Tag Archives: GFSI

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA and GFSI: Alignment and Gaps

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

A recent FSMA Fridays webinar, presented by SafetyChain and The Acheson Group, focused on the interesting topic of FSMA and GFSI: Alignment and Gaps. The discussion covered questions such as did FDA reinvent the wheel with FSMA, given GFSI? If you are GFSI certified, will you comply with all FSMA rules? What do you need to do in addition? Will FDA accept GFSI certification in lieu of an inspection?

David Acheson, M.D., and Jennifer McEntire, Ph.D., of The Acheson Group gave their perspective on where the rules and guidance shaping food safety programs in the industry are similar, and how they differ. We present below some excerpts.

Did FDA reinvent the wheel with FSMA, with GFSI already there?

Dr. Acheson: At a very fundamental level, GFSI is global and FSMA is more U.S.-centric, focused on protecting the American consumer. If you look back a few years, to the time when FSMA rules were being put together, there wasn’t clear understanding about the impact of GFSI and what it could accomplish. GFSI has evolved substantially since then, both in terms of the various standards, and in terms of the execution (preparing companies for audits and doing the actual audits). While there is a lot of alignment between FSMA proposed rules and the various GFSI guidance documents, I don’t think FDA reinvented the wheel with FSMA, which is more detailed, more prescriptive and U.S.-centric.

Which proposed rules are most similar to the GFSI guidance document, and which are different?

McEntire: If we consider the seven proposed rules under GFSI so far, and compare it with the different ‘scopes’ under GFSI, you can see within one scope several elements of FSMA rule:

Produce rule: In some areas what FDA is looking for is more prescriptive, more stringent than what GFSI has in their books, and in other areas, GFSI standard is more detailed. We need to remember that these are still ‘proposed’ rules, so it is hard to predict where FDA will land eventually.

Preventive controls: There is fairly strong alignment between this rule and GFSI. There is some minor differences, but the approach is quite similar.

Food defense: With this rule, you can see of the greater differences. Under FSMA, there’s a whole new rule, compared to just a few lines under GFSI for food defense. So FDA is more specific in what they are looking for and will expect food companies to do more work, over the GFSI scheme.

Sanitary transportation: FDA said they wanted to align with industry practices, and GFSI Logistics guidance for this rule. So broadly the requirements are consistent.

Foreign Supplier Verification Program: This is an interesting one, because there’s no GFSI call out for international versus domestic supplier. FDA is taking a more specific approach in what needs to be done to evaluate and verify foreign suppliers. In our mind, GFSI is taking a more appropriate approach, which FDA will need to consider, to include all suppliers, global or domestic.

There are other elements of GFSI that FDA has not issued rules such as traceability, but overall there’s general alignment between the two sets of food safety requirements.

When you look at some key differences, again, GFSI is global. FSMA more US focused. GFSI is more guidance documents and broad scope, while FSMA is actual rules.

When it comes to rule-specific differences, if you consider Preventive Controls, the proposed rule looks at it pretty comprehensively, not just at critical points. So while it’s aligned with HACCP principles, it builds on it, and goes beyond HACCP.

Also, there are some terminology differences: FDA calls the point person a ‘qualified individual.’ Each scheme has their own term for this person. Some standards require a team to evaluate – not just one individual.

Will FDA accept a certificate from one of the GFSI schemes instead of an inspection?

Dr. Acheson: This is a million dollar question and often asked. I feel if it is a full course inspection (based on a compliant, an RFR etc.), then no. FDA will want to do the inspection in order to do their regulatory job, as they are supposed to. Remember, there’s a lot of alignment between GFSI and FSMA, though it’s not a 100 percent. So will they accept a certificate in lieu of an inspection? Right now, no. but there will be a point, where FDA will take a certificate as recognition that a company is certified to a GFSI standard – and factor this in to a certain level, for instance, to determine who will get inspected this week versus next month. As the schemes evolve, and as GFSI becomes more aligned with FDA, keeping in mind that GFSI is intended to be more global than U.S. focused, if a company is certified against a GFSI standard, I think it’s likely that FDA will take it seriously.

