In 2011, the Food Safety Modernization Act (FSMA) was passed, marking a shift in the way the FDA would subsequently handle food safety. With the FSMA, the agency signaled that food safety should be a proactive concern, not a reactive one.
Four years later, the requirements related to Preventive Controls Qualified Individuals (PCQIs) were introduced, codifying the regulatory framework around the mission outlined in the FSMA. Grouped under the FSMA's Preventive Controls for Human Food (21 CFR Part 117), these rules defined the PCQI and created the requirements for having PCQIs and outlined their responsibilities.
The journey to establishing those rules was a long and complex one; how food producers incorporate PCQIs into their process can be the difference between simply meeting a requirement and creating a valuable strategic asset to supercharge growth. In this blog, we'll take a brief look at the history that shaped the PCQI role and PCQI regulatory requirements, as well as how to leverage it as a growth driver in food manufacturing facilities.
The Road to PCQI Regulatory Requirements
Modern food safety can be traced back long before the enactment of the FSMA. In 1906, the publication of Upton Sinclair's The Jungle rocked the food production industry and American society. Sinclair spent two months undercover in Chicago's meatpacking plants, and his account of what he saw sparked the quick passage of the Meat Inspection Act and the Pure Food and Drug Act, creating the first national oversight and inspections of food manufacturing facilities.
- 1930s: Toxic drugs cause a public outcry, leading to the Federal Food, Drug, and Cosmetic Act.
- 1950s: The Food Additives Amendment of 1958 is passed as a response to growing concern over dangerous food additives.
- 1960s: GMP regulations and rules are put in place to cover food facilities, creating enforceable sanitation and operational standards.
- 1970s: A series of Botulism outbreaks pushes the FDA to regulate the canning industry, instituting strict recordkeeping requirements and mandating that all canning be done under the supervision of trained personnel.
- 1990s: The Jack in the Box E. coli outbreak, one of the most severe food safety incidents in years, spurs the adoption of Hazard Analysis and Critical Control Point (HACCP) principles.
- 2000s: High-profile Listeria and Salmonella outbreaks lead to the creation and passing of the FSMA.
The through-line for much of the history of food safety regulation is that changes were often a response to health and safety crises. An outbreak would create public outrage, prompting the passage of a bill and the implementation of new rules designed to address the cause of the last incident.
The goal of the FSMA and PCQI regulatory requirements was to break out of this pattern. By focusing on preventive controls, the FDA hoped to prevent the next outbreak or incident, as opposed to just responding to the last one.
The Two Sides of PCQI Roles
The role of the PCQI, as envisioned by the FDA, was to serve as an expert overseeing a facility and crafting its food safety plan and policies. The goal of placing a rigorously trained team member directly in plants was to evaluate existing equipment and processes better and identify hazards before they became incidents.
For many food manufacturers, that's exactly what they are — an on-the-ground expert who knows the rules and keeps things running smoothly. But for the most successful food manufacturers, PCQIs are so much more. For the best manufacturers, PCQIs are plant quarterbacks — able to evaluate situations quickly, call an audible, and take charge in instituting facility-wide changes to create meaningful improvements and better outcomes.
The difference between the two is subtle: The former is there to check a box, while the latter is there to lead. The results are much clearer: Companies that view food safety roles as merely a requirement of doing business find themselves with a cost, while companies that see them as strategic assets find that their facilities have fewer incidents, better productivity, and a healthier overall environment.
Reimagining Your PCQIs
Turning a PCQI position into a business advantage takes hard work and a fresh approach to food safety, starting with reimagining the role of the PCQI at your facility. Even more fundamentally, it begins with acknowledging that food safety isn't a system placed on top of food production; it is food production.
Food safety is essential at every step of the food production process, from the moment someone arrives at the facility to the moment a finished product is shipped off, and PCQIs have insight into all of it. Companies that recognize this allow themselves access to highly skilled and trained human resources that can make every step in that journey safer and more efficient.
Trainer, Teacher, Coach
Training food manufacturing employees is a difficult and often expensive part of running a facility. Getting it wrong, however, is even more costly — which is all the more reason to lean on your PCQI food safety staff.
PCQIs, with their extensive knowledge of food safety processes and regulations as well as their training on how to effectively convey this information, make a great complement to your training and coaching staff. Their knowledge base can help you build or refine your existing training and successfully pass it along to other team members. Additionally, their familiarity with FSMA’s documentation ensures training records are properly recorded, supporting audit readiness and regulatory compliance.
Process Improvement Beyond Food Safety
Process and procedure design and implementation are a big part of the training that goes into PCQI regulatory requirements and qualification, but those same skills go beyond just analyzing food safety processes. When working with manufacturing process engineers, PCQIs can offer a wealth of suggestions on everything from facility design and construction, to equipment placement and layout to purchasing and operations.
Supervision and Safety
While PCQIs’ core responsibility is to ensure compliance with FSMA’s preventive controls rule, their training equips them for much more. PCQIs must be detail-oriented — it's a key component to keeping food production safe from contamination. But this skill can also be leveraged to make the facility safer overall, from intentional adulteration, infiltration by bad actors, and even common workplace hazards.
Using your PCQIs to aid in food defense is a given, but leveraging them as an extra set of eyes to aid in occupational safety or to combat food fraud makes them even more powerful. They can also collaborate cross-functionally with safety, HR, or security teams to ensure integrated risk management across the facility. All of these functions align naturally with the skill set that PCQI training develops, while reducing corporate risk and liability and improving the bottom line.
PCQIs Beyond Food Safety Checklists
Ultimately, having PCQI-trained staff in facilities just to fulfill FDA requirements is like having a multitool in your pocket and only using the nail clippers. The training involved in qualifying as a Preventive Controls Qualified Individual goes far beyond putting together a food safety plan; if you don’t use that training to its fullest potential, you leave money on the table. And as the PCQI position evolves, more and more companies will realize that having one on staff isn't just a requirement — it's a secret weapon.
For more on how you can utilize your PCQIs to their greatest potential, explore four questions you can ask yours to ensure your food safety program is up to par.
