Audit

Best Practices for ISO 17025 Accreditation: Preparing for a Food Laboratory Audit (Part I)

By Joy Dell’Aringa
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Audit

An increasing number of food testing laboratories are seeking accreditation to the ISO/IEC 17025:2005 standard. This growth is chiefly due to regulatory implications, customer requirements, and trade organization recommendations and is seen across laboratory segments: third-party contract laboratories, private in-house laboratories, and government laboratories. ISO 17025 is the most common standard in the food testing industry and sets the guideline for “Laboratories Performing Microbiological and Chemical Analysis of Food and Pharmaceuticals”. Accreditation is known generally as a third-party attestation related to a laboratory, which conveys formal demonstration of competency that implies a reliable and consistent level of quality across an operation for a well-defined parameter of tests, often referred to as the “Field of Testing”. There are several qualified organizations that accredit laboratories to the standard; these organizations are referred to as Accrediting Bodies and are responsible for assessing facilities for conformity to a given ISO standard.

Audit Preparation Guidance

Initial Accreditation: Considerations & Preparation

When a laboratory initially entertains applying for accreditation, several factors should be considered. The cost and time commitment required to become initially conformant, and the on-going resources required to maintain conformity should be thoroughly examined in an overall benefit analysis prior to applying for accreditation. Management should be fully aware of the investment and perpetual commitment of becoming an accredited facility. Accrediting Bodies (ABs) provide resources and literature that can help guide laboratories through the initial audit-preparation phase. However, creating the systematic application of these guidelines that balances the quality and operational objectives of the organization are unique from laboratory to laboratory. Simply put: There is no cookie-cutter approach to accreditation.

Consultant Considerations

Q Laboratories in Cincinnati, OH first embarked on the path to ISO 17025 accreditation in 2009. James Agin, director of regulatory compliance at Q Laboratories and member of the A2LA Laboratory Accreditation Council took the lead on preparing for the initial assessment eight years ago. Q Laboratories was initially unfamiliar with the process, so they hired a consultant who was also an assessor to walk them through the process. “We took about four to five months with a consultant,” says Agin,. “In addition to creating the necessary systems, we gathered the troops and did a deep training on what ISO 17025 is, why we were pursuing it, and why it was important to our business.” The Q Laboratory team created a deep sense of ownership during the education and training process from the supervisors to the bench analysts, which they credit to their ongoing success years later. Erin Crowley, chief scientific officer at Q Laboratories suggests new labs consider hiring a consultant to ease them through the process and get them audit-ready. “If you’re not accustomed to having certain systems in place, a consultant can provide clarity and help initiate processes,” says Crowley. “Having an open forum with an expert helped give our entire team confidence.”

A consultant can streamline the initial process and help avoid some of the pitfalls in creating a robust quality management system for the first time. Tim Osborne, senior director of training services at A2LA offers advice for organizations when vetting a consultant. “While certainly not required, a qualified consultant may be a good asset to have in your quiver,” says Osborne. “Look for industry references and pay close attention to involvement in the industry outside of its own laboratory. Does this person work for an accrediting body? What are the areas of analytical expertise? Does this person also provide training for an accrediting body? If so, it is likely the consultant will offer the quality of services you need to be successful.” It is important to note that assessors and consultants should be upfront with the accrediting body to avoid conflict of interest issues during the actual assessment. Impartiality is critical within the assessment process.

Application Process

Accrediting bodies publish their own “readiness” documents. Laboratories seeking accreditation should request an itemized guide that walks the organization through each phase of the process. The following is a general outline:

  • Obtain copy of ISO standard (17025, 17065, 17020, etc.). Review any specific requirements relevant to your field; these are generally available in a checklist format allowing the laboratory to prepare through an internal audit process.
  • Determine estimated costs with the accrediting body
  • Obtain a copy of the accrediting body s assessor checklist. This usually has to be completed as part of application process
  • Prepare the intended draft scope of accreditation (outlining, specific tests/test methods, calibration parameters/ranges, certification schemes)
  • Implement the management system, and ensure personnel are aware and accept the content
  • Perform an internal audit to verify compliance with the conformity assessment standard requirements, accrediting body requirements, your own management system requirements, and applicable technical requirements
  • Perform a management review
  • Foreign applicants may need to translate supporting application documents to English
  • Identify one specific individual to be responsible for accreditation efforts and interactions with the accrediting body. Identify the “quality manager” who is in charge of the management system
  • Obtain, prepare, and submit the application for accreditation to the accrediting body

