The Certified HACCP Auditor Handbook

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ASQ Quality PressMilwaukee, Wisconsin

The Certified HACCP Auditor Handbook

ASQ Food, Drug, and Cosmetic Division

John G. Surak and Steven Wilson, Editors

American Society for Quality, Quality Press, Milwaukee 53203 2007 by ASQAll rights reserved. Published 2006Printed in the United States of America12 11 10 09 08 07 06 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

The certified HACCP auditor handbook / John G. Surak and Steven Wilson, editors. p. cm. Includes bibliographical references and index. ISBN-13: 978-0-87389-706-8 (hardcover : alk. paper) ISBN-10: 0-87389-706-4 (hardcover : alk. paper) 1. Hazard Analysis and Critical Control Point (Food safety system)Handbooks, manuals, etc. 2. Food adulteration and inspectionHandbooks, manuals, etc. 3. Food handlingSafety measuresHandbooks, manuals, etc. 4. Food industry and tradeSafety measuresHandbooks, manuals, etc. I. Surak, John G. II. Wilson, Steven, 1959.

TX531.C468 2007 363.19'264dc22 2006039332

ISBN-13: 978-0-87389-706-8ISBN-10: 0-87389-706-4

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vTable of Contents

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiiForeword to the Previous Handbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Part I An Introduction to HACCP

Chapter 1 History and Overview of HACCP: Primitive and Modern Food Preservation Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

HACCP Predecessors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3HACCP and the Space Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Application of HACCP to Other Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Chapter 2 Tasks for HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . 7Assessing the Need for a HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Preliminary Tasks for HACCP Development . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Assembling the HACCP Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Describing the Product and Its Distribution . . . . . . . . . . . . . . . . . . . . . . . . 11Describing the Intended Use and End User . . . . . . . . . . . . . . . . . . . . . . . . 12Developing a Process Flow Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Verifying the Accuracy of the Process Flow Diagram . . . . . . . . . . . . . . . . 13

Establishing the Prerequisite Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Part II Principles of HACCP

Chapter 3 Principle #1Conduct Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . 20Purpose of Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Food Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Medical Device Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Performing a Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Hazard Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Documentation and Ongoing Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Chapter 4 Principle #2Determine Critical Control Points . . . . . . . . . . . . . . . 37Distinguishing between Critical Control Points and Control Points. . . . . . . . 37Common Sources of Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Raw Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

vi Table of Contents

Ingredient Receiving and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Identifying Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Considerations When Selecting a Decision Tree. . . . . . . . . . . . . . . . . . . . . 40Using a Decision Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Factors Leading to CCP Misidentification . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Documenting Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Chapter 5 Principle #3Establish Critical Limits . . . . . . . . . . . . . . . . . . . . . . . 51What Are Critical Limits?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Establishing Critical Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Microbiological. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Establishing Operational Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Chapter 6 Principle #4Establish Monitoring Procedures . . . . . . . . . . . . . . . 54What Is Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Collecting Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Monitoring by Observation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Monitoring by Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Recording Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Continuous versus Intermittent Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Determining Monitoring Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Qualifications of the Person Collecting the Data . . . . . . . . . . . . . . . . . . . . . . . . 58

Chapter 7 Principle #5Establish Corrective Action Procedures . . . . . . . . . . 59What Is Corrective Action? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Goals of Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Identifying Causes of Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Determining Product Disposition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Recording the Corrective Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Reevaluating the HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Corrective Action Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Chapter 8 Principle #6Establish Verification Procedures . . . . . . . . . . . . . . . 62Objectives of the Verification Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Types of Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Ongoing Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Revalidation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

External Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Chapter 9 Principle #7Establish Record Keeping and Documentation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Importance of Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Internal Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Table of Contents vii

Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Indirect Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Types of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Monitoring Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Corrective Action Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Verification Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Designing a Record Keeping/Documentation System . . . . . . . . . . . . . . . . . . . 77Modifying Existing Forms versus Creating New Forms. . . . . . . . . . . . . . 77Balanced Approach versus Overkill Approach. . . . . . . . . . . . . . . . . . . . . . 82Simplified versus Complex Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Computerized versus Manual Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Preventing Documentation Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Part III Implementing HACCP

Chapter 10 HACCP Plan Implementation and Maintenance . . . . . . . . . . . . . . 86Supporting Structures for HACCP Implementation . . . . . . . . . . . . . . . . . . . . . 86

Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Product Safety Policies and Objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

HACCP Team Formation and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Team Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Team Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Pilot Projects/Operational Qualification of HACCP Plans. . . . . . . . . . . . . . . . 94Companywide HACCP Deployment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96HACCP Plan Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Extending the HACCP System to the Supply Chain . . . . . . . . . . . . . . . . . . . . . 99

Part IV Auditing HACCP Systems

Chapter 11 The HACCP Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

HACCP Auditing As a Product Safety Auditing System . . . . . . . . . . . . . 102Audit Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Audit Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Conducting the Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Opening Meeting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Collection of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Analysis of Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121Exit Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122Audit Report, Follow-Up, and Closeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Chapter 12 The HACCP Auditor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128Auditor Competencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Conflict of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

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Proprietary Information and Confidentiality . . . . . . . . . . . . . . . . . . . . . . . 130Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Illegal or Unsafe Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Chapter 13 Quality Assurance Analytical Tools . . . . . . . . . . . . . . . . . . . . . . . . . 132Measurement of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Pareto Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Cause-and-Effect Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Scatter Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Check Sheets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Control Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Capability Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Continuous Improvement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Corrective Action/Preventative Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Part V Applying HACCP to the Food Processing Industry

Chapter 14 Food Industry in General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Food Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Sources and Types of Food Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Biological Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

New Foodborne Diseases and New Technologies . . . . . . . . . . . . . . . . . . . . . . . 154

Chapter 15 Prerequisite Areas for Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 155Evolution of Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Types of Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Good Manufacturing Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156Chemical Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159Cleaning and Sanitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163Microbiological Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163Sanitary Design and Engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165Trace and Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166Pest Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166Receiving, Storage, and Shipping Controls . . . . . . . . . . . . . . . . . . . . . . . . . 167Supplier Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168Water Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169Air Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170Food Safety Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170Equipment Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Customer ComplaintsFood Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Audits and Inspection Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Table of Contents ix

