Eurofins Food Safety Systems and Orion Assessment Services have announced a partnership that will expand their auditing and certification services on a global scale.
“The partnership will allow Eurofins to broaden their BRC Global Standards and GFSI scheme auditing resource base and provide them additional expertise in BRC to utilize. It will also allow Orion Assessment Services to operate under the Eurofins accreditation for BRC, SQF and FSSC 22000 schemes,” according to a Eurofins news release. “As a certification body, this collaboration will enhance the standards currently offered through Orion Assessment Services’ accreditation for ISO 17065 and ISO 17021, as well as offering brand new opportunities in the various GFSI schemes, for both existing and new clients internationally.”
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.
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.
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.
Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.
5. Don’t Scrap Your Current Plan
Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.
4. Education Is Key
A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).
3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”
Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.
Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.
There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.
IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.
A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.
Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.
Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.
In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.
When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:
Proof of Training and Certification
Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:
A copy of the valid registration or certification document
hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
Evidence of training on IPM and Good Manufacturing Practices (GMPs)
Proof of Service and Material Changes
A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.
It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.
Pest Sighting Reports That Correspond with Corrective and Preventive Actions
When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.
After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.
Records of Pest Monitoring Devices and Traps with Corrective Actions
Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:
When and how often the monitoring devices and traps were checked
The type and quantity of each pest found
Corrective actions taken to reduce pest activity and prevent further issues
Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.
Annual Pest Management Assessments and Resulting Actions Taken
With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.
These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.
This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.
So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.
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.
Many companies certified to a GFSI scheme appear to have a leg up on preparing for FSMA, especially in the area of documentation and record keeping. During a quick chat with Food Safety Tech, Bob Butcher, group operations manager at Ipswich Shellfish Company, explained how GFSI has helped the seafood processor get ready for FSMA. Do you agree? Sound off in the comments section.
Food Safety Tech: What common challenges do companies experience when managing compliance with a GFSI scheme?
Bob Butcher: Every time there’s a new regulation it’s a matter of understanding how that regulation applies to us. The seafood industry has been regulated by FDA mandatory HACCP requirements for years now. Some of the items that are covered under FSMA have already been covered by the seafood regulations. Our facilities have also undergone third-party audits for a number of years and three are already SQF certified—so in order to meet those certifications, we comply with all the FSMA requirements at this point. That being said, there’s always a challenge or opportunity to make sure we comply with all the regulations and above that, make sure that the quality [of the product] we send to our customers meets both their standards and our standards.
FST: Has being certified to a GFSI scheme helped your company better prepare for FSMA compliance?
Butcher: Because we’re SQF certified and are meeting most of the requirements of the seafood industry, we’re well ahead of meeting FSMA requirements. Maintaining the GFSI requirements put us in great shape for FSMA.
GFSI covers so many areas. [Regarding] vendor compliance, we critically examine the seafood that comes in every day and it’s a very perishable commodity, but every plant is a little different in the talent they have and the number of people. We’ve been able to focus on making sure that the product meets the same criteria at each of the facilities no matter who is receiving it and documenting it accordingly. And whether [complying with] GFSI or FSMA, documentation is important.
We’ve gone the extra step in automating so we can better track how each of the plants and suppliers are performing. We started rolling it out at one plant two years ago and then extended it to all plants. All of our facilities have been under it for a year.
I think more and more companies are acknowledging the need to automate. With paper forms it’s difficult to make sure the employee has the correct and latest version, and the filing and recovery of that document [is difficult]. If it’s digital, you can get your hands on the latest version any time you want. Plus, you can analyze digital information and easily look for trends.
However, the seafood industry isn’t like a number of other industries—the margins are low, and so cost is absolutely a factor. If it’s a single facility, having paper forms, depending on the extent of the operation, may be acceptable. But if you get into multiple locations, it’s a whole different challenge all together.
FST: What are the broader issues that the seafood industry is currently facing?
Butcher: Supply and sustainability—making sure that you have a handle on the sustainability of the species and are able to explain that to your customers. That ties into record keeping—getting the right product, when it’s an MSC [Marine Stewardship Council] or ASC [Aquaculture Stewardship Council] chain of custody, or whether it’s having the right relationship with the vendors so you know your source. Cost is a concern, along with quality and inventory levels.
There are a lot of very small companies and a lot of them aren’t GFSI certified. A lot of them don’t even have any type of third-party audits, so I’m not sure how ready they are. It’s always a challenge for a small company to get up to speed.
FST: Does compliance with a GFSI scheme help address these issues to some extent?
Butcher: As we started working on GFSI or FSMA, and even HACCP many years ago, we started looking at products differently. You’re documenting more and gaining information—and once you have that information, you can focus on cost factors and inventory. So from that standpoint, it has been very helpful. At this point, we’re SQF Level, and we plan to go Level 3, which involves more quality parameters and certification. That will greatly impact the product and the profitability as well.
FST: What are your tips for companies in terms of being audit ready?
Butcher: The software program we use helps us maintain our facilities to be as audit ready as we can from a documentation standpoint. With SQF there will be unannounced audits, and it’s always been FDA’s practice or the state inspector’s practice to pop in anyway, so you have to be ready for that inspection at any time. The whole principle of HACCP is to make sure you’re documenting what you’re doing. And whether it’s an auditor or an inspector, they’re coming in at any time and can look at records for the past two years, so you should be in compliance and be able to prove that.
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.
Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.
“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”
The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.
Many small companies are working with limited resources and as a result, employees wear a variety of different hats. As they look to begin the process of selecting a GFSI scheme, the process can be daunting. Where should they start? Which scheme makes the most sense? In an interview with Rick Biros, publisher of Food Safety Tech, Claudio Bauza discusses where small food companies can begin their journey.
At this year’s Food Safety Consortiumconference, don’t miss the “Ask the Experts–You Are GFSI Compliant. Now What?” The session takes place Wednesday, November 18.