EDGARTOWN, MA, June 27, 2019 – Innovative Publishing Co., publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo is pleased to announce a partnership with FSSC 22000 to hold the organization’s Focus Event 2019 at this year’s Food Safety Consortium in Schaumburg, IL.
Taking place on October 1 as a pre-conference workshop, the FSSC 22000 Focus Event will provide a firsthand update of the FSSC 22000 program worldwide and review the new Version 5, which includes the revised ISO 22000:2018. Experts will give attendees an overview of the benefits of the ISO approach and its alignment with FSMA, as well as the role of FSSC 22000 new scopes, including Transport and Storage, with a practical example of the benefits of certification in this new sector. There will also be discussion of the application of the FSSC Global Markets Program to smaller and medium-sized organizations.
“I am excited to welcome stakeholders from the GFSI-recognized food safety management system FSSC 22000 to the Food Safety Consortium as key participants in educating an important part of this industry,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo.
Speakers include Cornelie Glerum, Managing Director, FSSC 22000; Cor Groenveld, Market Development Director, FSSC 22000; Jacqueline Southee, North America Representative, FSSC 22000; and Jim Blackmon, President of Carry Transit (invited).
Professionals within the following roles/segments should attend this event: Food and beverage companies; FSSC 22000 certified companies and companies interested in becoming FSSC 22000 certified; certification bodies and contractor auditors; accreditation bodies; and training organizations.
The FSSC 22000 Focus Event is available and included in the Food Safety Consortium Conference registration fee.
Delegates registering for the FSSC 22000 Focus Event 2019 only will also receive complimentary admission to the plenary session of the Food Safety Consortium, presented by Frank Yiannas, deputy commissioner, food policy and response at FDA, and are invited to attend the evening reception in the exhibition hall.
About Food Safety Tech
Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
About the Food Safety Consortium Conference and Expo
The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.
About FSSC 22000
FSSC 22000 (Food Safety System Certification 22000) offers a complete certification program for the auditing and certification of Food Safety Management Systems (FSMS) and Food Safety and Quality Management Systems (FSSC 22000-Quality). Based on the internationally accepted ISO 22000 family of standards and benchmarked by the Global Food Safety Initiative (GFSI), FSSC 22000 sets out the requirements for companies throughout the supply chain for meeting the highest food safety standards. FSSC 22000 is recognized and relied upon by some of the world’s largest food manufacturers, is widely accepted by Accreditation Bodies worldwide and supported by important stakeholders like FoodDrinkEurope (FDE) and the American Grocery Manufacturers Association (GMA).
I attended the Safe Food California Conference last week in Monterey, California. Food fraud was not the main focus of the conference, but there was some good food fraud-related content. Craig Wilson gave a plenary session about the past, present and future of food safety at Costco. As part of that presentation, he discussed their supplier ingredient program. This program was implemented in response to the 2008 Salmonella Typhimurium outbreak in peanut paste but has direct applicability to food fraud prevention.
Food Fraud: Problem Solved? Learn more at the 2019 Food Safety Supply Chain Conference | May 29–30, 2019 | Attend in Rockville, MD or virtually Jeanette Litschewski from SQFI gave a breakout presentation on the most common SQF non-conformities in 2018. She presented data from 7,710 closed audits that cited 44,439 non-conformities. Of those, 756 were related to food fraud requirements. While this presentation was not focused on the specifics of the food fraud non-conformities, Jeanette did mention that many of them were related to broad issues such as not having completed a food fraud vulnerability assessment or appropriately documenting that each of the required factors was addressed in an assessment.
I was invited to give a breakout presentation with an overview of food fraud issues globally and a brief outline of some of the tools currently available to assist with conducting vulnerability assessments. Although many of the attendees had already began implementation of food fraud measures, there was a lot of interest in this list of tools and resources. Therefore, I am recreating the list in Table I. The focus is on resources that are either complimentary or affordable for small- and medium-sized businesses, with recognition that “full-service” and tailored consulting services are always an option.
Of course, there are quite a few companies that offer tailored tools, training and consulting services. Companies that offer courses in food fraud mitigation and assistance in creating a vulnerability assessment (or FDA-required food safety plan) include NSF, Eurofins, AIB International, SGS, and The Acheson Group.
