HNCR model following robust approach.

Abstract: This paper introduces a new model for Non‐Conformity Management, aimed at overcoming the limitations occurring when dealing with Non‐Conformities through traditional methods like Root Cause Analysis. The need to suggest a new approach to Non‐Conformities Management is connected to those situations where a large variety of Non‐Conformities is recorded, with a significant number of low‐impacting ones; addressing them directly through methods like Root Cause Analysis would often be not economically viable. In this context, the paper discusses Holistic Non‐Conformities Reduction (HNCR) approach as a suitable option to address this kind of business situations. In particular, the contribution of this paper is related to the development of HNCR model and the evaluation of how to properly structure the model and the flow that shall be followed. By clustering Non‐Conformities into flexible categories to be easily modified, expanded and rearranged through time, the HNCR model allows to identify new critical Non‐Conformity families, otherwise hardly detectable. A proof of concept relative to HNCR deployment is presented: 2 different scenarios are introduced, the first being the Non‐Conformities management within the extended supply chain of a large pharmaceutical distribution centre, while the second deals with Non‐Conformities in the context of a company's new programs development. [ABSTRACT FROM AUTHOR]