How FMEAs Can Be the Cornerstone of ISO 2001:2015 Compliant Risk Based Quality Management System

Author: Richard Harpster

Abstract

There are several key differences between ISO/DIS 9001:2015 and its predecessors. One of the differences is the standard incorporates risk-based thinking in requirements for the establishment, implementation, maintenance and continual improvement of the quality management system. The Design Failure Modes and Effects Analysis (Design FMEA) and Process Failure Modes and Effects Analysis (Process FMEA) are two powerful processes for defining and managing risk within any quality management system. This paper will show that the Design FMEA, Process FMEA and the tools which they are integrated with can be the foundation of a risk-based, fully compliant ISO/DIS 9001:2015 Quality Management System (QMS). For the FMEAs to fulfill their critical role in the QMS, they must be done correctly. The paper will identify common mistakes made when performing the two FMEA types that if made will severely inhibit the effectiveness of the FMEAs as well as the QMS. Companies who have corrected the mistakes identified in the paper have experienced tremendous financial benefits with one major facility experiencing an average weekly cost savings of $144,000 per week after implementing the required changes in their FMEA processes for only nine months.