Across
- 3. If it’s not this, it didn’t happen.
- 6. Training outcome measured by objective evidence.
- 7. Requires service records including device name and service details.
- 12. Proactive approach to insulate business from quality issues.
- 13. Documented evaluation of compliance with standards.
- 16. Used to monitor training system effectiveness.
- 17. Acronym for a quality incident.
- 18. System used to submit QI cases and manage documentation.
- 19. Must be completed prior to performing a task.
- 20. Requires approval from Legal Manufacturer before use.
Down
- 1. Materials used to promote products and educate on disease states.
- 2. Facility requiring temperature mapping and audits.
- 4. Must be reported within 1 business day of awareness.
- 5. Must include first initial, last name, and date; legally binding.
- 8. Can be internal, external, or customer-initiated audit.
- 9. Action taken to reduce health risks or regulatory noncompliance.
- 10. Must be evaluated and approved before onboarding.
- 11. Systematic approach to investigate, correct, and prevent quality issues.
- 14. Requires approval from Quality Team for market customization.
- 15. Requires adequate investigation and may lead to CAPA.