Yet another OBSERVATION vs. EVALUATION issue

Gerard Freriks gfrer at luna.nl
Tue Aug 14 10:55:59 EDT 2012


> Risk consists of:
> - A hazard
> - a probability that this hazard will typically occur
> - the severity of the harm that this hazard will cause on humans or non-human subjects
> - probability together with severity will describe the risk


Should we add the temporal factor?
E.g. the chances in a defined period of time.

When you mean that the constituting elements of a RISK are Observations and Evaluations, you are right.
The RISK itself is documented by these components.
E.g. RISK= High Risk of Something to occur in a certain time period.
The composite is an Evaluation.
The result expressed in the Evaluation is a semi-quantitative result consisting of the constituting Observations and Evaluations.


Gerard Freriks
+31 620347088
gfrer at luna.nl




On 14 Aug 2012, at 16:43, Stefan Sauermann wrote:

> Just out of the Risk analysis box see eg. ISO 14971:
> Took me some time to figure it out, so I share it just in case:
> 
> Risk consists of:
> - A hazard
> - a probability that this hazard will typically occur
> - the severity of the harm that this hazard will cause on humans or non-human subjects
> - probability together with severity will describe the risk
> 
> some parts of this may well be observations, others will be evaluations
> 
> Greetings from Vienna,
> 
> Stefan Sauermann
> 
> Program Director
> Biomedical Engineering Sciences (Master)
> 
> University of Applied Sciences Technikum Wien
> Hoechstaedtplatz 5, 1200 Vienna, Austria
> P: +43 1 333 40 77 - 988
> M: +43 664 6192555
> E: stefan.sauermann at technikum-wien.at
> 
> I: www.technikum-wien.at/mbe
> I: www.technikum-wien.at/ibmt
> I: www.healthy-interoperability.at

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