Introduction: Total Quality Management (TQM) is a systematic, organization-wide approach to achieving long-term pharmaceutical quality by integrating quality assurance, quality control, continuous improvement, and customer focus. For B. Pharm students, understanding TQM means learning core elements—leadership commitment, process approach, employee involvement, supplier quality, documentation, CAPA, validation, and data-driven decision-making—plus tools such as PDCA, Six Sigma, and ISO 9001. TQM aligns Good Manufacturing Practices (GMP) with quality culture, reducing errors, enhancing product safety, and ensuring regulatory compliance. This concise foundation helps future pharmacists contribute to robust quality systems in drug development, manufacturing, and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary aim of Total Quality Management (TQM) in the pharmaceutical industry?
- To maximize production output regardless of quality
- To ensure long-term customer satisfaction through continuous improvement
- To replace regulatory requirements
- To focus exclusively on cost reduction
Correct Answer: To ensure long-term customer satisfaction through continuous improvement
Q2. Which element of TQM emphasizes top management commitment and vision?
- Employee empowerment
- Leadership
- Process validation
- Statistical control
Correct Answer: Leadership
Q3. Which TQM tool represents cyclical continuous improvement?
- Gantt chart
- Fishbone diagram
- PDCA (Plan-Do-Check-Act)
- Batch record
Correct Answer: PDCA (Plan-Do-Check-Act)
Q4. In TQM, what does ‘process approach’ primarily focus on?
- Isolating departments to prevent interference
- Managing activities as interrelated processes to achieve consistent results
- Prioritizing paperwork over operations
- Outsourcing all critical functions
Correct Answer: Managing activities as interrelated processes to achieve consistent results
Q5. Which of the following is a key difference between Quality Assurance (QA) and Quality Control (QC)?
- QA is product testing; QC is system design
- QA focuses on preventing defects through systems; QC detects defects in products
- QC is performed only after market release
- QA does not involve documentation
Correct Answer: QA focuses on preventing defects through systems; QC detects defects in products
Q6. Which TQM element requires employees at all levels to participate in quality activities?
- Customer complaints
- Employee involvement
- Batch release
- Outsourcing
Correct Answer: Employee involvement
Q7. Which concept in TQM emphasizes decision-making based on data and statistical analysis?
- Intuition-based management
- Fact-based decision making
- Leadership charisma
- Top-down directives
Correct Answer: Fact-based decision making
Q8. Which regulatory quality system aligns closely with TQM principles and is often implemented in pharmaceuticals?
- Good Laboratory Practices (GLP) only
- ISO 9001 Quality Management System
- Tax compliance standards
- Occupational Safety and Health rules only
Correct Answer: ISO 9001 Quality Management System
Q9. In pharmaceutical TQM, what is CAPA?
- Corrective and Preventive Actions for addressing nonconformities
- Critical Analysis of Pharmaceutical Activities
- Computerized Automated Production Application
- Customer Approval for Product Allocation
Correct Answer: Corrective and Preventive Actions for addressing nonconformities
Q10. Which TQM tool is commonly used to identify root causes of quality problems?
- Root Cause Analysis (RCA) / Fishbone (Ishikawa) diagram
- Marketing mix
- Balance sheet
- Color coding system
Correct Answer: Root Cause Analysis (RCA) / Fishbone (Ishikawa) diagram
Q11. How does TQM support regulatory compliance in pharmaceutical manufacturing?
- By eliminating the need for audits
- By embedding quality systems that ensure GMP, documentation, validation, and traceability
- By prioritizing speed over documentation
- By reducing training requirements
Correct Answer: By embedding quality systems that ensure GMP, documentation, validation, and traceability
Q12. Which metric is commonly used in TQM to measure process capability and variation?
- Gross margin
- Cpk (process capability index)
- Sales volume
- Employee headcount
Correct Answer: Cpk (process capability index)
Q13. Which TQM practice directly helps reduce product recalls and deviations?
- Ignoring supplier quality
- Robust change control and validation programs
- Reducing environmental monitoring
- Minimizing batch records
Correct Answer: Robust change control and validation programs
Q14. What role do suppliers play in TQM for pharmaceuticals?
- They are irrelevant to final product quality
- Supplier qualification and monitoring ensure raw material quality and consistency
- Suppliers determine regulatory policies
- They handle all product testing
Correct Answer: Supplier qualification and monitoring ensure raw material quality and consistency
Q15. Which approach within TQM focuses on reducing variation and defects to near zero?