Also available are services that compile food safety recalls and alerts (including those resulting from food fraud) from multiple official sources, such as FoodAKAI and HorizonScan. EMAlert is a proprietary tool that merges public information with user judgment to inform food fraud vulnerability. Horizon Scanning is a system that can monitor emerging issues, including food fraud, globally.
In short, there are many resources available to help support your food fraud vulnerability assessments and mitigation plans. If I have unintentionally missed mentioning any resources you have found to be helpful, please let us know in the comments.
By Natalia Larrimer, Jacqueline Southee, Ph.D. No Comments
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.
Food Safety Tech recently sat down with experts from Eurofins to discuss FSSC 22000. According to Kristopher Middleton, technical manager at Eurofins, and Kim Knoll, food safety systems national sales manager at the company, there are still quite a few companies (especially in North America) that are unfamiliar with the ins and outs of the certification scheme. In a Q&A with FST, Middletown and Knoll break down the basics of FSSC 2000, along with explaining some of its benefits.
Food Safety Tech: How is the trend with FSSC 22000 evolving?
Kristopher Middleton: The scheme started in 2009 based on a demand for people wanting to have an ISO-based certification within the GFSI benchmarking process. When the program came out, it trended toward larger companies that already had ISO-based certifications, mainly ISO 22000 and ISO 9001. The FSSC 22000 scheme is the fastest growing GFSI benchmarking scheme currently. It’s not just for large multinational companies; a lot of smaller suppliers are seeking certification to this scheme. The foundation continues to expand its scopes to become a true farm-to-fork certification program.
FST: Is FSSC 22000 also appropriate for a single site or for a company with fewer than 50 employees?
Middleton: The certification doesn’t discriminate based on facility size—nor footprint or number of employees. It’s ideal for any company that has a robust food safety management system and manufacture products that fall within the FSSC 22000 scope of certification. This currently includes manufacturers of perishable animal products (feed and food), perishable vegetable products, products with a long shelf life, biochemical products (i.e., food ingredients, vitamins, biocultures, etc.), manufacturers of food packaging, and primary production of animal products.
The key thing about FSSC 22000 certification is that it is not a terribly prescriptive food safety scheme, when compared to others that are available. You will be successful with FSSC 22000 certification if you are confident and knowledgeable about your own food safety management system, and you have appropriate justification or validation for the method in which your programs have been implemented, as well as validation for the controls of your food safety hazards.
FST: Are there quite a few companies that have not heard of FSSC 22000 or are not aware that it is a GFSI-recognized scheme?
Middleton: Since ISO 22000 was not terribly popular here in North America, it didn’t catch on right away. It was more so overseas that it caught on. However, within the past two years the scheme has become increasingly popular here, especially among companies that have other ISO standards already implemented (i.e. ISO 9001, 14001, 18001,etc), where it relates to occupational health and safety, environmental, and quality. The reason for that is the FSSC can easily intertwine with that entire management system program so that it all works together versus having separate programs in place.
Kim Knoll: I’m having a lot of conversations with smaller manufacturers who are brand new to GFSI. Many of them are being asked by their customers to achieve a GFSI benchmarked certification and are in the early stages of researching scheme options. Some of these companies are surprised to learn that FSSC 22000 is a viable option. Like other certification schemes, Eurofins lends support to companies planning to pursue FSSC 22000 through training courses, consulting services, pre-assessments and ultimately certification services. Even though FSSC 22000 is a newer scheme, auditor availability is not an issue.
FST: What are the key differences between FSSC 22000 and the other GFSI schemes?
Middleton: Probably the most apparent difference with FSSC compared to other GFSI benchmark schemes is the fact that your certification lasts for three years, not one year. The reason for that is that it’s not a product-based certification like the others, it is a process-based certification and it uses the accreditation standard of ISO 17021 not ISO 17065. It also uses ISO 22003 for direction to the certification body for the conducting of the audit. That doesn’t mean that sites won’t be audited annually; it just means that once the certificate is granted, it’s good for three years.
Another key difference is that there is no true pass or fail within the audit. It’s a conform or not-conform audit. The decision to certify is based off the findings from the auditor and their recommendations, as well as the decision from a technical review meeting at the certification body. It requires the effective closure of a particular non-conformance or satisfactory plan being submitted for the closure of those non-conformances before the actual certificate can be granted. So that’s a bit different, because you can just submit plans for your non-conformances [instead of] actually showing that everything has been completely resolved. That being said, if a facility isn’t able to hold or get a certificate, if there’s an imminent food safety threat noted during an audit—if there’s an issue, such as a potential recall or contaminated goods, the ability to be granted that certificate is not feasible.
