Total Quality Management (TQM) is a systematic, organization-wide approach that integrates quality assurance, quality control and continuous improvement into pharmaceutical processes to ensure patient safety and regulatory compliance. For B. Pharm students, understanding TQM means learning principles like customer focus, leadership, employee involvement, process approach, and data-driven decision making applied to pharmaceutical manufacturing, QA/QC, validation, Good Manufacturing Practices (GMP), and documentation. Emphasis on tools such as PDCA, SPC, root-cause analysis, CAPA, and QbD helps optimize product quality and reduce errors. Mastering TQM concepts prepares future pharmacists for roles in quality systems, regulatory inspections, and production excellence. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary focus of Total Quality Management (TQM) in a pharmaceutical setting?
- Maximizing production output
- Minimizing regulatory inspections
- Continuous improvement of processes to ensure product quality and patient safety
- Reducing workforce size
Correct Answer: Continuous improvement of processes to ensure product quality and patient safety
Q2. Which of the following is NOT a core principle of TQM?
- Customer focus
- Employee involvement
- Short-term profit maximization only
- Process approach
Correct Answer: Short-term profit maximization only
Q3. PDCA cycle in quality management stands for:
- Plan-Do-Check-Act
- Prepare-Design-Check-Adjust
- Plan-Develop-Control-Assure
- Predict-Do-Confirm-Act
Correct Answer: Plan-Do-Check-Act
Q4. In pharmaceutical QA, CAPA stands for:
- Corrective and Preventive Actions
- Controls and Production Assessment
- Calibration and Performance Audit
- Clinical and Patient Assessment
Correct Answer: Corrective and Preventive Actions
Q5. Which quality tool is best for identifying the most frequent causes of defects?
- Fishbone (Ishikawa) diagram
- Pareto chart
- Control chart
- Scatter plot
Correct Answer: Pareto chart
Q6. Which statistical method is commonly used in TQM for monitoring process stability over time?
- ANOVA
- Control charts (SPC)
- Regression analysis
- Meta-analysis
Correct Answer: Control charts (SPC)
Q7. In pharmaceutical manufacturing, “quality by design” (QbD) primarily emphasizes:
- Testing quality only at final product stage
- Designing quality into the process using risk assessment and design of experiments
- Outsourcing all quality functions
- Relying only on inspection to ensure quality
Correct Answer: Designing quality into the process using risk assessment and design of experiments
Q8. Which ISO standard is directly related to quality management systems that many pharmaceutical companies align with?
- ISO 14001
- ISO 9001
- ISO 27001
- ISO 13485
Correct Answer: ISO 9001
Q9. Root cause analysis in TQM is performed to:
- Assign blame to an individual
- Identify underlying causes of a quality problem to prevent recurrence
- Reduce production costs immediately
- Increase the number of product batches
Correct Answer: Identify underlying causes of a quality problem to prevent recurrence
Q10. Process capability indices Cp and Cpk measure:
- Instrument calibration status
- Ability of a process to produce within specification limits
- Employee competency
- Supplier lead times
Correct Answer: Ability of a process to produce within specification limits
Q11. Which document is essential for demonstrating control of critical manufacturing steps in pharmaceuticals?
- Protocol for clinical trials
- Standard Operating Procedure (SOP)
- Marketing plan
- Employee payroll
Correct Answer: Standard Operating Procedure (SOP)
Q12. Which quality approach integrates customer needs into product and process design?
- Customer Focused Quality Management
- Ad hoc inspection
- Random sampling without trend analysis
- Only managerial review meetings
Correct Answer: Customer Focused Quality Management
Q13. The main aim of validation in pharmaceutical processes is to:
- Reduce paperwork
- Ensure processes consistently produce a product meeting predetermined specifications
- Avoid employee training
- Speed up batch release without testing
Correct Answer: Ensure processes consistently produce a product meeting predetermined specifications
Q14. Which TQM tool visually displays cause-and-effect relationships?
