It can be challenging to maintain good working relationships with the U.S. Food and Drug Administration (FDA) and/or the U.S. Department of Agriculture (USDA) even when things are going well, so how do you leverage your best efforts during an inspection when there are issues? Let's address how strategically handling the inspection itself can be your most important relationship-building asset, along with having a fundamental understanding of the science and regulations that are in play.
Why is this important?
Everyone in a food safety or quality role in a food or beverage plant under FDA and/or USDA jurisdiction interacts directly with those agencies. So do other functions such as operations, maintenance, and sanitation. And although functions such as senior management, sales, and marketing might like to assume they do not interact with the agencies, they do so at the very least indirectly.
FDA and USDA therefore affect behavior at food facilities across the board and from top to bottom.
Hiding from this reality only breeds issues that are far more insidious than simply deciding to maintain a hands-off professional relationship with agency inspectors and officials. It is hence very important to actively own the relationships. By doing so, credibility is built with the inspectors (and their management, which can be highly helpful down the line), more informative dialogue can occur, noncompliance and nonconformance identification can be mutually agreed upon, and odds of future inspections might go down. And truth be told, what should drive everyone is making sure that people do not get sick—inspections drive toward this objective, whether they are welcomed or not. That being the case, why not actively manage those inspections and the relationships with the people doing them?
Fostering effective relationships with regulatory inspectors can be extremely challenging due to the following factors:
- The inspectors change frequently and therefore have different backgrounds, expertise (or lack thereof), and personalities.
- The inspectors have different motives at different times (inspection, audit, compliance, for cause).
- Some inspectors show up only annually or even less frequently (e.g., FDA routine inspections, USDA food safety assessments), while others are in the facility almost daily (e.g., USDA Food Safety and Inspection Service consumer safety inspectors on-site).
- The inspectors carry a badge—they can shut down your facility.
- The people interacting with the inspectors might be inexperienced in such matters (this can be particularly true across second or third shifts).
- The frequency of inspection and/or the issues in play might affect the mood and therefore the actions of the employees in the facility.
Clearly, all the company’s functions want to keep the plant running, so any “interference” caused by regulatory issues can be counter to this—and bring all kinds of ire down upon the food safety organization, particularly in less mature corporate cultures where “food safety” is seen as the purview of the food safety function alone. Hence, having good relationships with the regulators is in everyone’s best interests. Naturally, these relationships can be nurtured on an ongoing basis, as they should be. But it’s in the crucible of an inspection that the opportunity for improvement is the highest.
The purpose of this article is therefore to provide advice and guidance for leveraging an inspection to build better relationships with the agencies. The tenets offered herein will be particularly useful to those new to this role, no matter how much experience they already have in the food and beverage industry.
Furthermore, these suggestions apply to relationship building with all regulatory inspectors, regardless of how often they are in the facility and regardless of how well they are known by the company.
The Authority of the Authorities
FDA has the right to inspect any and all food manufacturing facilities shipping food into interstate commerce. This authority comes from Sections 702 and 704 of the Federal Food, Drug, and Cosmetic Act of 1938. This authority was further strengthened and broadened by the Food Safety Modernization Act (FSMA), particularly Sections 102 (authority to suspend a food facility’s registration), 206 (authority to issue a mandatory recall order), and 207 (authority to detain certain foods).
USDA has the right to inspect facilities processing meat. This authority comes from the Federal Meat Inspection Act of 1906 and its subsequent amendments.
Because FDA and USDA have a responsibility to protect the public health, this authority is necessary and is expected by the consumer. This is also why such inspections have a hugely different gravitas than might a Safe Quality Foods audit. Getting a low score on the latter would likely be embarrassing and may lead to some loss of customer trust and/or business. But the facility can keep operating (barring complete failures in their food safety systems, of course). On the other hand, as is often said, FDA (and USDA) “can turn out the lights.”
The importance of this difference cannot be missed in the handling of agency inspections. There is no do-over.
Terminology Does Not Matter—You Are Being Looked At
The terms “inspection” and “audit” are often used interchangeably or even indiscriminately, although many people are adamant that the terms are different. Definitions can include how thorough and in-depth the critique is, whether the critique is only against a well-published set of criteria, whether it is documentation that is being critiqued and/or actual employee behaviors, and whether the critique is looking at present state only or is looking at prior records as exemplary of prior actions. All of this relates to “compliance,” one way or another. And assessing compliance can be solely at an instant in time (i.e., what is being looked at by the inspector at the time), or, more worrisomely, assessing compliance can be the inspector’s judgment on what might or will happen in the future.
FDA uses the term “inspection” almost exclusively, as does USDA. Third-party food safety assessment schemes tend to use the term “audit.” Regardless of what officials might call what they are doing, and regardless of what the company calls that assessment, a federal agent (or a state official acting on behalf of the federal government) is looking at your facility’s ability to produce safe food. An outcome of said inspection (or audit) is that FDA (for example) is making “observations.” The deliverable in this regard is an FDA Form 483 (“inspectional observations”). For routine inspections, USDA uses a process that relies on their noncompliance reports (NRs).
