{"product_id":"fsma-and-food-safety-systems-isbn-9781119258070","title":"FSMA and Food Safety Systems","description":"\u003cp\u003eThe 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.\u003c\/p\u003e \u003cp\u003eThis 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eFSMA and Food Safety Systems: A Guide to Understanding and Implementing the Rules\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eAbout the Author xiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 What is Modern Food Safety, and How is that Different from HACCP? 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 FSMA Sanitation and cGMPs 3\u003c\/p\u003e \u003cp\u003e1.3 FSMA Preventive Controls 4\u003c\/p\u003e \u003cp\u003e1.4 Process Controls 5\u003c\/p\u003e \u003cp\u003e1.5 Sanitation Controls 6\u003c\/p\u003e \u003cp\u003e1.6 Supplier Controls 8\u003c\/p\u003e \u003cp\u003eReferences 10\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Why is a Food Safety System the Best Path to Food Safety? 11\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 What are Biological Hazards and Their Controls? 11\u003c\/p\u003e \u003cp\u003e2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls? 15\u003c\/p\u003e \u003cp\u003e2.3 What are Physical Hazards and Their Controls? 17\u003c\/p\u003e \u003cp\u003eReferences 19\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 What are the Essential Elements of a Food Safety System? 21\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 What are Prerequisite Programs, and What Do They Do? 22\u003c\/p\u003e \u003cp\u003e3.2 What is a Hazard Analysis, and Why is it Performed? 23\u003c\/p\u003e \u003cp\u003e3.3 What are Risk-Based Preventive Controls, and How are they Assigned? 25\u003c\/p\u003e \u003cp\u003e3.3.1 What Controls are used to Control Allergen-Related Hazards? 26\u003c\/p\u003e \u003cp\u003e3.3.2 What Controls are used to Control Sanitation-Related Hazards? 27\u003c\/p\u003e \u003cp\u003e3.3.3 What Controls are used to Control Process Hazards? 29\u003c\/p\u003e \u003cp\u003e3.3.4 What Controls are used to Control Supplier-Related Hazards? 30\u003c\/p\u003e \u003cp\u003e3.4 What is a Food Safety Plan, and Who Develops It? 32\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 How is a Food Safety System Managed? 35\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 What is the Role of Management and Plant Operations in a Food Safety System? 35\u003c\/p\u003e \u003cp\u003e4.2 How are SOPs Developed and Managed? 36\u003c\/p\u003e \u003cp\u003e4.3 How are Preventive Controls Managed? 39\u003c\/p\u003e \u003cp\u003e4.3.1 What are Performance Criteria for Controls, Including Critical Limits? 39\u003c\/p\u003e \u003cp\u003e4.3.2 How are Preventive Controls Monitored? 40\u003c\/p\u003e \u003cp\u003e4.3.3 If Preventive Controls Fail, What Corrective Actions are Needed? 41\u003c\/p\u003e \u003cp\u003e4.3.4 How is the System and its Parts Verified as Being Compliant? 43\u003c\/p\u003e \u003cp\u003e4.3.5 How are Process Preventive Controls Validated? 44\u003c\/p\u003e \u003cp\u003e4.4 How are Records Established and Maintained? 46\u003c\/p\u003e \u003cp\u003e4.5 Why and How is a Recall Plan Developed and Managed? 48\u003c\/p\u003e \u003cp\u003eReferences 51\u003c\/p\u003e \u003cp\u003eSupplemental References for Recalls 51\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 How is a Food Safety System Developed and Implemented? 