Tag Archives: gap analysis

Steven Sklare, Food Safety Academy
FST Soapbox

What Is Your Company’s Level of Digital Risk Maturity?

By Steven Sklare
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Steven Sklare, Food Safety Academy

The digital transformation of food safety management programs is a common topic of discussion today, across the full range of media including print, blogs, websites and conferences. It has also been generally acknowledged that the COVID-19 pandemic has significantly accelerated the adoption of various digital technologies. However, let’s be clear, COVID-19 may have accelerated the process, but the process was under way as the only way for food companies to efficiently cope with the increase of required compliance documentation for regulatory bodies, such as FDA, USDA, etc., non-regulatory organizations such as GFSI, and customer specific requirements. COVID-19 has added a sense of urgency, as the fragility of both domestic and international supply chains has been exposed with long-term sources of ingredients or equipment being cut off overnight. We must also overlay the need to manage food safety risk and food fraud vulnerability in real time (or even predict the future, which will be discussed further in a future article). The food industry has also had to adjust to dealing with many aspects of work and production without typical face-to-face interaction—a norm of operating within the environment of a global pandemic over the past two years.

What is not clear, however, is the meaning of “digital transformation” or the “digitization” of a food safety management program. What is not clear is what these terms mean to individual organizations. The frenzy of buzzwords, “urgent” presentations, blogs and webinars help to create an improved level of awareness but rarely result in concrete actions that lead to improved results. I admit to being guilty of this very hyperbole—in a previous article discussing “Chocolate and Big Data”, I said, “If a food organization is going to effectively protect the public’s health, protect their brand and comply with various governmental regulations and non-governmental standards such as GFSI, horizon scanning, along with the use of food safety intelligent digital tools, needs to be incorporated into food company’s core FSQA program.” Sounds great, but it presupposes a high level of awareness of those “digital tools”. What is not clear to many organizations is how to get started and how to create a road map that leads to improved results, more efficient operations and importantly, to ongoing improvement in the production of safe food.

Addressing a new concept can be intimidating and paralyzing. Think back to the beginning days of HACCP, then TACCP, then VACCP, and post FSMA, preventive controls! So, where do we start?

Nikos Manouselis, CEO of Agroknow, a food safety data and intelligence company with a cloud-based risk intelligence platform, Foodakai, believes the place to start is for food companies to perform an honest, self-assessment of their digital risk maturity. Think of it as a digital risk maturity gap analysis. While there are certainly different approaches to performing this self-assessment, Agroknow has developed a simple, straightforward series of questions that focus on three critical areas: Risk monitoring practices and tools; risk assessment practices and tools; and risk prevention practices and tools. The questions within each of these areas lead to a ranking of 1–5 with 1 being a low level of maturity and 5 being a high level of maturity. One of the goals of the self-assessment is to determine where your company stands, right now, compared to where you want to be or should be.

While this is not a complete nor exhaustive process, it helps to break the inertia that could be holding a company back from starting the process of digitizing their food protection and quality systems, which will allow them to take advantage of the benefits available from continuous monitoring of food safety risks and food fraud vulnerabilities, artificial intelligence and predictive analytics.

magnifying glass

How to Survive an FDA Foreign Facility Inspection

By Maria Fontanazza
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Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.

First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International.  Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.

Prepare for the Inspection

  • Develop an internal policy for foreign inspections
  • To ensure readiness at all times, implement a proactive program that involves the following activities
    • Annual review of registered facilities
    • Review of any products or materials made for U.S. markets (including R&D samples)
    • Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
    • Employee training on FDA requirements
    • Create a site-specific FDA inspection manual for all necessary documentation

Survive the Inspection

  • Align expectations with the inspector at the start of the inspection
  • Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
  • Consider having a U.S. regulatory support colleague available for questions during the inspection


  • Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
  • If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions

At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Developing an Enduring Food Safety Culture

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

Food safety gap analysis is a process improvement management tool that helps to identify areas of risk and associated gaps in the internal food safety programs that must be addressed to ensure high confidence in your Food Safety management system. It is structured to benchmark the level of food safety, and to highlight potential areas of concern that might impact the business, customers and the overall business brand. Although a continuous internal self-assessment is encouraged, best practices require the use of third party consultants to sieve and weave through the entire organization to determine the efficiency and effectiveness of processes and systems and to make appropriate recommendations for improvement.

The NSF has a robust food safety gap analysis protocol which is referred to as a Maturity Model Assessment. It is very detailed and extensive involving site visits, observations and interviews of senior management. It is deliberately designed to completely evaluate the preparedness of the entire organization in food safety best practices. Such an unbiased third party instrument is an excellent assessment tool for any organization’s food safety culture.

