Using HIRARC method for addressing risks in QMS
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The FMEA is not the only method for identification and evaluation of risks in QMS, there are a lot of methods for risk assessment available, some of them are described in ISO 31010. There is no one single method that would fit all organizations and all issues related to the context of the organization, every methodology has it own limitations.
HIRARC is used in determining occupational health and safety risks, so the scope of the method is far from the requirements of the standard and that is to address risks and opportunities emerging form context of the organization that can affect ability of the QMS to achieve intended results, to enhance desirable results, prevent undesired effect and achieve the improvement. The only way to use this methodology is to modify it in a way that addresses the requirements of the standard.
Choosing the risk assessment methodology needs to be done carefully, because most of the methodolog ies do not identify opportunities which is also a requirement of the standard. Another important thing is that the standard does not require the methodology, so the process of addressing risks and opportunities can be done in much simpler manner that will ensure covering both risks and opportunities, for example using SWOT or PEST analysis.
For more information, take a look at this free webinar:
How to implement risk management in ISO 9001:2015 https://advisera.com/9001academy/binar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
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Feb 19, 2016