Tag Archives: FSMA

FSMA: What to Expect in 2015

By Aaron G. Biros
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Companies should start preparing for FSMA immediately, caution two food safety experts. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines. So are you prepared?

Two experts from The Acheson Group – Dr. David Acheson, and Melanie Neumann, in a recent FSMA Friday webinar, discussed what companies should expect from the FDA in 2015 and how they can adjust to comply with new rules as the final deadlines approach. FoodSafetyTech presents some excerpts:

With the FSMA comment deadline closed, what can we expect from FDA in terms of finalizing FSMA?

With the agency still answering questions and conducting FSMA related activities such as dealing with deadlines and proposals, we can expect to see the agency go silent on that. We have gone through multiple comment periods already so we should expect them to stick to their timeline of implementing rules.

What is FDA ultimately seeking to achieve with these rules?

When we look at where FDA is going in 2015, we need to look at what we should be doing in the private sector under FSMA’s prevention scheme. FDA is trying to require companies to think about preventative controls. It is about understanding where your risks are and using the appropriate controls. The main issue surfaces when regulators and suppliers have different senses of what appropriate controls really are. So, thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or importer, is going to be key in planning for the future.

When is it anticipated that the FSMA rules will be finalized?

Going from reactive to proactive and preventative strategies is the essence of FSMA’s effect on shifting the regulatory scheme. Therefore we should expect preventative control rules to come out first. We must put together a monitoring program and corrective actions in our food safety plan proactively. The FDA really wants to get these rules rolled out and enforced before the administration changes in 2016 with the next presidential election so we can safely assume they will try to stick to their published timelines (most proposed rules have a deadline in Fall 2015 with the latest in the spring of 2016).

What will some of the biggest challenges be for food and beverage companies as they begin to consider FSMA compliance?

The biggest challenges will deal with how to properly manage, store, and retrieve documentation. All the traceability data, information, and production and supplier documentation that is key in a recall should be readily presentable. Having all this data and documentation, being able to produce it quickly and turn it over to the on demand is the biggest hurdle. Companies need to leverage technology to manage this risk in documentation and data organization.

What should companies be doing now to begin to prepare for FSMA as we wait for the final rules?

Companies should start preparing for FSMA immediately. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines.

Supply chain risk control and environmental monitoring are new and challenging ventures. The behavior of FDA in the past few years have shown that any company that needs to comply with preventative control rules should really pay attention to their environmental monitoring program.

HAACP systems are likely to be fairly robust and will translate quickly, but environmental monitoring could be considered the Achilles’ heel. The other Achilles’ heel is the supply chain. This was in the original statute giving FDA the authority to require supply chain risk assessments and controls. This has resurfaced in the re-proposals, which is very reflective of the foreign supplier verification program. Look at what you know about your supply chain. The expectation will be that you control those risks.

The other challenge is FDA is expecting you to look more than one step upstream. If you are buying your ingredients from a distributor, it is your responsibility to institute preventative controls in environmental monitoring Companies need an organized central repository of all upstream, internal, and downstream documentation and data.

GFSI standards compare to the preventative control rules. The standards might be highly robust but that does not necessarily mean you comply with food defense and foreign supplier verification programs. Keep all that in mind when looking strategically toward 2016.

Summarized by Aaron Biros

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Final FSMA Rules – How to Prepare?

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent FSMA Fridays event, three experts from The Acheson Group – Jennifer Cleveland McEntire, Ph.D., Vice President and Chief Science Officer; <strong”>Anne Sherod, Director of Food Safety; and Valerie Scheidt, Director of Food Safety – talked about preparing for final FSMA rules. Food Safety Tech presents some excerpts:

FSMATo-DoListHow close are we to the final rules in terms of how much can things still change, and are we more confident about some rules than others in terms of how much change we might still see?

We anticipate some changes with the proposed Third Party Certification rules especially around the responsibility of auditors to have mandatory reporting to FDA if they find any signification non-conformances. And this covers findings from consultative audits as well, so we feel it may be counterintuitive to do this as companies are aiming for continuous improvement.

We also think they may be some changes with the Food Defense rule. The agency may consider how GFSI views food defense and some of the mitigation strategies that are being proposed.

But for the most part, we think the other proposed rules will pretty much be as is.

What are Top 3 things that companies should be doing NOW to prepare?

First, companies need to figure out who that qualified individual will be especially in manufacturing facilities that have to comply with the preventive controls or foreign supplier verification rule. It’s important that this qualified individual is adequate informed and understands their responsibilities and what they need to do.

