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 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:
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.
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.
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.
You’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
Many 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.
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.
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.
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.
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.
When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. To help shed light on some of the reasons companies fail audits and to help prevent future failure, here’s our top 5 reasons to why organizations fail.
When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. Whether it’s an audit for GFSI, FDA or an audit required by any of your customers, the consequences of failing can be very costly. And while the whole team receives praise when an audit is successfully completed, there are a select few that bear the burden of audit failure (QA professionals). To help shed light on some of the reasons companies fail audits and to help prevent future failure, we’ve listed our top 5 reasons to why organizations fail.
1. Human Error
It doesn’t matter what industry you’re in, human error is bound to occur. The key here is to be able to minimize the chances of human error as much as possible. As a quality assurance manager, it’s important to make sure all employees are well-trained and fully understand the reasoning for performing certain functions of the job in a particular way. When employees understand the why regarding processes, it will be easier to remember going forward. Additionally, you should have systems and internal audits in place to ensure that what is supposed to happen is happening.
2. Compliance vs. Business as Usual
During audit time, there is often a conflict of interest when it comes to quality assurance managers and making sure the business is still operating as usual. As part of the process to prepping for an audit, management needs to ensure everything is up to standards, and this can possibly include stopping production lines, which interferes with the operation manger’s strict schedules. The important thing to convey here is the fact that compliance should come before anything else. The consequences of failing to meet compliance requirements will surely cost more than a delay in product delivery.
3. HACCP Failure
Hazard Analysis and Critical Control Points (HACCP) is a management system that helps prevent foodborne diseases and essentially operates to protect consumer safety. When it comes to audits, HACCP documentation is incredibly important, which is why it’s crucial to have it complete and comprehensive. Not doing so can be enough to cause your organization to fail. (Download this HACCP checklist as a guide to help you get started).
4. Lack of Supplier Control
All the guidelines and processes in the world you use to keep your organization compliant wouldn’t help much if your suppliers weren’t in sync. And with today’s global food supply chain, it is becoming increasingly difficult to manage risks of food fraud and contamination. One way to help tackle this issue is supplier scorecarding. Automated scorecarding helps both parties examine data and results based on the same information, fostering closer collaboration, information exchange, review of standard and best practices, as well as the occasional review of ingredient specifications, so that all stakeholders involved can work toward the same goals.
5. Lack of Documentation and Organization
“The best part about prepping for an audit is gathering all the required documents,” said no one ever. Not being organized can definitely hinder your chances of successfully completing an audit. And with multiple suppliers providing multiple different documents, staying organized can be a challenge. A filing cabinet just won’t cut it anymore. As a quality assurance manager, you were not hired to be a paper clerk, but agile document management is critical to the success of your business. This is where automation comes into the picture. Are you getting the data and information out of your documents that you need to improve your business? Can you satisfy an auditor with just a few mouse clicks? Automating this process not only helps your organization overall, but also helps you—the quality assurance hero—save time and energy.
Check out our chat with John Paul Williams, Director, Enterprise Solutions and Market Development, Americas, at Polycom, to learn more about why automation is so important for evolving businesses.
The year 2015 is almost two months in, and the U.S. Food and Drug Administration has got its head down looking at the comments to the re-proposed rules under the Food Safety Modernization Act (FSMA), with the first of several deadlines – August 31, 2014 – looming ahead.
Against this backdrop, food safety experts Dr. David Acheson, and Melanie Neumann, at The Acheson Group, discussed the Top 5 Challenges for becoming FSMA Compliant with SafetyChain Software’s Barbara Levin.
The top 5 challenges were identified as:
Determining exactly which rules apply to you and what compliance will involve;
Building a food safety plan – migrating from HACCP to HARPC;
If you are a registered firm – building a supply chain management program;
Determining what testing you will need to do; and
Determining recordkeeping requirements for FDA.
Why have the above been identified as the top 5?
