How to Prepare for an FDA Inspection


Be prepared to calm the nervous energy and deflect crazy events.

April 7, 2017

© LiudmylaSupynska |

If you have been keeping up with the changes related to the Food Safety Modernization Act (FSMA) requirements, you are more than aware that it’s not a matter of if, but when, FDA will visit your site. You also may have heard that FDA inspectors have very focused agendas when they show up. FDA Consulate/Attorney Shawn Stevens outlined the agency’s new enforcement priorities during routine unannounced inspections in the document, FDA Inspection Checklist. These include

  1. Carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements.
  2. Conduct extensive Zone 1, Zone 2, Zone 3, and Zone 4 microbiological sampling inside all food facilities to find evidence of pathogenic contamination.
  3. Require recalls if the percentage of FDA samples testing positive for Listeria monocytogenes, Salmonella, or other pathogens exceeds FDA thresholds.
  4. Compare the DNA fingerprints of any pathogens found in the facility against the more than a million human isolates stored in the CDC’s PulseNet database to identify any matches, then require food product recalls if any matches are found.
  5. Initiate broader investigations, including criminal investigations, against food companies whose products are found to have caused human illness.

In his document, Stevens outlines what a facility should do to prepare for its next FDA inspection. This document is worth reading and analyzing to ensure you are prepared. AIB’s approach to preparing for an FDA inspection offers a solid structure for building, reviewing, and verifying your food safety plan, which includes the inputs and outputs for your manufacturing process and everything that interacts within it.

THE FOOD SAFETY PLAN. The food safety plan can be a complex system that creates chaos for the organization, or it can be a way of doing business. The best way to look at your system is to determine if you have a stand-alone food safety plan that is in an isolated compartment all tucked away — or if the food safety plan has been integrated into the daily functions of every task within the organization. Does customer service know how to react when a customer calls with a food safety complaint versus a quality related complaint? Is a management of change (MOC) only used for personnel safety changes or does it also include food safety changes? When doing new construction or renovations, is a food safety representative involved in the planning stages or does he or she confirm food safety after the project has been completed?

If it appears that food safety is isolated from these types of functions, it’s probably creating chaos; therefore, opportunities for failures in the food safety arena increase within the organization. If the food safety plan has been streamlined into a way of doing business, it will be an automatic well-oiled machine.

The food safety plan is often referred to as the HACCP (Hazard Analysis Critical Control Plan) or HARPC (Hazard Analysis and Risk-Based Preventive Control) programs consisting of all procedures, verification, and validation activities that will be conducted from start to finish of the process. It also includes who will be doing which task, the type of training required, the records to be completed, and how the records will be verified and audited.

A cross-functional team typically oversees the functions of the food safety plan. However, the ownership of the plan normally falls on the shoulders of one individual known as the food safety manager, coordinator, or other title created by the establishment. In any case, this individual has the privilege of knowing most of the ins and outs of every process associated with the food safety plan and communicating the effectiveness of the plan within the organization. They typically work with the Preventive Controls Qualified Individuals (PCQI) who know the details of each program such as pest control, sanitation, equipment maintenance, scheduling, and operations. These are the go-to folks for the answers about the detailed questions related to validation, verification, training, records, procedures, materials, or other elements associated with food safety.

Qualified Individuals (QI) are those employees who conduct the actual day-to-day duties. The intimate details of each system and the associated food safety elements are owned by QIs who are directly involved in the process. The key is communicating the plan throughout the organization in a way that becomes relevant to each individual and their roles.

As companies generate valuable and informative data about their systems, it becomes even more valuable for the team to have a well-rehearsed plan for when FDA comes for an inspection.
© Tatomm |

There are various quality tools that can be used to help with the creation and analysis of the food safety plans. This crossover of tools works nicely within the food safety programs. Some of these tools are the FMEA (Failure Mode Effect Analysis), Process Flow Diagram, 6Ms (Fishbone or Ishikawa Diagram), 5 Whys, Pareto Analysis, PDCA (Plan-Do-Check-Act), Run/Control/Pareto Charts, and checklists. For each step in the process flow diagram, an analysis using the 6Ms for possible food safety hazards and associated risks is needed.

After the risks are identified, this information can be placed into the FMEA. The FMEA has a built-in calculator that will help identify the most critical risk allowing for prioritization of actions and funds to reduce the risks. Applying the 5 Whys details the improvement process of those risks. Applying the PDCA approach for reducing the risk adds a layer of verification. This allows the team to plan the activity, do it, check for effectiveness (or verification), and then act by either accepting the changes or starting over if the effectiveness was not acceptable.

PROGRAM REVIEW. Next comes the review of the supporting food safety programs such as complaints, corrective and preventive actions, pest control, environmental monitoring, maintenance, recall, and traceability, to name just a few.