McEntire: If a company is certified to a GFSI scheme, and is willing to share information of that certification process with FDA, it will go a long way in establishing credibility of the food safety and quality program. Of course, you need to keep in mind that the certificate is limited to that audit, which at best, is a snap shot of the company’s food safety management program a given time. Also, note that GFSI audits are currently announced, versus FDA inspections which are unannounced, where an inspector show s up at your door.

Broadly, if you are certified to a GFSI standard, you are in a good place to comply with FSMA rules, and in better shape than other companies who are not certified. But you need to read the rules, understand the rules, and see what additional things you need to do to be compliant.

Hear more about FSMA and GFSI – Alignment and Gaps, and what you need to do by clicking here.Next FSMA Fridays, on October 31, will cover Foreign Supplier Verification, Produce, Human and Animal Rules – 2nd Review Cycle – Part 2.

Gary Nowacki, CEO, TraceGains, Inc.

How Can You Improve Your Supplier Qualification and Management?

By Food Safety Tech Staff
No Comments
Gary Nowacki, CEO, TraceGains, Inc.

Proposed rules under Food Safety Modernization Act are putting new demands on food and beverage companies for prevention-based risk controls. FSMA specifically addresses issues related to this for both foreign and domestic suppliers. This is going to mean either allocating more people and more time or coming up with modern ways to address these increasing and emerging demands.

Gary Nowacki, CEO at TraceGains, Inc. will address the topic of Supplier Qualification and Management at Food Safety Tech’s Food Safety Consortium to be held next month in Chicago. He will speak about how companies are struggling with managing up-stream supplier and ingredient risk and how they can both save time and be more in control of these challenges by using powerful tools and techniques.

Nowacki says that often companies have partial information on necessary documents: “Previously, companies might have felt ok about having at least certain data on their suppliers. That’s not enough under FSMA and the increasing demands of GFSI schemes, audits, and auditors.” By automating tasks that free up valuable human resources to focus on more complex issues, says Nowacki.

Giving an example, he says think about automatically sending out notices to suppliers who are non-compliant on certain information or documents so that a valuable resource doesn’t have to waste time calling or emailing the suppliers.

The role of desk audits

Another way to strengthen supplier relationships is by doing desk audits, the topic that Chris Petrlik-Siegel, Supplier Quality Manager at TIC Gums, will address at the Food Safety Consortium.

In a desk audit, the auditor checks to see if a supplier’s system as documented meets the requirements of the GFSI code under which they are certified. It also confirms if the concerned person has validated and verified the Food Safety Plans and Food Quality Plans. The Desk Audit can be conducted as an off-site or on-site activity and issues found during the Desk Audit will be documented as non-conformities. Depending on the number and type of non-conformities documented, the audit will move to the next phase – the Facility Audit – or not move forward until and critical and major non-conformities identified are properly corrected and corrective action is verified.

“Desk audits are a great way to check how ready you are to be audited. These take a lot less time than an on-site audit, and really help in preparing for the actual audit. Desk audits are more to establish or strengthen the partnership with the supplier rather than to work on an audit for the purpose of complying with regulations,” says Petrlik-Siegel.

She explains that many times, a food company visits a supplier to do an audit, and realizes that it’s a waste of time due to lack of preparedness of the supplier. “Now due to new rules being proposed under FSMA, as an end product supplier, we are responsible for the ingredients in the products, and all the products we are importing from foreign suppliers. So we rely on in-depth audits to ensure that our suppliers have robust systems and procedures in place, in addition to what we follow in-house,” describes Petrlik-Siegel.

So with 70 suppliers, each on an average supplying about 10 ingredients, the Quality Manager stresses on the importance of desk audits preparing you for the final site audits, and also for better compliance with FSMA rules. It’s often overwhelming to do a thorough audit in a matter of one or two days, so it helps to look at documentation and identify any gaps ahead of time, Petrlik-Siegel adds.

