Quality management and TQM MCQs With Answer

Quality management and TQM MCQs With Answer

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Quality Management and TQM MCQs With Answers for M. Pharm (Modern Pharmaceutics – MPH 103T)

Preparing for Quality Management and Total Quality Management (TQM) in Modern Pharmaceutics demands strong conceptual clarity and practical understanding. This carefully curated MCQ set helps M. Pharm students master key frameworks such as ICH Q8/Q9/Q10, cGMP, QbD, risk management, process validation, control strategies, data integrity (ALCOA+), CAPA, audits, and statistical process control. The questions go beyond definitions to test application, interpretation of tools, and decision-making aligned with regulatory expectations. Each item includes the correct answer to support rapid learning, self-evaluation, and revision. Use this quiz to reinforce lifecycle thinking, continuous improvement, and compliance-focused practices that underpin robust Pharmaceutical Quality Systems and TQM culture in development, technology transfer, and commercial manufacturing.

Q1. What is the primary purpose of ICH Q10 in a pharmaceutical organization?

  • To establish an integrated Pharmaceutical Quality System that manages product and process quality across the lifecycle (development, technology transfer, commercial manufacturing, discontinuation)
  • To replace GMP requirements with ISO 9001 clauses
  • To increase production speed regardless of risk to quality
  • To reduce the involvement of the Quality Unit in operations

Correct Answer: To establish an integrated Pharmaceutical Quality System that manages product and process quality across the lifecycle (development, technology transfer, commercial manufacturing, discontinuation)

Q2. In the PDCA cycle central to TQM, which step comes first?

  • Plan
  • Do
  • Check
  • Act

Correct Answer: Plan

Q3. In Quality by Design (QbD), which statement best defines the “design space”?

  • A set of acceptance criteria for raw materials
  • The documented list of critical quality attributes (CQAs)
  • The validated equipment capacity range
  • A multidimensional combination of input variables and process parameters that have been demonstrated to assure quality

Correct Answer: A multidimensional combination of input variables and process parameters that have been demonstrated to assure quality

Q4. Which statement best differentiates Corrective Action from Preventive Action in a CAPA system?

  • Corrective Action addresses potential nonconformities; Preventive Action addresses actual nonconformities
  • Corrective Action is optional; Preventive Action is mandatory
  • Corrective Action addresses the root cause of a detected nonconformity to prevent recurrence; Preventive Action addresses potential causes to prevent occurrence
  • Corrective Action is performed by Manufacturing; Preventive Action is performed by Quality

Correct Answer: Corrective Action addresses the root cause of a detected nonconformity to prevent recurrence; Preventive Action addresses potential causes to prevent occurrence

Q5. The ALCOA+ principles for data integrity stand for which of the following?

  • Actionable, Logical, Complete, Original, Accessible plus Networked, Auditable, Traceable
  • Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available
  • Attractive, Legal, Controlled, Organized, Aligned plus Calibrated, Compliant, Efficient, Assured
  • Assigned, Listed, Confirmed, Owned, Audited plus Centralized, Controlled, Enabled, Archived

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available

Q6. Stage 3 of process validation as per lifecycle concepts focuses on:

  • Process Design based on development data
  • Process Qualification using PPQ batches only
  • Continued Process Verification: ongoing monitoring during routine production to ensure a state of control
  • Continued Product Verification limited to finished product testing only

Correct Answer: Continued Process Verification: ongoing monitoring during routine production to ensure a state of control

Q7. Which risk assessment tool is most commonly used under ICH Q9 for prioritizing failure modes in a process?

  • Failure Modes and Effects Analysis (FMEA)
  • Design of Experiments (DoE)
  • SIPOC mapping
  • Kanban boards

Correct Answer: Failure Modes and Effects Analysis (FMEA)

Q8. Which control chart is appropriate for monitoring “defects per unit” when sample sizes vary?

  • p-chart
  • np-chart
  • c-chart
  • u-chart

Correct Answer: u-chart

Q9. Which standard is commonly used to design attribute sampling plans with AQL for incoming material inspection?

  • ANSI/ASQ Z1.4 (equivalent to ISO 2859-1)
  • ISO 9004: Quality management — quality of an organization
  • ICH Q3D: Elemental impurities
  • USP <1058>: Analytical instrument qualification

Correct Answer: ANSI/ASQ Z1.4 (equivalent to ISO 2859-1)

Q10. What is the first action when a QC laboratory obtains an Out-of-Specification (OOS) test result?

