Mitigate Food Contamination Risk

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Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what food products contain and help comply with food safety regulations.

Nuts containing mould, frozen strawberries contaminated with hepatitis pathogens, and pesticide-laden vegetables – more than 3,000 products were objected by EU authorities in 2013. With increasing government, industry and consumer concerns about the hazards of food contaminants, and the risks they pose, food manufacturers, governments and non-governmental agencies, are implementing policies and processes to monitor and reduce contaminants.

Key food contaminants

Food contaminants cover a wide range of potential substances including:

  • Dioxins: Produced as unintentional by-products of industrial processes such as waste incineration, chemical manufacturing and paper bleaching, dioxins can be found in the air, in water and contaminated soil.
  • Allergens: Virtually all of the known food allergens are proteins that can subsist in large quantities and often survive food processing.
  • Genetically modified organisms (GMOs): Banned in a number of countries, controversy still exists with regard to the use of GMOs. Selling food and/or feed that is non-GMO in restricted markets places the burden of proof on the supply chain.
  • Heavy metals: Whilst heavy metals, such as lead (Pb), cadmium (Cd), mercury (Hg) and arsenic (As), can be found in nature, industrial and environmental pollutants have resulted in their increased presence in food and feed.
  • Hormones: Commonly used in animal husbandry to promote growth, hormone residues can be found in the food supply.
  • Melamine: Harmful to animal and human health, melamine is not a permitted food additive.
  • Mycotoxins: Produced by several strains of fungi found on food and feed products, mycotoxins are often invisible, tasteless, and chemically stable both at high temperatures and during long periods of storage.
  • Pesticide residues: Over-use of pesticides can lead to dangerous levels of hazardous chemicals entering the food chain with fresh fruit and vegetables being most susceptible to pesticide residues.
  • Polychlorinated biphenyls (PCBs): Used in many products, some PCBs are toxic and stable enough to resist breaking down even when released into the environment.
  • Radiation contamination: There are three ways that foodstuffs can become contaminated by radiation: surface, ground and water contamination.
  • Veterinary drug residues: Used in the treatment of animals, veterinary drugs can leave residues in animals subsequently sent into the food chain. The impact of contaminants varies. Depending on their toxicity and the level of contamination their effects can range from causing skin allergies, to more serious illnesses (including cancers and neurological impairments) and, in the most extreme cases, death.

To ensure that your food and feed products are fit for consumption, you need to test for specific contaminants throughout the value chain. For example, in concentrated levels, melamine, antibiotics and hormones can be harmful to animals and humans. Only thorough contaminant testing will determine if the above-mentioned impurities, among others, are present. After identification the relevant goods can be eliminated from the production and distribution chain.

Maximum levels and regulations

In order to protect consumers, maximum levels permitted in food products have been set by food safety legislation in many countries. Disappointingly, and despite efforts in some product areas, maximum levels are rarely harmonized across national borders. This inconsistency places responsibility for compliance firmly with the food supply chain. A comprehensive testing program can verify that your products meet maximum levels and the safety standards they represent.

In the European Union (EU), it is the food business operator who carries primary responsibility for food safety and the General Food Law Regulation (EC) 178/20022 is the primary EC legislation on general food safety. More specific directives and regulations compliment this, for example, EU regulations concerning non-GMO/GMO products, include Directive 2001/18/EC and regulations 1829/2003 and 1830/2003.

The U.S. Food and Drugs Administration has overseen the development and signing into law of the Food Safety Modernization Act (FSMA). Within the U.S., state regulators retain the right to apply additional regulations and laws. As result, rules regarding maximum levels, for example, vary from state to state.

In China, the Food Safety Law (FSL) was passed into law by the Chinese government in 2009. It introduced enhanced provision for monitoring and supervision, improved safety standards, recalls for substandard products and dealing with compliance failures.

Brazil’s food safety agency, Anvisa, coordinates, supervises and controls activities to assure health surveillance over food, beverages, water, ingredients, packages, contamination limits, and veterinary residues for import. No specific restrictions have been established yet for export.

Monitoring

Monitoring programs are frequently used to identify any contamination issues. From seeds, through the growing process and harvest, transportation, collection, storing and processing to the market channel, independent monitoring delivers credible and independently collected data on both quality and contaminants.

With so many policies and standards, both nationally and internationally, anyone involved in the food industry needs to be sure of accurate and up-to date information on food contaminant regulations. Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what grain and food products contain.

For more information, please visit: www.SGS.com/foodsafety.

