Self-inspection in quality systems MCQs With Answer

Introduction: Self-inspection is a proactive, internal quality assurance activity vital for maintaining Good Manufacturing Practices (GMP) and continual improvement in pharmaceutical organisations. This blog presents focused MCQs on self-inspection in quality systems tailored for M.Pharm students, emphasizing practical and regulatory perspectives. Questions explore objectives, planning, execution, reporting, classification of findings, root-cause analysis, CAPA effectiveness verification, scheduling strategies, independence, documentation, and management responsibilities. Working through these MCQs will deepen understanding of how systematic self-inspections detect gaps, prevent product quality failures, guide corrective actions, and ensure regulatory readiness—skills essential for future quality professionals in the pharmaceutical industry.

Q1. What is the primary objective of conducting self-inspections in a pharmaceutical quality system?

• To replace external regulatory inspections
• To assess and improve internal compliance and effectiveness of the quality system
• To certify products for export
• To audit suppliers’ financial stability

Correct Answer: To assess and improve internal compliance and effectiveness of the quality system

Q2. Which of the following best distinguishes a self-inspection from a regulatory inspection?

• Self-inspections are unannounced, regulatory inspections are always scheduled
• Self-inspections focus on internal improvement, regulatory inspections assess legal compliance
• Regulatory inspections never document findings
• Self-inspections only review financial records

Correct Answer: Self-inspections focus on internal improvement, regulatory inspections assess legal compliance

Q3. Who should ideally perform self-inspections for maximum objectivity?

• Personnel from the same operational unit being inspected
• Independent qualified staff from other departments or a dedicated internal audit team
• External consultants only
• Line managers evaluating their own team’s activities

Correct Answer: Independent qualified staff from other departments or a dedicated internal audit team

Q4. Which element is NOT typically part of an effective self-inspection program?

• Defined scope, frequency and checklists
• Clear reporting, follow-up and verification of corrective actions
• Use of inspections solely to punish staff
• Management review of inspection outcomes and trends

Correct Answer: Use of inspections solely to punish staff

Q5. What is an appropriate scheduling approach for self-inspections?

• Random frequency with no documented plan
• Risk-based schedule targeting high-risk processes more frequently
• Only when a regulatory inspection is imminent
• Once every ten years for all areas

Correct Answer: Risk-based schedule targeting high-risk processes more frequently

Q6. Which type of evidence is considered most important during a self-inspection?

• Opinions from staff without documentation
• Objective evidence such as records, logs, calibration certificates and photographs
• Company promotional brochures
• Unofficial verbal assurances

Correct Answer: Objective evidence such as records, logs, calibration certificates and photographs

Q7. How should findings from a self-inspection be classified for effective follow-up?

• All findings treated as equal and low priority
• Classification into critical, major and minor based on risk to product quality and patient safety
• Classified only by the department responsible
• Classified by the length of time to fix them regardless of risk

Correct Answer: Classification into critical, major and minor based on risk to product quality and patient safety

Q8. What is the correct next step after identifying a nonconformity during a self-inspection?

• Ignore it until the next external audit
• Initiate a CAPA (corrective and preventive action) with root-cause analysis and defined timelines
• Delete the observation from the report
• Immediately terminate all staff in the area

Correct Answer: Initiate a CAPA (corrective and preventive action) with root-cause analysis and defined timelines

Q9. Which root cause analysis technique is commonly used following self-inspection findings?

• 5 Whys and fishbone (Ishikawa) analysis
• Random guessing
• Only blaming suppliers
• Waiting for customer complaints

Correct Answer: 5 Whys and fishbone (Ishikawa) analysis

Q10. How should effectiveness of corrective actions be verified after a self-inspection?

• Assume closure if corrective action is documented
• Perform follow-up inspections, review objective evidence and monitor trend data over time
• Rely solely on verbal confirmation from the department head
• Close the CAPA immediately after assigning the task

Correct Answer: Perform follow-up inspections, review objective evidence and monitor trend data over time

Q11. What role does trending of inspection findings play in a self-inspection program?

• Trending is unnecessary and wastes resources
• Helps identify recurring issues, systemic weaknesses and areas needing preventive action
• Only used to prepare presentations for management
• Trending should replace root cause analysis

Correct Answer: Helps identify recurring issues, systemic weaknesses and areas needing preventive action

Q12. Which item should a self-inspection report typically include?

• List of findings, classification, evidence, proposed CAPA, responsible person and target completion dates
• Only positive comments about the facility
• Employee salaries
• Proprietary customer data unrelated to quality

Correct Answer: List of findings, classification, evidence, proposed CAPA, responsible person and target completion dates

Q13. How should confidentiality and sensitivity of inspection findings be handled?

• Publish findings publicly without redaction
• Limit distribution to authorised management and QA personnel and protect sensitive information
• Share findings on social media for transparency
• Send findings to suppliers by default

Correct Answer: Limit distribution to authorised management and QA personnel and protect sensitive information

Q14. Which metric is useful to monitor the performance of a self-inspection program?

• Number of coffee breaks taken during inspections
• Percentage of CAPAs completed on time and reduction in recurring findings over time
• Employee age distribution
• Number of external press releases

Correct Answer: Percentage of CAPAs completed on time and reduction in recurring findings over time

Q15. In the context of self-inspections, what constitutes an ‘objective evidence’ for compliance?

• Managerial opinions without records
• Documents, records, calibration labels, training records and photographed conditions
• Only oral confirmations from staff
• External rumours

Correct Answer: Documents, records, calibration labels, training records and photographed conditions

Q16. How frequently should high-risk areas be self-inspected compared to low-risk areas?

• Less frequently than low-risk areas
• More frequently, based on a risk-based inspection schedule
• Never
• Only annually regardless of risk

Correct Answer: More frequently, based on a risk-based inspection schedule

Q17. Which statement best describes the relationship between management review and self-inspection?

• Management review should ignore self-inspection outcomes
• Self-inspection results should be analysed and presented in management review to drive strategic decisions and resource allocation
• Self-inspections replace the need for management review
• Management review is only for financial metrics

Correct Answer: Self-inspection results should be analysed and presented in management review to drive strategic decisions and resource allocation

Q18. When a self-inspection uncovers a major nonconformity, what is an appropriate immediate action?

• Document it and immediately initiate containment, notify relevant stakeholders and start root-cause analysis
• Wait until the next scheduled inspection to act
• Archive the observation without action
• Only inform external auditors

Correct Answer: Document it and immediately initiate containment, notify relevant stakeholders and start root-cause analysis

Q19. How should training needs be addressed following repeated inspection observations related to human error?

• Ignore training and hire new staff
• Perform targeted training, update procedures, and evaluate competency to prevent recurrence
• Only verbally advise staff to be careful
• Remove written procedures to simplify tasks

Correct Answer: Perform targeted training, update procedures, and evaluate competency to prevent recurrence

Q20. What is the benefit of using standardized checklists during self-inspections?

• They eliminate the need for inspector judgement
• They ensure consistent coverage, help capture objective evidence and facilitate trend analysis
• They are only useful for external auditors
• They increase the chance of overlooking nonconformities

Correct Answer: They ensure consistent coverage, help capture objective evidence and facilitate trend analysis

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