Chapter 1 INTRODUCTION TO FSPCA PREVENTIVE CONTROLS FOR HUMAN FOOD COURSE

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1 Chapter 1 INTRODUCTION TO FSPCA PREVENTIVE CONTROLS FOR HUMAN FOOD COURSE

2 Introduction to Course and Preventive Controls Objectives In this module, you will develop awareness of: The objectives of the course Format of the course How preventive controls build on established food safety principles Components of a Food Safety Plan The responsibilities of a preventive controls qualified individual Where to find definitions relevant for the course

3 Course Format Background and guidance information on food safety Food Safety Plan development Preventive Controls for Human Food regulation Class exercises in hazard analysis and Food Safety Plan development

4 Risk-based Preventive Controls Focus on what matters most for food safety Preventive, not reactive Work in conjunction with and supported by other programs like Good Manufacturing Practices Designed to minimize the risk of food safety hazards

5 Image source: Microsoft clip art Other Risk-based Food Safety Programs US Space program Low-acid canned food regs FDA Seafood HACCP regs FDA Juice HACCP regs USDA HACCP regs Codex HACCP Annex NCIMS Dairy HACCP

6 Historically HACCP Focuses on the Process Hazard Analysis Critical Control Points (CCPs) Critical Limits Monitor Verification & Recordkeeping Corrective Action

7 Preventive Controls Include More Than HACCP Hazard Analysis Preventive Controls (CCPs, allergen, sanitation, supplier, etc.) Parameters & Values Monitor Verification & Recordkeeping Corrective Action or Corrections

8 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Hazard Analysis Process Control Supplychain Sanitation Program Allergen Control Control Recall Plan GMPs and Other Prerequisite Programs

9 Preventive Controls Qualified Individual Definition A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. 21 CFR Definitions

10 Participate! Share examples with others Questions essential for understanding Mark up your manual Learn!

11 Introduction Summary Successful completion of this course is one way to meet the requirements for a preventive controls qualified individual to manage a food safety preventive controls program FDA s Preventive Controls for Human Food regulation builds on existing food safety principles Preventive controls reduce risk for the business and for the public Definitions used in the course are at the end of this chapter Participation is vital to successfully completing this course

12 Chapter 1 Exercise Read the definitions at the end of this chapter for: qualified individual preventive controls qualified individual and review 21 CFR (a) and (c) in Appendix 1: Regulation about requirements applicable to a preventive controls qualified individual Write down the tasks that 1. You are comfortable performing 2. You hope to learn to perform in this class 3. You will likely engage others to help you perform Discuss with your group and choose a spokesperson to report

13 HACCP Plan Food Safety Plan BACKUP SLIDE

14 What s New in a Food Safety Plan Element HACCP Plan Added in Food Safety Plan Hazard analysis Biological, chemical, physical Preventive controls CCPs for processes Parameters and values Chemical hazards to include radiological; consider economically motivated hazards Process CCPs + controls at other points that are not CCPs Critical limits Parameters and minimum/maximum values (= critical limits for process controls) Monitoring Required for CCPs Required as appropriate for other preventive controls Corrective actions or corrections Verification Records Recall plan Corrective actions Corrective actions or corrections, as appropriate For process controls As appropriate for all preventive controls; supplier verification required when supplier controls a hazard For process controls As appropriate for all preventive controls Not required in the plan Required when a hazard requiring a preventive control is identified

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