It allows teams to automate their processes, save time, keep Jira up to date and focus on what’s most important.Īutomation is perfect for minor automation tasks to achieve more from the existing features of any Jira app. Jira Automation is a no-code rule builder that enables customers to build if-this-then-that-rules based on events in Jira. SoftComply Risk Manager is a Jira app developed specifically for medical device risk assessment that supports both FMEA and Hazard Analysis, automates traceability between risks, requirements and test cases, and generates compliant Risk Reports.
#RISK PROBABILITY DESCRIPTORS HOW TO#
How to Implement P1 * P2 with SoftComply Risk Manager and Jira Automation? Vomiting, abdominal pain, deep gasping breathing, increased urination, weakness, confusion, loss of consciousness. Sweating and clamminess, chills, lightheadedness or dizziness, mild confusion, anxiety or nervousness, shakiness, rapid heartbeat, hunger, irritability, double vision or blurred vision, tingling in the lips or around the mouth.Ĭoncentration problems, seizures, unconsciousness, death. The underdelivery of insultin may result in diabetic ketoacidosis. This can result in (mild or severe) hypoglycemia. One of the failures related to insulin pumps is the over delivery of the drug. An Exampleįollowing is an example of P1 * P2 approach of an insulin pump failing, where P1 is the probability of hazardous situation occurring and P2 is the probability of harm for a given hazardous situation. In this case the physiological and clinical effect of hazards such as overdose or underdose are well known and can be assessed independently. This is particularly valid for a combination device or devices that channel drugs. mitigation by reducing or preventing the exposure of the patient / user to the hazardous situation.Ī P1 * P2 approach is definitely favorable, in case technical and clinical events can be estimated separately with a good degree of accuracy. P2 is instead affected more by controls related to Protection and Information, i.e. they tend to reduce, or eliminate, the probability of certain failures occurring. Risk controls based on the design of the device have an effect on P1, i.e. 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. The probability of a patient or user being injured when exposed to a certain hazard can be better estimated by clinical specialists. P2 is more related to the clinical aspects of the product. This is competence of the developers and engineer, who can give a good estimate (qualitative or quantitative) of a certain event occurring. P1 is typically related to device failures or use errors. Separation of technical and clinical events This decomposition is not mandatory and many companies use a single Probability value. The overall probability of a Harm occurring becomes then P = P1 * P2
![risk probability descriptors risk probability descriptors](https://www.coursehero.com/thumb/99/4f/994fdb20fd0d1605d8b07bdab817e2feb4f59a67_180.jpg)
P2 = Probability of Harm occurring for a given Hazardous situation P1 = Probability of Hazardous situation occurring
#RISK PROBABILITY DESCRIPTORS ISO#
ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: No we are not talking about the early Playstation versions…