TABLE 2.
Uncertainty components for the simulated procedure qualification for the example Lactobacillus spp.
| Uncertainty component | Condition |
|||
| 1 | 2 | 3 | 4 | |
| Days | A | B | C | D |
| Analyst | A | B | A | C |
| Lot of plating medium | 1 | 2 | 1 | 2 |
| Lot of suspension/rehydration medium | 2 | 2 | 1 | 1 |
| Lot of dilution buffer | 1 | 2 | 3 | 4 |
| Disposable serological pipettes | Lot 1 | Lot 2 | Lot 1 | Lot 3 |
| Pipettors with tips | Set A | Set B | Set A | Set C |
| pH meter | A | B | A | B |
| Analytical balance | 1 | 2 | 2 | 1 |
| Autoclave | 1 | 2 | 3 | 2 |
| Agar tempering water bath | 2 | 1 | 1 | 2 |
| Incubator | 2 | 3 | 1 | 5 |
The components were identified through the risk analysis, and the individual variation during the ANOVA experiment are shown for each condition.