Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

What to do Now to Migrate from HACCP to HARPC

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

There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
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While HACCP has been highly successful and truly promoted seafood safety and consumer confidence in these products, there are several useful lessons that may make your transition to FSMA compliance easier.

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods.

Since the requirement for preventive controls is about to be extended to all foods regulated by FDA, it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

1. Unnecessary CCPs. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry. Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans. Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.

2. Mixing sanitation controls with HACCP controls. The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls. A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.

3. Monitoring need to be available in their original form in an organized fashion. Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators. If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.

4. If a new product is introduced to your processing operation the HACCP plan should be amended immediately. Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same. Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.

5. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator. For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.

6. Generic HACCP plans should not be used. In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis. This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis. Not doing so could result in a serious charge.

This article originally appeared in EAS-e-News, March 2015 edition. 

 

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

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Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.

Millennials Are Changing the Food Industry

By Chelsey Davis
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Millennials are definitely changing the landscape of the food industry. What do they care about when it comes to food, and what does this mean for food manufacturers?

TraceGains_Millennials1

We’ve all heard the latest trends regarding that hard-to-reach audience we’ve dubbed the Millennials (those born roughly between the years 1980 and the early 2000s). And with so many how-to articles out there, it’s hard to really understand who these folks are and what they want. Here are just a few fun facts about this generation: 50 percent consider themselves politically unaffiliated, they have the highest average number of Facebook friends, 55 percent have posted a selfie or two to social media sites, and there are roughly 80 million of them. This makes Millennials the biggest generation thus far. And one thing is for certain, based on research, they are definitely changing the landscape of the food industry. So what do Millennials care about when it comes to food?

Millennials care about quality and sustainability

According to a 2014 study by the International Food Council (IFC), Millennials have the highest level of awareness out of any age group when it comes to food sustainability, and they are willing to pay more for it. And when it comes to quality vs. price, Millennials are more apt to be loyal to a brand deemed to have quality products as opposed to a brand that has a better price point.

Quality versus price for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Quality versus price for Millennials (Image courtesy of Business Insider via Goldman Sachs)

Take McDonald’s for example. In August of 2013, the fast-food chain reported a 13 percent decline in consumption for people between the ages of 19-21 since 2011. And while Millennials are still dinning out, they are opting for franchises like Chipotle and Five Guys. Why? These chains pride themselves on using local producers and sustainable food items, which makes paying that extra $2.00 for guacamole not so bad to this generation.

Additionally, Millennials are more apt to choose products that are socially responsible and produce lower carbon footprints. For example, Millennials are now paying attention to how much energy, water and effort it takes to grow, manufacture and transport food, including the packaging process. And as this environmentally friendly generation matures and moves into prime spending age, manufacturers will need to evolve the packaging of food products to ensure they are created with eco-friendly and recyclable materials if they wish to appeal to these folks.

Millennials care about their health

This generation, as research states, is more aware of their health than any other generation thus far, especially when it comes to what goes into their bodies. Locally grown, cage-free, all-natural, organic—these are all terms Millennials tend to gravitate towards when making food choices. As a result, organic coffee shops are popping up everywhere, farm-to-table restaurants are all the rage, and even private label brands are seeing increases in sales, with Millennials opting for those over national brands due to the perception that these labels are more innovative.

Millennials are also reading labels and are more aware of what the items on the labels mean—they understand the ingredients and what goes into their food more so than their parents and grandparents. As a result, we’re seeing an increase in natural and organic claims as we navigate through the grocery aisles.

Graphic showing wellness stats for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Graphic showing wellness stats for Millennials
(Image courtesy of Bushiness Insider via Goldman Sachs)

What this means for food manufacturers

Food manufacturers have an interesting challenge ahead, but also a great opportunity. The ones that will ultimately gain popularity among Millennials will be those that are willing to innovate while staying authentic. Millennials not only value the transparency of brands, they are also aware of shortcomings when it comes to unsubstantiated claims. Food manufacturers must now walk the line between making all-natural and sustainable product claims, and being 100 percent truthful in their statements. When it comes down to it, Millennials will do the research, read the labels and uncover the truth.

So how do you appeal to Millennials, while also mitigating the risks when it comes to labeling your product natural, organic or GMO-free? To answer tough questions like this, TraceGains got the inside scoop from Attorney Antonio Gallegos, who advises on compliance with regulations administered by the FDA, FTC, USDA and similar state-level agencies, and co-produced a guidance report. Use this free Natural Labeling Guidance Report to help you make informed decisions in the future for your products. Do you have additional tips for reaching Millennials? Leave a comment below and let us know!