FSMA has thrown out a number of different rules, and for food companies, figuring out where you should fit can be difficult. For instance, should you be looking at Preventive Controls, or Foreign Supplier Verification Program? The language in the Produce Rule is complicated, so if you are a mixed type facility, it can be challenging. While most companies are familiar with Hazard Analysis at Critical Control Points or HACCP, the concept of migrating into Hazard Analysis and Risk-based Preventive Controls or HARPC is not that easy.
Getting a handle around your supply chain and its various components is just difficult, and just understanding what this requirement will involve will be a huge challenge.
While testing of agricultural water was addressed in the initial Produce Rule, the re-proposed Preventive Controls rule included environmental monitoring and finished product testing as requirements for compliance. It will be a challenge for companies to determine what kind of testing they will need to do.
Keeping track of the variety and volume of records that FDA will need to for FSMA will be a huge challenge.
While we could have picked up many more than five, these were the top five that we think will be the most challenging.
To determine what rules will apply to you and what will compliance involve, what are the top things you should be doing now?
Firstly, if you are not starting already to see what applies to you, then you are already behind. Do a FSMA readiness assessment and look at all the rules to determine which ones apply to you. For instance, if you are a company that makes cereal and cookies, then you probably don’t need to worry about the produce rule.
Once you determine the rules that are applicable to you, then the heavy lifting begins. You need to do a gap analysis to see where you are now and where you need to get to. Drawing out this road map to compliance then becomes critical, and that’s what companies need to do be doing now.
Building a food safety plan and migrating from HACCP to HARPC, what are the top things that you should be doing?
The goal of the preventive controls rule is to encourage food companies to start thinking much more about prevention. While HACCP principles are a great start, in some areas, it could be limited in scope, and focused only on critical control points that we can measure. But HARPC expands our thinking to risks that we can control that are beyond classic HACCP thinking, and don’t fit nicely into the seven steps of HACCP. For instance, hand washing – we may not be able to measure this, but this would still be a critical step to control risk. So it will be a challenge for food companies to take their HACCP program and elevate it to HARPC thinking.
If you are a registered firm, building a supply chain management program has been identified as the third challenge. How do you know if you have to register? What can you do now to build a supply chain management program? And would you consider this the biggest challenge for FSMA compliance?
The requirement for food companies to register has nothing to do with FSMA; it was included as part of Bioterrorism Act. According to this, if you are packing, holding, processing or manufacturing food, you need to register with FDA. FSMA added the requirement that this registration would need to be updated every two years. This requirement is now important as several of the supply chain management program rules, which are part of the Preventive Controls rule, apply to companies that need to register.
The requirement to have a supply chain management program was in very early versions of FSMA and then got pulled out, and then now it’s back. And it’s not going away. What can you do to prepare for this rule? Look at all your suppliers, look at who they are, what they are shipping to you – do a hazard analysis of all their products, know their risks and understand what they are doing to control that risk.
For instance, your supplier Mr. Smith is supplying you ground black pepper, which you are using in a variety of products. We have determined that ground black pepper has a potential for Salmonella risk and has been historically linked to Salmonella. So you need to do a hazard analysis and determine if it is a risky food and who is controlling that risk. Is it you or Mr. Smith, and that depends on what you are using that ingredient for. If you use it as a garnish in based potato chips, then there is no cooking or kill-step involved, so the risk should be controlled by Mr. Smith. Thus, FDA will expect you to figure out that Mr. Smith is indeed controlling that risk, which you can do through site visits and data.
Another scenario is that you get that pepper from Mr. Smith, but you are using it in soup, and thus, have your own kill step to control that risk. So you don’t need to pay that visit, put have your own procedures to address risk with that ingredient.
While ground black pepper is a straightforward example, where it gets tricky is when you have to do this will ALL your ingredients. Companies typically have hundreds of suppliers and thousands of ingredients. So start NOW to understand how this little part of the preventive controls rule will affect you; you only have about 18 months to figure this out. And for that reason, I think this will be a huge challenge.
How can companies determine what testing they will need to do? What should companies starting doing now?