How to Run an Audit-Ready Co-Pack Operation

By James Houghton
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If an auditor were to walk through your site today, would you be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client?

I think many of us have once been – or are still – in a state of scurrying around right before an auditor knocks on our front doors. When you’re small and growing quickly, it’s hard not to be reactive for things like regulatory audits. But at some point, you have to proactively build out repeatable processes to drive long-term growth, and start really taking control of your own operation.

Here’s the ideal:

You want your co-pack operation to be in a state of audit-readiness. That is, if an auditor were to walk through your site today, you’d be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client.

Earlier in October, I presented a webinar on “How to Run an Audit-Ready Co-Pack Operation,” i.e., how to get your house in order. Here are the five pillars of maintaining a state of audit-readiness for your co-pack operation:

Culture

In the same way that you have built a culture of collaboration and client satisfaction you’ll also need to build one for Quality. The way you prioritize and permeate Quality initiatives throughout the organization, from your senior team to your shop floor staff, will show when the auditor walks through the doors.

Paperwork

It’s vitally important that your paperwork is in order, including your SOPs, transactional items like RFQs, POs, and SOWs, and most importantly, the batch record. The auditor will be looking for two things amongst all of your documentation: content and consistency. The content needs to meet regulatory requirements, and there needs to be consistency between what you say you do and what you actually do.

It’s not rocket science: you need to write out what you do, and then you have to do the activities that reflect what you’ve written down. This is often the one thing that won’t be maintained properly, unless it’s given attention.

Physical Space

Your physical space will be audited to ensure it’s set up with the correct flow, that it is kept clean, and there is documentation to that effect.

To make sure your physical space is up to par for an audit, imagine that you yourself are the product… go back to your receiving doors and physically walk through your facility, as a “day in the life” of your product. You’ll be able to see where you go, how you are handled, and where each step is documented. Along the way, anything that’s not delineated, not treated or identified properly, or does not follow a logical flow, are the areas you need to lock down before an audit.

Material Control

An auditor will want to see that you’re in control of your materials, and that you have track and traceability. Being able to track where you’re storing things in the site, where it’s moving, what your processes are for moving inventory, etc… all that demonstrates that you have the traceability controls to be able to handle mock and real recalls and maintain consumer safety.

Production

Ahh… the production line. It’s where the magic happens. When setting up your production line, you need to make sure you have appropriate line clearance, the lines are segregated, the correct staff are on the line to do the project, and that they have had the proper training for their particular activity in the line. In the co-pack world, where things are highly customized with low repeatability, it can be easy to overlook the extensive amount of training it takes to make sure each production line is in good hands. You need, however, to make sure you do your due diligence to maintain production accuracy, quality assurance, and regulatory standards.

In the webinar, I discuss each of these areas in greater detail. If maintaining a state of audit-readiness is an endeavor you’d like to pursue, watch the webinar for more details or access the slide deck by clicking here. 

Ask the Expert : Root Cause Analysis – Responding to Audit Non-Conformances

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A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful and to comply with their food safety standard. And root cause analysis is a great tool for problem solving when a site is found not to be in conformance.

The food industry has been introduced to the concept of third-party certification to help manage and control their food safety programs. Food manufacturers benefit from a food safety quality system that is based on Global Food Safety Initiative (GFSI) principles.

Business People with Puzzle Pieces and Teamwork Concept

A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful. Current GFSI benchmarking initiatives have introduced the concept of implementing root cause analysis as a tool for problem solving when a site is found not to be in conformance with their food safety standard.

A new white paper from CERT ID covers relevant information that can assist food companies understand how to implement their solution, review and evaluate the results, and reflect and act on what was learned. This Q&A with CERT ID’s Michael J. Pearsall, Vice President of Business Development, offers some insights.

Q: These RCA tools are nice but require large amounts of resources to solve problems. Is this really necessary?

A: The effort and resources utilized to solve a problem should reflect the scale of the issue with regard to the impact on the person or organization. The tools that are normally advertised are to be used for complex problems. What about the simple day-to-day problems we all face as managers? A human being solves problems without even realizing it. You have a built in mechanism that you have acquired through life experiences and this device should be called upon first. Develop a personal strategy as to how to approach a problem that starts with observation; defining the issue; prioritization; short term strategy and finally a long term strategy to prevent issues from reoccurring. Complexity of problems change but your strategy should not.

Q: We went through a complex root cause analysis and solved the problem but it keeps reoccurring. It is very frustrating so how do we prevent this?

