Categories and models of cost of quality MCQs With Answer

Introduction

This collection of MCQs on Categories and Models of Cost of Quality is designed specifically for M.Pharm students preparing for Quality Management Systems (MQA 102T). It explains core concepts—prevention, appraisal, internal and external failure costs—and explores theoretical models such as the PAF model, Taguchi’s Quality Loss Function, and approaches by Feigenbaum, Crosby and Juran. Questions emphasize application in pharmaceutical settings: GMP compliance, batch failures, recalls, supplier quality and lifecycle cost implications. Practicing these focused MCQs will strengthen exam readiness, improve ability to quantify quality investments, and aid decision-making to minimize cost of poor quality while ensuring patient safety and regulatory compliance.

Q1. Which of the following best describes the Prevention category in the Cost of Quality (COQ) framework?

• Costs related to inspection and testing activities
• Costs incurred to keep defective products from being produced or delivered
• Costs arising from warranty claims and product recalls
• Costs due to rework and scrap within the manufacturing process

Correct Answer: Costs incurred to keep defective products from being produced or delivered

Q2. In the traditional PAF (Prevention-Appraisal-Failure) model, which of the following is classified as an Appraisal cost?

• Supplier qualification and training
• In-process inspection and final batch release testing
• Customer refunds and product recall expenses
• Rework of nonconforming batches

Correct Answer: In-process inspection and final batch release testing

Q3. Which cost is typically considered an External Failure cost in a pharmaceutical context?

• Cost of validation and preventive maintenance
• Cost of outgoing inspection of finished goods
• Cost of a nationwide product recall due to contamination
• Cost of scrap from pilot-scale development

Correct Answer: Cost of a nationwide product recall due to contamination

Q4. Taguchi’s Quality Loss Function primarily emphasizes which idea about quality-related costs?

• Costs are zero until a specification limit is exceeded
• Cost increases continuously with deviation from the target value
• Inspection eliminates all quality costs if performed at sufficient levels
• Prevention is always less expensive than appraisal

Correct Answer: Cost increases continuously with deviation from the target value

Q5. Which statement best reflects Philip Crosby’s view on cost of quality?

• Quality must be continuously monitored through inspection to reduce costs
• Quality is conformance to requirements, and cost of quality is the expense of nonconformance
• Only external failures should be included in COQ calculations
• Quality loss is best modeled as a quadratic function of deviation

Correct Answer: Quality is conformance to requirements, and cost of quality is the expense of nonconformance

Q6. In COQ accounting, which of the following would commonly be categorized as an Internal Failure cost?

• Employee quality training programs
• Costs for scrap and rework discovered before product release
• Compensation for patients affected by a defective drug
• Periodic calibration of testing instruments

Correct Answer: Costs for scrap and rework discovered before product release

Q7. Which of the following is a limitation of only using Appraisal activities to control quality?

• Appraisal eliminates the need for prevention
• Appraisal can detect defects but often cannot prevent their root causes, leading to recurring costs
• Appraisal always reduces total COQ more than prevention activities
• Appraisal costs are typically lower than all other COQ components

Correct Answer: Appraisal can detect defects but often cannot prevent their root causes, leading to recurring costs

Q8. In a pharmaceutical company’s COQ analysis, which item would be considered a hidden or indirect cost?

• Direct labor for in-process inspection
• Loss of future sales due to damaged reputation after a recall
• Cost of materials for rework
• Cost of laboratory reagents used in release testing

Correct Answer: Loss of future sales due to damaged reputation after a recall

Q9. Which model explicitly links quality deviation to monetary loss through a continuous mathematical function?

• PAF model (Prevention-Appraisal-Failure)
• Taguchi Quality Loss Function
• Crosby’s Zero Defects model
• Feigenbaum’s Total Quality Control description

Correct Answer: Taguchi Quality Loss Function

Q10. According to quality economics, investing more in prevention typically leads to which overall COQ effect?

