John A. Wadie, U.S. Marketing Development Manager, 3M

Interview: 30 Years of Petrifilm Technology

By Sangita Viswanathan
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John A. Wadie, U.S. Marketing Development Manager, 3M

3M Food Safety celebrated a milestone this past summer – the 30th anniversary of its PetrifilmTM Plates – currently the worldwide standard for fast, simple, easy-to-interpret indicator testing.

First introduced in 1984, the 3M Petrifilm Plate technology has long been the industry standard for efficient and reliable colony interpretation and enumeration for the F&B industry. In a chat with Food Safety Tech, John A. Wadie, U.S. Marketing Development Manager for 3M Food Safety Department, talked about the adoption of Petrifilm continuing to grow worldwide, which spoke to the product’s value and utility to the industry. We present below excerpts from a Q&A.

FST: How has the food safety environment changed in the last 30 years?

Wadie: The food industry has become increasingly global, with great awareness among consumers about food safety issues. The combination of these trends, combined with constant information dissemination on a variety of food safety issues, has placed enormous pressure on food companies to test more, do it faster and do it more efficiently. From a regulatory stand point also, there is much more pressure on food companies to proactively maintain and manage stringent food safety procedures, and testing plays a big role in managing this. The biggest change has occurred with the speed of testing. Alongside even faster testing, is the demand for accurate and consistent testing and results.  

FST: What attributes of Petrifilm Plates have made it so popular over the last 30 years?

Wadie: With more than 2 billion units sold and counting, 3M Petrifilm Plates are the world’s leading food indicator testing technology. They are currently in used by all kinds of food processors, universities, governments and third-party contract labs in no fewer than 65 countries.

3M-Petrifilm-July-2014The standout feature of the product, and probably the primary reason for its longevity, is its simplicity, due to the fact there is no need for customers to prepare, purchase or store agar dishes. The technology has also received numerous country-specific, as well as global, validations from multiple, rigorous sources. With Petrifilm Plates, you also ensure the consistency and accuracy of test results from technician to technician, and between plant locations, and these are very important attributes in the current multi-location setting of food companies.

FST: Against the backdrop of FSMA, how is food safety testing set to change in the near future?

Wadie: With new regulations, there’s even greater focus on food safety testing, and getting fast, consistent and accurate results. The regulations, and the standards benchmarked under GFSI, are also laying emphasis on how the testing is done, where it’s done, and who is doing it.

The next 30 years will continue to bring faster and more accurate methods of testing as well as improvements to the preparation process. With greater innovation and rapid detection technologies, it may soon be possible to do inline testing – to identify pathogens and bacteria within production lines as opposed to testing being a separate step.

SCS Global's Sr. Technical Director and Auditor Heena Patel

What’s a Successful Food Safety Audit?

By Sangita Viswanathan
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SCS Global's Sr. Technical Director and Auditor Heena Patel

Audits and being prepared, and audit-ready are becoming increasingly important in the food safety world as the industry is moving to compliance with rules proposed under Food Safety Modernization Act. In this Q&A, from a webinar hosted bySafetyChain Software, and SCS Global Services, Heena Patel, SCS Global’s Senior Technical Director and Auditor answers some key questions about audits.

Q: What are the 5 top Best practices to follow for successful audits?

Heena Patel: As an auditor myself, I have conducted hundreds of audits. Auditors look for specific things and can make keen observations. They look for confidence, if the audit team on the site is well prepared for the audit or not. So be prepared for the audit. Be confident, follow the audit plan, have key staff present for the opening and closing meetings and for the facility walk through.

Don’t make the auditor wait for you to locate reports and records. Follow the audit plan; the plan is sent to the site ahead of time for a reason. It has details about the audit and what it would involve, and is a very good guideline that can be used to prepare for the audit by getting ready all the necessary reports and records.

Conduct mock internal audit to prepare for the final audit. Internal audits can help you prepare for any surprises. Use the information for the internal audit to answer questions during the actual audit.

Senior management must be prepared to show commitment and support for the food safety team. This matters a lot to the auditors.

And finally, feed your auditor well. It’s not a good idea to have a grumpy auditor.

Q: What are the biggest ‘No-Nos’ leading to deductions?

Patel: I would list the following items that lead to deductions:

  • Lack of management commitment and lack of team work;
  • Being unorganized and unprepared;
  • Not following and/ or not understanding code requirements; and
  • Not fully answering auditors’ questions.

