We take for granted that the United States food supply is safe. But do you know which food safety professionals are qualified and have a pivotal role in food safety culture and compliance? How are these professional trained to prevent and correct food contamination and hazards? Every registered FDA food manufacturing facility must have at least one named qualified individual on record.

These food safety professionals are Preventive Controls Qualified Individuals or PCQIs. This role with its acronym was established by the U.S. Food and Drug Administration (FDA) as part of its Preventive Controls for Human Food Rule under the Food Safety Modernization Act (FSMA). FSMA is a big deal because it introduced new rules that mandate certain human and animal food processing facilities to implement new preventive controls to reduce the risk of contamination and other hazards throughout the ingredient supply chain.

To meet the requirements in the Human Food Rule each registered facility must have a Food Safety Plan (FSP) that is overseen by a PCQI. The Food Safety Plan has distinct components and they must all be documented. The plan incorporates hazard analysis, preventive control measures, monitoring procedures, corrective actions, verification activities and records maintenance. It involves identification of potential risks associated with all aspects of production, from ingredient procurement to finished product labeling and distribution.

pcqi team trainingCompanies and the FDA expect PCQIs to be competent in complying with FDA regulations and to minimizing the likelihood of food safety contamination and safety issues. Being recognized as a PCQI takes experience and the right training on the Human Food or Animal Food rule. Here we will focus on the FDA-recognized standardized training for the PCQI in Human Food. Most PCQIs are qualified for this important role by taking this specialized curriculum and attaining a course completion certificate which is placed in their company’s Food Safety Plan.

The FDA-recognized PCQI curriculum is to assist food safety professionals to meet the regulation 21CFR part 17. Providers of this training include FSPCA and alternative expert providers as allowed by the regulation. But this regulation does acknowledge that some food safety professionals can have on the job training or self-learning to understand the law and develop a Food Safety Plan(FSP) that meets the regulation.

Most companies prefer to have their named PCQIs attain a completion certificate rather than self-qualify. The FDA-recognized standardized curriculum equips the PCQI with essential skills, knowledge, and competencies to develop robust preventive controls tailored to their specific operations and food products. PCQIs are the individuals who oversee a comprehensive Food Safety Plan for each product under their responsibility.

What is involved in the role of Preventive Controls Qualified Individual aka PCQI?

As defined by the FDA, the PCQI must be qualified to develop and apply risk-based preventive controls. This is a complex process. It starts with a thorough identification of all potential biological, chemical, and physical hazards that may be present and determine their significance to in terms of risks to public health.

Every registered facility that manufactures, processes, packs, or hold human or animal food must have at least one PCQI on their team. The PCQI relies on the various teams responsible for current Good Manufacturing Processes (cGMPs) to adhere to those programs so that hazards can be controlled there. When cGMPs cannot control a hazard, then process controls are dealt with in a HACCP plan. The Hazard Analysis and Critical Control Points (HACCP) Plan outlines specific steps that must be taken to prevent or mitigate identified hazards during various stages of food production. FSMA adds new preventive controls in addition to the process control CCPs (Critical Control Points) for HACCP.

How does the PCQI move from HACCP to the full Food Safety Plan in FSMA?

The PCQI moves collaboratively with other food safety team members to develop the HACCP plans. Because HACCP concentrates on process controls, it must be supplemented with other types of controls for hazards requiring them such as supply chain or allergen controls. This is what is meant by the term, “From HACCP to HARPC.”

Although the FDA does not officially use the acronym HARPC, it is used by some in the industry to distinguish the system and practice of Hazard Analysis and Risk-Based Preventive Controls to comply with FSMA. The PCQI along with the food safety team must include monitoring procedures, verification and validation, corrective actions, and record-keeping systems to the HACCP analysis foundation to arrive at the full Food Safety Plan required under the Preventive Controls for Human Food Rule.

Unlike HACCP, which concentrates on specific points within a process, the Human Food Rule under FSMA encompasses broader preventive controls throughout various stages of food production and transport. While there are similarities between HACCP and a full preventive controls FSP, they differ significantly in scope and regulatory requirements.

