In Focus

Abstract:Risk prediction and prevention are increasingly important to organizations and standards, such as the ISO 9001:2015, specifically when it comes to quality management systems (QMS). The ISO 9001:2015 requires that an organization must integrate risk prevention and risk-based thinking into any QMS. While there are many tools that can help with risk prevention, one of the more powerful tools is a failure mode and effects analysis (FMEA). FMEA helps organizations to identify possible risks, rank them based on priority or severity, and then generate risk priority numbers to help in assessing and preventing risks. This is especially useful for organizations that offer products or services that have a real impact on safety, as FMEA will help mitigate and predict future safety …

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--Gheorghe Dondera, 10-11-2017


This is quite possibly the most misleading article on risk based thinking and clearly the writers do not understand the concept. The use of RPN's is NOT risk based thinking. This is Risk Management NOT the risk based approach. I was present for the writing of the standard and this is not at all the concept. You should write a retraction.
--Mark Swanson, 10-11-2017


Excellent, precise article on FMEA approach.

I have been leader and member on this wisdom sharing tool, in global settings for 515 FMEA's.
--Girish Trehan, 10-07-2017


Excellent!! I was hoping for this article,using FMEA,ISO 9001 is a the same level of ISO 14001 and OHSAS 18001 in identifying and evaluating risks
--ENRIQUE CACERES, 10-02-2017


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