As a co-op at Getinge I was able to work on a project associated with updating the PFMEA (process failure mode effects analysis). This one document lays out each process for creating the final medical device for each product line at Getinge. It defines the risk of each process, the probability of the risk occurring and the severity of the risk. ISO 14971 defines risk as “probability of harm occurring and severity of the harm once it occurs.” A two-dimensional risk chart is a great way to analyze the risk. The chart is divided into generally acceptable (GA), generally unacceptable (GU) and as low as reasonably practical (ALARP). GA represents the region where the probability and severity are pretty low. GU represents the region where probability and severity are high. ALARP is the region in-between GA and GU. This illustrates the risk indexes which are included in defining a risk.