- Pareto chart
- Ishikawa (fishbone) diagram
- Histogram
- Box plot
Correct Answer: Ishikawa (fishbone) diagram
Q15. Sampling plans and acceptance criteria in QC are guided by which concept for batch release?
- Acceptance Quality Limit (AQL)
- Best Before Date
- Maximum Retail Price
- Employee satisfaction index
Correct Answer: Acceptance Quality Limit (AQL)
Q16. Which regulatory guideline emphasizes pharmaceutical quality risk management used in TQM?
- ICH Q9
- ICH Q1A
- ICH E6
- ICH M4
Correct Answer: ICH Q9
Q17. Which metric indicates the proportion of nonconforming items in a process?
- Zero defect index
- Defect rate or nonconformity rate
- Employee turnover
- Gross margin
Correct Answer: Defect rate or nonconformity rate
Q18. Which TQM element ensures employees understand quality expectations and procedures?
- Training and competency development
- Random hiring
- Reducing documentation
- Only senior management meetings
Correct Answer: Training and competency development
Q19. Which technique in TQM uses deliberate experiments to optimize formulations or processes?
- Design of Experiments (DoE)
- Benchmarking
- SWOT analysis
- Time-and-motion study
Correct Answer: Design of Experiments (DoE)
Q20. Which of the following best describes corrective action?
- Action to eliminate the cause of a detected nonconformity
- Action to increase sales
- Action to hire more staff
- Action to change packaging design for marketing
Correct Answer: Action to eliminate the cause of a detected nonconformity
Q21. In SPC, which type of control chart is used for monitoring the mean of a continuous variable?
- p-chart
- X̄ (X-bar) chart
- c-chart
- u-chart
Correct Answer: X̄ (X-bar) chart
Q22. Supplier quality management in TQM focuses on:
- Choosing suppliers based on lowest price only
- Collaborating to ensure raw material quality, audits and performance metrics
- Avoiding supplier audits
- Ordering larger quantities without qualification
Correct Answer: Collaborating to ensure raw material quality, audits and performance metrics
Q23. A deviation report in pharmaceutical operations should always include:
- Immediate batch disposal only
- Description of event, investigation, root cause and corrective actions
- Only the name of the operator
- Only final batch yield
Correct Answer: Description of event, investigation, root cause and corrective actions
Q24. Continuous improvement in TQM is most closely associated with which mindset?
- One-time fixes
- Kaizen culture of incremental, ongoing improvements
- Waiting for regulatory prompts only
- Avoiding change to maintain status quo
Correct Answer: Kaizen culture of incremental, ongoing improvements
Q25. Which performance indicator would best reflect laboratory testing reliability?
- Number of marketing campaigns
- Percentage of out-of-specification (OOS) results investigated and resolved
- Employee absenteeism only
- Raw material delivery time
Correct Answer: Percentage of out-of-specification (OOS) results investigated and resolved
Q26. Benchmarking in quality management means:
- Comparing processes and performance with industry best practices
- Only copying competitor branding
- Setting lower internal standards
- Ignoring external performance metrics
Correct Answer: Comparing processes and performance with industry best practices
Q27. Which document provides the overall quality intentions and direction of an organization?
- Quality Policy
- Batch production record
- Supplier invoice
- Maintenance log
Correct Answer: Quality Policy
Q28. What role does leadership play in TQM implementation?
- Setting vision, allocating resources and promoting a quality culture
- Focusing only on production schedules
- Keeping quality initiatives secret from staff
- Delegating all quality responsibilities without oversight
Correct Answer: Setting vision, allocating resources and promoting a quality culture
Q29. A validated analytical method in QC ensures:
- That the method is cheaper than alternatives
- Accuracy, precision, specificity, linearity and robustness for intended use
- Faster approval from marketing
- Reduced sample storage
Correct Answer: Accuracy, precision, specificity, linearity and robustness for intended use
Q30. Which TQM practice helps prioritize improvement projects using both impact and frequency of problems?
- Pareto analysis combining frequency and impact
- Random selection of projects
- Only employee suggestions without data
- Focusing solely on cosmetic changes
Correct Answer: Pareto analysis combining frequency and impact
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com