With less than a week under his belt as the new Deputy Commissioner for Foods and Veterinary Medicine, Stephen Ostroff, M.D., has made one of his first official statements about food safety. Calling the FSMA final rules a paradigm shift in prevention versus response, he emphasized the importance of the implementation stage on FDA Voice, the agency’s blog.
“The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system,” said Ostroff in the blog.
Although industry has “miles to go” during implementation, Ostroff emphasized the behind-the-scenes work that made FSMA happen—thanking specific members of Congress, consumer activists such as STOP Foodborne Illness, public policy organizations, national associations such as the Grocery Manufacturers Association, government organizations and global regulatory counterparts.
You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”
Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.
For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.
Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.
Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.
Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.
If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.
Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.
Dr. Hilary Thesmar, VP FMI Food Safety Programs reviews the difference in responsibility and required training for each role for your checklist.
FSMA introduced two different types of identified individuals, the Preventive Controls Qualified Individual and the Qualified Individual. Specific training requirements are associated with each. Dr. Hilary Thesmar, VP FMI Food Safety Programs reviews the difference in responsibility and required training for each role for your checklist. Watch the webisode
–UPDATE (5/27/2016)– The final rule has been published on the Federal Register‘s website. –END UPDATE–
FDA just released the final FSMA rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration”. Under the rule, domestic and foreign food facilities must complete and maintain a written food defense plan that assesses their vulnerabilities to intentional contamination.
“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming FDA deputy commissioner for foods and veterinary medicine in a press release. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”
The final rule will be published on the Federal Register tomorrow. To preview the PDF document, visit the Federal Register’s website.
Since the publication of the FSMA Preventive Controls Rule for Human Food, the term HARPC has become a common way of describing the type of food safety plan that is needed to comply with the requirements. On first glance its similarities to HACCP could possibly lead one to believe that the requirements for both systems are aligned. But beware, there are a number of fundamental differences and one main contradiction in the requirements, which requires a clarity of understanding when trying to amalgamate the two systems.
With the introduction of the FSMA Preventive Controls Rule, food facilities that have HACCP systems are now faced with the difficult task of trying to adapt their current food safety system to meet the HARPC requirements. These facilities will continue to be required by local law in the countries where they export to, by their customers and by standards such as those recognized by the GFSI to adhere to the HACCP principles. A straight swap from HACCP to HARPC is not going to be an option for many businesses. Therefore, a combined approach is required, one that meets both sets of requirements and has a clear, practical and effective methodology.
Structure of the Controls
One of the consequences of combining the requirements of HACCP and HARPC is that all of the control principles need to come together and work as one. For this reason, the distinctions between pre-requisite controls (PRCs), preventive controls (PCs) and critical control points (CCPs) must be fully understood.
Pre-requisite control: A facility-wide generic control, not specific to one particular process step
Preventive control: A control that prevents or significantly minimizes the hazard
Critical control point: A control that eliminates or reduces the hazard to an acceptable level
There is a hierarchy to the controls, with PRCs being the building blocks for facility-wide general controls; PCs are more specific controls that are typically associated with a particular step in the process; a CCP is one that is above and beyond a PC and is critical to the safety of the food (see Figure 1).
Figure 1.
A PC is one that either prevents the hazard from occurring in the first place, or if the hazard has occurred, it recognizes it and minimizes the impact of the hazard by controlling it and not allowing it to be released as product.
A CCP controls a hazard that is inherently expected in the product by eliminating it or reducing it to a level at which it is safe.
Key Challenges
There are a number of differences between the requirements of HACCP and HARPC. The PC Rule is not as specific or detailed in the way in which the plan should be documented or designed, as the principles laid out in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) or Codex Alimentarius. However, the FDA may not have directly stated that certain elements such as product description, intended use or intended user must be included, but they do elude to the fact, as the hazards that must be assessed would require this information to be understood and fed into the system. This means that in order to comply with both systems, the principles of HACCP must be adhered to as well as those of HARPC, so elements such as process flow diagram will still be required.
The key difference between the systems related to how significance is determined within the risk assessment. Both systems require a risk assessment that takes into account the severity of the hazard and the likelihood of the hazard occurring. The results of this should determine if the hazard is a significant food safety risk, where it is, and whether a PC is required. Hazards that are not significant would need to be managed through the application of PRCs.
The difficulty enters the picture when assessing the likelihood of the hazard occurring, as the two sets of requirements contradict each other:
The PC Rule asks for the likelihood to be determined in the absence of any controls.
HACCP principle states that the likelihood should be determined, taking the controls into account.
