“Advice for the government on communicating uncertainty” by Jessica Hullman on the blog Statistical Modeling, Causal Inference, and Social Science is a great read.
Great stuff to think about for those of us who constantly have to communicate uncertainty in our roles.
Contamination occurs in two ways:
Whether performing risk assessments or impact assessments there are six factors to consider in order to determine environmental impact and to inform contamination control.
Maybe you’ve been there too, you need to take a risk-based approach to determine environmental monitoring, so you go to a HAACP or FMEA and realize those tools just do not work to provide information to determine how to distribute monitoring to best verify that processes are operating under control.
What you want to do is build a heat map showing the relative probability of contamination in a defined area or room| covering six areas:
This approach builds off of the design activities and is part of a set of living risk assessments that inform the environmental monitoring part of your contamination control strategy.
Hope to see you in Bethesda to discuss more!
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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 |
| 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. |
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:
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.
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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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