Also it’s really important to understand thoroughly the preventive controls rule and how it applies to your facility for instance, to your pre-requisite programs, GMP etc. Analyze how the preventive control rule will go beyond process control, and CCPs.

Another aspect that companies are really struggling with is document management, and realizing how they will be used by FDA.

Adding a fourth to do, companies need to be thorough with Supplier Controls – understand who is in the supply chain, and how they have been approved. FDA will be interested to know if you know their risks and how you are managing them.

In the area of supplier control, FDA made some significant changes in this last round of revisions. Will these hold? If so, what should companies be doing now to prepare?

You will need to have strong supplier controls. Although it looks like a new component, it was always expected. While regulatory compliance is the baseline, what we are seeking in brand protection as an end result. There are two things to get started – get a supplier approval process in place, after assessing supplier risk and making decisions on what can control that risk. You will also need to have monitoring and verification programs, and corrective actions in place.

Step two will be managing all this information. Documentation needs to fully support this system. Companies can do this either manually, or leverage technology that they currently are using, or can look for new technology opportunities. Whatever option they choose, companies must have everything in writing, especially a list of non-negotiable items that they can provide to their suppliers to see what they can do to meet your requirements.

From a scientific standpoint, it looks like companies will need to validate safety processes. Will FDA will be flexible in accepting tried and true operations, or will new studies need to be conducted?

FDA will accept tried and true operations, e.g. if you are doing a cook process, and you are monitoring for end point internal temp of 160 degrees, or if you have pH control of less than 4.6, and if these help in eliminating pathogens, then you have scientific validation for what you are doing. However, if you are doing a new process or a novel product, and have no process that’s scientifically supported, such as cook process, temperature or pH control, you need to have supporting data. In such cases, you will need to reach out to a Qualified Individual, and possibility have to do those studies to to make sure you have scientific justification for validation of your food safety plan.

What are requirements for a qualified individual?

A qualified individual is someone who has the required education, training, and experience to make decisions that are needed. However, that FD training that is required, doesn’t exist yet. So there’s a little bit of ambiguity here. But you look at types of responsibilities and information they need to know, the individual primarily has to be knowledgeable and confident about food safety. Just because that training and curriculum aren’t out yet, it doesn’t mean that you cannot look intuitively, and tell and this is the appropriate person and identify any training they may need.

Click here to listen to this webinar, and get more of your questions answered.

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

Benchmarking Produce Safety in the New FSMA Regulatory Climate

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

Produce safety featured prominently in the recently concluded Food Safety Consortium in Chicago November 17-18, 2014 for two reasons: First, produce remains the largest source of foodborne illness outbreaks in the United States, and second, the recent supplemental notice by FDA calling for another round of public comments on the proposed rule for “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

Thus, a consortium of growers, processors, packers, suppliers, retailers, buyers, innovators, regulatory officials and food industry consultants came together in the retail foodservice track to discuss “Benchmarking Produce Safety from Farm to Fork.”

The central question revolved around compliance with FSMA provisions to continue supporting the availability of safe quality food in a cost-effective manner. Issues surrounding the provisions of foreign supplier verification and how to engage with FSMA-exempt small local growers and suppliers on produce safety were discussed. The thorny problem of a quick and reliable traceability system for produce was also addressed. Other issues that were discussed include: how to ensure and verify good agricultural practices in the farms; introducing a safe and effective kill step in both cut and whole produce; and how to avoid cross-contamination on washed ready-to eat (RTE) fruits and vegetables. We also deliberated on how to close the gap in-between FDA audits to ensure that proper food safety practices are in place all year round.

The consortium brainstormed on how to take the current produce safety industry practices to the next level, towards a science and risk-based preventive approach as provided for in FSMA. To adequately address the issue of auditing gaps and the FSMA foreign supplier verification provision, it was suggested that it could be cost-effective for large scale buyers to embed their employee on site with large scale growers, processors and suppliers, especially for those located in foreign countries. This will support a real time status update on the food safety practices in place at such foreign facilities by your corporate employees, and in fact reduce the need for expensive frequent and auditing visits that don’t really capture everything. It can also be a conduit for training and maintenance of corporate food safety and quality standard to enhance the delivery of safe quality products, especially if your company is doing business in developing countries where food safety policies and regulatory enforcement are still in rudimentary stages.

Alternatively, make it a corporate policy to do business with only GFSI-certified facilities and increase the frequency and duration of unannounced audit visits for a more representative assessment and documentation of the prevailing food safety practices in place.

