Risk assessment

In everyday Japanese documents, the word for a risk assessment: identifying what could go wrong in a process or product, estimating how likely and how severe it is, and deciding what to control first. The results feed the choice of critical process parameters and the control strategy. One ambiguity is worth knowing. Japanese quality texts based on ICH Q9 call the whole process a risk assessment (リスクアセスメント), made up of risk identification, risk analysis and risk evaluation, and the last step is also written with this word. When a Japanese SOP uses both terms, this one may mean only the comparison of the estimated risk against acceptance criteria.