Once the initial assessment is complete and the final response and corrections to any deficiencies is in, the laboratory will be reviewed and considered for accreditation through the accrediting body. When the decision is made in favor of accreditation, the laboratory will receive their accreditation certificate, which will correspond to a specific location and set of tests (commonly referred to as a Scope of Accreditation (“Scope”) for the Field of Testing (“FOT”) for which they were assessed). Depending on the accrediting body, the certificate may be valid for one to two years, and will require re-assessment and surveillance at defined frequencies. The laboratory is responsible to maintain conformance to the ISO 17025 standard in between assessments.

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barcode

How Digital Technology Streamlines Supply Chain Management

By Alex Bromage
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barcode

Today’s food and beverage producers must deliver to exact requirements and provide safe products of the highest quality. In an increasingly global and connected world, the emergence of new business models, such as Amazon Food and the offer of direct deliveries to consumers, is creating ever more complex supply chains for manufacturers. The number of steps between the raw ingredients and the consumer is increasing, creating new and more numerous challenges inside the production process for food and beverage manufacturers. Thus it is important to remain committed to constantly innovating and developing new services and technologies to support customers with increasing supply chain complexities. This includes systems to help track products as they enter the factory environment, when they leave the factory, and when they enter the retail distribution chain. The digitalization of management processes and services, alongside basic management processes, is playing an important role in helping food and beverage manufacturers to manage these complexities.

Learn more about keeping track of your suppliers at the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | Attend in-person or virtuallySupplier Base

The first step to keeping food safe starts before the raw ingredients enter the processing facility. The safety of raw material is so important because it impacts the end quality of the product. Pasteurization and heat treatment can only improve the product so much, and therefore the higher quality the raw ingredients, the better the final product.

Basic management processes must be in place at this stage of the supply chain, ensuring the good management of the supplier base. Working closely with customers to implement supplier framework audits that allow them to benchmark their suppliers’ performance is crucial. Through this supplier framework customers to collaborate transparently with their suppliers, encouraging the open sharing of information and traceability in the supply chain.

Production Process and Entering the Retail Distribution Chain

Increased sophistication of tools in the industry is also enabling high-level traceability at the packaging stage. This means that food and beverage manufacturers are tracking and tracing products right the way through to the consumer. One such available tool can enable food and beverage manufacturers to program their entire plant through a single data management system, and improve product traceability internally. Specifically designed for the food and beverage industry, specific software provides a user-friendly interface through which customers can control their entire operations—from raw material reception to finished packaged and palletized products. Streamlines data collection facilitates accurate data analysis to ensure that safety standards are maintained throughout the production process.

Using unique package identification technology, such as a 2-D barcode on packages, information can be processed this information and the product(s) tracked throughout the supply chain. For example, if a manufacturer were to experience a food safety issue in a certain production batch, the tool would be able to track all products in that batch and support making a recall. In addition to improving functions on a reactive basis, a reporting function, is designed to provide data to help prevent issues from happening again in the future, mitigating against food safety risks.

As new business models continue to emerge and more parties become involved in the production process, the complexity of the supply chain will only increase. Digital strategies alongside basic management processes have an increasingly important role to play in helping food and beverage manufacturers manage these complexities to ensure that their food is safe for the end consumer.

High processing pas

HPP: Achieve High Standards of Food Safety Without Compromising Food Quality

By Mark Duffy
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High processing pas

As food companies analyze and modify their production processes to ensure FSMA compliance, many are finding that traditional food processing technologies aren’t ideally suiting their needs. Conventional pasteurization technologies like heat pasteurization have been relied on to protect the safety of the food supply over the years, but they aren’t without their downsides. For example, sometimes they negatively impact the flavor, texture, nutrients and color of food products. Additionally, many traditional food processing methods require chemical additives to be integrated to preserve quality and taste. In a market where consumers are more frequently appreciating, if not demanding, cleaner labels with simple ingredients, these solutions are often becoming less attractive options for some companies.