Chapter 16 Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174Processing Categories for Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176Critical Control Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178Critical Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179Corrective Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Chapter 17 Seafood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Description of the Seafood Industry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Sources of Hazards Specific to Seafood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Biological HazardsBacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Biological HazardsViruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183Biological HazardsParasites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184Chemical HazardsMarine Biotoxins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

HACCP Regulations in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185Applied HACCP versus Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187HACCP Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

HACCP and Economic Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Chapter 18 Dairy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189Safety Regulations in the Dairy Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190Controlling Risks Through Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . 190

Supplier Control Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191Receiving/Storage Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191Premises, Equipment Performance, and Maintenance Program . . . . . . . 191Cleaning and Sanitation Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191Recall Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192Allergen Control Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192Personal Training Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Chapter 19 Fruits and Vegetables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193Defining GAPs and GMPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193Hazards Associated with Handling Fresh Produce. . . . . . . . . . . . . . . . . . . . . . 193

Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Significance of GAPs, GMPs, and HACCP for the Auditor. . . . . . . . . . . . . . . . 194Production Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Pesticide Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

x Table of Contents

Field Sanitation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196Sanitary Facilities in the Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196Sanitary Facilities in Packinghouses and Processing Plants. . . . . . . . . . . 196Employee Health and Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197Packing Facility Sanitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197Fresh-Cut Processing Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197Storage and Ripening Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197Transport of Packed Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197Retailers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

Third-Party Verification of GAPs, GMPs, and HACCP Implementation . . . . 198Case StudyThe Implementation of a HACCP Program in a

Fresh-Market Tomato Handling Organization. . . . . . . . . . . . . . . . . . . . . . . . 198

Chapter 20 Retail and Food Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200Integrating HACCP in Retail and Food Service Operations. . . . . . . . . . . . . . . 200HACCP Plan Development and Implementation . . . . . . . . . . . . . . . . . . . . . . . . 200

Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201Critical Control Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202Critical Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203Verification Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204Record Keeping and Documentation Procedures . . . . . . . . . . . . . . . . . . . 204

Management and Employee Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Part VI Applying HACCP to the Medical Device Industry

Chapter 21 HACCP Principles in the Design and Manufacture of Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

The History of HACCP in the Medical Device Industry . . . . . . . . . . . . . . . . . . 208Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208Design Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210Manufacturing Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Risk-Based Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212Quality Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213Develop Process Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213Process Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Application of HACCP to Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214Quality System Inspection Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Part VII Appendices

Appendix A Hazards in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

Appendix B Hazards in Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Appendix C Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Appendix D NACMCF HACCP Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

Table of Contents xi

Appendix E Codex HACCP Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257

Appendix F ISO 22000:2005, Food safety management systemsRequirements for any organization in the food chain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264

Appendix G The ASQ Code of Ethics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267

Appendix H Body of Knowledge for the Certified HACCP Auditor. . . . . . . . . . 269

Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287

xiii

Foreword

HACCP has evolved over the years, and so has the ASQ. As a result of this evolution, the Certified HACCP Auditor Examination also has evolved. This certification first started as an add-on certification to the Certified Quality Auditor. In 2004, the ASQ Certification Board approved the Certified HACCP Auditor as a stand-alone certification. Along with this change, the Body of Knowledge was updated to include the principles of management systems audit-ing and analytical tools of quality assurance. As a result, this new handbook was developed to assist the certification candidate in preparing for the CHA examina-tion. This volume incorporates most of the resource material that was published in The Quality Auditors HACCP Handbook. New chapters cover the HACCP audit, the HACCP auditor, and quality assurance analytical tools. In addition, appendi-ces describe ISO 22000:2005, Food safety management systemsRequirements for any organization in the food chain and validation of HACCP systems.

The editors again would like to thank all of the professionals who contributed to the development of the first edition. We also would like to thank Mr. Phil Ven-tresca, who reviewed the new material, and the ASQ Food, Drug, and Cosmetic Division, who supported this project.

The Food, Drug, and Cosmetic Division of the ASQ is committed to increasing customer satisfaction and continuous improvement by identifying, communicat-ing, and promoting knowledge and the use of management concepts, technolo-gies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. Their efforts are designed to ensure that quality and safety will be sustained for future generations.

John G. Surak, PhD Editor and project leader Clemson, South Carolina

Steven Wilson Co-editor Washington, D.C.

xv

Foreword to the Previous Handbook

The Quality Auditors HACCP Handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality audi-tors. It provides a description of the HACCP principles and a discussion of how these principles are applied to various segments of the food industry and the medical device industry.

HACCP is more than failure mode and effects analysis (FMEA) for food. It is a product safety management system that evolved and matured in the commercial food processing industry allowing food processors to take a proactive approach to prevent foodborne diseases. Over the years, HACCP has been slowly accepted by the food processing industry. In 1973, the United States Food and Drug Adminis-tration (FDA) published Low Acid Canned Food Regulations. These regulations were developed using the principles of HACCP. Later the FDA developed and published the Pasteurized Milk Ordinance, another set of regulations based on HACCP. In 1985, The Food and Nutrition Board of the National Research Coun-cil published two books recommending that HACCP be used as a product safety system to ensure the production of safe food. Since these landmark publications, HACCP has been incorporated into food regulations and customer purchasing requirements. Both the FDA and United States Department of Agriculture (USDA) have embraced HACCP as the most effective method to ensure farm-to-table food safety in the United States. Furthermore, with the incorporation of the seven prin-ciples of HACCP into the Codex Alimentarius Commission Food Hygiene stan-dard, HACCP has been embraced as the international standard for ensuring food safety. Recently, HACCP has expanded beyond the food processing industry and is being piloted in the medical device industry. The FDA is evaluating the pilot results to determine whether HACCP should be incorporated into medical device regulations.