Run charts, control charts, or Pareto analysis are tools that can be used to determine how well these programs are performing. Applying the stratification tool allows data from various programs to be analyzed to identify patterns that can be used to improve or correct possibilities of risk before they occur. For example, if a processing area requires the most maintenance, has a large number of environmental pathogen hits and a lengthy list of customer complaints, the chances of a major food safety issue occurring significantly increase. This becomes a key opportunity for preventive action and the PDCA method can also be applied.

Using these tools and gathering information on the food safety system may be overwhelming for the key individual (food safety manager or coordinator) responsible for the food safety plan. This is where all the PCQIs become a valuable asset to the program. The PCQIs can provide the data to the food safety coordinator for analysis. The PCQIs also can review their specific data and use the PDCA model to implement corrections before there is a huge concern.

A schedule to review each program in the form of a checklist is another quality tool that adds value to the food safety plan. A checklist can be used in many areas of the food safety plan.

During a routine inspection, the FDA inspector is looking for proof that the manufacturing system is following the FSMA requirements.

THE FDA INSPECTION. As companies generate valuable and informative data about their systems, it becomes more valuable to have a well-rehearsed plan for when FDA comes for an inspection. The team should have a procedure with details such as: who will interact with FDA inspectors; who at corporate must be contacted and by whom; how records, photos, documents, and samples will be handled; and last but not least, what to say and not say to the inspectors.

It’s advised that for each FDA inspector, there should be a team of three individuals: a primary contact, a scribe, and a runner. The remainder of the staff (PCQIs and QIs) are on stand-by ready to provide evidence, yes — evidence, of the procedures and processes that are in place. When FDA inspectors come for an inspection, they will collect evidence of compliance or non-compliance with FSMA requirements.

As the inspectors collect information, those appointed by the company to assist the FDA inspectors also need to collect information.

  • The primary spokesperson should be completely focused on the inspection. So someone else in the organization needs to be ready to handle that person’s day-to-day responsibilities.
  • The appointed scribe should write down everything that takes place during the inspection. He/she needs to be completely focused on the inspection, so someone else should focus on that person’s day-to-day activities.
  • The runner gives the primary spokesperson everything requested. One important function of this role is to review each record or other requested information prior to handing it over to the inspectors. Ensuring that the records are correct and completely accurate will help avoid unnecessary embarrassment or further questioning. It also allows for a thought process or plan in the event that something isn’t perfect. For example, if a sanitation record appears to be incomplete, the runner has an opportunity to talk to the PCQI and QI to gain clarification prior to handing the records over to the inspector.

This system of working together requires practice, solid communication, and trust within the team. Murphy’s Law will always kick in during an inspection, so being prepared helps calm the nervous energy and deflect crazy events.

As stated earlier, FDA collects evidence of compliance or non-compliance. During a routine inspection, the FDA inspector is looking for proof that the manufacturing system is following the FSMA requirements. Think of it as an investigation at a crime scene. The investigator is looking for clues that will help point to the cause of the crime and then, hopefully, who caused the crime.

FDA inspections are somewhat similar. The inspectors will look for clues demonstrating any food safety contamination risk to the public. They will ask questions, such as where the raw materials are sourced and sold, and how they are shipped. The answers will provide them with information on the direction of where the food supply has been and where it is going.

The inspectors will ask questions about incoming food safety testing, which will provide them with awareness of the company’s level of inspection prior to use in their facility. The inspectors will then ask questions about the manufacturing process from start to finish.

During the questioning, they will ask for proof of what was stated. It can be put as simply as “Show me the record for….” As this information is being collected, the inspectors will be making comparisons against the regulations and deciding whether or not the company is in compliance.

FDA’S NEW APPROACH. With FSMA, FDA is converting the former responsive approach to food safety to a preventive approach. The facility’s structure, materials, sanitation, and pest control practices will continue to be inspected; in addition, FDA also is inspecting the validation, verification, continuous improvement practices, training, and other components to solidify the preventive food safety plan.

By using various quality tools to help outline the food safety plan; and then using the same tools to identify continuous improvement and corrective actions, the company is simply following FDA’s objective of developing a preventive program. If evidence of compliance is readily available, and if the company is able to represent these examples of compliance, the FDA inspectors will be more comfortable that the facility is compliant, and are likely to focus their time and energy on a different company that is in a less preventive mode of operation.

At the end of the day, FDA is charged with ensuring that the food supply under its jurisdiction is safe and wholesome for U.S. consumers. By working with CDC, state and local governments, industry, and educational institutions, FDA has a significant number of resources to verify various activities and findings. Together, these groups are targeting unsafe opportunities so that consumers can have a much more enjoyable eating experience, prevent lifelong health effects, and ensure a wholesome food supply.

The author is Director, Quality Assurance, AIB International.