Tag Archives: Focus Article

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

By Joy Dell’Aringa
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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.

Continue to page 2 below.

Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

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.

Sanjay Singh, Eurofins
Food Genomics

How is DNA Sequenced?

By Sanjay K. Singh, Douglas Marshall, Gregory Siragusa
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Sanjay Singh, Eurofins

Here is a prediction. Within the next year or years, at some time in your daily work life as a food safety professional you will be called upon to either use genomic tools or to understand and relay information based on genomic tools for making important decisions about food safety and quality. Molecular biologists love to use what often seems like a foreign or secret language. Rest assured dear reader, these are mostly just vernacular and are easily understood once you get comfortable with a bit of the vocabulary. In this the fourth installment of our column we progress to give you another tool for your food genomics tool kit. We have called upon a colleague and sequencing expert, Dr. Sanjay Singh, to be a guest co-author for this topic on sequencing and guide us through the genomics language barrier.

The first report of the annotated (labeled) sequence of the human genome occurred in 2003, 50 years after the discovery of the structure of DNA. In this genome document all the genetic information required to create and sustain a human being was provided. The discovery of the structure of DNA has provided a foundation for a deeper understanding of all life forms, with DNA as a core molecule of genetic information. Of course that includes our food and our tiny friends of the microbial world. Further molecular technological advances in the fields of agriculture, food science, forensics, epidemiology, comparative genomics, medicine, diagnostics and therapeutics are providing stunning examples of the power of genomics in our daily lives.  We are only now beginning to harvest the fruits of sequencing and using that knowledge routinely in our respective professions.

In our first column we wrote, “DNA sequencing can be used to determine the names, types, and proportions of microorganisms, the component species in a food sample, and track foodborne diseases agents.” In this month’s column, we present a basic guide to how DNA sequencing chemistry works.

Image courtesy of US Human Genome Project Knowledge base
Image courtesy of US Human Genome Project Knowledge base

DNA sequencing is the process of determining the precise order of four nucleotide bases, adenine or A, cytosine or C, guanine or G, and thymine or T in a DNA molecule. By knowing the linear sequence of A, C, G, and T in a DNA molecule, the genetic information carried in that particular DNA molecule can be determined.

DNA sequencing happened from the intersections of different fields including biology, chemistry, mathematics, and physics.1,2 The critical breakthrough was provided in 1953 by James Watson, Francis Crick, Maurice Wlkins and Rosalind Franklin when they resolved the now familiar double helix structure of DNA.3 Each helical strand was a polynucleotide, which consists of repeating monomeric units called nucleotides. A nucleotide consists of a sugar (deoxyribose), a phosphate moiety, and one of the four nitrogenous bases—the aforementioned A, C, G, and T. In the double helix, the strands run opposite to each other, commonly referred as anti-parallel. Repeating units of base-pairs (bp), where A always pairs with T and C always pairs with G, are arranged within the double helix so that they are slightly offset from each other like steps in a winding staircase. On a piece of paper, the double helix is often represented by scientists as a flat ladder-like structure, where the base pairs (bp) form the rungs of the ladder while the sugar-phosphate backbone form the antiparallel rails (see Figure 1).

DNA Double Helix
Artistic representation of DNA Double Helix. Source: Eurofins

The two ends of each polynucleotide strand are called 5′ or 3′-end, a nomenclature that represents the chemical structure of the deoxyribose sugar at that terminus. The lengths of a single- or double-stranded DNA are often measured in bases (b) or bases pairs (bp), respectively. The two polynucleotide strands can be readily unzipped by heating, and on cooling, the initial double-helix structure is re-formed or re-annealed. The ability to rezip the initial ladder-like structure can be attributed to the phenomenon of base pairing, which merits repetition—the base A always pairs with T and the base G always with C. This rather innocuous phenomenon of base pairing is the basis for the mechanism by which DNA is copied when cells divide and is also the theoretical basis on which most traditional and modern DNA sequencing methodologies have been developed.

Other biological advancements also paved the way towards the development of sequencing technologies. Prominent amongst these were the discovery of enzymes that allowed a scientist to manipulate the DNA. For example, restriction enzymes that recognize and cleave DNA at specific short nucleotide sequences can be used to fragment a long duplex strand of DNA.4 The DNA polymerase enzyme, in the presence of the deoxyribose nucleotide triphosphates (dNTPs: Chemically reactive forms of the nucleotide monomers), can use a single DNA strand to fill in the complementary bases and extend a shorter rail strand (primer extension) of a partial DNA ladder.5 A critical part of the primer extension is the ‘primer’, which are short single-stranded DNA pieces (15 to 30 bases long) that are complementary to a segment of the target DNA. These primers are made using automated high-throughput synthesizer machines. Today, such primers can be rapidly manufactured and delivered on the following day. When the primer and the target DNA are combined through a process called annealing (heat and then cool), they form a structure that shows a ladder-like head and a long single-stranded tail. In 1983, Kary Mullis developed an enzyme-based process called Polymerase Chain Reaction (PCR). Using this protocol, one can pick a single copy of DNA and amplify the same sequence an enormous number of times. One can think of PCR as molecular photocopier in which a single piece of DNA is amplified up to approximately 30 billion copies!

The other critical event that changed the course of DNA sequencing efforts was the publication of the ‘dideoxy chain termination’ method by Dr. Frederick Sanger in December 1977.6 This marked the beginning of the first generation of DNA sequencing techniques. Most next-generation sequencing methods are refinements of the chain termination, or “Sanger method” of sequencing.

