Tag Archives: food safety

FST Soapbox

EQMS and HACCP – Friends or Foes?

By Kelly Kuchinski
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How quality processes can allow companies to take a more preventative approach to product recalls.

HAACP4 300x281 EQMS and HACCP Friends or Foes?I recently spoke to a friend who was a plant manager at a food manufacturing company, and he is all too familiar with today’s manufacturing challenges and product quality issues. We discussed how quality processes allow companies to take a more preventative approach to product recalls. He agreed that if quality and regulatory requirements are met before a product leaves the facility, organizations can be sure that they are providing safe product to their customers. The ability to identify issues before a product is distributed can also reduce additional costs associated with product recalls and the impact on a brand’s reputation and sales.

We then discussed how important HACCP was to his team. Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies where hazards might occur during the food production process and puts actions into place to prevent such hazards from occurring. By monitoring and controlling each step of the process, there is less chance for contamination or other hazards to occur.

He shared a story on his first experience implementing a HACCP plan at his previous facility. He noticed key areas where sanitation standards were not being met so he identified necessary corrective actions required to keep finished product safe. The process of monitoring these changes was difficult to manage and was draining the already limited resources in the plant.

During a team meeting, he brought up the issue and the QA Director mentioned that they were using a quality management system that managed workflow processes. They discussed how CAPA and complaint management were key processes that they were using in the QA area and it would easily support corrective actions associated with HACCP.

Within a few days, they were able to setup the system to support his team and automate the process. The most notable difference in using the QMS software was the time savings and reduction in recording errors. The system provided an interface that was easy to use and provided drop down menus for easier navigation through the system, unlike the cryptograms needed to use their ERP system.

As we finished up our call, we agreed that the true benefit of a quality system is visibility. We can now monitor potential hazards in the facility, manage outside supplier and third party manufacturers, and track compliance with regulatory requirements across the enterprise using one centralized system.  It is this visibility across the organization and its supplier network that allows organizations to tie in multiple quality controls, regulatory requirements and HACCP processes to automate and maintain the record of any change and preventative action to ensure consistency and safety of all finished products.

With companies encountering spikes in unforecasted demand, new levels of regulatory scrutiny, and fewer resources than ever before, my friend and I agreed that EQMS systems are more crucial than ever to help manage the complexities of quality process and allow issues to be resolved when they are identified early on.


About the Blogger:

Kelly Kuchinski, Industry Solutions Director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences and technology. Prior to joining Sparta Systems, Kelly focused on developing products and solutions to support companies across multiple industries to enhance functionality, increase efficiencies and reduce costs. She held product management and marketing positions at Merck Chemical, GS1, Checkpoint Systems and GE Capital. Kelly has an MBA from LaSalle University and received her Six Sigma Green Belt certification while at GE Capital.

Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
In the Food Lab

APEC Food Safety Cooperation Forum

By Janie Dubois, Ph.D.
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Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)

Efforts are ongoing in many regions to improve food safety; while the objective is obviously linked to public health outcomes, it is the business of food trade that really drives the funding for these activities. The reasoning is pretty simple: If efforts are made to meet the food safety requirements established based on risk (usually by developed nations) in order to enter or stay in trade markets, then the domestic population also benefits from safer foods. It is a win-win situation.

The Asia Pacific Economic Cooperation (APEC) Food Safety Cooperation Forum (FSCF) drives one such effort. The FSCF was established in 2007 to encourage the use of international food safety standards and recognized best practices to improve public health and facilitate trade among APEC member economies. The Forum also promotes information sharing and capacity building activities to accelerate the adoption of these standards and practices. The Forum is currently co-chaired by Australia and China. 

Why should we be involved in these initiatives? It is clear that it benefits the health of the U.S. population to improve the safety of food in the entire APEC region because we import it with minimal inspection (at least until FSMA rules come into effect). The U.S. imports just under $25 billion worth of fresh and processed fruits and vegetables, snack foods and red meats from the region. Once again, if we help the region adopt international standards, it also benefits their domestic population. Economically, we also benefit because the trade goes both ways and the region received over 70 percent of U.S. agricultural exports with soybeans, red meat, coarse grains and wheat adding up to ~$44.5 billion in 2012. The adoption of international standards reduces the likelihood that economies will impose their own standards, such as maximum limits (MLs) for example, that are not based on risk and may be hard to achieve using recognized good practices; these may be perceive as non-tariff trade barriers or reasons for devaluating crops from certain countries. 

