Six Sigma is a data-driven methodology for process improvement and defect reduction widely applied in pharmaceutical manufacturing and quality assurance. B. Pharm students should learn Six Sigma principles—DMAIC (Define, Measure, Analyze, Improve, Control), statistical tools, control charts, process capability, and Design of Experiments—to optimize formulation, validation, analytical methods, and batch release. Pharmaceutical applications include reducing assay variability, improving yield, minimizing contamination risk, supplier quality management, and compliance with GMP. Understanding sigma levels, measurement system analysis, root-cause analysis, CAPA, and risk-based approaches helps ensure patient safety and regulatory readiness. This set of MCQs focuses on theory and practical pharma scenarios to reinforce learning. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of Six Sigma in pharmaceutical manufacturing?
- To increase laboratory headcount
- To reduce process variation and defects
- To replace GMP with new standards
- To eliminate all manual processes
Correct Answer: To reduce process variation and defects
Q2. In DMAIC, what does the “M” stand for and what is its main focus?
- Manage — assigning supervisors
- Measure — collecting baseline process data
- Maintain — ongoing cleaning schedules
- Model — building theoretical models only
Correct Answer: Measure — collecting baseline process data
Q3. Which metric describes defects per million opportunities (DPMO) in Six Sigma?
- Process Capability Index
- Sigma Level
- Control Limit
- Batch Release Time
Correct Answer: Sigma Level
Q4. Which tool is most appropriate for identifying the most frequent causes of defects in a pharma QC process?
- Fishbone (Ishikawa) diagram
- Control chart
- Pareto chart
- DOE full factorial
Correct Answer: Pareto chart
Q5. What is the primary use of control charts in pharmaceutical production?
- To forecast drug sales
- To monitor process stability and detect special causes
- To design new formulations
- To calculate expiry dates
Correct Answer: To monitor process stability and detect special causes
Q6. Gage R&R is a tool for assessing which aspect of measurement?
- Environmental monitoring accuracy
- Analytical method specificity
- Repeatability and reproducibility of measurement systems
- Batch size optimization
Correct Answer: Repeatability and reproducibility of measurement systems
Q7. Which Six Sigma phase focuses on identifying root causes using statistical analysis?
- Define
- Measure
- Analyze
- Control
Correct Answer: Analyze
Q8. In pharmaceutical Six Sigma projects, what is a CTQ?
- Critical to Quality characteristic affecting patient safety or product efficacy
- Certificate to Qualify a supplier
- Clinical Trial Questionnaire
- Cost to Quality metric for budgeting
Correct Answer: Critical to Quality characteristic affecting patient safety or product efficacy
Q9. Which study design helps understand factor interactions in formulation development?
- Control chart analysis
- Design of Experiments (DOE)
- Pareto analysis
- Visual inspection
Correct Answer: Design of Experiments (DOE)
Q10. Which Six Sigma concept aligns directly with CAPA in pharmaceutical quality systems?
- Kaizen blitz without documentation
- Root-cause analysis leading to corrective and preventive actions
- Random sampling without analysis
- Eliminating validation protocols
Correct Answer: Root-cause analysis leading to corrective and preventive actions
Q11. What does process capability index Cpk indicate in pharma processes?
- Scheduling efficiency
- How centered and capable a process is relative to specification limits
- Stability of raw material supply
- Number of deviations per year
Correct Answer: How centered and capable a process is relative to specification limits
Q12. Which control chart is best for monitoring counts of defects per unit in tablet coating?
- X-bar chart
- p-chart
- c-chart
- Histogram
Correct Answer: c-chart
Q13. How does Six Sigma help during process validation of a new analytical method?
- By replacing validation with sampling
- By using statistical tools to reduce variability and define acceptance criteria
- By increasing the number of analysts
- By postponing method qualification
Correct Answer: By using statistical tools to reduce variability and define acceptance criteria
Q14. Which of the following is an example of a “special cause” variation in manufacturing?
- Normal instrument noise
- Slight batch-to-batch variability within limits
- A sudden HVAC failure causing contamination
- Routine calibration drift accounted for in SOPs
Correct Answer: A sudden HVAC failure causing contamination
Q15. In Six Sigma, what is a SIPOC diagram used for in pharma projects?
