Quality audit plans and audit reporting MCQs With Answer

Quality audit plans and audit reporting MCQs With Answer

This quiz set is designed specifically for M.Pharm students studying Quality Control & Quality Assurance. It focuses on planning, execution, documentation, and reporting of quality audits in pharmaceutical environments, emphasizing Good Manufacturing Practice (GMP) expectations and regulatory alignment. Questions address audit program design, risk-based scheduling, audit checklists, objective evidence, classification of findings, corrective and preventive actions (CAPA), follow-up and closure, and preparation of clear, actionable audit reports. Use this set to test and strengthen your practical understanding of how audit planning and reporting maintain product quality, ensure compliance, and drive continual improvement in pharmaceutical operations.

Q1. Which element is essential to include in an audit plan to ensure clarity of scope?

• List of auditors’ personal references
• Detailed description of areas, processes and systems to be audited
• Estimated cost of the audit team travel
• Historical production volumes

Correct Answer: Detailed description of areas, processes and systems to be audited

Q2. What is the primary purpose of a quality audit report?

• To publish the names of non-compliant employees
• To document audit findings, evidence and recommended actions for management review
• To serve as a marketing document for the audit department
• To replace regulatory inspection reports

Correct Answer: To document audit findings, evidence and recommended actions for management review

Q3. In a risk-based audit program, what factor most influences audit frequency?

• Length of the audit report
• Level of risk associated with the product, process or supplier
• Number of auditors available
• Time since the last staff meeting

Correct Answer: Level of risk associated with the product, process or supplier

Q4. Which type of evidence is considered objective evidence during an audit?

• Verbal assurances from a manager
• Photographs of non-conforming labels and batch records
• Auditor’s opinion without supporting documentation
• Informal staff conversations without documentation

Correct Answer: Photographs of non-conforming labels and batch records

Q5. How should audit findings be classified in a GMP audit report for clear prioritization?

• By the auditor’s seniority level
• As critical, major and minor based on patient safety and regulatory impact
• Alphabetically by department name
• By the length of time the deviation existed

Correct Answer: As critical, major and minor based on patient safety and regulatory impact

Q6. Which practice improves the quality and effectiveness of audit checklists?

• Using the same checklist for all audits regardless of scope
• Customizing checklists to the process, incorporating regulatory requirements and past findings
• Keeping checklists verbal to allow flexibility
• Only including yes/no questions without references

Correct Answer: Customizing checklists to the process, incorporating regulatory requirements and past findings

Q7. What is the correct sequence after identifying a non-conforming condition during an audit?

• Issue a regulatory citation immediately
• Record the finding with objective evidence, classify severity, and recommend CAPA
• Dismiss the finding if staff provide an explanation
• Close the finding without further action to avoid disruption

Correct Answer: Record the finding with objective evidence, classify severity, and recommend CAPA

Q8. Which metric is most appropriate for measuring audit program performance?

• Number of audit reports written per month regardless of quality
• Percentage of corrective actions completed on time and verified for effectiveness
• Salary of the audit team
• Total pages in each audit report

Correct Answer: Percentage of corrective actions completed on time and verified for effectiveness

Q9. What should an audit report state when an observation has no immediate product quality impact?

• Ignore it because it is not a deviation
• Document as an observation, provide evidence, and recommend monitoring or preventive action
• Elevate it immediately to critical non-conformance
• Delete any mention before distribution

Correct Answer: Document as an observation, provide evidence, and recommend monitoring or preventive action

Q10. Which role is responsible for ensuring independence and impartiality during internal audits?

• Auditee’s line manager
• Audit program owner or a team not involved in the audited activity
• Quality control analyst assigned to the audited area
• External sales representative

Correct Answer: Audit program owner or a team not involved in the audited activity

Q11. When reporting findings about computerized systems, what additional documentation is typically required?

• Screenshots, system logs, user access records and change control history
• Only the system vendor’s brochure
• Handwritten notes without timestamps
• Verbal summary from the IT staff

Correct Answer: Screenshots, system logs, user access records and change control history

Q12. Which method is commonly used during audits to identify root cause of recurrent deviations?

• Random guessing by the audit team
• Structured root cause analysis such as 5 Whys or fishbone (Ishikawa) diagrams
• Ignoring historical data
• Outsourcing the decision to non-technical staff

Correct Answer: Structured root cause analysis such as 5 Whys or fishbone (Ishikawa) diagrams

Q13. What is the primary reason for re-audit following closure of major non-conformances?

• To verify that corrective actions were implemented and are effective
• To add more non-conformances for record-keeping
• To reduce the audit department workload
• To change the audit schedule arbitrarily

Correct Answer: To verify that corrective actions were implemented and are effective

Q14. Which statement best describes “objective evidence” in the context of audits?

• Any opinion provided by personnel
• Records, statements of fact, or observations that are verifiable and documented
• Hearsay information from external sources
• Future plans for process improvement

Correct Answer: Records, statements of fact, or observations that are verifiable and documented

Q15. What must a well-prepared audit plan include regarding resources?

• Names of external consultants to be hired after audit
• Allocated time, competent auditors, tools and documentation required for the audit
• A wish list of resources without confirmation
• Only the budget code with no details

Correct Answer: Allocated time, competent auditors, tools and documentation required for the audit

Q16. Which practice improves credibility of audit findings during the closing meeting?

• Presenting findings without supporting evidence to avoid debate
• Discussing findings with objective evidence, agreed facts and proposed corrective actions
• Surprising staff with new findings at the last minute
• Threatening regulatory action to force agreement

Correct Answer: Discussing findings with objective evidence, agreed facts and proposed corrective actions

Q17. For supplier audits, what factor is critical when deciding whether to audit on-site or remotely?

• Auditor preference for travel
• Supplier’s criticality, complexity of processes and availability of objective evidence remotely
• Distance in kilometers only
• Whether the supplier offers gifts during audit

Correct Answer: Supplier’s criticality, complexity of processes and availability of objective evidence remotely

Q18. What is an audit trail in the context of computerized systems and why is it important?

• A list of user passwords for convenience
• A chronological record of system activities that ensures traceability and data integrity
• An internal memo summarizing staff opinions
• A backup copy of the system manual

Correct Answer: A chronological record of system activities that ensures traceability and data integrity

Q19. Which action should be taken if a critical non-conformance is identified during an audit affecting product safety?

• File it as a minor observation to avoid escalation
• Initiate immediate containment, notify management and regulatory affairs, and start CAPA
• Wait until the next scheduled meeting to discuss
• Remove the product from records to avoid reporting

Correct Answer: Initiate immediate containment, notify management and regulatory affairs, and start CAPA

Q20. What information is essential to include in the header section of an audit report?

• Auditor’s favorite quote
• Audit title, date, scope, auditee, audit team and audit criteria/references
• Company financial statements
• Personal contact details of all employees interviewed

Correct Answer: Audit title, date, scope, auditee, audit team and audit criteria/references

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