FSPCA PREVENTIVE CONTROLS FOR HUMAN FOOD Exercise Workbook Including Food Safety Plan Worksheets Developed by the
This workbook was created to assist participants in the Food Safety Preventive Controls Alliance s Preventive Controls for Human Food course to practice exercises in an attempt to reinforce learning. All exercises and examples are hypothetical. Application of preventive controls requires in depth knowledge of actual operating conditions, thus information in the curriculum and in exercises may not be directly applicable to a specific operation. Assistance from a preventive controls qualified individual may be necessary to ensure compliance with FDA regulations. 1 st Edition, Version 1.2, February 2016
Table of Contents Chapter 1: Course Introduction...2 Chapter 2: Food Safety Plan Overview...3 Chapter 3: GMPs and other Prerequisite Programs...3 Chapter 4: Biological Food Safety Hazards...4 Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards...5 Chapter 6: Preliminary Steps in Developing a Food Safety Plan...5 Chapter 7: Resources for Food Safety Plans...6 Chapter 8: Hazard Analysis and Preventive Control Deteremination...7 Chapter 9: Process Preventive Control... 12 Chapter 10: Food Allergen Preventive Control... 14 Chapter 11: Sanitation Preventive Control... 17 Chapter 12: Supply-chain Preventive Control... 18 Chapter 13: Verification and Validation Procedures... 19 Chapter 14: Record-keeping Procedures... 19 Chapter 15: Recall Plan... 20 Chapter 16: Regulation Overview... 20 FSPCA Exercis e Workbook Version 1.2 1
Chapter 1: Introduction to Course and Preventive Controls Read the definitions at the end of this chapter for qualified individual and preventive controls qualified individual, and review 21 CFR 117.180(a) and (c) in Appendix 1 about requirements applicable to a preventive controls qualified individual. Write down the tasks that You are comfortable performing You hope to learn to perform in this class You will likely engage others to help you perform Discussion notes: 2 FSPCA Exerci s e Workbook Version 1.2
Chapter 2: Food Safety Plan Overview Discussion notes: Chapter 3: GMPs and Other Prerequisite Programs Write down key learnings from presentation and from GMP violations observed on slides FSPCA Exercis e Workbook Version 1.2 3
Chapter 4: Biological Food Safety Hazards Notes for Exercises Pick a food that you make or an ingredient that you use, then the information in this chapter and Appendix 4 Foodborne Pathogen Supplementary Information to do the following: Food or ingredient: Biological hazard associated with this food How might you prevent contamination? How might you kill the pathogen? How might you control growth of the pathogen? Notes on other pathogens discussed: 4 FSPCA Exerci s e Workbook Version 1.2
Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards Discussion notes: Chapter 6: Preliminary Steps in Developing a Food Safety Plan Key learning from chapter and notes on your model food product: Would you group or separate the products in the sample plan? Record your reasoning. FSPCA Exercis e Workbook Version 1.2 5
Chapter 7 Resources for Preparing Food Safety Plans Discussion notes and key references you may want to consider for the products that you make: Notes for Exercises 6 FSPCA Exerci s e Workbook Version 1.2
Chapter 8: Hazard Analysis and Preventive Control Determination PLANT NAME ISSUE DATE PAGE ADDRESS SUPERSEDES PRODUCT CODE Hazard Analysis for: (1) Ingredient/ Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step B = biological, C = chemical (including radiological) P = physical B (3) Do any potential food safety hazards require a preventive control? (4) Justify your decision for column 3 (5) What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied at this step? Yes No Yes No C P B C P B C P B C P FSPCA Exercis e Workbook Version 1.2 7
Hazard Analysis for: (1) Ingredient/ Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step B = biological, C = chemical (including radiological) P = physical (3) Do any potential food safety hazards require a preventive control? (4) Justify your decision for column 3 (5) What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied at this step? Yes No Yes No 8 FSPCA Exerci s e Workbook Version 1.2
Hazard Analysis for: (1) Ingredient/ Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step B = biological, C = chemical (including radiological) P = physical (3) Do any potential food safety hazards require a preventive control? (4) Justify your decision for column 3 (5) What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied at this step? Yes No Yes No FSPCA Exercis e Workbook Version 1.2 9
