Auditing Quality Assurance department MCQs With Answer

Introduction: Auditing Quality Assurance department MCQs With Answer is a focused quiz collection tailored for M.Pharm students preparing for roles in pharmaceutical quality systems and regulatory inspections. This set of 20 multiple-choice questions covers core auditing concepts—internal and external audits, audit planning and execution, sampling, reporting, CAPA, supplier and process audits, audit trails, and compliance with GMP and regulatory expectations. Each question is designed to deepen understanding of audit objectives, techniques, documentation requirements, roles and responsibilities, and effective follow-up actions. Use these questions to test knowledge, identify learning gaps, and reinforce practical audit competencies essential for pharmaceutical quality assurance professionals.

Q1. What is the primary objective of a Quality Assurance (QA) departmental audit in a pharmaceutical company?

• To assign blame to personnel for deviations
• To verify compliance with procedures, regulations and identify opportunities for improvement
• To increase production output regardless of compliance
• To replace management responsibilities

Correct Answer: To verify compliance with procedures, regulations and identify opportunities for improvement

Q2. Which audit type is performed by the organization itself to check adherence to internal policies and readiness for external inspections?

• Regulatory inspection
• Supplier audit
• Internal audit (self-inspection)
• Certification audit by a third party

Correct Answer: Internal audit (self-inspection)

Q3. In audit planning, what is the importance of a risk-based approach when selecting processes or areas to audit?

• It allows random selection of departments without rationale
• It prioritizes audits on areas with higher potential impact on product quality and patient safety
• It ensures only low-risk processes are audited to avoid findings
• It focuses audits solely on administrative tasks

Correct Answer: It prioritizes audits on areas with higher potential impact on product quality and patient safety

Q4. Which document must an auditor review first to understand the intended operation of a process before conducting a process audit?

• Employee personal records
• Standard Operating Procedure (SOP) relevant to the process
• Financial audit report
• Marketing strategy document

Correct Answer: Standard Operating Procedure (SOP) relevant to the process

Q5. What is an audit checklist and why is it used?

• A legal requirement with no practical use
• A detailed list of questions and reference points that guide the auditor to evaluate compliance systematically
• An employee performance appraisal form
• A marketing questionnaire for customers

Correct Answer: A detailed list of questions and reference points that guide the auditor to evaluate compliance systematically

Q6. During an audit, what constitutes an objective evidence?

• Hearsay from staff about previous incidents
• Documents, records, observations, and measurements that can be verified
• Auditor’s opinion without supporting records
• Informal comments made in a coffee break

Correct Answer: Documents, records, observations, and measurements that can be verified

Q7. Which classification best describes a finding where a procedure exists but is not consistently followed, causing potential quality impact?

• Critical observation
• Opportunity for improvement only
• Nonconformity (major or minor depending on risk)
• No finding because the procedure exists

Correct Answer: Nonconformity (major or minor depending on risk)

Q8. What is the difference between a ‘major’ and a ‘minor’ nonconformity in QA audits?

• Major relates to paperwork only; minor relates to personnel only
• Major has significant impact on product quality or regulatory compliance; minor has limited or no immediate impact but indicates a deficiency
• Major is aesthetic; minor affects manufacturing speed
• There is no difference in an audit context

Correct Answer: Major has significant impact on product quality or regulatory compliance; minor has limited or no immediate impact but indicates a deficiency

Q9. What is the role of CAPA (Corrective and Preventive Action) following an audit finding?

• To document the finding and close it with no further action
• To identify root cause, implement corrective actions to eliminate recurrence, and preventive actions to avoid similar issues
• To punish the staff involved
• To postpone resolution until the next audit cycle

Correct Answer: To identify root cause, implement corrective actions to eliminate recurrence, and preventive actions to avoid similar issues

Q10. Which tool is commonly used during CAPA to investigate root cause of a recurring deviation?

