Yet another OBSERVATION vs. EVALUATION issue

Thomas Beale thomas.beale at
Tue Aug 14 12:41:01 EDT 2012

On 14/08/2012 15:43, 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,
> *
> *

Hi Stefan,

whenever you assess someone as having a risk, you are doing something 
similar to diagnosing: i.e. you are comparing some input data items 
about the patient (high BPs over last 3 months, smoker, 55years old etc) 
to some knowledge base that says that these things taken together 
constitute a risk for hypertension, due to some population studies. Any 
probability etc is derived from that knowledge base. So these are all 

- thomas

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