Deviation Management MCQs With Answer is a focused practice resource designed for M.Pharm students preparing for Quality Management Systems (MQA 102T). This set of multiple-choice questions covers conceptual and applied aspects of deviation management: types of deviations, investigation methodology, containment and corrective actions, risk assessment, documentation, regulatory expectations, and trending. Questions emphasize root cause analysis, CAPA, product disposition, and data integrity considerations in a pharmaceutical quality environment. Each MCQ challenges students to apply regulatory guidance and quality principles to realistic scenarios, strengthening exam readiness and practical understanding for roles in QA/QC and manufacturing supervision.
Q1. What is the primary purpose of documenting a deviation in pharmaceutical manufacturing?
- To assign blame to the operator responsible
- To record the event for training records only
- To ensure traceability, initiate investigation and enable corrective actions
- To delay batch release until management decides
Correct Answer: To ensure traceability, initiate investigation and enable corrective actions
Q2. Which of the following best defines a ‘major deviation’?
- An event that has no potential to impact product quality
- A deviation that could lead to regulatory non-compliance or patient risk
- A routine non-critical procedural lapse documented in training records
- A typographical error in an internal memo
Correct Answer: A deviation that could lead to regulatory non-compliance or patient risk
Q3. During a deviation investigation, which technique focuses on repeatedly asking “why” to reach root cause?
- Hazard Analysis and Critical Control Points (HACCP)
- 5 Whys analysis
- Pareto charting
- Design of Experiments (DoE)
Correct Answer: 5 Whys analysis
Q4. What is the correct immediate action when a deviation potentially affects a released product?
- Wait for the full root cause analysis before any action
- Initiate containment measures and quarantine affected batches
- Destroy all inventory without evaluation
- Notify marketing to adjust promotional claims
Correct Answer: Initiate containment measures and quarantine affected batches
Q5. Which document typically records the detailed stepwise investigation of a deviation?
- Master Production Schedule
- Deviation/Investigation Report
- Supplier invoice
- Sales order
Correct Answer: Deviation/Investigation Report
Q6. In deviation management, CAPA stands for:
- Containment, Assessment, Process Adjustment
- Corrective and Preventive Actions
- Control and Preventive Audit
- Compliance and Product Approval
Correct Answer: Corrective and Preventive Actions
Q7. Which regulatory body emphasizes prompt investigation and documentation of deviations impacting product quality?
- Federal Aviation Administration (FAA)
- Food and Drug Administration (FDA)
- Federal Trade Commission (FTC)
- National Highway Traffic Safety Administration (NHTSA)
Correct Answer: Food and Drug Administration (FDA)
Q8. What is an Out-of-Specification (OOS) result?
- A test result within internal target ranges
- A test result that falls outside established specifications
- A result that is not recorded
- A visual inspection finding only
Correct Answer: A test result that falls outside established specifications
Q9. Which risk assessment tool is frequently used to prioritize deviations based on severity, occurrence and detectability?
- Fishbone diagram
- FMEA (Failure Mode and Effects Analysis)
- Balanced scorecard
- SWOT analysis
Correct Answer: FMEA (Failure Mode and Effects Analysis)
Q10. What distinguishes a preventive action from a corrective action?
- Preventive actions fix the immediate batch; corrective actions are long-term
- Preventive actions aim to eliminate the cause before recurrence; corrective actions address existing non-conformities
- Corrective actions only involve documentation changes
- There is no difference; they are interchangeable
Correct Answer: Preventive actions aim to eliminate the cause before recurrence; corrective actions address existing non-conformities
Q11. Which is an appropriate metric to trend deviations over time?
- Number of deviations per million units produced
- Number of sales calls per month
- Employee turnover rate in HR
- Number of cafeteria meals served
Correct Answer: Number of deviations per million units produced
Q12. For data integrity related deviations, which principle is critical?
- Data should be manually transcribed to paper only
- ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available)
- Allow anonymous edits without audit trail
- Eliminate electronic logs to simplify reviews
Correct Answer: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available)
Q13. What is the appropriate disposition decision when a deviation investigation identifies a confirmed critical contamination?
- Release the product with a note in the file
- Quarantine and likely reject or recall the affected product after risk assessment
- Mix contaminated product with a larger batch to dilute
- Label product as investigational only
Correct Answer: Quarantine and likely reject or recall the affected product after risk assessment
Q14. Which root cause analysis tool visually maps possible causes into categories?
- Control chart
- Ishikawa (Fishbone) diagram
- Gantt chart
- Regression analysis
Correct Answer: Ishikawa (Fishbone) diagram
Q15. When should a deviation be escalated to a cross-functional quality review board?
- Only if marketing requests it
- When deviation has potential product quality or regulatory impact or is recurrent
- For minor documentation typos
- After the next annual audit
Correct Answer: When deviation has potential product quality or regulatory impact or is recurrent
Q16. Which of the following is NOT an effective containment action?
- Immediate quarantine of affected materials
- Enhanced monitoring of subsequent batches
- Destruction of unrelated compliant batches without assessment
- Temporary hold on distribution pending investigation
Correct Answer: Destruction of unrelated compliant batches without assessment
Q17. How long should deviation investigation records typically be retained?
- As per company policy and regulatory requirements, often as long as product retention plus defined years (e.g., shelf life + X years)
- One month after closure
- Only until the next audit
- They should not be retained
Correct Answer: As per company policy and regulatory requirements, often as long as product retention plus defined years (e.g., shelf life + X years)
Q18. Which statement about trend analysis of deviations is true?
- Trends are only useful for regulatory inspections, not quality improvement
- Trend analysis helps identify systemic issues and prioritize preventive actions
- Trends should be ignored if the deviation numbers are low
- Only absolute counts matter; rates normalized to production do not
Correct Answer: Trend analysis helps identify systemic issues and prioritize preventive actions
Q19. In a deviation report, what is the importance of defining containment effectiveness checks?
- They are optional and only for large companies
- To verify that immediate actions have controlled the problem and prevent further impact
- To delay CAPA implementation
- To document financial losses
Correct Answer: To verify that immediate actions have controlled the problem and prevent further impact
Q20. Which action demonstrates effective preventive action following a recurrent deviation caused by equipment calibration drift?
- Ignore the recurrence because it is minor
- Increase inspection frequency temporarily without addressing root cause
- Revise calibration intervals, improve alarm systems, and update SOPs with verification steps
- Replace SOP with a verbal instruction
Correct Answer: Revise calibration intervals, improve alarm systems, and update SOPs with verification steps