This volume could not have been undertaken without the help of a cross- functional team. The contributors to this volume represent industry, regulatory, and academic sectors. They also represent a wealth of perspectives and experi-ences in processed foods, meat and poultry, seafood, dairy, food service, farm-ing, and medical devices. The contributors have applied HACCP to both large and small manufacturing operations and many have extensive international experi-ence in applying the HACCP principles in other cultural settings. I would like to give special thanks to three friends who helped edit this volume: Prosy Abarquez-Delacruz, Don Cripe, and Janice Smith. In addition, I would like to thank the fol-lowing professionals (listed alphabetically) who wrote chapters for this volume:

Prosy Abarquez-Delacruz, JD Jeff Kronenberg

Bill Bennet Michael Mihalic

Dana Coleman Mary Ann Platt

Kathryn Cooper Irwin Plonk

Nate Geary Jim Rushing, PhD

Kelly Karr Getty, PhD Marianne Smukowski

Bruce Haggar Len Steed

Michael Hernandez John G. Surak, PhD

Masaaki J. Hori Steve Wilson

I also would like to thank Robert Diaz, Suchart Choven, Michelle Iannucci, Andy Gould, Ed Nelson, Cliff Pappas, PhD, and John Rushing, PhD, for providing valu-able input to this volume. This volume would not have been possible without the leadership of the 19992000 chair of the Food, Drug, and Cosmetic Division of the American Society for Quality (ASQ), Ed Nelson. Ed utilized the divisions chair award to fund this project.

The Food, Drug, and Cosmetic Division of ASQ has taken leadership in pro-viding services to assist companies verifying HACCP programs. In 1999, the Divi-sion led the development of the ASQ Certified Quality Auditors (CQA) HACCP examination. The Divisions 2001 vision of resources for quality systems and lead-ership development in FDA-regulated industries inspired the undertaking of this book. As quality professionals, it is the Division memberships intent also to be part of the leadership efforts to implement safety in conjunction with quality and oper-ational excellence in all industries, such that each manufacturing and distribution firm has a house of safety and quality anchored in HACCP (hazard analysis criti-cal control points), good manufacturing practices (GMPs), quality management systems, and sanitation standard operating procedures (SSOPs). By institutional-izing these efforts, quality and safety will be sustained for generations to come.

John G. Surak, PhD Senior editor and project leader Clemson, South Carolina, USA

xvi Forward to the Previous Edition

1Part IAn Introduction to HACCP

Chapter 1 History and Overview of HACCP: Primitive and Modern Food Preservation Methods

Chapter 2 Tasks for HACCP Plan Development

2Chapter 1

History and Overview of HACCP: Primitive and Modern Food

Preservation Methods

Humans have been concerned with the availability of food from the dawn of their existence. Prehistoric humans were hunters and gatherers who needed to find and catch food. As time passed, humans began to grow and preserve their own food. And still later in history, humans became concerned with preparing, conserving, and maintaining a steady supply of food. Advances in social organization from small-group to large-group living and from nomadic hunting and gathering to communal life in a fixed place paralleled the need for a reliable source of food.

The methods for saving food for the proverbial rainy day may have begun with air drying, salting, and the use of spices and herbs, and then advanced to more sophisticated technologies such as canning and freezing. Advances in technology took thousands of years and many occurred by accident. Transfer of technology occurred slowly because of lack of communication and commerce among geographically dispersed societal groups.

However, as trade and communications increased, primitive food preserva-tion technologies were transferred from one culture to another. Two examples of this are (1) the drying of grain and the storage of those grains in large granaries in the Middle East and Africa and (2) the bringing of pasta, a different form of preserved grain, from China to Europe by the explorer Marco Polo. As commerce became more important, laws were developed to control the quantity and quality of traded goods, including food, as well as services. The first comprehensive writ-ten code was set down by Hammurabi, circa 2500 B.C. Later, laws were set forth in the Torah and the Holy Bible (see Leviticus, Chapter 11 and Deuteronomy, Chapter 7). Since all of the advances in food preservation technology are impossible to chronicle here, only some of the more important advances that have influenced modern techniques for making safe food available to all are discussed below. All modern methods are not new: primitive preservation methods such as drying, salting, and smoking are still used. Other currently used methods for preserving foods include heat preservation by canning in hermetically sealed containers, pas-teurization, freezing, freeze-drying, and air drying. The use of these preservation methods was the first documented preventive response to anticipated hazards. The anticipatory and preventive methodology that became known as HACCP began here.

Chapter 1: History and Overview of HACCP 3

HACCP PREDECESSORSAt some point, scientists discovered that microscopic organisms could cause food spoilage. This led to the theory that food could be preserved if the spoilage organ-isms could be destroyed and kept from reentering the food product. For this to occur, the temperature and water content of food had to be reduced to levels that would not support the growth of spoilage organisms. Louis Pasteur and Clarence Birdseye were leaders in food processing technology. Additionally, research in industrial areas unrelated to the production of food by quality gurus such as Walter A. Shewhart, Joseph M. Juran, and W. Edwards Deming was adapted by others and applied to the control of quality in the production and preservation of food.

One of the earliest collaborative efforts of industry and government addressed the problems of milkborne disease. In the 1920s, two industry associations and one professional association developed uniform standards for fittings used in dairy and food handling equipment. The standards for fittings became known as 3-A Standards. Since 1944, the 3-A Program has included representation from suppli-ers and equipment fabricators, all national dairy processing associations, the U.S. Department of Agriculture (USDA), the U.S. Public Health Service (USPHS), and state regulatory agencies.*

Milk safety was accomplished by controlling the following factors, which are elements of what is known today as the hazard analysis critical control point (HACCP) approach to product safety:

The health and sanitation of the dairy herd

The times of collection and temperatures of milk from collection to processing

The use of a terminal heat treatment to reduce microbial content

The standardization of equipment

The scrupulous cleaning of processing plant and equipment

The temperature of the processed product after pasteurization and while in transit and in storage

As the populace of the United States shifted from agrarian to urban living, there was an increasing need to process foods for mass transport and consumption in cities. The earlier emphasis on raw agricultural products shifted to processed products. Currently, food is prepared outside of the home for consumption in homes, restaurants, schools, hospitals, nursing homes, and prisons, aboard air-planes, ships, and trains, during camping or wartime, and even in space vehicles.

* More information about the 3-A Program is available online at: www.3-a.org/main.html. Hazard analysis critical control point. The terms hazard analysis critical control point

system or hazards analysis critical control point concept are used interchangeably.

4 Part I: An Introduction to HACCP

These new modes of consumption required the development of new methods for use in the preparation, packaging, and storage of foods to ensure the availability of food that is safe, nutritious, and wholesome.

HACCP AND THE SPACE PROGRAMIn the late 1950s, the National Aeronautics and Space Administration (NASA) saw the need for special foods for space travel.* The early space vehicles were small, and there was room for neither standard kitchen appliancesrefrigerator, stove, freezernor for the pantry, cupboards, and countertops commonly used for the storage and preparation of foods. In addition, concerns existed about the kinds of food that an astronaut could take on a space journey that would provide proper nutritional, gustatory, and safety properties. It was also important that the space vehicle and its contents not introduce harmful microorganisms into space.