Hazard Analysis for: (1) Ingredient/ Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step B = biological, C = chemical (including radiological) P = physical (3) Do any potential food safety hazards require a preventive control? (4) Justify your decision for column 3 (5) What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied at this step? Yes No Yes No 10 FSPCA Exerci s e Workbook Version 1.2
Hazard Analysis for: (1) Ingredient/ Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step B = biological, C = chemical (including radiological) P = physical (3) Do any potential food safety hazards require a preventive control? (4) Justify your decision for column 3 (5) What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied at this step? Yes No Yes No FSPCA Exercis e Workbook Version 1.2 11
Chapter 9: Process Preventive Control PLANT NAME ISSUE DATE PAGE ADDRESS SUPERSEDES PRODUCT CODE Product Name: Notes for Exercises Process Preventive Controls Complete Gray columns after Verification and Record-keeping Chapters Process Control Step Hazard(s) Parameter, values or critical limits What Monitoring How Frequency Who Corrective Action Verification Records 12 FSPCA Exerci s e Workbook Version 1.2
Process Preventive Controls (continued) Complete Gray columns after Verification and Record-keeping Chapters Process Control Step Hazard(s) Parameters, values or critical limits What Monitoring How Frequency Who Corrective Action Verification Records FSPCA Exercis e Workbook Version 1.2 13
Chapter 10: Allergen Preventive Control What allergens are present in the facility? Food Allergens in Ingredient Formulation Egg Milk Soy Allergens in Precautionary Labeling Raw Material Name Supplier Leave blank for exercise Wheat Tree Nut (market name) Peanut Fish (market name) Shellfish (market name) 14 FSPCA Exerci s e Workbook Version 1.2
Do all products contain the same allergens? If not, what do you do to control these allergens? Intentional Allergens Egg Milk Soy Wheat Tree Nut (market name) Peanut Fish (market name) Shellfish (market name) Product Name Production Line What considerations did you take into account, e.g., scheduling and allergen cleaning? Scheduling implications: Allergen Cleaning Implications: Are there allergen labeling implications? Product Allergen Statement FSPCA Exercis e Workbook Version 1.2 15
Food Allergen Preventive Controls Allergen Control Hazard(s) Criterion What How Monitoring Frequency Who Corrective Action Verification Records 16 FSPCA Exerci s e Workbook Version 1.2
Chapter 11: Sanitation Preventive Controls Based on the E.G. Food Company omelet example, determine whether the following is a GMP or a preventive control. Activity Assemble/wrap area is separate from the cook area Employees wash their hands and don gloves The assemble/wrap table is cleaned and sanitized with 200 ppm quat Floors and walls in the assemble/wrap area are cleaned and sanitized Floors and walls are sanitized in the refrigerator GMP or Preventive Control Notes For your model facility s production areas requiring a sanitation preventive control, would you use dry cleaning, wet cleaning or both? Describe: For your model facility, is zoning appropriate? Is so, where would you apply it? FSPCA Exercis e Workbook Version 1.2 17
Chapter 12: Supply-chain Preventive Controls Identify at least one hazard requiring a supply-chain-applied control for your model food, then: Identify the control(s) to be applied by the supplier, identify at least one supplier verification activity, outline the elements the procedure would require, and identify required records. Raw material or other ingredient Hazard requiring a supply-chain-applied control Preventive controls applied by the supplier Identification of supplier verification procedure(s) Notes for Exercises Verification procedure Records 18 FSPCA Exerci s e Workbook Version 1.2
Chapter 13: Verification and Validation Procedures Add your activity results to the process preventive control form. Discussion notes: Chapter 14: Record-keeping Procedures Add your activity results to the process preventive control form. Discussion notes: FSPCA Exercis e Workbook Version 1.2 19
Chapter 15: Recall Plan Discussion notes: Chapter 16: Regulation Overview Discussion notes: 20 FSPCA Exerci s e Workbook Version 1.2