HACCP is a systematic approach to identifying food safety hazards and implementing control measures to mitigate them. It is a globally recognized framework that ensures food safety by analyzing each step in the food production process from manufacturing to distribution.

The FSP and its oversight by the PCQI is a designation introduced by the Food Safety Modernization Act (FSMA) of 2011 in the United States. HACCP is not specific to any particular regulation. It serves as a best practice framework globally. Thus, becoming recognized as a PCQI means one bound by FSMA rules in manufacturing or handling food. Understanding these differences is important for individuals and companies operating within the U.S. food industry or in countries wishing to export food to the United States.

What are other responsibilities of the PCQI?

As stated above, the PCQI must conduct a thorough hazard analysis for all ingredients in each food product at their supply chain and manufacturing steps. In addition to applying their expertise in identifying various types of hazards and evaluating risks, the PCQI is entrusted with constructing a full FSP that incorporates all types of preventive controls to mitigate risks. These controls may include process controls such as cooking or cooling processes, sanitation controls, allergen controls, supply chain controls, and other controls such as recall plans or training.

Oversight of a thorough documentation of monitoring, validating, verification, and corrective actions in respect to the preventive controls is needed for a robust Food Safety Plan. PCQIs oversee thorough documentation of monitoring results as evidence of validation critical limits and verification that preventive controls are working as intended. Regular inspection of records along with internal and third-party external audits are part of documenting the oversight function.

By proactively identifying any deviations from established SOPs and protocols or non-compliance issues within their facility, PCQI can take corrective actions more promptly. Some activities that make up routine checks are monitoring cGMPs, monitoring sanitation practices, equipment maintenance schedules, and environmental monitoring for pathogens or allergens.

It is evident that the role of PCQI make these professionals essential assets within FDA registered food facilities, diligently working to protect public health. With their team members they uphold the food safety culture in their organization.

How do I attain a PCQI course completion certificate?

The PCQI course completion certificate is obtained after a specialized course of the FDA- recognized standard curriculum. The curriculum is designed to equip the PCQI with knowledge and skills to implement and manage a food safety system that complies with the requirements of the Preventive Controls for Human Food Rule or Preventive Control for Animal Food Rule under FSMA. There are two separate courses for PCQI for Human Food and PCQI for Animal Food. This article covers the role and training for the PCQI for Human Food.

The FDA-recognized curriculum is offered in face-to-face, hybrid (synchronous online) or completely online (self-paced on your timeline) formats. The training topics include hazard identification and risk evaluation with the implementation of appropriate preventive controls where needed. The PCQI course may be offered in several languages other than English. For example, the PCQI Course Spanish Version.

During the PCQI course, participants are guided through case studies and practical examples that help them apply their learning to real-world scenarios. Major topics included are recordkeeping requirements and practices for monitoring, verification, validation, corrective actions, and product recalls addressed within the Human Food Rule.

Documenting PCQI training with the individual’s unique completion certificate serves as proof of training for an FDA inspector or third-party audit. The Preventive Controls for Human Food Rule allows that an individual may self-qualify or take a course from an FSPCA administered instructor or take the PCQI course from another expert instructor that is using the FDA-recognized curriculum.

When choosing a PCQI course look for quality training that has these attributes:

  • User friendly technology
  • Material that is consistent with the FDA-recognized curriculum
  • Links to FDA and other guidelines and resources
  • Motivational practice activities
  • Multiple types of assessment
  • Learning strategies that are based on workforce development methods

Holding a PCQI Course completion certificate opens opportunities for career advancement within the food industry and enhances one’s professional credibility. By investing in the 20-hour PCQI course, individuals can differentiate themselves as qualified professionals trained to effectively manage risk, implement preventive controls, and safeguard the public’s health through a robust safety system.

Does a PCQI course completion certificate expire?

