The Certified HACCP

Auditor Handbook
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ASQ Quality Press
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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 ASQ
All rights reserved. Published 2006
Printed in the United States of America
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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)
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3. Food handlingSafety measuresHandbooks, manuals, etc. 4. Food industry
and tradeSafety measuresHandbooks, manuals, etc. I. Surak, John G. II. Wilson,
Steven, 1959.
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ISBN-13: 978-0-87389-706-8
ISBN-10: 0-87389-706-4
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v
Table of Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Foreword 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
HACCP and the Space Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Application of HACCP to Other Industries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 2 Tasks for HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . 7
Assessing the Need for a HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Preliminary Tasks for HACCP Development . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Assembling the HACCP Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Describing the Product and Its Distribution . . . . . . . . . . . . . . . . . . . . . . . . 11
Describing the Intended Use and End User . . . . . . . . . . . . . . . . . . . . . . . . 12
Developing a Process Flow Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Verifying the Accuracy of the Process Flow Diagram. . . . . . . . . . . . . . . . 13
Establishing the Prerequisite Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Part II Principles of HACCP
Chapter 3 Principle #1Conduct Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . 20
Purpose of Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Food Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Medical Device Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Performing a Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Hazard Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Documentation and Ongoing Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Chapter 4 Principle #2Determine Critical Control Points. . . . . . . . . . . . . . . 37
Distinguishing between Critical Control Points and Control Points. . . . . . . . 37
Common Sources of Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Raw Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
vi Table of Contents
Ingredient Receiving and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Identifying Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Considerations When Selecting a Decision Tree. . . . . . . . . . . . . . . . . . . . . 40
Using a Decision Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Factors Leading to CCP Misidentification . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Documenting Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Chapter 5 Principle #3Establish Critical Limits . . . . . . . . . . . . . . . . . . . . . . . 51
What Are Critical Limits?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Establishing Critical Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Microbiological. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Establishing Operational Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Chapter 6 Principle #4Establish Monitoring Procedures . . . . . . . . . . . . . . . 54
What Is Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Collecting Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Monitoring by Observation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Monitoring by Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Recording Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Continuous versus Intermittent Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Determining Monitoring Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Qualifications of the Person Collecting the Data . . . . . . . . . . . . . . . . . . . . . . . . 58
Chapter 7 Principle #5Establish Corrective Action Procedures . . . . . . . . . . 59
What Is Corrective Action? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Goals of Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Identifying Causes of Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Determining Product Disposition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Recording the Corrective Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reevaluating the HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Corrective Action Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Chapter 8 Principle #6Establish Verification Procedures . . . . . . . . . . . . . . . 62
Objectives of the Verification Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Types of Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Ongoing Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Revalidation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
External Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Chapter 9 Principle #7Establish Record Keeping and
Documentation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Importance of Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Internal Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Table of Contents vii
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Indirect Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Types of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Monitoring Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Corrective Action Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Verification Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Designing a Record Keeping/Documentation System . . . . . . . . . . . . . . . . . . . 77
Modifying Existing Forms versus Creating New Forms. . . . . . . . . . . . . . 77
Balanced Approach versus Overkill Approach. . . . . . . . . . . . . . . . . . . . . . 82
Simplified versus Complex Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Computerized versus Manual Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Preventing Documentation Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Part III Implementing HACCP
Chapter 10 HACCP Plan Implementation and Maintenance . . . . . . . . . . . . . . 86
Supporting Structures for HACCP Implementation . . . . . . . . . . . . . . . . . . . . . 86
Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Product Safety Policies and Objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
HACCP Team Formation and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Team Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Team Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Pilot Projects/Operational Qualification of HACCP Plans. . . . . . . . . . . . . . . . 94
Companywide HACCP Deployment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
HACCP Plan Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Extending the HACCP System to the Supply Chain . . . . . . . . . . . . . . . . . . . . . 99
Part IV Auditing HACCP Systems
Chapter 11 The HACCP Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
HACCP Auditing As a Product Safety Auditing System . . . . . . . . . . . . . 102
Audit Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Audit Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Conducting the Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Opening Meeting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Collection of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Analysis of Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Exit Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Audit Report, Follow-Up, and Closeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Chapter 12 The HACCP Auditor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Auditor Competencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Conflict of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
viii Table of Contents
Proprietary Information and Confidentiality . . . . . . . . . . . . . . . . . . . . . . . 130
Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Illegal or Unsafe Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Chapter 13 Quality Assurance Analytical Tools . . . . . . . . . . . . . . . . . . . . . . . . . 132
Measurement of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Pareto Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Cause-and-Effect Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Scatter Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Check Sheets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Control Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Capability Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Continuous Improvement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Corrective Action/Preventative Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Part V Applying HACCP to the Food Processing Industry
Chapter 14 Food Industry in General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Food Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Sources and Types of Food Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Biological Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
New Foodborne Diseases and New Technologies . . . . . . . . . . . . . . . . . . . . . . . 154
Chapter 15 Prerequisite Areas for Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Evolution of Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Types of Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Good Manufacturing Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Chemical Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Cleaning and Sanitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Microbiological Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Sanitary Design and Engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Trace and Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Pest Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Receiving, Storage, and Shipping Controls . . . . . . . . . . . . . . . . . . . . . . . . . 167