Having incompetent team and incomplete documentation reveals the company not having the necessary training, or professionally trained personnel in-house. Having pre-requisite programs in place is huge in the audit checklist and this covers aspects such as sanitation practices, mock recalls, allergen management, training, testing, etc. We also look for business continuity plans, and management reviews. At SCS Global, we use a matrix with all this information to see what has been addressed well during the audit.

Q: What do auditors look for in demonstrating continuous improvement?

Patel: As an auditor, I love this aspect of an audit. Auditors don’t like to see that the program is not moving forward and is not getting the commitment and resources required from management. They must be focus on investing in employees with training and continuous education programs; and focus on upgrading structures and fixtures throughout the building as needed. Key performance indicators or KPIs must be developed that measure the performance of the food safety and quality program. These must be based on findings of the internal audit, external audit, or recalls etc. It’s also important to trend and evaluate this data during management meetings to see where the program stands and how it can be improved, as part of the continuous improvement program.

Q: How can companies best prepare for unannounced audits?

Patel: Unannounced audits are great from an auditor’s view point, as we can use this to see if the site is truly audit-ready at all times. Often with announced audits, we go in and notice that the floor has been swept well, there are no cobwebs anywhere, everything’s nicely arranged on the shelves etc. But you also realize that the mock recalls has been conducted the day before; the internal audit was conducted two days earlier. And this is not a good sign.

It’s important for food facilities to have a schedule in house in which records based on internal audits/ sanitation programs/ mock recalls etc. can be updated on a continuous basis. The actual audit should just be used to review and sign off on these records.

How can companies be audit ready at all times? By monitoring all programs continuously; keeping the facility clean at all times; and keeping the paperwork up to date at all times.

Q: How can automation/ technology facilitate audit readiness?

Patel: Many years ago when I used to audit food facilities, there were no automation systems in place. Auditors were using hard copies and paper checklists. Now, automation has made the entire process more efficient and communication friendly. Automation can help prepare audit plans, schedule tasks and assign food safety personnel to different parts of the program; have a centralized repository for records and data; work with Certified Bodies and suppliers who can all see information in one place; report non-conformances; put in place due dates for suppliers and auditors to either confirm or reject actions; have records on who conducted the audit, all non-conformances, all corrective actions etc. Having automation technology helps save on all the paper work involved in managing a food safety program and preparing for an audit.

To sum up, automation can:

  • Provide greater records efficacy;
  • Make it easier to communicate with your auditor when on-site and pre-/post audit;
  • Incorporate automated reminders to help food safety managers and auditors meet required deadlines; and
  • Save time preparing for your audit by automating record keeping.

Get more insights into the auditor’s point of view as Heena Patel answers more questions on this topic. Click here to access the recorded webinar. 

What’s the Long-Term Value of Compliance Management Software?

By Brenda Percy
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When looking for an enterprise software solution, it is important to take into consideration its potential for long-term value. What exactly does this mean?

EtQComplianceManagementCost-Nov2014In a nutshell, long-term value is the amount of savings you can expect after using the software for a long period of time. Are you paying less in the long run or do you end up paying more? Keep in mind that lower upfront costs don’t always equate to lower long-term costs. It’s important to consider this when evaluating software vendors in order to choose the vendor that will provide more for your money…even years down the line.

To make the case for long-term value, EtQ commissioned Forrester Consulting to conduct a Total Economic Impact (TEI) study to examine the potential Return on Investment (ROI) enterprises may realize by deploying the EtQ Reliance platform. This TEI study provides readers with a framework to evaluate the potential financial impact of the EtQ Reliance platform within their organizations.

Forrester derived its conclusions in large part from information received in a series of in-depth interviews conducted with executives and personnel at four customers, each of which had been using EtQ’s Reliance platform between 1 and 9 years. Forrester’s findings break down the cost saving potential of EtQ Reliance. Through interviewing these customers, Forrester created a composite organization to describe the TEI of EtQ Reliance.

Forrester classified the organization as a North American-based F-1000 company that manufactures and sells a wide variety of products and associated services, and with overseas operations in EMEA and APAC. This study projects the costs and benefits received over the course of three years. The composite organization has been using EtQ Reliance for three years to manage and track compliance and to meet its strategic goals. The study measured the use of the organization’s Document Control, Nonconformance Management, Change Management, Audits, Corrective Action and Delegation and Escalation tools.