• Increase in total COQ because prevention is expensive
• No change in total COQ because prevention only shifts costs
• Reduction in total COQ by lowering both appraisal and failure costs over time
• Immediate increase in external failure costs

Correct Answer: Reduction in total COQ by lowering both appraisal and failure costs over time

Q11. Which of the following represents an example of Opportunity Cost related to poor quality in pharmaceuticals?

• Direct cost of rework performed in the manufacturing line
• Wasted material cost from a rejected batch
• Foregone revenue because production capacity was diverted to handle nonconforming batches
• Cost of final product testing

Correct Answer: Foregone revenue because production capacity was diverted to handle nonconforming batches

Q12. Feigenbaum’s concept of Total Quality Control emphasizes which of the following?

• Quality is only the responsibility of the quality control department
• Continuous improvement and that quality is an organization-wide responsibility affecting cost and productivity
• Quality is defined strictly by meeting nominal target dimensions
• Inspection is the primary means to achieve zero defects

Correct Answer: Continuous improvement and that quality is an organization-wide responsibility affecting cost and productivity

Q13. Which measurement is most useful to prioritize quality improvement actions using the Pareto principle in COQ analysis?

• Number of employees in quality department
• Frequency and cost contribution of defect types (e.g., top contributors to COQ)
• Total number of quality procedures documented
• Average time spent in meetings discussing quality

Correct Answer: Frequency and cost contribution of defect types (e.g., top contributors to COQ)

Q14. Which choice best describes “Cost of Conformance”?

• Sum of prevention and appraisal costs aimed at achieving product quality
• Costs related to product failures after delivery to the customer
• Costs of inventory holding and transportation
• Costs only associated with regulatory inspections

Correct Answer: Sum of prevention and appraisal costs aimed at achieving product quality

Q15. In lifecycle cost considerations for pharmaceuticals, when should COQ be evaluated to capture full impact?

• Only during commercial production phase
• Throughout product lifecycle including R&D, validation, production, distribution and post-market surveillance
• Only after a regulatory inspection identifies nonconformance
• Only at the end of product patent life

Correct Answer: Throughout product lifecycle including R&D, validation, production, distribution and post-market surveillance

Q16. Which intervention is most directly considered a Prevention cost to reduce COQ?

• Compensation paid to customers after a recall
• Root cause analysis of a failed batch
• Employee training on aseptic technique and standard operating procedures
• Final product release testing

Correct Answer: Employee training on aseptic technique and standard operating procedures

Q17. Which of these is an example of an Appraisal cost in supplier management?

• Supplier development programs and audits
• Incoming raw material testing and supplier performance qualification
• Loss of market share due to inferior raw materials
• Recall costs when finished product fails stability

Correct Answer: Incoming raw material testing and supplier performance qualification

Q18. When calculating Cost of Poor Quality (COPQ), which of the following items is often underreported but important?

• Reportable external failure costs such as recalls
• Direct inspection labor hours
• Intangible costs like customer dissatisfaction and lost future business
• Cost of raw materials used in production

Correct Answer: Intangible costs like customer dissatisfaction and lost future business

Q19. A company spent heavily on inspection but still experienced high failure rates. Which strategic shift is most likely to reduce total COQ?

• Increase frequency of end-of-line inspections further
• Shift resources toward prevention activities such as process capability improvement and employee training
• Reduce spending on all quality activities to cut costs
• Outsource final inspection to a third party to avoid internal costs

Correct Answer: Shift resources toward prevention activities such as process capability improvement and employee training

Q20. In a pharmaceutical CAPA program, which COQ category best captures the costs of implementing corrective actions to eliminate root causes?

• External failure costs only
• Prevention costs, because CAPA aims to prevent recurrence
• Appraisal costs due to increased testing post-CAPA
• Inventory carrying costs

Correct Answer: Prevention costs, because CAPA aims to prevent recurrence

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