Quality management systems and TQM MCQs With Answer

Introduction: Quality management systems and Total Quality Management (TQM) are foundational to pharmaceutical manufacturing and regulatory compliance. This quiz collection for M.Pharm students focuses on core concepts such as ISO and ICH frameworks, CAPA, change control, risk-based approaches, process validation, continuous improvement tools, supplier qualification, and audit practices. Questions are designed to test conceptual understanding, application in real-world regulated environments, and critical thinking needed for designing and maintaining robust quality systems. Answers are provided to reinforce learning and prepare students for professional roles in quality assurance, regulatory affairs, and manufacturing within the pharmaceutical industry.

Q1. Which international guideline specifically provides a comprehensive model for an effective pharmaceutical quality system integrating product lifecycle management?

• ISO 9001:2015 Quality Management Systems
• ICH Q10 Pharmaceutical Quality System
• GMP Annex 15 — Qualification and Validation
• ICH Q9 Quality Risk Management

Correct Answer: ICH Q10 Pharmaceutical Quality System

Q2. In a pharmaceutical QMS, the primary purpose of CAPA (Corrective and Preventive Action) is to:

• Document routine maintenance activities
• Identify, eradicate and prevent recurrence of quality problems
• Train staff on standard operating procedures
• Approve suppliers for raw materials

Correct Answer: Identify, eradicate and prevent recurrence of quality problems

Q3. Which of the following best describes “Quality by Design” (QbD) in pharmaceuticals?

• Using only approved suppliers for raw materials
• Establishing quality through predefined process control and product understanding
• Performing end-product testing to ensure quality
• Documenting deviations and filing them with regulatory authorities

Correct Answer: Establishing quality through predefined process control and product understanding

Q4. Which tool is most appropriate for identifying root causes of a recurring batch failure?

• Pareto chart
• Fishbone (Ishikawa) diagram
• Control chart
• Histograms

Correct Answer: Fishbone (Ishikawa) diagram

Q5. Under ICH Q9 risk management, which activity is essential before implementing a change to a validated process?

• Immediate production restart
• Risk assessment to evaluate potential impact on product quality
• Only updating the batch record
• Notifying non-essential staff

Correct Answer: Risk assessment to evaluate potential impact on product quality

Q6. Which quality metric is most useful to monitor process stability over time?

• Number of SOPs
• Process capability index (Cpk)
• Total number of employees
• Annual budget variance

Correct Answer: Process capability index (Cpk)

Q7. The Plan-Do-Check-Act (PDCA) cycle is principally used for:

• Conducting regulatory inspections
• Continuous improvement and problem-solving
• Supplier contract negotiation
• Final product release testing

Correct Answer: Continuous improvement and problem-solving

Q8. Which of the following is a primary objective of management review within a pharmaceutical QMS?

• To perform routine equipment maintenance
• To assess QMS performance and allocate resources for improvement
• To issue production orders
• To train new operators only

Correct Answer: To assess QMS performance and allocate resources for improvement

Q9. What is the most appropriate action when an out-of-specification (OOS) result is obtained during routine testing?

• Release the batch if averages meet specification
• Initiate an investigation before any release decision
• Immediately destroy the batch without investigation
• Ignore and retest until a passing result is obtained

Correct Answer: Initiate an investigation before any release decision

Q10. Supplier qualification in a pharmaceutical QMS should primarily focus on:

• Lowest cost of materials
• Evaluating supplier capability, quality history and risk to product quality
• Geographic proximity to manufacturing site
• Frequency of supplier marketing emails

Correct Answer: Evaluating supplier capability, quality history and risk to product quality

Q11. Which document describes the sequence of activities required to control changes to production processes and systems?

• Batch Production Record
• Change control procedure
• Quality manual
• Training matrix

Correct Answer: Change control procedure

Q12. During an internal audit, a major nonconformity is identified. The immediate next step should be to:

• File the audit report and wait for the next audit
• Raise a formal nonconformance report and initiate CAPA
• Ignore it if production must continue
• Terminate the auditor

Correct Answer: Raise a formal nonconformance report and initiate CAPA

Q13. Which statistical tool is commonly used for ongoing real-time monitoring of a critical quality attribute in manufacturing?

• Pareto analysis
• Control charts (Shewhart charts)
• SWOT analysis
• Force field analysis

Correct Answer: Control charts (Shewhart charts)

Q14. In the context of pharmaceutical quality systems, “documentation control” primarily ensures:

• All documents are handwritten
• Documents are approved, current, accessible and obsolete versions are removed
• Only production staff can access QMS documents
• Unlimited copying of documents without revision tracking

Correct Answer: Documents are approved, current, accessible and obsolete versions are removed

Q15. Lean principles integrated into TQM in a pharmaceutical environment mainly aim to:

• Increase inventory to avoid shortages
• Eliminate waste and improve flow while maintaining quality
• Reduce workforce regardless of quality impact
• Increase batch cycle variability

Correct Answer: Eliminate waste and improve flow while maintaining quality

Q16. The primary focus of an effective calibration program in QMS is to:

• Ensure instruments are aesthetically clean
• Maintain measurement accuracy and traceability to standards
• Increase the number of instruments to speed production
• Record only failed calibrations

Correct Answer: Maintain measurement accuracy and traceability to standards

Q17. Which element is NOT a principle of Total Quality Management (TQM)?

• Customer focus
• Continuous improvement
• Top management commitment
• Acceptance of frequent uninvestigated defects

Correct Answer: Acceptance of frequent uninvestigated defects

Q18. Product lifecycle management under ICH Q10 includes which of the following activities?

• Only raw material procurement
• Design, commercialisation, ongoing production, and discontinuation with continuous improvement
• Marketing campaigns only
• Single batch production without review

Correct Answer: Design, commercialisation, ongoing production, and discontinuation with continuous improvement

Q19. Why is trending of deviations and complaints important in a pharmaceutical QMS?

• To increase paperwork volume
• To identify patterns, trending issues and prioritize preventive actions
• To delay corrective actions indefinitely
• To avoid conducting root cause analyses

Correct Answer: To identify patterns, trending issues and prioritize preventive actions

Q20. Which activity best demonstrates a risk-based approach to quality decision-making?

• Applying identical controls to all processes regardless of criticality
• Prioritizing controls, monitoring and resources on critical-to-quality attributes and high-risk processes
• Eliminating formal risk assessments altogether
• Randomly selecting processes for intensive oversight

Correct Answer: Prioritizing controls, monitoring and resources on critical-to-quality attributes and high-risk processes

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