This new demand for a higher level of food safety combined with an emphasis on food quality has led some producers of refrigerated foods to turn to an increasingly popular alternative: High pressure processing.

How HPP Works

High pressure processing, or HPP, is an effective technique that uses pressure rather than heat or chemicals to disable pathogens in food. After packaging, food products composed of some degree of water activity (Aw) are placed into a machine that applies incredibly intense water pressure to food—sometimes as much as 87,000 psi.

High pressure processing
How high pressure processing works. Graphic courtesy of Universal Pasteurization & Universal Cold Storage

This process interrupts the cellular function of the microorganisms both on the surface and deep within the food and can serve as a critical control point (CCP) in a HACCP program. Research studies on a wide range of refrigerated food products and categories confirm that HPP technology inactivates vegetative bacteria like Listeria monocytogenes, Salmonella, E. coli 0157:H7, and Campylobacter as well as yeasts and molds. Additionally, because pressure is applied after the food is packaged, HPP drastically reduces any chance of recontamination.

Besides its food safety benefits, HPP offers food producers added benefits over traditional methods. Because the pressure inactivates spoilage organisms along with pathogens, many foods see a substantial increase in shelf life after undergoing HPP, sometimes even twice as long. Processors use this shelf-life extension to increase their distribution reach and reduce food waste.

In a recent survey, 57% of respondents in the food and beverage industry characterized their companies’ use of HPP as substantial or growing. Survey respondents also scored HPP’s ability to make food safer by eliminating pathogens above a 4 on a 5-point scale, one of the highest of any food processing technology.

However, HPP isn’t right for every product. It isn’t effective on some enzymes and bacterial spores, like Clostridium botulinum. Producers need to tap into other techniques to address concerns not affected by HPP. The process also requires foods to be packaged in fairly flexible packaging to allow for an even application of pressure. Glass bottles or particularly hard plastics will not be suitable.

HPP can also be daunting to implement for some companies. Purchasing an HPP machine is a major investment, typically seven-figures, without factoring in specific facility requirements or staffing needs. In the same survey of food and beverage producers, the most commonly cited concerns had nothing to do with the efficacy or value of the technology, but rather with the cost of purchasing and staffing the equipment.

For businesses that don’t want to make that kind of capital expenditure commitment but want to take advantage of high pressure processing, HPP outsourcing providers offer a more affordable solution. These companies own and operate HPP machines on behalf of clients. That way, food brands don’t have to purchase expensive HPP machines and regularly maintain their own equipment.

Is HPP right for you? The answer and the nuances are highly variable, but HPP is a fast-growing food preservation technology offering many benefits, including food safety benefits, across a broad product spectrum.

Listeria

How One Company Eliminated Listeria Using Chlorine Dioxide Gas

By Kevin Lorcheim
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Listeria

The previous article discussed the various decontamination options available to eliminate Listeria. It was explained why the physical properties of gaseous chlorine dioxide make it so effective. This article focuses on one company’s use of chlorine dioxide gas decontamination for both contamination response and for preventive control.

The summer of 2015 saw multiple ice cream manufacturers affected by Listeria monocytogenes. The ice cream facility detailed in this article never had a supply outage, but ceased production for a short amount of time in order to investigate and correct their contamination. After a plant-wide review of procedures, workflows, equipment design and product testing, multiple corrective actions were put into place to eliminate Listeria from the facility and help prevent it from returning. One such corrective action was to decontaminate the production area and cold storage rooms using chlorine dioxide gas. This process took place after the rest of the corrective actions, so as to decontaminate the entire facility immediately before production was set to resume.