Supplier Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Water Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Air Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Food Safety Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Equipment Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Customer ComplaintsFood Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Audits and Inspection Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Table of Contents ix
Chapter 16 Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Processing Categories for Meat and Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
HACCP Plan Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Critical Control Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Critical Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Corrective Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Chapter 17 Seafood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Description of the Seafood Industry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Sources of Hazards Specific to Seafood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Biological HazardsBacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Biological HazardsViruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Biological HazardsParasites. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Chemical HazardsMarine Biotoxins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Physical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
HACCP Regulations in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Applied HACCP versus Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Prerequisite Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
HACCP Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
HACCP and Economic Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Chapter 18 Dairy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Safety Regulations in the Dairy Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Types of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
Controlling Risks Through Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . 190
Supplier Control Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Receiving/Storage Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Premises, Equipment Performance, and Maintenance Program . . . . . . . 191
Cleaning and Sanitation Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Recall Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Allergen Control Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Personal Training Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Chapter 19 Fruits and Vegetables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Defining GAPs and GMPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Hazards Associated with Handling Fresh Produce. . . . . . . . . . . . . . . . . . . . . . 193
Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Significance of GAPs, GMPs, and HACCP for the Auditor. . . . . . . . . . . . . . . . 194
Production Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Pesticide Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
x Table of Contents
Field Sanitation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Sanitary Facilities in the Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Sanitary Facilities in Packinghouses and Processing Plants. . . . . . . . . . . 196
Employee Health and Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Packing Facility Sanitation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Fresh-Cut Processing Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Storage and Ripening Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Transport of Packed Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Retailers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Third-Party Verification of GAPs, GMPs, and HACCP Implementation . . . . 198
Case StudyThe Implementation of a HACCP Program in a
Fresh-Market Tomato Handling Organization. . . . . . . . . . . . . . . . . . . . . . . . 198
Chapter 20 Retail and Food Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
Integrating HACCP in Retail and Food Service Operations. . . . . . . . . . . . . . . 200
HACCP Plan Development and Implementation . . . . . . . . . . . . . . . . . . . . . . . . 200
Hazard Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Critical Control Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Critical Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Verification Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Record 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. . . . . . . . . . . . . . . . . . 208
Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Design Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Manufacturing Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Risk-Based Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Quality Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Develop Process Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Process Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Application of HACCP to Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Quality 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
xiii
