Reducing process variability MCQs With Answer

Introduction

This blog provides a focused set of multiple-choice questions on reducing process variability, tailored for M. Pharm students studying Quality Management Systems (MQA 102T). It emphasizes practical statistical and procedural approaches used in pharmaceutical manufacturing to control and minimize variability that affects product quality and regulatory compliance. Topics covered include control charts, process capability, measurement system analysis, design of experiments, supplier control, SOPs, and validation strategies. Each question tests conceptual understanding and application of tools and techniques used to detect, attribute, and reduce variation in critical process parameters and quality attributes, helping students prepare for exams and real-world quality challenges.

Q1. What is the principal aim of reducing process variability in pharmaceutical manufacturing?

• To increase production speed irrespective of quality
• To ensure product quality and consistent therapeutic performance
• To reduce the number of operators on the shop floor
• To maximize raw material inventory

Correct Answer: To ensure product quality and consistent therapeutic performance

Q2. Which type of variation is inherent to a process and requires a change in the system to eliminate?

• Special cause variation
• Common cause variation
• Assignable cause variation
• Outlier variation

Correct Answer: Common cause variation

Q3. Which control chart is most appropriate for monitoring subgroup means of a continuous quality characteristic?

• p-chart
• X-bar chart
• c-chart
• Pareto chart

Correct Answer: X-bar chart

Q4. For attribute data representing the proportion of defective tablets in a sample, which control chart should be used?

• R-chart
• p-chart
• Individuals (I) chart
• Histogram

Correct Answer: p-chart

Q5. Which process capability index accounts for both process spread and the process mean location relative to specification limits?

• Cp
• Cpk
• Sigma
• R-squared

Correct Answer: Cpk

Q6. What is the primary purpose of a Gage R&R study in reducing process variability?

• To determine shelf-life variability
• To quantify measurement system variability from repeatability and reproducibility
• To calculate process capability indices
• To identify raw material suppliers

Correct Answer: To quantify measurement system variability from repeatability and reproducibility

Q7. Which experimental approach is most effective for identifying interactions between process factors that contribute to variability?

• Descriptive statistics
• Design of Experiments (DOE)
• Control chart plotting
• Visual inspection

Correct Answer: Design of Experiments (DOE)

Q8. Taguchi robust design focuses primarily on which strategy to reduce variability?

• Eliminating quality testing
• Making the product insensitive to noise factors
• Maximizing process complexity
• Using only expensive materials

Correct Answer: Making the product insensitive to noise factors

Q9. If a point falls outside the control limits on an X-bar chart, the best immediate action is to:

• Adjust the process setpoint immediately to bring mean to target
• Stop investigation because a single point is meaningless
• Investigate for potential special causes before making changes
• Change specifications to include the point

Correct Answer: Investigate for potential special causes before making changes

Q10. Which practice most directly reduces variability introduced by raw materials?

• Random sourcing from multiple unqualified suppliers
• Supplier qualification and incoming material specifications
• Eliminating incoming inspection entirely
• Increasing batch sizes to dilute variability

Correct Answer: Supplier qualification and incoming material specifications

Q11. Which quality tool helps prioritize the most significant causes of variability by frequency or impact?

• Control chart
• Pareto chart
• Scatter plot
• Box plot

Correct Answer: Pareto chart

Q12. To reduce measurement variability in an assay, which action is most appropriate?

• Ignore instrument drift
• Conduct a Gage R&R and improve measurement procedures
• Rely solely on operator judgment
• Use fewer calibration standards

Correct Answer: Conduct a Gage R&R and improve measurement procedures

Q13. Which sampling strategy provides statistically valid estimates of lot quality while helping control variability in release decisions?

• Convenience sampling based on operator choice
• Random or statistically designed sampling plans
• Sampling only failed batches
• Sampling a single unit per year

Correct Answer: Random or statistically designed sampling plans

Q14. What is the main difference between control limits and specification limits?

• Control limits are set by customers; specification limits are statistical
• Control limits reflect process performance; specification limits reflect product requirements
• They are the same and can be used interchangeably
• Specification limits are always wider than control limits

Correct Answer: Control limits reflect process performance; specification limits reflect product requirements

Q15. A process capability (Cp) greater than 1 generally indicates:

• The process spread is narrower than the specification width
• The process mean is exactly centered on the target
• The process has poor measurement system performance
• There is at least one special cause present

Correct Answer: The process spread is narrower than the specification width

Q16. Which validation approach emphasizes ongoing monitoring to control variability in a commercial manufacturing process?

• Prospective validation only during development
• Continuous Process Verification (CPV)
• Design qualification (DQ) without monitoring
• Retrospective validation without real-time data

Correct Answer: Continuous Process Verification (CPV)

Q17. How do well-written SOPs contribute to reducing process variability?

• By allowing each operator to perform tasks how they prefer
• By standardizing procedures and reducing operator-dependent variation
• By eliminating the need for training
• By increasing process flexibility at the expense of consistency

Correct Answer: By standardizing procedures and reducing operator-dependent variation

Q18. Which statistical metric compares inherent process variation to allowable specification tolerance?

• Standard error
• Process capability index (Cp or Cpk)
• Mean absolute deviation
• Confidence interval width

Correct Answer: Process capability index (Cp or Cpk)

Q19. Which approach is most effective to detect and reduce environmental variability (e.g., humidity, temperature) affecting a formulation process?

• Ignore environmental data unless a failure occurs
• Monitor environmental conditions and implement control or compensation strategies
• Only document environmental data after batch release
• Increase batch variability to mask environmental effects

Correct Answer: Monitor environmental conditions and implement control or compensation strategies

Q20. What is the Six Sigma goal in terms of defects per opportunity, aimed at reducing process variability?

• 3.4 defects per million opportunities
• 1 defect per hundred opportunities
• 50 defects per thousand opportunities
• Zero defects always achievable

Correct Answer: 3.4 defects per million opportunities

Download