Responsive Decontamination

The initial decontamination was in response to the Listeria monocytogenes found at various locations throughout the facility. A food safety investigation and microbiological review took place to find the source of the contamination within the facility in order to create a corrective action plan in place. Listeria was found in a number of locations including the dairy brick flooring that ran throughout the production area. A decision was made to replace the flooring, among other equipment upgrades and procedural changes in order to provide a safer food manufacturing environment once production resumed. Once the lengthy repair and upgrade list was completed, the chlorine dioxide gas decontamination was initiated.

The facility in question was approximately 620,000 cubic feet in volume, spanning multiple rooms as well as a tank alley located on a different floor. The timeline to complete the decontamination was 2.5 days. The first half-day consisted of safety training, a plant orientation tour, a meeting with plant supervisors, and the unpacking of equipment. The second day involved the setup of all equipment, which included chlorine dioxide gas generators, air distribution blowers, and a chlorine dioxide gas concentration monitor. Gas injection tubing was run from the chlorine dioxide gas generators throughout the facility to approximately 30 locations within the production area. The injection points were selected to aid its natural gaseous distribution by placing them apart from one another. Gas sample tubing was run to various points throughout the facility in locations away from the injection locations to sample gas concentrations furthest away from injection points where concentrations would be higher. Sample locations were also placed in locations known to be positive for Listeria monocytogenes to provide a more complete record of treatment for those locations. In total, 14 sample locations were selected between plant supervisors and the decontamination team. Throughout the entire decontamination, the gas concentration monitor would be used to continuously pull samples from those locations to monitor the concentration of chlorine dioxide gas and ensure that the proper dosage is reached.

As a final means of process control, 61 biological indicators were brought to validate that the decontamination process was effective at achieving a 6-log sporicidal reduction. 60 would be placed at various challenging locations within the facility, while one would be randomly selected to act as a positive control that would not be exposed to chlorine dioxide gas. Biological indicators provide a reliable method to validate decontamination, as they are produced in a laboratory to be highly consistent and contain more than a million bacterial spores impregnated on a paper substrate and wrapped in a Tyvek pouch. Bacterial spores are considered to be the hardest microorganism to kill, so validating that the process was able to kill all million spores on the biological indicator in effect also proves the process was able to eliminate Listeria from surfaces. The biological indicators were placed at locations known to be positive for Listeria, as well as other hard-to-reach locations such as the interior of production equipment, underneath equipment and inside some piping systems.

In order to prepare the facility for decontamination, all doors, air handling systems, and penetrations into the space were sealed off to keep the gas within the production area. After a safety sweep for personnel, the decontamination was performed to eliminate Listeria from all locations within the production area.

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Gears

Three Practices for Supply Chain Management in the Food Industry

By Kevin Hill
1 Comment
Gears

While building an effective logistics strategy, the end goal of supply chain management (SCM) needs to be kept in mind (i.e., allowing each member of the supply chain to achieve efficient inventory management as well as reach its customer service goals). To this end, it’s important to share information that will help each member achieve success. This includes data relating to demand forecasts, anticipated lead times and safety stock quantities. Let’s look at SCM best practices for food manufacturing and supply, and how this information plays a role.

Effective SCM: Best Practices for the Food Industry

Here’s an overview of SCM best practices in food supply and manufacturing:

Learn more about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MOREDemand Forecasts. This is generally based on demand, sales or usage patterns in the past. However, future demand can be affected by changing situations such as:

  • Gaining/losing customers
  • Increased/decreased product popularity
  • Introduction of new products
  • Short-term increase in demand through promotions, etc.

Better estimates can be achieved with an effective derived demand or a CPFR (collaborative planning, forecasting and replenishment) system. This can be done through automated data collection, or by the following process:

  • Identifying customers who can predict future demand (i.e., what they may use or sell in the future)
  • Collecting demand forecasts about specific products from them
  • Comparing these forecasts against their actual purchases on a monthly basis
  • Helping them improve future predictions by sharing this data with them

Customers may overestimate demand, but you might consider offering a discount based on accurate forecasts to encourage better results. In addition, you should also consider these five elements:

  • Usage patterns in the past, not including CPFR data
  • Increasing/decreasing product popularity trends
  • Higher/lower seasonal usage or demand
  • Events/promotions in the near future
  • Market and industry data from sources such as management, sales, etc.
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Organic, NonGMO, Natural, Labeling