Foreword
H
ACCP 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
T
he 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
1
Part I
An Introduction to HACCP
Chapter 1 History and Overview of HACCP:
Primitive and Modern Food
Preservation Methods
Chapter 2 Tasks for HACCP Plan Development

2
Chapter 1
History and Overview of HACCP:
Primitive and Modern Food
Preservation Methods
H
umans 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 PREDECESSORS
At 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 PROGRAM
In 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 INDUSTRIES
In 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
A
acidification, 47
agricultural chemical control, as prerequisite
program, 161
agricultural water, 195
AIB International, 156
air safety, as prerequisite program, 170
allergen control, as prerequisite program,
161 62
for dairy products, 192
allergen review, in hazard identification,
3233
allergens, 21, 153
American Society for Quality Code of Ethics,
129, 26768 (Appendix G)
analysis, of audit results, 12122
analysis and testing, in verification, 65
ANSI/ASQ Z1.4-2003, Sampling Procedures and
Tables for Inspection by Attributes, 144
ANSI/ISO/ASQ QE19011S-2004, Guidelines for
quality and/or environmental management
systems auditing, 11
audit, HACCP. See HACCP audit
audit and observation, in verification, 65
audit checklists, 8990, 107
National Marine Fisheries Service, 10911
audit escort, 116, 119
audit findings, 122, 123
audit results, analysis of, 12122
audit strategy, 1067
audit teams, 105
auditing, of HACCP team assembly and
maintenance, 811
auditor, HACCP. See HACCP auditor
auditor liability, 130
audits, and inspection programs, as
prerequisite program, 172
B
bacteria, in seafood, 18283
Baking Industry Sanitation Standards
Committee (BISSC), 165
biological hazards
in dairy products, 190
in food, 15053
in fruits and vegetables, 19394
in meat and poultry, 17677
medical device, 22
in seafood, 18284
bird controls, 167
block sampling, 144
Body of Knowledge for the Certified HACCP
Auditor (Appendix H), 26977
C
calibration
equipment, as prerequisite program, 171
in verification, 65, 180
calibration log, equipment, 74
Canadian Food Inspection Agency, 40
decision tree, 44
capability indices, 140
case study, 19899
cause-and-effect diagram, 134
CCP. See critical control point
central tendency, of data, 132
certificate of analysis (COA), 3132, 38
certificate of conformance, supplier, 71
Certified HACCP Auditor, xiii
CFR. See Code of Federal Regulations
check sheet, 13536
checklist, audit, 107
chemical control, as prerequisite program,
15962
chemical hazards
critical limits, 52
in dairy products, 190
in food, 21, 153, 159
in fruits and vegetables, 194
marine biotoxins, 184
in meat and poultry, 17677
medical device, 22
in seafood, 184
chemical limits, as critical limit, 52
chemicals
288 Index
to control microorganisms, 15152
in food processing plants, 152
in food products, 15152
chilling, as CCP, 39
cleaning, to control microorganisms, 152
cleaning and sanitation, as prerequisite
program, 163
for dairy products, 19192
closeout, HACCP audit, 12326
COA. See certificate of analysis
Code of Federal Regulations, 193
21 CFR Part 110, 155, 185, 187
21 CFR Part 113, 56
21 CFR Part 123, 6, 155, 185, 187
21 CFR Part 820.20, 211
Codex Alimentarius Commission, 6, 51, 93
decision tree, 40, 41
Food Hygiene standard, xv
HACCP Guidelines, 186, 25763
(Appendix E)
seven principles, 99
cold, to control microorganisms, 151
competency, of HACCP auditor, 12829
confidentiality, in HACCP audit, 130
conflict of interest, in HACCP audit, 130
contamination, 15054
prevention of, 15859, 16465
continuous improvement, 14041
continuous monitoring, 5657, 64
control chart, 13639
control measures, identification of, 33
control points
versus critical control points, 3738
definition, 37
determining, 3750
cooking, as CCP, 39
corrective action, 5961
definition, 59
documentation of, 60
in food service, 2034
FSIS requirements, 179
goals of, 5961
in HACCP audit, 12526
meat and poultry, FSIS requirements,
17980
as QA tool, 14142
in retail operations, 2034
steps, 60
corrective action plans, 61
corrective action records, 69
review of, 65
corrective action report, 76
corrective action request
example, 11213
in HACCP audit, 12526
C
p
, 140
C
pk
, 140
critical control points (CCPs), 21, 3750
common sources of, 3840
versus control points, 3738
controlling factors, as control measures,
37
decision tree, 48
definition, 37
determination form, 46
determining, 3750
distribution, 40
documenting, 50
and ECPs, 212
food service, 2023
identifying, 4049
ingredient receiving and handling, 39
for meat and poultry, 178
misidentification, factors in, 49
monitoring, 10, 63
packaging, 3940
versus prerequisite programs, 1617
processing, 39
raw materials, 38
retail, 2023
critical limits (CL)
and corrective action, 59
definition, 51
establishing, 5153
food service, 203
for meat and poultry, 178
versus operational limits, 52
retail, 203
cultural factors, in HACCP auditing, 129
customer complaintsfood safety, as
prerequisite program, 171
D
dairy, 18992
controlling risks through prerequisite
programs, 19092
