How To Prepare For FSMA Preventive Controls Inspections

By Sam Lewis

With Preventive Controls for Human Food inspections now underway, the food industry is beginning to observe trends with inspections. These trends are enabling improvements in current programs and documentation management practices, in addition to helping the food makers become prepared for future inspections. Here, Samantha Cooper, manager of food safety and quality assurance at the Grocery Manufacturers Association, answers my questions on what is being seen during the first round of FSMA’s Preventive Controls inspections and how the industry can further prepare.

Food Online: Can you give us the 30,000-foot view of what is required by FSMA in an effective Food Safety Plan?

Cooper: For covered facilities, the first requirement of a Food Safety Plan is a written hazard analysis. The hazard analysis is crucial to an effective food safety program, and will identify hazards requiring a preventive control. When a hazard is identified as requiring a preventive control, a written process, food allergen, sanitation, supply-chain, or other preventive control must be included. Written procedures for monitoring, corrective action, and verification are required as appropriate to the identified preventive control. A written recall plan is required when a hazard requiring a preventive control is identified. Implementation records are also a required component of the Food Safety Plan, and demonstrate the facility is doing what they said they would do.       

Food Online: What are some of the major issues you’re seeing in this first round of the FDA’s Preventive Controls inspections?

Cooper: From the feedback I’ve seen so far, the FDA is acting true to the “educate before and while we regulate” mantra. The way inspections are conducted under the Preventive Controls regulation is a new paradigm and the goal is to better protect public health by using a risk-based, preventive approach to food safety. The most common concern I’ve seen so far, from attending conferences and speaking with food manufacturers, is a general fear of the unknown: what will inspections look like? How can we prepare? What is an investigator going to ask?

Many facilities have already been using a HACCP program and the change to a Food Safety Plan requires additional analysis of how a prerequisite program may now be identified as a preventive control. Now, throw in certification to a GFSI recognized scheme and perhaps the facility is under dual jurisdiction… how will records be organized? Can management at the facility speak to their Food Safety Plan and the requirements of the Preventive Controls regulation? It’s going to take time for both industry and the FDA to conduct Preventive Controls inspections smoothly, but I foresee opportunities for feedback and growth while the FDA educates before and while it regulates.

Food Online: Regarding recordkeeping, what efforts can food companies make to better prepare for inspections?

Cooper: Records are essential to demonstrate the effectiveness of a facilities food safety program and the facility is operating as intended. When the FDA arrives for an inspection, it’s only a snapshot of the operation, so recordkeeping is extremely important, as well as mandatory. Food companies should read the general requirements applying to records in the final rule, which is found in Subpart F (requirements applying to records that must be established and maintained). Required records are identified in Subpart C (hazard analysis and risk-based preventive controls) and Subpart G (records documenting the supply-chain program).

Organization is important to ensure the delivery of appropriate records to the investigator upon request. Whether the facility keeps electronic files, hard copies, or utilizes off-site storage, know which records are located where. Additionally, a large part of recordkeeping will be implementation records, where a facility is capturing monitoring records for preventive controls, corrective action records, verification records, supply-chain program and supporting documentation, and training records. When verifying records, observe trends as this could prevent future deviations.    

Food Online: What about product testing and environmental monitoring? What trends are you seeing there and how can the industry adjust accordingly?

Cooper: In the final rule, product testing and environmental monitoring are listed as possible verification activities, and “only required as appropriate to the food, facility, the nature of the preventive control, and the preventive control’s role in the facility’s food safety system.” For example, a ready-to-eat food exposed to the environment prior to packaging and does not receive a control measure that would significantly reduce the pathogen would have an environmental monitoring program because it is appropriate to the food, facility, and the nature of the preventive control, as identified through the hazard analysis.

Another manufacturer applying a lethality step may determine through its hazard analysis an environmental monitoring program is not applicable. The decision for product testing and environmental monitoring is based on the results of the hazard analysis and an evaluation of environmental pathogens is required “whenever a ready-to-eat food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen.”

As for trends, I’ve seen requests for scientific justification related to environmental monitoring and a number of swabs being taken during inspections. The FDA recently released the draft guidance Control of Listeria monocytogenes in Ready-To-Eat Foods, which can help food companies prepare for upcoming inspections.  

Food Online: Where can food manufacturers find additional information on preparing for FSMA’s Preventive Controls inspections?

Cooper: The first stop for manufacturers should be the final rule. By now, all food manufacturers should have already read the final rule to determine if their facility is a covered facility under the Preventive Controls for Human Food final rule and their compliance date. In addition to the final rule, a much overlooked resource is the preamble to the final rule. Over 200 pages long, the preamble is extremely useful because it explains why the FDA made certain decisions, and addresses issues raised by comments. The FDA’s website is another great resource for all things FSMA with fact sheets translated into multiple languages, Q&A’s, webinars, and links to dozens of other resources.

The Food Safety Preventive Controls Alliance (FSPCA) is another great source of information. It has developed a training course recognized by the FDA as the “standardized curriculum” which provides training in the development and application of risk-based preventive controls. Successful completion of this course is one way an individual can meet the definition of a preventive controls qualified individual, the other being qualified through job experience to develop and apply a food safety system.

For GMA member companies, a great resource is the GMA staff. A team of food safety experts is always available for members to answer questions on FSMA compliance and other food safety related questions, such as effective processing techniques or how to conduct an effective recall. GMA also offers a variety of training opportunities and technical resources, which can be found on our website.

Lastly, it helps to prepare for FSMA’s preventive controls inspections by listening and discussing with others who have been through an inspection. Sharing firsthand experiences helps identify areas where facilities may need to spend more time developing appropriate programs, and provide a glimpse of potential questions an FDA investigator may ask. The 2017 GMA Science Forum will include a session, Key Issues and Strategies to Prepare for FSMA Preventive Controls Inspections. Panel guests will share common inspection trends they have observed, and attendees will get a chance to hear from the FDA to learn more about preventive control inspections.

About Samantha Cooper
Ms. Cooper is Manager of Food Safety and Quality Assurance within the Science and Regulatory Affairs division at the Grocery Manufacturers Association (GMA), which represents the world’s leading food, beverage, and consumer products companies. Her main responsibilities include working with member companies to identify, develop and recommend solutions to ongoing and emergent scientific, regulatory and public policy issues affecting the food products industry, analyzing regulatory developments and emerging food safety issues, and acting as staff liaison for the Regulatory Inspection Compliance Committee and the FSMA Supply Chain Management Working Group. She is recognized by the International HACCP Alliance as a HACCP Lead Instructor, FSPCA Human Food Lead Instructor, and FSPCA Foreign Supplier Verification Programs Lead Instructor; providing training both domestically and internationally. Prior to GMA, Ms. Cooper gained experience as a Food Safety Manager at a sous-vide manufacturer, and completed a management trainee program at a poultry processing facility. Ms. Cooper holds a Bachelor of Science in Food Science and Technology from Virginia Polytechnic Institute & State University (Virginia Tech), where she graduated cum laude.