Quality system inspection and regulatory expectations for manufacturers MCQs With Answer

Introduction: This MCQ collection focuses on quality system inspection and regulatory expectations for medical device manufacturers, designed for M.Pharm students. It highlights key standards and practices—such as ISO 13485, risk management (ISO 14971), design controls, CAPA, validation, supplier management, and post-market surveillance—emphasizing how regulators assess manufacturer compliance. Each question connects theoretical principles with practical inspection scenarios, covering documentation requirements, audit readiness, complaint handling, adverse event reporting, UDI/traceability, and recall actions. Use these questions to deepen your understanding of inspection criteria and manufacturer responsibilities, improve audit preparedness, and strengthen the ability to apply regulatory expectations to real-world quality systems.

Q1. Which standard is most commonly referenced by regulators as the benchmark for medical device quality management systems?

• ISO 9001:2015
• ISO 13485:2016
• Good Laboratory Practices (GLP)
• 21 CFR Part 210

Correct Answer: ISO 13485:2016

Q2. During an inspection, which document best demonstrates that a manufacturer has established formal design control procedures?

• Device Master Record (DMR)
• Design and Development Plan
• Purchase Orders
• Calibration Logs

Correct Answer: Design and Development Plan

Q3. Which of the following is a primary purpose of CAPA (Corrective and Preventive Action) systems in a medical device quality system?

• To document manufacturing throughput
• To identify, investigate, and prevent recurrence of nonconformities
• To increase inventory turnover
• To certify suppliers automatically

Correct Answer: To identify, investigate, and prevent recurrence of nonconformities

Q4. What is the chief regulatory expectation regarding supplier controls for critical components used in a device?

• Manufacturers must accept supplier certificates without verification
• Manufacturers must perform risk-based supplier selection and oversight
• Suppliers must be located within the same country as the manufacturer
• All suppliers must be ISO 9001 certified

Correct Answer: Manufacturers must perform risk-based supplier selection and oversight

Q5. Which record would an inspector request to verify traceability of implantable devices to individual patients?

• Device History Record (DHR)
• Design History File (DHF)
• Employee Training Matrix
• Annual Management Review Minutes

Correct Answer: Device History Record (DHR)

Q6. Under regulatory inspections, what is the expectation for complaint handling timelines?

• Complaints must be ignored unless they become litigation
• All complaints should be logged, triaged promptly, and investigated as required by risk
• Only complaints about sterile devices require documentation
• Complaints older than one year may be discarded

Correct Answer: All complaints should be logged, triaged promptly, and investigated as required by risk

Q7. Which activity is most critical to demonstrate process validation during an inspection of a sterilization operation?

• Having a signed sterilization SOP without records
• Reporting routine maintenance events only
• Providing qualification reports, validation protocols, and ongoing monitoring data
• Showing raw material certificates only

Correct Answer: Providing qualification reports, validation protocols, and ongoing monitoring data

Q8. What is the role of a Management Review in a medical device quality system as per regulatory expectations?

• To replace the need for internal audits
• To evaluate the overall effectiveness of the QMS and allocate resources
• To approve every production batch
• To record employee disciplinary actions

Correct Answer: To evaluate the overall effectiveness of the QMS and allocate resources

Q9. Which of the following best describes the regulatory expectation for device labelling controls?

• Labels can be modified locally without change control
• Label design, content, printing, and issuance must be controlled and traceable
• Labels are optional for in vitro diagnostic devices
• Only primary packaging labels require control

Correct Answer: Label design, content, printing, and issuance must be controlled and traceable

Q10. What type of audit focuses on evaluating compliance readiness specifically for external regulatory inspections?

• Supplier audit
• Mock (or readiness) inspection
• ISO certification audit
• Financial audit

Correct Answer: Mock (or readiness) inspection

Q11. Which record is most relevant for an inspector to assess the effectiveness of corrective actions after a field safety corrective action (recall)?

• Corrective Action Plan with verification and effectiveness check documentation
• Packing slip archives
• Job advertisements
• Energy consumption reports

Correct Answer: Corrective Action Plan with verification and effectiveness check documentation

Q12. Which element is essential in a quality system to satisfy regulators regarding software used in device manufacturing and control?

• Informal user notes
• Software validation documentation appropriate to intended use
• No documentation if software is commercially available
• Only source code repository access

Correct Answer: Software validation documentation appropriate to intended use

Q13. What is the primary regulatory requirement for complaint files that an inspector will review?

• They must be stored separately from other records
• They must contain complaint receipt, investigation, root cause, and actions taken
• They must be older than five years
• They must only document complaints that resulted in litigation

Correct Answer: They must contain complaint receipt, investigation, root cause, and actions taken

Q14. Which practice demonstrates appropriate change control for modifications to a device design?

• Immediate implementation without review
• Documented change request, risk assessment, approval, verification, and update of records
• Only verbal approval by a production supervisor
• Notifying customers after the change is in production

Correct Answer: Documented change request, risk assessment, approval, verification, and update of records

Q15. During an inspection, what evidence shows that a manufacturer is performing adequate post-market surveillance?

• Only marketing materials
• Systematic collection of complaints, trend analysis, vigilance reports, and periodic safety updates
• Annual holiday schedules
• Invoices from distributors

Correct Answer: Systematic collection of complaints, trend analysis, vigilance reports, and periodic safety updates

Q16. Which is the regulator’s expectation for retention of quality records for medical devices?

• Records should be retained only until the next audit
• Retention period should be risk-based and comply with applicable regulations (e.g., device lifetime plus X years)
• Records must be destroyed after one year
• Only electronic records are acceptable

Correct Answer: Retention period should be risk-based and comply with applicable regulations (e.g., device lifetime plus X years)

Q17. What must a manufacturer demonstrate to inspectors regarding sterile barrier system integrity?

• No testing is required if packaging looks intact
• Validated packaging processes, periodic integrity testing, and bioburden/sterility process controls
• Only supplier certificates for packaging materials
• Sterility guarantees from distributors

Correct Answer: Validated packaging processes, periodic integrity testing, and bioburden/sterility process controls

Q18. Which document will an inspector review to confirm that a manufacturer has conducted risk management throughout the device lifecycle?

• Risk Management File (per ISO 14971)
• Employee CVs
• Facility lease agreement
• Marketing plan

Correct Answer: Risk Management File (per ISO 14971)

Q19. For adverse event reporting, regulators expect manufacturers to:

• Report only events that lead to product replacement
• Timely submit serious adverse events and maintain evidence of investigations and reporting decisions
• Wait for distributor confirmation before any report
• Report events annually in a single consolidated file only

Correct Answer: Timely submit serious adverse events and maintain evidence of investigations and reporting decisions

Q20. What is the inspector most likely to evaluate to confirm training effectiveness of production personnel?

• Training matrix, records of competency assessments, and observed adherence to procedures
• Employee job applications
• Pay slips
• Company promotional flyers

Correct Answer: Training matrix, records of competency assessments, and observed adherence to procedures

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