Before the dawn of the space age, food quality and safety were controlled mainly by finished product inspection. But NASA wanted assurances that safety was built into the design of the food manufacturing process. In the early 1960s, the Pillsbury Company was asked to develop the first space foods, as well as to design a system for controlling the safety of space foods, used first for the Mercury flights and later for the Gemini and Apollo flights. NASA also was concerned about food crumbs floating in the cabin and fouling the instruments of the space vehicles. Pillsbury easily solved the crumb problem by coating bite-sized pieces of food to prevent crumbling. But they had a more daunting task in ensuring the bacterial quality of space foods.

To ensure that foods used in the space program were safe, Pillsbury devel-oped the hazard analysis critical control point (HACCP) system. HACCP was designed to prevent safety hazards. By systematically evaluating the ingredients, environs, and processes used to fabricate a food, identifying areas of potential risk, and determining the critical control points (that is, those points in the process that must be controlled to prevent an unacceptable risk), the manufacturer would have assurance of process and product integrity.

As the NASA flights became longer, additional logistical requirements chal-lenged Pillsbury to refine the HACCP system. Pillsbury collaborated with NASA and the U.S. Armys Natick Laboratories to develop HACCP as a proactive system for manufacturing and supplying safe foods for space travelers. By the time the Eagle landed and man set foot on the moon in 1969, Pillsbury had developed HACCP as we know it today (Figure 1.1).

In 1967 the U.S. Food and Drug Administration (FDA) and the food industry began a pilot self-certification program that was designed to incorporate HACCP concepts into the food manufacturing process. In addition, participants in the pilot program were required to share information about their products and pro-cesses and quality control, including planned changes, with the FDA. The over-all objectives were (1) to have the industry participants exercise more control over their operations and (2) to give the FDA a better view of the controls exercised

* More information about the U.S. space program is available online at: www.spaceflight.nasa.gov/history.

Chapter 1: History and Overview of HACCP 5

by the industry participants than a random inspection would allow. This pro-gram was ahead of its time. It was not politically correct then, so it felt the wrath of Congress and the consumer, neither of whom believed that industry was capa-ble of self-certifying. The FDA altered the program and eliminated the name self- certification, calling it instead, the cooperative quality assurance pro-gram. However, the revamped program (later discontinued) retained HACCP at its core.

APPLICATION OF HACCP TO OTHER INDUSTRIESIn the early 1970s, Pillsbury transferred the HACCP concept from the space pro-gram to production in its commercial food plants. This technology also was trans-ferred to the FDA in a contract for training FDA personnel in HACCP concepts. In the early 1960s, the State of Californias Department of Health Services pioneered the application of HACCP principles in its canning industry. It became the pro-totype for a regulation21 Code of Federal Regulations, Part 113promulgated by the FDA in the mid-1970s in response to an industry petition. This regulation, more commonly known as 21 CFR Part 113, incorporates HACCP concepts to

HACCP involves seven principles: Analyze hazards. Potential hazards associated with a food and measures to control those

hazards are identified. The hazards could be biological, such as a microbe, chemical, such as a toxin, or physical, such as ground glass or metal fragments.

Identify critical control points. These are points in a foods productionfrom its raw state through processing and shipping to consumption by the consumerat which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection.

Establish preventive measures with critical limits for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required to ensure the elimination of any harmful microbes.

Establish procedures to monitor the critical control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored.

Establish corrective action to be taken when monitoring shows that a critical limit has not been met. For example, reprocessing or disposing of food if the minimum cooking temperature is not met.

Establish procedures to verify that the system is working properly. For example, testing time-and-temperature recording devices to verify that a cooking unit is working properly.

Establish effective record keeping to document the HACCP system. This includes records of hazards and their control methods, the monitoring of safety requirements, and action taken to correct potential problems. Each of these principles must be backed by sound scientific knowledge, for example, published microbiological studies on time and temperature factors for controlling foodborne pathogens.

Figure 1.1 What is HACCP?Source: U.S. Food and Drug Administration. A State-of-the-Art Approach to Food Safety. FDA Backgrounder (August 1999).

6 Part I: An Introduction to HACCP

govern the production of low-acid canned foods in hermetically sealed contain-ers. HACCP is now mandatory in the FDA program for food safety for fish and shellfish (21 CFR Part 123) and other products.*

What made HACCP so popular after languishing for so long? After all, HACCP had been used in food processing plants since the late 1960s but had not been adopted on a large scale. Perhaps the climate was rightpublic health offi-cials were concerned about emerging pathogens and consumers and industry were concerned about food safety. These sectors with converging interests knew there had to be a better way to ensure the safety of foods. Similarly, the economy had become globalized and food safety had become an international, rather than simply a national, concern.

A succession of reports by three prestigious groups opened the door to HACCP on a global basis:

The National Academy of Sciences report Microbiological Criteria for Foods and Food Ingredients, 1985

Report of The International Commission for the Microbiological Specifications for Food (ICMSF), 1988

The Codex Commission on Food Hygienes Guidelines for the Application of the Hazard Analysis and Critical Control Point (HACCP) System, 1991, adopted by the Joint FAO/WHO Codex Commission, 20th Session, 1993.

Today, technology from the space meals systems has been transferred to the pri-vate sector and is being used in meal systems for the elderly. Regulators now require manufacturers of certain foods to use HACCP systems and will probably require HACCP systems for additional foods in areas where food safety prob-lems become apparent. U.S. Congressional committees with oversight of federal agency programs will watch closely as HACCPs proactive system of hazard iden-tification and prevention is integrated into these agencies industry requirements. Over time these actions at the federal level may lead to the adoption of HACCP by the entire food industry. In anticipation of this, some sectors of the food industry have adopted HACCP voluntarily as they gain a greater appreciation of its advan-tages in preventing food safety problems. HACCP has proven to be an effective system for preventing foodborne diseases and increasing the safety of foods. This knowledge has influenced other industries regulated by the FDA. Currently, the seven principles of HACCP are being applied on a pilot scale in the medical device industry to increase the safety of their products.