Listen to Nowacki and Petrlik-Siegel speak about Supplier Qualification and Management at the Food Safety Consortium. Click here for more information and to register.

John Kukoly of BRC Global Standards

Where BRC is Going, and How Can You Get There?

By Sangita Viswanathan
No Comments
John Kukoly of BRC Global Standards

Food Safety Tech (FST): We’re very excited to have you participate in the SafetyChain/ FoodSafetyTech’s GFSI Leadership Webcast Series with the October 24 BRC – The Road Ahead webcast. We know that you’ll first be addressing what is new with BRC today. What are some of the things you’ll be talking about in terms of current changes?

Kukoly: We are just on the cusp of releasing Issue 7 for BRC. This is scheduled to be released in January 2015. With this, there will be some changes made to how food companies and facilities can obtain the BRC standard. We have a really unique system, termed BRC Participate, that we propose to unveil during this time, which I will talk about more during the webinar.

FST: We know that audits will be a topic of many questions. Is BRC planning changes to the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?

Kukoly: One of the changes I will be talking about is the auditor-competency program. Other topics will include expansion of our unannounced audit program. BRC is currently the leader in this area, and Wal-Mart has specifically asked us about this. We have done such audits in over 600 sites already, and are currently the go-to people for unannounced audits now. We are also forming BRC Global Markets, which will help small and less developed companies to get ready for certification.

FST: You will also be talking about the direction of BRC in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to BRC?

Kukoly: In my opinion, the two most critical areas of focus for the food industry right now are risk management and supplier management. These are the two main key elements being covered in all new regulations under development, and if a food facility has these covered, then they are in a good place. These are the two specific drivers that are shaping future changes to the BRC standard.

FST: While we all know that while 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 BRC certification?

Kukoly: I don’t think ‘why’ should be the right question. We should focus on ‘HOW’ to go about this. And I think we need to talk about food safety culture and change management. These are the areas that are key to success and embracing change.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s BRC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Kukoly: One of the topics I will be addressing is training, not necessarily for BRC, but for obtaining the right skill sets such as risk assessment or HACCP. These are necessary for any food manufacturing organization to prepare for tomorrow’s BRC, and to have robust systems and processes in place.

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 alignment with BRC?

Kukoly: If you look at FSMA expectations, they are very well aligned with requirements of BRC standards, whether it be supplier management and verification requirements, or risk assessment etc. Beyond that, it is about strength of traceability procedures, knowledge of FSMA within the facility and its qualified individual. The focus is primarily on robust supplier management programs and implementation. If all these are in place, then you are in a very good starting place for FSMA compliance.

Listen to John Kukoly talk more on these topics and take your questions live in the BRC – The Road Ahead webinar on Friday, October 24, 2014 at 10:00 PT/ 1:00 ET. Click here to register. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

High False Positive Rates for Pathogen Food Safety Testing

By Thomas R. Weschler
No Comments
Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

This article looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6 percent false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).

While at IAFP this year, I met with Heather Jordan, who directs food PT programs at API. The proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.

More proficiency testing but less proficiency?

In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI. Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).

In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.

In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?

Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results? Surprisingly, that’s not what the API research found…

API study: Performance accuracy for food pathogens remains problematic

In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.

Over the 14-year period, “False negative results ranged from 3.3 percent to 14.0 percent for E. coli O157:H7; 1.9 percent to 10.6 percent for Salmonella spp; 3.4 percent to 11.0 percent for L. monocytogenes; and 0 percent to 19.8 percent for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6 percent.

As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.

Tom-Weschler-False-Negatives-Sep-2014

The cumulative average false positive rate was 3.1 percent, less than half of the false negative rate for the same period.

The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”

Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone. It also points to a number of follow-on questions:

  • Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
  • PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
  • What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
  • Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
  • How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
  • And finally, is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?
Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000

“Make Consumer Safety and Food Safety a Hard Priority”

By Sangita Viswanathan
No Comments
Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000

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?

