The ASQ Certified Food Safety and Quality Auditor Handbook

Steven Wilson

Description

Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools.
The updated fourth edition also includes:
The history of primitive and modern food preservation methods, including the introduction of HACCP methods
The evolution of prerequisite programs, such as chemical and microbiological controls
The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring
Preliminary tasks for developing a HACCP plan
About the Division
The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Agronomie
• Agronomy for Sustainable Development
• Qualité totale
• Engineering
• Technology
• Sciences et techniques
• Auditing
• Total Quality Management
• Food Science
• Food Safety
• Food Security

Informations

• Publié par: ASQ Quality Press
• Date de parution: 07 mai 2021
• Nombre de lectures: 0
• EAN13: 9781951058197
• Langue: English
• Poids de l'ouvrage: 7 Mo

Extrait

THE ASQ CERTIFIED FOOD SAFETY AND QUALITY AUDITOR HANDBOOK

CERTIFIED FOOD SAFETY AND QUALITY AUDITOR STEVEN WILSON, Editor

FOURTHEDIITIION

HANDBOOK

The ASQ Certified Food Safety and Quality Auditor Handbook

Fourth Edition

Steven Wilson, Editor

ASQExceence Mîwaukee, Wîsconsîn

Published by ASQExcellence, Milwaukee, WI Produced and distributed by Quality Press, ASQ, Milwaukee, WI

© 2021 by ASQExcellence

Pubîsher’s Cataogîng-în-Pubîcatîon data

Names: Wîson, Steven, 1959-, edîtor. Tîte: The ASQ certîied food safety and quaîty audîtor handbook, fourth edîtîon / Steven Wîson, Edîtor. Descrîptîon: Incudes bîbîographîca references and îndex. | Mîwaukee, WI: ASQ Exceence, 2021. Identîiers: LCCN: 2021933376 | ISBN 978-1-951058-18-0 (hardcover) | 978-1-952236-12-9 (hardcover) | 978-1-951058-19-7 (epub) | 978-1-952236-13-6 (epub) | 978-1-951058-20-3 (PDF) | 978-1-952236-14-3 (PDF) Subjects: LCSH Food aduteratîon and înspectîon—Handbooks, manuas, etc. | Food handîng—Safety measures—Handbooks, manuas, etc. | Food îndustry and trade—Safety measures—Handbooks, manuas, etc. | BISAC TECHNOLOGY & ENGINEERING / Food Scîence / Food Safety & Securîty Cassîicatîon: LCC TX531.A87 2021 | DDC 363.19/2—dc23

No part of thîs book may be reproduced în any form or by any means, eectronîc, mechanîca, photocopyîng, recordîng, or otherwîse, wîthout the prîor wrîtten permîssîon of the pubîsher.

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To pace orders or browse the seectîon of ASQExceence and Quaîty Press tîtes, vîsît our websîte at: http://www.asq.org/quaîty-press

Prînted în Canada. 25 24 23 22 21 FC 5 4 3 2 1

Table of Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part I An Introduction to HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1 History and Overview of HACCP: Primitive and Modern Food Preservation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Predecessors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP and the Space Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application of HACCP to Other Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . Moving to a Comprehensive Food Safety and Management System . . . . . . . Chapter 2 Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evolution of Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chemical Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Microbiological Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3 Other Food Systems Support Programs . . . . . . . . . . . . . . . . . . . . . . . Product Traceability and Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Crisis Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Food Defense and Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environmental Control and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4 Tasks for HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . Assessing the Need for a HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preliminary Tasks for HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . Establishing the Prerequisite Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part II Principles of HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 5 Principle #1—Conduct Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . Purpose of Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conducting a Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Documentation and Ongoing Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