* More information about the National Food Safety Initiative and HACCP in the federal government is available online at: vm.cfsan.fda.gov/list.html.

More information on meal systems for the elderly is available online at: www.jsc.nasa.gov/pao/spinoffs/mealsys.html.

287

Index

Aacidification, 47agricultural chemical control, as prerequisite

program, 161agricultural water, 195AIB International, 156air safety, as prerequisite program, 170allergen control, as prerequisite program,

161 62for dairy products, 192

allergen review, in hazard identification, 3233

allergens, 21, 153American Society for Quality Code of Ethics,

129, 26768 (Appendix G)analysis, of audit results, 12122analysis and testing, in verification, 65ANSI/ASQ Z1.4-2003, Sampling Procedures and

Tables for Inspection by Attributes, 144ANSI/ISO/ASQ QE19011S-2004, Guidelines for

quality and/or environmental management systems auditing, 11

audit, HACCP. See HACCP auditaudit and observation, in verification, 65audit checklists, 8990, 107

National Marine Fisheries Service, 10911audit escort, 116, 119audit findings, 122, 123audit results, analysis of, 12122audit strategy, 1067audit teams, 105auditing, of HACCP team assembly and

maintenance, 811auditor, HACCP. See HACCP auditorauditor liability, 130audits, and inspection programs, as

prerequisite program, 172

Bbacteria, in seafood, 18283Baking Industry Sanitation Standards

Committee (BISSC), 165

biological hazardsin dairy products, 190in food, 15053in fruits and vegetables, 19394in meat and poultry, 17677medical device, 22in seafood, 18284

bird controls, 167block sampling, 144Body of Knowledge for the Certified HACCP

Auditor (Appendix H), 26977

Ccalibration

equipment, as prerequisite program, 171in verification, 65, 180

calibration log, equipment, 74Canadian Food Inspection Agency, 40

decision tree, 44capability indices, 140case study, 19899cause-and-effect diagram, 134CCP. See critical control pointcentral tendency, of data, 132certificate of analysis (COA), 3132, 38certificate of conformance, supplier, 71Certified HACCP Auditor, xiiiCFR. See Code of Federal Regulationscheck sheet, 13536checklist, audit, 107chemical control, as prerequisite program,

15962chemical hazards

critical limits, 52in dairy products, 190in food, 21, 153, 159in fruits and vegetables, 194marine biotoxins, 184in meat and poultry, 17677medical device, 22in seafood, 184

chemical limits, as critical limit, 52chemicals

288 Index

to control microorganisms, 15152in food processing plants, 152in food products, 15152

chilling, as CCP, 39cleaning, to control microorganisms, 152cleaning and sanitation, as prerequisite

program, 163for dairy products, 19192

closeout, HACCP audit, 12326COA. See certificate of analysisCode of Federal Regulations, 193

21 CFR Part 110, 155, 185, 18721 CFR Part 113, 5621 CFR Part 123, 6, 155, 185, 18721 CFR Part 820.20, 211

Codex Alimentarius Commission, 6, 51, 93decision tree, 40, 41Food Hygiene standard, xvHACCP Guidelines, 186, 25763

(Appendix E)seven principles, 99

cold, to control microorganisms, 151competency, of HACCP auditor, 12829confidentiality, in HACCP audit, 130conflict of interest, in HACCP audit, 130contamination, 15054

prevention of, 15859, 16465continuous improvement, 14041continuous monitoring, 5657, 64control chart, 13639control measures, identification of, 33control points

versus critical control points, 3738definition, 37 determining, 3750

cooking, as CCP, 39corrective action, 5961

definition, 59documentation of, 60in food service, 2034FSIS requirements, 179goals of, 5961in HACCP audit, 12526meat and poultry, FSIS requirements,

17980as QA tool, 14142in retail operations, 2034steps, 60

corrective action plans, 61corrective action records, 69

review of, 65corrective action report, 76corrective action request

example, 11213in HACCP audit, 12526

Cp, 140Cpk, 140

critical control points (CCPs), 21, 3750common sources of, 3840versus control points, 3738 controlling factors, as control measures,

37decision tree, 48definition, 37determination form, 46determining, 3750distribution, 40documenting, 50and ECPs, 212food service, 2023identifying, 4049ingredient receiving and handling, 39for meat and poultry, 178misidentification, factors in, 49monitoring, 10, 63packaging, 3940versus prerequisite programs, 1617processing, 39raw materials, 38retail, 2023

critical limits (CL)and corrective action, 59definition, 51establishing, 5153food service, 203for meat and poultry, 178versus operational limits, 52retail, 203

cultural factors, in HACCP auditing, 129customer complaintsfood safety, as

prerequisite program, 171

Ddairy, 18992

controlling risks through prerequisite programs, 19092

safety regulations in, 18990types of hazards, 190

datacentral tendency of, 132dispersion of, 13233

data collection, 5556, 181HACCP audit, 11721in monitoring, 5556qualifications for, 58

data recording, 56data sheet, temperature, 57decision tree

Canadian Food Inspection Agency, 44CCP, 48Codex Alimentarius, 41considerations when selecting, 4047

Index 289

medical device, 45NACMCF, 42, 43raw material, 38using, 4749

decomposition, 149defective action points (DAPs), 186delayed treatment hazards, medical device,

22design control, for medical devices, 21012desk audit, 10814deviations, identifying causes of, 60discovery audit method, 106disease control, and personal hygiene, 157diseases, foodborne, 154dispersion, of data, 13233distribution, as CCP, 40DMAIC (definemeasureanalyzeimprove

control) methodology, 141document review, in HACCP audit, 117documentation

in food service, 204of hazard analysis, 36in retail operations, 204

documentation errors, preventing, 84documentation system, design of, 7784dry labbing, 84

EE. coli O517:H7, 102economic integrity, 18788ECP. See essential control pointelectrical hazards, medical device, 22element audit method, 107employee health and hygiene, as audit focus,