• Market trend analysis
• 5 Whys or Fishbone (Ishikawa) diagram
• Random guessing
• Financial audit spreadsheet

Correct Answer: 5 Whys or Fishbone (Ishikawa) diagram

Q11. What is an audit trail and why is it important in a pharmaceutical QA environment?

• A chronological record that provides documentary evidence of the sequence of activities affecting a result, essential for data integrity and traceability
• A marketing timeline for product launch
• A list of auditor names only
• A log of phone calls in the quality office

Correct Answer: A chronological record that provides documentary evidence of the sequence of activities affecting a result, essential for data integrity and traceability

Q12. When conducting a supplier audit, which aspect is most critical to evaluate?

• The supplier’s cafeteria menu
• The supplier’s quality system, including change control, release testing, and traceability
• Only the supplier’s proximity to your plant
• The supplier’s marketing materials

Correct Answer: The supplier’s quality system, including change control, release testing, and traceability

Q13. For CAPA effectiveness checks after implementation, what is the recommended verification timeframe?

• Immediately and then periodically based on risk and process stability
• Never—once implemented it is assumed effective
• Only after five years
• Only during external regulatory inspections

Correct Answer: Immediately and then periodically based on risk and process stability

Q14. Which regulatory guideline explicitly requires manufacturers to implement internal audits as part of their quality system?

• ICH Q9 on Quality Risk Management
• GMP guidelines (e.g., WHO, EU GMP, FDA’s 21 CFR part guidance) that require self-inspection/internal audits
• ISO 14001 only
• Tax regulations

Correct Answer: GMP guidelines (e.g., WHO, EU GMP, FDA’s 21 CFR part guidance) that require self-inspection/internal audits

Q15. Which best practice should auditors follow to maintain objectivity and independence during an internal audit?

• Audit only their own area to save time
• Avoid auditing areas where they have direct responsibility or recent involvement
• Make assumptions without verification
• Share draft findings with external stakeholders before finalizing

Correct Answer: Avoid auditing areas where they have direct responsibility or recent involvement

Q16. What is the purpose of a closing meeting at the end of an audit?

• To immediately escalate all staff to disciplinary action
• To present preliminary findings, allow clarifications, and agree on timelines for formal report and CAPA expectations
• To celebrate and stop documentation work
• To hand over audit files to the production manager only

Correct Answer: To present preliminary findings, allow clarifications, and agree on timelines for formal report and CAPA expectations

Q17. Which metric is most useful to monitor the effectiveness of the QA audit program?

• Number of audit attendees
• Percentage of CAPAs closed on time and recurrence rate of similar findings
• Length of the audit checklist only
• Number of pages in the audit report

Correct Answer: Percentage of CAPAs closed on time and recurrence rate of similar findings

Q18. How should confidential or proprietary information observed during an audit be handled?

• Shared freely on social media to promote transparency
• Kept confidential, documented appropriately, and disclosed only to authorized personnel per confidentiality agreements
• Destroyed immediately without documentation
• Used for competitive advantage outside the organization

Correct Answer: Kept confidential, documented appropriately, and disclosed only to authorized personnel per confidentiality agreements

Q19. What distinguishes a regulatory inspection from an internal QA audit?

• Regulatory inspections are informal and voluntary
• Regulatory inspections are conducted by external government bodies to assess compliance with laws and regulations and can have regulatory consequences
• Internal audits always require product recalls
• There is no difference in authority or consequence

Correct Answer: Regulatory inspections are conducted by external government bodies to assess compliance with laws and regulations and can have regulatory consequences

Q20. During an audit, if an auditor discovers data integrity concerns in electronic records, what is the most appropriate immediate action?

• Ignore and continue auditing other areas
• Document the specific observations as objective evidence, notify QA management, and secure the records for investigation
• Delete the records to protect the company
• Confront staff aggressively to extract explanations without documentation

Correct Answer: Document the specific observations as objective evidence, notify QA management, and secure the records for investigation

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