vii xi xiii

1

2 3 4 5 6 8 10 12 14 19 29 29 30 30 30 32 32 33 40

43 44 44 44 46 57

iv

Table of Contents

Chapter 6 Principle #2—Determine Critical Control Points . . . . . . . . . . . . . . Distinguishing Between Critical Control Points and Control Points . . . . . . . Common Sources of Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . Identifying Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Documenting Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 7 Principle #3—Establish Critical Limits . . . . . . . . . . . . . . . . . . . . . . . What are Critical Limits? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishing Critical Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishing Operational Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 8 Principle #4—Establish Monitoring Procedures . . . . . . . . . . . . . . . What is Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Collecting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recording Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous Versus Intermittent Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . Determining Monitoring Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Qualifications of the Person Collecting the Data . . . . . . . . . . . . . . . . . . . . . . . . Chapter 9 Principle #5—Establish Corrective Action Procedures . . . . . . . . . . What is Corrective Action? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Goals of Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Corrective Action Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 10 Principle #6—Establish Verification Procedures . . . . . . . . . . . . . . Objectives of the Verification Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . External Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 11 Principle #7—Establish Record-Keeping and Documentation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Importance of Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Designing a Record-Keeping/Documentation System . . . . . . . . . . . . . . . . . . . Preventing Documentation Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part III Implementing HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 12 HACCP Plan Implementation and Maintenance . . . . . . . . . . . . . . Supporting Structures for HACCP Implementation . . . . . . . . . . . . . . . . . . . . . HACCP Team Formation and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pilot Projects/Operational Qualification of HACCP Plans . . . . . . . . . . . . . . . . Company-wide HACCP Deployment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Plan Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Extending the HACCP System to the Supply Chain . . . . . . . . . . . . . . . . . . . . .

Part IV Auditing the Food Safety System . . . . . . . . . . . . . . . . . . . . . Chapter 13 Auditing Fundamentals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Auditing as a Product Safety Auditing System . . . . . . . . . . . . . . . . . .

58 58 59 61 71 72 72 73 74

75 75 76 77 78 78 79

80 80 80 82 84 84 84 88

90 90 91 100 107

109 110 110 112 116 119 119 121

123 124 124

Table of Contents

Audit Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Audit Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conducting the Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 14 Auditing Process and Auditor Competencies . . . . . . . . . . . . . . . . . Auditor Competencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Illegal or Unsafe Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . International Regulations and Third-Party Auditing Schemes . . . . . . . . . . . .

Chapter 15 Quality Tools and Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurement of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flow Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pareto Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cause and Effect Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scatter Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Check Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Capability Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Corrective Action/Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part V Food Safety and Quality in the  Food Processing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 16 The Food Industry in General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Food Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources and Types of Food Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New Foodborne Diseases and New Technologies . . . . . . . . . . . . . . . . . . . . . . . Chapter 17 Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Processing Categories for Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 18 Seafood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of Hazards Specific to Seafood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Regulations in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applied HACCP Versus Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP and Economic Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Food Safety Modernization Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 19 Dairy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Safety Regulations in the Dairy Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Controlling Risks Through Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . .

v

125 126 135 147

148 148 149 150 150 151

153 153 154 155 155 156 157 157 157 161 161 163 163

167 168 168 168 174 175 175 176 183 183 186 188 189 189

190 190 191 191

vi

Table of Contents

Chapter 20 Fresh Fruits and Vegetables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Defining GAPs and GMPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hazards Associated with Handling Fresh Produce . . . . . . . . . . . . . . . . . . . . . Significance of GAPs, GMPs, and HACCP for the Auditor . . . . . . . . . . . . . . . Third-Party Verification of GAPs, GMPs, and HACCP Implementation . . . . Case Study—The Implementation of a HACCP Program in a Fresh-Market Tomato Handling Operation . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 21 Retail and Food Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Integrating HACCP in Retail and Food Service Operations . . . . . . . . . . . . . . HACCP Plan Development and Implementation . . . . . . . . . . . . . . . . . . . . . . . . Management and Employee Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 22 Animal Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pet Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pet Food Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Animal Feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Animal Feed Ingredients and Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Animal Food Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part VI Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A Hazards in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C NACMCF Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HACCP Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Guidelines for Application of HACCP Principles . . . . . . . . . . . . . . . . . . . . . . . Implementation and Maintenance of the HACCP Plan . . . . . . . . . . . . . . . . . . Appendix C.A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C.H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix D CODEX HACCP Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix E ISO 22000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix F The ASQ Code of Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix G ASQ Body of Knowledge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

194 194 194 195 200

200 202 202 202 207

208 208 210 211 212 213 213

217 218 222 223 224 225 226 226 238 239 240 241 244 246 247 248 249 251 258 262 264