It is acceptable to HACCP principles to follow the requirement for HARPC and carry out the assessment in the absence of any controls, however there are consequences in doing so. The number of significant hazards that will be produced will be substantially higher than in a traditional HACCP plan. Each of these hazards will need to be controlled through a PC, and the CCPs will need to be determined from this set of PCs. Using the typical CCP decision tree is not a practical solution, as the result will likely mean that most of the PCs become CCPs. Nobody wants to go back to the days when facilities had many, many CCPs, as this produces an unmanageable and ineffective food safety system.
A new methodology is required for the determination of CCPs—one that is clear and does not contradict the HACCP principles.
The Benefits of HARPC
Although the introduction of HARPC makes designing and developing a food safety plan more complicated, it does have its benefits. Over time, as pre-requisite programs have developed, the number of hazards that are managed by PRCs have grown—to the point now where most facilities only have a handful, if not one or two, CCPs.
Through a HACCP plan, even very significant food safety hazards can be managed by the PRCs. These significant hazards are therefore managed, just the same as insignificant or low-risk hazards. This may be the reason that the most common recalls and withdrawals today are due to lack of control from pre-requisites.
By introducing the new tier of PCs and assessing significance without taking any controls into account, we mitigate this problem. Ensuring that the key food safety hazards, which perhaps are not critical, are managed through the application of PCs and they thus receive additional focus.
Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.
The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.
The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.
A new industry survey is highlighting several issues facing food safety and quality assurance professionals, from employee retention to understanding the final FSMA rules. The 2016 Annual TraceGains Food Safety & Quality Assurance (FSQA) Professional Survey digs into the top priorities (FSMA compliance, audit readiness, supplier relationship management, etc.) of professionals and sheds light on some of the current challenges that companies are facing, especially in the area of compliance, FSMA readiness and supplier documentation.
“We’re seeing a recipe for stress in the food and beverage industry: Take one-part low margins, blend in one-part increased government regulation, one-part unannounced audits, one-part increasing customer demands, and one-part manual paperwork,” says Gary Nowacki, CEO of TraceGains. “Mix well, bake on high, then spread thinly with a limited pool of FSQA professionals.”
Anthony Arocha, customer success consultant at TraceGains
Nearly 500 FSQA professionals participated in the survey. In a two-part Q&A with TraceGains, Anthony Arocha (customer success consultant), Rajan Gupta (vice president of customer success), and Jason Ulrich (customer success manager) explain what the results mean in to the broader industry.
Food Safety Tech: Were there any surprises with this year’s survey?
Anthony Arocha: FSMA compliance is across the board a top priority with staffing/training as one of the biggest obstacles to overcome. I would say this is a huge opportunity for automation to help reduce the risk and long-term costs incurred by the increasing demand for accurate documentation.
22% and 19% cited training and staffing respectively as a big challenge. Graphic courtesy of TraceGains.
Rajan Gupta: I do not think there are any surprises but a very strong restatement that FSQA staff is difficult to hire/retain due to limited individual growth, low salaries, inadequate training, incentives, etc. All of these lead to the fact that most food companies look at food safety and quality as a nuisance that they must deal with versus as a function that is a necessity or a requirement with adequate funding.
Rajan Gupta, vice president of customer success, TraceGains
FST: With FSMA being a top priority among survey respondents, are you finding that companies are concerned about any of the rules in particular?
Arocha: Honestly, it seems that most folks are trying very hard to get a handle on all the new rules and what their responsibility is for compliance. Not sure they have gotten to the point of having just one or two main concerns yet. There is more emphasis on creating strong relationships with the downstream and upstream customers and suppliers than ever before. Some of the rules seem vague, which will require an operation to be prepared to support how they meet a particular requirement or may be potentially exempt from it. These have been some of the concerns that seem to be popping up most.
Survey Question: What, if anything, hinders your company’s ability to on-board, recruit, and retain skilled FSQA staff? (Graphic courtesy of TraceGains)Jason Ulrich, customer success manager, TraceGains
Gupta: The main theme that we hear from our customers is that there is confusion. Companies have had to deal with many requirements in the past, some of which conflict each other. I think lack of a thorough understanding of food safety within an organization is a key limiting factor to truly determine what is needed at each organization to meet FSMA guidelines.
Jason Ulrich: Companies are concerned about FSMA. Most are concerned with FSMA as a whole. Many have taken steps to educate themselves, but the law is vague, especially for companies that are in multiple areas of food manufacturing.
The Sanitary Transportation of Human and Animal Food rule goes into effect June 6, 2016. Large businesses must comply by April 6, 2017; small businesses must comply by April 6, 2018. The rule governs the protection of food during transport, including the sanitation of transport vehicles and equipment, refrigeration of food for safety, and proper cleaning of bulk transport vehicles between loads. So you’ll need a game plan…but what should your game plan include?
