| Documented process for problem solving including:
Defined approaches for various types and scale of problems
Containment, interim actions, and related activities necessary for control of nonconforming outputs
Root cause analysis, methodology used, analysis, and results
Implementation of systemic corrective actions, including CAR impact on similar processes and products;
Verification of the effectiveness of implemented corrective actions;
Reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan).