Introduction
Customer focus is a cornerstone of Quality Management Systems, especially in pharmaceutical industries where patient safety and regulatory compliance are paramount. This blog offers M.Pharm students a focused set of multiple-choice questions on customer focus concepts to strengthen understanding of how customer requirements, feedback, complaints, and satisfaction metrics integrate with QMS practices. The questions emphasize practical applications such as handling complaints, using Voice of the Customer (VOC) data, forming quality agreements, CAPA initiation, and measuring customer satisfaction. These MCQs are designed to prepare students for academic assessments and real-world QMS responsibilities in pharmaceutical quality assurance and regulatory environments.
Q1. What best defines “customer focus” within a pharmaceutical Quality Management System?
- Prioritizing internal procedures over external needs
- Prioritizing meeting customer requirements and enhancing their satisfaction
- Focusing exclusively on regulatory inspections
- Maximizing production output regardless of feedback
Correct Answer: Prioritizing meeting customer requirements and enhancing their satisfaction
Q2. Who is considered an internal customer in the context of a pharmaceutical company?
- A patient buying a finished drug product
- An external contract research organization
- An employee or department within the organization that receives outputs from another department
- A regulatory authority conducting inspections
Correct Answer: An employee or department within the organization that receives outputs from another department
Q3. What does “Voice of the Customer (VOC)” primarily capture?
- Internal audit findings
- Customer needs, expectations, complaints, and suggestions
- Supplier performance metrics
- Laboratory stability data
Correct Answer: Customer needs, expectations, complaints, and suggestions
Q4. In quality terminology, CTQ stands for:
- Critical to Quality
- Customer Technical Query
- Compliance Test Questionnaire
- Corrective Test Quality
Correct Answer: Critical to Quality
Q5. Which method is most appropriate for measuring customer satisfaction for a marketed pharmaceutical product?
- Stability testing only
- Customer satisfaction surveys combined with complaint and return analysis
- Employee satisfaction surveys
- Raw material supplier audits
Correct Answer: Customer satisfaction surveys combined with complaint and return analysis
Q6. What does Net Promoter Score (NPS) measure in customer focus programs?
- Regulatory compliance level
- Product potency variation
- Customer loyalty and likelihood to recommend
- Internal training effectiveness
Correct Answer: Customer loyalty and likelihood to recommend
Q7. How should customer complaints be used within a QMS?
- Archived without review unless legally required
- Used as inputs for root cause analysis, CAPA, and continual improvement
- Forwarded to sales only
- Handled only by production staff
Correct Answer: Used as inputs for root cause analysis, CAPA, and continual improvement
Q8. What is the immediate action when a serious product-related customer complaint indicates potential patient harm?
- Delay action until annual review
- Initiate containment measures, notify regulatory authorities if required, and begin investigation
- Respond to the customer that investigation will start next quarter
- Only update marketing materials
Correct Answer: Initiate containment measures, notify regulatory authorities if required, and begin investigation
Q9. According to good QMS practice, what must organizations do regarding customer satisfaction?
- Monitor and measure customer perceptions and use the results to improve the QMS
- Only record complaints without analysis
- Focus solely on internal metrics and ignore external feedback
- Rely on sales figures alone to gauge satisfaction
Correct Answer: Monitor and measure customer perceptions and use the results to improve the QMS
Q10. Which document formalizes expectations between a contract manufacturer and its customer regarding quality and responsibilities?
- Purchase order only
- Quality agreement
- Marketing brochure
- Employee handbook
Correct Answer: Quality agreement
Q11. Which root cause analysis tool is commonly used to map multiple potential causes of customer complaints?
- Random sampling
- Ishikawa (Fishbone) diagram
- Stability chamber mapping
- Supplier scorecard
Correct Answer: Ishikawa (Fishbone) diagram
Q12. Which KPI is most directly linked to customer focus for pharmaceutical product delivery?
- On-time delivery rate to customers
- Number of internal meetings held
- Color of packaging boxes
- Amount of raw material inventory
Correct Answer: On-time delivery rate to customers
Q13. How does a “complaint” differ from general “feedback”?
- Complaint is positive feedback only
- Complaint indicates dissatisfaction that may require investigation; feedback can be neutral or positive
- Feedback always triggers regulatory action
- There is no difference in their handling
Correct Answer: Complaint indicates dissatisfaction that may require investigation; feedback can be neutral or positive
Q14. When should a CAPA (Corrective and Preventive Action) be initiated based on customer complaints?
- Only after three identical complaints have been received
- When investigation shows a systemic issue or a single event poses serious risk
- Never; CAPA is for manufacturing only
- CAPA is only for supplier nonconformities
Correct Answer: When investigation shows a systemic issue or a single event poses serious risk
Q15. What is the primary purpose of closing the customer feedback loop?
- To ensure the customer is billed correctly
- To implement corrective measures and inform the customer of actions taken
- To reduce the number of audits
- To archive emails for marketing
Correct Answer: To implement corrective measures and inform the customer of actions taken
Q16. Which department is typically responsible for formal customer complaint handling and investigations in a pharmaceutical company?
- Quality Assurance/Quality Unit
- Warehouse only
- Human Resources only
- Graphic design team
Correct Answer: Quality Assurance/Quality Unit
Q17. How does an effective product recall process support customer focus?
- By protecting customers through rapid removal of unsafe products and clear communication
- By increasing production speed regardless of safety
- By preventing customers from returning products
- By delaying communication until legal clearance
Correct Answer: By protecting customers through rapid removal of unsafe products and clear communication
Q18. What is the role of benchmarking in improving customer focus?
- To copy competitor packaging design exactly
- To compare processes and customer-related metrics with best-in-class and implement improvements
- To eliminate customer feedback channels
- To review only internal historical data
Correct Answer: To compare processes and customer-related metrics with best-in-class and implement improvements
Q19. Effective communication with customers during complaint handling should be which of the following?
- Delayed and informal
- Timely, transparent, documented, and responsive
- Only via social media
- Restricted to verbal messages without records
Correct Answer: Timely, transparent, documented, and responsive
Q20. Which sources should be analyzed to obtain a comprehensive view of customer satisfaction in a pharmaceutical QMS?
- Only internal audit reports
- Customer complaints, product returns, surveys, service records, and distributor feedback
- Laboratory reagent orders only
- Employee cafeteria menus
Correct Answer: Customer complaints, product returns, surveys, service records, and distributor feedback

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com