safety regulations in, 18990
types of hazards, 190
data
central tendency of, 132
dispersion of, 13233
data collection, 5556, 181
HACCP audit, 11721
in monitoring, 5556
qualifications for, 58
data recording, 56
data sheet, temperature, 57
decision tree
Canadian Food Inspection Agency, 44
CCP, 48
Codex Alimentarius, 41
considerations when selecting, 4047
Index 289
medical device, 45
NACMCF, 42, 43
raw material, 38
using, 4749
decomposition, 149
defective action points (DAPs), 186
delayed treatment hazards, medical device,
22
design control, for medical devices, 21012
desk audit, 10814
deviations, identifying causes of, 60
discovery audit method, 106
disease control, and personal hygiene, 157
diseases, foodborne, 154
dispersion, of data, 13233
distribution, as CCP, 40
DMAIC (definemeasureanalyzeimprove
control) methodology, 141
document review, in HACCP audit, 117
documentation
in food service, 204
of hazard analysis, 36
in retail operations, 204
documentation errors, preventing, 84
documentation system, design of, 7784
dry labbing, 84
E
E. coli O517:H7, 102
economic integrity, 18788
ECP. See essential control point
electrical hazards, medical device, 22
element audit method, 107
employee health and hygiene, as audit focus,
197
employee training, in food service and retail
operations, 205
employee training record, 81
end user of product, describing, 1213
Enforcement Reports, FDA, 31
environmental hazards, medical device, 22
environmental monitoring, in
microbiological control, 164
Environmental Protection Agency (EPA), 160,
186, 194
drinking water regulations, 169
seafood jurisdiction, 186
equipment calibration
as prerequisite program, 171
in verification, 180
equipment performance, prerequisite
program for dairy products, 191
equipment validation letter, 80
errors, documentation, preventing, 84
escort, audit, 116, 119
essential control point (ECP), 37, 212
decision tree for medical devices, 45
ethics, in HACCP auditing, 12930
European Union design standards, 165
exit meeting, HACCP audit, 12223
explosion hazards, medical device, 22
external review, in verification, 66
F
failure mode and effects analysis (FMEA),
21517
component, 216
fault tree analysis (FTA), 215
FDA. See Food and Drug Administration
FDA Bad Bug Web site, 150
field sanitation, as audit focus, 196
findings, audit, 122, 123
finished product report, 75
Fish and Fishery Products Hazards and Controls
Guide, 185, 186
FMEA. See failure mode and effects analysis
follow-up, HACCP audit, 12326
food, changes to, beneficial and detrimental,
14950
Food and Drug Administration (FDA), 3
Enforcement Reports, 31
food contamination policy, 15354, 158
and HACCP, 45
regulatory history, xv
and seafood regulations, 18586
Food and Nutrition Board, of National
Research Council, xv
food components, 148
food hazards, 17, 2021
Appendix A, 22224
sources and types, 14854
food industry, HACCP in, 14854
food components, 148
new foodborne diseases and new
technologies, 154
sources and types of food hazards, 14854
food preservation methods
modern, 36
primitive, 2
food process flows, 2012
food safety
customer complaints, 171
dairy, 18990
training, 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, 155
food service. See retail and food service
290 Index
foreign material control, as GMP, 15859
forms, modifying versus creating, 7782
formulation control, as CCP, 39
Freedom of Information Act (FOIA), and
product recalls, 31
fresh-cut processing facilities, as audit focus,
197
fruits and vegetables, 19399
case study, 19899
defining GAPs and GMPs, 193
hazards associated with, 19394
significance of GAPs, GMPs, and HACCP
in auditing, 19498
third-party verification of GAPs, GMPs,
and HACCP implementation, 198
FSIS. See Food Safety and Inspection Service
G
GAPs. See good agricultural practices
GMPs. See good manufacturing practices
glass control, as GMP, 15859
good agricultural practices (GAPs)
defining, 193
FDA regulations, 208
significance of in auditing, 19498
third-party verification of, 198
good manufacturing practices (GMPs)
defining, 193
establishment of, 155
and food safety, 15657
foreign material control, 15859
glass control, 15859
good operational practices, 15758
personal hygiene, 157
as prerequisite program, 15657
for seafood, 187
significance of in auditing, 19498
third-party verification of, 198
good operational practices, as GMP, 15758
Guide to Inspections of Quality Systems, 217
Guide 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
H
HACCP (hazard analysis critical control
point) system
application to medical devices, 21417
and economic integrity, 18788
history, xv, 26
in medical device industry, 208
and pathogen reduction final rule, 174
predecessors, 34
versus quality programs, 18687
reasons for implementing, 7
and the space program, 45
HACCP audit, 10226
conducting, 11426
format, 104
preparation, 10414
scope, 1023
types, 1024
HACCP auditor, 12831
competencies, 12829
ethics, 12930
and illegal activities, 13031
liability, 130
significance of GAPs, GMPs, 19498
and unsafe activities, 13031
HACCP implementation, third-party
verification, 198
HACCP plan
assessing need for, 7
development, for meat and poultry,
17581
maintenance, 9799
