| 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 |