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Implementing an Effective Listeria Control Plan for Dairy Products

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

In the last three years, there have been four major foodborne illness outbreaks caused by Listeria monocytogenes in dairy products (Oasis fresh curd cheese; Roos raw hard cheese; Crave Brothers pasteurized farmstead cheese; and Frescolina Marte pasteurized ricotta cheese). Before 2012, there have been multiple outbreaks due to raw and pasteurized Mexican-style soft cheeses and in pasteurized milk in 2007.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology LaboratoriesDr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories , recently spoke about Implementing an effective Listeria control plan for Dairy Products in a recent presentation. He described the pathogen as “a gram-positive bacteria, which is facultatively anaerobic, psychotrophic (can even multiply at refrigeration temperatures – though at slower rates), sensitive to heat processing, even found in healthy cows, raw milk and dairy processing environments, and can survive most cheese ripening processes.”

Though, listeriosis, the infection caused when a person is infected with LM, is relatively rare – only affecting about 1600 individuals a year – it has a high mortality rate, highest among foodborne illnesses, especially among high-risk individuals.

Dr. Marshall listed some of the contributing factors to a LM outbreak:

  • Inadequate thermal processing
  • Refrigeration temperature being too high
  • Inadequate product flow through processing plant
  • Inadequate personal hygiene
  • Product shelf-life too long
  • Inadequate cleaning and sanitation
  • Inadequate environmental monitoring and control
  • Inadequate end product testing

Thermal processing is a time-temperature process, and it can be inadequate if either the temperature is too low, or the process time is too short.

It is common knowledge that whether it’s during transportation, or at retail or at homes, often temperature of food storage is not adequately maintained. Dr. Marshall said that as high as 55 percent of household units and 32 of retail store units had refrigeration temperatures of greater than 9 °C. “And once you get past that temperature threshold of 10 °C, the bacteria reaches maximum population level within six days (average shelf life).”

Inadequate cleaning & sanitation is another major cause for LM contamination and this is often the battle between production & sanitation. Floor drains are a common culprit, responsible for 63 percent incidence of LM. Dr. Marshall also referred to other sources of inoculation that you are not getting effective control of such as filler heads and high pressure water sprays or air sprays, which can aerosolize bacteria and spread the contamination to other surfaces.

Inadequate product flow is usually due to the failure to segregate pasteurized product form raw product or the failure to segregate employees working in raw vs. pasteurized locations. Address this by mapping out product and employee flow (along with equipment) and look for areas where cross contamination can occur, advises Dr. Marshall, who cautions facilities to monitor and control the following direct food contact surfaces that can be cross-contaminated:

  • Fillers
  • Packaging stems
  • Conveyors
  • Chilling solutions
  • Slicers, dicers, shredders, blenders, hoops, molds
  • Collators, assemblers
  • Product movement items, such as racks, bins, tubs and buckets
  • Spiral coolers, blast freezers
  • Hand tools, gloves, aprons

Inadequate personal hygiene is another contributing factor and this can include clothing such as outerwear and gloves. Maintenance personnel should be thorough in their hand-washing and it’s recommended they use alcohol based wipes after hand-washing.

Address the issue of shelf-life being too long by determining the shelf life based on food safety, and not food quality. Also, run LM challenge test in each product, Dr. Marshall advises.

Eurofins-LM-in-Dairy-webinar-March2015

FDA, in their Preventive Controls rule proposed under the Food Safety Modernization Act, has a section on Environmental Monitoring, based on the rationale that that poor control of the environment can lead to LM cross contamination of finished product, explains Dr. Marshall, adding that inadequate environmental monitoring and control is a key component for LM contamination.

“Invest your testing dollars to find hot spots in your facility and ensure the control mechanisms are working every day,” he says, asking companies to “detect and control hot spots, measure effectiveness of general cleaning and sanitation programs, and test for Listeria species.”

Dr. Marshall asks, “If I were LM and wanted to hide, where would that be? Would it be on an easy to clean surface such as the floor, or would it be in a nook or cranny where it’s hard to reach and clean?” He lists the following as areas that commonly harbor the pathogen and advises extra caution and creativity to clean these spots:

  • Equipment framework – nuts, bolts, open tubing, spot welds
  • Floors and drains – standing water
  • Walls
  • Ceilings, overhead equipment, catwalks, pipes
  • Condensate
  • Exposed, wet insulation around pipes and walls
  • Fork lifts, trolleys
  • Cleaning tools – sponges, brushes, scrubbers
  • Maintenance tools
  • Conveyors, belts and rollers (need to be broken down and cleaned regularly)
  • Control panels and switches
  • Rubber seals (especially if they have cracks)
  • Trash cans
  • Air fillers
  • Motor/ pump housings
  • Cracked hoses
  • Ice makers

End product testing is an effective way for testing for LM, but Dr. Marshall points out that there are often arguments against this. “Companies often argue that their HACCP plan is working, their kill step is effective and that they have a history of doing end product testing, and they haven’t had any positive results so far. But this is not a convincing enough argument.” End product testing can address the failure to monitor and control high risk ingredients, and is very useful to detect gross contamination events. It should be used to assess risk of rework, and also test for LM, not just Listeria, Dr. Marshall advises.

