| Where warranty is required for their products:
Implement a warranty management process. The organization shall include in the process a
Method for warranty part analysis, including NTF (no trouble found) must be included.
| Documented process to determine the use of appropriate error-proofing methodologies
Details of methods documented in the PFMEA (or equivalent) - test frequencies in the control plan
Testing of error-proofing devices for failure or simulated failure. Records must be retained
Challenge parts shall be identified, controlled verified and calibrated
Error proofing device failures must have a reaction plan
| 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).
| Top management must document and implement an action plan when customer performance targets are not met.