A: I hate to tell you this but problems are only temporarily solved. Many very intelligent people forget, the most important part of problem solving, developing a strategy to maintain the gains you spent so much of your resources to obtain.

There is an overused Old Testament bible story about David and Goliath. Many think that David killed Goliath with a stone from his sling but this is not true. David had developed a strategy to maintain his gain. David had to immobilize the giant to gain access to him. He solved the problem by hitting him in the head with a stone, but the long term strategy was to grab his sword to cut his head off securing the gains to his problem solving effort. It is necessary to think about how you will maintain the gain once a problem is unraveled.

For more information, click here to download Responding to Audit Non-Conformances: Root Cause Analysis, a complimentary white paper from CERT ID. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Using Microbiology Studies to Support your Product

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

What is a Special Project? These are special testing projects that are not typically covered by laboratory testing when you run into a question that you really can’t answer, says Centrella. Special projects can be used for:

  • Development, validation or implementation of a new testing method;
  • Comparing performance of a new testing platform against a standard;
  • Validation of pathogen control, for instance, to check effectiveness of CCPs;
  • Shelf-life investigation;
  • Verification of effectiveness of antimicrobials; and
  • Determination of whether a product requires refrigeration.

With method validation, the situation can be that you work with PCR for Salmonella, and there are certain number of matrices approved, but you want to take advantage of that method and extend the matrix. So special projects can help you answer if that method would be suitable for your product.

Another category of special projects is pathogen control. In this situation, you can see if you have a process or an ingredient that’s in your product, or simulate that intervention in a lab setting (either heat or cool step or a treatment like a wash) to check for pathogen growth. In this case, the target matrix is inoculated with high level of analyte, and the aim is to show large log reduction, or even complete elimination, once the matrix is treated with the intervention.

Shelf-life studies is another example of special projects. In this case, we simulate retail storage of the product to determine expected shelf life or determine typical storage conditions. Here, assay are prepared to assess threats to product shelf-life, microbial, chemical or nutritional in nature. Such threats could be build-up of lactic acid due to bacterial activity, or might be gas-producing microorganisms, or chemical targets that cause rancidity in oils. Often these include an organoleptic compound which could change how a product looks, or if it has an odor. It’s important to remember that often the souring of the product due to lactic acid, gas bubbles or off odors will present themselves before microbial counts become obvious.

Shelf life testing is conducted at predetermined intervals, and depending on need, we can stagger these intervals, for instance, we can do more frequent testing during the anticipated end of shelf life. The final shelf life is defined by the last acceptable result.

Antimicrobial effectiveness is another example of special projects, and these involve products that already have an antimicrobial ingredient. In these situations, we inoculate target microorganism into the product and use assay to determine log reduction, or prevention of outgrowth. Antimicrobial effectiveness studies often include aspects of shelf life studies, where product is typically held at a given time-temp combination. These studies may use specific references such as using USP <51>, or reference could include specific microorganisms, and criteria to determine effectiveness (such as log reduction).

Another example is determination of if a product requires refrigeration. For this, we first start with the food product itself, which has a specific combination of pH and water activity to prevent growth of groups of pathogens. Once we have this information, we don’t have to look at broad range of organisms, but can look at specific organisms. The remaining potential threats become challenge organisms for the study. We store the product at room temperature and test for these challenge organisms.

For more information on Special Projects, contact Eurofins US or email Bill Centrella at WilliamCentrella@EurofinsUS.com. 

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

Ask the Experts – Automation Pathogen Detection

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An ideal pathogen detection solution should provide increased confidence in results, high reproducibility and robustness to routine testing labs, fit seamlessly in laboratory workflow without disrupting it, and work well for medium-to high-throughput testing laboratories. This Q&A provides some insights.

Q: How can an automation system help safeguard against false negative pathogen results?

Pathogen testing can typically be broken up into three categories:

  1. Raw material testing;
  2. Finished product testing; and
  3. Environmental monitoring.

Regardless of the type of testing that is done, it is clear that pathogen detection is an important component of any hazard analysis and risk-based preventative control program. Verification of results is crucial, particularly negative results. When performing pathogen testing with a real-time PCR based assay, the presence of an internal amplification control is critical. When present for each individual sample, the internal control monitors for inhibition, which can be common with matrices such as spices and chocolate. When a negative result is obtained, it is important to know if that sample is truly negative because the pathogen of interest is not present or if the reaction was inhibited.