In addition, some private-label food programs involve ownership of farms, manufacturing plants and processing facilities. Thus, some retailers operate their own farms and plants both here in the United States and in foreign countries, and that may enhance active managerial control on produce safety from farm to fork. Engaging small local growers who are FSMA-exempt through an organized Agricultural Extension Services will enable resource sharing for implementing standard food safety practices and support integration in the local market. It will not only bring down cost but will also increase the availability of fresh fruits and vegetables without the need of a long distance temperature-controlled distribution network.

Both government and the private sector can support the running of these extension services in a more robust manner that builds upon the current USDA Cooperative Extension System which provides useful, practical research-based information to agricultural producers. A safety gateway could be established for produce from local growers through innovation on an effective pathogen kill step that can achieve up to 5-log reduction using effective consumer-friendly sanitizers.

GRAS classified sanitizers like electrolyte water, Ozone, hydrogen peroxide, chlorine dioxide and sodium hypochlorite are under various stages of R&D and some have been found to extend produce shelf life as well. Since the absence of a microbial risk does not preclude chemical contamination; continuous testing and monitoring for chemical residues that may result from the use of pesticides, contaminated soil or manure is recommended. A reliable produce traceability system will facilitate the investigation of foodborne illness outbreaks and timely corrective actions.Current R&D innovations in this area include the use of DNA tagging to assist in identifying both cut and whole produce even when out of the box. It was also stressed that behavior change is as important as the technology-driven interventions, and as such should be encouraged among retail and foodservice workers to embrace best practices and avoid actions that may lead to cross-contamination of RTE foods. Washing and rinsing of produce singly in running cold water is not only recommended for removing dirt and foreign matter but also for eliminating potential cross-contamination that may result from soaking fruits and vegetables.

Overall, it was a lively discussion that was spiced with practical real world examples by highly experienced industry leaders and decision makers.

Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

How is FDA Surveillance Keeping Pace with FSMA Changes?

By Sangita Viswanathan
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Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

Proposed rules under the Food Safety Modernization Act will mandate more inspections, more testing, and better risk-based profiling of food products – both sourced domestically and imported. How is FDA planning to keep pace with these changes? Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA, provided some insights, while speaking at the recent Food Safety Consortium, organized by Food Safety Tech. 

Section 201 under the Food Safety Modernization Act requires the Food and Drug Administration to designate food facilities at high-risk and non high-risk facilities, and accordingly, establish minimum frequency of inspection of these facilities. While high-risk facilities will have to be inspected by FDA once every three years, facilities deemed non high-risk will be inspected once every five years. Wagner described that the following factors have been considered so far for determining if a domestic food manufacturing facility is determined to be high-risk or otherwise:

  • Whether the facility has been involved in a Class 1 outbreak or recall;
  • Whether the facility has a history of non-compliance (based on Official – Action Indicated (OAI) or Voluntary Action Indicated (VAI) data);
  • If the facility has had any significant violations;
  • Future data considerations (see below);
  • Type of activity the facility is involved in; and
  • Date of last inspection.

Future data for consideration of high-risk and non high-risk categorization will include:

  • Inherent risk factors at product level (for instance is the product bakery goods, or seafood/ fresh produce etc);
  • Has the facility been linked to an outbreak, recall or adverse event (if so the risk profile gets elevated);
  • If any sample testing (product or environmental) is positive;
  • If there’s a history of customer complaints;
  • Robustness of QA/QC programs and 3rd part audit reports;
  • Financial viability of the company; and
  • Food safety culture of the facility/ company.

Foreign facility inspections

Under FSMA, FDA has also been mandated to increase the number of inspections the agency does on foreign facilities, to ensure the safety of imported foods. Wagner explained that FDA currently conducts about 1200 foreign facility inspections a year to determine if those facilities meed FDA regulations. With FSMA rules, FDA will have increased authority to conduct such inspections of foreign faciligies, and look at Foreign Supplier Verification Programs, and Voluntary Qualified Importer Program records, adds Wagner.

Under the new regimen, FDA has been mandated to conduct at least 600 foreign inspections during the first year of FSMA rule implementation. And the target is to double this number every year, for the next five years, taking it to 19,200 inspections by Year 6. Wagner feels this is an impractical number as FDA does not have the resources to do so many foreign inspections. “If we get the Foreign Supplier Verification Program under FSMA rule right, we effectively place the responsibility for ensuring safety of imported foods on the food industry and importers. FDA cannot, and should not be doing this,” she explains.

