Strategic planning and implementation MCQs With Answer

Strategic planning and implementation MCQs With Answer

This quiz set is designed for M.Pharm students studying Quality Management Systems (MQA 102T) to deepen understanding of strategic planning and its practical implementation in pharmaceutical quality systems. Questions focus on frameworks (SWOT, PESTLE, Balanced Scorecard, Hoshin Kanri), regulatory alignment (GxP, ISO, ICH), risk-based prioritization (FMEA, risk registers), performance metrics (KPIs, leading vs lagging), and change management tactics critical for effective rollout. Each item tests applied knowledge needed to align quality objectives with organizational strategy, ensure compliance, and drive continuous improvement. Use these MCQs to self-assess, stimulate classroom discussion, and prepare for advanced quality-management tasks in pharmaceutical settings.

Q1. What is the primary purpose of strategic planning within a pharmaceutical quality management system?

• To document routine laboratory procedures
• To set long-term quality objectives and allocate resources to meet regulatory and business goals
• To replace operational SOPs with high-level policies
• To schedule daily production activities

Correct Answer: To set long-term quality objectives and allocate resources to meet regulatory and business goals

Q2. Hoshin Kanri (policy deployment) is especially useful in QMS because it:

• Focuses exclusively on corrective actions after audit findings
• Aligns strategic objectives from top management down to operational teams and tracks implementation
• Eliminates the need for key performance indicators
• Requires weekly redefinition of company mission

Correct Answer: Aligns strategic objectives from top management down to operational teams and tracks implementation

Q3. Which set of perspectives is central to the Balanced Scorecard as applied to pharmaceutical quality strategy?

• Financial, Customer, Internal Process, Learning and Growth
• Regulatory, Manufacturing, Distribution, Sales
• Strategy, Tactics, Operations, Compliance
• Leadership, Culture, Systems, Tools

Correct Answer: Financial, Customer, Internal Process, Learning and Growth

Q4. When conducting an external environmental scan for strategic planning, which tool most comprehensively captures political, economic, social, technological, legal, and environmental factors?

• SWOT analysis
• Pareto analysis
• PESTLE analysis
• Fishbone diagram

Correct Answer: PESTLE analysis

Q5. A robust quality KPI should be SMART. What does the “A” most commonly represent in KPI design for QMS?

• Available
• Actionable
• Achievable
• Analytical

Correct Answer: Achievable

Q6. In FMEA used for strategic prioritization of quality risks, the Risk Priority Number (RPN) is calculated as:

• Severity × Frequency × Detectability
• Probability + Impact + Cost
• Likelihood × Magnitude
• Severity × Cost × Resource

Correct Answer: Severity × Frequency × Detectability

Q7. Which activity is a core component of CAPA that links strategic planning to operational improvement?

• Root cause analysis followed by implemented corrective and preventive actions
• Annual mission statement rewrite
• Inventory count without follow-up
• Ad hoc staff reassignment without validation

Correct Answer: Root cause analysis followed by implemented corrective and preventive actions

Q8. When developing a regulatory strategy as part of strategic planning, the most important initial step is to:

• Ignore international guidelines and focus on local practice
• Map applicable regulatory and guidance requirements to product lifecycle stages
• Reduce documentation to save time
• Outsource all compliance decisions to vendors

Correct Answer: Map applicable regulatory and guidance requirements to product lifecycle stages

Q9. Which of the following is the most common human-factor barrier to implementing a new quality strategy in a pharmaceutical organization?

• Excessive financial investment
• Resistance to change due to entrenched culture and lack of leadership engagement
• Availability of cutting-edge technology
• Clear communication from top management

Correct Answer: Resistance to change due to entrenched culture and lack of leadership engagement

Q10. For prioritizing strategic quality initiatives, which approach most effectively balances risk and expected benefit?

• First-come, first-served project initiation
• Prioritization based on regulatory risk, patient safety impact, and business value
• Choosing projects with the shortest duration only
• Random selection to ensure fairness

Correct Answer: Prioritization based on regulatory risk, patient safety impact, and business value

Q11. Which monitoring mechanism provides the most formal evidence of strategic implementation compliance within a QMS?

• Internal audits scheduled against strategic objective milestones
• Informal hallway discussions
• Single annual employee satisfaction survey
• Unstructured email updates

Correct Answer: Internal audits scheduled against strategic objective milestones

Q12. How should departmental quality objectives be derived to ensure alignment with corporate strategic goals?

• Each department sets unrelated objectives autonomously
• Objectives are cascaded from corporate strategy and tailored to departmental processes and KPIs
• All departments copy a single template without customization
• Objectives focus only on cost reduction

Correct Answer: Objectives are cascaded from corporate strategy and tailored to departmental processes and KPIs

Q13. According to ISO 9001 and pharmaceutical best practices, what is the role of top management in strategic quality planning?

• Provide occasional comments but delegate all planning
• Demonstrate leadership and commitment, define quality policy, and ensure resources for objectives
• Only sign documents after operational teams finish planning
• Serve as passive observers to avoid bias

Correct Answer: Demonstrate leadership and commitment, define quality policy, and ensure resources for objectives

Q14. Which tool is most appropriate for systematically identifying internal strengths and weaknesses in strategic planning?

• PESTLE analysis
• SWOT analysis
• Monte Carlo simulation
• Control chart

Correct Answer: SWOT analysis

Q15. Leading performance indicators in a pharmaceutical QMS typically measure:

• Outcomes after failures have occurred
• Predictive processes or activities that indicate future performance, such as training completion or deviation detection rates
• Only financial returns
• Historical audit scores without context

Correct Answer: Predictive processes or activities that indicate future performance, such as training completion or deviation detection rates

Q16. A SIPOC diagram used during strategic implementation primarily helps to:

• Detail molecular structures for formulation scientists
• Identify Suppliers, Inputs, Process, Outputs, and Customers to clarify high-level process scope
• Replace risk assessment tools
• Define corporate financial forecasts

Correct Answer: Identify Suppliers, Inputs, Process, Outputs, and Customers to clarify high-level process scope

Q17. In Hoshin Kanri, what is “catchball” intended to achieve during implementation?

• Top-down unilateral decision-making without feedback
• Interactive dialogue between organizational levels to refine objectives and gain commitment
• Random allocation of tasks
• Annual budget approval only

Correct Answer: Interactive dialogue between organizational levels to refine objectives and gain commitment

Q18. Cascading KPIs from corporate to shop floor is important because it:

• Makes frontline employees responsible for strategic budgeting
• Ensures local activities directly contribute to strategic outcomes and enables measurable accountability
• Removes the need for training
• Focuses only on corporate image

Correct Answer: Ensures local activities directly contribute to strategic outcomes and enables measurable accountability

Q19. Which project management tool is most useful for planning milestones and tracking timelines during strategic implementation?

• Gantt chart
• Check digit algorithm
• Thermodynamic diagram
• Manpower roster only

Correct Answer: Gantt chart

Q20. How does integrating continuous improvement (PDCA) into strategic planning strengthen a pharmaceutical QMS?

• By limiting innovation to scheduled audits only
• By creating a cycle of planning, execution, evaluation, and standardization that embeds improvement into strategy and operations
• By eliminating the need for management review
• By focusing exclusively on cost-cutting initiatives

Correct Answer: By creating a cycle of planning, execution, evaluation, and standardization that embeds improvement into strategy and operations

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