While the original produce rule included testing requirements for water, the other testing requirements mandated by FSMA are mostly new. The preventive controls rule now requires food companies to have an environmental monitoring program in place. FDA has also laid out a strategy in which finished product testing can be used as a risk control system. It’s not mandated per se, but it may be a way to exercise the preventive controls rule. Companies need to plan right now to determine what kind of testing they will need to do, how to document it etc. The environmental monitoring program and product testing requirements are new. So start looking at these programs, understand the rules to determine which of these rules apply to you, and do the gap analysis and FSMA readiness assessment now.
You have identified that record keeping requirements for FDA will a major challenge. How can companies prepare for this?
Record keeping will be an area where companies are most likely to struggle. There will be mounds and mounds of documents that will be generated because of the FSMA rules. The days of filing cabinets are over, and it will be really hard to do this in a manual environment. Companies need to look at technology and automation to manage all this data. If companies happen to be regulated by dual agencies, we are talking about even more information that they need to collect and keep track of. So automate NOW.
We often notice that companies are keeping track of the right data and documentation, but are unable to prove this, and retrieve the information when needed. With FSMA, the agency is going to say, ‘if you can’t prove it, it didn’t happen.’ So companies need to get smart about having effective document retrieval systems.
Are there any additional challenges that FDA isn’t talking about that companies need to look out for?
While the above challenges broadly capture the most significant challenges, we think the following may also be something that companies would need to prepare for:
High-risk list: This year, we expect FDA to announce some rules regarding this.
Traceability requirements: FDA may reveal more about this and how his will link to the high-risk list.
Voluntary Qualified Importer Program or VQIP: The needs and requirements for this are still not clear. We expect some rules to be proposed this year.
Additionally, while we don’t expect it to happen, if FDA makes any radical changes with the final rules, that could generate some new challenges.
It can be challenging to make sure that you have covered all the bases during the tubing and hose selection process. Have you considered all the elements involved with the application? Temperatures, chemicals, pressures, flexibility needs? Have you ever ordered hundreds, even thousands, of feet of plastic tubing or reinforced hose and then found it wasn’t the best product for your application?
This article on Top 20 Tubing & Hose Buying Tips can help avoid the downtime, costs, and frustration involved with ordering the wrong tubing or hose. The tips highlight details that can be overlooked, present questions to ask your supplier, and suggest research you can do to help avoid buying errors.
In this first part, we present Tips 1 through 10; check back next week for tips 11 through 20.
1. Check for ingredient approvals
You may need to know if the tubing or hose under consideration is manufactured with FDA (Food and Drug Administration), NSF (National Sanitation Foundation), USP Class VI (United States Pharmacopoeia), 3-A (a dairy industry organization), or other association-approved ingredients.
If this is the case, check the supplier’s tubing specifications for this information. If you’re unsure whether the application calls for association-approved ingredients, find out from an informed source, such as the end user or product design engineer. Educate yourself about required ingredient approvals to avoid the hassle of buying something you may need to return.
2. Be aware of pressure or vacuum requirements
Applications can range from simple drainage lines, well handled by gravity and involving virtually no pressure, to those requiring a robust product able to manage full vacuum (29.9 in/Hg). You’ll need to consider whether your application is one of these extremes or, more likely, one that falls in between. Some unreinforced tubing can deal adequately with low pressure situations; others cannot. It often depends on the tubing material and how hard or soft it is (i.e., polypropylene or latex).
Reinforced hose is frequently called for in pressure and vacuum applications. In fact depending on the type of reinforcement (braid, fabric, stainless steel wire, convolutions), certain types of reinforced hose are well suited for pressure applications, while others are better for vacuum. If you’re unsure of your application’s pressure or vacuum needs, you’ll need to ask questions, conduct tests, or find out from an informed source. Research the needs and usage to avoid situations where the tubing or hose ruptures – or even explodes – because it was not the right product for the application. Human injuries can occur depending on the severity of the rupture.
3. Know the temperatures involved
Several things need to be investigated when it comes to tubing, hose, and temperatures. Can the tubing or hose being withstand the temperature of the product traveling through it? Is that product a liquid, gas, dry material, or electrical wiring? Also think about the temperature of the environment it is in. Will the tubing be inside a controlled environment that’s kept at a constant 72°F (22°C)? Will it lay next to other equipment that throws off heat? Will the hose or tubing be outside and subject to both heat and cold, plus variable sunlight? Will it need to operate and remain flexible below freezing?
