Currently, I have been working on updating a pFMEA for Maquet products and they follow a similar 1 to 5 scale to numerically quantify a risk. A pFMEA is a process failure mode effects analysis which breaks down each process for each major product line. Within each process their are set protocols or procedures along with controls. Each process for each product will identify and evaluate any potential failures of that process. The scale for determining a risk has a set outline but it is very subjective. A scale of 1 can be “not that harmful with a low possibility of occurring.” But that is based on the person identifying the risk. Each risk has to have statistical support for its claim. Meaning, for each numerical scale their is a 95% or 99% confidence interval which it is analyzed against. Keeping a pFMEA up to date is a project in itself because it requires that all protocols be updated along with controls. The changes in these protocols and controls may also affect the risk score in analyzing the process.