Hazard Analysis and Critical Control Points

Course Length: 16 hours

Objectives

·       Explain the basic concepts underlying HACCP

·       Describe the relationships between HACCP and prerequisite programs

·       Apply the 5 preliminary steps & 7 HACCP principles to develop an effective HACCP plan

·       Recognize and describe HACCP regulatory considerations

·       Describe how to implement and maintain a HACCP plan

Outcomes

·       Through active engagement in the presentation and participation in discussions, participants will identify, name and understand the principles and tasks to implement a HACCP 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 and the implementation of the management components of the HACCP plan.

·       Through the working group exercises, participants will gain experience utilizing the resources like form templates, the Code of Federal Regulations and Hazard Guides necessary to build a HACCP plan and its management components.

Target Industry

Meat/Meat containing product producers, Food producers seeking to meet 3rd audit organization training requirements, Food producers seeking to prep for Preventive Controls for Human Food Regulations

Primary Audience

Production, Quality Management, and/or Senior Management

Standards

Participants will be provided reference material like hazard guides, Codes of Federal Regulations, and plan templates to complete the working group exercises

Exercises

·       HACCP Plan Development Activities in working groups

·       Participants will be required to engage with a group of peers to complete a HACCP plan scenario.  They will be required to create the plan in stages and report their findings back to the course participants.  Participants are expected to engage in robust discussions that will provide perspective in the decision making process of other groups.