197employee training, in food service and retail

operations, 205employee training record, 81end user of product, describing, 1213Enforcement Reports, FDA, 31environmental hazards, medical device, 22environmental monitoring, in

microbiological control, 164Environmental Protection Agency (EPA), 160,

186, 194drinking water regulations, 169seafood jurisdiction, 186

equipment calibrationas prerequisite program, 171in verification, 180

equipment performance, prerequisite program for dairy products, 191

equipment validation letter, 80errors, documentation, preventing, 84escort, audit, 116, 119

essential control point (ECP), 37, 212decision tree for medical devices, 45

ethics, in HACCP auditing, 12930European Union design standards, 165exit meeting, HACCP audit, 12223explosion hazards, medical device, 22external review, in verification, 66

Ffailure mode and effects analysis (FMEA),

21517component, 216

fault tree analysis (FTA), 215FDA. See Food and Drug AdministrationFDA Bad Bug Web site, 150field sanitation, as audit focus, 196findings, audit, 122, 123finished product report, 75Fish and Fishery Products Hazards and Controls

Guide, 185, 186FMEA. See failure mode and effects analysisfollow-up, HACCP audit, 12326food, changes to, beneficial and detrimental,

14950Food and Drug Administration (FDA), 3

Enforcement Reports, 31food contamination policy, 15354, 158and HACCP, 45regulatory history, xvand seafood regulations, 18586

Food and Nutrition Board, of National Research Council, xv

food components, 148food hazards, 17, 2021

Appendix A, 22224sources and types, 14854

food industry, HACCP in, 14854food components, 148new foodborne diseases and new

technologies, 154sources and types of food hazards, 14854

food preservation methodsmodern, 36primitive, 2

food process flows, 2012food safety

customer complaints, 171dairy, 18990training, as prerequisite program, 17071

Food Safety and Inspection Service (FSIS)meat and poultry processing

requirements, 17475, 178, 179, 180, 181

SSOPs for meat and poultry, 155food service. See retail and food service

290 Index

foreign material control, as GMP, 15859forms, modifying versus creating, 7782formulation control, as CCP, 39Freedom of Information Act (FOIA), and

product recalls, 31fresh-cut processing facilities, as audit focus,

197fruits and vegetables, 19399

case study, 19899defining GAPs and GMPs, 193hazards associated with, 19394significance of GAPs, GMPs, and HACCP

in auditing, 19498third-party verification of GAPs, GMPs,

and HACCP implementation, 198FSIS. See Food Safety and Inspection Service

GGAPs. See good agricultural practicesGMPs. See good manufacturing practicesglass control, as GMP, 15859good agricultural practices (GAPs)

defining, 193FDA regulations, 208significance of in auditing, 19498third-party verification of, 198

good manufacturing practices (GMPs)defining, 193establishment of, 155and food safety, 15657foreign material control, 15859glass control, 15859good operational practices, 15758personal hygiene, 157as prerequisite program, 15657for seafood, 187significance of in auditing, 19498third-party verification of, 198

good operational practices, as GMP, 15758Guide to Inspections of Quality Systems, 217Guide to Minimize Microbial Food Safety

Hazards for Fresh Fruits and Vegetables, 155

Guidelines for Application of HACCP Principles, 97

Guidelines for the Application of the Hazard Analysis and Critical Control Point (HACCP) System, 6

HHACCP (hazard analysis critical control

point) systemapplication to medical devices, 21417

and economic integrity, 18788history, xv, 26in medical device industry, 208and pathogen reduction final rule, 174predecessors, 34versus quality programs, 18687reasons for implementing, 7and the space program, 45

HACCP audit, 10226conducting, 11426format, 104preparation, 10414scope, 1023types, 1024

HACCP auditor, 12831competencies, 12829ethics, 12930and illegal activities, 13031liability, 130significance of GAPs, GMPs, 19498and unsafe activities, 13031

HACCP implementation, third-party verification, 198

HACCP planassessing need for, 7development, for meat and poultry,

17581maintenance, 9799operational qualification, 9496reevaluation of, 61

HACCP plan developmentand implementation, in retail and food

service, 200204preliminary tasks for, 815tasks for, 717

HACCP plan form, 219HACCP plan implementation and

maintenance, 8699companywide deployment, 9697extending HACCP system to the supply

chain, 99HACCP plan maintenance, 9799HACCP team formation and training,

9194operational qualification of HACCP plans,

9496pilot projects, 9496reasons for, 8687supporting structures for, 8690

HACCP Plan Review Checklist, 97HACCP principles, compared to quality

system regulation, 209HACCP principles, in design and

manufacture of medical devices, 20819

application of HACCP to medical devices, 21417

Index 291

design control, 21012history of HACCP in medical device

industry, 208manufacturing processes, 21214QSIT inspection techniques, 217risk management, 20810

HACCP Principles Guide for Operators of Food Establishments at the Retail Level, 202

HACCP Quality Management Program (HACCP QMP), 186

HACCP regulations, seafood, in United States, 18586

HACCP system audit, 11HACCP system standard, 1112HACCP team

assembly and maintenance, 811formation, 9192training, 9294

HACCP training, 187Hammurabi, code of, 2hazard analysis, 2036

documentation of, 36of food, questions to ask when

conducting, 2325in food service operations, 2012FSIS requirements, 176to identify allergens, 16162for meat and poultry, 17677of medical devices, questions to ask when

conducting, 2527performing, 2236purpose of, 20raw material, documentation, 30in retail operations, 20102

hazard analysis worksheet, 218hazard evaluation, 2223, 3336hazard identification, 22, 2733hazards

dairy, 190food, sources and types, 14854in fruits and vegetables, 19394medical device, 22in seafood, 18285types of, 2022

hazards in food (Appendix A), 22224hazards in medical devices (Appendix B),

225heat, to control microorganisms, 15051histogram, 135history and overview of HACCP, 26

application of HACCP to other industries, 56

HACCP and the space program, 4HACCP predecessors, 34

hold and test programs, 38house of product safety, 15, 16

Iillegal activities, in HACCP audit, 13031implementation, of HACCP system. See

HACCP plan implementation and maintenance

implementation responsibilities, for HACCP system, 88

ingredient receiving and handling, as CCP, 39

insect controls, 167inspection log, label room, 73inspection programs, and audits, as

prerequisite program, 172intended use of product, describing, 1213International Commission for the

