laboratory (for example, solid agar media); risk assessment protocol forms were developed; calculations of a quantitative assessment of risk levels were carried out in order to determine the need for preventive actions and their implementation in order to minimize the negative consequences of risk in case of its implementation using the developed protocols. The results showed that this technique can be successfully implemented and used in the claimed area.