Open Access
Table 1
FMECA rating.
| Rating | Frequency | Severity | Non-detection |
|---|---|---|---|
| 1 | Less than once in 14 000 tests (1 month) | No direct consequences on result No lost time for laboratory No extra costs |
Problem can be seen directly |
| 2 | Once in 14 000 tests (1 month) |
No direct consequences on result Loss of time (But can be overcome internally) |
Problem can be detected within the hour through simple verification (IT, rapid) |
| 3 | Once in 3500 tests (1week) | No direct consequences on result Loss of time and resources Risk of deadline failure |
Investigation needed to identify failure, may be several hours before it is detected |
| 4 | Once in 500 tests (1day) | Indirect consequences on result possibly leading to a false result Loss of time and resources Risk of deadline failure |
Problem difficult to detect, involves extra costs (Observation by a technician, contamination tests) |
| 5 | Once in 42 tests (1series) | Potentially direct consequences on result Loss of time and resources High risk of deadline failure |
Problem almost impossible to detect |
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