One of the most difficult steps to perform in the establishment of standards for food safety is to assess the risk associated with particular foods for specific populations. Acute response and disease states are easier to spot and link to potential causes, but chronic conditions and responses triggered by combined risk factors are much more challenging, especially when they involve factors that are not food such as underlying diseases, genetic predisposition or environmental exposure. A very large project is active in the APEC FSCF to empower developing economies to perform risk analyses that will support their adoption of standards. Of course, it immediately comes to mind that risk assessment requires access to reliable data, an element that is non-trivial in a developing country environment. How does one measure exposure to a chemical or microbial risk when there are not enough trained analysts, not enough infrastructures or when the tests used are not fit for that purpose? THE APEC FSCF created the Partnership Training Institute Network in 2010 to stimulate a collaborative approach engaging industry, academia and governments to raise the capacity in the region. 

The impact of capacity building activities is often more far-reaching than meets the eye. A better understanding of the health and economic reasons behind international standards favors their adoption in countries that are modifying existing or adopting new standards. In turns, harmonization facilitates trade, trade improves the local economy and economic stability favors better health outcomes for the population. Beyond the big picture, there are very tangible benefits. In my line of work for example, we train laboratory analysts to perform tests in order to enable them to monitor their domestic food supply, which in time enables them to perform risk assessments that enable them to participate in international standards setting discussions, but it also benefits exporters to these markets by reducing the likelihood of unreliable results that could initiate shipment refusals or economic depreciation of shipments. International capacity building in food safety is a win-win situation.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech
Ask The Expert

Ensuring Microbial Safety of Compressed Air

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

Karen P. Cronholm, Director, Regional Marketing, for EMD Millipore’s BioMonitoring Group, says that “Compressed air contains water vapor, particulate matter, oil vapor and droplets, and microorganisms,” and this is a critical area that wasn’t paid much attention to until recently.

The new FSMA standard has created a great opportunity for their products, Cronholm explains. Of the first two sets of rules proposed under the Food Safety Modernization Act announced in January 2013, the Preventive Controls rule focuses on production and distribution sources and covers environmental testing of compressed air.

The requirements for microbial air monitoring do not only apply to ambient air but also to compressed gasses used in the aseptic environment. While FDA has increased the scrutiny and placed more responsibility on the food and beverage companies, there is still much ambiguity on the safety rules as there are a number of compressed air testing standards and guidelines, such as ISO® 8573, 21 CFR part 120 & 123, and the Safe Quality Food Program (SQF; which is being increasingly used by F&B companies to ensure compliance and safety).

“There is increased interest in compressed air monitoring as required by FSMA, and there is also a lot of education needed around compressed air; how to specify air particle counts; what are the types of filtration; how to test, what to test, how frequently to test etc,” Cronholm adds.

The technology to test needs to work with non-selective media. If you consider the food processing environment, Listeria monocytogenes is everywhere Cronholm says; “not just in the final product, but throughout the process. We have to adopt a Zone approach to testing, and closely check the process controls and process monitoring of the environment.”

“We offer a wide breadth and depth of air monitoring products, at a high quality and value price. There are both open and closed systems allowing for both active and passive air monitoring,” says Cronholm, referring to the RCS High Flow Touch system that offers “easy-to-handle, high-precision sampling for the effective monitoring of microorganisms in air and compressed gases.”

The RCS High Flow Touch Microbial Air Sampler is capable of fulfilling these requirements and furthermore assures easy operation for safe results. Some of the features include: RCS centrifugal based sampling; flow rate of 100 L/min; being portable, battery-driven, low weight instrument; validated system; maximum sampling efficiency; optimal design with aerodynamics diminishing air turbulence; sterility assurance – easy to disinfect, autoclave-able sampling head; and easy to handle – convenient operation by an integrated touch screen.

“With this technology you can test samples and get results in a minute. They are very rugged devices, and faster than technologies currently available in the market,” Cronholm describes.

For more information visit: EMD Millipore – RCS High Flow Touch System

Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
In the Food Lab

Capacity Building in Food Safety

By Janie Dubois, Ph.D.
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Janie Dubois, Ph.D., Laboratory Manager, Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
I’ll start this with a blunt and age-revealing truth: This is my first blog. This means I am more than happy to receive your “constructive advice” and suggestions for topics. This blog will appear monthly and focus on capacity building in food safety.
 
I would like to start by explaining what I do and through the months, introduce a number of initiatives and organizations involved in this field. The thing about food safety is that we all want it and there is a willingness to improve it; however, this objective can always benefit from more engagement and better knowledge of the tools that exist.
 
