Recipes for a Successful PCQI Team

Posted by Nancy Scharlach on June 5, 2019 at 9:02 AM

Food safetyOne of the biggest problems that I’m seeing right now is that the actual development of the Food Safety Plan is there but for some reason, the actual team and the execution is weak. I’m not seeing a lot of good cross-functional participation when it comes to the actual implementation of preventive controls. There are a lot of reasons for that. 

Similar, Not Identical

Most companies in the U.S. 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 team leader, with their training certificates, but there a lot of gaps here, where the cross-functional team doesn’t participate in the actual implementation of the Food Safety Plans.

There are also differences between Codex HACCP and FSMA Preventive Controls. There’s more work to be done within the Food Safety Plan. In Codex HACCP, once again, 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. Now, there is less need for critical oversight of monitoring because there’s 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. Now not only do we have CCPs, which is our process preventive controls, we’re adding supply chain controls and, of course, we have 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 actually prerequisite programs. Now, we’re adding them to our Food Safety Plan.

We’re including environmental monitoring programs, SSOPs, master sanitation, hygienic zoning, site swab list, results, and corrective actions. These used to be managed under a prerequisite program. Now, they’re being managed under food safety controls, too. That’s a significant change and a shift in our thinking and the amount of resources we’re going to need for the food safety team and the organization. You can see there’s a huge difference between managing those food safety controls.

With FSMA Preventive Controls, because there are more CCPs, more critical food safety monitoring oversight is necessary within the Food Safety Plan and the team. Because preventive controls are managed like CCPs, we now must monitor them more critically. So preventive controls such as allergen, sanitation, supply chains, they have multiple layers that require additional resources to monitor and manage. This is where I’m seeing a huge breakdown within organizations. We’re still seeing the QA department, the PCQI who’s working on their own try 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 important today. 

The food safety team participants, we know they should be cross-functional, but it is necessary to execute a robust Food Safety Plan like Preventive Controls, each department must play a role in the success of implementation. But how can one department or person, manage and successfully oversee the amount of food safety controls you need in Preventive Controls? Therefore, we need more cross-functional participation. If the plan is overseen by quality assurance only, if they’re the only department, those critical programs managed by other departments like supply chain, warehouse, sanitation, operations could become lost in the overall importance and not managed properly. That’s a problem. This is a gap I’m seeing in most areas when I’m doing audits, consulting, and training is the lack of cross-functional resource that are put toward this Food Safety Plan.

What does the cross-functional team look like?

First, identify your cross-functional team members and choose individuals with leadership skills. I can’t say how important that is because if you choose somebody who doesn’t want to be there, and they’re disgruntled, then they’re not going to give any effort to the team itself, which could emerge as a weak link. There could be failures and gaps in execution. 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 on the team. 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 when it comes to 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 actually 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 concentrated support and leadership needed for each preventive control to ensure all elements of the multiple buckets are fully implemented. 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. At the end of the day, you must endure that the preventive paperwork is complete, and your day-to-day documentation is fully executed to prove you’re controlling those food safety hazards.

Team leaders report trends or results, either positive or negative, to the team at each meeting. They will present any issues and trends that have been identified. Without that support cross-functionally, that one PCQI can’t be in 20 places every day, and so that team leader is super 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’re seeing the laboratory get involved for the environmental monitoring program, the allergen testing, the formulation test kits, again, reporting trends and usually, they can be the backup PCQI in this situation.

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 knows what’s going on and has full participation when it comes to controlling these hazards because we’re involving equipment here in the process. They’re responsible for monitoring and overseeing the process preventive controls.

The Sanitation department’s role is clear. They’re going to manage the sanitation preventive controls, report back to the team any issues with pre-ops. This could be 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 over time. This person needs to go back to the supply chain team and report back to the food safety team when changes occur. Make sure the approved supplier list is updated, missing documentation is located, and supplier performance issues are addressed. 

This is the main team. When you’re talking about the type of training you need for the main team leaders, everybody should go through the official PCQI training because they will not see how their role fits into the larger picture of preventive controls across your enterprise if you just focus on their narrow role in preventive controls. If they’re responsible for managing a preventive control, they should go through the formal class.

There are other departments that 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 ensuring employees are trained properly and those qualified individuals are trained on their designated functions. If somebody is responsible for process controls, they’re being trained in monitoring process. If they’re responsible for sanitation, they’re responsible for chemical control, and the application of sanitation and methods. R&D and commercialization, they’re also responsible for launching new products, maybe optimizing products, changing out ingredients, and asking for new suppliers. 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 biggest gap is the fact that we’re still trying to put all this work in one department, sometimes with just one person. This is way too much work when we’ve gone from zero to three CCPs typically in a HACCP program to one to four Preventive Controls with many sub-programs under each Preventive Control. We’re tripling the amount of work, or more, because there are so many programs under Preventive Controls 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 individual preventive control so the QA department isn’t solely responsible for manning all critical food safety buckets. This is too much work for them. 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 and 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.

Tags: FSMA, Food Safety, Qualified Individual, Preventive Controls, Food Safety Modernization Act