Define quality according to two different scholars (Crosby, Deming, etc.)
Crosby: Conformance to requirements; Deming: Quality is aimed at the needs of the customer, present and future.
TQM is mainly about inspection of final products. Sustainability in QM includes only environmental aspects. Continuous improvement is part of TQM.
(1) False, (2) False, (3) True
Name two ways QM can contribute to the UN SDGs.
Efficiency & waste reduction (SDG 12); innovation (SDG 9).
Discuss evolution of QM paradigms (inspection → control → assurance → TQM).
Shows increased stakeholder & sustainability focus.
Design a Green Quality Project for a food manufacturer using PDCA, QFD, or FMEA.
Use PDCA for continuous improvement, Green QFD for sustainability, FMEA + LCA for environmental risk.
Define internal and external customer.
Internal = colleagues inside organization; External = paying customers.
What does the Kano model describe?
Categories of needs: must-be, performance, excitement, indifferent, reversed.
Which service quality gap occurs if management misunderstands customer expectations?
Gap 1 (Knowledge gap).
One advantage of Mystery Shopping for feedback?
Captures real delivery, unnoticed by surveys.
Explain value-in-use vs exchange vs context.
Value-in-exchange = price; use = benefit during consumption; context = social/setting.
Define a process including three elements.
Interrelated activities transforming inputs into outputs of value.
What is a process owner?
Responsible for performance, authority to improve processes.
Palmberg’s two process management movements?
Single process improvement (tools) vs System management (holistic, integrated).
Difference between common and special cause variation?
Common cause = natural variation; Special cause = assignable variation.
Which QC tools for root cause, distribution, correlation?
Ishikawa = root cause; Histogram = distribution; Scatter plot = correlation.
Which control chart for individual daily measurements?
I-MR chart.
Define situational leadership.
Adapt style to follower maturity level.
Which two styles in full-range leadership model?
Transactional & transformational.
Why is culture key for change?
Shapes behavior, values, resistance.
Why TQM programs fail (Beer, 2003)?
Top-down talk, lack of commitment, silent killers (unclear strategy, poor communication).
Which ISO defines QMS certification?
ISO 9001.
Two top-management responsibilities in ISO 9001:2015?
Establish policy, ensure resources & customer focus.
Which clause not in ISO 9001:2015?
Marketing.
Why ISO 9004 not for certification?
Intended for self-assessment, not certification.
Explain the concept of quality dimensions and describe the difference between product quality and service quality.
Product quality = tangible performance features; Service quality = intangibles like responsiveness, reliability.
Discuss how Total Quality Management (TQM) contributes to the principle of customer focus through its cornerstones.
Customer focus supported by leadership, continuous improvement, employee involvement, and process approach.
Analyze how Biotage can use the PDCA model to manage potential quality issues.
Plan = identify problem; Do = test actions; Check = review data; Act = implement improvements systematically.
Describe the Kano model and its four main categories.
Must-be, performance, excitement, indifferent, with example for each category.
Discuss the concepts of use value and exchange value.
Use value = benefit derived from usage; Exchange value = price in transaction; Both shape customer satisfaction.
Analyze how QFD can be used to improve products.
Translate customer requirements into engineering characteristics using House of Quality.
Describe what a process map is and how it is used.
Visual diagram showing inputs, activities, outputs, and responsibilities; used for analysis and improvement.
Describe the three steps in introducing process management.
1: Define and map processes; 2: Measure and analyze; 3: Control and improve.
Analyze how Biotage can use the Process Management 1-2-3 model to increase efficiency.
Step 1: Standardize; Step 2: Control; Step 3: Continuous improvement.
Describe two advantages of SPC and when to adjust control limits.
Improves process predictability and saves resources; adjust control limits when process mean or variation shifts permanently.
Explain Kurt Lewin’s three-step model for change.
Unfreeze = prepare organization; Change = implement; Refreeze = institutionalize new behaviors.
Discuss the difference between transformational and transactional leadership.
Transformational = inspire and motivate; Transactional = reward compliance.
Analyze how Biotage can handle resistance using ADKAR model.
Awareness, Desire, Knowledge, Ability, Reinforcement with targeted communication and support actions.
Explain the overall purpose of implementing a QMS.
Ensure consistent quality, enhance efficiency, customer satisfaction, and sustainable success.
List ISO 9001 principles relevant to Biotage.
Customer focus, process approach, continual improvement, leadership, evidence-based decision making.
Describe methods to assess management system effectiveness.
Internal audit, management review, benchmarking, EFQM self-assessment.
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