Tag Archives: FSMA

Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
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Lance Roberie, D.L. Newslow

As a food safety plan manager, do you ever get asked these questions regarding your food safety plan: What was your thought process for making this decision? Why do you do it this way? How do you answer this?

And, do you ever answer with one of the following statements:

  • I’m not sure? What do you mean?
  • That’s the way it has always been.
  • Our customer asked us to do it that way.
  • That’s what our last auditor recommended.
  • We make a low-risk product.

If this is one of your answers, defending your food safety plan may be a challenge. There is a major shift taking place in the world of food safety. With the implementation of FSMA Preventive Controls, the widespread adoption of GFSI audits, along with advanced technologies such as rapid pathogen and allergen detection, whole genome sequencing, and transparency efforts such as Blockchain, as well as with the increasing use of social media and access of information via the internet, food industry professionals are more educated and informed than ever before and ready to challenge your every move. As a food safety plan manager, you and your team must be ready! Being prepared to defend your food safety plan can be the difference between a recall and a routine audit. If you cannot fully explain the reasoning behind your decision-making, then how will you be able to prove that you are in complete control and are being proactive against food safety hazards? It will not be easy.

You must be ready to defend each and every part of your food safety plan. You must be able to defend questions and challenges with certainty and facts. Every decision made in your hazard analysis should be written down and backed with factual evidence whenever possible. Even the “none identified” areas should be backed by strong reasoning if no other factual evidence is available. You can use the data that you collect daily to help justify your decisions. Data collected from your prerequisite programs (ATP swab results, allergen cleaning validations, GMP audit findings, pest control trends, etc.) and food safety plan (CCP’s, validations, verifications) is all support for your decisions. Have this on file and ready to review when necessary.

If something looks out of the ordinary in your plan, make sure you can fully explain it and can back it with solid justification. If not, auditors, regulators, customers, etc. may start to become suspicious, which can lead to unwanted questions. You will then oftentimes start to get suggestions for change based on others’ individual expertise. Regulators may make “strong suggestions” for changes, for instance, and some people will just go along with it to avoid the pushback or because they simply don’t have a better solution. If this happens, soon your plan is no longer yours—it’s everyone’s. Some of these suggestions may be good, but is it really the right change for your plan? If not, it will often make the plan less rational and often difficult to defend.

The following are tips to help you avoid this situation.

  1. Meet with your food safety team regularly. Go through each part of your food safety plan and figure out how to answer the “why’s”. Why are things done this way? Why did we decide if this hazard was significant or not? Have annual reviews to make sure your plan is still functioning as originally intended and review new industry trends to be proactive regarding new potential hazards.
  2. Write a process narrative. Writing a process narrative documenting what happens at each step of your process and explaining your “thought process” for making decisions is a great support tool. It gives your team a chance to elaborate on the “justification” column in the hazard analysis, providing more decision-making details without crowding the hazard analysis form.
  3. Gather supporting documents. Scientific studies, guidance documents, expert opinions, etc. are vital pieces to have in your supporting documents library. Make sure it is appropriate for your individual products and the documents are from reputable sources, such as FDA, USDA, universities, process authorities, etc. Oh, and don’t forget about history! A reputable supplier with a long track record of safe product, a low history of recalls for the products you produce, etc. can help justify your decision-making.
  4. Conduct Internal Audits. Having an internal audit schedule and well-trained internal auditors help with finding inconsistencies within your program and allow you to make corrections before outside parties find these issues.
  5. Prepare. Have a “mock audit” and prepare for questions that are commonly asked during audits. Practice your answers and make sure you have supporting evidence when needed. Stay up-to-date with industry trends, especially common audit non-conformances.
  6. Be organized. It’s great to have all the supporting documents that you need, but if you cannot find them, then you just as well have nothing.
  7. Be confident. People, especially experienced auditors and inspectors, can quickly sense fear and lack of confidence. This often prompts more questions. Knowledge is power, and knowledge also builds confidence. Simply put, the more knowledgeable you are about your food safety plan, the more confident you will be when someone is trying to test you.
  8. Continuously Improve. It’s understandable that mistakes will be made. However, the next logical question you will be asked is: What did you do about it? Remember, for every nonconformance you find in your system, there should be a correction or corrective and preventive action to address it. It must not simply restate the problem, but legitimately correct the issue. This will give regulators, auditors, customers and anyone else looking at your system confidence that you are in control and can provide a consistently safe product.
Adam Serfas, R.S. Quality
FST Soapbox

