Definition and dimensions of quality MCQs With Answer

Introduction

This quiz collection on the “Definition and Dimensions of Quality” is crafted for M.Pharm students to deepen understanding of fundamental quality concepts used in pharmaceutical quality management. It bridges theoretical definitions (ISO, Juran, Deming) with practical dimensions—such as conformance, reliability, stability, potency, and serviceability—emphasizing how these attributes affect product safety, efficacy and regulatory compliance. Questions also touch on measurement tools (CQAs, Cp/Cpk), Quality by Design (QbD) principles and service quality models relevant to pharmaceutical operations. Use these MCQs to test conceptual clarity, apply definitions to pharma contexts, and prepare for exams and quality-system implementation tasks.

Q1. Which definition of quality aligns most closely with the ISO 9000 family?

• Degree of excellence compared to competitor products
• Degree to which a set of inherent characteristics fulfills requirements
• Fitness for use as perceived by customers
• Lowest cost of production for acceptable performance

Correct Answer: Degree to which a set of inherent characteristics fulfills requirements

Q2. Which phrase best represents Juran’s classic definition of quality?

• Quality is conformance to specifications
• Quality is fitness for use
• Quality is absence of defects
• Quality is predictable uniformity and low cost

Correct Answer: Quality is fitness for use

Q3. Which of the following is NOT one of Garvin’s eight dimensions of product quality?

• Reliability
• Conformance
• Timeliness
• Aesthetics

Correct Answer: Timeliness

Q4. Which quality dimension specifically refers to meeting established specifications and standards?

• Performance
• Conformance
• Perceived quality
• Durability

Correct Answer: Conformance

Q5. In pharmaceutical products, the attribute that describes a drug maintaining its required potency over its shelf-life is called:

• Sterility
• Purity
• Stability
• Bioavailability

Correct Answer: Stability

Q6. What is the best definition of a Critical Quality Attribute (CQA) in pharmaceutical development?

• A manufacturing parameter that is easy to measure
• A property that must remain within limits to ensure product quality, safety and efficacy
• A marketing descriptor used to advertise product superiority
• An environmental factor that affects manufacturing labor efficiency

Correct Answer: A property that must remain within limits to ensure product quality, safety and efficacy

Q7. Which dimension is part of the SERVQUAL service quality model but not part of Garvin’s product dimensions?

• Aesthetics
• Responsiveness
• Durability
• Performance

Correct Answer: Responsiveness

Q8. Perceived quality of a pharmaceutical brand is most influenced by which factor?

• Only objective lab test results
• Customer perceptions, reputation and prior experience
• Manufacturing throughput rates
• Package weight

Correct Answer: Customer perceptions, reputation and prior experience

Q9. In quality terminology, reliability is best described as:

• The aesthetic appeal of the product
• The probability product performs without failure under specified conditions for a given time
• The ability to be repaired quickly
• The level of advertising supporting the product

Correct Answer: The probability product performs without failure under specified conditions for a given time

Q10. Which of the following is least likely to be considered a core pharmaceutical quality dimension?

• Potency
• Sterility
• Aesthetics
• Purity

Correct Answer: Aesthetics

Q11. Which statistical metric is commonly used to quantify process capability relative to specification limits?

• Mean Absolute Deviation (MAD)
• p-value
• Cpk
• R-squared

Correct Answer: Cpk

Q12. The phrase “fitness for use” emphasizes quality from which viewpoint?

• Regulatory paperwork completeness
• Manufacturer’s production efficiency
• Customer needs and satisfaction
• Absolute absence of any defects regardless of use

Correct Answer: Customer needs and satisfaction

Q13. Which practice is inconsistent with the principles of Quality by Design (QbD)?

• Understanding the relationship between process parameters and CQAs
• Using risk assessment to prioritize controls
• Designing robust processes using scientific knowledge
• Relying solely on end-product testing to assure quality

Correct Answer: Relying solely on end-product testing to assure quality

Q14. Which dimension refers to how easily a product can be serviced, repaired or maintained?

• Performance
• Serviceability
• Perceived quality
• Features

Correct Answer: Serviceability

Q15. Perceived quality in pharmaceutical context is most reliably assessed using:

• Customer surveys, complaint trends and brand reputation metrics
• Only in-process chemical analyses
• Factory floor humidity readings
• Raw material cost comparisons

Correct Answer: Customer surveys, complaint trends and brand reputation metrics

Q16. When prioritizing quality attributes for patient safety, which attribute typically receives highest priority?

• Packaging color
• Safety (absence of harmful contaminants and acceptable toxicity)
• Marketing claims
• Number of product features

Correct Answer: Safety (absence of harmful contaminants and acceptable toxicity)

Q17. Conformance to specifications can be quantified by which of the following metrics?

• Percentage of units meeting specifications
• Sales volume per quarter
• Advertising reach
• Employee headcount

Correct Answer: Percentage of units meeting specifications

Q18. Which dimension best captures the requirement for accurate labelling, complete documentation and regulatory adherence?

• Durability
• Compliance with regulatory requirements and documentation accuracy
• Perceived quality
• Features

Correct Answer: Compliance with regulatory requirements and documentation accuracy

Q19. Which quality dimension refers to the useful life or longevity of a product under normal use?

• Features
• Durability
• Perceived quality
• Responsiveness

Correct Answer: Durability

Q20. Why is quality described as a multi-dimensional concept in pharmaceuticals?

• Because quality can be reduced to a single numeric score
• Because it comprises various attributes—chemical, physical, biological and service-related—viewed by regulators, manufacturers and patients
• Because it only concerns manufacturing speed
• Because marketing decides the perception of quality alone

Correct Answer: Because it comprises various attributes—chemical, physical, biological and service-related—viewed by regulators, manufacturers and patients

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