One of the most critical roles I play for medical device startup clients is that of educator. And the usual topics for those involved with medical device product development include Design Controls, Risk Management, and Quality Management System. Let me dive a little more into Risk Management with this post. Specifically, I want to help explain hazard, harm, and cause.
First, a few official definitions according to ISO 14971:
- Harm – physical injury or damage to the health of people, or damage to property or the environment
- Hazard – potential source of harm
- Hazardous Situation – circumstance in which people, property, or the environment are exposed to one or more hazard(s)
- Risk – combination of the probability of occurrence of harm and the severity of that harm
- Severity – measure of the possible consequences of a hazard
While the definitions seem pretty clear, I can assure you from personal experience the concepts because risk management and how to capture the details can sometimes get confusing. Specifically, I’ve seen time and time again where the concepts of hazard, harm, and cause can get a little muddy.
So maybe thinking about it this way might help:
- Harm is the potential outcome of a hazard.
- Severity is the measure of the harm.
- Cause is what can lead to hazard.