The unique certificate to the individual signifies that the learner has successfully completed the PCQI FDA-recognized curriculum training to possess the necessary knowledge and skills to develop and manage a FSP in accordance with the regulations set forth in the Preventive Controls for Human Food Rule under FSMA.

Unlike some trainings that require periodic renewal or recertification, the PCQI course completion certificate does not have a specific expiration date. This means that your qualified status goes with you if you change facilities. The certificate remains in any Food Safety Plan for which you are responsible for the timeframe of your designated responsibility as PCQI.

Even though at this time the FDA has not specified an expiration date, it is expected that under the role of PCQI you will keep up to date with FDA rule advisories, recommendations, and guidelines pertaining to preventive controls and food safety plans. The FDA regularly reviews and revises its guidelines to ensure they align with current industry best practice and scientific advancements in food safety, such as food defense, newly declared allergens, and traceability.

Depending upon your food product and its ingredients, your facility may also have to adhere to other rules of FSMA. In your role as PCQI you may need additional training on some of the following rules:

  • Produce Safety
  • Preventive Controls for Animal Food
  • Sanitary Transportation
  • Protection Against Intentional Adulteration
  • Accredited Third-Party Certification
  • Voluntary Qualified Importer (VQIP)
  • Food Traceability

Maintaining competency as a Preventive Controls Qualified Individual requires ongoing education and staying current with industry practices. Attending workshops, seminars, webinars, or other professional development opportunities can help you remain knowledgeable about emerging trends and advancements in hazard analysis, risk evaluation and preventive controls within your industry. Continuing education is necessary to ensure that your qualified status remains relevant and valuable throughout your career journey. It is also reflection of your continued commitment to upholding the highest standards of food safety within your facility food safety culture, operations, and the industry.

How do I schedule PCQI training and what does it cost?

The duration of the course time is set by the Human Food Rule as 20 hours of material. This translates to 2.5 to 3 days in class for a face-to-face seat time class plus any travel time to the course site.

If the course is a hybrid synchronous format – that is part seat time and part online – plan on the required 20 hours scheduled over dates prescribed by the instructor.

If the course is self-paced and completely online (asynchronous) your learning time is set by your schedule. The learner is given credentials and logs on at their convenience. This format allows for more reflection time on analysis of gaps in your FSP and the intricacies of decisions.

It allows for teams to take the course in tandem and compare practice notes.

The approved curriculum is structured into modules. The higher quality courses have assessments within and after the modules as well as a comprehensive course assessment.

The online PCQI format allows for different types of virtual exercises and individual feedback.

The cost depends on the format chosen. The course registration ranges on average from $600 to $1500 plus travel, lodging and meals if appropriate. Some courses add on additional fees for manuals and an AFDO completion certificate.

What is the return on investment for my company when I become a PCQI?

Companies recognize that their brand and bottom line rely on a well-developed and implemented FSP with a strong food safety culture embedded in all departments. The PCQI is the bulwark against bad behaviors and outcomes. When management supports the PCQI and their team, risks are mitigated.

With this defensive and proactive strategy in mind, companies often train other members on the food safety team as PCQIs to have a back-up for the named PCQI. When other team members take the PCQI training the named PCQI is not responsible for training colleagues on the regulatory language and why the PCQI is asking for specific procedures and documentation.

Team training is a popular practice.

Internal audits, third-party audits and FDA visits to your facility are more successful when the entire food safety team is on the same page with the Preventive Controls for Human Food Rule and the other FSMA rules.

Company executives should know that while they are enjoying a meal with their family, it is thanks to PCQIs that have their back. We are depending on these professionals and their teams for clean and safe food.

Preventive Controls and ImEPIK’s Food Safety Training

ImEPIK’s courses guide employees in food production through the FSMA’s regulatory mandates, from building a food safety plan to ensuring that companies are prepared for FDA inspections. The course is also available in Spanish and there is also a version that addresses the Canadians for Safe Food Regulations.

Contact ImEPIK to learn more about our self-paced, multi-module training.