53\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Developing a Food Safety Plan 54\u003c\/p\u003e \u003cp\u003e5.2 Assemble the Food Safety Team 55\u003c\/p\u003e \u003cp\u003e5.3 Describe the Food and its Distribution 55\u003c\/p\u003e \u003cp\u003e5.4 Describe the Intended Use and Consumers of the Food 55\u003c\/p\u003e \u003cp\u003e5.5 Develop a Flow Diagram that Describes the Process 56\u003c\/p\u003e \u003cp\u003e5.6 Verify the Flow Diagram 56\u003c\/p\u003e \u003cp\u003e5.7 Conduct a Hazard Analysis 56\u003c\/p\u003e \u003cp\u003e5.8 Essential Elements of the Food Safety Plan 58\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 What Triggers a Reanalysis of the Food Safety Plan? 61\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Resources for Preparing Food Safety Preventive Controls Plans 63\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Examples of Prerequisite Programs 63\u003c\/p\u003e \u003cp\u003e7.2 Examples of Allergen Preventive Controls 65\u003c\/p\u003e \u003cp\u003e7.3 Examples of Sanitation Preventive Controls 65\u003c\/p\u003e \u003cp\u003e7.4 Examples of Process Preventive Controls 66\u003c\/p\u003e \u003cp\u003e7.5 Examples of Supplier Controls 68\u003c\/p\u003e \u003cp\u003e7.6 Useful Forms 68\u003c\/p\u003e \u003cp\u003e7.7 FSMA Training and the Food Safety Preventive Controls Alliance 75\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Example Food Safety Plans 77\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBarbeque Sauce – Example Food Safety Plan 78\u003c\/p\u003e \u003cp\u003eCompany Overview 78\u003c\/p\u003e \u003cp\u003eProcess Narrative 79\u003c\/p\u003e \u003cp\u003eChocolate Chip Walnut Cookies – Example Food Safety Plan 88\u003c\/p\u003e \u003cp\u003eCompany Overview 88\u003c\/p\u003e \u003cp\u003eProcess Narrative 89\u003c\/p\u003e \u003cp\u003eDeli Potato Salad – Example Food Safety Plan 102\u003c\/p\u003e \u003cp\u003eCompany Overview 102\u003c\/p\u003e \u003cp\u003eProcess Narrative 103\u003c\/p\u003e \u003cp\u003eMacaroni \u0026amp; Cheese Frozen Meal – Example Food Safety Plan 118\u003c\/p\u003e \u003cp\u003eCompany Overview 118\u003c\/p\u003e \u003cp\u003eProcess Narrative 119\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 FSMA Regulations: cGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods 131\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFDA Regulations on cGMP’s, Hazard Analysis and Risk-based Preventive Controls for Human Foods 132\u003c\/p\u003e \u003cp\u003ePart 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk–Based Preventive Controls for Human Food 132\u003c\/p\u003e \u003cp\u003eSubpart A—General Provisions 132\u003c\/p\u003e \u003cp\u003eSubpart B—Current Good Manufacturing Practice 132\u003c\/p\u003e \u003cp\u003eSubpart C—Hazard Analysis and Risk‐Based Preventive Controls 132\u003c\/p\u003e \u003cp\u003eSubpart D—Modified Requirements 133\u003c\/p\u003e \u003cp\u003eSubpart E—Withdrawal of a Qualified Facility Exemption 133\u003c\/p\u003e \u003cp\u003eSubpart F—Requirements Applying to Records That Must Be Established and Maintained 133\u003c\/p\u003e \u003cp\u003eSubpart G—Supply-Chain Program 134\u003c\/p\u003e \u003cp\u003eSubpart A—General Provisions 134\u003c\/p\u003e \u003cp\u003e§ 117.1 Applicability and status 134\u003c\/p\u003e \u003cp\u003e§ 117.3 Definitions 135\u003c\/p\u003e \u003cp\u003e§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food 141\u003c\/p\u003e \u003cp\u003e§ 117.5 Exemptions 141\u003c\/p\u003e \u003cp\u003e§ 