Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
1 Comment
Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Dana Johnson Downing, TraceGains
FST Soapbox

Dispelling the Myth that Food Safety is Not a Competitive Advantage

By Dana Johnson Downing
7 Comments
Dana Johnson Downing, TraceGains

“Food safety is not a competitive advantage” is one of the barf-worthy “feel good” messages you hear from food industry executives during speeches and public forums. Last week at the Global Food Safety Initiative (GFSI) conference in Houston, an audience of more than 1,150 from 54 countries heard this tired mantra repeated during a panel discussion featuring CEOs from Mondelez, Cargill, Tysons and Wegmans. The common theme espoused by the CEOs was that food safety is a given and it’s just the right thing to do. Under their flawed rationale, because food safety is mandated, it cannot be a differentiator. Huh? That’s like saying monogamy in marriage is a given. Sure, most brides and grooms pledge faithfulness, but hey, we all know cheaters gonna cheat.

I wasn’t the only one who didn’t buy the food safety kumbaya message the CEOs were peddling. BBC business journalist Adam Shaw was the moderator for the panel and he grilled the CEOs to try to expose the fallacy that food safety is not a competitive advantage as nothing more than high-mindedness with altruistic notions, but the CEOs deflected his pointed questions and stayed on-message. I thought the song from the Lego movie, “Everything is Awesome” might start blaring from the sound system at any moment. What I cannot discern is if the CEOs really believe that food safety is not a competitive advantage, or do they feel compelled to say it to bolster confidence in the food supply.

I think we can all agree that consumers expect their products to be safe. Objectively, I think we must also agree that there are some companies in the food industry that simply do a better job of managing risk in their food safety system. As Warren Buffet once said, “Risk comes from not knowing what you’re doing.” Have you ever read the warning letters issues by the FDA? There are plenty of food operators who either do not know what they are doing or their profits are more important to them than the safety of the products they produce.

Perhaps the real reason these CEOs say food safety is not a competitive advantage is because they are trying to trick us with some twisted reverse psychology technique. More likely they avoid positioning their company as having an extraordinary food safety system because you can never eliminate all risk, and a recall or foodborne illness outbreak could be lurking just around the corner. That logic is a little lost on me, but okay.

What about food safety as a competitive advantage in the business-to-business (B2B) environment? With all the transactions between ingredient suppliers, brokers, distributors, co-packers and manufacturers, there is often friction between vendor and customer over food safety standards and the underlying documentation. Who you do business with matters more than ever before, especially now that there is greater supply chain transparency and process control mandated by FSMA. According to Brian Perry, senior vice president, food safety & quality at TreeHouse Foods, he has had to drop suppliers who are not FSMA-compliant because they pose too much risk. Meanwhile, companies are willing to pay a premium for suppliers who have their food safety documentation in order and routinely deliver on time and within specifications. So at least in the B2B marketplace, we can see that food safety can definitely provide a competitive advantage.

Pesky undeclared allergens and foreign material find a way to sneak into food production. Unsanitary conditions are sometimes permitted and product is adulterated. Mistakes are made, stuff happens, and sometimes food makes people and animals sick or even leads to death. So please don’t tell me that food safety is a given! If you want consumers to have confidence in our food supply, then tell them what your company does to try to prevent stuff from happening. Consumers’ appetite for information and knowledge about the food they consume is at an all time high. If consumers care about GMOs or how ethically-raised, humanely-treated, or sustainably-produced their food is, isn’t it logical to think they care about how companies develop a culture of food safety, the technology they use, and how strictly they monitor their suppliers? In order to make food safety a competitive advantage, food companies need to show supply chain partners and consumers that transparency isn’t just a buzzword. They need to show how they are operationalizing transparency to elevate food safety as a corporate imperative. Share your food safety story and respect your consumers enough to make up their own minds about whether your food safety system sets your brand apart.

