Process Validation
- Validate the visual inspection process itself to ensure its effectiveness in detecting defects and maintaining product quality.
- This involves determining appropriate inspection parameters, establishing appropriate acceptance criteria, and conducting validation studies.
Data Integrity
- Ensure the integrity of data generated during qualification and validation activities.
- Use secure data management systems and follow good documentation practices to prevent data manipulation or loss.
Qualification of the inspectors
- It is done by conducting a well-documented, manual human inspection qualification that is accomplished by repeated manual inspection.
- Well-defined defect standards, a detection frequency or probability of detection (POD) is assigned.
Training and Qualification
- Implement a robust training program for visual inspectors.
- This includes training on relevant regulations, product knowledge, defect recognition, inspection techniques, and good documentation practices.
- Keep detailed records of training activities and individual qualifications.