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Unit 4: Risk Analysis




                                                                                                Notes
                 Example: It is necessary to clarify whether the risk manager needs estimates of population
          or individual risk, or both.
          3.   The type of risk assessment shall be responsive to the nature of the potential hazard, the
               available data, and the decision needs.


                 Example: If the objective is to decide whether a particular incident requires a product
          recall, the risk assessment will focus on that incident and not on the complete risk profile of the
          product.

               On the other hand, the risk profile should be determined as completely as possible in the
               design stage.
               Different risk assessment methods or tools are available for these different types of risk
               assessment. Selecting the type of risk assessment also means selecting the right methods
               and tools.
          4.   The level of effort put into the risk assessment shall be commensurate with the importance
               of the decisions to be made.
               This principle is linked with principles 2 and 3 and emphasizes that risk assessments may
               vary considerably in scale. The time frame available for decision making may also influence
               the scale of the risk assessment.

          5.   The assessment shall be objective, systematic, structured and – as far as practically possible
               – evidence based.
               This means that the processes used for risk assessment  should be methodical and use
               recognized methods to ensure that the results are repeatable and reliable.
               An  evidence  based assessment  also  implies  that  efforts  are necessary  to ensure  the
               availability of suitable data. Data are necessary at the start to picking up any signals that
               may call for a  risk assessment, and later  in the  risk assessment  itself. Therefore,  an
               organization that wants to perform risk assessments needs to prepare itself by establishing
               a system for collecting relevant data of good quality or to know where such information
               already exists.

          6.   The risk shall be characterized qualitatively and, whenever possible, quantitatively.
          7.   Risk Assessment should explicitly describe its own uncertainty and the  causes of  the
               uncertainty.

               This may  include: providing  a  range  of plausible  risk estimates  with a  quantitative
               characterization of risk; for critical assumptions, whenever possible, include a quantitative
               evaluation of reasonable alternative assumptions and their implications for the key findings
               of the assessment; documenting and disclosing the nature and quantitative implications
               of model uncertainty, and the relative plausibility of different models based on scientific
               judgment; where feasible, performing a sensitivity analysis; and providing a quantitative
               distribution of the uncertainty.
               The primary purpose of risk assessment should always be to deal with those aspects of
               decision making that are uncertain. If the outcomes of actions or decisions are completely
               certain in terms of what will occur, when and its extent and nature, then there is less need
               to assess the risks but just manage them and monitor the results. Decision makers need
               help understanding where uncertainty lies and how it is best treated and managed.






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