Color Coding Helps Brewers Button Up QA Procedures

By Adam Serfas
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Adam Serfas, R.S. Quality

The passage of FSMA sparked industry-wide tightening of food safety standards. Perhaps one industry that has been affected more than others is brewing. Prior to the passage of this sweeping legislation, brewers weren’t held to the same standards as other food manufacturers and food processors. The act’s new categorization for brewers as “food” means that the FDA now has some jurisdiction over the industry in conjunction with the Alcohol and Tobacco Tax and Trade Bureau (TTB).

This increased scrutiny, particularly in the event of a recall, has caused many brewers to look to color-coding as a measure to tighten up their quality assurance protocols. Fortunately for brewers, there are many benefits to incorporating color-coding, making the process a worthwhile one.

Happy Inspectors

Perhaps the most immediate effect of incorporating color-coding in a facility is delighting any inspectors that may drop in. A color-coding plan is a documented method for evaluating potential hazards and implementing precautionary measures to preventing contamination—all things inspectors want to see. Failure to live up to these standards can result in follow up inspections and, in some cases, fines.

Proper Tool Usage

A color-coding plan indicates where and when a tool is to be used. While mistakes can still be made, a clear plan that is reflected in all tools and paired with adequate signage and training makes it much more likely that a tool will be used properly. Much of the equipment in a brewery is very expensive and can be easily damaged by using the wrong tool. For example, if an abrasive brush were to be used on a stainless steel tank, there can be irreparable damage.

Higher-Quality Tools

Tools that are color-coded are generally made at a food-grade, FDA-approved quality. This means they are much less likely to leave behind bristles, a potential contaminant you wouldn’t want finding its way into the product. Additionally, many breweries make use of caustics and acids followed by sanitizers in the cleaning process. A low-quality tool will degrade at a much higher rate as a result of coming into contact with these chemicals than a higher quality tool will. Simply put, higher quality tools last longer, saving you money in the long run.

Less Tool Wandering

A color-coding plan should indicate where a tool is used and where it is stored when it is not being used. When tools have this designated storage area they are much less likely to be carelessly misplaced. And in the event of a lost tool, it becomes much easier to recognize these tool gaps and replace as necessary sooner rather than later to ensure that the proper tool is always used for the task at hand.

Higher Efficiency

When protocols are in place for tool usage, time isn’t wasted finding the correct tool for the job. This may seem insignificant, but over time those lost minutes can add up.

Removal of Language Barriers

For facilities that employ foreign speakers, color-coding is extremely helpful in breaking down language barriers. A brewery production area can be a busy, fast-paced environment, so it is helpful to have a plan in place that is easily recognizable and understood by all employees.

It is however important to consider the fact that you may need to keep in mind the visibility of these colors for colorblind employees. It’s best to try to use high contrast colors in your plan.

Greater Traceability

Finally, in the unfortunate event of a recall, a color-coding plan helps add traceability potentially decreasing the amount of product that needs to be pulled from shelves. Certainly color-coding helps to prevent contamination issues that can cause a recall.

A well thought out color-coding plan that is carefully implemented can have numerous benefits in breweries both small and large. For questions related to drafting a color-coding plan from scratch or updating an existing plan, contacting a color-coding specialist is recommended.

Question mark

FSMA: What Does ‘Qualified’ Mean?

By Maria Fontanazza
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Question mark

The term “qualified” appears a few different ways in the FSMA rules. In a Q&A with Food Safety Tech, Cathy Crawford, president of HACCP Consulting Group, was invited by DNV-GL to clear up some of the ways the term is used in the FSMA rules.

Food Safety Tech: Can you break down the difference what “qualified” means as it relates to a qualified individual, qualified auditor and qualified facility?

