Risk Analysis and Risk Evaluation - Biomedical company

[S.Mario]

Hi everyone,

I've just started to work for a biomedical company and I have got some realy basic question about the Risk analysis.

What is the difference between the risk analysis and the risk evaluation?

many thanks to everyone

 

[Martin IT]

Re: Risk analysis and risk evaluation

Hi, briefly:

The Risk analysis is a systematic use of information to identify specific sources of harm (hazards) and to estimate the risk.
The Risk evaluation compares the estimated risk against given risk criteria
using a quantitative or qualitative scale to determine the significance of the risk.

 

[S.Mario]

Re: Risk analysis and risk evaluation

... and the risk control?

 

[Martin IT]

Re: Risk analysis and risk evaluation

The Risk control describes the actions of implementing risk management decisions.

What can be done to mitigate and reduce risks?
What options for controlling risks are available?
What are the impacts of current risk management decisions on future options for risk management?

Risk mitigation focuses on a reduction of severity of harm.
Risk reduction focuses on the reduction of probabilities of occurrence of harm and detection of
harm.
Risk acceptance is a decision to accept risk, i.e., no additional risk control activities are necessary at that
time.

 

[S.Mario]

Re: Risk analysis and risk evaluation

Thank you, I've still got same doubts but I have to undestand a lot of thing

 

[Marcelo]

Hello S.mario, and welcome to the Cove.

Just one point, do you have access to the ISO 14971 standard? All these terms, and a lot of explanations and examples, can be found there.

 

[S.Mario]

Thank you, I will looking for those.