Principles of Six Sigma MCQs With Answer

Introduction

Principles of Six Sigma MCQs With Answer is a focused review crafted for M.Pharm students studying Quality Management Systems (MQA 102T). This collection explains core Six Sigma concepts—DMAIC/DMADV, CTQ, DPMO, process capability, control charts, FMEA, DOE and Lean integration—using concise multiple-choice questions that reflect pharmaceutical process and quality scenarios. Each question is designed to strengthen analytical thinking, statistical interpretation, and practical application of Six Sigma tools in drug development, manufacturing and quality assurance. Regular practice with these MCQs will help you improve conceptual clarity, prepare for exams, and apply data-driven problem solving to reduce defects and enhance product quality in pharmaceutical environments.

Q1. Which statement best describes the primary focus of Six Sigma?

• Reducing process variation to eliminate defects
• Maximizing production output regardless of defects
• Lowering raw material costs only
• Implementing more manual inspections

Correct Answer: Reducing process variation to eliminate defects

Q2. What does DMAIC stand for in Six Sigma methodology?

• Define, Measure, Analyze, Improve, Control
• Design, Measure, Analyze, Improve, Check
• Define, Monitor, Act, Improve, Control
• Diagnose, Measure, Act, Implement, Control

Correct Answer: Define, Measure, Analyze, Improve, Control

Q3. DMADV is a Six Sigma approach used mainly for:

• Designing new processes or products (Define, Measure, Analyze, Design, Verify)
• Monitoring process control charts continuously
• Reducing inventory levels without analysis
• Conducting supplier audits only

Correct Answer: Designing new processes or products (Define, Measure, Analyze, Design, Verify)

Q4. In Six Sigma, CTQ refers to:

• Critical to Quality characteristics that impact customer satisfaction
• Cost to Qualify suppliers
• Control thresholds for quantitative tests
• Customer Testing Questionnaire

Correct Answer: Critical to Quality characteristics that impact customer satisfaction

Q5. What is the approximate defects-per-million-opportunities (DPMO) associated with a Six Sigma process (accounting for 1.5σ shift)?

• Approximately 3.4 defects per million opportunities (with 1.5σ shift)
• Approximately 6,800 defects per million opportunities
• Approximately 233,000 defects per million opportunities
• Zero defects always

Correct Answer: Approximately 3.4 defects per million opportunities (with 1.5σ shift)

Q6. DPMO stands for:

• Defects per Million Opportunities
• Designs per Manufacturing Operation
• Deviation per Mean Observation
• Data Points Measuring Output

Correct Answer: Defects per Million Opportunities

Q7. The SIPOC diagram includes which five elements?

• Suppliers, Inputs, Process, Outputs, Customers
• Schedule, Inputs, Performance, Output, Cost
• Suppliers, Inventory, Procedure, Output, Compliance
• Source, Inspection, Process, Output, Charge

Correct Answer: Suppliers, Inputs, Process, Outputs, Customers

Q8. Which statement correctly contrasts Cp and Cpk?

• Cpk accounts for process centering while Cp measures only the potential spread
• Cp accounts for centering and Cpk measures only spread
• Both Cp and Cpk ignore standard deviation
• Cpk is only used for categorical data

Correct Answer: Cpk accounts for process centering while Cp measures only the potential spread

Q9. Control charts in Six Sigma are primarily used to:

• Monitor process stability and detect special-cause variation over time
• Determine raw material suppliers
• Calculate profit margins
• Record operator attendance

Correct Answer: Monitor process stability and detect special-cause variation over time

Q10. The ultimate goal of Six Sigma within pharmaceutical manufacturing is to:

• Reduce variation and defects to improve product quality and patient safety
• Increase batch sizes regardless of quality
• Eliminate all documentation to speed production
• Replace Good Manufacturing Practices (GMP)

Correct Answer: Reduce variation and defects to improve product quality and patient safety

Q11. Which best describes the role of a Six Sigma Black Belt?

• Lead projects full-time, mentor Green Belts, and facilitate DMAIC implementation
• Perform only routine QC testing
• Manage procurement and supplier payment schedules
• Act solely as an auditor with no project responsibilities

Correct Answer: Lead projects full-time, mentor Green Belts, and facilitate DMAIC implementation

Q12. FMEA in Six Sigma stands for:

• Failure Mode and Effects Analysis
• Formal Measurement of Engineering Accuracy
• Factory Maintenance and Efficiency Audit
• Frequency Matrix for Error Analysis

Correct Answer: Failure Mode and Effects Analysis

Q13. Which tools are commonly used for root cause analysis in Six Sigma?

• Ishikawa (Fishbone) diagram and 5 Whys
• Gantt charts and PERT diagrams only
• Balance sheets and income statements
• Customer surveys without data analysis

Correct Answer: Ishikawa (Fishbone) diagram and 5 Whys

Q14. Poka‑yoke techniques are implemented to:

• Provide mistake-proofing devices or methods to prevent human errors
• Increase product complexity intentionally
• Delay detection of defects until final inspection
• Reduce documentation of process steps

Correct Answer: Provide mistake-proofing devices or methods to prevent human errors

Q15. Hypothesis testing in Six Sigma is used to:

• Validate whether observed improvements or differences are statistically significant
• Replace all statistical analysis with visual inspection
• Ensure 100% inspection of every unit
• Set pricing strategies for products

Correct Answer: Validate whether observed improvements or differences are statistically significant

Q16. Design of Experiments (DOE) helps Six Sigma teams to:

• Systematically evaluate factor effects and interactions to optimize process settings
• Randomly change variables without measurement
• Only collect observational data without intervention
• Document SOPs without experimentation

Correct Answer: Systematically evaluate factor effects and interactions to optimize process settings

Q17. COPQ stands for and refers to:

• Cost of Poor Quality, the financial impact of defects and rework
• Coefficient of Process Quality, a statistical index
• Cost of Product Quantification in R&D only
• Customer Opportunity for Product Quality

Correct Answer: Cost of Poor Quality, the financial impact of defects and rework

Q18. Lean Six Sigma integrates Lean and Six Sigma primarily to:

• Reduce waste (non-value add) and process variation to improve flow and quality
• Replace statistical tools with manual counting
• Focus on aesthetics of the workplace only
• Increase lead time intentionally

Correct Answer: Reduce waste (non-value add) and process variation to improve flow and quality

Q19. Which is NOT a commonly recognized Six Sigma belt level in classical nomenclature?

• Blue Belt
• Yellow Belt
• Green Belt
• Black Belt

Correct Answer: Blue Belt

Q20. How is the Sigma level of a process commonly defined?

• As the number of standard deviations between the process mean and the nearest specification limit
• As the mean value of product dimensions only
• As the total number of inspections performed per shift
• As the sum of all measurement units used in the lab

Correct Answer: As the number of standard deviations between the process mean and the nearest specification limit

Download