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1. Introduction to Total Quality Management

1.1 Quality Management Evolution and Philosophy

• Quality definition including (fitness for purpose, conformance to requirements, customer satisfaction, value for money, excellence)

• Quality evolution including (inspection focus, quality control, quality assurance, TQM, business excellence, modern frameworks)

• Total Quality Management (TQM) definition including (organization-wide approach, customer focus, continuous improvement, employee involvement, long-term commitment)

• TQM benefits including (customer satisfaction, competitive advantage, cost reduction, employee engagement, market share, reputation)

• Quality costs including (prevention, appraisal, internal failure, external failure, Philip Crosby "Quality is Free" concept, cost of poor quality COPQ)

1.2 Quality Pioneers and Their Contributions

• W. Edwards Deming including (14 Points for Management, System of Profound Knowledge, PDCA cycle, statistical thinking, variation reduction)

• Joseph Juran including (Quality Trilogy planning/control/improvement, Pareto Principle 80/20, fitness for use, quality by design)

• Philip Crosby including (Zero Defects, Quality is Free, do it right first time, Four Absolutes of Quality, prevention not inspection)

• Kaoru Ishikawa including (Fishbone diagram, quality circles, company-wide quality control, seven basic quality tools)

• Genichi Taguchi including (robust design, loss function, parameter design, quality engineering, design of experiments)

• Armand Feigenbaum including (Total Quality Control, quality leadership, cost of quality, integrated systems approach)

1.3 TQM Core Principles and Framework

• Customer focus including (internal and external customers, requirements understanding, satisfaction measurement, value delivery, loyalty)

• Continuous improvement (Kaizen) including (incremental progress, everyone every day, never-ending journey, PDCA, small steps)

• Employee involvement including (empowerment, ownership, suggestion systems, training, teamwork, recognition)

• Process approach including (inputs-process-outputs, process management, process improvement, value streams, systems thinking)

• Data-driven decision making including (facts over opinions, measurement, statistical methods, analysis, evidence-based)

• Leadership commitment including (vision, values, resources, role modeling, culture building, strategic alignment)

• Supplier partnerships including (collaborative relationships, mutual benefit, quality cascade, supplier development, integration)

• Prevention over inspection including (build quality in, upstream focus, defect prevention, design quality, proactive)

2. Customer Focus and Stakeholder Satisfaction

2.1 Understanding Customer Requirements

• Voice of the Customer (VOC) including (gathering requirements, surveys, interviews, focus groups, complaints, observation, social media)

• Customer types including (external end users, internal next process, distributors, regulators, society, segmentation)

• Kano Model including (basic must-be, performance satisfiers, excitement delighters, customer expectation analysis, prioritization)

• Quality Function Deployment (QFD) including (House of Quality, customer requirements to design specifications, matrix approach, prioritization)

• Requirements translation including (customer language to technical specifications, measurable characteristics, design targets, verification)

2.2 Customer Satisfaction Measurement

• Satisfaction metrics including (CSAT customer satisfaction score, Net Promoter Score NPS, Customer Effort Score CES, retention rate, complaint rate)

• Survey design including (questionnaire development, Likert scales, sampling, response rates, actionable questions, benchmarking)

• Net Promoter Score (NPS) including (promoters 9-10, passives 7-8, detractors 0-6, NPS = % promoters - % detractors, loyalty predictor)

• Complaint management including (easy reporting, investigation, root cause, resolution, feedback, prevention, opportunity for improvement)

• Service recovery paradox including (effective complaint resolution increases loyalty, customer delight, relationship strengthening)

2.3 Stakeholder Engagement

• Stakeholder identification including (customers, employees, shareholders, suppliers, community, regulators, interested parties per ISO 9001)

• Stakeholder needs and expectations including (analysis, prioritization, balancing competing interests, communication, engagement)

• Balanced scorecard including (financial, customer, internal process, learning and growth perspectives, strategic alignment, measurement)

• Triple bottom line including (people, planet, profit, sustainability, social responsibility, environmental stewardship, economic viability)

3. ISO 9001:2015 Quality Management System

3.1 ISO 9001:2015 Structure and Requirements

• ISO 9001 overview including (international standard, quality management system, certification, customer focus, process approach, improvement)

• High-Level Structure (HLS) including (Annex SL, 10 clauses, common framework for ISO standards, integration facilitation)