Hear more about building an effective control plan for Listeria in your dairy processing environment, by listening to this archived webinar recording, presented by Eurofins.

Getting a Handle on Cleanliness

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Hand hygiene is a crucial aspect of food production and processing. How can food companies reduce the risks associated with human error in hand hygiene?

Ensuring that employees maintain a proactive and responsible attitude to hand cleanliness is worth a great deal to companies in food processing and production. This can be in regards to financial aspects- a contamination of food materials could cripple a company financially, as well as the damage to reputation that may result from poor cleanliness. In addition poor hand hygiene is a significant factor in individual illness; with employee illness hampering productivity. The costs associated with employee illness and the absences associated with such are also surprisingly high. While the vast majority of food production companies have in place a proactive approach to hand hygiene, ensuring employees themselves actually abide by hand hygiene practices can be more difficult.

CDCKeepCalm_WashyouhandsYou’d be forgiven for thinking that workers handling food would be proactive in terms of ensuring hand hygiene, deeming hand washing initiatives and education campaigns unnecessary. Yet research from the Environmental Health Specialists Network (ESH-Net), the collaborative forum of environmental health specialists associated with the Centers for Disease Control and Prevention (CDC), questions whether sufficient hand hygiene compliance is as widespread as one may have thought. ESH-Net found in one study that 12 percent of food workers had been into work despite suffering from a sickness bug and/or diarrhea1. Illnesses such as these can spread through a working environment very quickly and one sick employee can spiral into many more ill workers in a short period of time.

Other studies focusing on the economic cost of workplace absence due to sickness in the United Kingdom demonstrate the financial issues associated with avoidable illnesses. A report carried out by the Chartered Institute of Personnel and Development in conjunction with Simplyhealth found that the average cost of employee absence is £673 per employee, per year, with two-thirds of cases involving short-term (fewer than 7 day) absences2. The British Health and Safety Executive (HSE) put the annual cost of employee illness at more than £12billion3.

The potential for the spread of infection from an ill employee coming into work is high. It is also exacerbated by the fact that a large minority of workers do not practice adequate hand hygiene. The ESH-Net found that the average worker in facilities where food is handled will carry out an activity which would require hand washing before and after nine times an hour. The same ESH-Net report discovered that only 27 percent of workers fulfilled their hand hygiene obligations in carrying out these activities. It is also true that in many cases the quality of hand washing is insufficient and not enough to properly kill germs4. The guidelines for proper hand washing recommend the use of hot water and soap and for the whole process to take at least 20 to 25 seconds. One recommendation is that a sufficient hand washing session should take the same amount of time as singing the Happy Birthday song twice. Despite this it is clear that many people do not wash their hands for anywhere near as long as these guidelines. A report from Michigan State University found the average time spent washing hands was barely 6 seconds5.

Another piece of research suggested that 95 percent of people do not wash their hands to an adequate standard6. In addition to insufficient time spent washing hands, the efficacy of hand washing techniques employed by many people can be questionable. The Michigan State University report detailed how more than a third of people did not use soap when washing their hands, with 1 in 10 not washing their hands at all.

Although these data outline public hand hygiene practices, not specifically the practices of food workers, the findings still paint a worrying picture of ignorance of the dangers of the spread of germs or a lack of concern afforded to hand hygiene. This is especially clear when we consider how data indicating that in the food industry 89 percent of instances where workers were the source of food contamination, such contamination originated from the spread of germs directly from the hands of workers to the food itself.7  

Feb2015_FoodHandleMany food facilities do attempt to tackle the issue of hand hygiene amongst its workforce, with measures including hand washing ‘stations’ situated before entrances to production areas. Other measures include minimising direct hand contact with raw food by using utensils and wearing disposable gloves. However the latter measure, disposable gloves, can cause more problems than it solves with people forgetting that some germs can be spread on the gloves just the same as on bare hands. The frequency to which hands should be cleaned, and the number of different situations that warrant hand washing can also be underestimated. Workers should clean their hands whenever it is required, not merely at regular intervals.

The installation of full-compliance, non-optional hand hygiene measures has been a success for many food companies. The most significant benefit of products which provide this service is clear- they cannot be missed or bypassed, therefore helping to ensure far greater levels of hand hygiene.

