Potential Impact Levels of the Category “Compliance”
| Risk Level | Factor | Impact Assessment | Examples Based On Own Experience and/or Availability of Data (e.g., Inspections by PIC/S Inspectorates, WHO) |
|---|---|---|---|
| 4 | 10 | Very high or Not known | No compliance status available or Recent recall(s) caused by this manufacturer/trader or any indication for counterfeit |
| 3 | 6 | Moderately high or May represent major health risk | Result of the last audit: “unsatisfactory” (critical) or Inadequate response to observations |
| 2 | 3 | Not fully satisfactory or No major health risk | Result of the last audit: “satisfactory” or Result of last audit indicates some deficiencies |
| 1 | 1 | Satisfactory | Result of the last audit: “good” or Adequate response to all observations of the previous audit |