Cultivating Excellence in Food Safety: The Intrinsic Role of Employee Training in FSMA Compliance 

 April 1, 2024

By  Rachel Montgomery

Essential to the food industry’s compliance with the Food Safety Modernization Act (FSMA) is training for Preventive Controls Qualified Individuals, PCQI’s, as well as Qualified Individuals. FSMA affects not only US Manufacturers but US Importers and their Foreign Suppliers. This article aims to delve deeper into the pivotal role that employee training plays in not just meeting the regulatory requirements of training but in fostering a culture of food safety excellence within a company’s unique organizational framework.

The Profound Significance of Employee Training in FSMA Compliance

1. Foundational Knowledge: Navigating the Complexity of ‘the 7 foundational FSMA rules’

Understanding FSMA regulations (AKA ‘rules’) requires more than just a cursory glance; there are seven foundational rules.  Prepare to determine which rules apply to your situation as a manufacturer or importer of Human or Animal Food and then focus on the intricacies of those regulations.  Considering just one of the seven foundational rules (in bold type below), one example is that Human Food is subject to the Intentional Adulteration rule, whereas Animal Food is not. 

Considering four more of the seven rules, Importers are subject to the Foreign Supplier Verification Program (FSVP) rule and to ensuring the controls by their Foreign Supplier of the applicable of two Preventive Controls regulations or the Produce Safety regulation.  Also, human food and animal food manufacturers may receive culls or hulls or other byproducts from produce as human food byproducts for use by animals. 

Further, Supply Chain activities, for domestic entities, may be related to compliance with the Produce Safety rule.   An importer may also want to become a qualified importer under the Voluntary Qualified Importer Program) VQIP, which requires use of an auditing entity in compliance with a sixth rule, the Accredited 3rd Party Certification rule.  A seventh rule is Sanitary Transportation, which interestingly has different requirements from the PC rules regarding requirements for loaders of materials.

There are, as one would expect, certain training requirements related to these numerous rules.   The author provides training for the Preventive Controls for Human and Animal Food and FSVP regulations.  

The Preventive Controls for Human Food and the Preventive Controls for Animal Food training provided refers to the application of the seven foundational rules and reveal further intricacies of the Preventive Controls rules. The remainder of this article will focus primarily on training needed for the Preventive Controls rules.

2. Preventive Controls Implementation: A Cornerstone of Compliance

As you have seen in the paragraphs above, FSMA (The Food Safety Modernization Act and its implementing rules/regulations) affects Foreign and Domestic Processors as well as Importers of both Human and Animal Food.   The regulations are complex and can be quite confusing.  

For compliance with the Preventive Controls for Human Food and the Preventive Controls for Animal Food, a Food Safety Plan is the primary document needed for every processor, domestic or foreign.   That Food Safety Plan must be prepared by a Preventive Controls Qualified Individual (PCQI). Importers must develop a Foreign Supplier Verification Program, FSVP, for each product & each supplier, and ensure their suppliers are in compliance with the Preventive Control Rules or Produce Safety Rule.

The Preventive Controls rules have a much longer name, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls, and require that certain activities must be completed by a “preventive controls qualified individual,” (PCQI).    The PCQI courses for human food and for animal food, developed by FSPCA, are the “standardized curriculum” recognized by FDA; successfully completing a PCQI course meets the requirements for training of a “preventive controls qualified individual.”

Crafting a Comprehensive Employee Training Program: A Strategic Imperative

1. Role-Specific Expertise: Tailoring Training for Relevance to Food Safety Requirements.

Within the intricate web of a food business, different roles carry distinct responsibilities under FSMA. Tailored employee training ensures that each individual, whether in production, quality control, maintenance, or management, understands and fulfills their unique responsibilities within the context of FSMA compliance. This role-specific expertise is vital for the seamless integration of preventive controls and hazard analysis into daily operations.  The Preventive Controls regulations state that all individuals must be qualified to perform their duties: “A person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties.”

Role-specific training means that management must ensure that the food safety impact of each individual is identified and provide training in food safety and hygiene needed to carry out their particular roles in a way that ensures the safety of the food produced in the facility.

Training can be on the job, in a classroom or on-line setting, other means or a combination of these approaches, and must be documented in records according to the records requirements of the Preventive Controls rules.

The Preventive Controls regulations also state “A qualified individual may be, but is not required to be, an employee of the establishment.”   This means that the requirement for qualification applies to seasonal and temporary workers as well as to employees!

2. Customization for Relevance: Meeting Unique Organizational Needs and Leveraging Existing Practices for Implementation

No two food businesses are identical, and thus, no training program should be generic. Customization is the key to relevance. Plan for training in your organization to align with the specific processes, products, and the associated potential hazards. This customization ensures that training is not just checking a regulatory box but a strategic investment in the safety and success and thus the sustainability of your business.