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
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Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

Erika Miller
FST Soapbox

Employee Buy-in to Ensure FSMA Compliance

By Erika Miller
1 Comment
Erika Miller

Getting employees on board can be one of the most difficult parts of any major change within a company. When things are operating just fine from the perspective of the employee, the cries of, “but we’ve always done it this way!” can be deafening. As a manager, it is our job to explain the new requirements in a way that encourages buy-in from employees at all levels of the organization, and to always present a united front with the company, even if we do not fully understand why a change is important. It is almost a guarantee a business would not spend money implementing a major change if there was not an impetus behind it. One crack in the façade can lead to an entire shift becoming demoralized and disheartened.

Compliance with FSMA is no exception. Although the aim of the act is to reduce food safety risks to the population of the United States, the added paperwork and regulatory requirements can seem onerous to the employees responsible for doing the work. I would encourage any managers who are experiencing some feelings of “why me?” to search YouTube for the videos made by families touched by major foodborne illness outbreaks. The pregnant mothers whose babies are infected with Listeria from deli meat sandwiches are particularly heartbreaking for those who have children.

Once a manager has convinced him or herself of the importance of compliance with the new food safety regulations, it’s time to get your employees on board as well. If you can, show them the same videos you saw to encourage their buy-in. Listeria is a danger in any plant handling a ready-to-eat product or one that could be improperly cooked by the end user. Remember, cooking instructions do not absolve the manufacturer of the responsibility to produce food free of hazards! With the internet, impactful videos are only a click away. Just remember to always fully vet the video before attempting an at-work viewing party—lots of people on the internet have senses of humor that may not translate well to the workplace.

Making the issue personal also works well. This is a great way to get the message home about allergens. In any group of associates, chances are good that at least one of them will have a close friend or family member who is affected by a food allergy. Ask people to raise their hands if they know anyone who is allergic to food. Ask them what that person must do to protect themselves. Frequently, the answer is that the allergic consumer can only read the label. This is a great teaching tool for the importance of proper labeling and can be used as a lead-in to the introduction of a new Allergen Preventive Control, if one is required. Ask the employees to visualize the people they know with food allergies when completing the required records, or performing the onerous tasks, and imagine themselves as the last line of defense.

Many companies employ the services of temporary agencies. These companies can offer a great solution for a company that is concerned about the exposure to litigation that can occur through employee separation. Some industries have high levels of turnover or seasonal operations, which can prove difficult to manage for busy HR departments. Turnover can lead to a loss of accountability as well, such as when an employee informs you that their training was deficient (leading to a major snafu). If their predecessor was not in the position long enough and the chain of training was broken, it can take a substantial investment of time and energy from a senior individual to train that relatively low-paid position back to base minimum level. Outsourcing some of the work to a temporary agency can seem like a godsend at first. They find them, they train them, and all the hiring company must do is eliminate downtime. Who wouldn’t?

However, over time, many companies find the time and money they saved at the outset comes back around to bite them in the end. Temp agencies often do not keep good records, and if you are relying on them to deliver crucial introductory food safety training before they send candidates to you to begin, you may end up in a bind when your auditor or FDA investigator asks to see your training records. The obvious solution is to bring all training back in-house, but that can partly defeat the purpose of having the temp agency in the first place.

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Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Telling the Story of Foodborne Illness

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

If you are looking for someone who has been ill or has had family members who were ill or died from a foodborne illness to come and speak at your food safety training, give Stanley Rutledge or myself a call, or send us an email. Individuals want to tell their stories, they want to make a difference, and they want to have an impact.   The stories are powerful and their stories are “the why” behind food safety. People who have attended the trainings tell us they never forget the people they meet and the stories told—they think about them everyday in their work and especially when making decisions that impact food and public safety.

Tauxe, STOP Foodborne Illness
Deirdre Schlunegger of STOP Foodborne Illness presents the Advancing Science for Food Safety Award to Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases.