Some criticize hand sanitizers, arguing that it discourages thorough hand washing. It may be argued that points such as these misunderstand the role hand sanitizers play in hand hygiene. A proactive and effective approach to hand hygiene should combine comprehensive hand washing with sanitizing. This is why hand sanitizing products in places such as corridors can be useful as they act as a clean barrier in places where hand washing is not feasible. Hand sanitizers are most effective as an addition to hand washing, and should never be regarded as a stand-alone alternative. Using sanitizers alone is insufficient but in conjunction with thorough hand washing, it makes for is an effective hand hygiene regimen. Full-compliance products are already available. Their specific function varies from specialist hygienic door handles which dispense gel upon grip, to badges and other technology that reminds workers to wash their hands and notes when they do not, as well as simple products such as specialist self-cleaning sticker material.

Any company that includes aspects of work where food is handled face a difficult task in ensuring proper hand hygiene. Human error on the part of the worker, such as forgetting to wash hands before entering sensitive areas, or failing to wash hands to an adequate standard can result in serious consequences. This is why full-compliance products are becoming far more popular. To continue to make progress in fighting contamination in the food industry there must be a culture change amongst hygiene managers in addition to food workers as a whole towards ensuring, rather than merely encouraging hand hygiene. When hand hygiene is made compulsory the risks of human error become far less significant.

References:

  1. http://www.cdc.gov/nceh/ehs/ehsnet/plain_language/food-workers-working-when-sick.pdf
  2. CIPD Absence Management Report 2011, http://www.cipd.co.uk/hr-resources/survey-reports/absence-management-2011.aspx
  3. hse.gov.uk June 2011
  4. http://www.cdc.gov/nceh/ehs/ehsnet/plain_language/food-worker-handwashing-food-preparation.pdf
  5. http://msutoday.msu.edu/_/pdf/assets/2013/hand-washing-study-1.pdf http://www.wgtacc.com/wash-hands-after-bathroom.html
  6. http://www.cdc.gov/nceh/ehs/ehsnet/plain_language/food-worker-handwashing-food-preparation.pdf

Top 3 Things to Know about President Obama’s FY 2016 Food Safety Budget Proposal

By Miranda Peguese
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Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

Food safety funding has been a major focal point for the FY 2016 budget proposed by President Obama. Primarily due in support of the fact that all major Food Safety Modernization Act (FSMA) rules are scheduled to take effect by the end of FY 2016, the increased focus will impact each of the agencies governing food safety within the US and all entities which fall under their jurisdiction.

Here are three things to know about the proposed food safety funding allocation for FY 2016:

1. There will be a sizeable increase in the allocation of food safety funding.

President Obama’s $3.99 trillion FY 2016 budget proposal allocates $1.6 billion for food safety, a significant increase in food safety funding over previous years. This would include increases of $301 million for the U.S. Food and Drug Administration (FDA) to support new measures under the Food Safety Modernization Act (FSMA), resulting in a $109 million increase over the previous year as well as an additional $2.1 million increase to the Centers for Disease Control and Prevention (CDC) over FY 2015’s $48 million allocation going towards food safety.

USDA budget requests would decrease slightly for FY 2016, requesting $1.012 billion vs. $1.016 billion for the previous year’s budget as a result of program related cost savings and correlated efficiencies and expects that a portion of the $2.9 billion for agricultural research and extension activities would support additional food safety requirements set forth by FSMA.

2. The proposed increase in food safety funds would include a prioritized food safety spending plan.

The increases to the allocated funding for food safety do not come without guidance. The funding increase includes a detailed plan for spending to include the following allocation:

  • $32 million for Nation Integrated Food Safety System
  • $25.5 million for New Import Safety Systems
  • $25 million for Inspection Modernization Training
  • $11.5 million for Industry Education and Technical Assistance
  • $4.5 million for Risk Analytics and Evaluation
  • $4 million for Technical Staffing and Guidance Development

The top three funding allocations noted are for integration, import, and inspection. These allotments directly reflect the directives set forth in FSMA

3. The plan also includes a proposed single food safety regulatory entity.

In addition to the increase in funding, the new plan outlined by President Obama also asks for Congress to combine several programs overseeing US food safety into a single agency under the Department of Health and Human Services (HHS). Advocates of the plan state that the combination would provide “focused, centralized leadership, a primary voice on food safety standards and compliance with those standards, and clear lines of responsibility and accountability”, citing the current food safety system as being fragmented and outdated. Currently, a total of 12 agencies enforce 30 different laws. An alternate proposal has also been put forth by two members of congress which would suggest the formation of a new food safety agency independent of HHS.

How does this affect your facility? Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

To learn more about the food safety allocations within the proposed FY 2016 budget, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm432576.htm and http://www.usda.gov/wps/portal/usda/usdahome?navid=BUDGET.

Dietary Supplements: Verifying Label Claims “By Input” Unacceptable

By Tara Lin Couch, Ph.D.
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FDA issued more than 400 Warning Letter citations for inappropriate specifications in dietary supplement during 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications, but recent citations have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants.

