While compliance with FSMA and being ready for FDA inspections may seem like a sprint to satisfy FDA directives, the path to complying with the regulations is a long, methodical, marathon-like endeavor. At the 13th Annual North American Summit On Food Safety, Lauren Di Menna, scientific & regulatory affairs manager at Kraft Heinz, explained how Kraft Heinz has prepared for FSMA and gave insight into the company’s experience with FDA inspections.
In 2015, Kraft and Heinz, then two separate companies, joined forces to become one entity. The merger resulted in a major overhaul of many policies, including a complete “redo” of its HACCP policy — each legacy company’s HACCP policies were reviewed, with the end result being about 200 individual HACCP plans under the Kraft Heinz umbrella. The new HACCP policy was drafted to include requirements of FSMA’s Preventive Controls regulations. “Our HACCP policy sits within our quality risk management program and is part of our Global Quality Systems scheme,” says Di Menna. “Through this, we are able to dictate to our plants how we need to execute on our Preventive Controls plans to ensure we comply with FSMA.”
The company’s FSMA readiness strategy was developed internally and is centrally managed by a corporate team. The FSMA implementation team, consisting of — the legal department and the HACCP policy leader — has met weekly since FSMA’s proposed rules came out. The team discusses experiences the company has had with FSMA thus far, learnings from trade associations, and how to apply those practices moving forward.
Kraft Heinz’s policies and guidance apply universally to all of its plants, and the company conducts the same training for all employees. This training covers everything from greeting inspectors to the documentation required during an inspection.
Kraft Heinz has two employees who elected to become lead instructors for the Food Safety Preventive Controls (FSPC) Preventive Controls Qualified Individual (PCQI) training. These two individuals are, essentially, responsible for training the company’s entire PCQI-educated staff. “Our PCQI lead instructors set up training sessions throughout Canada and the U.S.,” says Di Menna. “From there, we trained two individuals per plant, then we trained our corporate staff — including the food safety micro team, the HACCP leaders, thermos-processing authorities, folks in business unit quality, as well as our suppliers and co-packers… totaling about 180 employees at Kraft Heinz who have completed the PCQI training.” To communicate all this data and documentation to its employees, Kraft Heinz has developed a regulatory compliance website for its employees with all staff having access to the documents, even the living documents, so new developments are not missed.
In addition to uniform, inspection-readiness training and corresponding website, the company has a regulatory inspection FAQ document. This FAQ is a living document, being continuously updated — especially after an inspector visits — due to the ongoing Q&A cycle between the company and inspectors.
On top of internally training its staff, Kraft Heinz also internally audits its employees. “Essentially, we go to a plant, and we determine if the plant is following policies we’ve implemented, find out how the policies were implemented, and determine where their inspection readiness stands,” says Di Menna. “Our factory teams are able to communicate in real-time with our corporate team, so any support they need during inspections is provided.”
Assessing its plants was a Herculean task for Kraft Heinz; with each of its plants in the U.S. and Canada — 41 total — receiving a FSMA assessment in early 2017 to ensure they were in compliance. The company also completed several “deep-dive” plant assessments last summer. “At each plant, the regulations were reviewed one-by-one to see how management would respond to inspector questions and find out what documents management would present to inspectors,” says Di Menna. “Kraft Heinz used those deep-dive plant assessments to develop regulatory inspection guides used to train the rest of our plants.”
Finally, to prepare for FSMA inspections, Kraft Heinz engages with trade associations, and singles out the Grocery Manufacturers Association (GMA). GMA has a FSMA steering committee meeting each quarter, that Kraft Heinz attends, reviewing what folks in the industry are seeing, what the current compliance challenges are, and discussing solutions and sharing insights to those challenges.
What To Expect When The FDA Inspector Arrives
When inspectors arrive, Kraft Heinz’s policy requires employees to ask, "What is the scope of the visit?" “We are finding the inspectors’ answer to be, ‘routine FSMA inspection,’” says Di Menna. “They aren’t distinguishing between Preventive Controls and modernized GMP inspections and are generally more focused on high-risk products. We’ve taken that knowledge back to other plants, which allows our employees to become more prepared and ask the right questions.”
