Statistical Process Control for the Food Industry

Preface xiii 1 Quality Management in the Food Industry 1 1.1 Introduction 1 1.2 Definition of Quality Control 1 1.3 Quality Control in the Food Industry 2 1.3.1 Quality Control (Raw Material) 3 1.3.2 Quality Control in Production (Processes and End Product) 4 1.3.3 Issues Related to the Quality Control 6 1.3.3.1 Late Adopters 6 1.3.3.2 Difficulties Identifying and Prioritising Hazards (Microbiological and Chemical) 6 1.3.3.3 Lack of Scientific and Quantitative Method to Assess Critical Points 6 1.4 Quality Assurance 7 1.4.1 Current Good Manufacturing Practice (cGMP) 7 1.4.2 HACCP (Hazard Analysis of Critical Control Point) 8 1.4.3 ISO 9 1.4.4 British Retail Consortium 9 1.5 Quality Management System in the Food Industry 9 1.6 Statistical Thinking 10 1.7 Summary 12 2 Food Industry and its Contribution to the Global Economy 13 2.1 Introduction 13 2.2 What Is the Role of Food Industry in the Global Context? 14 2.3 Several Classifications of Food Industry from Several Sources 15 2.4 How is the Food Industry Different from Other Industries? 18 2.5 Customers and Consumers 19 2.6 Government Plan 20 2.7 Summary 20 3 Quality and Safety in the Food Industry 23 3.1 Introduction 23 3.2 Food Quality 25 3.2.1 Objective and Subjective Quality 25 3.3 Food Safety 27 3.4 Hazard Analysis and Critical Control Point (HACCP) 28 3.4.1 Concept 28 3.4.2 HACCP Principles 30 3.4.2.1 Principle 1 30 3.4.2.2 Principle 2 30 3.4.2.3 Principle 3 30 3.4.2.4 Principle 4 30 3.4.2.5 Principle 5 31 3.4.2.6 Principle 6 31 3.4.2.7 Principle 7 31 3.4.3 Hazards 32 3.4.3.1 Physical Contamination 32 3.4.3.2 Chemical Contamination 33 3.4.3.3 Microbiological Contamination 33 3.4.4 Documentation 34 3.4.5 Critical Control Point (CCP) 34 3.4.6 How to Do it? 34 3.4.6.1 Step 1: Develop HACCP Team 34 3.4.6.2 Step 2: Describe and Characterise the Product 35 3.4.6.3 Step 3: Construct the Process Flow Diagram 36 3.4.6.4 Step 4: Identify the Hazards Control 36 3.4.6.5 Step 5: Quantify and Analyse the Hazards 36 3.4.6.6 Step 6: Identify Control Requirements, Targets and Tolerances 37 3.4.6.7 Step 7: Identify CCPs and Assess Existing Controls 37 3.4.6.8 Step 8: Establish a Monitoring System for Each CCP 38 3.5 Good Manufacturing Practice 38 3.5.1 Personnel 39 3.5.2 Plant and Grounds 39 3.5.3 Sanitary Operation 40 3.5.4 Sanitary Facilities and Controls 40 3.5.5 Equipment and Utensils 40 3.5.6 Processes and Controls 40 3.5.7 Raw Materials 40 3.5.8 Warehousing and Distribution 41 3.6 Food and Drug Administration (FDA) 42 3.7 Summary 42 4 An Introduction of SPC in the Food Industry: Past, Present and Future 43 4.1 Statistical Process Control: A Brief Overview 43 4.2 Quality Control in the Food Industry: Before SPC 44 4.2.1 Inspection! Inspection! Inspection! 45 4.3 The Evolution of SPC in the Food Industry 48 4.4 The Principle of Current Quality Control 50 4.4.1 Control in Raw Material 50 4.4.2 Control in the Finished Product 51 4.4.3 Control in Processing 51 4.4.4 The Practicality of SPC in the Food Industry 53 4.5 Future of SPC: Organisational Learning Through Statistical Methods Application 55 4.6 Summary 60 5 Tools in SPC 61 5.1 Basic Quality Tools 61 5.2 SPC Tools 61 5.3 Cause-and-Effect Analysis 62 5.3.1 What? 62 5.3.2 Why? 62 5.3.3 When? 62 5.3.4 How? 62 5.3.5 Where? 64 5.4 Pareto Diagram 66 5.4.1 What? 66 5.4.2 Why? 66 5.4.3 When? 67 5.4.4 How? 67 5.4.5 Where? 69 5.5 Process Flowchart 69 5.5.1 What? 69 5.5.2 Why? 69 5.5.3 How? 69 5.5.4 When? 71 5.5.5 Where? 71 5.6 Histogram 71 5.6.1 What? 71 5.6.2 Why? 72 5.6.3 When? 72 5.6.4 How? 72 5.6.5 Where? 73 5.7 Scatter Diagram 73 5.7.1 What? 73 5.7.2 Why? 73 5.7.3 When? 73 5.7.4 How? 74 5.7.5 Where? 