Criteria used to establish that these requirements are met are supposed to be provided in a Finished Product Specification developed by the dietary supplement company. FDA issued more than 400 Warning Letter citations for inappropriate specifications in 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications at all, but recent Warning Letters have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The input of a dietary supplement alone is not a scientifically valid analytical test method for determining the strength of a dietary ingredient in a finished product. Chemical testing of the ingredient should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, the testing may be exempted provided dietary ingredient raw material testing, in-process testing, other finished product testing, process controls, and additional information can support that the strength of the dietary ingredient can be verified without testing, as allowed in 21 CFR 111.75(d)(1).

The incoming dietary ingredient raw material must be verified to meet quality requirements for identity, purity, strength, and the lack of potential contaminants. Warehouse controls must then ensure that the material is held in a condition in which its quality is not altered. The material must be formulated at an appropriate amount, with sufficient overage, to meet the label claim while taking into account manufacturing variability. This is dictated in an approved Master Manufacturing Record (MMR). Once executed, the Batch Production Record (BPR) must document that the correct amount of the dietary ingredient was actually dispensed into the product during manufacture. Established in-process examinations and tests are then used to verify that the batch is uniformly mixed and meets the unit dosage weight and weight variation requirements. Variations on weight cannot exceed the overage amount to ensure that even the smallest dosage unit still complies with the label. In-process chemical tests can also be employed to verify the amount of a dietary ingredient. This can be particularly beneficial if the reason a dietary ingredient is exempted from testing is because of matrix interferences or instrumental quantitation limits.

Other finished product testing can also be used to support that an exempted ingredient is present in the product at the correct, labeled amount. Test results from chemically similar ingredients that are determined to be as expected suggest that the exempted ingredient is also present at expected levels because these ingredients will tend to react the same way during manufacture, especially if both ingredients are introduced and processed in the same step. Results obtained from finished product testing of other ingredients whose concentrations are associated with the exempted ingredient may also support that the exempted ingredient is present as expected.

Finally, the number of other finished product ingredient tests that are performed is important. If all other test results are determined to be within specification, it indicates that the product was manufactured according to the MMR and there is no reason to expect anything different from an exempted dietary ingredient.

Dietary supplement companies that are compliant with all parts of 21 CFR 111 will already be performing these activities. A procedure that summarizes the overall process of verifying the addition of a dietary ingredient can then be created and used as the test method reference on the Finished Product Specification. A separate document that describes the details of test exemptions per product should also be generated. The actual result obtained should be acquired from the completed batch production record.

The “By Input” approach is no longer relevant.

This article originally appeared in EAS-e-News February 2015 issue.

Top 20 Tips for Tubing and Hose Selection – Part 2

By John Stover
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How can you choose the right tubing or hose for your application the first time and avoid the hassle, frustration, downtime and costs associated with purchasing errors and product returns? In the first part of this article, we discussed tips 1 through 10 tips. We follow up this week with 10 more valuable tips.

11. Investigate hardness and softness needs

How soft or hard should your application’s tubing or hose be? Tubing hardness is measured as its durometer, and different scales, namely Shore A, Shore D, and Rockwell R, are commonly used for plastic and rubber materials. The lower the scale number, the softer and more flexible the material will be. For instance, silicone tubing is a very soft, flexible product. A typical hardness rating for it is Shore A50. Polyurethane tubing is not as soft as silicone and can measure between Shore A70 and A95. Harder materials such as nylon and polyethylene are normally measured on the Shore D scale, and actual ratings vary widely due to different material formulations (i.e., high density polyethylene and linear low density polyethylene). Others like polypropylene use the Rockwell R scale.

Flexibility and softness – or hardness – requirements differ greatly between applications, so the needs for your particular job must be carefully considered. In general, softer tubing materials are more flexible, and some may be a bit tacky. Harder products normally offer less friction and can easily glide across the surface of other items. Also, the type of fittings that are needed to make connections changes depending on tubing hardness, as does the necessity for clamps.

12. Check for flammability

Tubing and hose applications can involve high temperatures or electricity, leading to concerns about fire safety and flammability. How about your application? Do you know what will happen to the tubing or hose if it catches on fire? Might it emit fumes? Self-extinguish? Is it non-flammable? It all depends on the material.

Some tubing and hose, such as that made from particular polypropylene formulas, meets burn ratings established by Underwriters Laboratories (UL). Silicone tubing will self-extinguish, and fluoropolymer is non-flammable. Certain silicone and fluoropolymer formulations can withstand temperatures as high as 500°F (260°C) and are frequently used in electrically-associated applications like computers and appliances. But other tubing can release hazardous chemicals when burned. An example is the high-performance synthetic rubber, Viton®. Be sure to consider the likelihood of fire or burning when selecting tubing or hose for your particular application. If your supplier is unable to provide flammability data, evaluate the choices carefully and consider testing the product.