FST: Can you walk us through the auditing and certification process under FSSC 22000?
Middleton: Like any of the standards out there, you can get a pre-assessment, which is not necessarily part of the certification activity. The certification activity starts at a Stage 1 audit within this scheme (also known as a document audit within other schemes). It’s an evaluation of a facility’s food safety management system document to determine if they’re valid. The process does not include an entire evaluation of the implementation of the program, just simply that the programs are adequately designed and meet the requirements that are in place.
Next there’s a Stage 2 audit (sometimes referred to a facility audit) that is conducted no more than six months after the Stage 1 audit. The Stage 1 audit will identify the areas of concern—programs that might not meet exactly what the specifications required within the standard, which would become non-conformances in a Stage 2 audit (also called a facility audit or certification audit).
The Stage 2 audit is the full evaluation of the implementation of the program that was reviewed in the Stage 1 audit. Following completion of the audit, effective closure of non-conformances is required. This closure can either be [related to] major non-conformances, CAPA or root cause analysis. You have to supply evidence that the non-conformance is properly eliminated and will not recur, and this evidence must be supplied to the certification body and the auditor for review.
Any other non-conformances (also known as minor non-conformances) must have corrective action plans. Companies need to state how they plan on resolving the issue. They will be “closed” but left open for the next audit, which has to occur within one calendar year (known as a surveillance audit). The term “surveillance audit” within this standard is different from some of the other standards. Within some of the other standards, a surveillance audit is not a yearly activity—it is done within the year of certification. The surveillance audit within this standard is a yearly audit that is required to meet the requirements of GFSI. It’s also a requirement within [ISO] 17021 and [ISO] 22003 that surveillance audits are conducted. The GFSI requirement changed the surveillance audit within the ISO world because they used to do a sampling audit, which progressed to a full-blown audit. Your whole food safety management system will be evaluated, which is slightly different from ISO 22000 surveillance audits.
After that audit is conducted, you have another surveillance audit in the following calendar year. Within those surveillance audits, if any minor non-conformances or non-conformances from the previous audit are still present, they are upgraded to major non-conformances and [companies] would have to implement a full corrective action plan, root cause analysis, etc. and then determine the solution.
Once the second surveillance audit is conducted, the following year will be your recertification audit, which is simply another facility audit. It’s not a document audit—you don’t have to do Stage 1 audits after that initial one. This recertification audit occurs prior to your certificate expiring.
If my company is GFSI-certified, is it also FSMA compliant? The answer is: With shared goals of producing safe food, coordinating preventive measures and ensuring continuous improvement, if your company is FSSC 22000 certified, you’re well on the road to FSMA compliance, according to Jacqueline Southee, Ph.D., U.S. Liaison, FSSC 22000. Southee discussed several areas in which FSSC 22000 aligns with FSMA as part of a recent Leadership Series, “GFSI in the Age of FSMA”.
Supply Chain Visibility
FSSC 22000 is applicable to all aspects of the supply chain and requires interactive communication (all of which must be documented), from the downstream level in ensuring raw materials and suppliers meet requirements of ISO 22000 framework to communication with customers and suppliers to verify and control hazards.
FSMA controls the hazard of food within the United States, says Southee, whereas GFSI certification is a global initiative, thereby extending supply chain visibility to foreign suppliers.
The Food Safety Plan
There has been much discussion surrounding building a FSMA-ready food safety plan and the migration from HACCP to HARPC. “HARPC can be referred to as HACCP with preventive controls,” says Southee. FSSC 22000 provides a flexible yet robust approach in a framework that is applicable to all situations (i.e., different manufacturers have different issues, such as producing ice cream versus baked goods). Rather than being prescriptive, the prerequisite program has the flexibility to apply to a particular situation. In addition, validation, verification, monitoring and documentation are an inherent part of the ISO 22000 approach and the FSSC 22000 certification.
FSSC 22000 serves as an effective tool in preparing companies for FSMA compliance. “We’re not a regulatory system; FDA has that domain,” says Southee. “They’re the ones that carry the responsibility of meeting those regulations. We work with everyone…to do the best job we can.”
