FSMA and Food Safety Systems

Understanding and Implementing the Rules
(240 Seiten)
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Jeffrey T. Barach
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eBook Format:
Adobe DRM [Hard-DRM]

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.

About the author

Chapter 1: What is Modern Food Safety and How is That Different From HACCP?

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?

Chapter 3: What are the Essential Elements of a Food Safety System?

3.1 What are Pre-requisite 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 SOP's 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?

Chapter 5: How is a Food Safety System Developed and Implemented?

5.1 Assemble the Food Safety Team

5.2 Describe the Food and Its Distribution

5.3 Describe the Intended Use and Consumers of the Food

5.4 Develop a Flow Diagram Which Describes the Process

5.5 Verify the Flow Diagram

5.6 Conduct the Hazard Analysis

5.7 Essential Elements of the Food Safety Plan

Chapter 6: What Triggers a Reanalyze 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 BBQ Sauce

Chocolate Chip Walnut Cookies

Deli Potato Salad

Mac & Cheese Frozen Meal

Chapter 9: FSMA Regulations: cGMPs, Hazard Analysis, and Risk Based Preventive Controls for Human Foods

Appendix A: Food Safety Plan Checklist

Appendix B: HACCP Principles and Application Guidelines


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