operational qualification, 9496
reevaluation of, 61
HACCP plan development
and implementation, in retail and food
service, 200204
preliminary tasks for, 815
tasks for, 717
HACCP plan form, 219
HACCP plan implementation and
maintenance, 8699
companywide deployment, 9697
extending HACCP system to the supply
chain, 99
HACCP plan maintenance, 9799
HACCP team formation and training,
9194
operational qualification of HACCP plans,
9496
pilot projects, 9496
reasons for, 8687
supporting structures for, 8690
HACCP Plan Review Checklist, 97
HACCP principles, compared to quality
system regulation, 209
HACCP principles, in design and
manufacture of medical devices,
20819
application of HACCP to medical devices,
21417
Index 291
design control, 21012
history of HACCP in medical device
industry, 208
manufacturing processes, 21214
QSIT inspection techniques, 217
risk 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, 11
HACCP system standard, 1112
HACCP team
assembly and maintenance, 811
formation, 9192
training, 9294
HACCP training, 187
Hammurabi, code of, 2
hazard analysis, 2036
documentation of, 36
of food, questions to ask when
conducting, 2325
in food service operations, 2012
FSIS requirements, 176
to identify allergens, 16162
for meat and poultry, 17677
of medical devices, questions to ask when
conducting, 2527
performing, 2236
purpose of, 20
raw material, documentation, 30
in retail operations, 20102
hazard analysis worksheet, 218
hazard evaluation, 2223, 3336
hazard identification, 22, 2733
hazards
dairy, 190
food, sources and types, 14854
in fruits and vegetables, 19394
medical device, 22
in seafood, 18285
types of, 2022
hazards in food (Appendix A), 22224
hazards in medical devices (Appendix B),
225
heat, to control microorganisms, 15051
histogram, 135
history and overview of HACCP, 26
application of HACCP to other industries,
56
HACCP and the space program, 4
HACCP predecessors, 34
hold and test programs, 38
house of product safety, 15, 16
I
illegal activities, in HACCP audit, 13031
implementation, of HACCP system. See
HACCP plan implementation and
maintenance
implementation responsibilities, for HACCP
system, 88
ingredient receiving and handling, as CCP,
39
insect controls, 167
inspection log, label room, 73
inspection programs, and audits, as
prerequisite program, 172
intended use of product, describing, 1213
International Commission for the
Microbiological Specifications for Food
(ICMSF), 6
interviews, in HACCP audit, 11819
ISO 9001, 91, 99, 186
ISO 14971-1:1998, Medical devicesrisk
management, 210
ISO 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
J
judgmental sampling, 144
L
laboratory report, 78
liability, auditor, 130
Low Acid Canned Food Regulations, xv
M
maintenance, of HACCP plan, 9799
maintenance, prerequisite program for dairy,
191
maintenance chemical control, as
prerequisite program, 16061
management commitment, in HACCP
implementation, 8687, 187
management training, in food service and
retail operations, 205
manufacturing process instructions (MPIs),
213
292 Index
manufacturing processes, 21214
process audits, 21314
process flowcharts, 213
quality requirements, 213
risk-based assessment, 21213
marine biotoxins, in seafood, 184
materials
handling of, 29
physical state of, 2829
measurement monitoring, 56
meat and poultry, 17481
HACCP plan development, 17581
processing categories, 17475
mechanical control, of food hazards, 152
medical device hazards, 22, 225 (Appendix B)
medical devices
application of HACCP to, 21417
decision tree, 45
HACCP principles in design and
manufacture, 20819
microbiological control, as prerequisite
program, 16364
Microbiological Criteria for Food and Food
Ingredients, 6
microbiological hazards
control of, as prerequisite program,
16364
critical limits, 52
in food, 2021
microbiological testing, as critical limit, 52
microorganisms, as food hazard, 15052
MIL-STD 105E Sampling Procedures and Tables
for Inspection by Attributes, 144
milk, hazard identification, 2728
milk safety, 3, 18990
misdiagnosis hazards, medical device, 22
model HACCP plans, 35
monitoring
continuous versus intermittent, 5657
definition, 54
meat and poultry, FSIS requirements, 179
by measurement, 56
by observation, 56
monitoring points, determining, 5758
monitoring procedures, 5458
examples, 54
for food service, 203
for retail, 203
monitoring records, 69
review of, 6465
muscle classification, 148
N
NACMCF. See National Advisory Committee
on Microbiological Criteria for Foods
NACMCF 1997 HACCP Guideline, 156
NACMCF Guidelines for Application of HACCP
Principles, 197
NACMCF HACCP Guidelines (Appendix D),
22963
Appendix D.A, 24647
Appendix D.B, 247
Appendix D.C, 24851
Appendix D.D, 25152
Appendix D.E, 253
Appendix D.F, 254
Appendix D.G, 25556
Appendix D.H, 256
definitions, 23233
executive summary, 231
guidelines for application of HACCP
principles, 23344
HACCP principles, 233
implementation and maintenance of the
HACCP plan, 245
NASA. See National Aeronautics and Space
Administration (NASA)
National Academy of Sciences, 6
National Advisory Committee on
Microbiological Criteria for Foods
(NACMCF), 51, 87, 93, 97, 99
decision trees, 40, 4243
HACCP guidelines, 1516
as reference, 96
