Use this PFMEA template to document your process risks and take countermeasures against the high Risk Priority Numbers (download here).
Here are some screenshots from the template, and instructions for completing it.
This image captures most of the template. The header information is self-explanatory and can be updated for your business (this template designed for automotive).
Process Function, Failure Modes, Effect
Follow the process flowchart and note each process step. A single process step can have multiple rows associated with it, depending on the number of requirements carried out and the number of potential failure modes involved.
For each process function, there can be zero to any number of potential failure modes. Note each failure mode that the team is aware of.
For each potential failure mode, note the effect of the failure, both on the customer and inside the manufacturing facility (if applicable). The failure effect will determine the severity score.
Severity, Potential Causes, and Occurrence Score
Note the severity of the effect, using pre-determined guidelines. Note the causes of failure, and the associated likelihood of occurrence, also a 1-10 scale using pre-determined guidelines.
Detection Score and RPN Calculation
Assign a detection score on a 1-10 scale, then the spreadsheet will do the math to update the Risk Priority Number (RPN). If the RPN is too high, discuss possible countermeasures (recommended actions) to lower the rate of occurrence or increase detection capabilities.
Actions Take and Updated RPN Score
Based on the recommended actions, note which actions were implemented, along with the updated Severity, Occurrence, and Detection values.