A fuzzy-based multi-stage quality control under the ISO 9001: 2015 requirements

This work focuses on the problem of non conformity (NC) characterisation in quality management systems (QMS) and introduces a fuzzy inference engine (FE) for NC analysis based on multi-stage quality control. The research has a twofold objective: 1) to characterise NCs based on risk analysis principles, 2) to define NC priorities. The FE is implemented according to the main requirements of the new ISO 9001: 2015 Standard regarding risk analysis and NC assessment. The methodology was tested within an assembly line of mechanical components, where a number of NCs were detected and classified with respect to multiple features. Within this classification, risk analysis is explored through the use of failure mode effects and criticality analysis (FMECA). A risk criticality index (RCI) is defined and evaluated, which addresses NC criticality and the relative action priorities. [Received 28 January 2016; Revised 25 March 2016; Accepted 24 June 2016]