The Process FMEA (PFMEA) is a point in time audit of the adequacy of the process in producing a product that will meet the design specifications. The Process FMEA (PFMEA) identifies the risk that the company will be exposed to if the current process is used to produce the product. Using ISO terminology, you are trying to assess how well the process outputs meet the process input requirements.
Risk is comprised of two components, the level of exposure to harm when an objectionable incident occurs and the probability of exposure to the objectionable incident. A Process FMEA is a structured analysis of a process to define all of its sources of risk for a company due to objectionable process incidents known as Failure Modes. A properly performed Process FMEA is not just a brainstorming of how the process can fail as many people believe.
Process FMEAs can be performed on any type of process. Their most common use is to assess the risk of manufacturing processes.
The most important output of the Process FMEA is the Control Plan that will be used to control the process. When created correctly the Control Plan will document all required supplier final inspection controls, incoming receiving controls, process settings, equipment maintenance and in-process inspection requirements.