Achieving Transparency in Organic and Natural Product Claims

By Lori Carlson
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Organic, NonGMO, Natural, Labeling

Consumer preference for organic and “all natural” foods remains on the rise, according to market trend research and retailer sales.1,2 The Organic Trade Association (OTA) recorded $40 billion in U.S. organic food sales for 2015, stating that sales have nearly doubled since 2008.3 Pair this with $21 billion in sales for Q1 2016 for non-GMO labeled foods and $1.6 billion in 2015 gluten-free sales and, it is hard to ignore this thriving market sector, which seeks to support consumers in their quest for fresh, healthy and transparently-labeled foods.4,5

As a result of these trends, the industry is experiencing a surge in natural food and beverage start-up companies as well as the acquisition of organic and natural product companies by manufacturing giants such as Campbell Soup Co., Danone and General Mills, Inc. But in complex—and especially global—supply chains, achieving transparency comes with hurdles for verifying product claims  such as “all-natural”, non-GMO, antibiotic-free, and other nutrient content or functional claims.

Organic and other natural food manufacturers are under increasing regulatory and consumer scrutiny for tracing claims back to the source for all ingredients. Failing to verify the authenticity or identity preservation (IP) status of materials, maintain chain of custody and ensure the accuracy of labels can have devastating consequences for a manufacturer, including regulatory action and consumer fraud class action law suits.6 It’s not just consumers demanding the “right to know” where food comes from, but manufacturers must also push this sentiment back through their supply chain to drive transparency for ensuring safety, brand protection and verifying product claims.

With the goal of meeting consumer demands for healthy food products, improved transparency in food production and clean labels, how can organic, non-GMO and natural food manufacturers stay ahead of the curve when it comes to ensuring that product claims provide the value consumers seek?

Consider the following tasks for achieving transparency in organic and natural product claims.

Analyze Your Ingredients for Risk

Get to know the pitfalls, which can affect the integrity of product claims. Many of these stem from cross contamination, authenticity or mislabeling issues for sourced materials. To prevent these pitfalls, analyze each ingredient for supply chain risks. Identifying potential risks, which may affect the integrity of claims creating liability for misbranding, is a critical step in achieving transparency.

For example, is there a potential for cross contamination from a non-organic source? This is a common risk where a supplier engages in the co-production of organic and non-organic materials. A lack of segregation and clear product identification during transportation, storage and processing activities can lead to commingling or cross-contamination, which affects material integrity and thus, any downstream product claims. Ensuring suppliers and the manufacturer have clear measures in place for segregation is an important consideration when determining risk.

Or, consider adulteration from a non-authentic material, which can affect the integrity of the claim. Identifying vulnerabilities within the supply chain is necessary to reduce opportunities for perpetrating food fraud. Materials such as organic products and some natural ingredients are at greater risk for fraud where limited availability is an issue and/or the material is a high-value commodity or product. Mislabeling, counterfeit production or economically motivated adulteration, such as the substitution or dilution of ingredients in a sourced material, has a significant impact on downstream product claims.

Unverified packaging and labels are other sources of risk with the potential to affect the integrity of product claims. Ensure your supplier’s labeling practices include controls to verify the correct packaging and labels when producing IP materials or other ingredients with nutrient content or functional claims.

With a clear understanding of material risks, what attributes of an ingredient should be prioritized, tested and/or verified when considering the integrity of finished product claims?

Once material risks are analyzed, establish clear specifications for raw materials, which are agreed upon between the supplier and manufacturer. This serves as the basis for verifying material claims and subsequently, downstream product claims. Where specifications are in place, material verification may be performed through a variety methods including: testing, mass balance, COA review and audits. Verifying materials against agreed upon specifications not only supports due diligence in product claims but also brings manufacturers closer to their suppliers, steering us towards the next task.

Get to Know Your Suppliers

At the heart of food production transparency is the relationship a manufacturer has with its suppliers. Even the simplest of manufactured foods have a handful of ingredients, which are typically sourced through a global supply chain network. Due to the seasonality of produce or supply chain risks such as market fluctuations, business disruptions, natural disasters, or transportation failures; manufacturers can’t rely on a single supplier for the sourcing of a particular ingredient.