- Six Sigma
- Ad hoc troubleshooting
- Just-In-Time inventory only
- Batch-and-hold strategy
Correct Answer: Six Sigma
Q16. In TQM, what is the importance of documentation and record-keeping?
- It slows production without benefit
- It provides traceability, supports investigations, and demonstrates compliance
- It is only needed for marketing
- It is optional if products pass tests
Correct Answer: It provides traceability, supports investigations, and demonstrates compliance
Q17. How does continuous training contribute to TQM in a pharmaceutical setting?
- By increasing employee turnover
- By keeping staff skilled in GMP, procedures, and quality culture, reducing human error
- By replacing the need for SOPs
- By making audits unnecessary
Correct Answer: By keeping staff skilled in GMP, procedures, and quality culture, reducing human error
Q18. Which of the following is a preventive measure emphasized by TQM to avoid nonconformities?
- Reactive recall only
- Risk assessment and mitigation
- Stopping validation
- Eliminating supplier audits
Correct Answer: Risk assessment and mitigation
Q19. What is the relationship between GMP and TQM?
- GMP contradicts TQM principles
- TQM complements GMP by fostering continuous improvement and system-based quality
- TQM eliminates the need for GMP
- They are unrelated concepts
Correct Answer: TQM complements GMP by fostering continuous improvement and system-based quality
Q20. Which quality tool helps monitor a process over time to identify trends or shifts?
- Control chart
- Material safety data sheet
- Invoice register
- Organizational chart
Correct Answer: Control chart
Q21. Which element ensures that corrective actions are effective and prevent recurrence?
- Ignoring CAPA records
- Effectiveness checks and follow-up monitoring
- Reducing batch testing
- Deleting deviation reports
Correct Answer: Effectiveness checks and follow-up monitoring
Q22. In TQM, ‘customer focus’ for pharmaceutical products primarily means:
- Meeting regulatory timelines only
- Ensuring safety, efficacy, and patient satisfaction through quality products and services
- Marketing products aggressively
- Sacrificing quality for faster delivery
Correct Answer: Ensuring safety, efficacy, and patient satisfaction through quality products and services
Q23. What is the role of internal audits in a TQM system?
- To conceal nonconformities
- To objectively evaluate system effectiveness and identify improvement opportunities
- To replace training programs
- To increase paperwork without benefit
Correct Answer: To objectively evaluate system effectiveness and identify improvement opportunities
Q24. Which TQM principle emphasizes designing quality into processes rather than inspecting it in at the end?
- End-of-line inspection
- Quality by design (QbD) and built-in quality
- Ad hoc release
- Late-stage testing
Correct Answer: Quality by design (QbD) and built-in quality
Q25. Which of these is a common indicator of a mature TQM culture in a pharmaceutical company?
- Frequent unresolved deviations and blame culture
- Proactive problem-solving, low defect rates, and continuous improvement programs
- Minimal training and high turnover
- Ignoring supplier performance
Correct Answer: Proactive problem-solving, low defect rates, and continuous improvement programs
Q26. Which documentation practice supports traceability of a pharmaceutical batch?
- Incomplete batch records
- Comprehensive batch production records with signatures, dates, and equipment IDs
- Removing retention samples
- Anonymous logging
Correct Answer: Comprehensive batch production records with signatures, dates, and equipment IDs
Q27. How does risk management integrate with TQM in pharmaceuticals?
- By ignoring potential hazards
- By identifying, assessing, and controlling risks throughout product lifecycle to ensure quality
- By focusing only on financial risks
- By postponing risk assessment until after failures
Correct Answer: By identifying, assessing, and controlling risks throughout product lifecycle to ensure quality
Q28. Which activity is essential during implementation of TQM to sustain improvements?
- One-time training only
- Ongoing measurement, review, and employee engagement
- Restricting access to quality data
- Eliminating internal communication
Correct Answer: Ongoing measurement, review, and employee engagement
Q29. Which of the following best describes a ‘quality policy’ in TQM?
- An informal verbal statement by staff
- A formal, documented commitment from management describing quality objectives and scope
- A marketing slogan
- An annual sales target
Correct Answer: A formal, documented commitment from management describing quality objectives and scope
Q30. When implementing TQM in a pharmaceutical company, which measure helps link quality improvements to business outcomes?
- Tracking only production hours
- Using key performance indicators (KPIs) like defect rates, on-time release, cost of poor quality, and customer complaints
- Focusing solely on aesthetic packaging
- Eliminating product testing to save costs
Correct Answer: Using key performance indicators (KPIs) like defect rates, on-time release, cost of poor quality, and customer complaints
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