Total Quality Management (TQM) MCQs With Answer

Total Quality Management (TQM) MCQs With Answer

Introduction: Total Quality Management (TQM) is a comprehensive philosophy that integrates quality into every aspect of pharmaceutical operations—from R&D and formulation to manufacturing and distribution. For M.Pharm students, mastering TQM is essential because regulatory compliance (GMP/ICH) and patient safety depend on robust quality systems, continuous improvement, and data-driven decision making. This quiz set emphasizes core TQM concepts, statistical tools, problem-solving techniques, quality metrics, and regulatory linkages, helping students deepen their understanding and apply principles to real-world pharmaceutical scenarios. Use these MCQs to test knowledge, prepare for exams, and reinforce practices that ensure consistent product quality and regulatory readiness.

Q1. Which of the following is the central focus of Total Quality Management (TQM)?

• Maximizing short-term profits
• Customer focus and satisfaction
• Strict hierarchical control
• Minimizing employee involvement

Correct Answer: Customer focus and satisfaction

Q2. The PDCA cycle used in TQM stands for which sequence?

• Plan-Do-Check-Act
• Prepare-Document-Control-Assess
• Plan-Develop-Control-Adjust
• Probe-Design-Confirm-Act

Correct Answer: Plan-Do-Check-Act

Q3. What is the primary objective of Continuous Quality Improvement in TQM?

• To replace quality systems annually
• To continuously reduce cost without regard to quality
• To continuously improve processes and product quality
• To eliminate all variability by restricting production

Correct Answer: To continuously improve processes and product quality

Q4. Which of the following is NOT typically considered a TQM quality improvement tool?

• Pareto analysis
• Fishbone (Ishikawa) diagram
• Good Manufacturing Practice (GMP)
• Control charts

Correct Answer: Good Manufacturing Practice (GMP)

Q5. Which ISO standard is most directly associated with Quality Management Systems relevant to TQM?

• ISO 13485
• ISO 14001
• ISO 9001:2015
• ISO 27001

Correct Answer: ISO 9001:2015

Q6. Six Sigma primarily aims to:

• Increase the number of production batches per day
• Reduce process variability using DMAIC methodology
• Replace statistical tools with intuitive decision-making
• Focus only on external failure costs

Correct Answer: Reduce process variability using DMAIC methodology

Q7. FMEA as used in TQM and pharma quality management stands for:

• Failure Mode and Effects Analysis
• Functional Measurement and Evaluation Assessment
• Frequency, Mean, and Error Analysis
• Forward Modeling and Experimental Audit

Correct Answer: Failure Mode and Effects Analysis

Q8. Which control chart is most appropriate for monitoring process mean and range with small subgroup sizes?

• P chart
• X-bar and R chart
• c chart
• Moving range (MR) chart only

Correct Answer: X-bar and R chart

Q9. Which process capability index reflects both process spread and centering relative to specification limits?

• Cp (process potential)
• Cpk (process capability index)
• Ppk (performance capability)
• Z-score

Correct Answer: Cpk (process capability index)

Q10. The Ishikawa diagram is another name for which quality tool?

• Pareto chart
• Scatter plot
• Fishbone (cause-and-effect) diagram
• Box plot

Correct Answer: Fishbone (cause-and-effect) diagram

Q11. In TQM and pharmaceutical quality, VOC stands for:

• Validation of Controls
• Value of Compliance
• Voice of the Customer
• Verification of Calibration

Correct Answer: Voice of the Customer

Q12. Which of the following is classified as a prevention cost in the Cost of Quality model?

• Rework of failed batches
• External failure handling (recalls)
• Inspection and testing
• Training and process design

Correct Answer: Training and process design

Q13. CAPA in pharmaceutical quality systems refers to:

• Calibration and Performance Assessment
• Corrective and Preventive Action
• Control and Process Audit
• Customer Assurance and Product Authorization

Correct Answer: Corrective and Preventive Action

Q14. The primary purpose of benchmarking within a TQM framework is to:

• Identify superior practices and adapt them to improve performance
• Standardize only internal documentation formats
• Replace regulatory inspections
• Determine employee compensation

Correct Answer: Identify superior practices and adapt them to improve performance

Q15. The Taguchi method in quality engineering emphasizes:

• Maximizing process variability to test robustness
• Robust parameter design to minimize variation and noise
• Only visual inspection techniques
• Statistical significance without experimental design

Correct Answer: Robust parameter design to minimize variation and noise

Q16. An audit performed by an independent accreditation body to assess compliance is called a:

• First-party audit
• Second-party audit
• Third-party audit
• Internal process review

Correct Answer: Third-party audit

Q17. Which root cause analysis technique repeatedly asks ‘Why?’ to drill down to the underlying cause?

• Fault tree analysis (FTA)
• 5 Whys
• Control chart analysis
• Design of experiments (DOE)

Correct Answer: 5 Whys

Q18. Which statistical tool is most appropriate for visualizing the distribution and frequency of a measured quality attribute?

• Flowchart
• Pareto chart
• Histogram
• Cause-and-effect diagram

Correct Answer: Histogram

Q19. A key element of Supplier Quality Management under TQM in pharma is:

• Supplier qualification and regular auditing
• Assuming all suppliers are equally qualified without checks
• Maximizing the number of suppliers regardless of quality
• Relying solely on purchase price to select suppliers

Correct Answer: Supplier qualification and regular auditing

Q20. A cultural element essential to successful TQM implementation in a pharmaceutical organization is:

• Top-down decisions without employee input
• Employee involvement, empowerment, and cross-functional teamwork
• Restricting communication to formal memos only
• Rewarding only individual performance irrespective of quality

Correct Answer: Employee involvement, empowerment, and cross-functional teamwork

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