One of the biggest problems I see right now is that the Food Safety Plan development is there, but for some reason, the definitive team and the execution are weak. I don’t see a lot of good cross-functional participation in the actual implementation of preventive controls. There are a lot of reasons for that.
Similar, Not Identical
Most companies in the United States follow both the principles of the Hazard Analysis and Critical Control Point (HACCP) system adopted by the Codex Alimentarius Commission and the Hazard Analysis of Risk-based Preventive Controls under FSMA. Both Codex HACCP and FSMA Preventive Controls are risk-based standards to minimize and eliminate food safety hazards. That’s not quality-driven. They’re both based on prevention.
Both also focus on a team leader. When it comes to HACCP, there are HACCP coordinators. When it comes to FSMA Preventive Controls, there is a Preventive Controls Qualified Individual (PCQI), or a team of qualified individuals. Both HACCP and FSMA require formally trained individuals and team members to execute the plans effectively. Both plans suggest having a cross-functional team oversee the development and implementation of HACCP and the Food Safety Plan.
This is where a lot of gaps emerge. A lot of companies have a training certified team leader, but often the cross-functional team doesn’t receive formal training or participate in the actual implementation of the Food Safety Plans.
There are also differences between HACCP and FSMA Preventive Controls. There’s more work to be done within the Food Safety Plan. In Codex HACCP, the HACCP coordinator will go through an International HACCP Alliance or equivalent workshop. They’re responsible for managing critical control points, or CCPs, the vital monitoring areas in the Food Safety Plan.
HACCP coordinators are responsible for the critical monitoring of CCPs. In most HACCP plans, we see zero to three CCPs per facility. It could be a kill step of some sort, metal detection, X-rays, cold storage, things like that. That’s what we usually identify as a critical control point. There is less need for critical oversight of monitoring because there are typically critical control points in a HACCP plan versus FSMA Preventive Controls plans.
Now let’s outline the workload associated with a FSMA Preventive Controls plan. We’ve gone from HACCP to FSMA Preventive Controls. We’ve increased the amount of workload when it comes to Preventive Controls. The PCQI must go through the official training workshop. Preventive controls are now those critical areas of monitoring, and it’s required to monitor these areas for food safety and controlling hazards. Unlike HACCP, we’re looking at typically one to four preventive controls per facility. Not only do we have CCPs, which are our process preventive controls, but we’re also adding supply chain controls and now need to manage multiple suppliers. We’re adding allergen preventive controls for label review and removing unique allergens from shared equipment. Whereas in HACCP, those particular buckets were part of the prerequisite programs, the FSMA Preventive Controls addresses them in the Food Safety Plan.
The FSMA Preventive Controls also includes environmental monitoring programs, SSOPs, master sanitation, hygienic zoning, site swab list, results, and corrective actions. These were previously managed under a prerequisite program and are now also managed under food safety controls. Organizations must shift their thinking and allocation of resources for the food safety team to properly manage these food safety controls.
The higher number of CCPs as part of the FSMA Preventive Controls means more critical food safety monitoring oversight is necessary within the Food Safety Plan and the team. Because you manage preventive controls like CCPs, we now must monitor them more critically. And preventive controls such as allergen, sanitation, supply chains, have multiple layers that require additional resources to monitor and manage. This is where I see a considerable breakdown within organizations. We’re still seeing the QA department with the PCQI working on their own to manage all these buckets within their Food Safety Plan.
That just doesn’t work. There are way too many programs now when it comes to FSMA Preventive Controls for one person or even one department to manage it all. To execute a FSMA food safety team effectively, this cross-functional team is even more critical today.
To execute a robust Food Safety Plan like Preventive Controls, each department must play a role as part of the cross-functional team to succeed in the implementation. One department or person cannot manage and successfully oversee the amount of food safety controls you need in Preventive Controls. Therefore, we need more cross-functional participation. If Quality Assurances is the only department monitoring the plan, those critical programs managed by other departments like supply chain, warehouse, sanitation, operations could become lost in the overall importance and not handled properly. That’s a problem. The lack of cross-functional resources put toward the Food Safety Plan is the most troublesome area I see when I’m doing audits, consulting, and training.
What does the cross-functional team look like?
First, identify your cross-functional team members and choose individuals with leadership skills. I can’t stress how important this is because if you choose somebody who doesn’t want to be there and is disgruntled, they’re not going to give any effort to the team and could emerge as a weak link leading to gaps and execution failures. It’s also critical to choose individuals who have a desire to take on more responsibility. Those team leaders must have management skills and make sure they work well with others.
Second, designate a team leader for each preventive control. You’re more likely to get more out of the team if you can give them the responsibility to come back and report. It’s like being on the SQF and BRC team.
Choose a member of each key department. Usually, we see quality assurance that leads the team, but they shouldn’t be the only trained PCQI. It’s common to see QA and food safety. Laboratory personnel are on teams these days because of the amount of allergen changeovers, the environmental monitoring programs, the COAs, and things of that nature. Operations, of course, should be on the team. They need to take ownership of what’s going out on the production floor.