The TEI methodology consisted of four components to evaluate the investment value of EtQ—benefits, costs, flexibility and risks. So what was the outcome?

  • The research shows a three-year risk-adjusted ROI of 77 percent for organizations using the Reliance platform.
  • Net Present Value (NPV) of more than $1.6 million attributed to modules such as Document Control, Nonconformance Management, Corrective Action and others.
  • Savings of more than $3 million over the course of three years.
  • 30,000 manufacturing labor hours saved.

The organization had a goal of achieving the following benefits which it was able to do with EtQ:

  • Increased productivity through compliance tracking and reporting.
  • Reduced employee time and effort in managing and tracking compliance processes.
  • Reduced risk of nonconformance in safety and quality.
  • Grow revenue and profits.

EtQ has been proven to provide long-term value and we are pleased with the results. To see more highlights from this study, see the TEI infographic (click on it to enlarge).

*This is a commissioned study conducted by Forrester Consulting on behalf of EtQ. It is not meant to be used as a competitive analysis.

 

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.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSVP: What Has Changed in the Re-proposed Rule?

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

In a recent FSMA Fridays webinar, Dr. David Acheson, and Melanie Neumann of The Acheson Group covered some of these changes and its impact on the food industry. Food Safety Tech presents some excerpts:

What is FSVP all about?

Dr. Acheson: The foreign supplier verification program is supply chain risk control for imported foods. Following the melamine in pet foods scandal that originated in China, the legislation was aimed at tightening preventive controls for imported foods. The rule concerns companies that import food from foreign manufacturers, and requires them to ensure that those suppliers are complaint with FDA requirements in the U.S. and thus, you are addressing risks along the supply chain.

How did the re-proposals change FVSP rules?

While there are several changes proposed, the entire substance of the FSVP rules haven’t changed as whole. Overall the changes seem to align the FSVP rule closer to the preventive controls rule in terms of wording and intent. Some of the changes include:

  • Approved Suppliers: As long as an importer can demonstrate that they have a process to approve suppliers, and that they follow it, there is no need for them to maintain a list of approved suppliers. However, this raises a question: If you don’t have a list of suppliers, do you know if your supplier is approved or not?
  • Supplier Risk: FDA now requires an evaluation of supplier risk along with product risk. Factors that should be considered include regulatory compliance, the history with the supplier (including test results and their willingness to correct problems), and any other relevant factors.
  • Audit requirements: In the original rules, FDA asked whether or not an initial audit and subsequent annual audits should be required when an importer identifies hazards that could cause serious adverse health consequences or death to humans or animals. In the supplement, FDA has basically said that yes, audits should be required under these circumstances, but has also given the flexibility in stating that if an importer can demonstrate that the risk can be managed in some other way, and that suppliers can be just as effectively verified through other means, then the importer is free to use other tools, or to decrease frequency of the audits.
  • Duplication of efforts: FDA will not require food manufacturing facilities who are subject to preventive controls (and who rely on suppliers to control significant hazards) to keep a whole additional plan in place to comply with FSVP.
  • Definition of very small importer: In the re-proposed rule, FDA has set $ 1 million in annual sales as the definition for very small importer, which aligns with the definition in the Preventive Controls rule.

Will food and beverage importers be expected to do onsite audits of foreign suppliers?

As described above, importers are supposed to do onsite audits, but only for significant hazards. Earlier FDA had provided two options. In the re-proposal, FDA seems to going with Option 1, which requires an annual audit for those supplier with significant hazards, but had added flexibility, by which the importer can determine another way of determining risk, or a less frequent audit schedule in lieu of that annual audit. But here’ the concern: While I embrace flexibility and decision making power at the industry or importer level, but there’s no objective bar set. The new requirement seems to say, ‘You have to do this, but you don’t have to do this, if you think you don’t have to do it!’ As a lawyer, looking at this in writing, it raises some flags about enforcement.

Click here for more on this exciting and evolving topic, including answers on where GFSI audits fit in, and what should U.S. importers be doing now to be ready to comply with FSVP requirements.

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

Interview: “Look at your Food Safety Testing Needs, and Carefully Assess your Lab”

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

Food Safety Tech (FST): What’s so important about IS0 17025 accreditation?

