FSMA and Food Safety Systems : Understanding and Implementing the Rules.

Intro -- Title Page -- Copyright Page -- Contents -- Preface -- About the Author -- Chapter 1 What is Modern Food Safety, and How is that Different from HACCP? -- 1.1 Introduction -- 1.2 FSMA Sanitation and cGMPs -- 1.3 FSMA Preventive Controls -- 1.4 Process Controls -- 1.5 Sanitation Controls -- 1.6 Supplier Controls -- References -- Chapter 2 Why Is a Food Safety System the Best Path to Food Safety? -- 2.1 What are Biological Hazards and Their Controls? -- 2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls? -- 2.3 What are Physical Hazards and Their Controls? -- References -- Chapter 3 What are the Essential Elements of a Food Safety System? -- 3.1 What are Prerequisite Programs, and What Do They Do? -- 3.2 What is a Hazard Analysis, and Why is it Performed? -- 3.3 What are Risk-Based Preventive Controls, and How are they Assigned? -- 3.3.1 What Controls are Used to Control Allergen-Related Hazards? -- 3.3.2 What Controls are Used to Control Sanitation-Related Hazards? -- 3.3.3 What Controls are Used to Control Process Hazards? -- 3.3.4 What Controls are Used to Control Supplier-Related Hazards? -- 3.4 What is a Food Safety Plan, and Who Develops It? -- Chapter 4 How is a Food Safety System Managed? -- 4.1 What is the Role of Management and Plant Operations in a Food Safety System? -- 4.2 How are SOPs Developed and Managed? -- 4.3 How are Preventive Controls Managed? -- 4.3.1 What are Performance Criteria for Controls, Including Critical Limits? -- 4.3.2 How are Preventive Controls Monitored? -- 4.3.3 If Preventive Controls Fail, What Corrective Actions are Needed? -- 4.3.4 How is the System and its Parts Verified as Being Compliant? -- 4.3.5 How are Process Preventive Controls Validated? -- 4.4 How are Records Established and Maintained? -- 4.5 Why and How is a Recall Plan Developed and Managed?.

References -- Supplemental References for Recalls -- Chapter 5 How is a Food Safety System Developed and Implemented? -- 5.1 Developing a Food Safety Plan -- 5.2 Assemble the Food Safety Team -- 5.3 Describe the Food and its Distribution -- 5.4 Describe the Intended Use and Consumers of the Food -- 5.5 Develop a Flow Diagram that Describes the Process -- 5.6 Verify the Flow Diagram -- 5.7 Conduct a Hazard Analysis -- 5.8 Essential Elements of the Food Safety Plan -- Chapter 6 What Triggers a Reanalysis of the Food Safety Plan? -- Chapter 7 Resources for Preparing Food Safety Preventive Controls Plans -- 7.1 Examples of Prerequisite Programs -- 7.2 Examples of Allergen Preventive Controls -- 7.3 Examples of Sanitation Preventive Controls -- 7.4 Examples of Process Preventive Controls -- 7.5 Examples of Supplier Controls -- 7.6 Useful Forms -- 7.7 FSMA Training and the Food Safety Preventive Controls Alliance -- Chapter 8 Example Food Safety Plans -- Barbeque Sauce - Example Food Safety Plan -- Company Overview -- Process Narrative -- Chocolate Chip Walnut Cookies - Example Food Safety Plan -- Company Overview -- Process Narrative -- Deli Potato Salad - Example Food Safety Plan -- Company Overview -- Process Narrative -- Macaroni &amp -- Cheese Frozen Meal - Example Food Safety Plan -- Company Overview -- Process Narrative -- Chapter 9 FSMA Regulations: cGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods -- FDA Regulations on cGMP's, Hazard Analysis and Risk-based Preventive Controls for Human Foods -- Part 117-Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food -- Subpart A-General Provisions -- Subpart B-Current Good Manufacturing Practice -- Subpart C-Hazard Analysis and Risk-Based Preventive Controls -- Subpart D-Modified Requirements.

Subpart E-Withdrawal of a Qualified Facility Exemption -- Subpart F-Requirements Applying to Records That Must Be Established and Maintained -- Subpart G-Supply-Chain Program -- SubpartA-General Provisions -- 117.1 Applicability and status. -- 117.3 Definitions. -- 117.4 Qualifications of individuals who manufacture, process, pack, or hold food. -- 117.5 Exemptions. -- 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. -- 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities. -- 117.9 Records required for this subpart. -- SubpartB-Current Good Manufacturing Practice -- 117.10 Personnel. -- 117.20 Plant and grounds. -- 117.35 Sanitary operations. -- 117.37 Sanitary facilities and controls. -- 117.40 Equipment and utensils. -- 117.80 Processes and controls. -- 117.93 Warehousing and distribution. -- 117.110 Defect action levels. -- SubpartC-Hazard Analysis and Risk-Based Preventive Controls -- 117.126 Food safety plan. -- 117.130 Hazard analysis. -- 117.135 Preventive controls. -- 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. -- 117.137 Provision of assurances required under 117.136(a)(2), (3), and (4). -- 117.139 Recall plan. -- 117.140 Preventive control management components. -- 117.145 Monitoring. -- 117.150 Corrective actions and corrections. -- 117.155 Verification. -- 117.160 Validation. -- 117.165 Verification of implementation and effectiveness. -- 117.170 Reanalysis. -- 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor. -- 117.190 Implementation records required for this subpart.

SubpartD-Modified Requirements -- 117.201 Modified requirements that apply to a qualified facility. -- 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food. -- SubpartE-Withdrawal of a Qualified Facility Exemption -- 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption. -- 117.254 Issuance of an order to withdraw a qualified facility exemption. -- 117.257 Contents of an order to withdraw a qualified facility exemption. -- 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption. -- 117.264 Procedure for submitting an appeal. -- 117.267 Procedure for requesting an informal hearing. -- 117.270 Requirements applicable to an informal hearing. -- 117.274 Presiding officer for an appeal and for an informal hearing. -- 117.277 Timeframe for issuing a decision on an appeal. -- 117.280 Revocation of an order to withdraw a qualified facility exemption. -- 117.284 Final agency action. -- 117.287 Reinstatement of a qualified facility exemption that was withdrawn. -- SubpartF-Requirements Applying to Records That Must Be Establishedand Maintained -- 117.301 Records subject to the requirements of this subpart. -- 117.305 General requirements applying to records. -- 117.310 Additional requirements applying to the food safety plan. -- 117.315 Requirements for record retention. -- 117.320 Requirements for official review. -- 117.325 Public disclosure. -- 117.330 Use of existing records. -- 117.335 Special requirements applicable to a written assurance. -- SubpartG-Supply-Chain Program -- 117.405 Requirement to establish and implement a supply-chainprogram. -- 117.410 General requirements applicable to a supply-chain program. -- 117.415 Responsibilities of the receiving facility.

117.420 Using approved suppliers. -- 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). -- 117.430 Conducting supplier verification activities for raw materials and other ingredients. -- 117.435 Onsite audit. -- 117.475 Records documenting the supply-chain program. -- Appendix A Food Safety Plan Checklist -- FoodSafety Plan Checklist -- Introduction -- Purpose -- References -- Appendix B HACCP Principles and Application Guidelines -- NationalAdvisory Committee on MicrobiologicalCriteria for Foods -- Executive Summary -- Definitions -- HACCP Principles -- Guidelines for Application of HACCP Principles -- Introduction -- Prerequisite Programs -- Education and Training -- Developing a HACCP Plan -- Implementation and Maintenance of the HACCP Plan -- References -- Glossary -- EULA.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.