Building a supply chain verification program can be a complicated task. In the following exclusive video with Doug Marshall, Ph.D., chief scientific officer at Eurofins, we learn the top questions that should be asking their suppliers during the process. Marshall also gives his perspective on the integration of data into the supply chain and how it can mitigate risk, along with where he’s sees the future of food safety testing headed.
Video shot at the 2018 Food Safety Consortium.
Many industries are moving toward unannounced third-party certification audits and the food industry is no different. If regulatory audits are unannounced, why is the food industry reluctant to adopt unannounced third-party audits? There are a number of benefits to unannounced audits—most importantly is their positive impact on a company’s food safety culture and how they prepare facilities to face FDA inspections.
Unannounced audits for food are required for many third-party certification audits. Typically, regulatory audits are always unannounced. Unannounced audits help demonstrate compliance and provide confidence to all stakeholders that your manufacturing sites are operating on the same GMP level, day to day, shift to shift, for every day your organization is manufacturing and distributing food products. With announced audits, companies tend to prepare for them before they occur. However, if there is a significant amount of difference between your sanitary operations prior to and during an announced audit versus normal operating conditions, you are sending your employees the wrong message.
Although there are differences between certification schemes, the GFSI third-party unannounced audits usually have a 40- to 60-day window in which the audit must be completed to allow the certification body to complete technical reviews and review corrective actions so that the certificate does not lapse. If it is a surveillance audit, then the audit is more likely to be truly unannounced, but a company still has the option of using blackout dates and the auditor will verify that the request was necessary. The bottom line is most companies have a certain timeframe when they know unannounced audits will occur.
Leonard Steed will present “Unannounced Audits: Are You Ready?” on November 14 at the 2018 Food Safety ConsortiumThe biggest impact on third-party audits is when the audit score is directly related to financial incentives for employees. This situation motivates employees to pursue activities to achieve the maximum score, not directly related to food safety. Activities may include significant audit preparation to eliminate or reduce GMP deficiencies, reduce or control the auditor’s access to records or areas of known plant deficiencies, “auditor shopping”, and to appeal any audit finding that lowers the score. Switching auditors or appealing findings can be legitimate tools to correct a system when auditors make errors in judgement or behavior. The activities to achieve the highest score should be reasonably governed because they could take away from the primary goal to operate in a food safe mode.
The goal of an internal audit program is to be compliant with regulatory inspections and third-party certification requirements and should therefore be risk-based. Determine what factors present the most risk to an organization and then align internal audits with those risks. At this point in time, being able to perform well on a regulatory audit should be a primary concern. Since the FDA and state regulatory agencies usually perform unannounced inspections, it would seem necessary to have your food safety plan, prerequisite programs and operations in a constant state of readiness to mitigate the risk of potentially unsafe food in commerce resulting in a recall.
One way to evaluate your food safety culture is to anonymously survey employees at all levels of the organization to gather information on attitudes and opinions about food safety and institute changes to improve your position. Another way is to initiate change by instituting unannounced audits on all manufacturing shifts and require participation by all departments in the audit function to move away from “QA-centric” food safety verification systems. The significant change is that all departments would be involved as an auditor and responsible for maintaining regulatory compliance. For some companies, the inclusion of all plant departments in the audit function has moved the needle in the goal to improve their food safety culture. To further define food safety culture in other terms, it could mean adhering to GMPs all the time, the importance of accurately completing and verifying food safety records, and fostering consensus between departments on the severity of food safety nonconformances requiring prompt corrective action.
Maintaining GFSI certification is an excellent way to achieve food safety requirements for compliance with FDA inspections. Although not specifically required by GFSI, another application of your internal audit program is to review your regulatory policy by performing a mock FDA inspection to identify any gaps in hazard analysis, identify preventive controls including the supply chain controls, accurately complete food safety records, and provide examples of corrective actions when preventive controls were not completed properly, and environmental corrective actions. If you decide to perform a mock FDA inspection of your facility, do not forget to include the FDA Guidance document criteria, as it is important to understand what the FDA expects to see when they are evaluating your implementation. Your internal audit program is a proactive program to note nonconformances before they become full blown problems, so don’t be afraid to use it to its fullest extent.
Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill. Mike joined Cargill in January 2004 to lead the company’s corporate food safety and regulatory affairs programs. In this role, he helps partners innovate and manage risk so they can feel empowered to nourish the world
Mike has also worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. He serves as chairman of the board of directors of the Global Food Safety Initiative (GFSI) and is a member of the Institute of Food Technologists and the International Association of Food Protection, among many other organizations dedicated to ensuring safe food and bringing innovative technology into the agricultural industry. He has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health and food safety standards.
Mahni Ghorashi: What are the biggest risks to our food safety infrastructure in 2018? What’s keeping you up at night?
Mike Robach: The biggest risks I see have to do with supply chain integrity and how companies implement their systems. Too often we do not have line-of-sight to the origin of the commodities and ingredients that make up our products. With global supply networks it’s important to understand where and from whom you are getting your inputs. There is also a need for food safety capacity building throughout the global food system. Many small and medium companies, along with some large companies, do not have the proper training for their employees to manage a food safety program. We also have an issue with constantly changing regulations that are not uniform from country to country, adding risk to our business.
Ghorashi: What are you most excited about? What’s changing in a good way in the food safety sector?
Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace. Blockchain technology gives us the chance to drive greater transparency throughout the supply chain.
Ghorashi: Let’s talk about regulation. How is the implementation of FSMA going? Do you foresee any challenges with the next phase of implementation?
Check out last month’s Q&A with Frank Yiannas of WalmartRobach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.
Ghorashi: If you take a look at the homepage of Food Safety News, all you see is recall after recall. Are transparency and technological advancement bringing more risks to light and are things generally trending towards improvement?
Robach: I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.
Ghorashi: What is the number one challenge of securing global supply chains for 2018?
Robach: Knowing and understanding the integrated supply chain. Having knowledge and control of the process from origination to consumption would be ideal. We need the implementation of risk-based, harmonized food safety management systems based on the principles of Codex. Assuring the application of these systems along with properly trained employees to implement these programs would be the first step towards a secure, safe global food system.
Ghorashi: How do international trade deals and the stance of the current administration affect the future of food safety policy?
Robach: International trade deals such as the Trans Pacific Partnership and NAFTA can do a lot for the assurance of safe food around the world and within regions. Making sure that food safety provisions are included in these trade deals can drive the implementation of food safety management systems that will ensure safe food for consumers everywhere. These types of deals should allow us to remove technical barriers to trade by basing the requirements on Codex principles and adhering to the WTO SPS agreement.
Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?
Robach: Blockchain has a role to play in driving more transparency across the integrated supply chain. It can allow companies to show consumers where their food comes from. It can also be used to quickly trace back product in the event of a food safety problem. Still, it’s an enabling technology, not a solution.
Ghorashi: What about CRISPR? How is the food industry starting to respond to this technology from both a policy and GMO screening?
Robach: Gene editing holds great promise and many companies are looking at its potential benefits. However, there is always the policy question on whether or not the use of this type of technology should be labeled. I think the food industry has not done enough to promote the use of technology and how food production has improved over the years. We should let consumers know how we apply science to making food safer, more nutritious and more sustainable. At Cargill we have the vision of being the leader in nourishing the world in a safe, responsible and sustainable way.
Ghorashi: What trends are you seeing in food safety processes within food companies? Are they becoming more decentralized? Less? How are they balancing innovation with decades-old food safety practices?
Robach: Through the Global Food Safety Initiative, we have promoted harmonized, risk-based food safety management systems. The GFSI-benchmarked certification programs provide an opportunity for companies to implement consistent food safety programs regardless of where they are in the world. Through the GFSI Global Market Program there’s a tool kit that less sophisticated companies can use as a pathway towards full certification. We are constantly updating the benchmarking requirements to assure they are keeping up with changing science and technology.
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:
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.
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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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.
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:
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.
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:
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?
The more you understand your own supply chain, the more helpful it will be to your food defense program.
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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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.
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.
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:
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.
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.
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 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.