13. Consider quality

Will your application’s tubing or hose transfer critical fluids? Is there reason for you to be concerned with the environmental conditions under which the tubing or hose is manufactured? Or is the application a simple drainage tube that needs to transfer condensation from point A to point B? Applications vary greatly, and the highest quality product available is not always necessary. When the application involves high purity (vaccine manufacture, for example), standards from organizations such as the FDA (Food and Drug Association) and USP (United States Pharmacopoeia) may dictate which tubing and hose materials can be used.

Factors such as leachables (chemicals or additives that can migrate out of the tubing or hose), material and product curing processes, and traceability may be vital. Research the products under consideration and ensure they meet the required standards. When the application’s not so critical, you may be able to save money by using tubing or hose that doesn’t meet stringent requirements. Relatively inexpensive products like unreinforced PVC or polyurethane tubing perform well in many applications. Be sure to consider products discontinued by a manufacturer, too. They may be acceptable for your application and available at a reduced cost.

14. Consider moisture-related factors

Does your application involve water, condensation, or humidity? Tubing and hose materials react to moisture in different ways. Some materials absorb water and other liquids, and that may be unacceptable. Absorption (the penetration into the mass of one substance by another) can cause the tubing to swell, so if the application involves dispensing measured amounts of a fluid, you may actually be getting less than the desired amount. Swelling can affect physical properties such as elasticity and tensile strength. Tubing that absorbs fluids can leach those fluids back into the stream and cause contamination in critical applications. Problems with fitting connections can occur, too, and applications involving a tight fit may be jeopardized.

Materials such as PVC and fluoropolymer have smooth, slick surfaces, leaving less opportunity for fluid adsorption (the process by which molecules of a substance, such as a gas or a liquid, collect on the surface of another substance, such as a solid; the molecules are attracted to the surface but do not enter the solid’s minute spaces as in absorption). Other materials like ether-based polyurethane resist attack from moisture and inhibit mold growth. Be sure to check tubing and hose descriptions for information regarding moisture absorption when you believe it could affect your application’s performance.

15. Look for incompatible ingredients or substances

What will travel through the tubing or reinforced hose used in your application? The ingredients of the substance, be it a gas, fluid, powder, or granular material, must be compatible with the tubing or hose you plan to use. An adverse reaction between tubing and the material flowing within it could be disastrous. You don’t want a situation where, for instance, an acidic fluid eats its way through the wall of the tubing.

Several tubing materials (PVC, fluoropolymers, Viton®) offer a high degree of chemical resistance and can be used in a wide variety of applications. Others are better suited for simple air transfer or water drains. The ingredients of the tubing or hose can also have an effect on the materials flowing within. Sometimes chemical compounds used in their manufacture can leach out or react with substances. Certain tubing materials like polyurethane are less likely to leach ingredients. Don’t forget about other fluids and gases with which the tubing or hose may come in contact. Consider cleaning products that may be used on the exterior or gases that may exist in the same room as the tubing or hose. The chemicals may seem harmless enough, but their effects on particular tubing and hose materials should be investigated. When you’re unsure about ingredients being well suited to each other, consult chemical compatibility charts, ask colleagues, and question suppliers to be sure the tubing/hose and the material it will carry will work well together.

16. Check for abrasion and corrosion resistance

If your application involves the movement of tubing or hose against other equipment, you’ll need to make sure that both the tubing and the equipment can withstand any abrasion. You’ll want to avoid a situation where motion or vibration causes friction between tubing and equipment. But when that’s not possible, the tubing material selected must be abrasion resistant. Certain materials like polyurethane and nylon handle abrasion better than others. The materials’ properties allow them to naturally withstand repetitive scraping or rubbing. Other materials – silicone, for example – are better suited to applications that do not involve abrasive environments, although options like jacketing and special formulations can make materials acceptable.

Corrosion resistance is another item to consider. Is the liquid in your application acidic? It will need to flow through tubing or hose that can withstand such a chemical formula. PVC is known for its corrosion resistance, as are fluoropolymers like PTFE, FEP, and PFA. Consider, too, the environment the tubing or hose will be in and whether corrosive fluids will come into contact with the tubing or hose. Will anything drip down onto the tubing? Splash up? Might a lubricant used on other parts of the equipment (i.e. metal) affect the tubing?

17. Research alternate materials

Do not assume you’re aware of every tubing and hose material available. Research each need individually to make sure you’re not over- or under-engineering your application. Advances in plastic and rubber development occur frequently, and you should keep yourself informed. Some plastic materials have similar properties and can be substituted for each other, depending on the application. For instance, polypropylene and fluoropolymer tubing often have comparable performance characteristics such as their tensile strength, excellent chemical resistance, and outstanding electrical properties. Polypropylene doesn’t have fluoropolymer’s wide temperature range, but it can often serve as a less-costly replacement.