Another potential for false negative results can come from technician error. If a sample is not actually added to the reaction block, tube or strip for testing, the result will be negative. Therein lies the power of an automation system. The iQ-Check Prep automation system employs a liquid level sensing volume verification step at the beginning of the run. Utilizing monitored air displacement technology and conductive pipette tips, users are alerted if a sample was missed in the setup. The user then has the option to add the sample or skip it and continue the run. If the sample is not added, the result is flagged as invalid. Combining the internal control of iQ-Check real-time PCR detection kits with the verification of the iQ-Check Prep automation system, users can be confident in their results and safeguard against false negatives.

Q: How can an automation system be incorporated into a laboratory without disrupting existing workflow?

Incorporating an automation system into a laboratory can greatly increase efficiency, traceability and throughput…if it is the right solution for the lab. Many factors need to be taken into consideration, for example batch processing. Examining time intervals at which samples finish incubation can determine how batch processing fits into the lab workflow. Technician responsibilities also play a part. Does the system require monitoring and continuous feeding of samples or is it a walk away system that frees technicians up to perform other lab duties? Another important consideration is maintenance. The scheduled upkeep of the system needs to be evaluated not only for the amount of time required but for the cost associated with the maintenance.

The iQ-Check Prep system was designed with efficiency in mind. Samples are processed in batches (plates of 94 samples at a time) for a throughout of >500 samples per instrument per eight hour shift. The system is a true walk away system that does not require constant monitoring or continuous feeding. The maintenance is self-contained and completed by the instrument in 5 minutes. These are just a few questions to ask when considering an automation system for the laboratory. The chosen system should fit effortlessly into the laboratory workflow and increase throughput and efficiency without causing major disruptions.

For more information, visit Bio-rad.com. 

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.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Top 10 Elements of a Successfully Certified GFSI Program

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

GFSIstandardsDec2014The Global Food Safety Initiative (GFSI) relies on a number of benchmarked schemes to establish food safety requirements, all are designed to ensure the quality and safety of a company’s products.

In order to become certified to one of these GFSI-recognized schemes, a company must undergo a third-party audit by a certified auditor. Kestrel’s experience conducting these audits has revealed that companies who successfully achieve certification demonstrate a number of common attributes—regardless of their chosen scheme:

  1. Corrective and preventive actions are up-to-date and current.
  2. Continuous improvement/root cause analysis process is in place to make ongoing improvements and to ensure final resolutions to all out-of-control issues or non-conformances to the Food Safety Program.
  3. Premises, facility, and building programs are established and operating, including controls, signage, direction, job training, and physical evidence of a fully implemented Food Safety Program.
  4. Preventive maintenance system links scheduled maintenance to Hazard Analysis & Critical Control Points (HACCP) critical equipment monitoring requirements.
  5. Approved materials and process specifications are managed and controlled.
  6. Product identification and traceability processes are in place, including complete records detailing all activities for the production of food product.
  7. Document management and control program is updated, validated, and maintained. Developing program management systems helps ensure compliance with document management and control.
  8. Food safety program updates and management are completed through annual and multi-year planning for maintaining the Food Safety Program, including management of change, management review, approvals, and internal audit.
  9. Records and verification management systems provide access to supporting data, as determined by FDA/FSMA and company programs.
  10. Data management of food safety records outlines processes for assuring prompt or immediate access to critical records, as needed, for audit, compliance, or regulatory purposes.

 

John Kukoly of BRC Global Standards

BRC in 2015: What’s Changing, and How to Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

What’s new for BRC this year?

2014 has been an extremely busy year for BRC. We wanted to think of BRC standard as not just an audit or a standard for certification. We want to strengthen food safety and help grow respect for food safety around the world. So in that spirit, we have strengthened our program.

One of the new changes is auditor competency programs. Under this, auditors need to understand the standard, know the audit technique, have a strong grasp of the industry they are in, whether it be dairy or thermal processing etc. They need to truly understand the processes involved, and where the risks are. While there have been some challenges with the auditor competency program, we have identified some auditors that are clearly strong. We are also addressing the gaps.

With the horse meat scandal, we realized that there are some times gaps and barriers with distributors and agents. So we have developed a standard for brokers and distributors to strengthen the supplier approval program. This year, we have also worked on BRC Issue 6, and developed best practices from our experiences. The standard has been growing in the U.S., Canada, Mexico, and Italy, and we are also expanding into new areas both geographically and industry sectors such as packaging, storage and distribution etc.

