Tag Archives: GFSI

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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Patricia Wester, PA Wester Consulting

Q&A On FSMA Audits: A Conversation With AFSAP CEO Patricia Wester

By Food Safety Tech Staff
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Patricia Wester, PA Wester Consulting

As a trade association for auditors and the auditing industry, AFSAP has researched the various references to audits found in all of the FSMA rules, and monitored the steps taken across the auditing community to meet these requirements. In this Q&A, we sit down with Patricia Wester, chief executive officer of AFSAP, to talk FSMA audits, criteria for supplier audits, preventive controls and FDA guidance. She will be running the Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at this year’s Food Safety Consortium.

Background on the AFSAP and FSC Alliance

In July 2016, GFSI announced they would re-open the Guidance document revision process so that FSMA’s requirements could be considered for inclusion. When the final GFSI Guidance document was released, it included most of FSMA’s requirements. At this point, the Schemes still had to accommodate these changes, which were then provided to the CB’s. Depending on the Scheme, a CB also had to consider including content to address any FSMA related gaps. In the end, these audits could take more than a year to reach the market, and depending on the individual site’s renewal period, it could be many more months before a supplier was actually audited.

Patricia Wester moderated the Plenary Panel “What’s Next for Audits”
and running the
Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at the
2017 Food Safety Consortium November 29 – December 1, 2017 in Schaumburg, IL.

Recognizing the need to inform the market, the inaugural Plenary Panel on Auditing, moderated by AFSAP’s Patricia Wester was presented at the 2016 Food Safety Consortium meeting. Dr. Ostroff opened the discussion to share FDA’s perspective on the use of audits for FSMA. His remarks were followed by representatives from GFSI, Schemes and CB’s as each described their role and recent activities to meet the new regulatory requirements, and provide insight into the timelines involved.

Dr. Ostroff has agreed to join us again for the 2017 meeting, and will participate in the Plenary Panel “What’s Next for Audits” as Industry, Retailers and the auditing community prepares for the accredited certification audits necessary for VQIP.

FoodSafetyTech: How are audits used in FSMA?

Patricia Wester: In the Third Party Audit rule, FDA outlines an accredited certification program for imported food that applies in 2 specific situations. The first applies to any imports FDA designates as “a high risk food” and the second is the use of certification audits for importers in The Voluntary Qualified Importer Program, (VQIP). Under VQIP, participating importers are required to source their products from suppliers that are certified under the FDA program.

In addition to the certification audits for VQIP and high-risk foods, audits are one of the options for supplier verification activities under the human and animal food preventive controls rules. When the hazard analysis identifies a raw material has a serious hazard, (SAHCODHA hazard), that ONLY the supplier controls, a supply chain preventive control is required, and the supplier verification activity must be an onsite audit. FDA allows some flexibility here, the audit can be a second or third party audit as long as it meets the requirements listed in 117.435, and is performed by a qualified auditor as defined in 117.3. These requirements are applicable to audits used to verify foreign suppliers (FSVP) as well as domestic suppliers.

FST: Don’t GFSI Scheme audits meet the criteria for Supplier Audits?

Wester: FDA allows the use of any audit that meets FDA’s criteria for audit content. This includes second party audits executed by employees of the receiving facility and third party audits, including GFSI audits, as long as they meet the requirements for audit criteria and are performed by a qualified auditor.

FDA acknowledges that the GFSI Auditor Competence provisions are consistent with the Agency’s findings, but that recognition does not extend to the audit criteria/content of GFSI audits.

In fact, any audit program in use prior to the publication of FSMA’s rules would probably need to be updated for these new requirements. GFSI, the Schemes, the CB’s, and others involved in the delivery of audits have likely all updated their audits to eliminate the major gaps, however, there are still some key FDA requirements that remain unmet.

FST: So, even though audit programs have been updated for FSMA’s new requirements, they are still missing some of FDA’s requirements? Why didn’t they just add everything?

Wester: In most cases, it appears to be due to a misinterpretation of the audit criteria that underpins all FDA’s audits. FDA’s audits focus on assessing a suppliers compliance with “applicable food safety regulations, the HACCP and/or Food Safety Plan and the plan’s implementation”. The Preventive Controls for Human Food Rule states the audit requirements in Subpart G:

§117.435 states:

If the raw material or other ingredient at the supplier is subject to one or more FDA food safety regulations, an onsite audit must consider such regulations and include a review of the supplier’s written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled.

