Which comes first: generating standard operating procedures (SOPs) to drive improvements in quality and food safety behavior, or improving behaviors and then generating the appropriate SOPs? Does the SQF/GFSI process drive the first approach or the second? The answer to both questions is: yes.

Many food manufacturing companies presume (and hope) that the SQF (Safe Quality Foods)¹ process will certify that their food is safe and of high quality. Hence, a common approach is to follow the SQF Code line by line to generate the appropriate SOPs and to generate document templates to match the SOPs. These documents are then filled out by employees in real time to "prove" that the food must, therefore, be safe. To clarify for those new to this arena: the SQF process is just one of many different certified processes to satisfy the food safety requirements of GFSI (the Global Food Safety Initiative).²

Although these steps are necessary, they are woefully insufficient without a systematic approach to achieving consistent and self-improving food safety behaviors in the plant. Put another way, the goal is for food safety behaviors to improve continuously and organically. The SQF process is not an end in itself, but rather a means to an end: sustainable behaviors ensure the food is safe, drive cross-functional goals and training, and allow even better food safety behaviors to become habits. Documentation provides the bookends to these behaviors. However, even without complete and thorough documentation, improved behaviors are still the right approach to keeping food safe.

A Common SQF Approach

I have seen the SQF scheme applied from "rookie" organizations (no food safety plan or process in place) to "veteran" organizations (successful SQF audits across many years). I have also seen the SQF scheme applied to dry products (powder blends), wet products (juices), and in-between products (deli salads). In all situations, a common mindset was a laser-sharp focus on developing SOPs and subsequent documentation (monitoring, verifying, validating) to prove that each step in the SQF Code was being followed.

As we all know, if something is not written down, it "did not happen." This regulatory principle drives the "documentation mindset," which is easily accepted and understood by everyone in the organization, across all levels and functions. However, this ease of acceptance can be the very thing that drives a bias that gets in the way of changing behaviors. This is a mindset of, "if the documents are in place, then we must be doing the right things." Of course, this is not sufficient.

Another common mistake is to let the quality assurance (QA) department lead the SQF effort independently. This leads to a mindset of: Get it done, and report back when finished. As long as the company gets good scores, everything must be okay. If scores start falling and/or issues keep occurring, however, then who should be blamed?

The Need for Documentation

Documents for food safety must be thorough, accurate, and effective. They must reflect the reality of what is happening in the facility. Not having proof of a manufacturing step or a verification measurement can lead to a recall or regulatory action. Documents are essential; this article does not intend to suggest otherwise. Since everyone at the organization needs to embrace food safety, this also applies to documentation. SOPs are not only within the purview of the QA department. QA needs buy-in from everyone in the organization who plays a role in the operation or in the information being documented. Not gaining buy-in to something as straightforward as an SOP hugely correlates with making it impossible to drive any behavior changes.

TIP: Determine what behaviors you are trying to achieve, and then write the SOP to do so. Do not do it the other way around!

SQF and Regulatory Demands for Behavior Change

Even though the rules seem to state that food safety is all about documentation, in principle, all of the regulations and guidelines point to a requirement for behavior change. Some examples follow (emphases added):

• GFSI's 2018 position paper, "A Culture of Food Safety,"³ is based on food safety culture being defined as "the shared values, beliefs, and norms that affect mind-set and behavior..."
• 17 CFR 117.135: Good Manufacturing Practices (GMPs),⁴ as published in the Code of Federal Regulations, specify that preventive controls must be written and require an underlying systemic approach. For example, each of the mandatory preventive controls (e.g., process, food allergen, sanitation, etc.) includes the phrase, "…controls include procedures, practices, and processes..."
• In its September 2023 Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food,⁵ FDA defines preventive controls very broadly—e.g., "…procedures, practices, and processes." These three "P" words cover far more than just documents!
• The National Fisheries Institute's March 2019 Ready-To-Eat Seafood Pathogen Control Guidance Manual⁶ relates to preventing issues with seafood products. The manual states, "…the primary cause of contamination is Good Manufacturing Practices (GMPs)/sanitation…"
• For "management commitment," the SQF Food Safety Code for Manufacturing⁷ has a mandatory element that the company "continually improve the site's food safety management system." Note the use of the word "system"—not "documentation." Similarly, the Code requires that senior management ensures that "food safety practices… are adopted and maintained." Note the use of the word "practices" and the requirement for continuous improvement.

The Need for Behavior Change and Continuous Improvement

A basic tenet is that behavior must be changed in order to effect real change in food safety practices, control, and outcomes. This change requires the proper organizational mindset. Leaving potential change in the hands of only the QA organization will not work in the long run. Simply telling employees to follow changed SOPs will not work either. To borrow a concept from Dr. Carol Dweck,⁸ the organization needs to adopt a "growth mindset"—i.e., believing that the organization can improve, starting with senior management. As Dr. Dweck notes, the process includes more than just effort. She contrasts the "growth mindset" with a "fixed mindset" in terms of people and their parents, yet she espouses that these principles apply equally well to organizations.

As another analogy, consider the concepts of micro-optimization vs. macro-optimization. A given function (e.g., QA) can do everything in its power to excel at checking quality and ensuring that GMP behaviors are followed. Similarly, another function (e.g., sanitation) can, in parallel, also do everything possible to ensure that its workers are handling chemicals safely and following manufacturer recommendations for chemical contact times. Both are examples of micro-optimization—i.e., optimizing the inputs and outputs of single functions independent of other functions. But whose job is it to identify the highest-risk piece of equipment, and to ensure that it is cleaned and sanitized properly?

