Improving of the filtering respirator development process

Purpose. To improve the process of filtering respirators developing. Methodology. To achieve the goal, the dialectical method was used to discuss the component stages of design, the induction method to form a holistic approach based on the identified stages of design, and the systemic method to assess risks during the development of respiratory personal protective equipment. Results. The process of designing universal filtering respirators has been improved, which consists of the well-known five stages: design, preparation, production, conformity assessment and post-production (disposal), each of which provides a risk assessment procedure that allows you to identify and prevent unforeseen events that prevent you from achieving the goal of manufacturing a quality device. It is proposed to conduct a risk assessment to identify design flaws in respirators at the marketing search stage and the stage of their manufacturing using the FMEA method, as well as to make management decisions at all stages regarding the development of respirators using the FRAM method, which allows you to reduce variability in the timely manufacture of a quality filtering respirator. Examples are given from the description of the stages of respirator development, based on the six main aspects of the FRAM method: input and output data of each stage, as well as the resources required for its implementation, prerequisites, control and time. Consider examples of possible scenarios of events at the stages of respirator manufacturing that increase the variability of the initial result and develop recommendations to eliminate the identified shortcomings. Scientific novelty. The scientific novelty consists in combining the FMEA and FRAM methods for assessing risks in the development of new respirator designs and making management decisions at each stage of development in order to reduce the variability of the initial results. Practical significance of the work lies in the description of risk assessment at each stage of respirator manufacturing, which helps to quickly make decisions on the effectiveness of the actions taken and planning the further steps. Key words: risk assessment, development stages, respirator, design, product model.