consequence – Investigations of a Dog

Hazard, harm and risk

Hazard	Harm	Risk
Enabling state that leads to the possibility of harm	Injury or damage	Probability of harm from a situation triggered by the hazard.

Hazard harm and risk

A hazard is defined in ISO 12100 as “The potential source of harm.” This definition is carried through other ISOs and regulatory guidances. The hazard is what could go wrong, our “What If…”, it is when we start engaging the outcome identification loop to query uncertainty about the future.

Harm are those injuries or damages I should care about.

Every risk assessment is really asking “What could go wrong,” and then answering two questions:

If it did go wrong how bad is it – the Harm

And how likely is it to go wrong – Probability.

Risk is then the combination of those things as a magnitude or priority.

Risk assessment tools break down into two major camps. Those that start with the hazards, asking how something can fail; and those that start with the harms, asking what bad things do we want to avoid.

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.

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	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			Incorporate Risk – Reduction Measures
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

Tag: consequence

Risk, Hazard and Harm

Hazard, harm and risk

Qualitative Risk Analysis