FSMA Preventive Controls for Human or Animal Food – PCQI Training – Course Description

Each human or animal food processing facility will need a Preventive Controls Qualified Individual to oversee or conduct preparation of the food safety plan, validation of the preventive controls, review of records, and reanalysis of the food safety plan.

To become a PCQI, an interested person must successfully complete training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized by FDA (requirements of 21CFR117.180.) or be otherwise qualified through job experience to develop and apply a food safety system.

Job experience qualifies only if person’s knowledge is at least equivalent to FDA-recognized training.

Food Safety & Quality Systems, LLC offers the FDA-recognized training FSPCA Preventive Controls for Human Food course.

The Food Safety Preventative Controls Alliance (FSPCA) in collaboration with the FDA has designed this course. It is taught by a Lead Instructor for the FSPCA Preventative Controls for Human Food Course and meets the Preventive Controls Qualified Individual Training requirements. Participants will receive their official FSPCA Preventive Controls Qualified Person certificate issued by AFDO.

This course is the certain way to ensure compliance to the trained qualified individual requirements.


A valid HACCP Plan essentially addresses most of the requirements for the PROCESS Preventive Controls (CCPs).  However, the preventive controls rule incorporate controls beyond those managed as CCPs as in traditional HACCP Plan.

Learning 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


This course is designed for individuals who shall become members of a HACCP/HARPC/Preventive Controls team responsible for the development and maintenance Food Safety Plan.  Students should have a general understanding of at least one sector of the food industry from agriculture, manufacturing or warehouse/distribution.


Ability to read, write and speak Basic English and/or Spanish.   It is recommended that participants attend or be familiar with 21 CFR Part 117 Good Manufacturing Practices prior to attending the HARPC -Preventive Controls for Human or Animal Food Training Course

Instruction Hours

2.5-day class (20 hrs. total)

Training Methodology

This course is interactive and hands-on.  It is based on adult learning theory and it includes presentations, demonstrations, activities, exercises, multi-media tools, and a hands-on evaluation. Working through product specific case scenarios, trainees are placed in practical plant situations that culminate with the development of a Food Safety Plan outline.

There will be a pre-assessment before the start of training and a post assessment and a student evaluation at the end of training. Food Safety & Quality Systems, LLC will also issue a training engagement report after the completion of training with assessment, evaluation, attendance, and instructor information.


This course will be delivered by a highly skilled, FSPCA Lead Trainer with real world experience in development and implementation of Food Safety systems.

Course Outline

Day 1

  • Chapter 1 Introduction to Course and Preventive Controls
  • Chapter 2 Overview of a Food Safety Plan
  • Chapter 3 Good Manufacturing Practices and Prerequisite Programs
  • Chapter 4 Biological Food Safety Hazards
  • Chapter 5 Chemical, Physical and Economically Motivated Hazards
  • Chapter 6 Preliminary Steps in Developing a Food Safety Plan
  • Chapter 7 Resources for Preparing Food Safety Plans

Day 2

  • Chapter 8 Hazard Analysis and Preventive Control Determination
  • Chapter 9 Process Preventive Controls
  • Chapter 10 Allergen Preventive Controls
  • Chapter 11 Sanitation Preventive Controls

Day 3

  • Chapter 12 Supplier Preventive Controls
  • Chapter 14 Record-keeping Procedures
  • Chapter 15 Recall Plan
  • Chapter 16 Regulation Overview – cGMP and Hazard Analysis and
    Risk-Based Preventive Controls for Human Food


Fees for the HARPC/FSPCA Preventive Controls for Human Food Course are $749.00 per participant.  This includes electronic course materials and workbooks. Successful completion of the course workbooks will qualify each individual as FSPCA Preventive Controls Qualified Person.