Participating in a mock inspection can be an effective method to determine whether your team is prepared for an unannounced inspection. AIB International’s latest field service, FDA Preparedness Inspection, simulates a FSMA-type investigation and determines if a facility’s regulatory policy is in line with requirements, if employees understand their company’s policy for handling regulatory inspections and if its food safety plan meets requirements.
Alicia Pulings, quality compliance manager at Schaumburg, Ill.-based Gonnella Baking Co., set up one of AIB’s FDA Preparedness Inspection knowing there were minor gaps in the facility’s FSMA compliance process but still confident in her group’s abilities. With the exception of two key decision-makers, the visit was unannounced to its staff, including the plant manager.
“Even though it was a test inspection, I could sense our team’s uneasiness, and it reminded them that we need to be audit-ready at all times,” Ms. Pulings said.
When an AIB inspector began collecting swabs at the Gonnella plant, it was a big reveal for the staff. Ms. Pulings believed this was an eye-opener for employees, especially those who did not attend a FSMA training.
“Knowing FDA could collect swabs is new and important,” Ms. Pulings said. “We needed minor revisions to a few of our existing programs. During the inspection, we learned that FDA has granted an extension to one of our new programs that are in the process of being implemented — without this simulated inspection, we would not have known.”
Making sure an operation’s team also understands how to interact with investigators is crucial, as any of them can be pulled aside at any moment to discuss procedures in detail or to pull records. This may entail taking extra time to train employees on methodologies and educating them on the reasoning behind it.
“If people are going to do their job well, they have to understand why they’re doing it,” Mr. Thorson said. “We’ve got to do better at explaining processes. Whether it’s the employee on the floor operating and cleaning the line or the engineer building the system, everyone has to understand why we have the expectations we do: ‘Why do I need to clean to this level? Why are you swabbing it with that swab?’”
What to expect
Being prepared for an inspection means more than having preventive controls in place. Such preparation includes mapping out a process for when investigators arrive and understanding the actions they will take while conducting the inspection. In his checklist, Mr. Stevens outlined how operators can effectively navigate the process from beginning to end and appropriately respond to any FDA criticisms once the site visit concludes.
Before the inspection begins, Mr. Stevens advised teams determine which members will interact with FDA investigators, revisit where critical documents are stored and organized, and review topics employees can discuss with the agency. To ensure all measures are in place, perform a mock audit that includes all staff performing their specified roles. Undergoing this practice will help employees feel confident when interacting with investigators.
When FDA representatives arrive, they will ask to conduct an entrance meeting to detail how they plan to conduct the inspection, how long they anticipate it will last and the specific tasks they intend to accomplish. These typically include a facility inspection, records review and “swab-a-thon.”
During the inspection, the agent will tour the production, packing, distribution and storage locations searching for physical deficiencies and sanitation violations and conditions that allow bacteria to grow. Throughout the process, the investigator should be accompanied by a designated guide to observe and immediately document and respond to any concerns.
At the time of the records review, the FDA will have wide access to most documents within the organization. However, the agency is not entitled to review or copy any recipes or data pertaining to finances, pricing, research, sales or personnel, other than to ensure that the company’s employees have received training appropriate to their position and responsibilities. If the FDA requests copies of any records the company deems confidential, be sure to mark those records accordingly.
Once investigators enter the plant floor, they will collect approximately 100 to 200 microbiological samples from incoming ingredients, outgoing finished products and various environments within the facility. Staff charged with accompanying the inspection should carefully document the areas where samples are being collected. If any samples are positive, this information will be critical to determine the most appropriate response.
If the FDA collects finished product or processing line samples to test for the presence of Listeria Monocytogenes, Salmonella or any other pathogens, that facility should hold back any products made from the same lot or batch until the results come back. If any are positive, and the product has been held, a recall will not be issued.
Once the inspection is complete, the investigator will conduct an exit interview and share the findings. If violations have been identified, the agency personnel will issue a Form 483, which details the specific issues. Although not required by law, a company is generally expected to provide a written response with the appropriate documentation within 15 business days. The FDA will not pursue further regulatory action if the response adequately addresses the agency’s concerns.
In some cases, the investigator may ask the company to consider a recall of certain products. Any recall decisions — and whether to announce it — should be made very carefully and only after consultation with legal counsel. Mr. Stevens noted that many companies have successfully convinced the FDA, based on the availability of supporting facts, forensic analysis and scientific data, that a recall is not needed or that the scope can be significantly limited.
Continue reading to learn why food safety should not be a competitive process.