So back to me… I manage the International Food Safety Training Laboratory (IFSTL), a public-private partnership between the University of Maryland and the Waters Corporation. The Lab is the latest program at Joint Institute for Food Safety and Applied Nutrition (JIFSAN), which itself is a public-academic partnership between the University and the U.S. FDA. Why so complicated, you might wonder, because it takes a village… Put simply, what we do is deliver courses on laboratory methods fit for the purpose of demonstrating the safety of food. Why the village? Because one important reason for testing is to meet regulatory requirements put in place to ensure the health of populations and enforced through trade channels. We are lucky enough to be able to involve the regulators in the US (i.e. FDA, USDA and EPA) to explain why the rules are there, why some methods fit the purpose and others don’t, but also we ask them to explain what the health and economic consequences of failures to deliver safe food are. Then we needed teachers for hands-on laboratory work, and we needed some resources to make it happen. As I said, it takes a village.
 
The IFSTL is a resource for technical assistance and training identified in the FDA’s International Food Safety Capacity-Building Plan published in February 2013. Goal 4 of the Plan specifically addresses technical assistance and objective 4.4 further defines the vision for multilateral acceptance of fit-for-purpose laboratory methods. Personal experience has taught us that some laboratory analysts embrace the flexibility brought about by requiring methods to be equivalent instead of a rigid imposition of pre-defined methods, but others would rather simply be told what to do. The flexibility allows each laboratory to apply the methods that best fit their situation in terms of access to trained staff, to instrumentation, to test kits and to financial resources, while still fitting the purpose of the measurement. There are usually quite a few recommended validated methods and good reasons to select any of them. So for that topic only, there are lots of questions requiring not only technical expertise on instrumentation, but also on the requirements of the regulatory system and, let’s face it, tricks of the trade.
 
The selection of courses we offer is guided by input from FDA foreign posts informing us of needs observed in their region. The need may arise from a new regulatory requirement, from a change in agricultural production and exports or simply because training is not available in the region. We also receive input from the industry, primarily but not exclusively from members of the JIFSAN Advisory Council. Finally, we also receive requests from other countries either through technical assistance activities or directly from analysists. Generally, we prepare courses that are open to the public (of laboratory analysts) from the US and foreign countries for registration, and these courses always benefit from a heavy involvement from the U.S. regulatory agencies. In some cases, we develop and deliver private courses for industry that include aspects of their own laboratory quality control systems. In a nutshell, that’s what we do at the IFSTL.
 
In the coming months, I will talk about a number of initiative in food safety capacity building and I hope that it will encourage us to continue to work together to achieve the goal of providing safe food to the world. 
FST Soapbox

The Private Food Label Dilemma

By Barbara Levin
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Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry.

Tuesday morning I had my typical breakfast while running out the door – Trader Joe’s almond butter on a toasted whole grain waffle. Good, and good for you, as my mom likes to say. Then of course I got to my desk, looked through my daily FSQA news feeds, and saw that the peanut butter recall was expanded to almond butter – and to other brands besides Trader Joe’s from the supplier, Sunland!

Well so far so good – I’m healthy and not in a high risk group, but it did make me think once again about the problem for food retailers that – in the need to remain competitive for shelf space in their own stores – have turned to private labeling for more and more products store-wide.

I’m a big fan of Trader Joe’s.  I buy a lot of their private label brands – everything from almond butter, to tomato sauce to olive oil. And they did a good job of aggressively getting the tainted nut butters off of their shelves.

But it does make one think of the added challenge for those manufacturing and selling private label goods – where a manufacturer problem can create a huge negative impact on your private label brand. Obviously in cases such as the Sunland nut butters, the ability to trace where the product had gone was key for recalling it. And while that ability is critical – the initial damage to the private label brands is done. Now, it’s just a matter of how extensive the damage is and how much it will cost to repair: loss of inventory, loss of sales, loss of consumer confidence and of course the cost of illness and related lawsuits which have already begun to follow.

And this doesn’t count the non-direct costs – such as advertising to eventually get those customers back – those who may now be “private label shy” and go back to the brand names under the perception that they may be safer.

We challenge the industry to look not just at reactive measures – but proactive, preventative measures as well. How are you leveraging food safety and quality technology? Are you using technology only to trace back once a problem has already occurred? Or are you also using technology to help prevent contaminated ingredients from going into production – and non-compliant finished goods from being labeled and shipped – in the first place. Are you as retailers putting this extra pressure on your manufacturers to take not just the reactive steps but the proactive ones as well?  

Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry. Have a thought on this topic? Join the conversation by posting a comment below.