Quality as a strategic decision MCQs With Answer

Quality as a strategic decision MCQs With Answer

This blog presents a focused set of MCQs on “Quality as a strategic decision” tailored for M.Pharm students studying Quality Management Systems (MQA 102T). The questions explore how quality considerations shape corporate strategy, regulatory compliance, product development, and operational excellence in pharmaceutical industries. Emphasis is placed on concepts such as Total Quality Management, Quality by Design, risk-based decision making, cost of quality, process capability, and strategic quality metrics. Each question is designed to deepen understanding, encourage critical thinking and prepare students for examinations and professional practice. Answers are provided to facilitate self-assessment and revision of strategic quality principles relevant to pharmaceutical quality systems.

Q1. Which statement best describes quality as a strategic decision in a pharmaceutical company?

• Quality activities only ensure regulatory inspections are passed
• Quality is an operational task separate from business goals
• Quality is integrated into corporate strategy to drive product value, compliance and competitive advantage
• Quality decisions are made only by production staff

Correct Answer: Quality is integrated into corporate strategy to drive product value, compliance and competitive advantage

Q2. Which framework most directly supports managing product quality through design and understanding of critical attributes?

• Good Distribution Practice (GDP)
• Quality by Design (QbD)
• Total Product Life Cycle (TPLC)
• Hazard Analysis and Critical Control Points (HACCP)

Correct Answer: Quality by Design (QbD)

Q3. In strategic quality decision-making, which metric best helps link manufacturing performance to customer satisfaction?

• Number of internal audits performed
• Process capability index (Cpk) for critical quality attributes
• Volume of raw material purchased
• Number of training hours logged

Correct Answer: Process capability index (Cpk) for critical quality attributes

Q4. Which element is essential when elevating quality to a strategic level within an organization?

• Centralizing all decisions with the production manager
• Strong leadership commitment and alignment of quality objectives with business goals
• Reducing documentation to speed up processes
• Focusing only on cost reduction

Correct Answer: Strong leadership commitment and alignment of quality objectives with business goals

Q5. How does implementing risk-based decision making contribute to strategic quality management?

• By eliminating the need for validation studies
• By prioritizing resources to areas with highest impact on patient safety and product quality
• By replacing corrective actions with punishment policies
• By avoiding any changes to existing processes

Correct Answer: By prioritizing resources to areas with highest impact on patient safety and product quality

Q6. Which cost category reflects investments that prevent defects and improve long-term strategic quality?

• External failure costs
• Appraisal costs
• Prevention costs
• Opportunity costs

Correct Answer: Prevention costs

Q7. Which strategic quality tool helps in defining customer needs and translating them into critical quality attributes (CQAs)?

• Control chart analysis
• Voice of the Customer (VOC) and Quality Target Product Profile (QTPP)
• Balance scorecard
• Pareto chart

Correct Answer: Voice of the Customer (VOC) and Quality Target Product Profile (QTPP)

Q8. What role does a pharmaceutical quality system (PQS) play in strategic decisions?

• PQS only documents past deviations
• PQS provides a risk-based framework for decision-making, continuous improvement and regulatory compliance
• PQS replaces the need for regulatory inspections
• PQS focuses solely on laboratory testing

Correct Answer: PQS provides a risk-based framework for decision-making, continuous improvement and regulatory compliance

Q9. Which approach aligns continuous improvement initiatives with corporate strategy in quality management?

• Project-by-project improvements without strategic linkage
• Using key performance indicators (KPIs) tied to strategic quality objectives
• Conducting annual party events for staff
• Focusing only on short-term cost savings

Correct Answer: Using key performance indicators (KPIs) tied to strategic quality objectives

Q10. Which regulatory expectation reinforces quality as a strategic decision through lifecycle management?

• Issuance of import licenses
• Regulatory emphasis on post-approval change management and product lifecycle verification
• Only periodic GMP inspection schedules
• Allowing unqualified suppliers indefinitely

Correct Answer: Regulatory emphasis on post-approval change management and product lifecycle verification

Q11. How can supplier quality be managed strategically to support product quality?

• By using a single supplier regardless of performance
• By applying supplier qualification, performance monitoring and risk assessment
• By ignoring supplier audits to reduce costs
• By accepting supplier certificates without verification

Correct Answer: By applying supplier qualification, performance monitoring and risk assessment

Q12. Which concept best describes using quality as a source of competitive advantage in the pharmaceutical sector?

• Competing only on price
• Differentiation through consistent product quality, robust processes and regulatory reliability
• Reducing quality controls to speed market entry
• Limiting R&D to legacy products

Correct Answer: Differentiation through consistent product quality, robust processes and regulatory reliability

Q13. Which strategic quality initiative most effectively reduces variability in critical processes?

• Random employee transfers
• Implementation of process analytical technology (PAT) and statistical process control (SPC)
• Increasing batch sizes without process changes
• Reducing raw material testing

Correct Answer: Implementation of process analytical technology (PAT) and statistical process control (SPC)

Q14. Which element is a strategic indicator of a mature quality culture within a pharmaceutical organization?

• Employees conceal deviations to avoid repercussions
• High engagement in continuous improvement and transparent reporting of quality issues
• Quality decisions made only at senior management retreats
• Frequent ad-hoc process changes without investigation

Correct Answer: High engagement in continuous improvement and transparent reporting of quality issues

Q15. How does integrating Quality by Design (QbD) into early development influence strategic regulatory interactions?

• It makes regulatory submissions unnecessary
• It enables science- and risk-based regulatory discussions and potentially more flexible post-approval changes
• It increases regulatory scrutiny without benefits
• It delays product development indefinitely

Correct Answer: It enables science- and risk-based regulatory discussions and potentially more flexible post-approval changes

Q16. Which quality metric is most useful for assessing the financial impact of quality within a strategic framework?

• Number of CAPAs opened
• Cost of poor quality (COPQ) including internal and external failure costs
• Length of GMP manual
• Number of procurement orders

Correct Answer: Cost of poor quality (COPQ) including internal and external failure costs

Q17. Which strategic action improves alignment between R&D and quality functions to ensure product robustness?

• R&D works independently until commercialization
• Cross-functional teams with early involvement of quality and regulatory specialists
• Postponing quality involvement to validation stage only
• Outsourcing quality decisions entirely

Correct Answer: Cross-functional teams with early involvement of quality and regulatory specialists

Q18. Which practice demonstrates a strategic approach to regulatory inspections and compliance?

• Waiting for inspection notices to start preparations
• Proactive compliance monitoring, mock inspections and continuous improvement from inspection learnings
• Only responding to FDA or regulatory findings when forced
• Reducing staff training to save time

Correct Answer: Proactive compliance monitoring, mock inspections and continuous improvement from inspection learnings

Q19. How should CAPA (Corrective and Preventive Action) be treated when quality is a strategic decision?

• As a purely administrative requirement
• As an integral part of strategic improvement, addressing root causes and preventing recurrence across the organization
• By closing CAPAs quickly without investigation
• Only documenting CAPAs for major product failures

Correct Answer: As an integral part of strategic improvement, addressing root causes and preventing recurrence across the organization

Q20. Which maturity model outcome indicates an organization has truly embedded quality into its strategy?

• Quality activities remain siloed within QC laboratories
• Reactive firefighting with no preventive planning
• Quality objectives are measurable, aligned to business goals, and drive investment and innovation
• Quality metrics are absent from executive dashboards

Correct Answer: Quality objectives are measurable, aligned to business goals, and drive investment and innovation

Download