FSSC 22000 LogoDr. 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.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

SQF: Where is it Going and What Does it Mean to You

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent webinar, Robert Garfield, Senior Vice President of the Safe Quality Food Institute talked about the SQF standard, changes made in 2014, what is expected in 2015, and how companies can use SQF to be better prepared to comply with rules proposed under the Food Safety Modernization Act. We present below some excerpts from the webinar, organized under the 2014 GFSI Leadership Series. The next webinar in the series will focus on FSSC 22000. Click here to register.

Where is SQF going in 2015 and beyond?

Garfield: The standard is going to be focused on enhanced compliance programs and improving the database reporting systems. For instance, if it concerns someone in the bakery or dairy industry, we would like to know how they are doing versus the industry as a whole. We are hoping that better database reporting can help with this, especially when it comes to non-compliances.

Another area we are working on is establishing Cooperative Agreements. In 2014, we finalized an agreement with the American Feed Industry Association and we are working with their food safety program. We are hoping to not just work cooperatively with the private sector, but also with various government agencies and other stakeholders.

Other areas we are growing in 2015 are expanding our language alternatives, subject matter training and developing industry specific guidance.

There are many changes proposed to food safety regulations and food safety schemes such as SQF. How will companies be affected by these changes and why is embracing these changes so important to industry?

Garfield: Embracing all these changes is critical for the food industry to do everything they possibly can to ensure that they are making and selling a safe product. At the end of the day, there is no one ‘magic bullet’ solution to food safety. Embracing these changes to food safety rules and standards will help the CEO and management team sleep better at night, knowing that they are doing what they can to protect their product, their brand name and their consumers. Also, companies need to understand that the regulatory climate will completely change in the next few years, so it’s critical for companies to start acting now to meet these new requirements that will start being in effect from October 2015.

How can companies start preparing today for tomorrow’s SQF?

Garfield: I tell companies and retailers I talk to that if they are interested in doing SQF because they want to be ‘GFSI certified,’ that’s the wrong reason to do this. To get started, management commitment and changing the culture of the entire company is critical. Starting from the CEO and going all the way to the man operating machinery on the floor, you should aim to get a commitment to food safety, where food safety management is the most important issue for the company. If you start working on that today, you can accomplish great things for the company in not just reducing recalls, but improving the overall functioning of that company.

How can SQF help prepare companies for FSMA?

Garfield: The first step is to look at the Preventive Controls and the Fresh Produce rules and see how these apply to your company. I suggest hiring an independent expert to take a look at your facility and see how your company fares against these rules and have a better understanding about where you will be when these rules are finalized by October 2015. While you will have one to three years to comply with these rules after that point, you need to get the management buy in and strong food safety management systems in place now. Start now, and don’t wait for the final rules to be announced.

Listen to this complimentary webinar today to learn more about how SQF differs from other food safety programs, unannounced audits, changes with allergen control standards, and how to become SQF certified. Click here to access the recording.

2014 GFSI Leadership Series continues with FSSC 22000: The Road Ahead. Click here to register for this informative webinar on Friday, September 26, 2014, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000, who will talk about what’s new for FSSC 22000 this year, where FSSC 22000 is going in 2015 and beyond, how you will be affected by the changes, and how to start preparing today. Plus Jacqueline will take your questions live!

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Supplier Qualification and Compliance using GFSI Benchmarking

By Dan Okenu, Ph.D.
1 Comment
Dan Okenu, Ph.D., Food Safety Manager, H-E-B

An efficient supply chain is very important in retail food operations. To safeguard the supply chain, a comprehensive supplier food safety program should be an integral part of retail foodservice (see my previous blog on Combating Norovirus Hazards in Retail Foodservice). This becomes even more challenging because one, retail foodservice chains don’t own their suppliers; they’re independently managed businesses, and two, the new regulatory burden placed on retailers by FDA through the proposed FSMA rule to ensure that retailers are accountable on the sources and safety of their products to continue serving safe quality foods to their customers.