Coextrusions – tubing with one material on the interior that’s permanently bonded to another on the exterior during the manufacturing process – are another option. When an application requires different performance characteristics for the inside and outside of tubing, coextrusions can often save costs.

Another example of coextruded tubing is polyethylene-lined EVA (ethylene vinyl acetate). Polyethylene tubing is typically a semi-rigid product. The addition of EVA enhances its flexibility and allows its use with economical barb-style fittings. Like Hytrel-lined PVC, this tubing offers different performance characteristics for the inside and outside of the tube – cleanliness inside, flexibility outside. Keeping alternate tubing materials in mind or researching them for a project, whether it’s a new one or a retrofit situation, can help hold down costs. Using a material that does more than you need isn’t always the best choice.

18. Consider indoor or outdoor use

Does your application involve the use of tubing or hose inside a facility or out of doors? Conditions can vary greatly in either environment, but indoor usage normally offers more predictable surroundings. Temperature and humidity can be monitored and maintained indoors. Ventilation, whether it’s automatically operated or controlled by fans that are turned on manually, can be regulated. Lighting is manageable.

Outdoor usage can have particular requirements. The tubing or hose may need to resist temperatures that vary from well below freezing to over 100°F or higher. It may need to handle the effects of rain, wind, and gases like ozone. And regardless of the effects of weather, the tubing’s flexibility should remain predictable. Sun exposure is another important consideration. Sunlight and its heat can alter some tubing and hose materials by hardening or discoloring them. Certain materials (polyurethane, for example) and/or colors (black) handle the effects of sunlight and ultraviolet rays better than others. Consider the whole environment in which your tubing or hose will operate when choosing the best product for each application, whether it’s indoors or outdoors.

19. Explore custom options

Don’t settle for stock products if they don’t fulfill your requirement – ask about customization. Can the tubing be made in a different size? Can it be tinted to match your company’s identifying colors? Can it be made in a different hardness (durometer)? Can it be molded to fit around a particular design element? Can you get it with fittings and clamps already attached? Can you get 8,000 pieces, each a foot long, with a 4″ slit at one end? Some companies are able (or willing) to sell only full coils of tubing or reinforced hose and offer no alternatives. But you may not know if you don’t ask.

Customization can be as simple as a different I.D. (inner diameter) or as complex as color-matched tubing with a static dissipative additive that’s printed with temperature limitations and formed into 10 foot retractable coils with a diameter of 5″. Be sure to explore your options when an application calls for a non-stock item. Examples of customized tubing and hose include performance additives, different colors and sizes, in-line cutting, thermal bonding, heat-formed shapes, coiling, printing, overbraiding, and hose assemblies. Keep in mind that minimum quantities and lead times are likely with custom products.

20. Don’t forget about fittings and clamps

In most cases you’ll need to attach your tubing or hose to other equipment. Fittings and clamps come in many different materials – from nylon to PVDF, fluoropolymer to brass – so you can select the best match for your application. You can even build an entire system from one material (polypropylene, nylon, polyethylene, fluoropolymer), which can greatly simplify the upfront work of checking for chemical compatibility. When using different tubing and fitting materials, remember that the two materials must be suited to each other and must both work well in your application. Pressure and temperature also need to be considered.

In general, softer tubing like PVC, polyurethane, and silicone work best with barb style fittings. Barbed fittings are inserted into the tubing, which stretches to grip the barbs and form a seal. They are available in plastic or metal in a variety of styles and may be used repeatedly or for single uses. Clamps are typically needed when barbed fittings are used, and they, too, come in various styles and materials. Some can be applied by hand, while others require the use of screw drivers or hand tools. Harder tubing materials such as polyethylene, polypropylene, and nylon are better suited to push-to-connect and compression fittings. Unlike barbed fittings, these types grip the exterior of the tubing. O-rings and/or the fitting’s surfaces seal the tubing ends for leak-free connections. In the case of a hose assembly with a permanently-attached, stainless steel barbed fitting, a collar is typically used. The collar acts like a clamp by putting pressure on the hose, sealing it to the fitting on the hose’s interior. The attachment is done by trained personnel using special equipment. Your fitting and clamp choices will be determined primarily by your application, but be sure to do the research needed to determine which material and style will work best.

Click here for the first part of this article – Tips 1-10. 