National Aeronautics and Space
Administration (NASA), 4
National Conference on Interstate Milk
Shipments (NCIMS), 189
National Food Processors Association, 151
National Marine Fisheries Service (NMFS),
186
audit checklist, 10911
National Oceanic and Atmospheric
Administration Seafood Inspection
Program (NOAA SIP), 186
National Research Council, xv
National Restaurant Association Educational
Foundation, ServSafe guidelines, 201
National Sanitary Foundation (NSF) design
standards, 165
noncontinuous monitoring, 6465
non-spore-forming pathogens, 20
Notice of Unusual Occurrence and
Corrective Action (NUOCA), 60
O
observation
as data collection, 56
in HACCP audit, 11921
observation monitoring, 56
Index 293
ongoing assessment, in verification, 6365
opening meeting, HACCP audit, 11517
operating characteristic (OC) curve, 145
operational limits
versus critical limits, 52
establishing, 53
operational prerequisite program, 37
operational sanitation, 155
operations teams, 9192
P
packaging, as CCP, 3940
packing facility sanitation, as audit focus, 197
parasites, in seafood, 184
Pareto analysis, 13334
pasteurization, 47, 151, 169, 178, 18990, 191
Pasteurized Milk Ordinance, xv
pathogen reduction final rule, USDA/FSIS,
174
pathogenic microorganisms, 2021
pathogens, 15051
performance quality hazards, medical
device, 22
personal hygiene
as audit focus, 197
as GMP, 157
pest control, as prerequisite program, 16667
pesticide use, as audit focus, 195
pesticides
control, as prerequisite program, 160
in insect and rodent control, 152
PFMEA. See process failure mode and effects
analysis
pH, in controlling microorganisms, 15152
physical control, of food hazards, 152
physical hazards
critical limits, 53
in dairy products, 190
in food, 21, 15354
in fruits and vegetables, 194
in meat and poultry, 17677
medical device, 22
in seafood, 185
Pillsbury Company
and HACCP, 5
space foods development, 4
pilot projects, 9496
plandocheckact (PDCA) cycle, 141
Polo, Marco, 2
possibility versus probability, 3536
poultry, and meat, 17481
HACCP plan development, 17581
processing categories, 17475
premises, prerequisite program for dairy, 191
preoperational procedures, 155
prerequisite program(s)
auditing, 11920
categories, 8990
versus CCPs, 1617
controlling risks through, 19092
dairy, 189
establishing, 1517
evolution of, 15556
in HACCP implementation, 8990
for seafood, 187
prerequisite programs, types of
air safety, 170
audits and inspection programs, 172
chemical control, 15962
cleaning and sanitation, 163
customer complaintsfood safety, 171
equipment calibration, 171
food safety training, 17071
good manufacturing practices (GMPs),
15659
microbiological control, 16364
pest control, 16667
preventive maintenance, 16566
receiving, storage, and shipping controls,
16768
sanitary design and engineering, 16465
supplier control, 16869
trace and recall, 166
water safety, 16970
preventive action, as QA tool, 14142
preventive maintenance, as prerequisite
program, 16566
probability of risk, in hazard evaluation,
3436
probability versus possibility, 3536
process aid chemical control, as prerequisite
program, 160
process audit, for medical devices, 21314
process audit documents summary, 213
process audit observations sheet, 214
process failure mode and effects analysis
(PFMEA), 212, 21517
process flow diagram
developing, 13
and HACCP plan development, 17576
verifying accuracy of, 1315
process flowchart, for medical device
manufacture, 213
process owners, 9192
process review, in hazard identification,
3132
process validation letter, 79
processing, as CCP, 39
processing log, 72
processing water, 19596
product
contamination, 38
294 Index
description and distribution, 1112
transport of, as audit focus, 19798
product disposition, determining, 60
product recalls, 35, 166
and Freedom of Information Act (FOIA),
31
product safety
auditing system, HACCP audit as, 1024
policies and objectives, 8788
production site, as audit focus, 195
proprietary information, in HACCP audit,
130
Q
qualitative index, 56
quality assurance analytical tools, 13245
attribute data versus variable data, 13233
capability indices, 140
cause-and-effect diagram, 134
check sheet, 13536
continuous improvement, 14041
control chart, 13639
corrective action, 14142
flowchart (flow diagram), 133
histogram, 135
Pareto analysis, 13334
preventive action, 14142
sampling, 14245
scatter diagram, 135
variable data versus attribute data, 13233
quality programs, versus HACCP, 18687
quality requirements, for medical devices,
213
quality system inspection technique (QSIT),
217
quality system regulation (QSR), 211
quantitative index, 56
R
radiation, to control food hazards, 15253
radiation hazards, medical device, 22
random sampling, 142
raw materials
as CCPs, 38
decision tree, 38
evaluation sheet, 70
hazard identification, 2831
sensitive, 28
recall, 35
for dairy products, 192
of product, 31
and trace, 166
receiving controls, 16768
for allergens, 162
for dairy products, 191
as prerequisite program, 16768
for dairy products, 191
recipe categorization, 201
record keeping
balanced approach versus overkill
approach, 82
in food service, 204
forms, modifying versus creating, 7782
importance of, 67