In the fall, I was on a phone call with a man from Smithfield Foods. We, along with a few others from the company, were planning an upcoming training and speaking engagement. He said that he would never forget listening to Nancy Donley talk about her son, Alex. Dr. Robert Tauxe told me a similar story about hearing Nancy in a public forum talk about her son. Rylee Gustafson, recently through STOP Foodborne Illness, spoke at The Partnership for Food Safety Education and told her story. Now a college student, she spoke about the long-term impacts of her illness—the diabetes, the damaged pancreas, the voice and vision problems, and the high blood pressure. The room was silent and so many people came up to her afterwards to thank her for sharing.

These stories illustrate that this is real: It does happen and when the person who was involved is standing before you reliving their story, you Will remember! Of course, we have fact sheets and a lot of other information on our website for your use, but there is nothing that is more direct, thought provoking and memorable than listening. If you want to read some of the stories, visit our website.  You can contact Stanley at srutledge@stopfoodborneillness.org or me at dschlunegger@stopfoodborneillness.org

Thanks for all that you do for food safety!

Bryan Armentrout, Food Leadership Group

Audits: The Opening Meeting

By Bryan Armentrout
2 Comments
Bryan Armentrout, Food Leadership Group

Read Part I: What Do Food Facility Auditors Really Want?When I train my QA managers on how to start an audit, I teach them to always say something to this effect: “Thank you, Mr. Auditor for coming here today. We are proud of the work we have done on our quality system and are happy to show you our hard work. To be clear, we are using SQF Version 7.2 Level 2 as our standard for this audit. If you have any suggestions for improvement outside of that expectation, we would love to hear them. Sound fair?”

Who would not agree to that? It establishes the rules of the game and if the auditor steps out of bounds, it sets up an expected course of action on your part.

So, during the audit, if the auditor does step outside of the standard (and they usually do at some point), you can return easily and without confrontation to the scope of the audit.

If this happens, you can respond like this: “I hear what you are saying, Mr. Auditor. That is very interesting, but I am confused. I know the standard and the section you are referencing, but I cannot find where it addresses your requirement. Where in the standard do I find your point?”

If he cannot find it, it is a suggestion for your program to improve and not something that can be written up as a deviation. Tell him that you will consider it and that you appreciate the advice.

If the auditor still wants to include this in the audit as a deviation, you don’t have to accept that.

Don’t wait if this happens. Immediately call your contact at the audit company headquarters. Sit down with the auditor on speakerphone. Explain what you are discussing and have both sides state their case. Ask for clarification on what the auditor is proposing.

This is not confrontational; you are simply getting clarification from the authority. If is it is in the standard, you learned something. If not, the auditor did. You both win.

As a bonus, the auditor will think twice before writing up the next out of scope deviation. He knows what you do.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

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Elise Forward, Forward Food Solutions
FST Soapbox

Take Food Defense Concepts Beyond Your Four Walls

By Elise Forward
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Elise Forward, Forward Food Solutions

The new food defense regulations have caused quite a stir in the food industry and have left many scratching their heads. Many companies are worried about how to implement these programs. The regulations have created a format and structure in which many companies can adapt within their existing food defense programs to comply with the new law. Still, one of the biggest challenges of food defense is merely the idea of developing the food defense plan and coming into compliance with the FDA’s new Food Defense rule. The FDA received many comments from industry in response to the draft guidance. Many of these comments asked the agency for additional time to come into compliance, and the FDA responded by delaying the compliance dates well beyond what was proposed in the draft rules.

According to the regulations, companies are required to implement a food defense plan that focuses on the vulnerabilities in their facility. If you follow the FDA’s template, a food defense plan will look very similar to the traditional HACCP plan. The term, VACCP, Vulnerability Analysis Critical Control Points, is a term that is being tossed around as of late. The FDA wants companies to make sure that they consider an internal attacker, one that has inside access to the buildings, processes and products that are being produced. For many companies, this is stretching them beyond their current paradigms and may force some to implement new procedures. In reality, this paradigm shift is not insurmountable when the items to be controlled are within the four walls of their facility. Even subcontractors, such as pest control providers, maintenance subcontractors, auditors, etc., can be included in these programs. However, is this enough to ensure the safety of the product you are selling, the one you are putting your name on, and the one you are personally standing behind?