By contrast, the key leadership in a company is focusing on optimizing the inputs and outputs of the entire organization in order to meet stakeholder needs (e.g., profits, consumer complaints, service). Optimizing the "macro" may even come at the expense of the optimization of a "micro." In the context of continual improvement of food safety behaviors, this may mean that decreased food safety risk requires more time from production to execute certain line changeovers that minimize risk of allergen exposure. This runs counter to the typical production mindset (i.e., pounds per hour), but aligns perfectly with ensuring that the final product is safe.

TIP: Get the leaders from each function involved in food safety, not just the QA/food safety team!

Learnings from Companies Who "Get It"

Outlined below are some proven principles that were developed and used by food manufacturers who had significant, but different, SQF issues. Each manufacturer was able to turn things around with significant, but different, behavioral solutions.

One is a "rookie" organization that had never used a GFSI scheme before, and chose SQF. It hired an "SQF coordinator" to write all of the SOPs and then train everyone on them. The company failed its first gap audit miserably.

The second is a "veteran" organization that had been receiving good SQF scores across multiple plants, year over year. However, overall scores were not increasing, and some plants were even seeing their scores decreasing.

The third is a "veteran" organization that had received good SQF scores in the past, but in the past five years found itself with scores decreasing every year, which put it at risk of surveillance audits.

Each of these organizations turned around their SQF scores. In all cases, this took close to two years. Below are the principles that led to success:

1. Have patience. Changing employee behaviors takes time, and then it takes time for the results to manifest. This could take up to two annual audit cycles, even with all due urgency and attention.
2. Build cross-functional food safety teams. Food safety (and quality) improvements cannot be driven solely by the QA department. Trying to implement behavioral changes in functional silos might optimize the "micro," but will fail at optimizing the "macro." This is especially true if QA is not directly reporting to top leadership in the company and/or if QA is not forthcoming with a truthful representation of the actual state of affairs on the plant floor. The latter is insidious, as the leadership of the company could easily be fooled that food safety risks are minimal when they are seeing relatively "high" SQF scores. In this regard, there is a huge warning when scores are clearly decreasing year over year.
3. Build cross-functional corporate leadership. Similarly, although QA can and should lead the overall food safety team, other functional leaders of the organization (e.g., production, maintenance, purchasing) need to be actively involved. The best results were achieved in the examples above when the CEO/president held all of these leaders accountable for improved food safety results and when the CEO/president was personally involved.
4. Do not focus on the numerical scores. The real goal is to identify food safety risks and decrease them. The way to do this is by focusing on the behaviors that need to be in place. SOPs, documentation, execution, and results will follow, as will improved SQF scores. Please note that a couple-point difference in the score year over year, one way or the other, does not mean that the underlying systems and behaviors are any better or worse. Keeping a focus on risks and proper behaviors will let you sleep at night, knowing that scores will consistently be in the 90s no matter what. Look at the SQF score not as an endpoint, but as a metric in the overall food safety auditing process. It provides a snapshot of the organization's progress (or lack thereof) in improving its food safety culture and practices.
5. Maximize plant-to-plant consistencies. For companies with multiple plants, ensuring that all plants are putting food safety actions into place consistently is extremely important. If plants are allowed to develop their programs independently (which is a common belief, since each plant can be different in product mix, equipment, infrastructure, etc.), then by definition best practices are not being reapplied across the corporation. If each plant is allowed to operate its food safety system independently, then the plants might be optimizing the "micro" at the expense of optimizing the "macro." Solutions to this problem include forming a food safety team that includes appropriate members from every plant (no matter the size or product mix) and/or creating a corporate food safety team that services each plant with common SOPs and accountabilities.
6. Focus on continual improvement. The SQF Code⁷ demands a commitment from the organization to strive for continual improvement, as does the GFSI position paper² in its examples of increasing levels of maturity within an organization.

This is not easy work. It is easier to simply revert to generating and changing SOPs. However, changing behaviors one step at a time rather than getting overwhelmed by trying to change everything immediately will lead to success.

Figure 1 provides a visual representation that appropriate, risk-based SOPs are the basis for action in a plant. These are effective only if employees are properly trained (and retrained), and the training is effective only if the employees are documenting the right things at the right time, per the SOPs. If all of this happens effectively, then behaviors are improved and new habits are created. Processes and procedures succeed when behavior (and the resulting company culture) supports them.

Documentation of food safety processes and procedures is critical to minimizing regulatory risk. Equally important, if not more so, is aligning SOP development with the leadership necessary to change behaviors in the plant across all functions.

Driving improved behaviors into beneficial habits is tantamount to decreasing food safety risk. Lower risk means everyone sleeps better at night, including the ultimate consumer of the food.

References

1. SQFI Institute. "What is SQF?" 2024. https://www.sqfi.com/our-program/what-is-sqf.
2. Global Food Safety Initiative (GFSI). "Who We Are: Overview."https://mygfsi.com/who-we-are/overview/.
3. GFSI. "A Culture of Food Safety, A Position Paper from the Global Food Safety Initiative." November 4, 2018. https://mygfsi.com/wp-content/uploads/2019/09/GFSI-Food-Safety-Culture-Full.pdf.
4. Code of Federal Regulations. "Title 21, Chapter I, Subchapter B, Part 117.135, Subpart C: Preventive Controls." https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-C/section-117.135.
5. U.S. Food and Drug Administration (FDA). Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry. January 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food.
6. National Fisheries Institute. Ready-to-Eat Seafood Pathogen Control Manual. April 2018. https://aboutseafood.com/wp-content/uploads/2018/09/RTE-Manual-Second-edition-April-2018.pdf.
7. SQFI. "Section 2.1: Management Commitment." SQFI Food Safety Code. 9^th Ed. https://www.sqfi.com/the-sqf-code/choose-your-code/library-of-codes/code/food-manufacturing.
8. Dweck, C.S. Mindset: Changing the Way You Think to Fulfil Your Potential. Robinson Publishing, 2017.