Remember, the higher the temperature, the less pressure the tubing or hose can handle. Your application may be well served with, for instance, 1/4” silicone tubing conveying water at 200°F and a working pressure of only 20 psi at 70°F. But if the temperature increases to 300°F, your pressure handling capabilities will decrease. Reinforced silicone hose should then be considered.
4. Consider flexibility and resistance to kinking
Flexibility is a property that varies greatly depending on the type of plastic or rubber material and its construction. Factors that affect flexibility include durometer (softness or hardness), force-to-bend, size, wall thickness, reinforcement style, and temperature. Some plastic tubing and hose, like that made from softer-durometer PVC or polyurethane, is very flexible. Most rubber tubing such as silicone and latex is also flexible. Examples of harder durometer flexible plastic tubing include those made from nylon, fluoropolymers like PTFE, polyethylene, and polypropylene. These are fairly stiff in their common straight tubing styles but are bendable. Customization such as coiling, convoluting, and corrugating can make them more flexible.
Some applications call for repeated flexing of the tubing or hose. Situations involving robotics or circumstances where the tubing is repeatedly moved require special consideration. The tubing or hose must be durable enough to withstand such movements. Instances where the tubing comes into contact with other equipment should be examined as well. Many materials offer abrasion resistance and are able to withstand repeated flexing and rubbing.
Closely related to flexibility concerns is kink resistance. If your application calls for the tubing or hose to bend around machinery, its resistance to kinking and collapsing upon itself must be considered. Sometimes a very flexible material – silicone, for instance – can address the issue. But if pressure and/or durability requirements will not allow the use of such a soft material, the hose’s construction can come into play. Braid or wire reinforcement can help to reduce the occurrence of kinking, as can products that are multi-layered. Stiff materials can also resist kinking provided that enough length is incorporated into the design.
5. Consider weight
The weight of a tube or hose can have a big impact on a final product. You need a product that will help keep overall equipment weight at a minimum but one that can handle the job. Tubing material, size, wall thickness, and reinforcement (if any) affect its heaviness. For example, a typical 100 ft. coil of unreinforced polyurethane tubing, 1″ I.D. x 1-1/4″ O.D., weighs about 21 lbs. A similar size and length of reinforced PVC tubing weighs 35 percent more.
Multi-layered hoses – especially those incorporating metal reinforcement – can be quite heavy. Add metal fittings and clamps to form an assembly, and that increases the weight further.
The overall weight of the tubing, reinforced hose, and/or assembly components used in your application must be examined. You’ll want to make sure you don’t create a situation where a hose assembly’s weight pulls on other components such as fitting connections. If your application involves a bulkhead, you don’t want the assembly putting a strain on the entire system or structure.
6. Know if the tubing or hose would impart a taste or odor to the product
If your application involves foods, beverages or dairy products, any taste or odor transferred to those products could be critical. Some tubing and hose materials contain plasticizers (chemical agents) to facilitate processing and aid in the flexibility of the finished tubing or hose. Under certain circumstances these additives can leach out from the tubing or hose. They can appear in the streams conveyed by the tubing or hose or possibly affect the stream with a taste or odor. That may be fine if the line is used for drainage or a waste product, but if the fluid is part of a finished product that someone will consume, taste and odor transfer is a significant concern.
Certain tubing and hose materials (silicone and polyurethane, for instance) are naturally flexible. There are no plasticizers used in their manufacture, so the potential of taste and odor issues that can come from the use of plasticizers is eliminated. In any case, if taste or odor is a concern in your application, you should sample a candidate hose or tubing to test if the material might affect your stream.
7. Decide if you need to see the products being conveyed within the tubing or hose
Do you need to see the flow of product through the tubing or hose to check for consistency, progression, or to note measurements? Perhaps the nature of the application makes it undesirable to see what’s inside, so an opaque color is called for.