Why is developing an enduring food safety culture important to the business? A senior manager in a large retail food company once told us in a meeting that although he had been with the company for almost 15 years that he still didn’t really understand what the Food Safety team was doing. We all thought that this manager was just being sarcastic but on closer scrutiny, we discovered that not only did he not understand the why and how of the many ongoing food safety projects, but also thought that a lot of those projects were not really required, since according to him, there had not been any major food safety event in the last 15 years while he had been with the company.

This is obviously a bad commentary on this particular organization’s food safety culture. First, the food safety team appeared not to be doing a good job in sensitizing all parts of the business on the importance and business value proposition of its food safety practices and initiatives. Second, that senior manager may have been working in a silo without interfacing with other business functions and stakeholders to completely understand how his projects and programs impact other parts of the business. Consequently, every food company must encourage and support the development of an enduring food safety culture to avoid such grievous disconnect between its food safety management system and the important stakeholders that influence its successful implementation.

An enduring food safety culture – will the customer notice?

Recently, we had an opportunity to visit a large retail food company in the Southwest. The parking lot was so tidy that we couldn’t find a single piece of trash usually left by customers on carts or littered around cars and cart holding stations. The facility floors were so polished and sparkling clean that you could see your reflection and yet the floor coefficient of friction remained at its best to avoid slip and fall accidents. After taking in all the neatly arranged food prep work areas, the correct use of gloves, proper hand washing and the overall professionalism of the foodservice workers, I managed to excuse myself to take a look at the restroom. In my mind, the condition of the restroom would be the true test for an organizational food safety commitment from the customers’ standpoint. Even as a Cleaning & Sanitation enthusiast who is never satisfied unless it feels and smells clean and sanitary, I was impressed by what I saw.

To further validate my observations, I left the guided tour and sneaked into one of the company’s stores in a less affluent neighborhood, and it still looked good.

Several days later, I had an opportunity to meet with the company’s senior vice president. How did you do it? I asked. I got a very simple response but yet so revealing. Food safety culture is taken seriously by the company leadership, from the top down (and not from the bottom up! my emphasis). The Director of Food Safety reports directly both to the senior vice president and to the CEO. This means that food safety has direct access to top level management.

Listen to this: every employee in the organization including senior management sat through a food safety training certification on a regular basis. The best part – the CEO actually attends food safety conferences along with the food safety team. According to the senior vice president, the rate of return on investment continues to be outstanding, and the company is still expanding, in spite of the uncertainty in the current business environment. Thus, it appears that an enduring food safety culture is also good for business!

Although a third party food safety gap analysis is recommended for evaluating an organization’s food safety culture and commitment, let me challenge you to do it differently using the benchmarks from this exemplary retail food company in the Southwest, as follows:

  • Are you able to get your CEO to attend a major food safety conference?
  • Does your food safety team have direct access to top level leadership management or at a minimum reports directly to a Vice President who can take far reaching decisions before situation snowballs into something big and messy for your customers?
  • Is there any kind of company-wide food safety awareness training for all employees especially including senior leadership management in your organization?
  • Is every company employee aware of how their specific job function interfaces with food safety in fulfilling the company’s mission and supporting customer satisfaction? A good example would be an hourly worker at the store level knowing why we need 50 – 100 ppm chlorine based sanitizer to sanitize food contact surfaces, and the CEO understands that proper sanitation of food contact surfaces using the right tools by employees with the right training is mandatory.

Cleanliness and the perception of cleanliness are the key customer indicators for any good food safety culture. Customers don’t care about complex food safety management system that sometimes is so cumbersome to implement by folks at the frontlines. Instead, customers care about the little tell-tale signs of food safety that they see during their brief visit to your retail foodservice establishment. If the customer can trust you in such little things like keeping the parking lot, dining room, restroom or drive-through clean, it becomes even easier to trust you on the big stuff that happens away from the prying eyes of the customer at the back of the house. There’s an empirical evidence that cleanliness is directly and significantly associated with increased sales and profitability.

So, let’s take a moment at the beginning of this year and make yet another new year resolution to perform our annual food safety gap analysis, assess our organization’s food safety culture and implement the much needed corrective actions to fill these gaps towards the establishment of an enduring food safety culture. Let us convince senior management that it is good business that not only pays for itself but pushes customer satisfaction and profitability beyond our wildest dreams. Happy New Year, folks!