This leads to reliance on multiple suppliers, which may be geographically dispersed. Sourcing from multiple suppliers—especially when this occurs for multiple ingredients across multiple products—can create hurdles to relationship building for enhanced transparency due to time and resource constraints for acquiring first-hand knowledge of a supplier’s operation. Thus, proactive supply chain management, which enables a manufacturer to learn about the supplier’s history and operation, is essential for transparency.

This can be accomplished by establishing supplier approval criteria to provide a baseline for getting to know your supplier and establish minimum criteria for sourcing. Building upon this, is the use of approved suppliers to solidify the relationship and develop out a stable supply chain network. And finally, it is best practice to visit the supplier’s site to learn more about operational practices and the people responsible for ensuring material specifications and identity status are consistently achieved.

Apply Supply Chain Management Best Practices

Effective management of suppliers to prevent or reduce risks, which can lead to mislabeling and false claims, relies on the risk assessment conducted for materials and suppliers, applied controls (e.g., segregation) and verification that the supplier’s controls consistently ensure material integrity.

GFSI benchmarked schemes paved the way for enhanced supply chain management and risk mitigation when it comes to sourcing materials to ensure food safety and legal status. Some schemes additionally require controls and verification activities such as the validation of health claims or verification of nutrient content to provide a framework for helping manufacturers develop a system, which ensures product integrity. For food sold in the United States, a GFSI-based system is now reinforced by the  FSMA Preventive Controls rule, which requires supply chain-applied controls to mitigate material risks along with additional controls to ensure that food is not adulterated or misbranded under the U.S. Food, Drug and Cosmetic (FD&C) Act.

It is important to note that while the FSMA Preventive Controls rule regulates most processors and manufacturers, organic raw agricultural commodities (RAC’s), dietary supplements and unprocessed meats are not covered by the rule as they are covered by other U.S. food regulations. Since these products may be included in organic and natural product formulations, manufacturers may want to consider applying a Preventive Controls methodology to their supply chain or pursue certification to a recognized food safety standard such as a GFSI benchmarked scheme where this is not already in place.

Simplify Your Supply Chain

Complex supply chains reduce visibility, add latency into monitoring, and increase opportunities for contamination or fraud.7,8

Simplifying your supply chain can take a variety of forms such as the sourcing of local or domestic materials.

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product recall sheet

Effective Supplier/Retailer Communication Eases Pain of Food Recalls

By Holly Mockus
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product recall sheet

Food recalls are not 100% avoidable, and they are costly. The hit to an individual food company or retailer, on average, can run to tens of millions of dollars. Annually, millions of consumers become ill as a result of contaminated food products, and the dollar costs in terms of lost productivity, medical treatment and deaths run into the tens of billions.1 More than 20% of consumers have said that they would not purchase any brands from a company suffering a food recall.2 At best, damage to a company’s brand and reputation could take a long time to repair. Clearly, the need to prevent food contamination is obvious and should be the ultimate goal of all food safety professionals.

But despite the best industry efforts, recalls inevitably occur. And since they aren’t 100% avoidable, suppliers and retailers must continue to look for ways to minimize the safety and financial impact of the recall events that do occur. It’s good to begin that process by understanding some statistics surrounding the most common recalls. Globally, 46% of food recalls are for chemical hazards or the introduction of non-food-grade ingredients. 79% of these are due to undeclared allergens. 26% of recalls are for food-borne pathogens, and 8% are due to physical hazards (metal, glass, plastic, paper, wood, etc.). The remaining 20% are generally quality-based recalls and withdrawals.3

Head Off Recalls Before They Occur

Knowing the numbers helps suppliers and retailers home in on their most likely problem areas and get a leg up on potential product contamination problems. Since chemical hazards are the single biggest culprit, and because most of these instances are due to allergens, food companies should closely examine their cleaning and sanitation practices during production line changeovers. Keep in mind the potential role of contract service providers as sources of adulteration. Regarding pathogens, evaluate raw and ready-to-eat segregation procedures, staff access points, and  good manufacturing practices and employee traffic patterns.

