Tag Archives: automation

SafetyChain Software

Six Steps to Getting a Handle on Cost of Quality

By Barbara Levin
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SafetyChain Software

The importance of food safety is understood and hopefully, unquestioned. It is industry’s responsibility to protect consumers and of course, a major food safety event can ruin a company’s brand and financial health.

Yet when it comes to food quality management, the complexities and overall economics of quality are often underestimated. While lapses in food safety can destroy a brand, it is the consistent adherence to food quality attributes that build brand loyalty. This is why that brand of bread always has that certain softness, or why that French fry always has the same taste regardless of where you buy it. And that is why manufacturers continue to purchase, or decide not to purchase, ingredients from certain suppliers.

Food quality management can often be more complex than food safety. Think 3 CCPs vs. 30 quality attributes, for example. And, Cost of Quality can have the biggest impact on a food company’s overall key performance indicators (KPIs), profitability and brand reputation. Non-conformances in food quality often cause the most rework and the most customer rejections, which has a significant impact on what can be referred to as the Economics of Food Quality Management.

Since most food safety and quality assurance (FSQA) operations are often “data rich and information poor” — meaning they don’t have an effective way to do trending and benchmarking on the volume of quality data they collect — it can be difficult to fully understand, and therefore reduce, Cost of Quality.

Getting a handle on Cost of Quality is a process. These six steps are a good place to start:

  • Define quality in your organization
  • Determine the right metrics for a better understanding of Cost of Quality
  • Improve transparency and visibility of your processes, products and supplier quality requirements
  • Fully understand where your quality risks come from
  • Make your quality data both accessible and actionable for continuous improvement to reduce Cost of Quality
  • Understand what tools are available, such as automation technologies, that can improve performance and lower Cost of Quality

SafetyChain is hosting a complimentary webinar, “The Economics of Food Quality Management: Understanding and Reducing Cost of Quality,” on June 25. The event features Lamont Rumbers, president and founder of Fully Integrated Quality Solutions, and former senior director of quality for Sam’s Club. Rumbers will discuss these six steps and much more. Learn more about the webinar and register.

Randy Fields, Repositrak
FST Soapbox

Despite FSMA Exemptions, Compliance Will Not Be Optional For Small Suppliers

By Randy Fields
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Randy Fields, Repositrak

The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.

The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.

In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.

Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.

Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.

The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.

Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.

Ask the Experts – Automation Pathogen Detection

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

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

Pathogen testing can typically be broken up into three categories:

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

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

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

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

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

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

For more information, visit Bio-rad.com

Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific
In the Food Lab

Molecular Diagnostics – Generation 3: 2005 to Present

By Ravi Ramadhar
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Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific

In my previous blog, I covered the first two generations of Molecular Diagnostics: Generation one, was the advent of these tests prior to 1995, while the second generation saw the evolution of molecular diagnostics with the emergence of standardized food molecular and method workflow.

The advent of automated DNA sequencing and use of multiple fluorescent dyes by companies like Applied Biosystems and Roche led to the development of multiple fluorescent dyes and real- time quantitative PCR systems (qPCR). At first these qPCR systems were only used in the research environment, but quickly found their way to the food industry.

Applications such as quantitation of GMOs and multiple pathogen targets became common. Real-time PCR systems permitted users to visualize amplification as it happened and enabled simultaneous detection of multiple targets. With the use of newer chemistries and improved enzymes, shorter amplification cycles – sometimes as low as 40 minutes – could be achieved. The real-time systems offered faster time-to-result with additional target probes and thus higher target specificity. As with most molecular methods, the workflow was sensitive to food matrix inhibition and required alternative sample preparation methods to meet the wide variety of food matrixes.

Within this generation of solutions, alternatives were introduced, that promised faster, easier or more sensitive results. These included alternative to either the detection method or enzymes utilized Iisothermal amplification, for example without need for multiplexing capability of qPCR or internal controls, as well as targeting alternative nucleic acid such as RNA were introduced to the food market. These incremental improvements did not lead to any significant new paradigms or improvements to the food testing workflow. Their emergence instead led to an explosion of additional and alternative molecular platforms for food, without any real innovation. Within this, solutions introduced to the food industry eventually brought us to where we are today.

Directly taking systems from the clinical diagnostics workflow and introducing these platforms and systems as food solutions. While these systems automate the entire workflow or automate the PCR setup it remains to be seen if with their higher complexity and high maintenance these systems can survive the food industry. The basic molecular workflow for food has remained intact since its introduction in the late 1990s with innovation more or less stagnant. What’s needed is for someone to truly develop a platform from the ground up with the food laboratory in mind.

Today’s landscape and what’s next

Today, there are some early signals of where innovations and changes for food labs will emerge. A recent poster by Nestle, for example, highlighted the uses of next-generation sequencing (NGS) and DNA sequencing to develop a DNA method to allow the identification of coffee varieties through the value chain, from the field to the finished product. The method is applied on routine basis to guarantee the purity and authenticity of raw material used by Nespresso.

Applications of NGS in outbreak response and trace back investigations are being used in parallel with existing technologies. Finally, availability of new sequencing data enables better assay design and development of adjacent technologies.

NGS was preceded by emulsion amplification and sequencing by synthesis. These developments led to the development and introduction of digital PCR. Within a digital PCR reaction, millions of simultaneous reactions from one sample occur. The advantages of dPCR include lower and absolute, not relative gene copy number. The data has high precision and has better tolerance to inhibitors. These characteristics can lead to better and more precise molecular tests in food. , Before dPCR wide spread adoption is seen, however, the limitations of high cost and limited dynamic range must be addressed.

It’s not only in the testing labs and adjacent technologies that NGS is having an impact. In the labs driving innovation in food and food ingredient development, applications of NGS are being used to develop targeted food ingredients.

Nestle is the leader in this convergence of food, health and nutrition and over the last three years, the company has acquired and formed partnerships targeting the space. In its formation of the Nestle Institute of Health Sciences, Emmanuel Baetge, head of NHIS, emphasized NHIS expertise and research capabilities using systems biology, next generation sequencing, and human genetics.

The world of food safety is as dynamic as the natural flora of food itself. Changing regulations, evolving organisms, technological change and consumers’ changing tastes require new solutions. The requirements of the food laboratory have not changed. They are the protectors of brands and the teams we trust to deliver safe and quality foods. However, how they do that has and will continue to change.

Next time… molecular serotyping.

References:

  1. Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP) Available at: www.genome.gov/sequencingcosts. Accessed 1/13/2014 [DOA 1/13/12014].
  2. Beilei Ge and Jianghong Meng , 2009 14: 235 Advanced Technologies for Pathogen and Toxin Detection in Foods: Current Applications and Future Journal of Laboratory Automation DOI: 10.1016/j.jala.2008.12.012.
  3. Morisset D, Sˇ tebih D, Milavec M, Gruden K, Zˇ el J (2013) Quantitative Analysis of Food and Feed Samples with Droplet Digital PCR. PLoS ONE 8(5):e62583. doi:10.1371/journal.pone.0062583.
  4. http://www.nestle-nespresso.com/asset-libraries/Related%20documents%20not%20indexed/Nespresso%20poster%20ASIC2012%20DNA%20traceability.pdf