- Mapping Suppliers, Inputs, Process, Outputs, Customers to clarify process scope
- Calculating sigma level numerically
- Replacing GMP documentation
- Designing packaging labels
Correct Answer: Mapping Suppliers, Inputs, Process, Outputs, Customers to clarify process scope
Q16. When applying Six Sigma to stability testing, what is a likely objective?
- To shorten shelf-life without data
- To identify critical factors that affect degradation rate and reduce variability
- To avoid conducting forced degradation studies
- To standardize packaging color
Correct Answer: To identify critical factors that affect degradation rate and reduce variability
Q17. Which Lean tool often complements Six Sigma to improve pharmaceutical workflow?
- 5S workplace organization
- Only statistical hypothesis testing
- Batch destruction
- Increasing buffer stock
Correct Answer: 5S workplace organization
Q18. In pharmaceutical supplier quality, Six Sigma helps primarily by:
- Selecting suppliers based on lowest price only
- Setting strict control charts and requiring capability data from suppliers
- Eliminating supplier audits
- Outsourcing all quality functions
Correct Answer: Setting strict control charts and requiring capability data from suppliers
Q19. What role does Failure Mode and Effects Analysis (FMEA) play in Six Sigma pharma projects?
- Planning packaging aesthetics
- Identifying potential failures, their severity, occurrence, and detectability to prioritize risks
- Calculating batch potency
- Scheduling validation runs
Correct Answer: Identifying potential failures, their severity, occurrence, and detectability to prioritize risks
Q20. Which statistical test is often used in Analyze phase to compare means between two process settings?
- Chi-square test
- t-test
- FMEA scoring
- Pareto ranking
Correct Answer: t-test
Q21. How can Six Sigma reduce assay variability in an HPLC method?
- By increasing column length without study
- By applying DOE to identify critical method parameters and optimize them
- By switching solvents randomly
- By removing system suitability criteria
Correct Answer: By applying DOE to identify critical method parameters and optimize them
Q22. Which is a typical Six Sigma deliverable at the end of the Control phase?
- Uncontrolled process variability
- Control plan, monitoring charts, and documented standard procedures
- Immediate product recalls
- Removal of all SOPs
Correct Answer: Control plan, monitoring charts, and documented standard procedures
Q23. What is the relationship between Six Sigma and GMP compliance?
- They are unrelated
- Six Sigma supports GMP by providing tools to control quality and document process capability
- Six Sigma replaces GMP entirely
- GMP prohibits statistical methods
Correct Answer: Six Sigma supports GMP by providing tools to control quality and document process capability
Q24. Which of the following indicates a high measurement system variation relative to process variation?
- Gage R&R showing low percent contribution
- Gage R&R showing high percent contribution
- Control chart inside limits
- High supplier rating
Correct Answer: Gage R&R showing high percent contribution
Q25. During Define phase, which document clarifies project scope and objectives in pharma Six Sigma?
- Project charter
- Batch record only
- Invoice from supplier
- General company memo
Correct Answer: Project charter
Q26. Which Six Sigma concept quantifies how often a process produces out-of-spec units?
- Sigma conversion table and DPMO calculation
- Supplier audit schedule
- Employee training log
- Visual inspection checklist
Correct Answer: Sigma conversion table and DPMO calculation
Q27. In a pharmaceutical context, what is a practical outcome of a successful Six Sigma project?
- Longer batch release times
- Reduced rework and fewer batch failures, improving on-time release
- Increased undocumented process changes
- Higher uncontrolled variability
Correct Answer: Reduced rework and fewer batch failures, improving on-time release
Q28. Which visualization helps prioritize issues by frequency and cumulative impact in a QC lab?
- Control chart
- Pareto chart
- SIPOC diagram
- DOE response surface
Correct Answer: Pareto chart
Q29. How does Six Sigma address contamination control in aseptic manufacturing?
- By ignoring environmental data
- By applying root-cause analysis, control charts for contamination events, and process improvements to reduce excursions
- By reducing cleaning frequency
- By removing monitoring requirements
Correct Answer: By applying root-cause analysis, control charts for contamination events, and process improvements to reduce excursions
Q30. Which outcome indicates a process has achieved near Six Sigma performance?
- Very high defect rate per batch
- Approximately 3.4 defects per million opportunities
- Complete elimination of variability
- No documented control plans
Correct Answer: Approximately 3.4 defects per million opportunities
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