Cathy Crawford, HACCP Consulting Group
Cathy Crawford, president of HACCP Consulting Group

Cathy Crawford: Explaining the term happens all at once. I think it’s not clear in the preventive controls or sanitary transportation [FSMA] rules; they use the word in two different ways. “Qualified” sometimes means that you’re officially recognized as trained or suitable for something, but “qualified” can also mean modifications or limitations or exceptions. That’s why it is confusing, because it can seem like it has opposite meanings.

“Qualified” [means] trained or ready to do a certain job—that’s the most common meaning. The preventive controls rule talks about a qualified individual, as a person who has the training, education or combination of those needed to manufacture, process or hold food. That’s appropriate to their duties—meaning not everyone has to be qualified to do everything, but individuals have to be qualified when it comes to doing their job when it pertains to food safety.

The regulation goes on to say that it might be education and experience, but there is also some mandatory training. I think a lot of companies aren’t paying attention to this—that all qualified individuals have to be trained in food safety, hygiene and the specific duties of their job, and because that’s a regulatory requirement, they have to have documentation to support that they did this. The regulation also says that supervisors should have the education or experience necessary to supervise, so their training should demonstrate that it’s a little more in depth than what other qualified individuals would get.

Then there’s the PCQI, the preventive controls qualified individual. That’s someone with the education, experience or training to be able to perform specific functions that are called out in the preventive controls rule—meaning they can create a food safety plan, they can conduct or oversee verification, validation and corrective action, or they can reanalyze the food safety plan. The regulation specifically says the PCQI has to do those things. So that’s a different sort of qualified individual; it’s another step basically.

The other term is the qualified auditor. That definition starts with a qualified individual (QI) and elevates from QI to supervisor to PCQI and then to a qualified auditor. A qualified auditor is a QI who has the technical experience needed to conduct audits. That’s about as far as it goes in the regulation, except that they give examples such as that it could be a government employee or an agent of a certification body, but you have to take it in context. The regulation doesn’t say those are the only examples, so I think there’s some flexibility in those examples, and we have yet to see how FDA is going to implement the rule going forward.

When we talk about these qualified individuals, we mostly think about the preventive controls rule, but it also pops up in the sanitary transportation rule. In that rule, the term isn’t defined at all, so I suspect they would share the definition that’s in the preventive controls rule for a qualified individual. But under the sanitary transportation [rule], only the qualified individual can make decisions about what to do when there is an unusual circumstance in transportation such as an accident or a refrigeration unit that breaks down.

FST: Can a “qualified” person be company staff or is there an inclusion that someone can be brought in to take care of these duties, for example, on an outsourcing basis?

Crawford: That’s certainly an option. I haven’t experienced any companies that have chosen that option. I suspect maybe smaller companies or those that are members of a strong affiliation like a coop or trade association might reach out to get someone to play the role of PCQI. But it’s a very significant role, and there’s a certain level of responsibility and therefore liability associated with it, so I think it’s best that the person is a company employee.

I also highly recommend training. Although the two-and-a-half-day class on the preventive controls rule isn’t technically mandatory, it’s extraordinarily helpful.

At first when our company (as a consulting group) was teaching this course, many of the classes contained 50% or more of participants from FDA. It was interesting because industry and FDA were learning together. I think most companies are sending one or two people so they can get the information and share it when they come home.

FST: Discuss some of the confusion surrounding the term “qualified facilities”.

Crawford: This is where “qualified” has almost the opposite meaning. Here’s an analogy: There’s the concept of a lifeguard—you can be qualified to be a lifeguard like a person can be a qualified individual in a food facility, but you could also have a qualified lifeguard certificate, which means you’re limited and can only do lifeguarding when there’s no more than 25 people in the pool; versus someone who has more training and can do it anytime. It’s a limitation.

In the regulation, a facility is the qualified facility when it meets certain characteristics that don’t have to follow the entire rule, but can follow a smaller piece of it.

“Qualified” is based on size. If a facility is very small, with inventory less than $1 million in food assets and sales annually, then they are a qualified facility, so they don’t have to follow the entire preventive controls. They follow a modified version, which is primarily around having the GMPs in place but not necessarily having a food safety plan like the larger facilities must have.

FST: When a company is uncertain about their status, where can they go to get help?

Crawford: Many companies ask their own attorneys and FDA. The FDA has a website called the TAN (Technical Advisory Network) where companies or citizens can submit questions. It takes a bit of time but you will get an answer, and that’s a good way to go.