• Clause 4: Context of organization including (internal/external issues, interested parties, QMS scope, processes)

• Clause 5: Leadership including (top management commitment, quality policy, roles/responsibilities/authorities, customer focus)

• Clause 6: Planning including (risk and opportunities, quality objectives, planning to achieve objectives, change management)

• Clause 7: Support including (resources, competence, awareness, communication, documented information)

• Clause 8: Operation including (operational planning and control, product/service requirements, design, production, release)

• Clause 9: Performance evaluation including (monitoring/measurement/analysis, internal audit, management review)

• Clause 10: Improvement including (nonconformity and corrective action, continual improvement, preventive action integrated)

3.2 Risk-Based Thinking and PDCA

• Risk-based thinking including (ISO 9001:2015 fundamental, opportunities and threats, preventive action, uncertainty management, proportionate response)

• Risk identification including (context analysis, SWOT, process risks, product risks, compliance risks, strategic risks)

• Risk assessment including (likelihood, impact, risk matrix, prioritization, tolerability, treatment decisions)

• Risk treatment including (avoid, reduce, share/transfer, accept, controls, contingency, monitoring)

• PDCA cycle (Plan-Do-Check-Act) including (Deming cycle, continuous improvement, problem-solving, systematic approach, iterative)

• PDCA application including (Plan objectives and processes, Do implementation, Check monitoring and measurement, Act improvement)

3.3 Process Approach and Process Management

• Process approach per ISO 9001 including (network of interrelated processes, inputs-activities-outputs, process owners, SIPOC)

• SIPOC diagram including (Suppliers, Inputs, Process, Outputs, Customers, high-level process map, scope definition)

• Process documentation including (procedures, work instructions, flowcharts, process maps, level of detail appropriate, simplicity)

• Process performance including (key performance indicators, objectives, monitoring, measurement, analysis, improvement opportunities)

• Process interaction including (sequence, relationships, interfaces, handoffs, integration, system optimization)

4. Continuous Improvement Methodologies

4.1 PDCA and Kaizen Philosophy

• PDCA (Plan-Do-Check-Act) detail including (Plan problem analysis and solution design, Do pilot implementation, Check results evaluation, Act standardize or iterate)

• Kaizen philosophy including (continuous improvement, small incremental changes, employee-driven, daily practice, respect for people)

• Kaizen events including (focused improvement workshops, 3-5 days, cross-functional teams, rapid implementation, measurable results, kaizen blitz)

• Kaizen culture including (everyone participates, suggestion systems, management support, problem visibility, celebrate improvements)

4.2 Problem-Solving Methodologies

• 8D (Eight Disciplines) including (team approach, problem description, interim actions, root cause, corrective actions, verification, prevention, team recognition)

• DMAIC (Six Sigma) including (Define, Measure, Analyze, Improve, Control, data-driven, defect reduction, variation reduction)

• A3 problem solving including (Toyota one-page format, structured thinking, PDCA, visual, root cause, countermeasures, coaching)

• Six Sigma DMAIC detail including (Define project/CTQ, Measure baseline/capability, Analyze root causes, Improve solutions, Control sustain gains)

4.3 Root Cause Analysis Techniques

• 5 Whys including (ask why five times, drill to root cause, simple technique, avoid jumping to solutions, verify root cause)

• Fishbone diagram (Ishikawa) including (cause-and-effect, categories 6M Man/Machine/Method/Material/Measurement/Environment, brainstorming, structure)

• Fault Tree Analysis (FTA) including (top-down, logic gates, system failures, probability, complex systems, prevention)

• Failure Mode and Effects Analysis (FMEA) including (proactive, potential failures, severity/occurrence/detection, Risk Priority Number RPN, prioritization, prevention)

• Pareto analysis including (80/20 rule, vital few versus trivial many, prioritization, bar chart, cumulative line, focus efforts)

5. Statistical Process Control and Quality Tools

5.1 Seven Basic Quality Tools

• Check sheet including (data collection forms, tally marks, frequency, structured data gathering, stratification, simple)

• Histogram including (frequency distribution, bar chart, central tendency, spread, shape, normality, process capability assessment)

• Pareto chart including (80/20 rule, bar chart descending order, cumulative line, prioritize problems, focus resources)

