There's an old saying that says, "The Lazy Tradesman blames his Tools."
If the only risk assessment tool you are using is Failure Mode and Effects analysis (FMEA), you may be such a Lazy Tradesman.
Even though FMEAs come in 6+ 'flavours', there are dozens of other risk assessment tools other than FMEA that might actually be better. In managing risk, play full regard to ISO 31010 - an ISO standard that provides guidance on how to choose the right tools for assessing risks in different types of situations.
ISO 9001, ISO 13485, ISO 27001, ISO 45001 and many other management system Standards require Risk-based thinking or fully-fledged risk management.
If the only objective evidence you have to offer is a few FMEAs and some vague S-W-O-T Analysis, don't expect external auditos to be impressed. They won't be, because they will be aware that there is a Toolbox of risk management methods that you have avoided using.
The Risk Assessment Toolbox
We have prepared a Table (using ISO 31010) indicating which Risk Assessment Tools you should consider (or strongly consider) for a variety of business situations.
The Table includes 31 of the most popular tools from the Risk Assessment Toolbox including the choices available for:
- Risk Identification
- Risk Analysis
- Level of Risk
- Risk Evaluation
And in the right-hand column is given the Annex Number in ISO 31010 where details of the Tool in question, including examples in most cases, can be found.
But what of ISO 14971, Application of risk management to medical devices?
This Standard gives a good overall description and framework for managing patient safety risks for medical devices.
It highlights about 6 risk assessment methods and clearly states that these are not the only tool s to be considered. All of the tools in ISO 14971 are included in ISO 31010 and therefore the latter is the better choice when considering all the possibilities.
Get your own copy
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