As the author has often counseled management, resource limitations, both in terms of manpower and finances, can always be obstacles to regulatory compliance. With knowledge from taking training courses, a company can integrate its existing procedures and programs for maximum efficiency and also effectiveness.   Virtual courses which don’t require travel save both valuable time as well as money.  Live and interactive virtual training can enable management and other key team members in a PCQI class to learn best practices within the industry that other participants may have discovered and implemented.

Training Awarding the PCQI Certificate and Providing Elevated Expertise in Preventive Controls

1. The Significance of the PCQI Certificate: Leadership in Compliance

At the heart of FSMA compliance is the role of the Preventive Controls Qualified Individual (PCQI). Employee training programs should not just touch upon PCQI responsibilities but actively seek to thoroughly train their key personnel for their day-to-day implementation of FSMA requirements. Holding a PCQI certificate demonstrates an individual’s qualification in overseeing and managing preventive controls comprehensively, thereby minimizing risks and ensuring compliance.

The FSMA regulations require that key personnel in charge of developing and implementing the Food Safety Plan at a company, domestic or foreign, must be a Preventive Controls Qualified Individual, PCQI. 

The regulations specify that the responsibilities of a PCQI include ‘to perform or oversee 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, and 4) reanalysis of the Food Safety Plan.’  We will explore this summary of duties with the details which are listed as 8 separate duties of a PCQI.

2. Training of Multiple PCQI’s for Day-to-Day Compliance and Other Benefits for Your Business

There are actually 8 requirements applicable to a PCQI spelled out in the Preventive Controls rules in 21CFR parts 117 (Human Food) and 570 (Animal Food): 

(1) Preparation of the food safety plan;

(2) Validation of the preventive controls;

(3) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of

production of the applicable food;

(4) Determination that validation is not required;

(5) Review of records;

(6) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;

(7) Reanalysis of the food safety plan; and

(8) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to

the nature of the preventive control and its role in the facility’s

The PCQI certificate courses provides an understanding of what these requirements mean and how they must be carried out.   By investing in a PCQI certificate course for not only one PCQI but for other key personnel, businesses amplify their ability to implement preventive controls. 

The requirements, including the timely reviews of documentation needed, are more easily handled by multiple personnel AND the ‘all-hands-on-deck’ approach ensures thorough implementation through the company, from ingredients through processing, and distribution of products. 

Fostering a Culture of Food Safety through Training

Training is not only a regulatory requirement but is an empowerment of workers and a demonstration of management commitment to, and desire for input from, cross functional personnel which fosters an organization’s food safety culture.

1. Food Safety Culture: No Longer a “Want” but a “Need”

Training of multiple PCQI’s is not just practical for managing the compliance workload.   Investing in this training demonstrates management commitment to integrating food safety and thereby fosters development of a strong food safety culture.  Food safety culture has become more and more understood as a key to food safety; demonstration of that culture has become a requirement in third party food safety certification schemes. 

2. Open Communication and Reporting: The Cornerstone of Culture.

The link between PCQI training and food safety culture continues in other ways:  The sense of empowerment and recognition employees gain from PCQI training fosters open communication within the workforce and with management.

As more PCQI’s are trained over time, they are exposed to updates in FDA guidance documents and to industry best practices and return from the training with more insights and information to share with others and enhance implementation of the organization’s food safety plan.  There is desire and ability to communicate their new understanding with those already serving as PCQI’s and to provide feedback to management. 

As the knowledge on updates and best practices is shared with other PCQI’s and through the workforce, empowerment further increases and leads to more and more common understanding and beliefs in food safety. 

Food safety practices and behaviors become ingrained in a company’s operation.   Dedication to food safety is magnified.  

3. Management Credibility for Effective Employee Feedback:  A Key Impact of Training

If those in upper management have somehow missed the call to PCQI training themselves they will want to proceed with it, enabling more opportunities for them to dialog with everyone in the workforce on an ongoing basis.  Management will have even more credibility as they are communicating their expectations about food safety and requesting feedback.

Conclusion: A Trained Workforce – A Secure Future in FSMA Compliance and Your Organization’s Future.

The role of employee training in FSMA compliance transcends the mere checking of a box on a regulatory compliance checklist.  By investing in comprehensive and customized training programs, businesses not only meet regulatory requirements but cultivate a culture where food safety is ingrained in every aspect of operations.

As you embark on the journey of FSMA compliance, remember that a well-trained workforce is your greatest asset. From PCQI to role-specific food safety in each function, each trained individual contributes to the overall success of your compliance efforts. In the dynamic landscape of food safety, a trained workforce is not just a necessity – it’s a strategic advantage when all the members of your organization are ready to adapt to new food safety opportunities and challenges as they emerge.

About the author

Mrs. Montgomery is an FSPCA Lead Instructor for PCQI Human Food, PCQI Animal Food and Foreign Supplier Verification Programs (FSVP) courses with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery offers virtual training spread over multiple shorter days to fulfill the hours required yet allow team members more time to absorb the training and also stay in touch with their work teams. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists).

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