The rise of COVID-19 in February and March 2020 changed the world, and that included the food processing industry.
The pandemic, which now seems to have evolved into an endemic, caused many changes in how the industry carried on their business: Regulatory inspections ground to a halt, supply chain issues at many levels caused numerous companies to rethink where and how they purchased ingredients; staffing issues, which remain to this day, were abundant; and food companies scrambled to enact programs to protect their workers from the virus. And, there were many more effects.
Unlike some businesses, food processing could not take a break during the worst of the pandemic; billions of people around the world had to eat. The industry had to operate short-handed in many cases, however, and many of those who were out sick were those responsible for food safety. The food industry as a whole was somewhat fortunate from a food safety perspective; while there have been recalls and outbreaks over the past two and a half years, until the recent issue with infant formula, there was really nothing that was exceptionally high profile. The food industry may well have dodged a bullet from a food safety standpoint; however, there were other issues, one of which was the inability to conduct regular audits of facilities by certifying bodies and buyers. Travel and visits were curtailed for months, and, in addition, many companies established “no visitor” policies that lasted for a year or more—so, no auditors were allowed.
Elements of an Audit
Audits have become an integral part of conducting business in the food industry, and the smart companies view them as an important element in their continuous improvement program. A fresh set of eyes often sees things that company people take for granted.
Audits generally incorporate several different elements, including:
- A review of documented procedures;
- A record review;
- Inspection of the plant and grounds; and
- Determination of whether procedures are being followed.
In short, an auditor should review and understand the programs and procedures included in the food safety plan and then confirm their implementation and effectiveness at controlling hazards through observation of operations and assessment of the facility and grounds.
The first two elements are often referred to as desk audits. There has been a push among many audit firms to place a greater emphasis on the time spent in a plant so that the focus of the audit is more on what’s going on rather than on the review of documents and records. While it’s not uncommon to find perfect records, it’s rare to find perfect plant practices or pristine facilities.
As an example of the importance of observing what goes on in a plant, here is a story from a long-time auditor I spoke with. The auditor was asked to conduct a GMP/food safety audit of a plant. He met with plant management who basically gave him free access to the whole facility. The auditor found a niche in a balcony overlooking the production floor and made himself comfortable. The plant manager, who was a very hands-on person, came by several times over the next few hours and observed the auditor sitting up on the balcony. He finally waved the fellow down and wanted to know why he had planted himself in one place—he was paying for an audit. The auditor then proceeded to show the plant manager several pages of adverse observations that he had made just sitting. This underscores the importance of observing the process.
So, if one cannot visit a facility and conduct this observation in person, what is the alternative? Enter the remote or virtual audit, an audit conducted via a web-enabled remote system.
The Virtual Audit
Many companies mandate that their suppliers successfully pass one of the Global Food Safety Initiative (GFSI) certification schemes and these programs all require an annual on-site audit. Early in the pandemic, GFSI provided a six-month extension on audit requirements while continuing certification. When the pandemic showed no sign of abating quickly, GFSI allowed the use of virtual or remote audits in lieu of further extension of certification without any audit at all. Proponents of remote auditing saw this as a move forward; however, there are those who opposed their use even in such extenuating circumstances. Let’s look at the pros and cons of the virtual or remote audit.
I spoke with Warren Edde, manager of supply chain for the J.R. Simplot Company, a potato and French fry producer based in Boise, Idaho. As part of his job duties, Edde manages and conducts audits directly for Simplot:
“About June of 2020, when I realized travel would be off the docket for quite some time, I began to conduct virtual audits. At that time, though, it was only put on as a bridge and was not intended to be a long-term program. Two years later, the virtual audit program has continued to be an integral part of my supply chain verification activities, especially with foreign suppliers and new suppliers.
The virtual audits I perform are conducted over video conferencing tools. These platforms provide the ability to review programs, ask clarification questions, and review implementation records to ensure the food safety programs are being followed. This gave me confidence that the hazards had been properly assessed, the preventive controls necessary were in place, and that the facility was performing essential monitoring, verification, and corrective actions according to the written programs. The virtual audits are an essential component during no-travel times and, quite honestly, are a useful tool for assessment of programs for new and existing vendors. The downside [is that] they do not allow for conducting operator interviews, facility observations, assessing hygiene controls, [or for] adherence to cGMPs, which are essential components of the on-site audit.