FST: With all the differences and nuances in these terms, what can companies do to better familiarize themselves with what these terms mean as they relate to FSMA so they can effectively execute required tasks?

Crawford: Number one: Either read the regulation on your own or attend the class that goes over the regulation like the two-and-a-half-day preventive controls course.
Second, companies need to document their training activities, because it’s required to demonstrate that someone is qualified. FDA has said they don’t intend to visit a facility and then document a 483 due to lack of a PCQI or a QI. That’s not the focus of their inspection—it’s an important part of the regulation, but they wouldn’t write a 483 just for missing training records. What they’re looking for is an effective system. If they visit and the system isn’t in place or it’s not documented, then they might back up and realize the reason it wasn’t done right is because they don’t have a QI or PCQI.

Finally, understand the terms, and make sure you have qualified people in place and that you can prove with records that they really are qualified.

FDA

FDA Issues Guidance on FSMA Enforcement Discretions

By Food Safety Tech Staff
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FDA

FDA will be exercising enforcement discretion for specific provisions in four FSMA rules, which means that the agency doesn’t expect to enforce the provisions as they apply to certain entities or activities. The agency made the announcement yesterday.

“In general, the FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance but is now exercising enforcement discretion.”

According to an FDA release, the enforcement discretion applies to provisions in: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety). The applications is as follows:

  • Facilities that would be farms except for certain factors and activities
  • Written assurances provisions in the four rules related to the control of identified hazards or microorganisms that could be a risk to public health
  • Animal food PC requirements for certain manufacturing/processing activities performed on human food by-products used as animal food
  • FSVP requirements for importers of food contact substances
Stephen Ostroff, FDA

FDA’s Ostroff Says Foodborne Illness Still Resistant to Change

By Maria Fontanazza
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Stephen Ostroff, FDA

“Everything changes; nothing remains without change.” It’s the Buddha quote that Stephen Ostroff, M.D., FDA deputy commissioner for food and veterinary medicine, used to kick off his plenary presentation at this year’s Food Safety Consortium. Yet “there is one thing that is stubbornly resistant to change,” he commented, and that’s foodborne illness. The incidence of culture-confirmed human infections hasn’t improved, and it can be seen in the number of cases reported through CDC’s FoodNet system. Why?

Stephen Ostroff, FDA
FDA’s Stephen Ostroff, M.D. answers audience questions during a town hall meeting at the 2017 Food Safety Consortium.

Ostroff has a few theories. First, there are much better diagnostics and surveillance systems in place versus 10 or 20 years ago. “Those improvements in finding the cases may be masking improvements that have occurred,” he said. Second, looking at the data from the big picture perspective may mask positive sub-trends. “We are actually doing better,” Ostroff said. “Within the data, there is some good news and some bad news.”

Ostroff also proposed that emerging food safety risks are having an impact on the rates of foodborne illness, including new trends that are altering the food landscape. The global food supply is more diverse than ever. In addition, the change in consumer preferences and eating patterns may lead to gravitation towards higher risk foods that are improperly handled. Other areas of risk include new methods of food delivery (i.e., e-commerce—Ostroff added that within a few years, up to 20% of our food will be delivered to our homes.). The final risk he touched on was new food types, such as synthetic foods (i.e., synthetic meat). “Nobody is quite familiar with the potential hazards associated with those foods,” he said.

FSMA Update

Over the past year, a new administration has come into place, along with a new FDA commissioner. In addition, compliance dates for six out of the seven foundational rules are now in effect (the compliance date for the Intentional Adulteration rule is July 2019). Although the new administration is focused on reducing the regulatory burden, it doesn’t appear to be impacting FSMA requirements. “To date we have no requests to change or delay FSMA requirements,” said Ostroff. “And that’s very good news.”

Third-party certification program. In June FDA launched a website through which organizations could apply to be recognized as an accredited body. Ostroff said the response and interest related to the program has been “overwhelming”, with hundred of entities visiting the agency’s website to learn more.

Voluntary Qualified Importer Program (VQIP). The agency anticipates that the application window will open January 2018 (however, Ostroff hinted that it may be delayed a bit). October 2018 is the projected start of the first benefit period.