Do not assume that because one style of a particular hose material is crystal clear that all hose of that material is the same. The hose’s construction, whether it’s reinforced with wire, braid, or spirals, can greatly affect its clarity. Several tubing products are available in clear styles – PVC, polyurethane, and some fluoropolymers are examples. But when they’re in the form of reinforced hose, their clarity can be compromised.
Many tubing materials can be tinted or colored to varying degrees of clarity. Clear or color-tinted transparent tubing allows light to pass through so that objects within or behind can be easily seen. Some tubing materials (silicone, polypropylene, latex) offer translucency and allow light to pass through but not detailed images.
8. Learn whether the tubing or hose can be sterilized and reused
Plastic tubing is often considered a disposable item, but it doesn’t always have to be. Learning whether the tubing or hose for your application can be cleaned and used again can save you money.
Discover whether the tubing or hose can handle one or more standard cleaning methods. Other important information to know is how many cycles, or how many times, it may be cleaned using the same procedure. Testing for your specific application is best. Research the best cleaning method for the type of tubing material you have in mind. Can it be autoclaved? Low-pressure steam sterilized? Gamma irradiated? Cleaned with a specific chemical? Does the application call for a simple flush cleaning with water?
Some plastic tubing materials such as polyurethane and PVC are quite durable and chemical resistant. Other materials may handle high temperatures well but not certain cleaning fluids or gases. Depending on the tubing material and cleaning method used, tubing may become brittle or gummy, break down chemically, loose its shape, or absorb the cleaning agent.
Consider, too, that depending on the labor, equipment, and resources involved with cleaning or sterilizing the tubing or hose, it may be more efficient to replace it.
9. Evaluate surface characteristics
Many people naturally think of plastic as having a smooth surface. The plastic products we use regularly (computers, toothbrushes, phones, pens, cars, items from your kitchen) often have smooth, even glossy, surfaces. In some cases the surface is textured for aesthetic or gripping purposes.
What type of surface does the tubing or hose in your application need? Whether your tubing will carry fluid, air, or a granular or powdery substance, you’ll likely want a smooth interior for the most efficient transfer. An irregular surface can cause resistance and slow the rate of flow.
Some thermoplastic tubing materials – PVC, for example – offer a very smooth surface (a low coefficient of friction). Others like fluoropolymer and polyethylene are even smoother and feel almost slippery. Polyurethane and certain thermoset rubbers such as silicone can feel tacky, and that might be a desired characteristic in particular applications.
What about the exterior? Should it, too, be smooth, or does it need a surface texture like ribbing to make it easier to grip and hold on to? Some tubing styles, specifically stainless steel overbraided types, can be supplied with a protective outer layer of silicone to make the product easier to handle at high temperatures and to eliminate entrapment issues. Other styles are coextrusions where one material is used for the inside and another for the outside. For instance, Hytrel®-lined PVC can be useful in a harsh environment application involving the transfer of oil. The durability of PVC works well for the exterior, while the oil resistance properties of Hytrel are a good fit for the interior.
Surface properties can also affect electrical conductivity and static dissipation.
10. Know your packaging requirements
Are 100-foot coils of tubing or hose acceptable? Do you need 10,000 straight pieces, each five feet long? Must they be bagged, double bagged for extra cleanliness, boxed, or are stacked coils on a wooden pallet satisfactory? Can lengths of rigid products be cut and boxed to meet requirements for shipping by UPS or a similar carrier, instead of forcing a truck shipment?
Knowing how the tubing or reinforced hose will be used can help determine your packaging needs. If it’s going to be inventoried, you may want a protective covering like a bag or box. If the tubing will be used immediately, that may be unnecessary. Ask about bulk packaging (multiple coils or lengths in one box), and see if it will save you money.
Perhaps the tubing is part of a kit that you assemble. You’d like six-foot lengths of 1/8″ I.D. clear, unreinforced PVC coiled into 4″ diameter circles, and then placed in individual bags and sealed. Order it that way, so you don’t need to do anything with it other than place each bag with your kit.