74 5.8 Control Chart 74 5.8.1 What? 74 5.8.2 How? 75 5.8.3 Assumptions 75 5.8.4 Why? 75 5.8.4.1 Process/Product Monitoring 75 5.8.4.2 Process Prediction 76 5.8.5 How? 76 5.8.6 Types of Control Charts 77 5.8.7 Variable Control Chart 77 5.8.7.1 Xbar Chart and R Chart or Xbar and S Chart 77 5.8.7.2 ExponentiallyWeighted Moving Average (EWMA) Chart 78 5.8.7.3 Cumulative Sum (CUSUM) Chart 79 5.8.8 Attribute Control Chart 80 5.8.8.1 Proportion Defective Chart (p-Chart) 80 5.8.8.2 Number Defective Chart (np-Chart) 81 5.8.8.3 c-Chart 81 5.8.8.4 U-Chart 82 5.8.9 Run Chart 82 5.8.10 Interpreting Control Chart Signals 83 5.8.11 Rules for Interpreting a Control Chart 83 5.8.12 Where? 84 5.9 Common Mistakes 85 5.10 Summary 86 6 Team Formation, Team Dynamics and Training 87 6.1 The Team 87 6.2 Team Dynamics 88 6.2.1 Team Structure 88 6.2.2 SPC Team Characteristics 91 6.2.3 Team Maturity 93 6.3 Training 94 6.4 Consultant 97 6.5 Follow-Up in-House Training 97 6.6 Measuring Training Effectiveness 98 6.7 Summary 100 7 SPC Readiness Self-Assessment Tool 103 7.1 Ready...? 103 7.2 Concept of Readiness 104 7.3 History of the Readiness Concept 105 7.4 An Approach to Assessing SPC Readiness in the Organisations 107 7.5 Key Components of SPC Readiness 108 7.6 Top Management Support 109 7.6.1 Capable Measurement System 109 7.6.2 Organisational Culture 109 7.6.3 Employee Involvement 110 7.6.4 Urgency to Change 111 7.7 Identifying the Readiness Level 112 7.7.1 How to Use the SPC Readiness Assessment Tool? 112 7.8 Summary 116 8 Critical Aspects in SPC Implementation Process 117 8.1 Introduction 117 8.2 Key Findings from an Empirical Study in the UK Food Manufacturing Industry 117 8.3 CSF of SPC Implementation 120 8.4 Gap Between the Importance of SPC and the Frequency of Actual Practice 122 8.5 Common Barriers to SPC Implementation 124 8.6 Process Performance Measurement 126 8.7 Summary 128 9 Roadmap for the Deployment of SPC 129 9.1 A Cookbook Approach 129 9.2 Phase Awareness: Sell the Program 129 9.2.1 Step 1: Top to Bottom 131 9.2.2 Step 2: SPC Awareness Sessions 133 9.2.3 Step 3: SPC Training 133 9.3 Phase Preparation 135 9.3.1 Step 4: Corporate SPC Vision Create/Creating a SPC Corporate Vision 135 9.3.2 Step 5: SPC Team Establishment 136 9.3.3 Step 6: Develop Strategic Plans for the SPC Implementation 137 9.4 Phase Initiation 138 9.4.1 Step 7: Process Prioritisation 138 9.4.2 Step 8: Process Description 139 9.4.3 Step 9: Process Synthesis 140 9.4.4 Step 10: Measurement System Analysis (MSA) 140 9.4.5 Step 11: Control Chart 141 9.4.6 Step 12: Establish Out-of-Control-Action-Plan (OCAP) 143 9.4.7 Step 13: Process Capability 144 9.4.8 Step 14: Reflection 146 9.5 Phase Institution: Company-Wide Implementation 147 9.5.1 Step 15: Communicate the Success of Initial Project 147 9.5.2 Step 16: Company-Wide Training 147 9.5.3 Step 17: Progress Evaluation Systems 148 9.6 Phase Sustainability 148 9.6.1 Step 18: Maintenance of In-house Expertise 148 9.6.2 Step 19: Towards Learning Organisation 149 9.6.3 Step 20: Reward System 149 9.7 Summary 150 10 Case Studies 151 10.1 Application of the Control Charts in the Industries 151 10.2 Case Study 1 Monitoring Fish Product Packaging (Grigg, Daly, and Stewart, 1998) 152 10.2.1 Problem Statement 152 10.2.2 Processes 152 10.2.3 Sampling 152 10.2.4 Type of Data 153 10.2.5 Construction of the Control Chart 154 10.2.5.1 Determine the Target Level 154 10.2.6 Interpret x . R Chart 154 10.2.7 Conclusion 156 10.3 Case Study 2 Monitoring the Sausage Production 156 10.3.1 Problem Statement 156 10.3.2 Processes 157 10.3.3 Sampling 158 10.3.4 Type of Data 158 10.3.5 Construct Control Chart 159 10.3.6 Interpreting the p-Chart 160 10.3.7 Conclusion 161 10.4 Case Study 3 Controlling Microbiological Hazards on the Food Products 161 10.4.1 Problem Statement 161 10.4.2 Process 162 10.4.3 Sampling 162 10.4.4 Type of Data 162 10.4.5 Construct Control Chart 162 10.4.5.1 Modification of the Data 162 10.4.6 Interpret the Charts 167 10.4.6.1 The Individuals Chart 167 10.4.6.2 The CUSUM Control Chart 167 10.4.7 Conclusion 168 References 169 Index 181