275 279 283

Part I Figure 1.1 Table 4.1

Figure 4.1 Figure 4.2

Part II Figure 5.1

Table 5.1 Figure 6.1 Figure 6.2 Figure 6.3 Figure 6.4 Figure 6.5 Figure 6.6 Figure 6.7 Figure 8.1 Figure 11.1 Figure 11.2 Figure 11.3 Figure 11.4 Figure 11.5 Figure 11.6

List of Figures and Tables

What is HACCP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishingcompanyaccountabilitiesandaudit responsibilities for HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verified process flow diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . House of product safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Examplesofquestionstobeconsideredinhazardanalysis of food products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Raw material hazard analysis documentation . . . . . . . . . . . . . . . . Codex Alimentarius Commission decision tree . . . . . . . . . . . . . . NACMCF decision tree 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NACMCF decision tree 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Decision tree developed by Canadian Food Inspection Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ECP decision tree table for medical devices . . . . . . . . . . . . . . . . . . CCP determination form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A CCP decision tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Temperature data sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Raw material evaluation sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier certificate of conformance . . . . . . . . . . . . . . . . . . . . . . . . . Processing log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Label room inspection log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment calibration log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Finished product report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

vii

5

34 41 42

47 51 63 64 65

66 67 68 69 78 93 94 95 96 97 98

viii

List of Figures and Tables

Figure 11.7 Corrective action report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.8 Laboratory report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.9 Process validation letter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.10 Equipment validation letter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.11 Employee training record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.12 Simple CCP receiving record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11.13 More complex CCP receiving record . . . . . . . . . . . . . . . . . . . . . . . .

Part III Figure 12.1

HACCP system implementation responsibilities . . . . . . . . . . . . . .

Part IV Figure 13.1 Examples of types of management system audits as  defined by scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 13.1 Parts of the audit plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 13.2 Audit checklist (example) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 13.3 National Marine Fisheries Service audit checklist that  uses a rating system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 13.4 CAR form (example) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 13.5 Comprehensive schedule form (example) . . . . . . . . . . . . . . . . . . . . Figure 15.1 Flow diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.2 Pareto diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.3 Cause and effect diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.4 Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.5 Scatter diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.6 Variable control chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.7 Control chart showing only common causes of variation . . . . . . Figure 15.8 Control chart showing a special cause of variation where one point exceeds the upper or lower control chart limit . . . . . . Figure 15.9 Control chart showing a special cause of variation where two out of three consecutive points are in zone A . . . . . . . . . . . . Figure 15.10 Control chart showing a special cause of variation where four out of five consecutive points are in zone B or zone A. . . . . Figure 15.11 Control chart showing a special cause of variation where eight consecutive points are on one side of the central line . . . . . Figure 15.12 Example of a record sampling and assessment system and end-product sampling procedure . . . . . . . . . . . . . . . . . . . . . . . . . .

99 101 102 103 104 106 106

113

125 127 129

130 133 134 154 155 156 156 157 158 159

159

160

160

160

164

List of Figures and Tables

Table 15.1 Definitions in acceptance sampling . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15.13 OC curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Part V Table 22.1 Table 22.2 Table 22.3 Table 22.4

Part VI Table A.1 Table A.2 Table A.3 Table A.4 Figure C.1 Table C.1 Figure D.1 Figure D.2 Figure D.3 Table E.1

Reportable food registry summary—animal food hazard breakdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pet food recalls by hazard breakdown (86 total recalls), 2017-2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Animal feed recalls by hazard breakdown (16 total recalls), 2017-2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hazardsnotfound in animal food . . . . . . . . . . . . . . . . . . . . . . . . . .

Examples of biological hazards in food. . . . . . . . . . . . . . . . . . . . . . Factors affecting the growth of some foodborne pathogens . . . . Examples of chemical hazards in food . . . . . . . . . . . . . . . . . . . . . . Examples of physical hazards in food . . . . . . . . . . . . . . . . . . . . . . . Preliminary tasks in the development of the HACCP plan . . . . . Example of a company-established HACCP verification schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Logic sequence for the application of HACCP . . . . . . . . . . . . . . . . Example of decision tree to identify CCPs . . . . . . . . . . . . . . . . . . . Example of a HACCP worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . Structure of ISO 22000:2005. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ix

165 166

209

209

210 215

218 219 220 221 228

236 251 253 255 259