Many companies focus their efforts on passing food safety certification audits, but faithful adherence to food safety measures just to pass an audit misses the point. Focus on the development and implementation of comprehensive food safety systems to guard against contamination and food safety incidents, and not just avoid non-conformances to certification codes. Preventing food safety incidents and recalls before they happen must be the priority.

Supplier Best Practice: The Mock Trace

Manufacturers, suppliers and certification bodies have evolved a set of best-practice recommendations that will go a long way toward reducing the number of food safety incidents and recalls. These include conducting regular internal audits of food safety plans and procedures, including approved supplier programs and environmental monitoring programs, both to re-evaluate their effectiveness and discover new or previously overlooked gaps.

Suppliers should consider taking things to the next level. SQFI’s LeAnn Chuboff suggests that suppliers “make their retailers happy” through the use of mock trace exercises.3 These “dry runs” are invaluable for reinforcing the close examination and evaluation of recall plans and to become intimately familiar with the necessary procedures in the event of an actual adulteration event. Mock trace exercises should be intensive: They are particularly effective in identifying gaps when they occur during off shifts. Making the exercise challenging rather than check-the-box easy helps companies reveal and close critical gaps. Conduct the mock trace in both directions, from raw materials to finished goods, and vice versa.

Include every department in the company. For mock trace exercises to be completely effective, review all documentation for errors or omissions. All employees should be interviewed to determine whether they fully understand food safety and documentation procedures. Review training modules and observe manufacturing procedures for evidence of knowledge or operational gaps. Examine bulk material receiving and storage, employee and material traffic patterns, packaging materials and procedures, and cleaning and maintenance chemicals.

Speed as well as accuracy and thoroughness are critical in the event of an actual recall event. Companies should practice rapid response. Take advantage of all the accumulated experiences from the mock exercise to improve every aspect of the company’s food contamination response tools and practices.

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Peas, UV light

Controlling and Mitigating Pathogens Throughout Production

By Troy Smith
1 Comment
Peas, UV light
Sampling
Product sampling

As the enforcement of rules, regulations and inspections get underway at food production facilities, we are faced with maintaining production rates while looking for infinitesimal pathogens and cleaning to non-detectible levels. This clearly sets demand on the plant for new and creative methods to control and mitigate pathogens pre-production, during production and post production.

As this occurs, the term clean takes on new meaning: What is clean, and how clean is clean? Swab and plate counts are now critically important. What method is used at the plant, who is testing, what sampling procedure is used, and how do we use the results? As we look at the process from start to finish, we must keep several key questions in mind: What are harboring points in the process, and what are the touch-point considerations to the product? Let’s review the overall processing progression through the factory (see Figure 1).

Figure 1.
Figure 1. The progression of processing of a food product through a facility.

Now consider micro pathogen contamination to the product, as we look deeper in the process for contamination or critical control points as used in successful HACCP plans. Consider contamination and how it may travel or contact food product. It is understood through study and research of both pathogens and plant operations that contamination may be introduced to the plant by the front door, back door, pallet, product, or by a person. In many cases, each of these considerations leads to uncontrolled environments that create uncontrolled measurements throughout, which lead to cleaning procedures based on time rather than science. This is certainly not to say that creating a preventive maintenance schedule based on a calendar is a bad thing. Rather, the message is to consider a deeper look at the pathogens and how they live and replicate. From the regulatory and control measures this should be a clear message of what food-to-pathogen considerations should be taken at the plant level as well as measurement methods and acceptable levels (which is not an easy answer, as each product and environment can change this answer). A good example to consider is public schools and children. Health organizations work to help the schooling system understand what immunizations children should have based on the current health risk tolerance levels. In food production, the consideration is similar in an everchanging environment. As we see contamination levels change the methods, techniques and solutions to proper food production must account for the pathogens of concern.