FSMA Fixes. “There have been quirky issues that ended up in the FSMA regulations either because of the way FSMA was written by Congress or because of the way the regulations ended up,” said Ostroff, who added that the most problematic “quirk” is the intersection of whether an entity must comply with the Preventive Controls rule or the Produce Safety rule, and it all comes down to the farm definition. As a result, the agency extended compliance dates for a number of situations, one of which involves the agricultural water provision (January 2022 for large farms, January 2023 for small farms, and January 2024 for very small farms). Related to this provision, FDA is looking to reducing the regulatory burden but will keep standards in the lab analytic methods, frequency of testing and determination of water quality.

Training. The FDA has been partnering with many entities around the world to implement FSMA training both for industry and regulators. More than 50,000 people have been trained for the Preventive Controls for Human Food rule and more than 5000 have been trained for the animal food rule.

Inspection. At last year’s Food Safety Consortium, there was a lot of chatter about agency enforcement and inspection. Although Ostroff didn’t touch on enforcement, he provided a few figures on inspection activity for fiscal year 2017:

  • Preventive Controls for Human Food
    • Modernized CGMPs: 720
  • Preventive controls: 165 (46 outside of the United States)
  • Preventive Controls for Animal Food
    • CGMPs: 220
  • Foreign Supplier Verification Program: 285
  • Produce safety rule: 8 (sprouts)
3M Food Safety

From Culture To Compliance: The Link Between Food Safety Culture & Audit Preparedness

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3M Food Safety

On Tuesday, December 5th, 3M Food Safety and Neumann Risk Services will host the final part of a 4-part webinar series on the Food Safety Modernization Act (FSMA). A special panel discussion of food safety experts will provide insight into how a robust food safety culture can positively impact audit preparedness and signal a culture of compliance.

Attendees will learn what a strong food safety culture looks like and how it can help comply with FSMA and the Safe Quality Food (SQF) Code. The free webinar will be recorded at the 2017 SQF International Conference in Dallas on November 9. It will conclude with a live Q&A for attendees and be offered on-demand to webinar registrants.

The first three webinars are currently available for on-demand listening at the 3M Health Care Academy, and each presents the opportunity to learn about the challenges companies are facing in operationalizing FSMA rules. The webinars offer real-world insight into how companies streamline implementation and execution of food safety plans, supply chain programs and other FSMA-driven programs.

Melanie Neumann, Neumann Risk Services
Melanie Neumann Neumann Risk Services, LLC

Melanie Neumann, president, Neumann Risk Services, a Matrix Sciences Company, will be moderating the panel discussion. Panelists will include:

  • Bill McBride, principal and managing director of Foodlink Management Services and SQFI Asia Pacific representative
  • Dr. Lone Jespersen, principal and founder, Cultivate
  • Dr. Martin Wiedmann, Gellert Family professor in food safety, Cornell University
  • Dr. Jay Ellingson, corporate director of food safety and quality assurance, Kwik Trip, Inc.

The webinar will take place on Tuesday, December 5 at 1:00 p.m. Central Standard Time. To sign up for the webinar, click here.

Randy Fields, Repositrak
FST Soapbox

Technology’s Role In The Future Of Food Safety

By Randy Fields
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Randy Fields, Repositrak

As we have all read in the media, when a food safety emergency occurs, a company’s reputation stands to take a significant hit that may be unrecoverable. This phenomenon isn’t going away soon, nor are compliance requirements that pose a threat to the personal freedom of executives. If these aren’t enough reasons to get busy automating your food safety programs, read on.

Learn more about the future of food safety and technology at this year’s Food Safety Consortium, November 12–16 in Schaumburg, IL

The trends toward social and health-related product claims, like organic, the ‘free-froms’ and locally-grown, have had the impact of adding dozens if not hundreds of new suppliers to a retailer’s procurement list. And, it’s important to note, that these generally smaller suppliers are just now approaching their compliance deadlines for FSMA, and if they are very small, still have another year. New trends appear every year, and they will compound the challenge for retailers and wholesalers of knowing exactly who all of their suppliers are, which in turn will worsen compliance issues.

