Across
- 1. Departure from a pre-established requirement, execution step, or acceptance criterion
- 3. Translates into “good change” in Japanese and represents the concept of continuous improvement
- 4. System used for CAPAs
- 6. Failure to fulfill a specified requirement
- 9. Immediate controls used to limit impact while an issue is investigated
- 10. Processing performed to bring nonconforming product into conformance using approved instructions
- 12. Electronic Document Management System
- 13. Visualize workflow and track the progress of tasks through different stages
Down
- 1. Written evidence of completed activities
- 2. Confirming that something is accurate and correct
- 5. FDA framework aligning device quality-system requirements more closely with ISO 13485
- 7. Identifying potential problems before they occur
- 8. Direct observation and problem solving where the work occurs
- 9. Action taken to fix a detected nonconformity without necessarily eliminating its cause
- 11. Formal process used to investigate quality issues and prevent recurrence
- 14. Process or record used to evaluate nonconforming material