FSMA and food safety systems : understanding and implementing the rules
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FSMA and food safety systems : understanding and implementing the rules
Wiley, 2017
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Includes bibliographical references
内容説明・目次
内容説明
The FDA's (Food and Drug Administration) FSMA (Food Safety Modernization Act) is the most sweeping reform of United States food safety laws in more than 70 years. The key to successful implementation of FSMA rules depends on building a comprehensive Food Safety System with effective prerequisite programs in place and a well-designed Food Safety Plan that incorporates risk-based preventive controls to mitigate hazards.
This book provides essential guidance for small to mid-sized businesses on how to design, implement, and maintain a world-class Food Safety Plan that conforms to FSMA regulations. With practical and up-to-date advice, the author offers a straight forward approach for readers to successfully migrate into FSMA. The inclusion of fully developed Food Safety Plans as well as examples of hazards and preventative controls make this a must-read not only for those that are new to the regulations, but also those with a plan already in place.
FSMA and Food Safety Systems: A Guide to Understanding and Implementing the Rules is an indispensable resource for all those managing the manufacture of FDA regulated products, food safety regulators and educators, as well as scientists and students of food science and technology.
目次
Preface xi
About the Author xiii
1 What is Modern Food Safety, and How is that Different from HACCP? 1
1.1 Introduction 1
1.2 FSMA Sanitation and cGMPs 3
1.3 FSMA Preventive Controls 4
1.4 Process Controls 5
1.5 Sanitation Controls 6
1.6 Supplier Controls 8
References 10
2 Why is a Food Safety System the Best Path to Food Safety? 11
2.1 What are Biological Hazards and Their Controls? 11
2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls? 15
2.3 What are Physical Hazards and Their Controls? 17
References 19
3 What are the Essential Elements of a Food Safety System? 21
3.1 What are Prerequisite Programs, and What Do They Do? 22
3.2 What is a Hazard Analysis, and Why is it Performed? 23
3.3 What are Risk-Based Preventive Controls, and How are they Assigned? 25
3.3.1 What Controls are used to Control Allergen-Related Hazards? 26
3.3.2 What Controls are used to Control Sanitation-Related Hazards? 27
3.3.3 What Controls are used to Control Process Hazards? 29
3.3.4 What Controls are used to Control Supplier-Related Hazards? 30
3.4 What is a Food Safety Plan, and Who Develops It? 32
4 How is a Food Safety System Managed? 35
4.1 What is the Role of Management and Plant Operations in a Food Safety System? 35
4.2 How are SOPs Developed and Managed? 36
4.3 How are Preventive Controls Managed? 39
4.3.1 What are Performance Criteria for Controls, Including Critical Limits? 39
4.3.2 How are Preventive Controls Monitored? 40
4.3.3 If Preventive Controls Fail, What Corrective Actions are Needed? 41
4.3.4 How is the System and its Parts Verified as Being Compliant? 43
4.3.5 How are Process Preventive Controls Validated? 44
4.4 How are Records Established and Maintained? 46
4.5 Why and How is a Recall Plan Developed and Managed? 48
References 51
Supplemental References for Recalls 51
5 How is a Food Safety System Developed and Implemented? 53
5.1 Developing a Food Safety Plan 54
5.2 Assemble the Food Safety Team 55
5.3 Describe the Food and its Distribution 55
5.4 Describe the Intended Use and Consumers of the Food 55
5.5 Develop a Flow Diagram that Describes the Process 56
5.6 Verify the Flow Diagram 56
5.7 Conduct a Hazard Analysis 56
5.8 Essential Elements of the Food Safety Plan 58
6 What Triggers a Reanalysis of the Food Safety Plan? 61
7 Resources for Preparing Food Safety Preventive Controls Plans 63
7.1 Examples of Prerequisite Programs 63
7.2 Examples of Allergen Preventive Controls 65
7.3 Examples of Sanitation Preventive Controls 65
7.4 Examples of Process Preventive Controls 66
7.5 Examples of Supplier Controls 68
7.6 Useful Forms 68
7.7 FSMA Training and the Food Safety Preventive Controls Alliance 75
8 Example Food Safety Plans 77
Barbeque Sauce - Example Food Safety Plan 78
Company Overview 78
Process Narrative 79
Chocolate Chip Walnut Cookies - Example Food Safety Plan 88
Company Overview 88
Process Narrative 89
Deli Potato Salad - Example Food Safety Plan 102
Company Overview 102
Process Narrative 103
Macaroni & Cheese Frozen Meal - Example Food Safety Plan 118
Company Overview 118