1.     Course Content

1.1.  Learning Objectives

2.     HACCP Overview & Learning Objectives

2.1.  HACCP – The Big Picture

2.2.  Historical Perspective

2.3.  Basic Components

2.3.1.     5 Preliminary Task

2.3.2.     7 Principles

3.     Prerequisite Programs and SSOPs & Learning Objectives

3.1.  Prerequisite Programs

3.1.1.     PRP & GMP Overview

3.1.2.     History

3.1.3.     Examples

3.1.3.1.         Facility

3.1.3.2.         Personnel

3.1.3.3.         Production Equipment

3.1.3.4.         Control of Raw Materials

3.1.3.5.         Sanitation & Environmental

3.1.3.6.         Traceability & Recall

3.1.3.7.         Consumer Complaint Management

3.2.  SSOPs

3.2.1.     SSOPs Overview and

3.2.2.     Regulatory Requirements

3.2.3.     8 SSOPs

3.2.3.1.         Safety of Water

3.2.3.2.         Food Contact Surfaces

3.2.3.3.         Cross Contamination

3.2.3.4.         Maintenance of Hand Washing, Hand Sanitation, and Toilet Facilities

3.2.3.5.         Adulterants

3.2.3.6.         Toxic Compounds

3.2.3.7.         Employee Health

3.2.3.8.         Exclusion of Pests

3.2.4.     FDA

3.2.5.     FSIS

3.3.  Establishing and implementing PRPs

3.4.  Verification of PRPs

3.5.  PRP vs. HACCP

3.6.  PRP or HACCP

4.     Food Safety Hazards & Learning Objectives

4.1.  Food Safety Hazard Overview

4.2.  Biological

4.2.1.     Overview

4.2.2.     Types of Hazards

4.2.2.1.         Bacterial Foodborne Pathogens

4.2.2.2.         Pathogenic Viruses

4.2.2.3.         Pathogenic Parasites

4.2.3.     Types of illness due to Hazards

4.2.3.1.         Intoxication

4.2.3.2.         Infection

4.2.4.     Biological Hazards Examples

4.2.4.1.         Clostridium botulinum & Control

4.2.4.2.         Clostridium perfringens & Control

4.2.4.3.         Salmonella & Control

4.2.4.4.         Pathogenic Escherichia coli & Control

4.2.4.5.         Staphylococcus aureus & Control

4.2.4.6.         Listeria monocytogenes & Control

4.2.4.7.         Campylobacter & Control

4.2.4.8.         Vibrio parahaemolyticus & Control

4.2.4.9.         Viruses, Parasites & Control

4.3.  Chemical

4.3.1.     Overview

4.3.2.     Types

4.3.2.1.         Naturally Occurring Substances

4.3.2.2.         Unavoidable Poisonous or Deleterious Substances

4.3.2.3.         Toxins of Microbial Origins

4.3.2.4.         Allergens

4.3.2.4.1.             Top 8 Food Allergens

4.3.2.4.2.             Allergens and Food safety

4.3.2.4.3.             Chemical Sensitivities

4.3.2.4.4.             Control Measures

4.3.2.5.         Establishment operations

4.3.2.5.1.             Chemicals

4.3.2.5.2.             Pesticides

4.3.2.5.3.             Storage

4.4.  Physical

4.4.1.     Overview

4.4.2.     Regulatory Guidance

4.4.3.     Sources

4.4.3.1.         Glass

4.4.3.2.         Metal

4.4.3.3.         Raw Materials

4.4.4.     Controlling/Minimizing Physical Hazards

4.4.4.1.         Raw material Receipt

4.4.4.2.         Facility

4.4.4.3.         Employee practices

4.4.4.3.1.             GMP

4.4.4.3.2.             Glass Control Program

4.4.4.4.         Detection Equipment

5.     Preliminary Tasks & Learning Objectives

5.1.  Overview

5.1.1.     Gain Management Support

5.1.2.     Well Designed PRP first

5.2.  5 Tasks

5.2.1.     Assemble a HACCP Team

5.2.2.     Describe the product

5.2.3.     Describe the Intended Use and Consumers

5.2.4.     Construct a Flow Chart

5.2.5.     Verify the Flow Chart

5.3.  Regulatory requirement

6.     Hazard Principle #1 - Hazard Analysis & Learning Objectives

6.1.  Overview

6.2.  Objectives of a Hazard Analysis

6.3.  Steps of a Hazard Analysis

6.4.  Reasonably Likely To Occur – RLTO

6.5.  Examples

6.5.1.     Analysis for an egg product (Biological)

6.5.1.1.         Identification

6.5.1.2.         Evaluation

6.5.2.     Analysis for an blending process (Chemical)

6.5.2.1.         Identification

6.5.2.2.         Evaluation

6.5.3.     Analysis for a Grinding Step

6.5.3.1.         Identification

6.5.3.2.         Evaluation

Group Activity

Perform Preliminary Task and Develop a Hazard Analysis (Materials and templates provided)

·      Break up into groups and form a HACCP committee

·      Review Product Description

·      Review Intended Consumers and Use

o   Unintended use

·      Review Flow Diagram

·      Verify Flow Diagram

·      Perform a Hazard Analysis

·      Groups will stay together from here on out to finish the class and their HACCP plan (This Group activity HACCP plan will follow the groups through the presentation with each successive module adding to the development of the HACCP principle with a group activity at the end of each module)

7.     Hazard Principle #2 – Determining Critical Control Points & & Learning Objectives

7.1.  Overview

7.1.1.     Control Point Defined

7.1.2.     Critical Control Point Defined

7.1.3.     Based on results of the Hazard Analysis

7.1.3.1.         Significant Hazards

7.1.3.2.         Control Measures

7.2.  Example

7.3.  Decision Trees

7.4.  Important considerations

7.5.  How many?

7.6.  Regulatory requirement

Group Activity

Determine the Critical Control Points based on the groups Hazard Analysis

·      Resources will need to be provided based on the products and processes the group chooses

8.     Hazard Principle #3 – Establishing Critical Limits & Learning Objectives

8.1.  Overview

8.2.  Examples

8.3.  CL failure

8.4.  Setting Critical Limits

8.5.  Operating Limits

8.6.  Critical Limits vs. Operating Limit

8.7.  Regulatory Requirements

Group Activity

Determine the Critical Limits based on the groups Critical Control Points

·      Resources will need to be provided based on the products and processes the group chooses

9.     Hazard Principle #4 – Establishing Monitoring Procedures & Learning Objectives

9.1.  Overview

9.2.  What will be monitored?

9.3.  How will it be monitored?

9.4.  When or how often will it be monitored?

9.5.  Who will be performing the monitoring?

9.6.  Examples – Screen Monitoring

9.7.  Regulatory Requirements

9.8.   

Group Activity

Determine the Monitoring Procedures based on the groups Critical Limits

·      Resources will need to b e provided based on the products and processes the group chooses

10. Hazard Principle #5 – Establishing Corrective Action & Learning Objectives

10.1.               Overview

10.1.1. Corrective Actions Defined

10.1.2. Corrective Actions Procedure

10.2.               Process adjustments

10.3.               Noncompliant Product

10.4.               Responsibility

10.5.               Corrective Action Log/Report

10.6.               Regulatory Requirements

10.6.1. FDA

10.6.2. FSIS – 9 CFR part 417.3

Group Activity

Determine the Corrective Actions based on the groups product and process

·      Resources will need to be provided based on the products and processes the group chooses

11. Hazard Principle #6 – Establishing Verification Procedures & Learning Objectives

11.1.               Overview

11.2.               Initial Validation

11.3.               Validation Example

11.4.               Verification

11.4.1. Types

11.4.2. Certification of CCP

11.4.2.1.      Activities

11.4.3. Calibration

11.5.               Record Review

11.6.               Independent Checks

11.7.               HACCP system verification

11.8.               Regulatory Verification requirements

11.8.1. FSIS

11.8.2. FDA

11.9.               Revalidation vs. Reassessment

Group Activity

Determine the Verification Procedures based on the groups product and process

·      Resources will need to be provided based on the products and processes the group chooses

12. Hazard Principle #7 – Establishing Record-keeping Procedures & Learning Objectives

12.1.               Overview

12.1.1. Types of records

12.1.2. Record Components

12.1.3. Record Keeping System

12.1.4. Documentation

12.1.5. Record Retention Regulatory Requirements

12.1.6. Regulatory Access

Group Activity

Determine what records will support your monitoring, verification and validation of your CCP and HACCP system

·      Resources will need to be provided based on the products and processes the group chooses

13. Organizing and Managing HACCP Programs

13.1.               Overview

13.2.               Problems

13.3.               Costs

13.4.               Benefits

13.5.               HACCP Coordinator

13.6.               HACCP Team

13.7.               Plan Development

13.8.               Implementation

13.9.               Management

13.10.           System to address Change

13.11.           Daily Operations

13.12.           Evaluation and Revisions

14. Enforcement of HACCP

14.1.               Overview

14.2.               FSIS

14.3.               FDA

14.4.               Canada

14.5.               EU

14.6.               FSMA and HARPC

14.7.               Regulatory HACCP

14.8.               HACCP Analysis

14.9.               HACCP Plan

14.10.           Corrective Actions

14.11.           Verification & Validation

14.12.           Reassessment

14.13.           Records Retention

14.14.           Records Review

14.15.           Training

14.16.           Imported Foods