The goal of current risk-based thinking is to find the weakest link in the process, evaluate the risk and likelihood of a threat to food safety, and respond appropriately to control the risk. Unlike the Preventive Controls rule and the FSVP rule, the Food Defense rule focuses on the processes occurring in a facility and does not take into account the processes involved in the supply chain.  CargoNet Command Center found that there were 1500 security breaches in the transportation industry in the United States and Canada in 2015. The data was categorized by types of product and the highest percentage of any group of products was the food and beverage products which comprised 28% of the cargo thefts.  On average, that is greater than one food or beverage cargo theft per day. CargoNet Command Center provides a nice map on their website showing the location of these instances and I encourage you to review this map.  If your product passes along the hot spots of cargo theft, as well as having risk factors such as being valuable or in limited supply, it would be very beneficial to build systems and programs in place to address these additional risks to your product.

In another study presented at the Food Defense conference, there was a statistically significant link between breaches in IT systems to a follow-up cargo theft. Many quality and food safety professionals, much less executives, fully understand the interdependence of all business units on food safety. Many companies have problems with siloed departments, and unfortunately, this increases the vulnerabilities to attacks on the food we are trying to protect. This is a great example of how food safety is everyone’s job, and having this mentality is key to the success of food safety programs.

Of course, the requirement to the Food Defense rule must be addressed, but I challenge the industry to look beyond the walls of our facilities and instead, take a whole business approach and apply the principals of food defense to all inputs of the process that impacts the finished product. As food safety professionals, we need to work with our suppliers and our customers to ensure that the whole supply chain is protected from an attack.

Resources

Bryan Armentrout, Food Leadership Group

What Do Food Facility Auditors Really Want?

By Bryan Armentrout
4 Comments
Bryan Armentrout, Food Leadership Group

Third-party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does This Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the QA manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”

So much stress and so much pressure just to get a “good score”. Corporate wants to know what happened before the auditor even leaves the plant. Performance evaluations, raises, year-end bonuses and sometimes even jobs are at risk. It’s no wonder people worry about audits so much.

What if I told you it doesn’t have to be that stressful? It doesn’t if you implement some of the things I have learned over the years.

What Is an Audit?

I informally define an audit as verification that things are being performed to established rules. Those rules can be a customer contract, an audit scheme such as SQF or government regulatory standards. For this article, we are going to talk specifically about independent third-party audits.

Who Is an Auditor?

An auditor is a person.

It’s easy to forget sometimes. They are people with their own story, training and experience. They may be a retired QA director from a major food company with decades of experience. They may be a former plant QA manager in the automotive industry with no food experience. This may be their first audit. They have a story and that will influence your audit.

Few people know that you can choose who audits you. Make sure the person who is coming in to evaluate your plant has the right experience and temperament to work with you. Ask the audit company to provide you with three to five resumes of auditors that they would like to send to your facility. Arrange for interviews with them and choose the one that fits best. You are looking for the right mix of experience and temperament. You don’t have to take who they want to send.

What Is an Audit About?

An audit is an answer to a series of specific questions and how you meet them. This is key to how you should approach an audit. The PDCA model is an ideal way to remember this point (see Figure 1).

PDCA Model
Figure 1. PDCA Model
  • Plan: What are the rules of the game?
  • Do: What is your procedure?
  • Check: What proof do you have that it was done?
  • Act: What happens if it is not correct?

Let’s address these one at a time.

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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

GFSI in 2017: The Year of FSMA Compliance

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.

At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.

GFSI Conformance

The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.

GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.

With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.

As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.

FSMA Compliance

During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.

By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.

The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.

This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.

Bringing GFSI and FSMA Together

The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.

As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).

In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.

Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.

As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.

Global Food Safety Conference

The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:

  • Food safety management commitment and corporate governance
  • Required training of food safety roles, including management, staff and operations
  • Specific requirements of the documented food safety program or written programs under FSMA
  • FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
  • Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
  • The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
  • How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
  • Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
  • Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
  • Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration

Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.