T. Boyko, R. Kochan, O.S. Korchynska
Thursday 11 October 2018 by Libadmin2018


The term and interpretation of "risk" is analyzed in various regulatory documents, particularly in the standard of German automobile manufacturers VDA 6.3 and ISO. In their interpretation was found partial inconsistency. It is shown that the normative document of audit processes should be developed based on the requirements of ISO/IEC, taking into account the industry specifics. For this, it is proposed to separate the concept of " non-conformity of requirements" and "risk" and to identify risks during the audit process, as the combination of undesired consequences, wastes, evaluated through the "quality wastes" process elements and their likelihood, obtained by statistical information processing. To determine the component of the risk level – the consequences for each of the above elements of the "turtle" model, it is proposed to use the method, according to which such consequences lead to technical (material, resource) or economic wastes. The size of wastes is proposed to be defined as a "quality loss" of the process element. Let the investigated element of the process become a "victim" of the influence of a certain undesirable factor and lose its positive properties - compliance with the purpose, safety, functionality, etc. The listed characterizes the quality of the process or its element. If the "quality" as set of all estimated properties, aspires to unit, then "quality loss" because of influence of undesirable factors tends to zero and vice versa. Quality is possible to estimate on methodology of a qualimetry using indicators of properties of process which are "sensitive" to a source of an undesirable factor. As a quantitative measure of likelihood, frequencies are often used - the number of events for a certain period of time. Frequency usually characterizes past events and in this sense it acts as a measure of the likelihood of future events. The enterprise should collect statistical information and apply it as a base to determine the second component of the risk level. In particular, this may be the frequency of incidents, the number of detected defects in products, the number of mistakes made by staff, the frequency of unplanned repairs, the frequency of wastes or decrease in efficiency, etc.

Keywords: process auditing, product life cycle, supplier evaluation, risk analysis, risk assessment

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