Use whatever terms motivate employees, leaders, and management, and which ensure utterly transparent communication. But recognize that an inspection is an opportunity to allow harm to befall an organization or to allow trust to be built with the regulatory agencies.
Understand Your Rights and Plan Your Principles
It is all too common to assume that you have to be quiet during an inspection and/or accept whatever the inspector mentions and documents. Even if you try to engage an inspector in discussion and interpretation (e.g., of a regulation or of an observation) during the inspection itself, this certainly does not mean the inspector needs to respond. There are many inspectors who keep their observations to themselves until they issue a 483 or NR.
There are no laws that require someone whose facility is being inspected to keep quiet. One does not have to “sit there and take it.” And certainly, at an exit meeting where a 483 (for example) is being discussed, the inspectors are expecting dialogue at that point. This is particularly to ensure understanding on the part of the company of the observations that the inspector has documented.
The main governing “law” is therefore the one of common sense. Although some people might believe this is a sixth sense, knowing when to speak up and when not to can be an art. But that should not stop a company from attempting to engage in a meaningful dialogue with inspectors.
By interacting with the inspector during the inspection, the company gives itself its best chance to influence the outcome of that audit. At the very least, the company gains a much more solid understanding of the observations and potential issues from the inspector’s point of view.
Deciding to “wing an inspection” on the spot is a recipe for disaster—or, perhaps less dramatically, is certainly a recipe for ending up with more work than you might otherwise have had to address the inspector’s noncompliance list. This is also the case for the less mature organizations that merely put the inspection outcome in the hands of a single group or individual.
The main point is to embrace that the company will be engaging in dialogue with the inspector throughout the inspection process. That being the case, then the company and especially the food safety organization must identify the principles it will use during its interactions with the inspector during the audit.
Here are some suggestions to consider, starting with “The Four Knows”:
- Know Your RegulationsThe inspectors’ training and experience base are an outcome of the regulations under which they are operating. The inspectors therefore have guide rails that limit what they can look at—and which markedly reduce the lens by which they look at a facility (its documents, its behaviors). On the other hand, these guide rails make them experts in the relevant regulations. The company cannot afford to have its food safety professionals not understand the regulations as deeply as the inspectors do. The people in direct contact with FDA/USDA must be able to determine immediately whether the inspector is quoting a relevant regulation (or document or standard). They must also be able to quote potential regulations that are contrary to what the inspector is quoting and/or quote case law (or other germane examples) that call the inspector’s citation of a regulation into doubt. Such education can take a lot of ongoing work on that part of the food safety organization but cannot be underestimated or underfunded. It is critical to success.
Know Your Science
Equally important is understanding all the science underlying the food, manufacturing processes, quality, and shelf life inherent to the company’s products. This responsibility does not need to fall on one person only (as such a broad set of knowledge may be impossible), so should be shared. However, the people in direct contact with the inspector must have a working knowledge of all the science and be able to recruit the “experts” immediately. This knowledge “bubble” is extremely important for multiple reasons: (a) to counter wrong comments by the inspector; (b) to establish credibility with the inspector; and (c) to be able to leverage a superior understanding of the science to influence the inspector’s observations.
Know Your Procedures & Systems
One of the most embarrassing ways to receive a perhaps-unwarranted noncompliance is not to understand your company’s own procedures, systems, and documentation. This is unacceptable. Hence, the company’s senior management must ensure that the food safety organization (especially its leaders) truly understands and is accountable for the relevant procedures backward and forward. At the other end of the spectrum, showing an inspector complete knowledge of procedures and how systems interact with and reinforce each other is yet another way to provide possible leverage points to influence the inspector’s observations.
Know You Can Push Back
The best time to push back is in real time, in the heat of the moment. One’s confidence and ability to do so lie in following the three tenets listed above. If you know what you are talking about, the skillful inspector will listen. The “art” involved in this is in knowing when to push hard, when to argue, and even when to raise your voice. This last one can win the day, or lose it. Hence, discretion, lots of experience, and an ability to read the inspector are absolutely critical. Building these skills is necessary in the organization (take heed, senior management), as even half-baked skills are likely to be better than keeping quiet.
Have Inspection Policies in Place
Corporate policies are the first round of defense to an inspection. The inspectors need to be put on notice as to what is allowed and what isn’t, independent of what the inspector might allege. This can include taking pictures, reviewing certain proprietary documents, off-limits areas of the facility, and in what manner the inspector is received. It is best to get these procedural items agreed to prior to the inspector going out on the floor (this assumes the inspector is not there for cause).