Sanitation is the most critical department for food safety because if you have a dirty plant, you won’t have food safety. Sanitation must be on your cross-functional team. If you don’t have somebody from purchasing or supply chain, you’re going to have a weak link when it comes to managing these new preventive controls. The warehouse, engineering, HR, commercialization, all of these members can fulfill a role. All these members play a part and keep all those requirements up to speed when it comes to your new Food Safety Plan.
Roles and Responsibilities
What are the team leaders’ roles and responsibilities? And how does the team look when you outline it? What does the Preventive Controls team leader do? The leader’s role is to be responsible for monitoring and actions related to each preventive controls’ element: allergen, sanitation, supply chain, and process. Team leaders provide the focused support and leadership needed for each preventive control to ensure the successful implementation of all elements of the multiple buckets. And again, fully implemented means you have record-keeping, verification, validation in some cases, that you have all those records to prove you’re controlling specific hazards. You must endure that the preventive paperwork is complete, and fully execute your day-to-day documentation to verify you’re controlling those food safety hazards.
Team leaders will identify issues and report trends or results, either positive or negative, to the team at each meeting. One PCQI can’t be in 20 places every day, so the cross-functional support is incredibly valuable to the main PCQI on the food safety team by being extra eyes and ears on the manufacturing floor with the documentation on the day-to-day performance.
Someone in the QA department usually serves as the main PCQI. They oversee the rest of the team leaders, monitoring and verifying all the preventive controls. They’re the ones looking at the trends. They’re the ones updating the paperwork. They look at the process, allergen, sanitation, and supply chain. They manage all the elements of the Food Safety Plan with the rest of the team leaders.
A lot of new participants on teams these days are part of the lab. We see the laboratory get involved because of the environmental monitoring program, the allergen testing, the formulation test kits, again, reporting trends.
The Operations department should be responsible for the process preventive controls. These are the preventive controls on the production floor to control food safety hazards. Operations is knowledge of the equipment and therefore has full participation in controlling the process hazards. They’re responsible for monitoring and overseeing the process preventive controls.
The Sanitation department’s role is clear. They manage the sanitation preventive controls, report back to the team any issues with pre-ops, sometimes in conjunction with the lab and QA.
Lastly, there’s the supply chain. Someone must oversee the fluidity of the supply chain program because you’re going to be adding and subtracting suppliers, ingredients, and packaging. This person needs to communicate with the supply chain team and report back to the food safety team when changes occur. This role should update the approved supplier list, located missing documentation, and address supplier performance issues.
These departments comprise the main team. For the most success, every leader on the main team should go through the official PCQI training to understand how their role fits into the larger picture of preventive controls across your enterprise. In sum, if they’re responsible for managing a preventive control, they should go through the formal class.
Other departments can benefit from being on this team, such as the warehouse. Why? Because they’re the ones receiving those approved suppliers, the ingredients, and the allergen controls, meaning they’re also responsible. The Engineering and Maintenance departments are also crucial.
The HR and Training departments are responsible for properly trained employees and to ensure training for those qualified individuals on their designated functions. R&D and commercialization are responsible for launching new products, optimizing products, updating ingredients, and asking for new suppliers. So having them on the team would be very beneficial for everyone for transparency when it comes to updates.
The food safety team is the driving force of executing preventive controls. The most significant issue is the fact that we’re still trying to put all this work in one department, sometimes with just one person. It is way too much work when we’ve gone from zero to three CCPs typically found in a HACCP program to one to four Preventive Controls with many sub-programs under each Preventive Control. There are so many programs under Preventive Controls, tripling the work, and that it’s just too much for one person or one department to execute.
It’s not just a quality assurance function to ensure each element of the Food Safety Plan is adequately working to control hazards. It takes a strong, dedicated cross-functional team to support each step of the Food Safety Plan. Therefore, the traditional HACCP team must transform and improve into a more robust, educated, and committed food safety team with added responsibilities. Designate a Preventive Controls team leader for each specific preventive control so that the QA department isn’t solely responsible for managing all critical food safety buckets. This helps shift the food safety culture and forces other departments to share that food safety responsibility with quality assurance and the designated PCQIs.
It takes a considerable amount of resources, teamwork, and support from senior management to execute a successful FSMA Food Safety Preventive Controls Plan. Your senior management is courting disaster if they choose to skimp on providing the necessary training and personnel resources to do the job right.
Want to learn more about the similarities and differences between HACCP and FSMA Preventive Controls? To understand more about the specific rules and responsibilities of the PCQI team, watch the “Recipe for a Successful PCQI Team” on-demand webinar hosted by Nancy Scharlach here.
This blog was written by guest blogger, Nancy Scharlach, a registered SQF consultant, a Lead Trainer for FSPCA FSMA Preventive Controls and FSCPA FSVP, and a lead trainer through the International HACCP Alliance. She serves as the CTO for FSMA International, a consulting, coaching, and training food safety and quality firm that services the global food and beverage industry.