Contamination, Risk tolerance, Opportunity for Growth

Contamination, risk tolerance, and opportunity for growth are the considerations when looking at a plant design or a plant modification. Modification to modernization should be a top-of-mind critical quality control measure. If there are a few things we know, it is how to produce food at high rates of speed, measure and value production rates, and delays or failures can be measured by equipment and personnel performance. In the case of quality control, we must review, comprehend, and protect process risk. From a management or non-technical viewpoint, quality control can be very difficult to understand. When discussing pathogens, our concerns are not visible to the human eye—we are beyond a dirty surface, weare looking at risk tolerance based on pathogen growth in logarithmic measurement. When combining quality control and production, the measurement control and mitigation measures complement the effort. The use of quality control is expected and should coordinate with production to ensure the product is produced at the expected quality level.

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FSMA, One Year Later: Top 5 Things We’ve Learned

By Erika Miller
No Comments

Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.

5. Don’t Scrap Your Current Plan

Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.

4. Education Is Key

A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).

3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”

Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.

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2017 Food Industry: 4 Trends to Watch

By Katy Jones
1 Comment

From countless recalls, to FSMA deadlines, to the rising demand for transparency, 2016 has been a monumental year in the food industry. With 2017 knocking, here are the top trends and predictions to watch out for in the food industry next year.

1. Moving Toward a Fully Digital, Connected Supply Chain

The food supply chain in many ways is still lagging behind in technology compared to other supply chains. In 2017, many companies will begin or continue on their journey to fully digitize their supply chain, whether that is simply getting their list of approved suppliers out of an Excel spreadsheet and  into a supplier management software technology solution or fully capturing every step of their products along the journey from farm to fork.

The spectrum of digitization across the supply chain is quite broad. But bottom line, supply chain analytics will empower food companies to create useful KPIs, allow them to truly measure the ROI of their supply chain initiatives and give consumers the transparency that they demand. And systems that fully support the daily monitoring, sharing and interpretation of those analytics needed to help companies will experience tremendous growth in 2017.

Collaboration with your supply chain partners is an absolutely critical element, and we can expect to see more companies fully integrate throughout their network of suppliers and customers. Food companies that will succeed in 2017 will need a fully integrated supply chain network, with access to the same information, working towards a shared mission to deliver results and be ahead of their competitors. A connected supplier network will allow food companies to be agile when faced with an issue, responsive to recalls, as well as be flexible and efficient.

2. Recalls, Recalls, Recalls

We saw a high volume of recalls this year, and this trend is not going away anytime soon. As more and more advances in food testing are made, companies will have access to new technologies across their supply chain that will identify issues early. Consequently, more products will need to be pulled out of the supply chain because of that increased testing in order to maintain consumer sentiment.

The companies that are able to roll out these capabilities quickly and efficiently—armed with the data needed—will be well poised to manage their supply chain, potential recalls and the impact to their customers. With the knowledge that we can expect to see several recalls in the new year, food companies should be looking to mitigate risks and better manage their supply chain.

3. Full-force FSMA Is Here Whether You Like It or Not

FSMA focuses on amplifying preventive controls for food production in order to alleviate potential food contamination outbreaks, and the past two or more years have been focused on this preparation. This preparation will come to a pinnacle in 2017, the first full year of FSMA implementation worldwide, with the FDA starting audits for larger companies. This could lead to the FDA requesting required records, conducting audits and in the worst situation for food companies, shutting down operations if they feel it’s necessary.

FSMA will require detailed record keeping when a recall or outbreak occurs, with clearly defined corrective actions in place. Companies will see an increased need for technologies that help supply preventive processes such as food allergen and sanitation controls, as well a prepared recall and supply chain plan. Tracking and traceability will be the two key parameters that will offer manufacturers the ability to examine specific foods and trends to improve their overall process. In order to comply with these new FSMA regulations at every step of the process, food companies will increasingly look to utilize these technologies to account for full traceability of the supply chain.

4. Growth in Foodservice At the Consumer’s Doorstep

Brands like Starbucks and Panera have been testing the food home delivery waters, but more companies seem to be jumping onto the trend of bringing gourmet food directly to the consumer’s doorstep—Blue Apron, Plated, HelloFresh just to name a few.