Frederick Sanger chemically modified each base so that when it was incorporated into a growing DNA chain, the chain was forcibly terminated. By setting up a primer extension reaction where in one of the chemically modified ‘inactive’ base in smaller quantity is mixed with four active bases, Sanger obtained a series of DNA strands, which when separated based on their size indicated the positions of that particular base in the DNA sequence. By analyzing the results from four such reactions run in parallel, each containing a different ‘inactive’ base, Sanger could piece together the complete sequence of the DNA. Subsequent modifications to the method allowed for the determination of the sequence using dye-labeled termination bases in a single reaction. Since, a sequence of less than <1000 bases can be determined from a single such reaction, the sequence of longer DNA molecules have to be pieced together from many such reads.

Using technologies available in the mid-1990’s, as many as 1 million bases of sequence could be determined per day. However, at this rate, determining the sequence of the 3 billion bp human genome required years of sequencing work. By analogy, this is equivalent to reading the Sunday issue of The New York Times, about 300,000 words, at a pace of 100 words per day. The cost of sequencing the human genome was a whopping  $70 million. The human genome project clearly brought forth a need for technologies that could deliver fast, inexpensive and accurate genome sequences.  In response, the field initially exploded with modifications to the Sanger method. The impetus for these modifications was provided by advances in enzymology, fluorescent detection dyes and capillary-array electrophoresis. Using the Sanger method of sequencing, one can read up to ~1,000 bp in a single reaction, and either 96 or 384 such reactions (in a 96 or 384 well plate) can be performed in parallel using DNA sequencers. More recently a new wave of technological sequencing advances, termed NGS or next-generation sequencing, have been commercialized. NGS is fast, automated, massively parallel and highly reproducible. NGS platforms can read more than 4 billion DNA strands and generate about a terabyte of sequence data in about six days! The whole 3 billion base pairs of the human genome can be sequenced and annotated in a mere month or less.

Continue to page 2.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

With FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Dana Johnson Downing, TraceGains
FST Soapbox

Dispelling the Myth that Food Safety is Not a Competitive Advantage

By Dana Johnson Downing
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Dana Johnson Downing, TraceGains

“Food safety is not a competitive advantage” is one of the barf-worthy “feel good” messages you hear from food industry executives during speeches and public forums. Last week at the Global Food Safety Initiative (GFSI) conference in Houston, an audience of more than 1,150 from 54 countries heard this tired mantra repeated during a panel discussion featuring CEOs from Mondelez, Cargill, Tysons and Wegmans. The common theme espoused by the CEOs was that food safety is a given and it’s just the right thing to do. Under their flawed rationale, because food safety is mandated, it cannot be a differentiator. Huh? That’s like saying monogamy in marriage is a given. Sure, most brides and grooms pledge faithfulness, but hey, we all know cheaters gonna cheat.

I wasn’t the only one who didn’t buy the food safety kumbaya message the CEOs were peddling. BBC business journalist Adam Shaw was the moderator for the panel and he grilled the CEOs to try to expose the fallacy that food safety is not a competitive advantage as nothing more than high-mindedness with altruistic notions, but the CEOs deflected his pointed questions and stayed on-message. I thought the song from the Lego movie, “Everything is Awesome” might start blaring from the sound system at any moment. What I cannot discern is if the CEOs really believe that food safety is not a competitive advantage, or do they feel compelled to say it to bolster confidence in the food supply.

I think we can all agree that consumers expect their products to be safe. Objectively, I think we must also agree that there are some companies in the food industry that simply do a better job of managing risk in their food safety system. As Warren Buffet once said, “Risk comes from not knowing what you’re doing.” Have you ever read the warning letters issues by the FDA? There are plenty of food operators who either do not know what they are doing or their profits are more important to them than the safety of the products they produce.

Perhaps the real reason these CEOs say food safety is not a competitive advantage is because they are trying to trick us with some twisted reverse psychology technique. More likely they avoid positioning their company as having an extraordinary food safety system because you can never eliminate all risk, and a recall or foodborne illness outbreak could be lurking just around the corner. That logic is a little lost on me, but okay.

What about food safety as a competitive advantage in the business-to-business (B2B) environment? With all the transactions between ingredient suppliers, brokers, distributors, co-packers and manufacturers, there is often friction between vendor and customer over food safety standards and the underlying documentation. Who you do business with matters more than ever before, especially now that there is greater supply chain transparency and process control mandated by FSMA. According to Brian Perry, senior vice president, food safety & quality at TreeHouse Foods, he has had to drop suppliers who are not FSMA-compliant because they pose too much risk. Meanwhile, companies are willing to pay a premium for suppliers who have their food safety documentation in order and routinely deliver on time and within specifications. So at least in the B2B marketplace, we can see that food safety can definitely provide a competitive advantage.

Pesky undeclared allergens and foreign material find a way to sneak into food production. Unsanitary conditions are sometimes permitted and product is adulterated. Mistakes are made, stuff happens, and sometimes food makes people and animals sick or even leads to death. So please don’t tell me that food safety is a given! If you want consumers to have confidence in our food supply, then tell them what your company does to try to prevent stuff from happening. Consumers’ appetite for information and knowledge about the food they consume is at an all time high. If consumers care about GMOs or how ethically-raised, humanely-treated, or sustainably-produced their food is, isn’t it logical to think they care about how companies develop a culture of food safety, the technology they use, and how strictly they monitor their suppliers? In order to make food safety a competitive advantage, food companies need to show supply chain partners and consumers that transparency isn’t just a buzzword. They need to show how they are operationalizing transparency to elevate food safety as a corporate imperative. Share your food safety story and respect your consumers enough to make up their own minds about whether your food safety system sets your brand apart.

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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Randy Fields, Repositrak
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Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
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Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

Gears

Three Practices for Supply Chain Management in the Food Industry

By Kevin Hill
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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.