Deviation management MCQs With Answer

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

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