Risk-based foreign facility site selection

FDA will also adopt a risk-based approach to select foreign facilities for further inspection. This approach will consider:

  • Food safety risk associated with the sector or commodity;
  • Risk associated with manufacturing process;
  • Compliance history of facilities associated with an industry sector commodity in a given country or region (for instance, look at refusal rates for products denied try into the U.S. by country);
  • Quantity or volume of imported product from country or region;
  • Robustness of food safety system in the country; and
  • Portion of resources retained by the facility for compliance, follow up inspections and emergency response situations.

Based on this FDA will continue to diversify the product that it considers high risk, for instance dairy, baby food, candy… Wagner added that economically motivated adulterated continues to be a concern and cause for focus on food products such as oils, honey and dietary supplements.

Wagner also talked about Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT, a risk management tool used by FDA to efficiently and effectively make entry admissibility, decisions that prevent entry of adulterated, mis-branded or otherwise violative imported goods into the U.S., while expediting the entry of non-violative goods. Based on risk scores allocated to different products, this computerized tool targets entries of highest risk for further scrutiny, including field reviews and sampling.

She explained that this dynamic tool, which constantly adapts to different risk situations and products, provides automatic data mining and pattern recognition, provides automated queries of FDA databases including facility registration information, and thus, allows for risk-based allocation of FDA resources.

Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

What Should You Know About Food Safety Testing?

By Sangita Viswanathan
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Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

Food safety is in the news. Recent food industry, regulatory and consumer trends stress proactive, systematic and preventive approach to food safety by managing food hazards and risks. Testing for food safety hazards, particularly microbial hazards and allergens throughout the food production and processing chain is becoming increasingly important in assuring food safety. Food testing is also becoming important for detection of adulteration.

In next week’s Food Safety Consortium to be held in Schaumburg, IL, Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin, River Falls, and President of PCV & Associates, LLC, will discuss trends in the food safety testing market and approaches for testing of food and food plant environment, emphasizing microbial and other significant food hazards. In this article, PC, as he is popularly referred to, gives a sneak-peek into his presentation.

Food Safety Tech (FST): You will be speaking about the Food Testing Market – what are some broad trends that you are seeing?

PC: Food Microbiology testing is increasing worldwide but majority of testing is still dealing with food quality assurance and ingredient and product testing. Testing for pathogens seem to be driven by regulatory requirement. According to recent market reports, 76 percent of test volume in North America is for routine microbiology. In the EU and Asia, routine microbiology accounts for 81 percent and 72 percent of test volume, respectively.

Most pathogen testing is for Salmonella, E. Coli 057:H7 and Stex, Listeria and as L. monocytogenes. There is an increasing interest in testing for Campylobacter.

Testing of in-process and environmental samples is more common in NA and Europe. In Asia in-process/environmental testing only accounts for 9 percent of total test volume.

FST: In your presentation at the Consortium, what will you talk about FSMA and its impact on food safety testing?

PC: I plan to include a brief discussion on testing as related to monitoring and verification of Preventive Controls.

FST: Where is food safety testing headed, and what should food safety managers keep in mind?

PC: Given the emphasis on supply chain management and process control to manage identified hazards in preventive mode, food safety managers should understand testing internal and external testing requirements and complexity of sampling, testing tools and approaches not simply focus on cost aspects. Even if testing is outsourced, becoming familiar with various methods and testing tools will be necessary.

FST: Who should attend your presentation and why?

PC: Plant managers, quality assurance supervisors, marketing managers, food safety testing methods, equipment and service providers as well as anyone interested in food safety testing would find this presentation very useful and relevant to their day-to-day activities.

Are you registered for the Food Safety Consortium yet? Sign up now, and hear from over 70 experts in this area.

Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

Food Safety Consortium Sneak Peek – Food Defense Rule

By Sangita Viswanathan
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Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

The Food Safety Modernization Act is the first instance of codified food defense regulations. This discussion is a hard look at the proposed food defense requirements and examining what compliance may look like. 

At the upcoming Food Safety Consortium, to be held November 17-18 in Schaumburg, IL, Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association (GMA), will address the key takeaways associated with the proposed regulation.

Following this presentation, Sarah Sunday from Kraft will talk about challenges the industry will face in implementing the rule as written and how the industry currently addresses food safety.

In a chat with Food Safety Tech, Cooksey provides a sneak-peek into her presentation.

FST: How are Food Defense requirements evolving under proposed FSMA rules?