Our studies show that at least 12% of documents that certify organic, ‘free-froms’ and other product label claims have some level of discrepancy or inaccuracy making them invalid, and rendering the systems that rely on vendor self-disclosure near useless. With sales expected to skyrocket within these categories during the next few years, companies need to leverage technology to protect the supply chain, and consider having the system hold purchase orders generated for vendors who are not compliant with requirements.

An alternative is to have the system add a compliance fee to the purchase order that escalates over time or swiftly replace suppliers if they are not willing or not able to comply. That also speeds compliance as news travels quickly if there is a hard-hitting consequence for non-compliance. Either way, it’s important to be able to substantiate any claims to the consumer, since if those assertions are deemed unreliable, retailers and their suppliers risk a breach in consumer confidence and will suffer economically when shoppers turn away from them at the shelf.

And while retailers and wholesalers have begun to turn the Titanic on regulatory and business compliance, they need to continue to diligently find the risks in their supply chain, working even more aggressively to automate their current food safety and quality programs using new technology and procedures. Otherwise, their reputation and their existence are in jeopardy.

Cloud-based compliance management solutions that help retailers, wholesalers and suppliers meet the new food safety requirements can be configured to manage documentation requirements by supplier type vs. requiring the same documents from all suppliers. These systems also go beyond just storing digital copies of documents, and actually manage any form of compliance by reading inside the document to confirm it meets requirements. The benefits of these compliance management tools extend to streamlining new vendor approvals, which can save time and enable the redeployment of resources to more productive business-building activities.

Make no mistake: business and regulatory compliance will continue to be a focal point in the future. This includes addressing potential safety, certification and quality challenges throughout the extended supply chain as nearly one-third of all recalls are due to ingredient suppliers. We believe that in less than three years, retailers will require supply chain visibility from the shelf all the way back to “dirt”. It’s been proven too risky not to have that kind of visibility for ultimately everyone’s customer – the consumer. And now technology companies are on the hook to deliver it.

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

FSMA Checklist: Intentional Adulteration Rule

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

The FSMA Intentional Adulteration rule is focused on preventing intentional adulteration from acts intended to cause wide-scale food safety impacts to public health, including acts of terrorism, economic adulteration and disgruntled employees. Such acts, while unlikely, could cause illness, death and economic disruption of the food supply absent mitigation strategies. This rule requires mitigation strategies to reduce risk versus specific food hazards.

How much do you know about the Intentional Adulteration Rule? Test your smarts by taking the FSMA IQ Test here The Intentional Adulteration rule is established to address large companies with products that reach many people, while exempting smaller companies. This rule requires covered facilities to conduct a “vulnerability assessment” to identify vulnerabilities and actions to take for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these vulnerabilities must be identified and evaluated. Covered facilities must also prepare and implement a Food Defense Plan. This written plan must identify the vulnerabilities and actionable process steps; mitigation strategies; and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA Intentional Adulteration requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA, Intentional Adulteration
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Intentional Adulteration program for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Intentional Adulteration requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their program. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Brendan McCahill

Four Ways Technology Can Ease The Burden Of New FSVP Compliance Regulations

By Brendan McCahill
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Brendan McCahill

What if it was possible for importers, or the customs broker that imports food into the U.S. on behalf of shippers, to stop salmonella-tainted food before it arrives in the hands of a consumer? While there are assorted systems in place to prevent contamination, often times, grocery stores and other businesses are unable to track the supply chain of foreign food importers, leaving customers blind to the origin of a product.

Descartes FSVP InfographicThe U.S. Food & Drug Administration (FDA) is working to address this issue with the Foreign Supplier Verification Program (FSVP). The new program makes importers responsible for better tracking hazards, identifying their suppliers and ensuring that their food is compliant with processes that meet the FDA’s standards for preventive controls and safety.

On the surface, this visibility seems like a great benefit to both consumers and businesses. But what will it mean for importers as they try and keep up with reporting requests and new regulations?

To prepare businesses for the continuing list of FSVP regulations that must be implemented by 2019, here are four ways in which technology will ease the burden and make the food industry’s supply chain even stronger.

