Table 1.
FMEA for risk assessment in HPLC-FLD method development by AQbD
| Parameter | Effect | Probability | Severity | Detectability | RPN |
|---|---|---|---|---|---|
| Injection volume* | Changes in peak resolutions | 2 | 3 | 4 | 24 |
| Mobile phase composition | Changes in retention time, peak resolutions, and shape | 2 | 3 | 3 | 18 |
| Organic phase %* | Changes in retention time and peak resolutions | 3 | 3 | 3 | 27 |
| Mobile phase pH* | Changes in retention time, peak resolutions, and shape | 4 | 3 | 2 | 24 |
| Buffer concentration * | Changes in retention time, peak resolutions, and shape | 3 | 2 | 4 | 24 |
| Flow rate* | Changes in retention time and peak resolutions | 3 | 4 | 2 | 24 |
| Sample temperature | Degradation of analyte and changes in peak resolutions | 2 | 2 | 2 | 8 |
| Column temperature* | Changes in retention time and peak resolutions | 3 | 3 | 3 | 27 |
| Detection wavelength | Decrease of sensitivity or selectivity | 2 | 3 | 2 | 12 |
| Sample pretreatment method* | Changes of matrix effects or reproducibility | 3 | 4 | 3 | 24 |
| Column type | Changes in retention time, peak resolutions and shape | 1 | 5 | 1 | 5 |
RPN: risk priority number
* Selected for the factor screening assay