Production and Process Controls
1. Select a process for review based on:
a. CAPA indicators of process problems;
b. Use of the process for manufacturing higher risk devices;
c. Degree of risk of the process to cause device failures;
d. The firm's lack of familiarity and experience with the process;
e. Use of the process in manufacturing multiple devices;
f. Variety in process technologies and Profile classes;
g. Processes not covered during previous inspections;
h. Any other appropriate criterion as dictated by the assignment
2. Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored.
3. If review of the Device History Records (including process control and monitoring records, etc.) reveals that the process is outside the firm's tolerance for operating parameters and/or rejects or that product non-conformances exist:
a. Determine whether any non-conformances were handled appropriately;
b. Review the equipment adjustment, calibration and maintenance; and
c. Evaluate the validation study in full to determine whether the process has been adequately validated.
4.If the results of the process reviewed cannot be fully verified, confirm that the process was validated by reviewing the validation study.
5. If the process is software controlled, confirm that the software was validated.
6. Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.