Being audit ready all the time is a key part of preparing for FSMA. FSSC 22000 certifies a food safety management system (a three-year certification cycle) and requires internal audits of company performance, along with helping companies ensure that their records are organized at all times. The goal is to install a management system that enables constant monitoring, reevaluation and assessment as part of an ongoing process of keeping food safe, according to Southee. “If you’re certified and have an effective ongoing management system, unannounced audits won’t be an issue,” she says.
Food Safety Culture
FSSC 22000 and ISO 22000 provide a strong foundation for building food safety culture. ISO 22000 requires proof of management commitment to the food safety process, along with accountability, and for management to make resources available to see the food safety process through. “We agree that culture has to come from the top,” says Southee. “The personnel have to see that management is committed, and the culture will come from that commitment.” It also requires constant communication, up and down the supply chain as well as internally. This includes involving all employees and making sure that they know what they’re doing (i.e., training). “Everyone needs to know they’re valued and important, and how their function contributes to the function of safe food,” says Southee.
FSMA Alignment and Gap Analysis
There are sure to be some gaps when it comes to FSSC 22000 and FSMA. FSSC 22000 has commissioned a gap analysis to compare the preventive controls for human and animal food rules with the GFSI scheme and will add addendums as needed. Areas of review include a requirement to include food fraud into the hazard analysis and a review of unannounced audit protocol.
The “GFSI in the Age of FSMA” three-part series wrapped up in early December, providing the food safety community insight on how leading GFSI schemes align with, and help prepare for, compliance with FSMA. The series was presented by SafetyChain with media partner FoodSafetyTech.
Each GFSI scheme leader from SQF, BRC and FSSC 22000 discussed how their schemes align with FSMA in several key areas, including Supply Chain Controls, migrating Food Safety Plans from HACCP to HARPC, and audit readiness. While each scheme leader provided insights and details on how their scheme aligns with FSMA, common key themes across all three sessions included:
FSMA’s focus on prevention vs. reaction is similar and aligns with GFSI’s objectives; Scheme certifications and ongoing compliance is centered around continuously assessing risks and putting preventive measures in place to mitigate those risks
GFSI’s global approach surrounding a company’s food safety program—to ensure better supply chain controls internally, upstream and downstream prepares companies to manage FSMA’s increased focus on both domestic and foreign supplier compliance
GFSI stringent documentation and recordkeeping requirements—along with unannounced audit protocols—are a strong foundation to help food and beverage companies prepare for FSMA’s “if it isn’t documented you didn’t do it” mantra
The GFSI scheme leaders also spoke about the importance and opportunity companies have to leverage technology tools to help more effectively manage the complexities and requirements of GFSI and FSMA compliance. Series participants were able to see an example of how these automation tools work and the impact they can have on managing a robust food safety program via a post session demo of SafetyChain Software.
Archived recordings of all three sessions—SQF in the Age of FSMA, featuring Robert Garfield, Senior VP, SQF; BRC in the Age of FSMA, featuring John Kukoly, Director, BRC Americas; and FSSC 22000 in the Age of FSMA, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000—are available and can be accessed here.
Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?
Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference. LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?
Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.
The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”. FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.
When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.
To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.
Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.
So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment. And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.
As industry awaits next month’s final rule on preventive controls for animal food, companies in the animal feed business must be prepared for the changes, especially as it relates to having an aligned system with HACCP principles. In a Q&A with Food Safety Tech, Victor Muliyil, food technical project manager at SGS SSC North America, and Mary Williams, a quality assurance and regulatory affairs expert at Land O’Lakes, Inc, discuss where companies should be looking for gaps in their systems.
Food Safety Tech: What critical changes does FSMA introduce to the animal feed industry?
Victor Muliyil: FSMA introduces the primary change that all feed manufacturers must have a feed safety hazard control program that is in line with HACCP principles. Hazards likely to occur must be identified and controls implemented; and [although] hazards related to medications and prohibited material must still be controlled, the responsibility is on the manufacturer to identify all hazards and controls. The focus is on prerequisite programs, not just on critical control points.
In addition, feed industry recalls can now be mandated by FDA, not just recommended. HACCP certification is not mandated by FDA, but several feed and food industry customers are looking for competent independent audit and certification of feed safety control programs. Trained internal auditors are required to verify the system. Traceability is required to the next level of distribution, as well as backward to key ingredients such as medications.