As of April 2017, Kraft Heinz has been subject to seven FSMA inspections — one full Preventive Controls Rule inspection and six modernized GMP inspections. These inspections have lasted anywhere from one to five days, with the average inspection lasting four or five days.
Of Kraft Heinz’s seven inspections, four included swabbing — usually 100 to 150 samples across zone one (30 percent of swabs), zone two (20 percent of swabs), and zone three (50 percent of swabs). No zone four swabs have been taken. “The inspectors are very interested in environmental monitoring programs, what records are being kept, and corrective actions being taken should swabs reveal positive results,” says Di Menna. “In terms of verification activities, there is a heavy focus on records, such as corrective action logs, production schedules, sanitation records, and calibrating inspection equipment.”
Di Menna also notes the inspections have placed an emphasis on food safety plans. “The FDA wants to review and discuss the hazard analysis,” she says. “Further, they want to understand the justification behind each of our physical, biological, and chemical hazards.” Additionally, at each audit, inspectors have asked for and reviewed Kraft Heinz’s written recall plan.
In Kraft Heinz’s most recent FDA inspection, the company’s supply chain program was reviewed. “This visit happened on the day before the Supply Chain Program rule went into effect, so their questions may have been a bit lighter than what they might ask now,” says Di Menna.
Di Menna notes a few other areas the FDA inspectors were interested in reviewing:
The FDA inspections are very intensive, in terms of time the plant’s management team spends accompanying the auditors. In Kraft Heinz’s cases, the FDA brought, an average of three inspectors — one trainer and two trainees — to the inspections. “With that number of inspectors, we weren't sure if they would try to divide and conquer, but we haven't seen that yet,” says Di Menna. “There have not been any staff resourcing issues, but through our learnings from trade associations, we learned it is a possibility.”
What The FDA Wants Vs. What The FDA Requires
Not all items the FDA asks to see at your facility — and some of the actions they may take — are required in your FSMA audit. Photographs of the facility are one such item. “The FDA believes, and they are training auditors to this belief, they have authority to take photos at your facilities,” says Di Menna. “It is within your rights to not allow the agency to take photos. I strongly encourage you to make sure your corporate policy and training has a consistent approach to this.”
Copies of internal documents are another point of contention between industry and the FDA. “From what we’ve gathered in our discussion with trade associations, inspectors should not be asking for copies,” says Di Menna. “However, many are asking for them for learning purposes of the agency. Kraft Heinz approaches this subject on a case-by-case basis, depending on the record and its relevance.”
Kraft Heinz’s organization chart has also been asked for by inspectors. The company has not granted inspectors access to this as it contains proprietary data, as well as personal employee information. However, Kraft Heinz does walk inspectors through the organizational chart and answers any questions inspectors may have about it.
FSMA readiness and inevitable FDA inspections are completely manageable. But, the key is to be prepared and ensure your policies comply with regulations. Assessing your facility, finding its strengths and weaknesses, and bridging any gaps you find will ensure you don’t receive a warning letter. From a training perspective, plant employees should feel comfortable leading inspectors though the plant, and all staff, including support staff, needs to know how to execute your company’s policies. Finally, support during an inspection will help ensure your inspection goes smoothly. “During our inspections, our staff communicates what inspectors are asking for, all the way up to the VP of Food Safety,” says Di Menna. “Because of this support system, we are able to fully answer the FDA’s questions in a timely manner. The experience is documented and we are better prepared for our next inspection.”
About Lauren Di Menna
Lauren Di Menna is at the forefront of an evolving food industry and regulatory environment, working as the Scientific & Regulatory Affairs Manager – CFIA Lead at Kraft Heinz, the largest food company in Canada. Lauren grew up in Leamington, Ontario and pursued her formal education at the University of Western Ontario and holds a Bachelor of Medical Sciences degree, with honors, specializing in Microbiology and Immunology. After completing her degree, Lauren continued the immunology research she undertook for her undergraduate thesis at Robarts Research Institute. She then accepted a position at Campbell’s officially beginning her career in the food industry. She joined the HJ Heinz Company in late 2010 and has held various manufacturing quality and corporate quality positions during her tenure. Following the Kraft Heinz merger, she assumed her current role, supporting many Kraft Heinz factories throughout Canada and the US, working closely with both the CFIA and the FDA.