One major development in 2014 was growth in unannounced audit, in response to customer requests. Customers came to us and asked us for that option that if they really feel ready for unannounced audits, they should do it. BRC currently has over a 1000 sites that are getting audited unannounced. And while it hasn’t been simple or straightforward, this is great progress.

Where’s BRC going in 2015 and beyond?

2015 is going to be a big game changer for us. In January, BRC Issue 7 will be launched, and for the first time, you can download the entire standard from the BRC website free of charge. Audits using the new Issue 7 will begin July 1. It’s a nice clean standard with a handful of changes, and cleaned up from Issue 6. Things we have added are food fraud, based on industry demand, given what happened with horse meat, olive oil, rice etc. BRC auditors are not forensic auditors or food fraud investigators. They will, however, focus on food defense programs, to confirm that you have control mechanisms in place to prevent fraud.

The revised standard will also included Expanded High Care, in which we have identified certain products with certain characteristics for greater scrutiny, for instance RTE products susceptible to pathogen growth. You need to make sure there’s no process to reintroduce the pathogens in the final product. This change has been a huge shift for some industries. While all standards cover the basic GFSI requirements, we have noticed that when it comes to RTE products, BRC is much more rigorous.

Another focus area will be prevent labeling errors to avoid recall. Often, the number one or two cause for recall is mislabeling, where the product inside the packaging is not accurately specified on the label. Often this is around allergen control, but if it’s in the package, it has to be on the label, and this is a big focus for the new version.

We are also expanding our BRC Global markets program to align better with the GFSI global markets program. In this we have roughly split the standard into three schemes – beginning, intermediate and full certification. If companies don’t have the ability, knowledge, or processes in place to get fully certified, it’s a systemic approach to work themselves forward. It’s one thing to get the standard and set the bar, but another process to prepare these companies for certification. So it’s very exciting program to work with real small sites, in developing areas of the world, where the food industry is still growing.

How will companies be affected by these changes? And why is embracing these changes important?

Management commitment is always important. We have done a lot of audits: Over the world, we have over 17,000 sites that are BRC certified on the food side alone. Ones that have done best are those that have embraced food safety culture as an organization. It’s really about how as an organization, you take something on. The companies that have always struggled are those that say, ‘it’s the QA manager’s job, and let them take care of it.’ BRC is trying to see how to improve, engage and then measure the culture of an organization especially when it comes to food safety. And this starts with training and the commitment to training. Sites should increase and improve their training, and focus on continually evolving and getting better with their food safety, food quality and regulatory compliance programs.

It’s important to embrace these changes, because we need to move forward to continue to reduce risks. Knowing our suppliers is a big part of that, and the new standards enable enhanced supplier approval, and controls, and transfer of information. In BRC Issue 7, supplier controls will be a critical focus area.

We also do have to get the internal house in order, so we need to have strong internal controls in place, and quality internal audits. Companies need to understand how to do these internal audits very well, and have process controls and, verification and validation programs in place. People understand the importance of food safety. But they don’t often use all the tools they have in their tool box as well as they can. We can use internal audits, root cause analysis, risk assessment, etc. more effectively to get more insights in our internal FSQA progams.

Overall, we should enhance food safety. The bar should be constantly raise. We can never be in a position where we say it’s safe and good enough, and we don’t have to do any more. We constantly have to move forward to meet expectations of consumers and customers. We need to follow continuous improvement, and get our partners involved, whether they are raw material suppliers, packaging providers, or distributors. What do they need to do, and how do we expect them to be our partners? We are certified, that’s great, but how can we transfer that along the supply chain? All these questions need to be continually addressed.

Listen to John Kukoly address more questions on how BRC can help you better prepare for FSMA and take on questions for the participants. Click here to access the webinar.

Gary Smith, Eurofins’ Food Safety Systems

Moving from GMP to GFSI Audits

By Sangita Viswanathan
1 Comment
Gary Smith, Eurofins’ Food Safety Systems

Ask any one in the food safety and quality sectors of the F&B industry and they all talk about one uniform concern: Audits. The sheer number of audits, supplier audits, GFSI audits, FDA audits, unannounced audits, the work involved in preparing for these, and the possibility of still things not working as planned on the actual day of the audit.

Dispelling some of these concerns, Gary Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, spoke to Food Safety Tech about how companies can be better prepared; challenges in moving from traditional GMP audits to GFSI recognized certification audits; role of management; and what do you if you disagree with the auditor.

