ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where:
P1 = Probability of Hazardous situation occurring.
P2 = Probability of Harm occurring for a given Hazardous situation.
The overall probability of a Harm occurring becomes then P = P1 * P2
Advantages of Using this Approach
1. Separation of technical and clinical events
P1 is typically related to device failures or use errors. This is competence of the developers and engineer, who can give a good estimate (qualitative or quantitative) of a certain event occurring.
P2 is more related to the clinical aspects of the product. The probability of a patient or user being injured when exposed to a certain hazard can be better estimated by clinical specialists.
So, developers don’t have to “guess” the probability of a negative clinical impact and clinical specialists do not need to get involved in the technical aspects of the device.
2. Allocation of controls
Risk controls based on the design of the device have an effect on P1, i.e. they tend to reduce, or eliminate, the probability of certain failures occurring.
P2 is instead affected more by controls related to Protection and Information, i.e. mitigation by reducing or preventing the exposure of the patient / user to the hazardous situation.
A P1 * P2 approach is definitely favorable, in case technical and clinical events can be estimated separately with a good degree of accuracy. This is particularly valid for combination device or devices that channel drugs. In this case the physiological and clinical effect of hazards such as overdose or underdose are well known and can be assessed independently.
How to implement this approach with SoftComply Risk Manager & Jira Automation
Jira Automation is a no-code rule builder that enables customers to build if-this-then-that-rules based on events in Jira. It allows teams to automate their processes, save time, keep Jira up to date and focus on what’s most important.
Automation is perfect for minor automation tasks to achieve more from the existing features of any Jira app. In this particular case, we will use automation to update Probability (P) value when either P1 or P2 is updated.
To learn more about how you can use the approach of P1 and P2 with the SoftComply Risk Manager, please keep reading.
