Strategic Control: Example of a Control Dashboard to Confirm the CCS Effectiveness over Time (t)
| Element to Consider | Representative RPN Values Over Time | |||
|---|---|---|---|---|
| (t) | (t + 1) | (t + 2) | (t + 3) | |
| Facility design | 3 | 4 | 4 | 3 |
| Utilities | 4 | 3 | 3 | 5 |
| Equipment | 3 | 4 | 3 | 3 |
| Product cleaning validation | 2 | 5 | 2 | 3 |
| Product bioburden control | 2 | 4 | 2 | 2 |
| Product sterilization | 2 | 3 | 2 | 2 |
| Cleaning and disinfection | 2 | 2 | 4 | 3 |
| Aseptic process simulation | 2 | 2 | 3 | 2 |
| Grade A continuity | 1 | 1 | 1 | 1 |
| Environmental monitoring | 2 | 3 | 2 | 2 |
| Starting materials | 3 | 4 | 3 | 3 |
| Excipient | 3 | 2 | 2 | 2 |
| Third party (e.g., outsourced activities, suppliers) | 4 | 2 | 2 | 3 |
| Process design | 3 | 3 | 3 | 3 |
| Personnel (e.g., personnel flows, interventions, activities) | 3 | 2 | 2 | 2 |
| Human factors (e.g., behavior, hygiene, training, qualification, disqualification) | 2 | 4 | 3 | 4 |
| Depyrogenation | 3 | 3 | 3 | 3 |
| Etc. | ||||
t: year, month, semester.
Table explanation: Each element in this table (e.g., facility design) is composed of subelements (e.g., HVAC, cleanroom design, etc.) that may have individual RPN values. The representative RPN values of each element are based on considering the normalized (rules of proportionality) RPN values of its subelements.
The numbers used in this table are examples of possible observations and are not representative of any company or its facilities.