Thus, continuous verification of supplier qualification and compliance is as important for food manufacturers and food processors, as it is for food retailers. To fulfill this very important business requirement, the retail Food Safety & Quality Assurance job function would usually include the following roles:

  • To conduct continuous food safety audits and monitor suppliers to ensure compliance with all FDA/USDA, State and local regulatory standards;
  • To monitor adherence to product specifications, identify deficiencies and implement corrective actions in a timely manner;
  • To perform internal and external testing to verify risk assessment and risk mitigation procedures.

How do retail folks try to tackle these important business functions, especially since most retail chains have so many domestic and international suppliers? The Global Food Safety Initiative (GFSI) benchmarking provides a common ground for farmers, manufacturers, food processors and retailers on global food safety best practices. GFSI strengthens the supply chain, eliminates multiple auditing, increases confidence in safe quality food delivery while protecting the public health.

The different GFSI schemes which include PrimusGFS, BRC, SQF, GlobalGAP and FSSC2200 are auditing entities involved with several scopes of food safety and quality assurance service standards, while others like AIB, SGS, NSF and SAIGlobal are certification bodies that perform facility audits. As a business-driven initiative, majority of food processing facilities depend on the GFSI Guidance Document for supplier qualification and compliance by using any of their benchmarking schemes. The advantages are tremendous and include less product recalls and voluntary withdrawals, enhanced traceability, clearly defined risk management and HACCP control, acceptable uniform international standards, eliminates redundancy and frees up time and resources for both food manufacturers and retailers.

Apart from supplier compliance and approval, food retail companies also want to ensure that all potential suppliers align with their corporate values and standards of ethics. GFSIschemes however do not cover these corporate needs like environmental sustainability, animal welfare, ethical sourcing, compliant labor utilization, organic and non-GMO product verification. Moreover, the auditing time frame for most GFSI schemes is only about a few days and thus gives just a snapshot of the food safety practices in these GFSI-approved facilities. Retail food companies will therefore require a more elaborate supplier monitoring and approval system to ensure that certified facilities are not just compliant within the FDA auditing time frame of about one to four days, but that their food safety culture and practices are consistent with their corporate mission to deliver safe quality food to customers.

Additionally, such continuous monitoring and verification will ensure that suppliers are also complying with company policies outside the provisions of GFSI schemes. Proper training of retail Food Safety & Quality Assurance managers on FDA/USDA inspection requirements and corporate expectations at the food processing facilities is absolutely required. The use of third party auditors to assist retailers in verifying supplier qualification and compliance is also advisable because of the often overwhelming number of suppliers involved.

Finally, as FDA begins to implement FSMA, it would be pertinent to verify FSMA readiness of the different GFSI schemes. This will ensure that GFSI certified food manufacturing and processing facilities remain in compliance with the new regulatory provisions for FSMA covered facilities. It would help to avoid costly disruptions in the supply chain and allow businesses to meet their projected growth while serving safe quality food to their customers and protecting their business brand. Overall, GFSI certification remains the gold standard that will guarantee supplier qualification and compliance at both domestic and international locations.

 

Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Big Picture Understanding for Better Food Safety

By Sangita Viswanathan
No Comments
Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Having worked in the food & beverage industry as a plant manager, Katie Moore knows just how important food safety is to a company’s brand and profits. As GE Intelligent Platforms’ Global Industry Manager for Food & Beverage, she uses today’s connected technology to help prevent food safety issues and expensive recalls.

Companies want to do the right thing and try to control what is known. They want to mitigate risks when possible. But without a clear and complete line of sight to real-time process data and information, like whether or not your HACCP processes have been followed, correctly, each and every time as stated in your HACCP Plan, how can you truly have peace of mind going to sleep every night? That’s the gap that’s plaguing food companies and managers, says Moore.

Against the backdrop of evolving food safety rules under the Food Safety Modernization Act, Moore sees manufacturers in the food and beverage industry in a wait-and-watch mode.

