PCQI Training: Preventive Controls for Human Food

If your facility is registered under section 415 of the Federal Food, Drug, and Cosmetic Act and manufactures, processes, packs, or holds human food for consumption in the U.S. (or exports to the U.S.), then yes.

FSMA requires that a trained Preventive Controls Qualified Individual (PCQI) be in place to develop and manage a compliant Food Safety Plan.

The course includes about 20 hours of expert-led content.

You can start anytime, move at your own pace, and save your progress as you go. Our course is designed to fit even the busiest schedule.

The course is divided into 16 chapters, each featuring videos and interactive exercises that provide hands-on experience in creating and implementing a Food Safety Plan based on the FDA’s model. You’ll work with real-world scenarios to reinforce the concepts covered in each chapter.

By the end of the training, you will have gained valuable experience and a deeper understanding of the steps involved in developing and implementing a Food Safety Plan that meets the FSMA rule requirements. There is no final exam, allowing you to focus on practical application and mastery of the material.

Yes. Once you complete the course, you’ll receive the official FSPCA certificate. Since FSPCA is recognized by the FDA, your certificate will show inspectors and auditors that you’ve met the PCQI training requirement under FSMA.

There is no expiration date on PCQI certificates and no requirement for retraining. Everyone who completes this course meets the requirements for becoming a PCQI.

A PCQI (Preventive Controls Qualified Individual) is someone who has completed training in the development and application of risk-based preventive controls.

The PCQI is trained to understand the requirements of the Preventive Controls Rule and to write the Food Safety Plan according to the FSMA requirements.

What is new and unique about the Preventive Controls Rule is that it focuses on preventing food safety incidents instead of reacting to them after they happen. It requires a food safety plan that includes preventive controls in addition to the process controls you will find in traditional HACCP plans.

In addition to critical limits in your HACCP plan, you will establish parameters and values to monitor preventive controls. The preventive controls rule includes controls that have not typically been included in HACCP programs. They include: allergen controls, sanitation controls, and supply chain controls.

The Food Safety Plan must include:

Hazard analysis

Identify any known or reasonably foreseeable biological, chemical, and physical hazard and determine if any of those hazards require a preventive control, and must consider:

• The formulation of the food
• The condition, function, and design of the facility and equipment
• Raw materials and other ingredients
• Transportation practices
• Manufacturing/processing procedures
• Packaging activities and labeling activities
• Storage and distribution
• Intended or reasonably foreseeable use
• Sanitation, including employee hygiene, and
• Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins)
• Facility and product/process specific

Preventive controls

If the hazard analysis identified a hazard requiring a preventive control, you must implement risk-based measures to significantly minimize or prevent food safety hazards

Types of Preventive Controls:

• Process Controls (equivalent to CCPs)
• Allergen Controls (human food only)
• Sanitation Controls
• Supply Chain Controls
• others

Risk-based supply chain program

If you identify any hazards related to ingredients purchased from your supplier and if you depend on the supplier to control that hazard, you must have a supply-chain control program with verification activities.

• Evaluate suppliers for approval
• Establish written procedures for receiving and use of approved suppliers
• Conduct appropriate supplier verification activities

A recall plan

You will need a written recall plan including the procedures detailing the steps you will take to perform a recall and assigning responsibility for performing them. You will need this if your hazard analysis identifies a hazard requiring a preventive control.

Record keeping

• The Food Safety Plan must be signed by the owner, operator, or agent in charge, upon completion and after any modification
• Records related to the Food Safety Plan
  • must be accurate, indelible, and legible
  • must be signed, dated, and properly identified
  • must be kept for at least 2 years
  • subject to FDA review

Taking this course will clarify the requirements, ensuring you are ready to implement them in your facility and prepare for your next FDA inspection.

Learn more about FSMA requirements.