Course Length: 24 hours

Objectives

·      Understanding the differences between HACCP and HARPC

·      Identification of process preventive controls (CCPs) and applying critical limits to control identified hazards

·      Identification of other preventive controls (PCs) such as allergen, sanitation and supplier controls at each applicable step and applying the parameters and values to support control of the identified hazard

·      Establish the Monitoring of critical limits or parameters and values to ensure the process stays in control

·      Taking corrections, assigning corrective or preventative actions when control is compromised

·      Verifying/Validating that the HACCP/HARPC plan is being applied and working as intended

·      Developing documents and records to demonstrate that the Food Safety Plan is operating effectively

Outcomes

·      Through active engagement in the presentation and participation in discussions, participants will identify, name and understand the principles and tasks to implement a Food Safety plan.

·      Through the working group exercises, participants will gain practical experience working through an example plan.  This exercise will provide participants with experience around the decision-making process of hazard analysis, identification of hazards and the implementation of the management components of the HACCP plan.

·      Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.”  (21 CFR part 117.3)

Target Industry:  Food production facilities

Primary Audience:  Production Supervisors, Production, Quality, and Executive Management

Standards:  FSPCA Preventive Controls For Human Food Training Curriculum,  FSPCA Preventive Controls For Human Food Exercise Workbook

Exercises 

o   10 exercises based on Chapter content

Outline

1.     Outline Content

2.     Course Objectives

3.     Course Format

4.     Introduction to Preventive Controls

4.1.  HACCP compared to Preventive Food Safety Systems

4.2.  New developments in a Food Safety Plan

5.     Food Safety Plan Overview

5.1.  Definitions

5.2.  Required & Useful Contents

5.3.  Outbreak examples

5.4.  Organizational Sections

5.4.1.     Back Ground

5.4.2.     Hazard Analysis

5.4.3.     Preventive Controls

5.4.4.     Recall Plan

5.4.5.     Implementation Procedures

6.     Good Manufacturing Practices and Other Prerequisite Programs

6.1.  Definitions

6.2.  Components of GMPS

6.3.  Training

6.4.  Personnel

6.4.1.     What’s Wrong with this Picture – Food Handler’s Hand

6.5.  Plant and Grounds

6.5.1.     What’s Wrong with this Picture – Waste Disposal and & Drainage

6.5.2.     What’s Wrong with this Picture – Ceiling Light Fixture

6.6.  Sanitary Operations

6.6.1.     What’s Wrong with this Picture – Chemical Segregation

6.6.2.     Condition and Cleanliness of Food-contact Surfaces

6.6.3.     What’s Wrong with this Picture – Cleaning and Sanitation

6.7.  Sanitary Facilities and Controls

6.7.1.     Water Supply and Plumbing

6.7.2.     What’s Wrong with this Picture – Ware-washing sink

6.7.3.     Hand Washing, Hand Sanitizing and Toilet Facilities

6.7.4.     What’s Wrong with this Picture – Employee Toilet

6.7.5.     What’s Wrong with this Picture – Hand Washing Sink

6.8.  Equipment and Utensils

6.9.  Processes and Controls

6.9.1.     Raw Materials and Ingredients

6.9.2.     What’s Wrong with this Picture – Poly bags holding Pita Chips

6.9.3.     Manufacturing operations

6.10.               Warehousing & Distribution

6.11.               GMPs for By-products sent to Animal Food

6.12.               Defect Action Levels

6.13.               Other Regulatory Considerations

7.     Biological Food Safety Hazards

7.1.  Definitions

7.2.  Hazards may not refer to..

7.3.  Reportable Food Registry Identifies Concerns

7.4.  Biological Agents Cause More Outbreaks

7.5.  Potential Biological Hazards

7.6.  Foodborne Illness by the numbers

7.7.  Infections and Intoxications

7.8.  Potential Control Methods for Bacteria

7.8.1.     Prevent

7.8.2.     Kill

7.8.3.     Control

7.9.  Factors that Influence Bacterial Growth

7.10.               pH of Selected Foods

7.11.               Water Activity and Pathogen Growth

7.12.               Other Factors Influencing Bacterial Growth

7.13.               Salmonella spp.

7.14.               Foodborne Viruses

7.14.1. Primary Viral Foodborne Hazards

7.14.2. Methods to Prevent Viral Transmission

7.15.               Foodborne Parasitic Protozoa

7.15.1. Methods to Prevent Parasite Transmission

7.16.               Biological Hazards of Concern in Selected Ingredients

7.17.               Biological Hazard Sources & Potential Controls

8.     Chemical, Physical and Economically Motivated Food Safety Hazards

8.1.  Chemical Hazards

8.1.1.     Health Effects

8.1.2.     Examples

8.1.3.     Undeclared Food Allergens

8.1.4.     Food Allergies

8.1.4.1.         Symptoms

8.1.4.2.         Major Food Allergens

8.1.4.3.         Avoidance is the Primary Treatment

8.1.4.4.         Recalls

8.2.  Mycotoxins

8.3.  Chemicals used in Formulation

