ISO 9001:2015 and Its New Requirement to Address Risk: A Demonstration Case-Study

Filipe Perdigão ； Celeste Jacinto ； Sandra Lopes ； Ana Sofia Matos

《International Journal of Systematic Innovation》 4卷4期 (2017/09) Pp. 46-55

https://doi.org/10.6977/IJoSI.201709_4(4).0004

摘要

The recent 2015 edition of ISO 9001 introduces a risk-thinking approach in its new section 6.1. Comparing with previous editions of the standard, the main innovation is the need to address risk and identify improvement opportunities within quality management processes. The aim of this work was to show how the new requirements can be fulfilled. This was achieved through a case-study in an industrial company, by applying a structured analysis to a specific management process. This paper describes a practical example, demonstrating how this type of analysis can be applied to any management process within a companies' quality system. Two methods were used; the first was Failure Mode and Effect Analysis (FMEA/FMECA), and the second was a Hazard and Operability Study (HAZOP). In the latter case, the authors used the designation QF-HAZOP to highlight the fact that this is a HAZOP study applied to the analysis of Quality Functions. The current work is restricted to the study of main process (management function) ＂Sales＂, for which the analysis of a particular sub-process, ＂Sales plan development＂, is herein presented and discussed step-by-step, to give insight of details. Within ＂Sales plan development＂, the results revealed 10 failure modes that, in turn, can originate from 17 potential causes that were organized into 4 ＂sets of causes＂ because certain failure modes share the same causes and require similar improvement actions; these are also pinpointed in this paper. With regard to the main process ＂Sales＂, this analysis disclosed 38 sets of causes that were categorized by risk level, i.e., by their risk priority number (NPR), using a Pareto Diagram, to establish intervention / improvement priorities. It was also found that, apparently, either FMEA/FMECA or the adapted QF-HAZOP produce similar results. Both constitute useful approaches to fulfil the new requirements of ISO 9001:2015 Quality Standard.

關鍵字

Quality ； Risk analysis ； Risk-based thinking ； Quality management ； ISO 9001:2015 ； FMEA/FMECA ； HAZOP