1. Gain a holistic view of the supply chain

For navigating FSVP specifically, technology provides food importers with an efficient way to identify and better trace a supplier network, as well as and a quick and easy way to locate D&B D-U-N-S® Numbers*. For importer self-filers and customs brokers, similar solutions enable them to streamline techniques to transmit data to U.S. Customs & Border Protection (CBP) in the Automated Commercial Environment (ACE) as their goods move across borders, as well as to store details, such as D&B D-U-N-S Numbers, Harmonized System (HS) codes and more.

Ultimately, food importers and customs brokers that enlist the expertise of one technology provider can better prepare for FSVP compliance. While piecing together a technology solution using multiple logistics technology providers may work in the short term, a forward-looking, compliance-centric approach that aligns with future regulations must be adopted – one that gives a holistic view of the supply chain via one service provider.

2. Identify and better trace the supplier network

Supplier verification is an additional area of FSVP whereby suppliers must undergo periodic review and approval, and must be identified in order to perform an effective supplier hazard analysis and evaluation. Accurately identifying suppliers is a highly complex task due to intricate supply chains, compound food formulations and the number of SKUs in a product line. Plus, a supplier ecosystem evolves over time for many reasons, such as changing cost and consumer demand. Simply put, managing a complex supplier network can be a drain on resources and costly. Luckily, technology can help.

Logistics solutions that feature periodic updates that adapt to changing supply chains can help food importers better target suppliers to ensure regulations are followed. It can also help focus on suppliers with higher shipment volumes to optimize data management and prioritize compliance responsibilities.

In the event a food code is subject to FSVP, customs brokers are required to input the importers’ name, mailing address, email address and D-U-N-S Number. Because the FDA’s consumer protection function is dependent on the entry process, brokers are aware of the added scrutiny shipments subjected to FSVP-related information will be under, especially if any of the above information is noted as Unknown (UKN). Logistics technology can help automate this process and ease custom entries, booking, security filings and more.

3. Streamline techniques to transmit important data

Transmitting data to the CBP as goods move across borders can be challenging in its own right. Basic customs issues include import/entry process, tariff classification, valuation and duty assessment.

Innovative technology solutions can help businesses go beyond the bare minimum to improve the speed and accuracy of submitting entry and Partner Government Agency (PGA) data to CBP. Users can receive and react to responses and customs status messages by exception. Proactive alert functionality can notify users of actionable items including rejections, intensive exams, requests for electronic invoices, Temporary Importation Bonds (TIB) expiration notices and more. On-demand solutions also enable brokers and forwarders the ability to run complex international operations more efficiently.

4. Dedicate D&B D-U-N-S numbers for imported food product

The D&B D-U-N-S Number was selected by the FDA as the recording system to identify importers by a common reference system. The FSVP regulation indicates that a D-U-N-S Number must be provided by an importer for each line entry of food product imported into the U.S.

Today’s complex food industry means importers often work with an extensive ecosystem of subsidiaries, affiliates and Doing Business As (DBA) divisions. To comply with FSVP, technology can help quickly locate the D&B unique identifier for each member of the network, and streamline the complicated process of managing each line entry of food product offered for importation into the U.S.

A tech-driven pathway forward

There is no doubt that the new FSVP regulation is complex. U.S. food importers are now responsible for ensuring compliance in an effort to improve the safety of food entering the U.S. This will require food importers to fully understand the regulation on a practical level and react accordingly, using technology to its fullest.

Leading businesses should consider the FSVP regulation as an opportunity to look forward and prepare. With the right logistics technology and processes in place, organizations can improve their readiness to enable compliance, improve data management and execute a holistic regulatory strategy to meet the new stringent requirements.

* D&B D-U-N-S Numbers are proprietary to D&B, are licensed from D&B and are for internal use only. 
D-U-N-S is a registered trademark of D&B.

Accreditation

Why Accredited Services Increase Business Opportunities And Contribute To The Harmonization Of Regulations

By Natalia Larrimer, Jacqueline Southee, Ph.D.
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Accreditation

Accreditation is an internationally accepted independent oversight process for maintaining operational standards and ensuring confidence. It is accepted by many governments and private industries, including at various levels of the global food supply.

Recognized within the food industry and endorsed by the Global Food Safety Initiative (GFSI), the process of accredited certification has become essential for business.

