Open Access
Table 3
Summary of risks analyzed using the FMECA method, showing breakdown of risks according to the stage of analytical process.
| Stage of analytical process | Number of risks analyzed | Number of initially identified critical risks | Number of critical risks after application of measures |
|---|---|---|---|
| Viral inactivation | 19 | 0 | 0 |
| Extraction of nucleic acids | 25 | 5 | 2 |
| Preparation of mix | 24 | 5 | 2 |
| Amplification | 15 | 2 | 1 |
| Validation of results | 19 | 4 | 4 |
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