We (FDA) have revised phrasing to state “and its implementation” to emphasize that implementation of the plan is distinct from the plan itself (e.g., § 117.126(c). (The PCHF Final rule preamble)

Similar phrasing such as “any applicable FDA regulations” is used elsewhere when FDA discusses audit criteria, such as FSVP and VQIP and the Third Party Certification Audit rules. Further, the PCHF rule, §117.190 provides a comprehensive list of “Implementation Records” that can be used as a guide to understanding what meets this element of the FDA’s requirement.

The auditing community and Industry have assumed the regulatory reference was limited to the FSMA regulations, such as Preventive Controls for Human or Animal Food or the Produce Safety final rules), and has focused on those regulations to update their audit programs. Other FSMA regulations, such as Intentional Adulteration and Sanitary Transport, could easily be considered part of the requirement, so there are a few audit options that include those rules.

FST: What about products that are exempt from the Preventive Controls Rules?

Wester: Audits for products that are exempt from the PCHF (human Food) rule, such as Juice and Seafood HACCP, are probably available under a general HACCP format, but they may not include the level of detail required under FSMA, and would have to specifically requested when arranging a supplier audit.

Audits for other PCHF exempt products, such as bottled water or low acid canned foods, would be audited using a general food safety audit, with the specific product treated as a product category under that audit. Once again, these audits lack the product specific regulatory content and implementation details required by FSMA.

The question becomes, which FDA regulations (beyond FSMA) apply to an audit used for regulatory compliance and how much detail in the audit is necessary?

In other words, what is the full scope of regulations needed for the audit, and what are the audit criteria? Is it just FSMA or does it go further?

FST: Where does one look for this information? Does FDA offer any guidance about the scope of the audit?

Wester: The CFR, or Code of Federal Regulations is the starting place for regulations. Finding the regulatory information would not be difficult, Title 21, CH 1 Parts 1-1499 include FDA’s food regulations. In addition each part can have multiple subparts etc.

Given the sheer quantity of regulations, and that some are product specific while some are not, developing different audits for all of the possible regulatory combinations would be a daunting task and enormously costly. Remember, every auditing company will have to go through this process.

There are FDA references to scope and criteria in several responses to comments:

Audit Criteria means the set of policies, procedures or requirements used as a reference against which audit evidence is compared. During regulatory and consultative audits, accredited third-party certification bodies will examine compliance with applicable food safety requirements of the FD&C Act and FDA regulations within the scope of the audit. In consultative audits, the third-party certification bodies also may be conducting an examination to determine conformance with applicable industry standards and practices.

The applicable requirements that accredited third-party certification bodies and their audit agents will use relate to the food safety standards under the FD&C Act, such as the adulterated food provisions in section 402 of the FD&C Act and the provisions on the misbranding of food allergens in section 403(w) of the FD&C Act. The applicable requirements of the FD&C Act and FDA regulations would depend on the type of eligible entity being audited. Other examples include labeling requirements and the CFR citations listed under scopes.

Certainly, more detail than this is needed, and AFSAP is working to engage all parties, including FDA, in collaborative discussions to resolve these questions and concerns. The auditing community will need to address these issues in the near future, and industry should be vigilant to understand the requirements and make sure any audits used for FSMA are compliant.

Melody Ge, InstantLabs
FST Soapbox

Five Tips to Add Food Fraud Prevention To Your Food Defense Program

By Melody Ge
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Melody Ge, InstantLabs

Food defense is the protection of food products from intentional contamination or adulteration, as well as biological, chemical, physical or radiological agents. It addresses additional concerns including physical, personnel and operational security. A traditional food defense program is generally perceived as a program that includes site security, visitors control or even on-site personnel monitoring. However, with the new FSMA Preventive Controls Rules and GFSI Guidance for all the recognized schemes, additional to consumer demand on product transparency, we must now take food fraud into consideration within our food defense program.

What is food fraud? According to the study from Michigan State University, food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false misleading statements made about a product, for economic gain. It becomes not just a potential for food safety issues, but also a severe issue that could potentially damage your brand reputation. It is hence critical to have appropriate protection and prevention, as the umbrella encompasses both food defense and food safety.

What does this mean to food manufacturers? The awareness of traceability and transparency certainly should rise. Most facilities should have a food defense program in place to comply with any GMP or GFSI requirements. To make it more competent for food fraud, what could we do? Here are some quick tips to strengthen your food defense program with food fraud prevention:

  • Tip 1: Review your entire supply chain one more time, considering fraud risks
  • Tip 2: Use the HACCP concept for food fraud risk analysis
  • Tip 3: Double-check incoming goods
  • Tip 4: Make the entire supply chain transparent
  • Tip 5: Document all records

Tip 1: Review your entire supply chain one more time, considering fraud risks

The unknown could potentially hurt you or your program. You would prefer to be aware of what might go wrong before it goes wrong, which is why a review should be one of the key steps in your food safety program. It might be a familiar terminology in the industry; however, we could not eliminate its importance to your entire food safety management system. To maintain product authenticity, understanding where your ingredients come from and who your business partners and suppliers are become the first step to success. It also gives you an excellent opportunity to analyze the risks and potential risk sources. A thorough review should include all the approved suppliers and vendor information. Knowing the source of your product provides you with a good foundation for your food defense program. How can we efficiently review our own supply chain?

