Preface xiii
Acknowledgement xv
1 A Necessary Evolution 1
References 6
2 The HACCP System 9
2.1 Characteristics of the HACCP System 11
2.2 The Limitations of Final Product Analyses 12
2.3 Reasons to Implement HACCP 15
2.4 Legal Basis of HACCP 17
2.5 HACCP Pillars 19
2.6 HACCP Barriers 21
2.7 HACCP Principles and Methodology 23
2.7.1 The HACCP Document of the Codex 25
2.7.2 Principles of the HACCP System 29
2.8 The Four Stages for the Implementation of HACCP 30
2.9 Preparation and Planning 31
2.9.1 Establish the Terms of Reference and Scope of the HACCP Study 31
2.9.2 Gap Analysis 32
2.9.3 Timeframe 33
2.10 The 12 Steps of HACCP 33
2.11 Assemble the HACCP Team 35
2.12 Describe the Product 38
2.13 Determining Intended Use 44
2.14 Construct a Flow Diagram 46
2.15 On-site Flow Diagram Verification 49
References 50
3 The Seven Principles of HACCP 53
3.1 Principle 1 53
3.1.1 Brainstorming 55
3.1.2 Hazard Identification 57
3.1.3 Establish Control Measures 72
3.2 Principle 2 74
3.2.1 Operational Prerequisites 88
3.3 Principle 3 91
3.3.1 Operational Limits 94
3.4 Principle 4 97
3.5 Principle 5 100
3.6 Principle 6 106
3.6.1 Interrelationships among Validation, Monitoring, and Verification 109
3.6.2 Validation Methods 112
3.6.2.1 Tasks Prior to Validation Include: 112
3.6.2.2 Approaches for Validating Control Measures 113
3.6.3 Verification Methods 116
3.6.4 HACCP Revision 118
3.7 Microbiological Analyses in the HACCP System 120
3.7.1 Types of Sampling Plans 123
3.8 EU Regulation 2073/2005 and HACCP 125
3.9 Principle 7 129
References 133
4 The Prerequisites of the HACCP System 135
4.1 Type of Prerequisites 139
4.2 Flexibility in HACCP 140
4.2.1 Background 140
4.2.2 Flexibility in the Implementation of GHP 142
4.2.3 Flexibility in the Implementation of HACCP-based Procedures 142
4.3 Development and Implementation of Hygiene Prerequisites 145
4.4 Water Control 149
4.5 Cleaning and Disinfection Plan 151
4.6 Pest Control Plan 153
4.6.1 Diagnosis of the Situation 153
4.6.2 Preventive Measures 154
4.7 Training Plan 155
4.8 Supplier Control 159
4.9 Traceability Plan 161
4.9.1 Documentation and Recordkeeping 166
4.10 Maintenance Plan 167
4.10.1 Documentation and Recordkeeping 171
4.11 Good handling Practices 171
4.11.1 Documentation and Recordkeeping 173
4.12 Good Manufacturing Practices 174
4.12.1 Documentation and Recordkeeping 175
4.13 Waste Control Plan 175
4.13.1 Documentation and Recordkeeping 176
References 176
5 HACCP as a Management System 179
5.1 From Words to Work 179
5.2 What is Required to Implement HACCP? 180
5.3 Building a Food Safety Culture 181
5.4 Management System Concept 182
5.5 The Concept of a Food Safety Management System 183
5.6 System Documentation 184
5.6.1 Document Hierarchy 184
5.6.2 Document Control 184
5.6.3 Control of Records 186
5.7 Food Safety Standards 186
5.7.1 Safe Quality Food (SQF) 186
5.7.2 Dutch HACCP Code 187
5.7.3 The Danish Standard DS 3027 187
5.7.4 Brand Reputation Compliance Global Standards (BRCGS) 187
5.7.5 International Featured Standards (IFS) 188
5.7.6 ISO 22000 190
5.7.6.1 FSSC 22000 191
5.7.7 Global Food Safety Initiative 191
References 193
6 Audit: Concept, Types, and Personnel 195
6.1 Audit Concept 195
6.2 Why Audit? 197
6.3 Persons Involved in an Audit 198
6.3.1 Client 199
6.3.2 Audit Team 199
6.3.2.1 Lead Auditor 199
6.3.2.2 Auditor 200
6.3.2.3 Trainee Auditors 200
6.3.2.4 Technical Expert 200
6.3.3 Guide 201
6.3.4 Observer 201
6.3.5 Consultant 202
6.4 Types of Audit 202
6.4.1 Product Audit 203
6.4.2 Process Audit 203
6.4.3 System Audit 204
6.4.4 Research Audit 204
6.4.5 Follow-up Audit 205
References 205
7 The Food Safety Auditor 207
7.1 Competence of the Auditor 207
7.2 Achieving the Auditor’s Competence 209
7.3 Audit Principles 210
7.4 Personal Attributes of Auditors 211
7.5 Management Skills 215
References 215
8 Audit in Official Control 217
8.1 Audit vs Inspection 219
References 222
9 The Audit Process 223
9.1 Stages of the Audit Process 223
9.2 Initiating Audit 226
9.3 Selection of Auditors 226
9.4 Team Size 227
9.5 Establishing Contact with Auditee 228
9.6 Determining the Feasibility of the Audit 229
9.7 Preparation of Audit Activities 229
9.7.1 Initial document review 229
9.7.2 Preparation of the Audit Plan 230
9.7.3 Allocation of Tasks to the Audit Team 231
9.8 Opening Meeting 233
9.9 The Audit Tour 234
9.10 Document Review During the Audit 234
9.11 Conducting On-site Audit Activities 237
9.12 Sources of Information 237
9.12.1 Observation of Activities 238
9.12.2 Physical Examination 239
9.12.3 Review of Documents and Records 239
9.12.4 Interviews 240
9.12.4.1 Types of Questions 241
9.12.5 Analytical 244
9.13 Sampling in Auditing 246
9.13.1 Judgment-based Sampling 247
9.13.2 Statistical Sampling 247
9.13.3 Sampling Techniques 249
9.13.3.1 Vertical Audit vs Horizontal Audit 249
9.14 Tools to Guide the Audit 250
9.14.1 Audit Strategies 250
9.14.2 Checklists 251
9.14.2.1 Types of Questions in Checklists 254
9.15 Counter-auditing Techniques 255
9.16 Generating audit findings 257
9.17 Classification of Findings 259
9.18 Elements of a Finding 260
9.19 Classification of Nonconformities 262
9.20 Drafting of Nonconformities 264
9.21 Preparing Audit Conclusions 267
9.22 Closing Meeting 268
9.23 Audit Report 269
9.24 Completing Audit 271
9.25 Audit Follow-up Activities 271
9.26 Managing an Audit Program 271
References 273
Case Study 1: Slaughterhouse for Rabbits, with an Adjoining Cutting Plant 275
Case Study 2: HACCP System of the Mass Catering Establishment Culinaria 323
Index 363