Food Safety Tech: What is the biggest challenge for a company moving forward from traditional GMP audits to GFSI recognized food safety certification audits?

Smith: A good GMP audit program has probably got about 80 percent of the full GFSI scheme. It’s a great precursor. But there are some aspects that are not addressed in GMP audits which are facility-specific, such as would we know if the floor is in bad shape etc.? With GFSI you can’t have any non-conformance. Internal audit programs, corrective action management, root cause analysis, all of these are a must for GFSI. So it’s much more advanced than what’s required in GMP.

The audits are also difference from a validation stand point. For instance, with GMP audits, you need to have six elements of a Pest Control program and a facility can say, I have all six, so I am set. But with GFSI certification programs, you need to have these six elements, but you also have to prove that these are effective.

GMP audits provide a snapshot in time, a look behind the curtain to make sure you are following all the requirements. With certification, it’s a more consistent and continuous process – you are always looking for ways for improvement, and ensuring the standards and systems are working the way they are supposed to.

FST: What is the role of management in the audit process – whether GMP or GFSI?

Smith: There’s a big difference when it comes to management participation with both these sets of audits. Management needs to understand that with GFSI certification, management is required to have a culture of continuous improvement, where they are constantly looking for issues to manage and ways to get better. Leadership has to drive that change and a lot of folks struggle with this. QA managers should focus on training them to bring managers to embrace and communicate that culture.

FST: For companies first looking into certification services, what criteria should they be using while selecting a certification body?

Smith: The most basic requirement according to me is auditor availability. You need to identify a certification body that has more than one or two certified auditors. While price should be a consideration, it shouldn’t be the top priority.

As companies move to certification versus auditing, it is also important to look for a food safety partner, one who can service many of your foods safety needs such as testing, consulting, training etc., versus just auditing. For instance, can you call the Certified Body in case you have a recall or a food safety incident, and can the CB help you minimize the issue and solve the problem? Of course, customer service is an important consideration; the auditor and the team have to be responsive and polite.

FST: What steps can a company take prior to an audit to give themselves the best chance for success on the audit?

Smith: Training is critical. The facility and the personnel concerned with the audit process need to thoroughly understand the standard against which they are being audited, what will be asked and assessed for. Companies need to be harder on themselves than the auditor will be. Get others in maintenance and product involved in the facility and ask them questions that an auditor may ask. Train them to answer those questions.

Have strong internal auditing programs so you are prepared. You should know your issues and some auditor shouldn’t be telling you what the gaps are. All this is time and energy consuming, but it’s worth it.

Taking pictures both internal and external can also help, and can be a great training tool. When you have actual pictures from the facility and the processes, there can’t be too much room for debate.

FST: If the company disagrees with an auditor or the audit findings, what should they do?

Smith: The first thing I would say is don’t be afraid to ask the auditor questions. It is okay to say, ‘show me in the standard where it says this is a nonconformance.’ Remember to ask them before they leave. In most cases, asking such questions can help solve 75 percent of the issues.

Auditors can help describe why something is a nonconformance. If as a facility there’s still disagreement, you can go to the CB and provide a written description with as much information as you can, specific to the standard, about why you disagree with the audit. You can do an investigation and in many cases, probably 40 percent of the time, the auditor could have made an error, and gone beyond the standard. Remember that for the CB also, it’s important for them to get it right. So sites shouldn’t be worried about asking auditors questions, and CBs should respond to them – all in the process of continuous improvement.

Unfortunately, in some instances, it gets escalated beyond the CB to the standard owner. Though it’s a really drastic step, it has happened with SQF. As the final step, the site can still contact the Accreditation body, the American National Standards Institute.

FST: What are some other concerns regarding audits against the backdrop of FSMA proposed rules and GFSI?

Smith: As the industry is still waiting for final FSMA rules, one requirement that is causing some concern is auditors having to inform FDA when they see a nonconformance during a consultative audit. There is some concern that such a requirement would discourage people to try and get better. Industry is also waiting to see how FDA views certification audits. Can this be a process to ease imports, or, for domestic suppliers, be a risk-reduction tool? For instance, if there are two food facilities that make the same product, one that uses a GFSI scheme and one that doesn’t, can the one that uses be considered lower risk and not require as much resources to assess risk? Can inspections be done less frequently for such a facility? Will FDA accept such factors in the final requirements?

Ultimately, we need to remember that certification in the food industry in the U.S. is only about six years old. We all need to collectively continue to drive the process forward.