Cooksey: GMA led industry in developing comments on the proposed Food Defense rule earlier this year, specifically focusing two things: one, food defense is different from preventive controls and two, food defense cannot be prescriptive—it needs to be tied to a facility-specific risk evaluation. While FDA has not yet re-proposed new food defense language as part of the supplementals released on September 29 of this year, we have good reason to believe that FDA has shifted some of its positions in light of our comments. We also believe another opportunity to submit comments on a food defense supplemental proposal, similar to what was done with Preventive Controls, would be a valuable use of time for both the industry and the Agency as they move towards issuance of a final food defense rule in May of 2016.

FST: What are some things that companies need to keep in mind to be prepared to comply with these requirements?

Cooksey: While this is the first time food defense is being proposed as a regulation, there are already some existing training materials available to industry to begin developing food defense plans. Since the requirement to have someone specially trained in food defense will likely be part of the final rule, GMA recommends that companies start early and take advantage of the available materials already available. GMA and the GMA Science and Education Foundation are planning to release additional materials and courses in 2015.

FST: Who should attend this discussion, and how would they benefit from it?

Cooksey: Security specialists at the facility and corporate level regulatory affairs staff who oversee food defense and/or FSMA within their companies should attend. Also, food quality assurance and food safety managers will need to know how the food defense plan will work in combination with food safety plans.

Click here for more information on the Food Safety Consortium, and learn from over 75 of the Food Industry’s top food safety SMEs.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA and GFSI: Alignment and Gaps

By Sangita Viswanathan
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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
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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.

Gary Smith, Eurofins’ Food Safety Systems

Why Food Safety Training Fails, and What Can be Done?

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

The food industry has multiple levels of people involved, ranging from leadership and supervisors, all the way to line and front-end workers. Training, thus, has to not just give directions, but also provide better understanding of why we do what we are supposed to, says Gary Smith at Eurofins.

Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, says that “training for supervisors and leadership usually works well. But training workers is fraught with challenges. General training is focused more on giving directions, but not so much on providing understanding. People often skirt this rationale with the line workers, or it’s lost in translation, or missed out due to time constraints, turnover, vacation days etc. That’s where training fails.”

What would happen if we don’t spend this time address the ‘why’ behind training? People then get busy, and then miss out on steps and processes, and that causes problems, Smith replies. “It’s also critical to aim to strike a balance, for instance with line workers training – you have to ensure they understand the importance of what you are training them on, but at the same time, you cannot go too deep into the training, that would be either unnecessary or redundant.”

So what kind of training will continue to be the focus for the industry? The usual ones will continue to be important, according to Smith: Regulatory requirements for seafood, specific HACCP requirements for meat, HACCP training for employees directly responsible for food safety and quality, standards training; training for audits… For line workers, training also needs to cover specifics of their jobs, employee hygiene practices (for instance, why it’s important to wear gloves, hairnets etc.), and how to handle customer complaints.

Proposed rules under the Food Safety Modernization Act are having a positive impact on training needs, says Smith. “Everyone is now waiting for the final set of rules to be announced and implemented. A lot of good things are coming out of it, such focus on risk management and process control, understanding which products are high risk and low risk. FSMA has brought back HACCP for those industries that haven’t really had strict regulatory requirements for food safety – such as seafood, fresh produce, juice etc., or ready-to-eat products that may have escaped regulatory scrutiny in the past, such as fresh produce, and bakery products. Now the industry as a whole needs to focus on FSMA implementation, by companies helping its employees understand where the food safety risks are, how to manage them, document them, and mitigate them.

How can training help companies towards certification? When training leaders that are going to be implementing the food safety standards within their facility, it’s important to be comprehensive about understanding the specific standard. There is also the opportunity to focus on common non-conformances and say ‘this is where others have struggled and this is what you can do to avoid those non-conformances.’ Training can provide lessons, solutions and ideas to address common problems to addresses non-conformances before an audit. It can help drive continuous improvement, and help secure management commitment.

What are some of the common training themes that have resonated with Smith? He says that mostly employees bring up the issue of getting management to understand the need to focus on food safety training and procedures. “People who have attended my classes are usually struggling with getting management commitment. They are often told they need to be certified to a particular standard by end of the year, and so figure it out, but there’s no skin in the game from management. I help these trainees walk through the various steps that they can take to secure that commitment, how to talking their language in terms of more efficient production, and higher dollar savings etc.,” Smith describes.

Some challenges that he has observed in his years of training? Smith says that often times the trainers are great auditors, but poor trainers. “They will quote standards, and regulations. They are too black and white, and objective. However, training can have successful outcomes only when it’s practical and linked to real situations and ideas.”

John Kukoly of BRC Global Standards

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

By Sangita Viswanathan
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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.