Microbiological Specifications for Food (ICMSF), 6

interviews, in HACCP audit, 11819ISO 9001, 91, 99, 186ISO 14971-1:1998, Medical devicesrisk

management, 210ISO 22000:2005, Food safety management

systemsRequirements for any organization in the food chain (Appendix F), 26466

ISO 22004:2005, Food safety management systemsGuidance on the application of ISO 22000:2005, 227

ISO certification, and hazard identification, 29

Jjudgmental sampling, 144

Llaboratory report, 78liability, auditor, 130Low Acid Canned Food Regulations, xv

Mmaintenance, of HACCP plan, 9799maintenance, prerequisite program for dairy,

191maintenance chemical control, as

prerequisite program, 16061management commitment, in HACCP

implementation, 8687, 187management training, in food service and

retail operations, 205manufacturing process instructions (MPIs),

213

292 Index

manufacturing processes, 21214process audits, 21314process flowcharts, 213quality requirements, 213risk-based assessment, 21213

marine biotoxins, in seafood, 184materials

handling of, 29physical state of, 2829

measurement monitoring, 56meat and poultry, 17481

HACCP plan development, 17581processing categories, 17475

mechanical control, of food hazards, 152medical device hazards, 22, 225 (Appendix B)medical devices

application of HACCP to, 21417decision tree, 45HACCP principles in design and

manufacture, 20819microbiological control, as prerequisite

program, 16364Microbiological Criteria for Food and Food

Ingredients, 6microbiological hazards

control of, as prerequisite program, 16364

critical limits, 52in food, 2021

microbiological testing, as critical limit, 52microorganisms, as food hazard, 15052MIL-STD 105E Sampling Procedures and Tables

for Inspection by Attributes, 144milk, hazard identification, 2728milk safety, 3, 18990misdiagnosis hazards, medical device, 22model HACCP plans, 35monitoring

continuous versus intermittent, 5657definition, 54meat and poultry, FSIS requirements, 179by measurement, 56by observation, 56

monitoring points, determining, 5758monitoring procedures, 5458

examples, 54for food service, 203for retail, 203

monitoring records, 69review of, 6465

muscle classification, 148

NNACMCF. See National Advisory Committee

on Microbiological Criteria for Foods

NACMCF 1997 HACCP Guideline, 156NACMCF Guidelines for Application of HACCP

Principles, 197NACMCF HACCP Guidelines (Appendix D),

22963Appendix D.A, 24647Appendix D.B, 247Appendix D.C, 24851Appendix D.D, 25152Appendix D.E, 253Appendix D.F, 254Appendix D.G, 25556Appendix D.H, 256definitions, 23233executive summary, 231guidelines for application of HACCP

principles, 23344HACCP principles, 233implementation and maintenance of the

HACCP plan, 245NASA. See National Aeronautics and Space

Administration (NASA)National Academy of Sciences, 6National Advisory Committee on

Microbiological Criteria for Foods (NACMCF), 51, 87, 93, 97, 99

decision trees, 40, 4243HACCP guidelines, 1516as reference, 96

National Aeronautics and Space Administration (NASA), 4

National Conference on Interstate Milk Shipments (NCIMS), 189

National Food Processors Association, 151National Marine Fisheries Service (NMFS),

186audit checklist, 10911

National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP), 186

National Research Council, xvNational Restaurant Association Educational

Foundation, ServSafe guidelines, 201National Sanitary Foundation (NSF) design

standards, 165noncontinuous monitoring, 6465non-spore-forming pathogens, 20Notice of Unusual Occurrence and

Corrective Action (NUOCA), 60

Oobservation

as data collection, 56in HACCP audit, 11921

observation monitoring, 56

Index 293

ongoing assessment, in verification, 6365opening meeting, HACCP audit, 11517operating characteristic (OC) curve, 145operational limits

versus critical limits, 52establishing, 53

operational prerequisite program, 37operational sanitation, 155operations teams, 9192

Ppackaging, as CCP, 3940packing facility sanitation, as audit focus, 197parasites, in seafood, 184Pareto analysis, 13334pasteurization, 47, 151, 169, 178, 18990, 191Pasteurized Milk Ordinance, xvpathogen reduction final rule, USDA/FSIS,

174pathogenic microorganisms, 2021pathogens, 15051performance quality hazards, medical

device, 22personal hygiene

as audit focus, 197as GMP, 157

pest control, as prerequisite program, 16667pesticide use, as audit focus, 195pesticides

control, as prerequisite program, 160in insect and rodent control, 152

PFMEA. See process failure mode and effects analysis

pH, in controlling microorganisms, 15152physical control, of food hazards, 152physical hazards

critical limits, 53in dairy products, 190in food, 21, 15354in fruits and vegetables, 194in meat and poultry, 17677medical device, 22in seafood, 185

Pillsbury Companyand HACCP, 5space foods development, 4

pilot projects, 9496plandocheckact (PDCA) cycle, 141Polo, Marco, 2possibility versus probability, 3536poultry, and meat, 17481

HACCP plan development, 17581processing categories, 17475

premises, prerequisite program for dairy, 191preoperational procedures, 155

prerequisite program(s)auditing, 11920categories, 8990versus CCPs, 1617controlling risks through, 19092dairy, 189establishing, 1517evolution of, 15556in HACCP implementation, 8990for seafood, 187

prerequisite programs, types ofair safety, 170audits and inspection programs, 172chemical control, 15962cleaning and sanitation, 163customer complaintsfood safety, 171equipment calibration, 171food safety training, 17071good manufacturing practices (GMPs),

15659microbiological control, 16364pest control, 16667preventive maintenance, 16566receiving, storage, and shipping controls,

16768sanitary design and engineering, 16465supplier control, 16869trace and recall, 166water safety, 16970

preventive action, as QA tool, 14142preventive maintenance, as prerequisite

program, 16566probability of risk, in hazard evaluation,

3436probability versus possibility, 3536process aid chemical control, as prerequisite

program, 160process audit, for medical devices, 21314process audit documents summary, 213process audit observations sheet, 214process failure mode and effects analysis