8.4.  Unintentionally or Incidentally Added Chemicals

8.5.  Pesticides

8.6.  Industrial Chemicals

8.7.  Heavy metals

8.8.  Drug Residues

8.9.  Radiological Hazards

8.10.               Chemical Hazards Potential Controls

8.11.               Physical Hazards

8.11.1. Choking Hazards for Young Children

9.     Preliminary Steps in Developing a Food Safety Plan

9.1.  Assemble the food safety team

9.2.  Describe the product and its distribution

9.3.  Describe the intended use and consumers of the food

9.4.  Develop a flow diagram and describe the process

9.5.  Verify the flow diagram on-site

10. Resources for Preparing Food Safety Plans

10.1.               Personnel

10.2.               Publications

10.3.               Reliable Internet Sites

10.4.               FSMA Technical Assistance Network

10.5.               FDA Hazards and Control Guidance

11. Hazard Analysis & Preventive Controls Introduction

12. Hazard Analysis & Preventive Controls Determination

12.1.               Definitions

12.2.               Process to Identify Hazards and Control

12.3.               Hazard Analysis Example

12.4.               Hazard Evaluation considerations

12.5.               Evaluating Severity of Food Safety Hazards

12.6.               Evaluating Likely Hood of Occurrence

12.6.1. Establishments Historical Information

12.6.2. Factors affecting Likely Hood of Occurrence

13. Process Preventive Controls

13.1.               Forms

13.2.               Parameters and Values (Critical Limits)

13.3.               Monitoring Procedures

13.4.               Corrective Actions for deviations

14. Food Allergen Preventive Controls

14.1.               FALCPA Required Food Allergen Labeling

14.2.               Allergen Preventive Control Requirements

14.3.               Cross Contact Considerations

14.4.               Equipment Cleaning

14.5.               Verification of Allergen Cleaning

14.6.               Scheduling

14.7.               Manufacturing Controls

14.8.               Allergen Ingredient Control

14.9.               Receipt and Storage of Incoming goods

14.10.           Rework

14.11.           Personnel Practices

14.12.           Labeling Considerations

14.13.           Label design Control Examples

14.14.           “May Contain”

14.15.           Allergen Preventive Controls for Labeling

14.16.           Allergen Control By Suppliers

14.17.           Training

15. Sanitation Preventive Controls

15.1.               Hazards and Conditions Relevant to Sanitation Preventive Controls

15.2.               GMPs That Support Cross-contact Prevention

15.3.               Definitions

15.4.               Considerations

15.5.               Hygienic Zoning

15.6.               Documentation

15.7.               Cleaning and Sanitizing Procedures

15.8.               Monitoring

15.9.               Actions to correct deficiencies

15.10.           Verification

15.11.           Environmental Monitoring

16. Supply Chain Preventive Controls

16.1.               Who Controls the hazard? Supplier, Receiving Facility, Customer

16.2.               General Requirements

16.3.               Approved Suppliers

16.4.               Supplier Verification Activities

16.5.               Who Can Perform Supplier verification?

16.6.               Onsite Audit Requirements

16.7.               Sampling and Testing

16.8.               Actions for Non-conformance

16.9.               Supply-chain program Review

16.10.           Change Control Process

16.11.           Documentation

17. Verification & Validation Procedures

17.1.               Definitions

17.2.               Potential Verification Procedures

17.3.               Validation Procedures

17.4.               Validation Frequency

17.5.               Exceptions

17.6.               Sources

17.7.               Safe Harbor matrix

17.8.               Equipment calibration

17.9.               Product Sampling and Testing

17.10.           Environmental Monitoring

17.11.           Record Review

17.12.           Food Safety Plan Reanalysis

17.13.           Significant Changes

18. Record-keeping Procedures

18.1.               Required Records

18.2.               Implementation Records

18.3.               General Requirements

18.4.               Computerized Records

18.5.               Monitoring Records

18.6.               Corrective Action Records

18.7.               Verification Records

18.8.               Validation Records

18.9.               Product Testing and Environmental Monitoring Records

18.10.           Record Review

18.11.           Training Records

18.12.           Retention

19. Recall Plan

19.1.               Definitions

19.2.               Recall Classifications

19.3.               Requirements

19.4.               Common Elements

19.5.               Recall Team Roles and Responsibilities

19.6.               External notification

19.7.               Identifying product

19.8.               Effectiveness checks

19.9.               Product Disposition

19.10.           Corrective Actions

19.11.           Mock Recalls

20. Regulation overview