That said, the virtual audit will remain in my toolbox and will continue to be incorporated into future auditing, not replacing the on-site audit, but acting as an extension to the onsite audit. This approach will allow for review of programs and records prior to the onsite review and allows me to better schedule my time. I can conduct multiple virtual audits in a week, and in many cases I can then travel to a process location and perform multiple onsite inspections at a future time. I can honestly say that I prefer conducting the program and record review at my desk where I have plenty of room and plenty of monitors.”
So, there are pros and cons to a virtual audit program in Edde’s mind, but he is very clear that on-site audits are not going away. One point that should be underscored is that having access to documents and records before going into a plant is important; reviewing these materials beforehand can considerably reduce the time spend in the plant.
John Surak, PhD, professor emeritus of food science at Clemson University in Clemson, S.C., and past chair of the United States delegation that helped develop the ISO 22000 for safety standard told me that he has similar thoughts on virtual audits:
“I do not support virtual audits when the auditor is in the production part of a site. For example, [when] auditing PRPs. I also believe that virtual audits are not effective when auditing the lab. The auditor has a limited view of what is happening. In addition, the auditor is at the mercy of the person holding the camera. You do not have the ability to smell or clearly hear what is happening in the manufacturing part of the facility.
However, there is some value in the virtual audit. I was working with a plant in the pre-COVID days. The manufacturing plant was located in the U.S., and corporate was located in Germany. Two individuals on the plant’s organizational chart were located in Germany. The question was, do these individuals need to travel from Germany to the U.S. for a one-to-two-hour interview as part of the audit? There was substantial interaction between the managers located in Germany and the United States. To eliminate needless waste, the audit interview of the German managers was conducted via video conference. I observed the interview, and I did not see any problems. The auditor was able to access any needed documents electronically.
I can see the use of video conferences as a useful tool for auditors. It can increase efficiency in the audit process when the auditor is auditing a portion of the food safety management system that is carried out by professionals at remote locations such as at the corporate location. When this is done, the auditor should assess the effectiveness of the communication between the two different sites. This process could be useful in the days of unannounced audits. It would allow the interviewing of the management team that may be away from the facility because of travel.”
In chatting with other food industry professionals, I found that they echoed similar thoughts. One individual stated that she participated in a virtual audit, but when travel opened up and she was able to actually visit the plant, she found much in the plant itself that the camera did not show. This same person acknowledged that the desk audit could be done virtually, however.
The Value in the Virtual Audit
Dr. Surak’s comments about utilizing all the senses when doing an audit are absolutely correct. There are those who say that one way to evaluate cleanliness is to ensure that the equipment looks clean, smells clean, and feels clean, and that test results verify this. You really can’t do any of these activities virtually; even looking through a camera lens isn’t always as effective as the human eye.
So, while virtual audits do have a role in managing food safety, auditors, certifying bodies, and the companies under audit need to understand the potential concerns and the commitments that are required for this remote inspection to be successful. The company has to be willing to share information via hard copy or electronically with the auditor. This means that signing a nondisclosure agreement may be an essential first step in the audit process; however, there needs to be a culture of nondisclosure for all participants involved in the audit process. If documents are shared, the auditor may be asked to return them at the end of the audit or erase them from their computer, a procedure to be avoided since the documents form the completed audit record. With programs such as Zoom, completed records may be shared in real time, but such a session may not give the auditor enough time for a proper review.
On the upside, virtual audits can drastically reduce travel costs, which could increase audit frequency. In many cases, travel costs can account for as much as 60% to 75% of the total audit. More importantly, it reduces wear and tear on auditors, a significant concern in a field that is chronically understaffed; auditor burnout is common
Another upside is the value of training new auditors using virtual audits. Sending a trainee to accompany an auditor can add as much as $5,000 to travel costs, which can severely limit the amount of training new auditors receive before going out alone.
Still, the on-site audit should never be ignored. The time in plant allows the auditor to verify that what they saw in the documents and records is accurate and true. Remember, there are places with great records that are imperfect when the records or procedures are viewed against actual practices. Even though cameras and cell phones will provide access to a plant, they only provide an incomplete snapshot of what is actually going on. Auditors need to use all their senses, including hearing. A well-run plant may be compared with one’s own car; the owner can usually detect issues by how the car sounds. The same is true with a food plant that is up and running well—it has its own sound.
As virtual audits increase in use, procedures and practices will improve, as will the auditor’s skills in detecting hidden problems. Technology improvements will also contribute to improved results as demand increases. The ultimate answer to the question of on-site versus virtual audits likely lies somewhere in the middle. A hybrid using local third-party staff guided remotely by a seasoned auditor seems like the best of both worlds.
Stier is a consultant food scientist and a member of the Food Quality & Safety Editorial Advisory Board. Reach him at [email protected].
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