Complaints evaluation and handling MCQs With Answer

Complaints Evaluation and Handling MCQs With Answer — Introduction

This blog presents a focused set of multiple-choice questions on Complaints Evaluation and Handling tailored for M.Pharm students studying Quality Management Systems (MQA 102T). The MCQs probe practical elements of complaint intake, triage, investigation, root-cause analysis, CAPA, sample retention, recall decision-making, trend analysis and regulatory expectations. Each question is designed to test conceptual understanding and application of GMP-based quality procedures used in pharmaceutical operations. Attempt these MCQs under timed conditions to simulate exam settings and identify knowledge gaps; detailed practice will strengthen your ability to ensure product quality, patient safety and regulatory compliance in real-world roles.

Q1. What is the most appropriate definition of a product complaint in pharmaceutical quality management?

• Any marketing feedback that can improve product promotion
• Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, purity or potency of a drug product
• A routine customer satisfaction survey response
• An internal audit finding about documentation

Correct Answer: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, purity or potency of a drug product

Q2. How does a product complaint differ from an adverse drug reaction (ADR)?

• A complaint always indicates a manufacturing deviation while an ADR is always recreational
• An ADR relates to an untoward medical occurrence in a patient; a complaint primarily alleges a product quality or manufacturing issue
• There is no difference; both terms are interchangeable
• Complaints are only about packaging and ADRs only about storage

Correct Answer: An ADR relates to an untoward medical occurrence in a patient; a complaint primarily alleges a product quality or manufacturing issue

Q3. What is the appropriate immediate action upon receipt of a product complaint indicating potential health risk?

• Ignore until periodic review meeting
• Record the complaint in the complaint log, triage for health risk and quarantine associated batch or returned material
• Destroy the returned product immediately
• Issue a press release before investigation

Correct Answer: Record the complaint in the complaint log, triage for health risk and quarantine associated batch or returned material

Q4. What is the recommended practice for retention of complaint samples?

• Never retain samples; return them to the customer
• Retain a representative sample from the implicated batch, in appropriate storage, until the investigation is complete
• Retain only packaging components, not the product
• Retain samples only after regulatory request

Correct Answer: Retain a representative sample from the implicated batch, in appropriate storage, until the investigation is complete

Q5. Which root-cause analysis tool is commonly used to systematically identify potential sources of a complaint?

• Monte Carlo simulation
• Ishikawa (fishbone) analysis
• Random sampling without hypothesis
• Only subjective opinion without documentation

Correct Answer: Ishikawa (fishbone) analysis

Q6. Which sequence best represents the CAPA process in complaint handling?

• Preventive action → Investigation → Corrective action → Effectiveness check
• Investigation → Corrective action → Preventive action → Effectiveness check
• Corrective action → Investigation → Preventive action → Review
• Effectiveness check → Corrective action → Investigation → Closure

Correct Answer: Investigation → Corrective action → Preventive action → Effectiveness check

Q7. If investigation identifies a supplier-related cause for a complaint, the most appropriate next step is:

• Ignore supplier responsibility and fix in-house only
• Initiate supplier notification, request supplier root cause and CAPA, and evaluate supplier performance and incoming controls
• Terminate the supplier immediately without investigation
• Proceed with product recall before contacting supplier

Correct Answer: Initiate supplier notification, request supplier root cause and CAPA, and evaluate supplier performance and incoming controls

Q8. For proactive quality oversight, what is an appropriate frequency to perform complaint trend analysis?

• Quarterly, with additional immediate review for safety-significant trends
• Only once per product lifecycle
• Every ten years
• Trend analysis is unnecessary for pharmaceutical products

Correct Answer: Quarterly, with additional immediate review for safety-significant trends

Q9. Which of the following classification schemes is commonly used to assess complaint severity in GMP systems?

• Critical, Major and Minor based on patient risk and regulatory impact
• High, Medium, Low based solely on customer emotion
• Immediate, Delayed, Never based on sales impact
• Type A, Type B, Type C where types are marketing categories

Correct Answer: Critical, Major and Minor based on patient risk and regulatory impact

Q10. Under which circumstance is a product recall most likely to be initiated?