Have a Support Team at the Ready
As an inspection is triggered, so too must be the people who might be needed to respond to observations and, if necessary, to push back on the inspector to clarify needs and/or to disagree with specific observations. Waiting until the middle of an audit is not the time to figure out who is needed! Information (i.e., talking points) should already be in the food safety organization’s arsenal from the appropriate trade associations, previous inspection results (including corrective actions), comments (published or otherwise) from FDA/USDA supervisors, legal case studies, and published best practices. In addition, legal counsel should be identified and ready to engage in the inspection, along with senior management (who needs to be already knowledgeable of the company’s food safety practices, guidelines, and aspirations).
The Inspection – Now
The inspector has shown up. As should be clear, the wrong strategy is waiting for the inspection to be done “to see how we did.” The right strategy is following predeveloped principles and taking deliberate, engaging action. Suggested actions include:
Stay Informed in Real Time
A fail-safe communications network needs to be established immediately, operating at all times, so the inspector’s location, questions, comments, and spoken and written observations can be shared and reacted to immediately. This includes following the eyes of the inspector and wherever the flashlight beam points. If multiple inspectors are on-site at the same time, then company employees need to remain close enough to listen to their conversations. Such observations of the inspector need to be communicated broadly, as the cumulative set of such observations may be quite revealing as to what the inspector is looking for and/or whatever may be eye-catching to the inspector (e.g., spilled food product, condensate accumulation, no gloves on an employee).
Be Responsive in Real Time
Fix whatever can be fixed immediately. This maxim holds true regardless of whether the inspector considers it a major issue, whether it might end up on the final report, or whether you want to argue about it. Fix it. This action pairs up with the sixth tenet above—have a team ready to get to work, any time of day or night. Many nonconformances have not made it to the final report because a company made extraordinary efforts to fix an issue in real time.
Push Back When the Opportunity Arises
Sometimes it is beneficial to push back even when the opportunity looks weak or when it is hard to tell how the inspector will respond. Particularly for relatively minor issues, pushing back early and often can help diagnose the inspector’s needs, strengths, and weaknesses. Then use that knowledge to push back (and strongly argue) for the battles that are really worth fighting. Some might say this skill relies on gut instinct or another sixth sense. But an easy way to tell when to respond is when you feel offended or wronged—these feelings are good signals that you should push back appropriately.
Anticipate the Exit Document
Setting aside emotions, beliefs that the inspector is wrong, and perhaps a bit of panic that suggests that the inspector is right, build a list of what may end up on the final observation/noncompliance documentation. This is a conservative strategy yet smart. If this is done well (and the inspector is relatively communicative), you will have captured most if not all of what the inspector has identified. Even if you capture more than the inspector does, these observations still provide further foundation for improvement.
- Plan the Content of the ResponseRather than wait for the final exit document and for the response clock (deadline) to kick in before starting to write a response, start during the inspection. Doing so will bring utter clarity to the quality of your response. For example, you may quickly learn that your response might be far less than adequate—if so, the time to start working on that both with the inspector and with the company is now. Separately, drafting corrective actions before the inspection is completed also brings clarity to the strength of your position of being able to make sufficient and sustainable corrections. If the inspector provides an opportunity (at the exit meeting if nowhere else), then these actions can be powerful at reinforcing trust and displaying the ability to demonstrate a sound food safety plan.
The Inspector – Now
It is important for regulatory inspectors to understand that they play a role in the success of an inspection beyond just finding non-compliant documents and behavior. Of course, there are differences in personality and approach by different inspectors. Yet it’s vital to realize that an inspector’s being communicative during the inspection can lead to a far better outcome. The inspector should believe that a successful outcome includes improvements in the company’s documents and behavior, and the inspector should be identifying items and issues that truly improve the public health and well-being.
If, on the other hand, the inspector is merely “doing a job,” checking the boxes, or perhaps just being punitive, then the risk is that only the boxes get “fixed.”
Do note that the company must be forthright and sincere in its communications, too, following the principles and actions outlined above. Otherwise, the inspector really has no reason to follow suit either.
Having FDA and USDA inspectors walk through a food facility is normal and expected and provides an opportunity to improve one’s systems to enhance food safety practices (and therefore further protect public health). Such opportunities should never be viewed as a necessary evil, a game, or something to be avoided at all costs. Rather, as a USDA regional supervisor opined, “we actually both have the same goal.” Accepting a common goal is very helpful to encourage a mindset of fostering good relationships with agency inspectors.
Fostering a good relationship with regulatory inspectors and having a good inspection outcome are founded on a few criticalities: know your science, regulations, and procedures—and in real-time—stay informed, and take action.
It is also very helpful to remind the company to stand up for itself, especially when its systems, processes, and procedures are actually excellent.
Bob Lijana, M.Sc., has held director- and VP-level positions in food safety, quality, and operations for over 35 years at companies producing ready-to-eat foods, prepared meals, and pasteurized juices. He has a B.Sc. and an M.Sc. in chemical engineering from the Massachusetts Institute of Technology and the University of California–Berkeley, respectively.