(PFMEA), 212, 21517process flow diagram

developing, 13and HACCP plan development, 17576verifying accuracy of, 1315

process flowchart, for medical device manufacture, 213

process owners, 9192process review, in hazard identification,

3132process validation letter, 79processing, as CCP, 39processing log, 72processing water, 19596product

contamination, 38

294 Index

description and distribution, 1112transport of, as audit focus, 19798

product disposition, determining, 60product recalls, 35, 166

and Freedom of Information Act (FOIA), 31

product safetyauditing system, HACCP audit as, 1024policies and objectives, 8788

production site, as audit focus, 195proprietary information, in HACCP audit,

130

Qqualitative index, 56quality assurance analytical tools, 13245

attribute data versus variable data, 13233capability indices, 140cause-and-effect diagram, 134check sheet, 13536continuous improvement, 14041control chart, 13639corrective action, 14142flowchart (flow diagram), 133histogram, 135Pareto analysis, 13334preventive action, 14142sampling, 14245scatter diagram, 135variable data versus attribute data, 13233

quality programs, versus HACCP, 18687quality requirements, for medical devices,

213quality system inspection technique (QSIT),

217quality system regulation (QSR), 211quantitative index, 56

Rradiation, to control food hazards, 15253radiation hazards, medical device, 22random sampling, 142raw materials

as CCPs, 38decision tree, 38evaluation sheet, 70hazard identification, 2831sensitive, 28

recall, 35for dairy products, 192of product, 31and trace, 166

receiving controls, 16768for allergens, 162for dairy products, 191as prerequisite program, 16768

for dairy products, 191recipe categorization, 201record keeping

balanced approach versus overkill approach, 82

in food service, 204forms, modifying versus creating, 7782importance of, 67indirect benefits, 68internal benefits, 67meat and poultry, FSIS requirements,

18081and regulatory compliance, 68in retail operations, 204simplified versus complex records,

8283record keeping system, design of, 7784record review, in HACCP audit, 11718records, 6465

complex versus simplified, 8283computerized versus manual, 8384corrective action, 69manual versus computerized, 8384monitoring, 69simplified versus complex, 8283types of, 6877

corrective action records, 69monitoring records, 69verification records, 6977

regulatory compliance, of record keeping, 6869

report, HACCP audit, 12326responsibilities, in HACCP plan

implementation, 9retail and food service, 200205

HACCP plan development and implementation, 200204

integrating HACCP in, 200management and employee training, 205

retailers, as audit focus, 198retort, 47revalidation, in verification, 6566rework, as CCP, 39rework project, 14ripening facilities, as audit focus, 197risk, 3336

controlling through prerequisite programs, 19092

risk analysis, 210risk assessment, as continuous process, 102risk management, for medical devices,

20810

Index 295

risk priority number (RPN), 217risk-based assessment, of medical devices,

21213rodent controls, 167root cause analysis, 60

Ssafe handling instructions, 12safety, as process audit focus, 214safety regulations, in dairy industry, 18990sampling

as QA tool, 14245records, 118

sanitary design and engineering, as prerequisite program, 16465

sanitary facilities, as audit focus, 196sanitation and cleaning

packing facility, as audit focus, 197as prerequisite program, 163

for dairy products, 19192sanitation chemical handling, as prerequisite

program, 15960sanitization, to control microorganisms,

152scatter diagram, 135seafood, 18288

applied HACCP versus quality, 18687HACCP and economic integrity, 18788HACCP regulations in the United States,

18586industry description, 182sources of hazards, 182 85

Seafood HACCP Encore Course, 186Seafood HACCP Regulation, 155second-party verification, 98self-inspection, to control physical hazards,

158sensitive raw material, 28ServSafe guidelines, National Restaurant

Association Educational Foundation, 201

seven principles of HACCP, 10for meat and poultry plans, 174in pilot programs, 9596

severity of risk, in hazard evaluation, 3334shipping controls, as prerequisite program,

16768site audit, 29soft drinks, hazard identification, 2728space foods, 4space program, and HACCP, 4spoilage, 150spore-forming pathogens, 2021standard deviation, 13233

standard operating procedures, to control physical hazards, 158

standard sanitation operating procedures (SSOPs)

as prerequisite program, 155, 187and record keeping, 83for seafood, 187

State of California Department of Health Services

Food and Drug Branch, 185and HACCP, 5

steering team, 91storage controls, as prerequisite program,

16768for dairy products, 191

storage facilities, as audit focus, 197stratified sampling, 14244subject matter experts (SMEs), in HACCP

audit, 105supplier control, as prerequisite program,

16869for dairy products, 191

supply chain, extending HACCP system to, 99

Ttasks for HACCP plan development, 717

assessing the need for a HACCP plan, 7establishing the prerequisite program,

1517preliminary tasks for HACCP plan

development, 815technology, new, to control food hazards, 154temperature, of food products, 15051testing and analysis, in verification, 65third-party verification, 983-A Program, dairy standards, 3, 165tools and equipment, as process audit focus,

214total quality control (TQC) points, 213, 214total quality management (TQM), 91trace and recall, as prerequisite program, 166trace backward audit method, 106trace forward audit method, 106training

and controls, 162dairy personnel, 192and documentation, 84employee, in food service and retail

operations, 205food safety, as prerequisite program,

17071HACCP, 187of HACCP team, 9294

296 Index

management, in food service and retail operations, 205

training record, employee, 81transport of packed product, as audit focus,

19798

UU.S. Armys Natick Laboratories, 4U.S. Customs Service, 186U.S. Department of Agriculture (USDA), xv

requirements in food industry, 86seafood jurisdiction, 186

U.S. Department of Commerce, 186U.S. Environmental Protection Agency

(EPA). See Environmental Protection Agency

U.S. Food and Drug Administration. See Food and Drug Administration

U.S. Public Health Service (USPHS), 3unsafe activities, in HACCP audit, 13031USDA/FSIS

HACCP and pathogen reduction final rule, 174

regulatory requirements, 97SSOPs for meat and poultry, 155

Vvalidation, in verification, 63verification, 9799, 180

definition, 62in food service, 204formal, 97, 98meat and poultry, FSIS requirements,

180ongoing assessment, 6365in retail operations, 20revalidation, 6566

verification, types of, 6266ongoing assessment, 6365revalidation, 6566validation, 63

verification audits, 65steps of, 9899

verification process, objectives of, 62verification records, 6977

review of, 65verification reports, 63viruses, in seafood, 18384

Wwater, as audit focus, 19596water activity (Aw), in controlling

microorganisms, 151water safety, as prerequisite program,

16970

Zzoonotic microorganisms, 148