Preventive Controls Qualified Individual (PCQI)

A Preventive Control Qualified Individual (PCQI) is a professional who is trained and certified to develop, implement, and manage a food safety plan that complies with the requirements of the FDA's Food Safety Modernization Act (FSMA).

The FSMA requires that certain food facilities have a PCQI on staff to oversee the development and implementation of a food safety plan that identifies and controls potential hazards in food production. The PCQI is responsible for ensuring that the facility's food safety plan is properly designed, implemented, and updated as necessary.

To become a PCQI, an individual must successfully complete a training program that is recognized by the FDA. The training must cover the FDA's Current Good Manufacturing Practices (cGMPs), Hazard Analysis and Risk-Based Preventive Controls (HARPC), and the development and implementation of a food safety plan.

There are several training options available to become a PCQI, including in-person classes, online courses, and hybrid formats. It is important to choose a training program that is recognized by the FDA and meets the requirements for PCQI certification. Upon completion of the training program, the individual will receive a certificate of completion that can be used to demonstrate their PCQI qualifications.

PCQI Certification for Human and Animal Foods

There are separate PCQI certifications for human food and animal food. While the requirements for both certifications are similar, there are some differences in the training and curriculum based on the specific needs and risks associated with the respective food products.

For example, the PCQI training for human food focuses on preventive controls for hazards that can affect human health, while the PCQI training for animal food focuses on preventive controls for hazards that can affect animal health. Additionally, the training for animal food PCQI covers topics such as animal nutrition, feed ingredients, and feed manufacturing, which are not covered in the human food PCQI training.

It is important to ensure that the PCQI training program you choose is specific to the type of food product you work with or plan to work with. This will ensure that you receive the appropriate training and certification to develop and manage an effective food safety plan for your particular product.

Contents of PCQI Training Materials for Certification

The contents of PCQI training materials for human foods and animal foods are similar in many respects, but there are some important differences based on the specific hazards and risks associated with each type of food product.

Here is a general overview of the main topics covered in PCQI training materials for both human foods and animal foods:

1. Introduction to Food Safety Modernization Act (FSMA): The training covers the background and purpose of FSMA, which was signed into law in 2011 to improve the safety of the US food supply.
2. Current Good Manufacturing Practices (cGMPs): The training provides an overview of cGMPs, which are a set of guidelines and regulations that food manufacturers must follow to ensure the safety and quality of their products.
3. Hazard Analysis and Risk-Based Preventive Controls (HARPC): The training covers the principles of HARPC, which involves identifying and evaluating potential hazards in the food manufacturing process and implementing preventive controls to minimize or eliminate those hazards.
4. Biological, Chemical, and Physical Hazards: The training covers the various types of hazards that can affect food safety, including biological (e.g. pathogens), chemical (e.g. toxins), and physical (e.g. foreign objects) hazards.
5. Preventive Controls and Validation: The training covers the various types of preventive controls that can be implemented to control hazards, such as process controls, sanitation controls, and allergen controls. It also covers the importance of validation and verification to ensure that the preventive controls are effective.
6. Recordkeeping and Documentation: The training covers the importance of keeping accurate and complete records to demonstrate compliance with FSMA regulations and to facilitate traceability in the event of a food safety issue.
7. Supplier Verification and Management: The training covers the importance of verifying and managing suppliers to ensure the safety and quality of raw materials and ingredients.
8. Recall Planning: The training covers the importance of having a recall plan in place to quickly and effectively address any potential food safety issues that may arise.

In addition to these general topics, PCQI training materials for animal foods may also cover additional topics specific to animal nutrition, feed ingredients, and feed manufacturing, such as:

1. Animal Feed Safety Hazards: The training covers the specific hazards that can affect animal health, such as mycotoxins, heavy metals, and pesticide residues.
2. Animal Feed Production Process Controls: The training covers the specific process controls that can be implemented to control hazards in animal feed production, such as ingredient handling, mixing, and processing.
3. Animal Feed Quality Control: The training covers the specific quality control measures that can be implemented to ensure the safety and quality of animal feed, such as testing and sampling.

Overall, PCQI training materials for both human foods and animal foods are designed to provide a comprehensive understanding of food safety principles and regulatory requirements, as well as practical tools and strategies for implementing effective preventive controls and ensuring compliance with FSMA regulations.

FDA-Regulated Products and Import Requirements

• What is Food Safety Modernization Act (FSMA)?
• Prior Notice of Imported Foods
• Food Facility Registration
• Risk-Based Preventive Controls for Human Food
• Risk-Based Preventive Control for Animal Food
• What is a Preventive Controls Qualified Individual?
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• What is Foreign Supplier Verification Program (FSVP)?
• Protect Food against Intentional Adulteration
• FDA Regulated Product in Foreign Trade Zone (FTZ)
• Entry Review Process for FDA Regulated Products
• Country of Origin  VS  Country of Manufacture
• Foods Regulated by FDA or USDA: What is the Difference?
• Label and Labeling Claims for Conventional Food and Dietary Supplements
• What is USDA Country of Origin Labeling (COOL)?
• Import for Export of FDA Regulated Products
• FDA Regulated Products in Personal Baggage or Sending by Mail or Courier
• International Mail Facility (IMF) and FDA Regulation
• Importing Biological Product Regulated by CBER
• Importing Cosmetics and Voluntary Cosmetic Registration Program (VCRP)
• Importing Drugs into the U.S.
• Importing OTC Drugs into the U.S.
• Importing Veterinary Drugs into the U.S.
• Importing Tobacco Products into the U.S.
• Importing Medical Devices into the U.S
• Importing Food Products into he U.S.
• Importing Radiation-Emitting Products into the U.S.