Shaw: The ISO 17025 standard is a gold standard for lab quality. The standard is system based, and not prescriptive, so there can be a lot of differences in how it’s implemented. ISO requires you to have a procedure to do something, it doesn’t tell you what that procedure is. For instance, the standard requires you to have a procedure for customer complaints, however the lab can either have a very basic system of recording and investigating these complaints, or it could process that complaint and get to the root cause, and correct the nonconformance, so that the problem wouldn’t be repeated. Similarly when it comes to personnel requirements, the standard can be interpreted as having competent people on staff, or having elaborate six-week long training programs and documenting this.

FST: How does laboratory design impact microbiology operations?

Shaw: Lab design is very important from both an operation and quality point of view. It’s important to keep in mind that you are dealing with potentially dangerous pathogens and contaminants, and after you have prepped and enriched the sample, and it’s positive for a pathogen, you have a huge number of microorganisms in that sample. You have to make sure that this is not moved back into the lab. Thus lab design has to ensure single directional flow of sample from one side of the lab to the other side, with both sample and personnel moving along the clean to dirty direction. Once samples come in, are prepped, enriched, incubated, and then tested, positive samples then are a threat to the lab, and the environment, in case there’s a spill or a bad technique in place.

From an efficiency point of view, LEAN is a big concept now. So lab design, if done well, can help realize efficiencies in consumables, personnel, minimizing foot traffic etc. If everything is set up correctly – in terms of reagents, equipment, testing kits etc – then you can reduce time and effort spent in gathering samples, and moving around the lab. At Eurofins, we take this very seriously. We have a team that’s dedicated to lab design process and engineering around our workflow, and believe investing resources in the necessary software system LIMS to drive up efficiencies.

FST: How should high risk samples be treated? Should customers notify the lab of hot samples?

Shaw: There are two schools of thought about this. The first one is we want to treat all samples the same, so that we don’t bias the technician. We barcode all samples in the same way, test them in the same way.

On the other hand, we don’t want to open the lab to unnecessary risk, and contaminate the lab. So we handle high-risk samples differently, by taking extra precautions. Sometimes, a customer can bring in a sample and say it has Salmonella, and needs to be tested. We will still run the sample through the same procedure, but will separate it from the other batches. We also have to take care to schedule testing of these positive samples carefully such as moving it towards the end of a shift or break.

FST: With changing rules for food safety testing, what’s changing with regards to documentation?

Shaw: It’s important, as always, to record anything that can affect the result of a test. Also clear time stamps must be documentation. When things happened, who did the preparation of the sample, who analyzed the sample? Consumption of media, test kits, chemicals and agents, or anything that was used in the analys, all must be clearly recorded. In some labs, all of the documentation is still in paper, and hence is a very manual process, while other labs are highly digitized and have the ability to track a lot of this information electronically.

FST: What are some practical challenges that food safety testing lab typically encounter?

Shaw: Labs typically face challenges with result validation, typos in documenting test results, and customer requests around retest situations. When it comes to reporting, it’s important to have a number of eyes looking at your data, to make sure that it makes complete sense. For instance, if you are testing a product for coliform bacteria, and specifically for E.coli, then the latter number cannot be higher than the total coliform number. If there is, it means there’s an issue with the analysis.

Typos with lab results, sample number etc. are other issues that every lab suffers on a day to day basis. Fundamentally, humans make errors, but as technology evolves, and systems learn to interface better with each other, such errors can be minimized.

Another challenge relates to situations when we have released the CoA and then the customer calls us to modify the lot numbers. This is a gray area, and potentially could become problematic. In such situations, when the customer requires something to changed, it’s prudent to have some kind of documentation about this, clearly specifying that it was a customer-initiated request. Of course, such situations also have an ethical component to it, so they need to be handled carefully.

Accommodating requests for retesting samples can also be a challenge. For instance, you test a sample on Day 1, and are also to test again on Day 3, you could get different results. Getting similar results with microorganisms, even when the samples are homogenized etc., is challenging and not realistic if you consider that the microorganism could increase or decrease in those few days.

Overall, Shaw encourages food companies to take a careful look at their food safety testing needs and the lab’s abilities. “Don’t just accept an ISO certificate. Ask to look at the labs, their processes etc. Good labs will encourage that, while the not so robust ones, may not accept that request, even though they have an ISO certificate, and that, in my mind, should raise a red flag,” explains Shaw.

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.