Questions and answers of Incident Procedure in Pharma EUGMP- Annex-1
Question 1. What is an incident as per the definition?
A planned deviation
B. An unplanned or uncontrolled event
C. A customer complaint
D. A routine process step
Answer: B
Question 2. Incidents occur due to:
A. Market complaints
B. System failure, equipment breakdown, or manual error
C. Supplier issues
D. Regulatory audit findings
Answer: B
Question 3. What are the two types of incidents?
A. Major and Minor
B. Product and Process
C. Quality Impacting and Quality Non-Impacting
D. Critical and Non-Critical
Answer: C
Question 4. Quality Impacting Incidents may affect:
A. Environment
B. Quality, Purity, and Strength of the product
C. Supplier relations
D. Customer satisfaction only
Answer: B
Question 5. Quality Non-impacting Incidents have:
A. Major impact on strength only
B. No impact on quality, purity, or strength
C. Impact only on packaging
D. Major regulatory impact
Answer: B
Question 6. When an incident occurs, who evaluates its impact?
A. Marketing Department
B. Identifier with Department Head or designee
C. Regulatory Affairs
D. Warehousing
Answer: B
Question 7. Classification of an incident depends on:
A. Batch size
B. Customer feedback
C. Evaluation of Quality/Purity/Strength impact
D. Equipment age
Answer: C
Question 8. For a Quality Impacting Incident, the identifier must:
A. Ignore the incident
B. Fill relevant batch and processing details
C. Wait for QA to investigate
D. Report to production only
Answer: B
Question 9. In Quality Impacting Incidents, affected batches may require:
A. Reprocessing only
B. Isolation if necessary
C. Automatic rejection
D. No action
Answer: B
Question 10. For Quality Non-Impacting Incidents, the identifier must:
A. Only inform QA
B. Fill relevant information and inform HOD and QA
C. Discard the batch
D. Perform trend analysis
Answer: B
Question 11. Who carries out detailed investigation for Quality Non-impacting incidents?
A. Microbiology Department
B. Head of Department or designee with the identifier
C. QA Head only
D. External auditor
Answer: B
Question 12. Investigation aims at identifying:
A. Audit comments
B. Root cause / probable root cause
C. Reviewer expectation
D. Supplier feedback
Answer: B
Question 13. All documents/operations related to incident cause must be:
A. Archived
B. Ignored
C. Investigated
D. Deleted
Answer: C
Question 14. Corrective and preventive actions for non-impacting incidents are written by:
A. QA Head
B. Concerned HOD or designee
C. Vendor
D. HR Department
Answer: B
Question 15. Non-impacting incident reports must be forwarded to QA within:
A. 24 hours
B. 7 working days
C. 30 working days
D. Immediately
Answer: B
Question 16. If during review a Non-Impacting Incident is found to be impacting:
A. It is ignored
B. It is handled as a Quality Impacting incident
C. It is deleted
D. It is archived
Answer: B
Question 17. Investigation must be carried out:
A. After batch release
B. Immediately after occurrence
C. Only when QA instructs
D. At month end
Answer: B
Question 18. Additional testing or simulation study may be conducted to:
A. Satisfy customer
B. Confirm root cause
C. Fill documents
D. Complete CAPA
Answer: B
Question 19. Recommended actions for affected batches must be completed:
A. Anytime
B. After product release
C. Before batch release
D. Only if QA requests
Answer: C
Question 20. All incident reports must be investigated within:
A. 7 days
B. 15 working days
C. 30 days
D. 1 year
Answer: B
Question 21. If CAPA is not completed in time, the concerned person must:
A. Ignore it
B. Provide justification & new timelines
C. Assign to another person
D. Close CAPA
Answer: B
Question 22. Monthly review is required for:
A. Quality Non-impacting Incidents
B. Quality Impacting Incidents
C. Environmental Incidents
D. Customer Complaints
Answer: B
Question 23. Incident review on a tri-monthly basis is done to:
A. Identify repetitive incidents and CAPA effectiveness
B. Prepare invoices
C. Update training records
D. Maintain equipment
Answer: A
Question 24. Investigation report must include:
A. Sales forecast
B. Logical sequence of possible root causes
C. Marketing plan
D. Equipment lifecycle
Answer: B
Question 25. Who is responsible for reporting the incident?
A. QA Head
B. QMS Coordinator
C. Any person of the initiator/concerned incident
D. Document Control
Answer: C
Question 26. Who requests QA for issuance of an incident form?
A. QA personnel
B. Initiator department person
C. Head QA
D. IPQA
Answer B
Question 27. Which department issues the incident form?
A. Production
B. QA
C. HR
D. Safety
Answer: B
Question 28. Who ensures the incident/event is reported to QA?
A. QA Head
B. Head of concerned department
C. IPQA
D. User department
Answer: B
Question 29. Who categorizes the incident based on evaluation?
A. QMS Coordinator/Designee
B. QA Head
C. Production Head
D. Document Control
Answer: A
Question 30. Who assigns responsibility to investigate the incident?
A. QA Head
B. QMS Coordinator
C. Department Head
D. IPQA
Answer: C
Question 31. Investigation uses tools such as:
A. Pareto and RPN
B. Fish Bone Diagram and 5 Whys
C. Control Charts only
D. Trend Analysis
Answer: B
Question 32. Who reviews the investigation report and monitors CAPA?
A. HR Department
B. QA Head
C. Concerned department head
D. QMS Coordinator
Answer: C
Question 33. Quality non-impacting incidents are considered:
A. Critical
B. Major
C. Minor
D. Serious
Answer: C
Question 34. Quality impacting incidents are considered:
A. Minor
B. Major and Critical
C. Insignificant
D. Operational
Answer: B
Question 35. Risk analysis is performed for:
A. Only non-impacting incidents
B. Only safety incidents
C. Quality impacting incidents
D. All incidents
Answer: C
Question 36. If CAPA is not completed by target date, the department HOD must:
A. Cancel the incident
B. Request timeline extension with justification
C. Close the incident immediately
D. Reassign the incident number
Answer: B
Question 37. The extension approval is granted by:
A. Production Head
B. IPQA
C. Head QA
D. Document Control
Answer: C
Question 38. All incident actions must be closed within:
A. 15 working days
B. 90 working days
C. 30 working days
D. 7 days
Answer: C
Question 39. Who preserves the incident report for future reference?
A. QA
B. Document Control Department
C. Production Department
D. QMS Coordinator
Answer: B
Question 40. If an incident is associated with a batch, IPQA shall release the batch only after:
A. Risk analysis
B. QA approval
C. Closing of the incident
D. CAPA creation
Answer: C
Question 41. Trend analysis of incident reports is performed:
A. Monthly
B. Quarterly and annually
C. Weekly
D. Every two years
Question 42. Who ensures the effectiveness of planned CAPA before closing the incident?
A. QMS coordinator
B. Production Manager
C. HR Representative
D. QC Analyst
Answer: A
Question 43. Incident status can only be closed if:
A. CAPA or change control is raised and approved
B. A meeting is conducted
C. Batch is released
D. QA issues a new format
Answer: A
Question 44. The closed incident is finally handed over to:
A. Production Department
B. Document Control
C. QA Head
D. QMS Coordinator for log update
Answer: D