  • List all approved suppliers and contract vendors
  • Make sure all ingredients are used accordingly and as intended
  • Keep the supplier registration list up to date

The more you understand your own supply chain, the more helpful it will be to your food defense program.

Tip 2: Use HACCP concept for food fraud risk analysis within supply chain

Hazard Analysis Critical Control Point (HACCP), as defined by FDA, is a management system in which food safety is ensured by addressing through the analysis and control of biological, chemical and physical hazards throughout the entire supply chain. This mentality of HACCP could be used and very helpful to analyze the potential fraud risks. Its seven principles and 12 steps could be implemented to identify your own fraud risks. And it is important for us to identify the hazards from potentially adulterated ingredients to determine the next step for what needs to be controlled. Utilizing the 12 steps, we can list all the key points and steps that could potentially impact your products’ authenticity. The risks can come from personnel, visitors or the ingredients themselves. There are many resources out there; for example, US Pharmacopeia (USP) has developed a global food fraud database that is a good resource for all ingredients that have been falsely used in food products.

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Tip 3: Double-check incoming goods

Many articles address the importance of vulnerability assessments to prevent food fraud plus any documentation your suppliers have provided. Yes, it is critical; however, as one of the important steps in the HACCP program, verification is also important to make sure what goes into your finished products is safe and guaranteed. This could be addressed and monitored by implementing genetic testing. Each product and ingredient has its own DNA, just like our fingerprints. Nowadays, there are many methodologies developed for this type of test. The DNA testing could be a helpful tool to help your facility verify the authenticity of your incoming raw materials. Genetic testing using techniques like polymerase chain reaction (PCR) technology to detect the DNA of the product upon receiving the incoming goods. Moreover, as fast as it can be, facilities can now receive the test results within one to two hours. The testing itself might seem like an extra step with more effort and labor. However, the return is a huge saving on damages caused by food fraud. You can now start to verify and control your supply chain from the beginning to avoid any potential adulteration.

Tip 4: Make the entire supply chain transparent

This transparency not only applies to internal employees but also outward to your customers and vendors. That way you can familiarize yourself with your own supply chain, while at the same time establish brand reputation and confidence to your customers.

Tip 5: Keep all records documented

The records you should keep, besides a registration list of all your ingredients and vendors, should include the inventory list, how ingredients are used, whether it is used outside of its intended use and authorized personnel signatures. The following are some tips for an efficient document control:

  • Make it clear and straightforward
  • Categorize it based on your own facility operations
  • Keep the records in the same order of your supply chain from ingredients to end consumers

After all, with the newly released requirements, as QA professionals, we need to start developing a mindset that considers food fraud as a type of hazard, and develop monitor and control strategies for mitigating it. Just like we are now so familiar with the physical, chemical and biological hazards within our production facilities compared to decades ago, food fraud will no longer be a scary term once it is proficiently understood and properly controlled.

FSMA

Company Resources Critical to FSMA Implementation

By Maria Fontanazza
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FSMA

In Part II of Food Safety Tech’s Q&A with Kathy Wybourn, Director Food & Beverage, USA & Canada at DNV-GL, we discuss FSMA preparedness and alignments of the regulation with GFSI.

Food Safety Tech: Now that we’re in the compliance phase, how prepared are food companies to meet FSMA requirements?

Read Part I: Embracing Big Data as an Asset to Your CompanyKathy Wybourn: It depends. Food companies must want to stay informed and make the necessary changes. What is critical in this change is the resources and organization, and not the size of a company. We still see large companies that are not ready for FSMA, same as with smaller companies. It comes down to what they have done proactively to keep up with the regulations, understanding the preventive pieces of that and the shift within their organization.

There are two pieces: It’s about being informed, plus the company’s culture for change. It comes down to management commitment. If you don’t have the management commitment to move an organization to being compliant with FSMA, you can be informed, but the culture isn’t there to support it.

FST: GFSI recently released Version 7.1 to incorporate more harmonization with FSMA. Any thoughts on this new version?

