| Process Step | Potential Failure Mode | Potential Effect(s) of Failure | Severity | Potential Cause(s) of Failure | Occurrence | Current Design Controls (Prevention) | Current Design Controls (Detection) | Detection | |
| Donor Registration | -Donor register without ID | -Donor give wrong name | 7 | -In donor registration not ask for the ID | 2 | - | - |
9 | |
| Medical history of donor | -Donor fill wrong medical information | -Complication during the donation process | 6 | -In family donation the donor need to help his patient and he don’t want to reject him as donor | 5 | - | - | 5 | |
| Measure the hemoglobin level and blood grouping | -Wrong hemoglobin reading | -Fainting, heart rate acceleration | 4 | Defect in hemoglobin analyzer (heamocue) | 2 | Quality control | - | 2 | |
| -Wrong blood grouping | -Blood bag will tack wrong blood group label | 7 | Problem in the Monoclonal Antibodies used | 2 | Make regrouping | - | 1 | ||
| -Wrong labeling information | -Sample wasted | 5 | Lack of attention | 3 | Developing the staff performance |
| 1 |