Thermometer, Thermostat, or Smart Thermostat? Supply Chain Quality Approaches

By John McGlinn
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What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

The seasons bring with them our sensitivity to weather conditions, and especially to how hot or cold it is, inside or out. We measure those conditions, and we try to regulate them so that we can stay within a safe and comfortable range. In many ways, the processes we use to do these things have analogies in the world of Quality Assurance. What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

Thermometer

The definition of a thermometer is “a device that measures temperature or a temperature gradient, using a variety of different principles.” Two components are required: it must be able to sense the temperature and any change in it, but then it must also convert that information into some kind of scale using numbers. A key property is standardization, especially when regulating production processes. There should be nothing subjective about a temperature reading. Without standardization and agreement on the scale to be used, the readings are meaningless.

While a thermometer is critical to many production processes (not to mention in medicine, weather and scientific research) it has, by design, some limitations. 1. A thermometer does not initiate a reading. Someone decides to use a thermometer at a certain time to get a reading. In this way, a thermometer is a highly effective, yet passive instrument. 2. It shows a snapshot of what is happening at the moment of the reading. 3. It does not show any comparisons to what happened before, or what comes after, unless it is integrated into a system that goes beyond being the technology of the thermometer, i.e., beyond the” bulb” and the “mercury” it contains.

Supply chain quality tools: Audits and self audits

The analogue to the thermometer in the world of Quality Assurance is an audit. An audit is initiated by some agent (management, legislative enforcement, voluntary compliance with industry standards). Someone or something then takes the “temperature” of a process at some moment in time. It shows just that – what is happening at the moment. It makes the assumption that the next moments in time, until the next audit, will be just as “healthy.”

Thermostat

Rather than a self-contained tool (like a thermometer), a thermostat is a part of a control system. The system has the capacity to sense the temperature of a system, and respond in such a way that the system returns to a certain level, a “set point.” When it senses an anomaly, it responds by switching on either the heating or cooling components, or by regulating the flow of heat transfer materials.

Supply chain quality tools: Reports

The analogue to a simple thermostat in the supply chain quality world is an assortment of reports. They include information that is collected, such as:

  • Certificates of Analysis (COA)
  • Certificates of Compliance (COC)
  • Dynamic questionnaires
  • PDF Forms
  • Certifications

When the reports show that, at that moment, things are “too hot” or “too cold” (in other words, out of specification), then the system responds to what is collected with:

  • Corrective action plan
  • Material specifications, whether new or adjusted
  • Purchase order information
  • Supplier nonconformances
  • Supplier scorecards
  • Supplier rankings
  • Supplier processes (to be used)
  • Supplier procedures (to be used or changed.)

It’s clear that the system is set up to respond. However, it also means that the system may swing between various points of being outside the range of necessary specifications, just as a simple home thermostat may be constantly adjusting to return to a desired temperature, although much of the time it is in a condition of “returning to” rather than “at” a specified temperature. Once it reaches that temperature, it immediately begins to destabilize. Once it reaches a certain boundary, the thermostat kicks in to move back toward the “ideal.”

In the supply chain quality management context, this may allow for material variability that is constantly trying to return to a condition of compliance with specifications.

Smart Thermostat

No modern building is without a “smart” thermostat. What makes smart thermostats truly smart is that they reduce the amount of variability. They are so sensitive to changes that the response is quick and decisive. The variability is broken up into very small stages, and even a small increment triggers a quick correction, making the system much more consistent and stable.

Supply chain quality tools: Material variability management and Statistical process control

Just as a thermostat is really a component of a system, Material Variability Management (MVM) is a “smart thermostat” in the domain of supply chain quality management. Electronic documents flowing at a constant rate through a system, powered by Statistical Process Control (SPC), can spot trends and anomalies much more quickly than the large increments that cause a system to constantly react, getting too hot and too cold, while assuming that averaging the two makes the environment pleasantly warm.

Material Variability Management is based on the physical inspection and/or testing of all critical inputs and sub-assemblies in real time, along with specification verification, as well as approval to ship so that no material that doesn’t meet specifications moves through the supply chain. It is a system that integrates an array of tools such as:

  • Specification collaboration/distribution/sign-off
  • Supplier COA test data capture (manual and computer-to-computer)
  • Production batch tests data capture
  • Outbound COA generation from batch test data capture
  • SPC Analyses including individual test trending of out-of-spec conditions and into problem zone (beyond 3 sigma and approaching spec limits)
  • Ship-to-Control visualizations and range setting
  • Alerts for material problem performance
  • ANSI Z1.4 Sampling data capture and analysis
  • Lab test analysis data capture and comparisons
  • Advanced-BI for user-definable reports and dashboards
  • Material and location QA audits

MVM powered by SPC turns a supply chain quality management system into a truly SMART thermostat. Instead of taking a snapshot of reality and reacting to it, it can sense trends and send early warning signals that prevent the entire system from becoming unstable. Your enterprise deserves state-of-the-art support, especially when the technology is affordable, reliable, will save you money, and will secure your reputation for high quality.