In the United States, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), in its rule on accredited third-party certification, incorporates the accreditation process for oversight over third-party certification bodies certifying foreign food facilities manufacturing for import into the United States.

With accredited services increasingly becoming an integral part of business operations, many wonder how the processes of accreditation and certification work.

Accreditation is the process of ensuring that an organization has the necessary technical competence to perform a specific task, and has met and continues to meet a specific set of operational requirements. An accreditation body (AB) uses internationally established techniques and procedures to assess conformity assessment bodies (CABs) against recognized standards to ensure their impartiality, competence, and ability to produce consistently reliable, technically sound and impartial results.

Accreditation provides formal recognition that an organization is competent to carry out specific tasks, and provides an independent assessment of conformity assessment bodies (CABs)1 against recognized standards to ensure their impartiality and competence. Accreditation provides assurance to a CAB’s customers and industry that the CAB continuously operates according to internationally accepted criteria applicable to CAB’s scope of accreditation.

Although there is flexibility for an AB to design its accreditation process within the constraints of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the standard to which all internationally recognized ABs must conform, some aspects are mandatory.

As part of the application process, the applicant for accreditation submits information about the desired scope of accreditation and its documented quality management system. The AB conducts a document review to verify that the applicant has documented all management system requirements specified in the relevant criteria and any other applicable requirements. Additional requirements could include, for example, those mandated by a specific regulatory authority or industry. During the assessment, through witnessing of the CAB conducting a conformity assessment activity, interviews of personnel, and review of records and other objective evidence, the AB’s assessment team verifies the CAB’s technical competence and implementation of the quality management system.

The applicant is required to provide corrective action for all identified deficiencies. Only after all identified issues have been addressed can the accreditation decision process begin. To ensure that the accreditation decision is impartial, members of the assessment team do not take part in the decision. The designated decision maker, which may be a group or an individual, is responsible for reviewing the assessment team’s recommendation and ensuring that all accreditation requirements have been met by the applicant and are properly documented before granting accreditation.

A certificate and scope of accreditation are issued only after a favorable accreditation decision.

Once accredited, the CAB is regularly re-assessed to ensure continued conformance to the accreditation requirements, and to confirm that the required standard of operation is being maintained.

To ensure transparency, the AB is required to make publicly available information on the status and scope of accreditation for each accredited CAB. Any changes occurring after initial accreditation, such as suspension for all or part of the scope of accreditation, are published on the AB’s website.

It is important to note while ABs provide oversight over CABs, internationally recognized ABs are themselves subject to regular oversight from organizations orchestrating the harmonization and recognition of the accreditation process internationally.

The International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) provide this international oversight. ABs that are signatories of the ILAC and/or IAF mutual recognition agreements (MLAs or MRAs) must conform with the requirements of ISO/IEC 17011 as applicable program-specific requirements, and are admitted to the agreements for a specific capability, for example, as an accreditor for testing labs or for management systems certification bodies. Technical competence of the AB and conformance to the requirements is verified through rigorous on site evaluation by other member of the IAF or ILAC community.

Without international oversight, there would be no evidence or confirmation that an AB operates in accordance with international requirements when providing oversight of accredited CABs. This oversight provides assurance that the AB understands the CAB’s process and can attest to the CAB’s competence.

The IAF, MLA and ILAC agreements are internationally recognized forms of approval; signatories have demonstrated their compliance with specified standards and requirements. Accreditation by a signatory of the ILAC MRA and/or IAF MLA provides assurance that decisions are based on reliable results, thus minimizing risk.

This is of particular importance in the constantly evolving global food-supply network. Many specifiers, such as regulatory authorities, have acknowledged the importance of credible accreditation programs.

A number of government agencies in the United States and around the world, including the U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA) and the Canadian Food Inspection Agency (CFIA), have mandated accreditation by an internationally recognized accrediting body for their programs.

Accreditation within the MLA/MRA process helps regulators meet their legislative responsibilities by providing assurance that testing, inspection and evaluation results are issued by organizations whose technical competence and compliance with specified criteria has been verified by an independent third party. It provides assurance to stakeholders, such as the regulatory authorities, that the accredited CAB operates in accordance with recognized and accepted criteria.

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