Mary Williams: Food industry leaders must now show they have “planned to work safely,” and this plan must be written down with documented evidence of training. This is a fundamental shift in approach, as FSMA indicates that all feed manufacturers must control feed safety hazards consistent with principles many of us have learned in HACCP. This speaks to prevention vs. reaction, so the prerequisite programs as a foundation must be in place first. This is a time of unprecedented change in the U.S. Food/Feed industry plus global supply chains that are expanding. While it is widely accepted that zero risk is unattainable, the approach that companies take to prevent having an issue, and to prepare for efficient and effective response in the event of a problem is seen as critical.
Product Safety Culture must be leadership driven and reinforced and furthermore, a strong product safety culture is a “choice”. Leaders of an organization set the tone and must proactively reinforce the expected outcome because it’s the right thing to do, not just because it is the newest food safety law.
While many feed companies are moving toward HACCP certification, it is not mandated by the FDA. Regardless of whether you build a HACCP plan or a Food Safety Plan, it is important for feed/food companies to start now. The cGMPs, new GMPs and most FSMA requirements are generally understood thus having more time to live and practice the programs implemented allows time for adjustments.
FST: Regarding GFSI certification, in what areas are companies in the animal feed industry the most under-prepared?
Muliyil: Management commitment, understanding and communication are key. Better training is needed to understand feed industry specific hazards and realistic controls. Currently, internal auditing is not very thorough and must be more structured. Corrective actions are not followed through to gauge effectiveness and are often not documented in adequate detail. Finally, validation is not well understood, nor is there specific guidance on this topic.
Williams: Management does not always clearly understand the need and requirements of “Management Commitment”. It requires active and visible participation at all levels of management. Managers must “walk the walk” and “talk the talk”. It may also require an investment in resources such as staffing, capital improvements, and training, to name a few. Management commitment is essential to support the development of a strong product safety culture. Failures in product safety culture increase the potential risk of outbreaks and deaths from foodborne illness.
The skills needed in the industry to meet these new expectations are different than what we needed before. It is not enough to just adopt new standards. We have to train and educate those who implement them.
We need to train for behavior – what do we want the trainee to be able to do? The training needs to be clear and practical. In addition, we need to educate for increased knowledge across the employee base. Don’t just send the managers and supervisors to HACCP class or auditor training, make sure we educate a multi-disciplined team including production employees.
Continuous improvement is an everyday concept and involves having a strong corrective action/preventive action program. Often deficiencies are corrected quickly, but not prevented over the long term, and this requires increased due diligence.
FST: Are companies with FSSC 22000 certification more prepared for the preventive controls rule?
Muliyil: FSSC 22000 is one of the GFSI benchmarked schemes that offer effective integrated food safety management, covering:
Specific controls and scheme criteria for animal feed and pet food
Global buy-in and adoption by many of the world’s leading feed and food manufacturing companies
A top-down focus, including defined roles for management, requirements for policies and regular management review
Prerequisite programs focused on hazard control, in line with HARPC and FSMA
The HACCP system approach to structured food safety control, focused on medications & prohibited material control
Traceability from suppliers through to customers
Communication:External: Consumers, customers, service providers, suppliers, associations and regulators.
Internal: Within a company and between all elements of the system
Internal audit of the entire food safety management system and follow up
Regular system updating to maintain rigor
Williams: A company certified in FSSC 22000 or one of the other GFSI benchmarked standards has implemented Codex HACCP and hygiene principles in their foundation programs. These same HACCP and foundation programs overlap with the requirements in the preventive controls rule and will support compliance to FSMA. It will be important to review all the FSMA requirements to ensure all elements are effectively covered in the current company program.
FSSC 22000 requires annual recertification and an annual self-audit. These two elements of review ensure that internal and external eyes are always looking for program compliance before a failure occurs. These are solid “prevention” elements that support FSMA compliance as well.
With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.
The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.
The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.
Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:
Reducing duplication of audits
Creating a comparable audit approach and outcomes
Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
Enhancing trade opportunities
Gaining cost efficiencies throughout the supply chain
Increasing competitiveness in the global market
Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.
On September 26, Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000, will present FSSC 22000 – The Road Ahead, as part of the 2014 GFSI Leadership Webcast Series presented by SafetyChain Software and FoodSafetyTech.
Dr. Southee will talk about what’s new for the scheme, what changes are expected in 2015 and beyond, how these changes will affect you, and why it’s important to embrace these changes to be better prepared for upcoming food safety regulations such as FSMA. In this interview with Food Safety Tech’s Sangita Viswanathan, Dr. Southee discusses some of the topics that will be examined in more depth during the webinar – including FSSC 22000’s international food safety management certification scheme and its global integrity program.