  • Immediately retest new samples without any investigation
  • Quarantine and reject the batch
  • Initiate a prompt Phase I laboratory investigation to assess potential analytical error and data integrity
  • Open a CAPA and change the specification limits

Correct Answer: Initiate a prompt Phase I laboratory investigation to assess potential analytical error and data integrity

Q11. Which of the following is NOT one of the seven basic quality control tools?

  • Histogram
  • Control chart
  • Scatter diagram
  • Gantt chart

Correct Answer: Gantt chart

Q12. In a TQM culture, Kaizen primarily emphasizes:

  • Breakthrough innovation through large capital projects
  • Continuous, incremental improvements driven by employee involvement
  • Quality control performed only by the Quality Unit
  • Inspection-based detection rather than prevention

Correct Answer: Continuous, incremental improvements driven by employee involvement

Q13. What is the correct order of the Six Sigma DMAIC methodology?

  • Define, Measure, Analyze, Improve, Control
  • Define, Analyze, Measure, Control, Improve
  • Measure, Define, Improve, Analyze, Control
  • Diagnose, Measure, Act, Improve, Control

Correct Answer: Define, Measure, Analyze, Improve, Control

Q14. Which statement reflects best practice for pharmaceutical change control?

  • Changes can be implemented immediately if proposed by Manufacturing
  • Any planned change to GMP-critical systems, processes, equipment, or documents requires prior documented risk assessment and Quality approval before implementation
  • Only post-implementation notification to QA is required
  • Only regulatory changes require control; technical changes do not

Correct Answer: Any planned change to GMP-critical systems, processes, equipment, or documents requires prior documented risk assessment and Quality approval before implementation

Q15. Cleaning validation limits for shared equipment are best justified using:

  • A fixed 10 ppm limit for all actives
  • Visual cleanliness only
  • Maximum Allowable Carryover (MACO) calculated from PDE/therapeutic dose, batch size, and shared surface area, with appropriate safety factors
  • Vendor-recommended detergent levels

Correct Answer: Maximum Allowable Carryover (MACO) calculated from PDE/therapeutic dose, batch size, and shared surface area, with appropriate safety factors

Q16. A customer conducting an audit of its API supplier is performing which type of audit?

  • First-party audit
  • Second-party audit
  • Third-party audit
  • Regulatory inspection

Correct Answer: Second-party audit

Q17. Which option reflects proper SOP document control in a GMP environment?

  • Allow multiple uncontrolled copies on the shop floor
  • Maintain only one controlled current version accessible at point-of-use; promptly archive obsolete versions with version history and authorization
  • Revise SOPs without recording change history
  • Delete obsolete SOPs to reduce storage space

Correct Answer: Maintain only one controlled current version accessible at point-of-use; promptly archive obsolete versions with version history and authorization

Q18. In ICH Q8/Q10 terminology, a “control strategy” is best described as:

  • A set of batch records used during commercial production
  • Only in-process testing limits
  • A planned set of controls, derived from product and process understanding, that assures process performance and product quality
  • A list of supplier qualifications

Correct Answer: A planned set of controls, derived from product and process understanding, that assures process performance and product quality

Q19. A process has Cp = 1.50 and Cpk = 0.80. What does this most likely indicate?

  • The process is highly centered and capable
  • The measurement system is the only source of variation
  • The process has potential capability but is not centered within the specification limits, causing increased defects on one side
  • The process is in statistical control and needs no action

Correct Answer: The process has potential capability but is not centered within the specification limits, causing increased defects on one side

Q20. Which sequence best represents a risk-based supplier qualification and ongoing control workflow?

  • On-site audit → Approval → Risk assessment → Performance monitoring
  • Questionnaire → Approval → On-site audit → No further monitoring
  • Risk ranking/classification → Paper assessment (questionnaire/dossier) → On-site audit as needed → Approval/technical agreement → Ongoing performance monitoring
  • Direct approval based on COA → Annual re-approval without review

Correct Answer: Risk ranking/classification → Paper assessment (questionnaire/dossier) → On-site audit as needed → Approval/technical agreement → Ongoing performance monitoring

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