Handling customer complaints MCQs With Answer

Introduction: Handling customer complaints MCQs With Answer is a focused quiz resource designed for M.Pharm students studying Quality Management Systems (MQA 102T). This set of questions emphasizes practical and regulatory aspects of complaint management in the pharmaceutical industry, including receipt, documentation, investigation, root-cause analysis, CAPA, sample retention, communication, trending and use of complaint data for continuous improvement. The questions encourage understanding of core SOP requirements, risk-based decision making and effective customer communication while reinforcing expectations from regulatory authorities. Use these MCQs to test comprehension, prepare for exams and develop the competency needed to manage complaints in a compliant, patient-safety driven manner.

Q1. What is the primary objective of an effective customer complaint handling system in the pharmaceutical industry?

• To compensate the customer financially regardless of cause
• To record complaints for archival only
• To ensure product safety, satisfy customers and prevent recurrence through corrective actions
• To reduce advertising costs

Correct Answer: To ensure product safety, satisfy customers and prevent recurrence through corrective actions

Q2. Upon first receipt of a customer complaint, the most appropriate immediate action is:

• Dispose of the returned material immediately
• Acknowledge receipt, record complaint details and quarantine any returned sample
• Initiate a product recall without investigation
• Forward the complaint to marketing for public relations response

Correct Answer: Acknowledge receipt, record complaint details and quarantine any returned sample

Q3. Which statement best differentiates a product complaint from an adverse event?

• A product complaint always indicates a patient has been harmed
• An adverse event is any dissatisfaction expressed by a customer
• A product complaint relates to perceived product quality or service issues; an adverse event indicates actual or suspected harm to health
• There is no difference; both are handled identically

Correct Answer: A product complaint relates to perceived product quality or service issues; an adverse event indicates actual or suspected harm to health

Q4. Which document should define the process, responsibilities and timelines for complaint handling in a pharmaceutical company?

• Stability study protocol
• Master production record
• Complaint handling standard operating procedure (SOP)
• Marketing strategy document

Correct Answer: Complaint handling standard operating procedure (SOP)

Q5. Which piece of information is essential to capture for every product-related complaint?

• Customer’s favorite color
• Batch/lot number and product identification
• Competitor product details
• Sales price at purchase

Correct Answer: Batch/lot number and product identification

Q6. A formal technical investigation should be initiated when:

• The complaint is about delivery time only
• The complaint suggests a potential product quality defect or a safety risk to patients
• The complaint praises the packaging design
• The complaint pertains solely to billing queries

Correct Answer: The complaint suggests a potential product quality defect or a safety risk to patients

Q7. The primary purpose of a Corrective and Preventive Action (CAPA) resulting from a complaint investigation is to:

• Assign blame to an individual
• Document the complaint for inspection only
• Eliminate the root cause and prevent recurrence of the problem
• Increase production throughput

Correct Answer: Eliminate the root cause and prevent recurrence of the problem

Q8. Which root cause analysis tools are commonly used during complaint investigations?

• 5 Whys and Fishbone (Ishikawa) analysis
• Random number generation
• Branding matrix
• Annual sales forecast

Correct Answer: 5 Whys and Fishbone (Ishikawa) analysis

Q9. Which of the following is NOT a usual classification for customer complaints in a pharmaceutical Quality Management System?

• Product quality complaint
• Service complaint
• Technical complaint
• Weather-related complaint

Correct Answer: Weather-related complaint

Q10. When a complaint indicates a potential manufacturing defect, best practice for retained samples is to:

• Discard all samples immediately to save storage space
• Retain representative sample(s) from the same batch under controlled conditions pending investigation
• Return the sample to the customer without analysis
• Send the sample to marketing for consumer testing

Correct Answer: Retain representative sample(s) from the same batch under controlled conditions pending investigation

Q11. Routine trending and analysis of complaint data are performed primarily to:

• Develop new advertising campaigns
• Identify systemic issues, high-risk products and trigger CAPA or process improvements
• Increase product pricing based on complaint volume
• Reduce employee headcount in customer service

Correct Answer: Identify systemic issues, high-risk products and trigger CAPA or process improvements

Q12. Which metric is most appropriate to monitor the performance of a complaint handling system?

• Number of colors used on packaging
• Complaint rate per units distributed and time to closure of investigations
• Number of marketing emails sent
• Employee turnover in the sales department

Correct Answer: Complaint rate per units distributed and time to closure of investigations

Q13. During complaint handling involving patient information, what is an essential compliance consideration?

• Publicly publish patient identity to discourage complaints
• Maintain confidentiality of patient data and comply with relevant privacy regulations
• Share patient details with all departments without restriction
• Destroy all complaint records immediately after closure

Correct Answer: Maintain confidentiality of patient data and comply with relevant privacy regulations

Q14. Which party is typically responsible for auditing complaint handling records and ensuring compliance?

• External marketing agencies
• Quality assurance or quality control unit
• Distribution vendors
• Customer’s family members

Correct Answer: Quality assurance or quality control unit

Q15. A recall should be considered when a complaint investigation determines that:

• The product has a labeling omission that could result in significant risk to patient health
• The complaint is only about courier delay
• The customer prefers a different flavor
• The package color fades over time without impact on quality

Correct Answer: The product has a labeling omission that could result in significant risk to patient health

Q16. A comprehensive complaint investigation report should include which of the following elements?

• Root cause analysis, corrective/preventive actions and verification of effectiveness
• Only the customer’s name and phone number
• Only the name of the investigator
• Only marketing suggestions for product relaunch

Correct Answer: Root cause analysis, corrective/preventive actions and verification of effectiveness

Q17. Which statement correctly distinguishes corrective action from preventive action?

• Corrective action prevents potential problems; preventive action corrects existing nonconformities
• Corrective action addresses and eliminates the cause of an existing nonconformity; preventive action addresses potential causes to avoid future nonconformities
• Both terms mean the same and can be used interchangeably
• Preventive action is only used by the marketing team

Correct Answer: Corrective action addresses and eliminates the cause of an existing nonconformity; preventive action addresses potential causes to avoid future nonconformities

Q18. How should the effectiveness of implemented corrective actions be demonstrated?

• By verbal assurance from the responsible person only
• Through documented monitoring, objective evidence of reduced recurrence and verification activities
• By increasing production speed
• By closing the complaint file immediately after action assignment

Correct Answer: Through documented monitoring, objective evidence of reduced recurrence and verification activities

Q19. In the context of product lifecycle management, complaint data are used to:

• Inform risk assessments, support stability considerations and guide post-marketing improvements
• Determine employee vacation schedules
• Replace the need for clinical data
• Only satisfy auditor curiosity

Correct Answer: Inform risk assessments, support stability considerations and guide post-marketing improvements

Q20. Which of the following best describes the relationship between complaint handling and regulatory inspections?

• Complaint records are irrelevant to regulators
• Well-documented complaint handling and trending demonstrate a functioning quality system and are routinely reviewed during inspections
• Regulators only care about sales numbers
• Companies should hide complaint records during inspection

Correct Answer: Well-documented complaint handling and trending demonstrate a functioning quality system and are routinely reviewed during inspections

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