Process Narrative 119
9 FSMA Regulations: cGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods 131
FDA Regulations on cGMP's, Hazard Analysis and Risk-based Preventive Controls for Human Foods 132
Part 117-Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 132
Subpart A-General Provisions 132
Subpart B-Current Good Manufacturing Practice 132
Subpart C-Hazard Analysis and Risk-Based Preventive Controls 132
Subpart D-Modified Requirements 133
Subpart E-Withdrawal of a Qualified Facility Exemption 133
Subpart F-Requirements Applying to Records That Must Be Established and Maintained 133
Subpart G-Supply-Chain Program 134
Subpart A-General Provisions 134
117.1 Applicability and status 134
117.3 Definitions 135
117.4 Qualifications of individuals who manufacture, process, pack, or hold food 141
117.5 Exemptions 141
117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food 149
117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities 150
117.9 Records required for this subpart 150
Subpart B-Current Good Manufacturing Practice 150
117.10 Personnel 150
117.20 Plant and grounds 151
117.35 Sanitary operations 153
117.37 Sanitary facilities and controls 154
117.40 Equipment and utensils 155
117.80 Processes and controls 156
117.93 Warehousing and distribution 159
117.110 Defect action levels 160
Subpart C-Hazard Analysis and Risk-Based Preventive Controls 160
117.126 Food safety plan 160
117.130 Hazard analysis 160
117.135 Preventive controls 161
117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control 163
117.137 Provision of assurances required under 117.136(a) (2), (3), and (4) 164
117.139 Recall plan 164
117.140 Preventive control management components 165
117.145 Monitoring 165
117.150 Corrective actions and corrections 166
117.155 Verification 167
117.160 Validation 167
117.165 Verification of implementation and effectiveness 168
117.170 Reanalysis 170
117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor 171
117.190 Implementation records required for this subpart 172
Subpart D-Modified Requirements 172
117.201 Modified requirements that apply to a qualified facility 172
117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food 174
Subpart E-Withdrawal of a Qualified Facility Exemption 175
117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption 175
117.254 Issuance of an order to withdraw a qualified facility exemption 176
117.257 Contents of an order to withdraw a qualified facility exemption 176
117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption 177
117.264 Procedure for submitting an appeal 177
117.267 Procedure for requesting an informal hearing 178
117.270 Requirements applicable to an informal hearing 178
117.274 Presiding officer for an appeal and for an informal hearing 179
117.277 Timeframe for issuing a decision on an appeal 179
117.280 Revocation of an order to withdraw a qualified facility exemption 179
117.284 Final agency action 180
117.287 Reinstatement of a qualified facility exemption that was withdrawn 180
Subpart F-Requirements Applying to Records That Must Be Established and Maintained 181
117.301 Records subject to the requirements of this subpart 181
117.305 General requirements applying to records 181
117.310 Additional requirements applying to the food safety plan 181
117.315 Requirements for record retention 182
117.320 Requirements for official review 182
117.325 Public disclosure 182
117.330 Use of existing records 182
117.335 Special requirements applicable to a written assurance 183
Subpart G-Supply-Chain Program 183
117.405 Requirement to establish and implement a supply-chain program 183
117.410 General requirements applicable to a supply-chain program 184
117.415 Responsibilities of the receiving facility 186
117.420 Using approved suppliers 186
117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) 187
117.430 Conducting supplier verification activities for raw materials and other ingredients 187
117.435 Onsite audit 189
117.475 Records documenting the supply-chain program 190
Appendix A Food Safety Plan Checklist 193
Food Safety Plan Checklist 193
Introduction 193
Purpose 194
References 198
Appendix B HACCP Principles and Application Guidelines 199
National Advisory Committee on Microbiological Criteria for Foods 199
Executive Summary 199
Definitions 200
HACCP Principles 202
Guidelines for Application of HACCP Principles 203
Introduction 203
Prerequisite Programs 203
Education and Training 204
Developing a HACCP Plan 204
Implementation and Maintenance of the HACCP Plan 215
References 216
Glossary 217
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