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\u003c\/p\u003e \u003cp\u003e§ 117.8 Applicability of subpart B of this part to the off‐farm packing and holding of raw agricultural commodities 150\u003c\/p\u003e \u003cp\u003e§ 117.9 Records required for this subpart 150\u003c\/p\u003e \u003cp\u003eSubpart B—Current Good Manufacturing Practice 150\u003c\/p\u003e \u003cp\u003e§ 117.10 Personnel 150\u003c\/p\u003e \u003cp\u003e§ 117.20 Plant and grounds 151\u003c\/p\u003e \u003cp\u003e§ 117.35 Sanitary operations 153\u003c\/p\u003e \u003cp\u003e§ 117.37 Sanitary facilities and controls 154\u003c\/p\u003e \u003cp\u003e§ 117.40 Equipment and utensils 155\u003c\/p\u003e \u003cp\u003e§ 117.80 Processes and controls 156\u003c\/p\u003e \u003cp\u003e§ 117.93 Warehousing and distribution 159\u003c\/p\u003e \u003cp\u003e§ 117.110 Defect action levels 160\u003c\/p\u003e \u003cp\u003eSubpart C—Hazard Analysis and Risk-Based Preventive Controls 160\u003c\/p\u003e \u003cp\u003e§ 117.126 Food safety plan 160\u003c\/p\u003e \u003cp\u003e§ 117.130 Hazard analysis 160\u003c\/p\u003e \u003cp\u003e§ 117.135 Preventive controls 161\u003c\/p\u003e \u003cp\u003e§ 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\u003c\/p\u003e \u003cp\u003e§ 117.137 Provision of assurances required under § 117.136(a) (2), (3), and (4) 164\u003c\/p\u003e \u003cp\u003e§ 117.139 Recall plan 164\u003c\/p\u003e \u003cp\u003e§ 117.140 Preventive control management components 165\u003c\/p\u003e \u003cp\u003e§ 117.145 Monitoring 165\u003c\/p\u003e \u003cp\u003e§ 117.150 Corrective actions and corrections 166\u003c\/p\u003e \u003cp\u003e§ 117.155 Verification 167\u003c\/p\u003e \u003cp\u003e§ 117.160 Validation 167\u003c\/p\u003e \u003cp\u003e§ 117.165 Verification of implementation and effectiveness 168\u003c\/p\u003e \u003cp\u003e§ 117.170 Reanalysis 170\u003c\/p\u003e \u003cp\u003e§ 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor 171\u003c\/p\u003e \u003cp\u003e§ 117.190 Implementation records required for this subpart 172\u003c\/p\u003e \u003cp\u003eSubpart D—Modified Requirements 172\u003c\/p\u003e \u003cp\u003e§ 117.201 Modified requirements that apply to a qualified facility 172\u003c\/p\u003e \u003cp\u003e§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food 174\u003c\/p\u003e \u003cp\u003eSubpart E—Withdrawal of a Qualified Facility Exemption 175\u003c\/p\u003e \u003cp\u003e§ 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption 175\u003c\/p\u003e \u003cp\u003e§ 117.254 Issuance of an order to withdraw a qualified facility exemption 176\u003c\/p\u003e \u003cp\u003e§ 117.257 Contents of an order to withdraw a qualified facility exemption 176\u003c\/p\u003e \u003cp\u003e§ 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption 177\u003c\/p\u003e \u003cp\u003e§ 117.264 Procedure for submitting an appeal 177\u003c\/p\u003e \u003cp\u003e§ 117.267 Procedure for requesting an informal hearing 178\u003c\/p\u003e \u003cp\u003e§ 117.270 Requirements applicable to an informal hearing 178\u003c\/p\u003e \u003cp\u003e§ 117.274 Presiding officer for an appeal and for an informal hearing 179\u003c\/p\u003e \u003cp\u003e§ 117.277 Timeframe for issuing a decision on an appeal 179\u003c\/p\u003e \u003cp\u003e§ 117.280 Revocation of an order to withdraw a qualified facility exemption 179\u003c\/p\u003e \u003cp\u003e§ 117.284 Final agency action 180\u003c\/p\u003e \u003cp\u003e§ 117.287 Reinstatement of a qualified facility exemption that was withdrawn 