| Root Cause Category |
|---|
| Environment |
| Equipment |
| Material |
| Process/Procedure |
| Personnel |
| Root Cause Sub-Category | Root Cause Category |
|---|---|
| Work Environment | Environment |
| Acts of Nature | Environment |
| Environmental Monitoring | Environment |
| Facility Design | Environment |
| Equipment Design | Equipment |
| Technical Error/Failure | Equipment |
| Maintenance | Equipment |
| Validation/Qualification | Equipment |
| Out of Tolerance | Equipment |
| Calibration | Equipment |
| Contamination | Material |
| Expired Material | Material |
| Labeling Error | Material |
| Incorrect Material | Material |
| Out of Specification | Material |
| Damaged Material | Material |
| Distribution Error | Material |
| Raw Material or Component Issue | Material |
| Qualification | Material |
| Process Design | Process/Procedure |
| Vendor Management | Process/Procedure |
| Procedure Not Available | Process/Procedure |
| Training Material Inadequate | Process/Procedure |
| Procedure Inadequate | Process/Procedure |
| Incorrect Version Used | Process/Procedure |
| Management Error | Personnel |
| Calculation Error | Personnel |
| Entry Error | Personnel |
| Failure to Follow Procedure | Personnel |
| Incomplete Training | Personnel |