“Since these rules are still in the process of being finalized, everyone’s waiting to see what the final regulations will look like. This is the right time for manufacturers to educate themselves, and implement new steps and programs to assess and mitigate risk,” she explains. Moore feels larger companies are much better at addressing these changes, because of having greater resources or collaborations with industry associations, while small and medium sized companies are continuing to implement HACCP and GFSI standards, but are a step or two behind their larger counterparts.

There is a lot of risk management going on, and it all begins with HACCP, says Moore. But a gap she’s noticing is a lot of records still being paper-based.

“There is still a lot of work being done on paper. And data is not being transferred automatically. Because of this, there is no way to go back and learn from what’s going on and identify trends and issues. There is truly no electronic capture of data. This lack of learning and understanding of trends and changes is a big gap,” Moore adds.

A lot of recent recalls are due to supplier problems, so everyone focuses on that. Companies are managing the biggest risk, which is their suppliers, and there are a lot of solutions available to manage supplier compliance. “But true value can be realized when this is tied in with your manufacturing processes and specifications. How is the food handled in my line, my tanks and my processing facility…. If companies have this continuous visibility it will contribute to food safety and quality improvements growing by leaps and bounds. And also companies will be able to track and trace throughout the process, and react a lot quicker,” she describes.

Mergers and acquisitions in the F&B space

These days, there is a lot of consolidation happening in the F&B space. Historically, whenever there is a merger of two food companies, there is a challenge to have in place a sound business continuity plan. For instance, Moore asks, if there’s a recall, then how do we react? If there is an issue isolated to one facility, how can we cover our bases and mitigate risks? How can we make sure our customers get our products? From an IT perspective also, there are some challenges that need to be addressed. For instance, what GFSI scheme are we using? Do we merge these two standards and our supporting IT infrastructure, or continue to work with two separate standards? The key in making this decision is to utilize big data analytics to determine which process has been working most efficiently and to factor in the cost of replacing or retrofitting the extremely expensive manufacturing equipment.

According to Moore, F&B managers need tools that can help them improve compliance to food safety, have better visualization and hence greater visibility either on the plant floor or via mobile platforms, have the ability to pull up a wide range of information and share it with people. F&B companies usually handle a wide range of project management systems, typically working on different software from different vendors.

At GE Intelligent Platforms, Moore says, the products ‘talk’ to different systems and data management software to try and address the challenge of collecting, managing and trending large amounts of data.

So are companies embracing technology solutions to better manage food safety and quality? Moore feels that a driving force is lacking.

“Once something happens and FDA has to react, the chips will start to fall. There will be a lot of recourse to technology that will be required, but right now there’s no driving force. Once FDA puts the hammer down on electronic documentation, F&B companies will start to move faster,” she sums up.

GFSI Position on Mitigating the Public Health Risk of Food Fraud

By Michael Biros
No Comments

New Food Fraud mitigation elements will be added to the next revision of the GFSI Guidance Document.

The GFSI board has decided to add two new key elements to the GFSI Guidance Document that address food fraud mitigation according to a recently published white paper. 

The additions to the Guidance Document will require a company to perform a food fraud vulnerability assessment and to have a control plan in place. The vision for the mitigation of food fraud to become an integral part of a company’s food safety management program. 

During a food safety certification audit, conducted against GFSI recognized schemes, the auditor will review the documentation related to the vulnerability assessment process and confirm that a comprehensive control plan has been developed and implemented by the company. 

Food fraud, including the subcategory of economically motivated adulteration, is not the same as food defense. Food defense protects against tampering with intent to harm whereas food fraud concerns the deception of consumers and includes substitution, unapproved enhancements, misbranding, counterfeiting, and stolen goods. The food safety risks associated with food fraud can be more dangerous and challenging to address than traditional food safety risks because the contaminants are unconventional. Some high profile food fraud incidents include the melamine tainted milk crisis, mislabeled recycled cooking oil, and knowingly shipping Salmonella contaminated peanuts. 

The new food fraud mitigation key elements will be included in the next revision of the GFSI Guidance Document (Version 7) to be released in 2016.