Preventing cost of poor quality MCQs With Answer

Introduction: This blog provides M.Pharm students with focused multiple-choice questions on preventing the cost of poor quality (COPQ) within pharmaceutical Quality Management Systems. It explains how prevention strategies—such as process validation, effective supplier management, robust training, CAPA, and risk-based tools like FMEA—reduce internal and external failure costs. The content links theoretical COPQ categories to practical pharmaceutical examples (batch failures, recalls, regulatory noncompliance) and highlights measurement approaches and cost-benefit reasoning. These MCQs are designed to deepen your understanding and prepare you for exam questions in MQA 102T by testing applied knowledge of prevention-oriented quality practices and metrics used to control COPQ in pharma environments.

Q1. What is the primary objective of investing in prevention activities in a pharmaceutical Quality Management System?

• To increase inspection frequency to detect defects before shipment
• To shift costs from appraisal to internal failure
• To reduce the incidence of defects and downstream failure costs
• To eliminate documentation for faster production

Correct Answer: To reduce the incidence of defects and downstream failure costs

Q2. Which category of cost of poor quality includes costs associated with rework, scrap, and re-testing within the manufacturing site?

• Prevention costs
• Appraisal costs
• Internal failure costs
• External failure costs

Correct Answer: Internal failure costs

Q3. In a pharmaceutical context, which example best represents an external failure cost?

• Costs for additional in-process testing to verify a batch
• Costs related to product recall due to contamination discovered after distribution
• Costs for staff training on aseptic techniques
• Costs for supplier qualification audits

Correct Answer: Costs related to product recall due to contamination discovered after distribution

Q4. Which tool is most appropriate for identifying potential failure modes and their effects before a process is implemented?

• Root cause analysis (RCA) after a deviation
• Failure mode and effects analysis (FMEA)
• Control chart analysis of historical data
• Internal audit checklist

Correct Answer: Failure mode and effects analysis (FMEA)

Q5. How does CAPA (Corrective and Preventive Action) primarily contribute to preventing COPQ?

• By increasing batch release frequency
• By documenting release criteria only
• By identifying root causes of failures and implementing systemic corrections and preventive measures
• By outsourcing non-critical quality activities

Correct Answer: By identifying root causes of failures and implementing systemic corrections and preventive measures

Q6. Which metric is most useful for quantifying defects produced per million opportunities in a pharmaceutical process?

• Cost of poor quality (COPQ) in currency
• Defects per million opportunities (DPMO)
• Mean time between failures (MTBF)
• Inventory turnover ratio

Correct Answer: Defects per million opportunities (DPMO)

Q7. Which action is a prevention cost rather than an appraisal cost?

• Final product testing before release
• Implementing process analytical technology (PAT) for in-line control
• End-of-line visual inspection
• Hiring additional QC analysts for sample testing

Correct Answer: Implementing process analytical technology (PAT) for in-line control

Q8. When performing a cost–benefit analysis for a new prevention activity (e.g., automated filtration monitoring), which of the following should be included as a benefit?

• Increased variability in output to detect issues
• Reduced risk of batch rejection and lower recall probability
• Higher short-term capital expenditure only
• Increased paperwork burden

Correct Answer: Reduced risk of batch rejection and lower recall probability

Q9. Which regulatory practice directly supports prevention of COPQ by ensuring process control and consistent product quality?

• Reactive market surveillance after complaints
• Process validation and continuous verification
• Reducing employee training to save costs
• Limiting supplier audits to annual frequency regardless of risk

Correct Answer: Process validation and continuous verification

Q10. In root cause analysis for a repeated deviation, which technique helps structure contributing causes into categories (e.g., machinery, method, personnel, environment) commonly used in pharma investigations?

• Histogram plotting
• Fishbone (Ishikawa) diagram
• Scatter plot of two variables
• ANOVA statistical test

Correct Answer: Fishbone (Ishikawa) diagram

Q11. Which practice reduces supplier-related external failure costs for critical raw materials?

• Accepting all deliveries without inspection
• Establishing approved supplier lists, qualification, and periodic audits
• Buying only cheapest available materials
• Reducing supplier communication to written purchase orders

Correct Answer: Establishing approved supplier lists, qualification, and periodic audits

Q12. How does training and competency assessment of manufacturing staff function as a preventive measure to reduce COPQ?

• By delaying production schedules
• By increasing the number of QC samples required
• By reducing human errors that lead to deviations, rework, and rejects
• By replacing SOPs entirely

Correct Answer: By reducing human errors that lead to deviations, rework, and rejects

Q13. Which statistical tool is most appropriate for monitoring a critical process parameter in real time and thereby preventing quality drift?

• Control charts (Statistical Process Control)
• Linear regression for final release potency
• FMEA for supplier selection only
• Kaplan–Meier survival analysis

Correct Answer: Control charts (Statistical Process Control)

Q14. What is the direct relationship between prevention costs and total COPQ when prevention is effective?

• Higher prevention costs should lead to increased total COPQ
• Investing in prevention typically increases internal and external failure costs
• Effective prevention increases prevention costs but reduces overall COPQ
• Prevention costs have no impact on appraisal costs

Correct Answer: Effective prevention increases prevention costs but reduces overall COPQ

Q15. Which approach best balances prevention and appraisal activities for a high-risk aseptic filling line?

• Eliminate ongoing environmental monitoring to save appraisal costs
• Focus on rigorous prevention (training, validated processes, maintenance) with targeted appraisal (real-time alerts)
• Rely solely on end-product testing for quality assurance
• Reduce preventive maintenance intervals to once a year

Correct Answer: Focus on rigorous prevention (training, validated processes, maintenance) with targeted appraisal (real-time alerts)

Q16. A manufacturer tracks the cost of rework and scrap monthly. This activity contributes to measuring which COPQ category?

• Prevention costs
• Appraisal costs
• Internal failure costs
• External failure costs

Correct Answer: Internal failure costs

Q17. In designing experiments to reduce COPQ, which methodology helps identify process factors that significantly affect quality attributes?

• Design of Experiments (DoE)
• Pareto chart of revenue streams
• Simple random sampling without factor variation
• Document control revision logs

Correct Answer: Design of Experiments (DoE)

Q18. Which is the best indicator that prevention measures are effective over time in a pharmaceutical facility?

• Increasing number of deviations recorded without analysis
• Decreasing trend in both internal failures (rework) and external failures (complaints/recalls)
• Rising appraisal testing costs with no change in failure rates
• Higher inventory levels of intermediate products

Correct Answer: Decreasing trend in both internal failures (rework) and external failures (complaints/recalls)

Q19. When estimating COPQ for a failed batch discovered post-distribution, which costs should be included?

• Only the cost of raw materials used in the batch
• Recall logistics, customer compensation, regulatory fines, reputation loss, and replacement product costs
• Only internal laboratory reanalysis costs
• Future prevention training unrelated to the incident

Correct Answer: Recall logistics, customer compensation, regulatory fines, reputation loss, and replacement product costs

Q20. Which strategy aligns with Quality by Design (QbD) principles to prevent COPQ during product development?

• Develop product quality solely by end-product testing
• Define critical quality attributes, link them to process parameters, and control via robust design
• Delay risk assessment until after commercialization
• Design shorter training programs to reduce time to market

Correct Answer: Define critical quality attributes, link them to process parameters, and control via robust design

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