First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs.
Risks combine the severity of harm (S) and the probability of occurrence(O). A numerical score is assigned to assess the risk.
Risk = probability of damage x severity of damage. A simple evaluation scale needs to be used and it must be equivalent for all products. See the table below as an example:
Then the score is interpreted by this table:
Then risk control measures must be defined and implemented according to the score.
Two methods are applicable when performing a risk analysis; the fault tree analysis and the failure mode and effect analysis.
Author: Alix Auter, Life Science Consultant KVALITO
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