• Cause-and-effect diagram (Fishbone) including (Ishikawa, 6M categories, root cause identification, team brainstorming)

• Scatter diagram including (correlation, relationship between variables, positive/negative/no correlation, regression analysis)

• Control chart including (time series, process monitoring, control limits, special versus common cause variation, stability)

• Flowchart including (process mapping, decision points, activities, flow, standardization, improvement identification, communication)

5.2 Statistical Process Control (SPC)

• SPC purpose including (process monitoring, stability assessment, variation reduction, control versus capability, prevention)

• Variation types including (common cause inherent/random, special cause assignable/non-random, response differences)

• Control charts including (X-bar and R, individuals, p-chart, c-chart, attribute versus variable data, selection)

• Control limits including (UCL/LCL upper/lower, mean ± 3 sigma, 99.73% probability, different from specification limits)

• Control chart interpretation including (out of control points, runs, trends, cycles, patterns, Western Electric rules, investigation)

• Process capability including (Cp, Cpk, process spread versus specification limits, centered process, Six Sigma level)

5.3 New Seven Quality Tools

• Affinity diagram including (grouping ideas, KJ method, brainstorming organization, patterns, themes, complex problems)

• Interrelationship digraph including (cause-effect relationships, driver identification, complex systems, arrows, key issues)

• Tree diagram including (hierarchical breakdown, systematic detail, objectives to means, project planning, comprehensive)

• Matrix diagram including (relationships between factors, L-shaped, T-shaped, priority matrix, resource allocation)

• Matrix data analysis including (principal component analysis, multivariate data, quantitative relationships, statistical)

• Process Decision Program Chart (PDPC) including (contingency planning, what can go wrong, countermeasures, risk mitigation)

• Arrow diagram including (activity network, CPM/PERT, project scheduling, critical path, dependencies, timeline)

6. Six Sigma Methodology

6.1 Six Sigma Fundamentals

• Six Sigma definition including (3.4 defects per million opportunities, variation reduction, data-driven, DMAIC/DFSS, statistical rigor)

• Sigma level including (process capability, defect rate, Z-score, benchmark, world-class 6σ, typical 3-4σ)

• Six Sigma roles including (Champion executive sponsor, Master Black Belt coach, Black Belt project leader, Green Belt team member, Yellow Belt support)

• CTQ (Critical to Quality) including (customer requirements, measurable characteristics, performance standards, voice of customer translation)

• Six Sigma benefits including (defect reduction, cost savings, customer satisfaction, process knowledge, data-driven culture)

6.2 DMAIC Methodology Detail

• Define phase including (project charter, problem statement, goal, scope, team, stakeholders, CTQ, project plan, business case)

• Measure phase including (data collection plan, operational definitions, baseline performance, measurement system analysis MSA, process capability)

• Analyze phase including (root cause analysis, hypothesis testing, statistical analysis, value-added versus non-value-added, waste identification)

• Improve phase including (solution generation, pilot testing, design of experiments DOE, implementation planning, risk assessment)

• Control phase including (control plan, SPC implementation, standardization, documentation, training, transition to process owner, sustain gains)

6.3 Six Sigma Statistical Tools

• Process capability analysis including (Cp, Cpk, Pp, Ppk, short-term versus long-term, Z-score, DPMO calculation)

• Hypothesis testing including (null and alternative hypotheses, p-value, significance level alpha, t-test, ANOVA, chi-square)

• Regression analysis including (linear, multiple, correlation, prediction, Y = f(X), driver identification, optimization)

• Design of Experiments (DOE) including (factorial design, main effects, interactions, optimization, Taguchi, efficient testing)

• Measurement System Analysis (MSA) including (gage R&R, repeatability, reproducibility, accuracy, precision, bias, linearity)

7. Lean-Six Sigma Integration

7.1 Lean Principles and Tools

• Lean philosophy including (value maximization, waste elimination, customer pull, continuous flow, perfection pursuit, respect for people)

• Eight wastes (DOWNTIME) including (Defects, Overproduction, Waiting, Non-utilized talent, Transportation, Inventory, Motion, Extra processing)

• 5S workplace organization including (Sort, Set in order, Shine, Standardize, Sustain, visual workplace, foundation)

• Value stream mapping including (current state, future state, lead time reduction, waste identification, flow improvement)