Food Safety Tech (FST): We’re very excited to have you participate in the GFSI Leadership Webcast Series. What will you be talking about in terms of current changes with FSSC 22000?
Dr. Southee: The most striking change that FSSC 22000 is undergoing revolves around the rapid uptake of the scheme by industry and the increase in the number of certified sites which currently stand at more than 8000. This represents a 48 percent increase since mid-2013. The standard is currently operating in 146 countries, and has become a truly global scheme. We are also working to extend the scope in line with the GFSI goal to cover the entire supply chain. For instance, we have added animal feed to our scope, and will soon be adding animal farming. We are constantly making adjustments within the scheme to keep in line with GFSI requirements in terms of maintaining the highest possible scheme integrity. Overall, FSSC 22000 is creating a lot of buzz out there and we continue to work to meet the growing needs of the industry.
FST: We know that audits will be a topic of many questions. Is FSSC 22000 planning changes on the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?
Dr. Southee: FSSC 22000 does not do audits itself. It oversees the FSSC 22000 scheme which provides the specifications for the audit which is conducted by a qualified Certification Body. We work with 96 licensed Certification bodies and more than 1500 auditors throughout the world who conduct FSSC 22000 audits. Our goal is to ensure that these audits are conducted consistently and in line with GFSI requirements. We focus on having a global integrity program, and are in regular contact with auditors and Certified Bodies to monitor auditor competence and to ensure that both CB’s and auditors are meeting these requirements. This monitoring may require an increase in the communication that we have with our CB’s and may even result in an increase in the number of visits that we pay to them. The overall goal is to maintain the highest standard of food safety audits for FSSC 22000 certified companies.
FST: You will also be talking about the direction of FSSC 22000 in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to FSSC?
Dr. Southee: The main business drivers for FSSC 22000 are increasing transparency across the supply chain, maintaining the highest standard of consistent audits around the globe to promote a continuous improvement in food safety. As a global scheme, we are in a good position to work with many of the world’s leading food manufacturers. We work on ensuring transparency throughout the supply chain to maintain efficiency in the control of food safety, raise the confidence of the customers and the regulators in the third party certification process and to ensure the production of safe food ingredients and products for the consumer.
FST: While we all know change is important, it’s not always easy to get already-burdened food safety organizations to embrace change. What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of FSSC 22000?
Dr. Southee: The global food manufacturing industry is currently under a tremendous burden with pressures coming from all sides. They must produce safe food efficiently and effectively to meet the demands of the retailers, the regulators and the consumer. What’s more in this truly digital age, where social media drives consumer preference more than anything else, they need to show their commitment to food safety. The new norm is that consumers are “involved” in what they eat. Every step industry takes is scrutinized by everyone with access to the information, and if anything slips out of compliance, it is public knowledge almost within the hour. There’s a constant demand for information, so food manufacturers need to invest in management systems such as FSSC 22000 to manage their food safety effectively, maintain transparency across the industry both for their customers and their consumers and be quick to respond to issues.
FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s FSSC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?
Dr. Southee: One topic I’ll be addressing is that food safety management should not be considered a cost center. In order to prepare for FSSC 22000, it is critical for senior management within an organization to recognize the need to take responsibility for food safety and that this will involve the need to have a robust food safety management program in place. Many companies now recognize the importance of investing in food safety and this is to the benefit of all. We also hear about the importance of establishing a “food safety culture” and we can talk more about what this means.
FST: It has been said that GFSI certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance and FSSC 22000?
Dr. Southee: First of all, I think that the establishment of the GFSI is an example of the food industry already regulating itself. The benchmarking approach has raised the standard of the accredited third party certification process and a company that is certified under a GFSI scheme is already meeting a high standard of food safety. A scheme such as FSSC 22000 provides additional evidence of a company’s commitment to food safety practices and management. The FSSC 22000 scheme meets many of requirements specified by the initial draft of the FSMA rules and existing data suggests that GFSI certification is a very important start to ensuring compliance with FSMA requirements.
To learn more about all of these and many more topics on FSSC 22000 – including live questions from the audience – register today for FSSC 22000 – The Road Ahead, Friday, September 26, with Dr. Jaqueline Southee.
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