• There is a minor typographical error on a non-critical marketing brochure
• Complaints and investigation indicate a product defect that could cause serious adverse health consequences
• A single customer dislikes the product color
• There is a delay in a shipping schedule

Correct Answer: Complaints and investigation indicate a product defect that could cause serious adverse health consequences

Q11. Which documents should be included in a formal complaint investigation file?

• Complaint record, batch history and QC test data, root cause analysis, CAPA plan and verification records, communication with complainant and disposal/release decision
• Only the initial customer email
• Only marketing materials and invoices
• Internal personnel performance appraisals

Correct Answer: Complaint record, batch history and QC test data, root cause analysis, CAPA plan and verification records, communication with complainant and disposal/release decision

Q12. When laboratory testing is performed as part of a complaint investigation, the lab should:

• Test only for the original release specification and ignore complaint specifics
• Perform tests relevant to the complaint and compare results to original release and stability specifications, documenting methods and deviations
• Use any quick field test without documentation
• Return results verbally without written record

Correct Answer: Perform tests relevant to the complaint and compare results to original release and stability specifications, documenting methods and deviations

Q13. If a complaint alleges product degradation, what is an appropriate technical response?

• Recommend immediate disposal of all products without testing
• Initiate stability testing (accelerated and real-time as appropriate), review storage and distribution conditions, and compare to stability data
• Assume customer mishandling without investigation
• Blame packaging vendors without data

Correct Answer: Initiate stability testing (accelerated and real-time as appropriate), review storage and distribution conditions, and compare to stability data

Q14. What are appropriate criteria to authorize complaint closure?

• Root cause identified, CAPA implemented and effectiveness verified, documentation completed and communicant informed where necessary
• Investigation started but never completed
• CAPA planned but implementation deferred indefinitely
• Complaint closed based solely on time elapsed

Correct Answer: Root cause identified, CAPA implemented and effectiveness verified, documentation completed and communicant informed where necessary

Q15. When a complaint investigation reveals a death or serious injury potentially linked to the product, the quality unit must:

• Conceal findings to avoid reporting
• Immediately escalate to pharmacovigilance/medical safety and regulatory affairs for timely regulatory reporting and risk mitigation
• Only inform sales to manage customer relations
• Wait for monthly management review to decide

Correct Answer: Immediately escalate to pharmacovigilance/medical safety and regulatory affairs for timely regulatory reporting and risk mitigation

Q16. How is an Out of Specification (OOS) laboratory result related to a customer complaint?

• OOS is a lab result that may support the complaint investigation if testing of complaint samples shows deviation from specifications
• OOS only refers to clinical trial outcomes
• OOS and complaints are unrelated and cannot be compared
• OOS always means the complaint was fraudulent

Correct Answer: OOS is a lab result that may support the complaint investigation if testing of complaint samples shows deviation from specifications

Q17. What is the primary role of Quality Control (QC) during complaint investigations?

• Provide independent testing, data interpretation, and technical support to confirm or refute product nonconformity
• Authorize product release without testing
• Only prepare marketing responses
• Approve CAPA without evidence

Correct Answer: Provide independent testing, data interpretation, and technical support to confirm or refute product nonconformity

Q18. How should returned or allegedly defective goods be handled pending completion of investigation?

• Quarantine and tag as retained evidence; do not reintroduce into inventory without disposition
• Immediately repackage and resell
• Discard without documentation
• Use for internal training exercises without notation

Correct Answer: Quarantine and tag as retained evidence; do not reintroduce into inventory without disposition

Q19. What constitutes an effective verification of CAPA implementation for complaints?

• Documented evidence that corrective and preventive actions were implemented and measured through metrics or follow-up testing demonstrating reduction or elimination of the issue
• Stating CAPA is effective without data
• Closing CAPA based on completion date only
• Archiving CAPA records without verification

Correct Answer: Documented evidence that corrective and preventive actions were implemented and measured through metrics or follow-up testing demonstrating reduction or elimination of the issue

Q20. Which metrics are most useful to monitor the performance of a complaint handling system?

• Number of complaints per million doses, percentage of repeat complaints, average time to closure, CAPA effectiveness rate and trend of safety-significant complaints
• Only the dollar value of returned goods
• Number of marketing calls per month
• Employee headcount in the sales department

Correct Answer: Number of complaints per million doses, percentage of repeat complaints, average time to closure, CAPA effectiveness rate and trend of safety-significant complaints

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