Read the rule—every word of it—to understand the reasoning behind the decisions made in crafting it and to get a glimpse into how it will be regulated and enforced.
Review all of your processes, protocols, procedures, and contracts to ensure compliance with the rule, and outline responsibility for how you’ll manage the safe transportation of food.
Close any gaps in your current programs to ensure you’ll meet the regulations well in advance of the compliance date.
Kick the tires by conducting mock inspections. Find non-compliances and give yourself time to correct them, rather than wait for bad news during a real inspection.
Confirm the accuracy of all your documentation on a regular basis. Documentation can be the difference between success and failure when it comes to proving that you’re doing the right things.
Get all stakeholders on board to empower employees at all levels and drive culture change.
Establish a driver training program to ensure compliance with the Sanitary Transport rule. Image courtesy of Alchemy Systems (Click to enlarge)
Use Driver Training to Prepare
Drivers are the conductors of the food supply chain. They literally have loads of responsibilities, including maintaining the cold chain, meeting delivery requirements, practicing safe driving always, and meeting all Department of Transportation regulations and requirements. Whether transporting raw materials, packaging, work-in-progress, or finished goods, drivers are the people that keep food safe in transit. So how can you take advantage of your driver training program to ensure compliance with the Sanitary Transport rule?
A blended learning strategy, combining online and instructor-led training, has been shown to provide the best food safety training outcomes.
Use online lessons to introduce and reinforce knowledge of new FSMA regulations and food safety awareness topics. Digital lessons are economical, learner-paced, provide consistent messaging, and are accessible 24/7.
Use hands-on direct instruction for refreshers or for topics like proper vehicle inspections, reefer unit checks, cargo securement, etc.
Subject matter experts should conduct any instructor-led training using a skills check-off approach to document driver’s abilities and to ensure that drivers perform to standard.
Group and prioritize drivers for training based on their compliance history.
Use online lessons and safety messaging proactively to sustain driver compliance and performance.
Use online training at least quarterly, but use safety messaging monthly. Drivers, like all learners, need regular reminders in order to break old habits and form new ones. Communications programs can provide multi-touchpoints to reinforce new knowledge, shift behaviors, and help ensure compliance.
Put Your Game Plan Into Action
The Sanitary Transport Rule is a reality. Now is the time to put written procedures and protocols in place and make sure all stakeholders have a clear understanding of them. Determine precisely who has responsibility for compliance throughout the distribution channels. A blend of online and face-to-face training will ensure compliance, increase performance, and protect foods during transportation operations. The benefits far outweigh the cost.
Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.
GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.
The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.
A screenshot of EMAlert
“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.
When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.
Recent recalls and outbreaks associated with Listeria coupled with FDA’s finalization of the FSMA preventive controls rule have heightened the industry’s need to focus on environmental testing programs. The need for a preventive control program with higher resolution is especially highlighted by the government’s increasing use of whole genome sequencing data to more rapidly link human illness to food processing establishments. I work with many customers who simply do not recognize all of the factors that influence their ability to detect Listeria in environmental samples. For many, an environmental sample is collected, shipped to a third-party lab, results are received within two to four days, and few questions asked. Most companies have not invested the time and resources needed to truly understand how each component of an environmental sample impacts their ability to detect Listeria. So what factors should be considered to maximize Listeria detection in the plant environment?
Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREListeria is a True Survivor
Listeria is inherently a hearty organism that can withstand highly adverse conditions in the plant environment. It is able to survive and grow across a wide range of temperatures, including refrigeration, and it is more tolerant to heat than Salmonella and E. coli. Additionally, the organism survives across a wide pH range, including extended periods in highly acidic conditions, and can survive food processing and preservation with up to 25.5% salt. These traits may result in highly injured Listeria being collected in environmental samples, and requires optimization of the sample collection and analysis process in order for detection and culture confirmation to occur.
Sanitation Programs May Not Destroy Listeria
Sanitation practices are intended to destroy Listeria in the plant environment, but not all sanitizers will be 100% effective. In some cases, sanitizers may not fully kill Listeria, leaving highly injured Listeria that may require an extended lag phase in order for growth and detection during testing. Sub-lethally injured Listeria remains a food safety concern, as the bacteria maintain the ability to recover and flourish in a nutritive environment. Additionally, Listeria readily forms biofilms in the plant environment, which many traditional sanitizers do not effectively remove. Biofilms in the plant environment may maintain low levels of Listeria that may be challenging to detect without the use of a sensitive detection method.