• Kanban pull systems including (visual signal, replenishment, inventory control, production leveling, just-in-time)

7.2 Lean Six Sigma Synergy

• Lean and Six Sigma complementary including (Lean speed/flow, Six Sigma quality/variation, combined power, operational excellence)

• Integration benefits including (waste elimination and defect reduction, faster and better, cultural alignment, comprehensive improvement)

• DMAIC with Lean tools including (VSM in Analyze, 5S in Improve, Kanban in Control, integrated approach, holistic solutions)

• Application examples including (manufacturing operations, healthcare processes, service industries, transactional processes, administrative functions)

7.3 Visual Management and Standardization

• Visual management including (information at a glance, self-explaining workplace, andon boards, KPI displays, problem visibility)

• Standard work including (best known method, sequence, takt time, work-in-process, baseline for improvement, training tool)

• Performance boards including (team ownership, metrics display, trends, targets, actions, daily review, transparency)

• Error proofing (Poka-Yoke) including (mistake prevention, detection devices, design for quality, foolproofing, defect elimination)

8. Quality Culture and Leadership

8.1 Leadership Role in Quality

• Leadership commitment including (vision communication, resource allocation, role modeling, accountability, removing barriers, strategic priority)

• Deming's 14 Points including (constancy of purpose, new philosophy, cease dependence on inspection, partnerships, continuous improvement, training, leadership not supervision, drive out fear, break down barriers, eliminate slogans, remove management by objectives/numbers, pride of workmanship, education and self-improvement, transformation everyone's job)

• Management responsibilities including (quality policy, objectives, planning, resources, review, communication, culture building)

• Gemba leadership including (go to workplace, observe processes, talk to people, learn, show respect, support problem-solving)

8.2 Employee Empowerment and Engagement

• Empowerment including (authority to act, decision-making, problem-solving, ownership, accountability, trust)

• Quality circles including (small groups, voluntary, regular meetings, problem identification, solution proposals, implementation support)

• Suggestion systems including (employee ideas, evaluation process, recognition, implementation, continuous participation, improvement culture)

• Cross-functional teams including (diverse perspectives, collaboration, breaking silos, innovation, comprehensive solutions)

• Training and development including (quality tools, statistical methods, problem-solving, continuous learning, competency building)

8.3 Change Management for Quality

• Change resistance including (fear, comfort zone, misunderstanding, lack of trust, addressing concerns, communication)

• Kotter's 8 steps including (urgency, coalition, vision, communication, empowerment, short-term wins, consolidate, anchor in culture)

• Communication including (why change, what's in it for me, transparency, frequency, channels, two-way dialogue)

• Sustaining quality culture including (reinforcement, celebration, storytelling, metrics tracking, leadership commitment, continuous evolution)

9. Supplier Quality Management

9.1 Supplier Selection and Development

• Supplier selection criteria including (quality capability, capacity, delivery, cost, financial stability, technology, certifications, audits)

• Supplier evaluation including (scorecards, performance metrics, audits, quality history, site visits, capability assessment)

• Supplier development including (collaborative improvement, training, technical assistance, joint problem-solving, long-term relationship)

• Partnership approach including (mutual benefit, transparency, shared goals, win-win, strategic alignment, integration)

9.2 Supplier Quality Requirements

• Quality agreements including (specifications, acceptance criteria, inspection requirements, documentation, change control, dispute resolution)

• First Article Inspection (FAI) including (initial production verification, dimensional inspection, material certification, documentation, approval before full production)

• Incoming inspection including (sampling plans ANSI/ASQ Z1.4, acceptance criteria, testing, certification review, nonconformance handling)

• Supplier corrective action including (8D process, root cause, corrective actions, verification, prevention, monitoring)

9.3 Supply Chain Quality Integration

• Quality cascade including (customer requirements flow downstream, supplier capability upstream, end-to-end quality)

• Supplier audits including (process audits, system audits, product audits, ISO 9001 certification, second-party audits, findings follow-up)

• Performance monitoring including (quality metrics DPPM, delivery, responsiveness, continuous improvement, scorecards, reviews)

• Supplier certification including (qualification process, ongoing performance, approved supplier list, preferred status, risk reduction)

10. Quality Cost Management

10.1 Cost of Quality Framework

• Prevention costs including (quality planning, process capability studies, training, supplier evaluation, preventive maintenance, design reviews)