Do you want the tubing bagged and labeled with your part number, your customer’s, or other useful information such as temperature limitations? Will the tubing be used in a medical, pharmaceutical, or other clean application? Check into having it gamma irradiated before it ships to you, so it’s ready for use upon delivery.
Consider the tubing’s application and how the proper packaging can assist the end user. Keep in mind that special packaging is a custom process that will likely involve minimum order quantities, additional lead time, and added costs.
For more information, check back next week for Tips 11-20.
GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains’ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.
GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains‘ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.
Linnekin is a licensed attorney and is the founder and executive director of Keep Food Legal Foundation, a Washington, DC-based 501(c)(3) nonprofit that promotes food freedom of choice—the right of every American to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of their own choosing. He serves as an adjunct professor at George Mason University Law School and an adjunct faculty member at American University, where his teaching focuses largely on contemporary food-policy issues. Along with faculty from Harvard Law School and UCLA Law School, Linnekin is one of six founding board members of the new Academy of Food Law & Policy. He is currently writing his first book, which focuses on the ways that government policies often thwart sustainable food practices, for Island Press. He is also serving as an expert witness in an ongoing First Amendment food-labeling lawsuit.
What are your thoughts on the final rules for menu and vending labeling that are set to be enforced by December 2015 (2016 for vending)? Do you think it will help fight obesity?
Linnekin: From both a theoretical and practical standpoint, mandatory menu- and vending-labeling is a lousy idea. Looking forward—from a theoretical perspective—even the chief architect of the country’s first menu-labeling law, former New York City health department head Thomas Farley, admits menu labeling “won’t stop the obesity epidemic[.]” Practically, we know Farley is right, as study after study has found that mandatory menu labeling doesn’t lead consumers to choose lower-calorie options, and may even cause them to choose options with more calories.
What is your take on “natural” labeling and advertising claims? Do you think things like this should be regulated, or better yet, more specific in regulation?
Linnekin: This is properly a matter for the courts. If someone believes they’ve been harmed by an “all natural” label—e.g., they were tricked into buying something by what they believe is a misleading label—then they should sue. The FDA should stay out of it. Instead, the FDA should permit any food label so long as it contains the required information—including an accurate list of ingredients—and doesn’t contain statements that are demonstrably false (fraudulent).
You talk about GMO labeling in a few of your recently published articles. If Congress were to pass a mandatory GMO-labeling law, what do you think would be the immediate ramifications to food manufacturers?
Linnekin: Mandatory GMO-labeling laws are bad for food manufacturers and consumers. Costs would rise for both thanks to new regulatory requirements and, for the former, threats of lawsuits. Thankfully, there doesn’t seem to be any stomach in Congress for passing a mandatory GMO-labeling law.
Can you elaborate on what you mean when you say things like, our “food freedom is under attack”?
Linnekin: I define food freedom as an individual’s right to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of his or her own choosing. Federal, state, and local government officials—both elected and working in regulatory agencies—are threatening this individual right. Many cities restrict a person’s right to plant a garden in their own yard, or to share food with the homeless and less fortunate. States have banned foods and food ingredients—from foie gras to Four Loko to raw milk. The federal government subsidizes farmers who grow some crops (i.e., corn and soy) and bans farmers from growing others (e.g., hemp). And it’s cracking down on foods that contain salt, caffeine, trans fats, and other ingredients. The list goes on. If the government were to restrict our speech—what comes out of our mouths—in the same way it does what we put into our mouths, we wouldn’t hesitate to say that free speech is under attack. That’s why I say food freedom is under attack.
With so many food recalls that occurred during 2014 and in previous years, how would you suggest food manufacturers prevent these issues while also not requiring additional regulation?
Linnekin: The U.S. food supply is remarkably safe. That’s thanks in very large part to the nation’s farmers and food manufacturers. The threat of harming consumers and consumer confidence—not to mention the lawsuits and calls for increased regulations that arise when such harm occurs—should be incentive enough for food companies to seek to prevent these issues from arising. But not all food regulations—even newer ones—are bad. I support the FDA’s mandatory recall authority under FSMA for many reasons, including because I think it makes lots of sense given the FDA’s original mission to protect food safety.
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