The phrase, “FDA inspection” often sends a shiver down the spines of food manufacturers. But, a routine visit from the agency doesn’t have to be a scary thing. Here, Miriam Maxwell, senior principal regulatory scientist, corporate scientific and regulatory affairs at Ocean Spray, reviews how her company prepares for and executes FSMA inspections, as well as explains what the FDA looks for when it arrives at your door.
Preparing For The Inspectors’ Arrival
At Ocean Spray, every new employee is subject to inspection-readiness training as part of their orientation. Safety/quality staff and managers receive additional inspection-readiness training — a two-day session covering, in great detail, what happens when it’s time for an FDA inspection and why it’s essential to have a successful inspection. “First, and foremost, we need to demonstrate, to both our employees and the FDA, our commitment to food safety,” says Maxwell. “Secondly, there are many unfortunate and adverse aftereffects for companies scoring poorly in FDA inspections.”
Ocean Spray trains employees in inspection readiness so employees are prepared for an inspection at any time. “FDA inspections shouldn’t be a scary thing,” says Maxwell. “An inspection is showing the agency what you do in your daily operations; no more, no less.” Ocean Spray’s employees are trained, through ongoing preparation and practice, on what the written inspection plan is and what their specific roles are to execute the plan. “Our actions and answers to inspectors’ questions should be automatic; we shouldn’t be looking things up mid-inspection,” says Maxwell. “The only way to reach that point is to prepare and practice your plan for an inspection.”
The Inspection Plan
The first thing to be done when creating a written FSMA inspection readiness plan is determine who is going to be part of the inspection team. More often than not, the person responsible for creating the plan is the highest-ranking individual at a plant. “At Ocean Spray, the person responsible for the written inspection plan is the plant director. At other companies, it could be a quality manager or food safety inspector,” says Maxwell. “Regardless, it should be someone who knows the ins and outs of the plant and its happenings on all levels.”
Falling under the highest-ranking individual is a wide range of employees at the plant — quality and safety personnel, operations staff, maintenance, office staff, even IT workers could be involved should retrieving records from ERP systems be required. A record keeper should be named with the responsibility of keeping track of all actions and questions from inspectors, actions and responses of plant employees, as well as retrieving requested documents for inspectors. Lastly, don’t forget the FDA headquarters reviewer is part of the team. After all, this person will return to the FDA office with records of your facility and his word and documentation of facilities will matter to inspection scores.
The Inspectors Arrive
It’s not a question of “if” the inspectors arrive, it’s a question of “when” they arrive. Inspectors from the FDA will make their way to your facility’s doorstep (Maxwell notes inspectors have always arrived during reasonable hours, never late on a weekday and never on weekends) and it’s imperative that those who greet them know what to say and do. “At Ocean Spray, greeting inspectors is built right into our readiness plan,” says Maxwell. “Those who have been determined by the plan as an escort — usually a receptionist or other office staff member — greets the inspectors, checks credentials, asks to see the 482 letter (notice of inspection), invites them in, and alerts the plant, as well as corporate, an inspection is happening.” Further, it is important to have a designated area for inspectors to wait for personnel to welcome them into the plant. “Knowing the room you will have inspectors wait in is important,” says Maxwell. "When you put them there, ensure the garbage cans are empty, the whiteboards are blank, and any filing cabinets are secure. There should not be private information regarding sensitive subjects for the agency to access easily unbeknownst to you.”
So the plant is “at-the-ready” and the inspection is underway. What are inspectors doing and looking for? Inspectors are well-informed on the facility and the products it makes, so initially they will just want to complete a walk-through, looking at everything. Included in that broad spectrum could be traceability records and verification and validation procedures. According to Maxwell, over the last 18 months, the FDA has been heavily focused on food contact surfaces, environmental contamination, and product labeling. “Recently, in two of our plants, inspectors asked about labeling processes,” says Maxwell. “Everything from the design of graphics and how we acquire them, to knowing the ins and outs of correctly labeling multiple lines of products has been inquired about.”
But, just because the agency has focused heavily on food contact surfaces, pathogen controls in processing environments, and labeling procedures doesn’t mean they couldn’t ask for additional information about your plant, including propriety information. “The FDA could ask, for instance, to see pretty much anything — customer lists, consumer complaints, and ingredient information — within your plant,” says Maxwell. “Part of the written inspection plan should determine what is permissible for FDA inspectors to see and what is not. If you don’t believe there is any food safety reason for the inspectors to see certain things, let them know it is company policy to withhold proprietary information. We’ve done this and haven’t had pushback.”
However, there is a blurry line when it comes to inspectors taking photographs within facilities during inspections. FDA professionals believe they have the right to take in-plant photographs during inspections while industry believes taking photographs during inspection is a violation of proprietary information. “If the agency pushes back against the policy, typically our company’s legal team speaks with the inspectors,” says Maxwell. “Normally, we allow them to take pictures under protest, and we take identical photos simultaneously for our records. Any photos the agency takes could be used in a trial. This way, we have the same evidence the agency does and it can be noted we objected to it.”
Answering Inspectors’ Questions
As stated earlier, an inspection is essentially showing the FDA your daily activities and proving the company is in compliance with FSMA; nothing more, nothing less. So, when inspectors ask a question, it is important to answer it clearly and simply. “Answering questions from inspectors is not the time to gloat or ‘show off,’ says Maxwell. “Only answer the question asked. Don't try to anticipate the question or give more of an answer to the question than what is being asked. Inspectors are trained to interview with probing questions; give truthful answers with as few words as possible.”
Maxwell also advises on not falling for an inspector’s bait. “Be prepared and be professional. Don’t be argumentative even if an inspector ‘may appear to be,’” says Maxwell. “I say, ‘may appear to be,’ because they may be using it as an interviewing technique. Part of Ocean Spray’s training focuses on this; embedding what to say, how to behave, and how to respond to adverse conditions and unexpected questions.” Finally, not knowing the answer to a question or being uncomfortable answering a question is also okay. Just be sure to let the inspector know the item will be looked into and followed up on.
Always be prepared and remember: first impressions are lasting and typically are the most important. “Evaluate your inspection-readiness systems and how they’re working. If they’re not working, change them and reevaluate,” say Maxwell. “Educating plant personnel on inspection readiness and communication has been a big change to our policy. Our FSMA inspections have gone very smoothly because of our personnel’s demeanor, careful listening, and honest, to-the-point answers.”