• Appraisal costs including (inspection, testing, audits, measurement equipment, quality audits, calibration, laboratory)

• Internal failure costs including (scrap, rework, re-inspection, downtime, yield losses, supplier returns, design changes)

• External failure costs including (warranty, returns, complaints, recalls, liability, lost sales, reputation damage, customer dissatisfaction)

• Cost of Poor Quality (COPQ) including (failure costs, opportunity costs, hidden costs, measurement, reduction strategies, tracking)

10.2 Quality Cost Analysis

• COPQ measurement including (data collection, categorization, analysis, trends, benchmarking, goals)

• Pareto analysis including (identify major cost drivers, prioritization, focus improvement efforts, resource allocation)

• Cost-benefit analysis including (prevention investment versus failure cost reduction, ROI calculation, project justification)

• Optimal quality cost including (balance prevention/appraisal versus failure, economic quality level, continuous reduction goal)

10.3 Quality Improvement Economics

• Return on Quality (ROQ) including (financial justification, customer satisfaction impact, market share, profitability, investment prioritization)

• Project selection including (financial impact, strategic alignment, feasibility, resources, prioritization, portfolio management)

• Savings verification including (baseline establishment, benefit tracking, financial validation, sustainability, reporting)

11. Advanced Quality Techniques

11.1 Design for Six Sigma (DFSS)

• DFSS purpose including (design quality in, prevent problems, robust design, customer focus, first-time quality)

• DMADV methodology including (Define customer requirements, Measure CTQs, Analyze alternatives, Design detailed, Verify performance)

• Quality Function Deployment (QFD) including (House of Quality, customer voice to design, prioritization, cross-functional)

• Robust design including (Taguchi methods, parameter design, tolerance design, noise factors, signal-to-noise ratio, variation reduction)

11.2 Advanced Statistical Methods

• Multivariate analysis including (multiple variables, principal component analysis, factor analysis, cluster analysis, data reduction)

• Reliability engineering including (failure analysis, MTBF mean time between failures, Weibull analysis, reliability prediction, life testing)

• Acceptance sampling including (sampling plans, OC curves, AQL acceptable quality limit, LTPD lot tolerance percent defective, ANSI/ASQ Z1.4)

• Statistical tolerancing including (tolerance stack-up, worst-case, statistical, Monte Carlo simulation, cost optimization)

11.3 Quality in Product Development

• Stage-Gate process including (phase reviews, go/no-go decisions, risk management, resource allocation, quality gates)

• Design reviews including (concept, preliminary, critical, manufacturing, multifunctional, checklist, DFMEA)

• Design for Manufacturability (DFM) including (simplification, standard parts, assembly ease, tolerance rationalization, cost reduction)

• Prototype testing including (functionality, reliability, environmental, user acceptance, design validation, lessons learned)

12. Quality Management Systems Implementation

12.1 QMS Implementation Planning

• Gap analysis including (current state assessment, ISO 9001 requirements, identify gaps, prioritization, action planning)

• Implementation roadmap including (phases, milestones, resources, responsibilities, timeline, quick wins, communication plan)

• Documentation structure including (quality manual, procedures, work instructions, forms/records, document control, appropriate detail)

• Process documentation including (SIPOC, flowcharts, procedures, work instructions, process owners, review and approval)

12.2 Internal Auditing

• Audit purpose including (compliance verification, effectiveness assessment, improvement opportunities, management information, continuous improvement)

• Audit types including (process audits, product audits, system audits, compliance audits, value-added audits)

• Audit planning including (annual schedule, scope, criteria, team selection, preparation, checklist, communication)

• Audit execution including (opening meeting, examination, sampling, objective evidence, findings, closing meeting, report)

• Auditor competence including (training, knowledge, skills, impartiality, communication, lead auditor, certification)

12.3 Management Review

• Management review purpose including (strategic alignment, effectiveness evaluation, improvement opportunities, resource decisions, top management engagement)

• Review inputs per ISO 9001 including (previous actions, changes, performance, customer satisfaction, nonconformities, audit results, opportunities)

• Review outputs including (improvement opportunities, changes needed, resource needs, decisions, action items, strategic direction)

• Effective reviews including (preparation, data-driven, decision focus, action orientation, follow-up, strategic not operational)