Sample Collection: Choose the Right Tool for the Job
The neutralizing and nutritive capacity of the collection media used with the collection device can have a significant impact on the ability to resuscitate, detect and culture stressed Listeria. When selecting a collection media, it is important to ensure that the media will effectively neutralize the sanitizers used in the plant environment. For instance, peroxyacetic acid and quaterinary ammonia-based sanitizers will not be neutralized well by commonly used collection media such as Neutralizing Buffer or Letheen Broth. Neutralization of the sanitizer in environmental samples is important in order for resuscitation and growth of any Listeria present within the sample. Additionally, use of a collection media that contains nutrients to begin the resuscitation process for Listeria immediately upon collection is also important for detection and culture confirmation of Listeria in samples. Collection media such as Neutralizing Buffer contains monopatassium phosphate, sodium thiosulfate, and aryl sulfonate complex intended only to neutralize sanitizers. Conversely, D/E Broth and HiCap Broth have components to nourish Listeria and facilitate resuscitation in addition to neutralizing sanitizers.
Enrichment Media Determines Recovery & Growth
Enrichment media plays a major role in the speed of recovery and growth of Listeria in environmental samples. Medias that facilitate faster recovery of injured Listeria allow for shortened lag phases facilitating more rapid growth. Enrichment media that facilitate faster recovery and growth allow Listeria to reach the limit of detection for screening tools more quickly. When paired with a highly sensitive method, enrichment media, which foster greater Listeria growth and recovery, can allow for significant reductions in time to results for screening methods. Additionally, faster recovery and growth of Listeria due to enrichment media can increase the likelihood of culturally confirming Listeria found at low levels pre-enrichment.
Not All Detection Methods are the Same
The ability of a detection method to find Listeria in an environmental sample is impacted by two factors: 1) method sensitivity and 2) method robustness in the presence of sanitizers. The more sensitive a rapid test method, the greater the chance of finding low levels of Listeria in an environmental sample. Low levels of Listeria in environmental samples are likely due to the injured state of Listeria in the plant environment post sanitization. Immuno-based rapid methods have a sensitivity of 105–106, DNA-based methods have a sensitivity of 104–105 and RNA based methods have a sensitivity of 102–103. Using an RNA-based method offers 1 to 2 logs greater sensitivity and greatly increases the chance of finding low-level Listeria.1 This can be particularly true when sampling conditions such as collection media or enrichment media are less than optimal for the neutralization of sanitizers and growth and recovery of Listeria.
Another important factor that influences a test method’s ability to detect Listeria in an environmental sample is the method’s ability to amplify and detect the organism in the presence of sanitizers. Most molecular-based methods do not include a sample clean up step resulting in sanitizer being present during the amplification step. For some methods, sanitizers may inhibit amplification, resulting in indeterminate or false negative results.
Confirmation Requires Optimization of the Sampling Process
The ability to culturally confirm a Listeria sample that screens positive is influenced by the entire environmental sampling process. In order to culture confirm samples with highly injured, low-level Listeria, it is necessary to optimize the sample collection media, enrichment media, and confirmation process to provide the greatest likelihood of culture recovery. If Listeria is not adequately resuscitated and able to achieve sufficient growth, the level of Listeria present in the sample post-enrichment may be below the limit of detection for culture. The likelihood of culture confirmation can be increased by incorporating steps such as a secondary enrichment or concentration via IMS capture. Culture confirmation for samples that screen positive on a rapid method can be especially challenging if a highly sensitive test method is used for screening that may detect Listeria at lower levels than culture. Thus, optimizing the environmental sample program is especially important if confirmation of screening results for highly sensitive methods is desired.
Method Sensitivity and Increased Positivity
Employing a highly sensitive screening tool for environmental samples provides a better lens to view risk within the food safety processing environment. Many companies fear that a more sensitive method will result in significant increases in positivity and cost for increased sanitation. In working with customers who have moved from immune-based methods to a highly sensitivity molecular method, I’ve observed an initial increase in positivity followed by a leveling off of low-level positivity after enhanced interventions are taken in the plant. Companies that proactively seek out and destroy Listeria in their plants are then able to maintain low level rates of positivity with routine cleaning measures, while also maintaining the confidence that they are using the best tool available for Listeria monitoring.
Understand Your Risk & Establish a Culture of Food Safety
It is important for food safety professionals to fully consider the hidden risks that may exist in their plant environment due to the environmental sample process masking the true presence of Listeria. Each component of the environmental monitoring process, sanitizer, collection media, enrichment media, detection method and culture process plays an important role in a company’s ability to be able to detect and culture confirm Listeria in the plant environment. Optimizing each step within the environmental sample process allows a company to be proactive instead of reactive. This approach creates a company culture of food safety that can seek out, detect and destroy Listeria in the plant environment, can significantly mitigate risk. The good news is that by incorporating the right food safety culture and making data-driven choices, today’s manufacturer can achieve both short-term dividends of risk reduction as well as a long-term elevation of control of its process.
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