180\u003c\/p\u003e \u003cp\u003eSubpart F—Requirements Applying to Records That Must Be Established and Maintained 181\u003c\/p\u003e \u003cp\u003e§ 117.301 Records subject to the requirements of this subpart 181\u003c\/p\u003e \u003cp\u003e§ 117.305 General requirements applying to records 181\u003c\/p\u003e \u003cp\u003e§ 117.310 Additional requirements applying to the food safety plan 181\u003c\/p\u003e \u003cp\u003e§ 117.315 Requirements for record retention 182\u003c\/p\u003e \u003cp\u003e§ 117.320 Requirements for official review 182\u003c\/p\u003e \u003cp\u003e§ 117.325 Public disclosure 182\u003c\/p\u003e \u003cp\u003e§ 117.330 Use of existing records 182\u003c\/p\u003e \u003cp\u003e§ 117.335 Special requirements applicable to a written assurance 183\u003c\/p\u003e \u003cp\u003eSubpart G—Supply‐Chain Program 183\u003c\/p\u003e \u003cp\u003e§ 117.405 Requirement to establish and implement a supply‐chain program 183\u003c\/p\u003e \u003cp\u003e§ 117.410 General requirements applicable to a supply‐chain program 184\u003c\/p\u003e \u003cp\u003e§ 117.415 Responsibilities of the receiving facility 186\u003c\/p\u003e \u003cp\u003e§ 117.420 Using approved suppliers 186\u003c\/p\u003e \u003cp\u003e§ 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity) 187\u003c\/p\u003e \u003cp\u003e§ 117.430 Conducting supplier verification activities for raw materials and other ingredients 187\u003c\/p\u003e \u003cp\u003e§ 117.435 Onsite audit 189\u003c\/p\u003e \u003cp\u003e§ 117.475 Records documenting the supply‐chain program 190\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix A Food Safety Plan Checklist 193\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFood Safety Plan Checklist 193\u003c\/p\u003e \u003cp\u003eIntroduction 193\u003c\/p\u003e \u003cp\u003ePurpose 194\u003c\/p\u003e \u003cp\u003eReferences 198\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix B HACCP Principles and Application Guidelines 199\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eNational Advisory Committee on Microbiological Criteria for Foods 199\u003c\/p\u003e \u003cp\u003eExecutive Summary 199\u003c\/p\u003e \u003cp\u003eDefinitions 200\u003c\/p\u003e \u003cp\u003eHACCP Principles 202\u003c\/p\u003e \u003cp\u003eGuidelines for Application of HACCP Principles 203\u003c\/p\u003e \u003cp\u003eIntroduction 203\u003c\/p\u003e \u003cp\u003ePrerequisite Programs 203\u003c\/p\u003e \u003cp\u003eEducation and Training 204\u003c\/p\u003e \u003cp\u003eDeveloping a HACCP Plan 204\u003c\/p\u003e \u003cp\u003eImplementation and Maintenance of the HACCP Plan 215\u003c\/p\u003e \u003cp\u003eReferences 216\u003c\/p\u003e \u003cp\u003eGlossary 217\u003c\/p\u003e  \u003cstrong\u003eJeffrey T. Barach, PhD, Barach Enterprises LLC, Virginia, US\u003c\/strong\u003e\u003cbr\u003eDr Barach is responsible for forming, initiating programs and setting direction for this technical consulting firm focused on a mission of providing technical services, influencing policy issues and building the scientific, technical and regulatory strength of the food industry through stewardship, training and education programs.","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989251506405,"sku":"NP9781119258070","price":82.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119258070.jpg?v=1761783382","url":"https:\/\/k12savings.com\/es\/products\/fsma-and-food-safety-systems-isbn-9781119258070","provider":"K12savings","version":"1.0","type":"link"}