Advantages of statistical process control MCQs With Answer

Introduction: Advantages of Statistical Process Control (SPC) MCQs With Answer

Statistical Process Control (SPC) is a cornerstone of modern pharmaceutical quality management. This blog presents targeted multiple-choice questions focused on the advantages of SPC for M.Pharm students preparing for Quality Management Systems (MQA 102T). The questions explore how SPC reduces variability, lowers costs, supports regulatory compliance and process validation, enables real-time monitoring, and fosters continuous improvement. Each MCQ reinforces practical understanding of control charts, process capability, and the role of data-driven decisions in ensuring consistent product quality. Use these questions to deepen conceptual knowledge and prepare for examinations and real-world pharmaceutical manufacturing challenges.

Q1. What is the primary advantage of implementing Statistical Process Control (SPC) in a manufacturing process?

• Reduces process variability and improves consistency
• Increases process variability to find defects
• Replaces quality assurance personnel entirely
• Eliminates the need for any inspection

Correct Answer: Reduces process variability and improves consistency

Q2. How does SPC improve final product quality most directly?

• By detecting assignable causes of variation early and preventing defects
• By relying solely on final product inspection
• By increasing random sampling without analysis
• By ignoring process trends and focusing on batches

Correct Answer: By detecting assignable causes of variation early and preventing defects

Q3. Which of the following is a major economic advantage of SPC?

• Reduces scrap, rework, and warranty costs
• Always increases inspection headcount
• Requires larger inventories to manage risk
• Increases cost of goods due to extra testing

Correct Answer: Reduces scrap, rework, and warranty costs

Q4. How does SPC support regulatory compliance in the pharmaceutical industry?

• Provides documented evidence of process control and supports validation
• Replaces the need for process validation reports
• Is not recognized by regulatory agencies
• Delays filing of regulatory submissions

Correct Answer: Provides documented evidence of process control and supports validation

Q5. Which SPC tool most directly contributes to improving batch-to-batch consistency?

• Control charts (e.g., X̄ and R charts)
• Pareto diagrams of complaints
• Process flow diagrams only
• Final visual inspection checklists

Correct Answer: Control charts (e.g., X̄ and R charts)

Q6. Which control chart is commonly used in SPC to detect shifts in the process mean for continuous data?

• X̄ (X-bar) chart
• Pareto chart
• Histogram
• Scatter plot

Correct Answer: X̄ (X-bar) chart

Q7. Why does SPC facilitate continuous improvement initiatives?

• It provides objective, data-driven information for decision making
• It replaces process experiments with guesswork
• It focuses only on short-term fixes
• It discourages measurement and analysis

Correct Answer: It provides objective, data-driven information for decision making

Q8. What is a key advantage of real-time SPC monitoring on the plant floor?

• Enables faster corrective actions before off-spec product is produced
• Causes unnecessary production stoppages without benefit
• Delays decision making until end-of-shift reviews
• Has no impact on defect rates

Correct Answer: Enables faster corrective actions before off-spec product is produced

Q9. How does SPC help control Critical Quality Attributes (CQAs) in pharmaceutical processes?

• Maintains tighter process control and reduces CQA excursions
• Increases the frequency of CQA failures
• Makes CQAs less measurable
• Only benefits non-critical attributes

Correct Answer: Maintains tighter process control and reduces CQA excursions

Q10. What effect does implementing SPC typically have on process capability indices such as Cpk?

• Improves process capability indices by reducing variation
• Always reduces Cpk due to added measurement noise
• Has no relationship to Cpk
• Makes Cpk obsolete

Correct Answer: Improves process capability indices by reducing variation

Q11. How can SPC benefit supplier quality management?

• Enables objective acceptance and monitoring of incoming material quality using statistical criteria
• Eliminates the need for supplier audits entirely
• Guarantees zero defects from suppliers regardless of monitoring
• Replaces supplier qualification documents

Correct Answer: Enables objective acceptance and monitoring of incoming material quality using statistical criteria

Q12. What is an inspection-related advantage of using SPC rather than 100% final inspection?

• Shifts emphasis to process control and reduces reliance on end-of-line inspection
• Makes 100% inspection mandatory in addition to SPC
• Removes the need for any verification activities
• Always increases total inspection costs

Correct Answer: Shifts emphasis to process control and reduces reliance on end-of-line inspection

Q13. Compared with only doing final product testing, control charts in SPC primarily allow you to:

• Detect trends or shifts and prevent defects before they occur
• Only verify product quality after production is complete
• Provide slower feedback than batch release testing
• Increase variability by adding more checks

Correct Answer: Detect trends or shifts and prevent defects before they occur

Q14. How does SPC affect the cost of poor quality (COPQ)?

• Reduces COPQ by preventing defects and reducing rework
• Increases COPQ due to extra data collection
• Has no measurable effect on COPQ
• Shifts COPQ from production to administration only

Correct Answer: Reduces COPQ by preventing defects and reducing rework

Q15. In troubleshooting, what advantage does SPC provide when investigating variability?

• Helps distinguish between common-cause and special-cause variation
• Makes all variation appear as special cause
• Hides the source of variation by averaging data
• Prevents root cause analysis

Correct Answer: Helps distinguish between common-cause and special-cause variation

Q16. How does SPC contribute to process robustness?

• Identifies sensitive process parameters and reduces their impact on output
• Makes processes more sensitive to environmental changes
• Only focusses on cosmetic product features
• Cannot be applied to robustness studies

Correct Answer: Identifies sensitive process parameters and reduces their impact on output

Q17. What is an advantage of SPC regarding the type of measurements used for control?

• Uses simple, objective measurements that support statistical decision-making
• Depends primarily on subjective operator judgments
• Requires complex, non-repeatable tests for every sample
• Forbids using automated sensors for control

Correct Answer: Uses simple, objective measurements that support statistical decision-making

Q18. How can SPC support modern approaches like Real-Time Release Testing (RTRT)?

• By continuously monitoring process performance to provide assurance for RTRT
• By preventing any form of real-time assessment
• By requiring offline batch testing only
• By increasing regulatory burden for RTRT implementation

Correct Answer: By continuously monitoring process performance to provide assurance for RTRT

Q19. What is the likely impact of SPC on manufacturing cycle time?

• Can reduce cycle time by stabilizing processes and reducing rework delays
• Always increases cycle time due to more checks
• Has no effect on cycle time in any scenario
• Randomly affects cycle time without benefit

Correct Answer: Can reduce cycle time by stabilizing processes and reducing rework delays

Q20. Which long-term business advantage is commonly associated with effective SPC implementation?

• Continuous quality improvement and lower operating costs leading to competitive advantage
• Short-term gains only with no long-term benefit
• Higher product prices without quality improvement
• No measurable impact on business competitiveness

Correct Answer: Continuous quality improvement and lower operating costs leading to competitive advantage

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