Qualitative Risk Analysis

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.

Risk Is….

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.

Qualitative

Below is a good way to break down consequences and likelihood for a less formal assessment.

Consequence

Increase Likelihood

Severity

People

Assets

Requirements

Ability to Meet Regulations

  1. Never Heard of in Industry

B. Has Occurred in Industry

C. Occurs Several Times Per Year in Company

D. Occurs Several Times Per Year at Location

0

No Injury

No Damage

No Effect

No Impact

Manage for Continuous Improvement

1

Slight Injury

Slight Damage

Slight Effect

Slight Impact

Incorporate Risk – Reduction Measures

2

Minor Injury

Minor Damage

Limited Effect

Limited Impact

3

Major Injury

Localized Damage

Localized Effect

Considerable Impact

Intolerable – Immediate Corrective Action

4

1-3 Fatalities

Major Damage

Major Effect

National Impact

5

Multiple Fatalities

Extensive Damage

Massive Effect

International Impact

 

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