Risk can be associated with a number of different types of consequences, impacting different objectives. The types of consequences to be analyzed are decided when planning the assessment. The context statement is checked to ensure that the consequences to be analyzed align with the purpose of the assessment and the decisions to be made. This can be revisited during the assessment as more is learned.
Methods used in analyzing risks can be qualitative, semiquantitative, or quantitative. The decision here will be on the intended use, the availability of reliable data, and the decision-making needs of the organization. In ICH Q9 this is also the level of formality.
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Risk Is…. |
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The combination of the probability of the occurrence of the harm and the severity of that harm. |
The effect of uncertainty on objectives |
Often characterized by reference to the potential event and consequences or combination of these |
Often expressed in terms of a combination of the consequences of an event (including in changes in circumstances) and the associated likelihood of the occurrence |
Qualitative assessments define consequence (or severity), likelihood, and level of risk by significance levels, such as “high,” “medium,” or “low.” They work best when supporting analysis that have a narrow application or are within another quality system, such as change control.
Below is a good way to break down consequences and likelihood for a less formal assessment.
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Consequence |
Increase Likelihood |
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Severity |
People |
Assets |
Requirements |
Ability to Meet Regulations |
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B. Has Occurred in Industry |
C. Occurs Several Times Per Year in Company |
D. Occurs Several Times Per Year at Location |
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0 |
No Injury |
No Damage |
No Effect |
No Impact |
Manage for Continuous Improvement |
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1 |
Slight Injury |
Slight Damage |
Slight Effect |
Slight Impact |
Incorporate Risk – Reduction Measures |
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2 |
Minor Injury |
Minor Damage |
Limited Effect |
Limited Impact |
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3 |
Major Injury |
Localized Damage |
Localized Effect |
Considerable Impact |
Intolerable – Immediate Corrective Action |
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4 |
1-3 Fatalities |
Major Damage |
Major Effect |
National Impact |
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5 |
Multiple Fatalities |
Extensive Damage |
Massive Effect |
International Impact |
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