indirect benefits, 68
internal benefits, 67
meat and poultry, FSIS requirements,
18081
and regulatory compliance, 68
in retail operations, 204
simplified versus complex records,
8283
record keeping system, design of, 7784
record review, in HACCP audit, 11718
records, 6465
complex versus simplified, 8283
computerized versus manual, 8384
corrective action, 69
manual versus computerized, 8384
monitoring, 69
simplified versus complex, 8283
types of, 6877
corrective action records, 69
monitoring records, 69
verification records, 6977
regulatory compliance, of record keeping,
6869
report, HACCP audit, 12326
responsibilities, in HACCP plan
implementation, 9
retail and food service, 200205
HACCP plan development and
implementation, 200204
integrating HACCP in, 200
management and employee training, 205
retailers, as audit focus, 198
retort, 47
revalidation, in verification, 6566
rework, as CCP, 39
rework project, 14
ripening facilities, as audit focus, 197
risk, 3336
controlling through prerequisite
programs, 19092
risk analysis, 210
risk assessment, as continuous process, 102
risk management, for medical devices,
20810
Index 295
risk priority number (RPN), 217
risk-based assessment, of medical devices,
21213
rodent controls, 167
root cause analysis, 60
S
safe handling instructions, 12
safety, as process audit focus, 214
safety regulations, in dairy industry, 18990
sampling
as QA tool, 14245
records, 118
sanitary design and engineering, as
prerequisite program, 16465
sanitary facilities, as audit focus, 196
sanitation and cleaning
packing facility, as audit focus, 197
as prerequisite program, 163
for dairy products, 19192
sanitation chemical handling, as prerequisite
program, 15960
sanitization, to control microorganisms,
152
scatter diagram, 135
seafood, 18288
applied HACCP versus quality, 18687
HACCP and economic integrity, 18788
HACCP regulations in the United States,
18586
industry description, 182
sources of hazards, 182 85
Seafood HACCP Encore Course, 186
Seafood HACCP Regulation, 155
second-party verification, 98
self-inspection, to control physical hazards,
158
sensitive raw material, 28
ServSafe guidelines, National Restaurant
Association Educational Foundation,
201
seven principles of HACCP, 10
for meat and poultry plans, 174
in pilot programs, 9596
severity of risk, in hazard evaluation, 3334
shipping controls, as prerequisite program,
16768
site audit, 29
soft drinks, hazard identification, 2728
space foods, 4
space program, and HACCP, 4
spoilage, 150
spore-forming pathogens, 2021
standard deviation, 13233
standard operating procedures, to control
physical hazards, 158
standard sanitation operating procedures
(SSOPs)
as prerequisite program, 155, 187
and record keeping, 83
for seafood, 187
State of California Department of Health
Services
Food and Drug Branch, 185
and HACCP, 5
steering team, 91
storage controls, as prerequisite program,
16768
for dairy products, 191
storage facilities, as audit focus, 197
stratified sampling, 14244
subject matter experts (SMEs), in HACCP
audit, 105
supplier control, as prerequisite program,
16869
for dairy products, 191
supply chain, extending HACCP system to,
99
T
tasks for HACCP plan development, 717
assessing the need for a HACCP plan, 7
establishing the prerequisite program,
1517
preliminary tasks for HACCP plan
development, 815
technology, new, to control food hazards, 154
temperature, of food products, 15051
testing and analysis, in verification, 65
third-party verification, 98
3-A Program, dairy standards, 3, 165
tools and equipment, as process audit focus,
214
total quality control (TQC) points, 213, 214
total quality management (TQM), 91
trace and recall, as prerequisite program, 166
trace backward audit method, 106
trace forward audit method, 106
training
and controls, 162
dairy personnel, 192
and documentation, 84
employee, in food service and retail
operations, 205
food safety, as prerequisite program,
17071
HACCP, 187
of HACCP team, 9294
296 Index
management, in food service and retail
operations, 205
training record, employee, 81
transport of packed product, as audit focus,
19798
U
U.S. Armys Natick Laboratories, 4
U.S. Customs Service, 186
U.S. Department of Agriculture (USDA), xv
requirements in food industry, 86
seafood jurisdiction, 186
U.S. Department of Commerce, 186
U.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), 3
unsafe activities, in HACCP audit, 13031
USDA/FSIS
HACCP and pathogen reduction final
rule, 174
regulatory requirements, 97
SSOPs for meat and poultry, 155
V
validation, in verification, 63
verification, 9799, 180
definition, 62
in food service, 204
formal, 97, 98
meat and poultry, FSIS requirements,
180
ongoing assessment, 6365
in retail operations, 20
revalidation, 6566
verification, types of, 6266
ongoing assessment, 6365
revalidation, 6566
validation, 63
verification audits, 65
steps of, 9899
verification process, objectives of, 62
verification records, 6977
review of, 65
verification reports, 63
viruses, in seafood, 18384
W
water, as audit focus, 19596
water activity (A
w
), in controlling
microorganisms, 151
water safety, as prerequisite program,
16970
Z
zoonotic microorganisms, 148