Wybourn: I was in the Technical Work Group for Version 7 guidance document. Adding in the food fraud and food defense components, and the new 7.1 Version brings the GFSI benchmark document closer to FSMA around suppliers and the use of non-approved suppliers.

It puts more requirements on the food manufacturer if they have supplier problems. For example, if there’s an interruption in the supply of a critical ingredient and you don’t have another supplier that’s going through the preventive hazard. It’s very important to know how to follow the requirements around non-approved suppliers. It all fits with the bigger picture of supply chain risks and transferring risks from a supplier (those things you don’t know about), understanding your suppliers and having a contingency plan. And if you don’t have that formal approval through your system, what are the requirements around using a non-approved supplier.

FST: How can the BRC FSMA Readiness Module help food companies with the Preventive Controls rule?

Wybourn: If you’re a BRC-certified site, it gives you guidance on what is needed to be FSMA ready. BRC benchmarked and identified what was missing in the standard and created a module that minimizes the gap. It gives you guidance and reference to the actual CFR and explains what’s needed.

Food fraud

Mitigating Food Fraud: Top Tips

By Food Safety Tech Staff
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Food fraud

The complimentary webinar, Top Tips to Mitigate Food Fraud, takes place on June 22 at 1 pm ET. Register now.Recently, the topic of food fraud has been discussed with increasing urgency. From understanding the basics of what is food fraud to navigating the regulatory requirements, quality assurance, compliance and procurement professionals must have a general understanding of the components.

An upcoming free webinar will review the hazard analysis requirements surrounding the FSMA Preventive Control for Human Food, GFSI requirements for raw materials and risk assessments and food fraud mitigation plans. Attendees will also learn about food fraud mitigation implementation strategies. The speakers participating in this webinar are Jeff Chilton, vice president of professional services at Alchemy Systems and Peter Claise, marketing director for foods programs at USP.

GFSI

GFSI Releases Version 7.1 to Incorporate More Harmonization

By Food Safety Tech Staff
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GFSI

GFSI has just released a new benchmarking requirements version that was developed for food safety certification schemes. Following stakeholder input, Version 7.1 intends to reflect changes happening in the market. The new version includes the addition of clauses for each scope under Food Safety Management requirements, including purchasing from non-approved suppliers and compliance with food safety legislation.

The previous version, Version 7, was released in February and introduced requirements to combat food fraud, incorporate unannounced audits, and increase transparency in the benchmarking process. It also included a new scope of supply chain food brokers and agents.

Dana Johnson Downing, TraceGains
FST Soapbox

Dispelling the Myth that Food Safety is Not a Competitive Advantage

By Dana Johnson Downing
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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.

GFSI and SENASICA

GFSI 2017: Working for International Partnerships and Global Harmonization

By Food Safety Tech Staff
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GFSI and SENASICA

There were several common threads during last week’s GFSI conference—collaboration to build stronger and more transparent food safety systems, international partnerships, and a global supply chain. This year’s event saw a record-breaking turnout, with nearly 1200 industry professionals from 54 countries in attendance.

GFSI and SENASICA
(left) Mike Robach, Vice President, Corporate Food Safety, Quality & Regulatory for Cargill, Inc. USA & Chair of the GFSI Board of Directors and (right) Hugo Fragoso of SENASICA

For the first time, GFSI entered into a public-private partnership with the Mexican National Service of Health, Food safety and Agro-Food Quality (SENASICA) that will help the entities to reach the goal of continuous improvement in food safety management systems. GFSI and SENASICA will sign a letter of intent this week in Mexico City. The partnership will focus on enabling private schemes to act under Mexican regulation (in addition to the Certification of the official scheme) to increase the amount of officially certified products. The two entities will also work together to enhance Mexico’s Global Markets Programme. The hope is that the partnership will be a model for other countries and will promote the adoption of third-party certification that facilitates the harmonization of food safety systems and global requirements.

Other highlights included a G30 summit held by 30 countries to talk about food safety and international harmonization; the work between GFSI and Certification Programme Owners to improve auditor performance; and the first GFSI award, which went to Champion Petfoods.

BRC’s FSMA Readiness

Recorded March 15, 2017: BRC’s FSMA Readiness module is designed to provide a gap analysis of a BRC certified facility’s preparedness for FSMA. John Kukoly, BRC’s well-known manager for the Americas, will deliver information on what the program is, how it should be prepared for, what expectations should be regarding added audit time, and how to get started. Open to all food processing, distribution, and packaging material companies, whether currently BRC certified, thinking about BRC certification, or simply want to see what’s going on at BRC, this Webinar will bring value to QA leaders.

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

GFSI in 2017: The Year of FSMA Compliance

By Bill Bremer
1 Comment
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.