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November 27, 2023
Do you have a training budget left to spend this year and aren’t sure how to use it?    Don’t lose your training dollars before the year ends. Instead, spend it wisely by stocking up on Registrar Corp’s regulatory compliance courses for you and your team.   Here are three ways to spend your training dollars wisely by the end of the year.   Catch Up on Food Safety Education   From FSVP to PCQI, food safety professionals must stay current on —and comply with— many FDA regulations. Registrar Corp offers dozens of food safety courses for regulatory and quality assurance professionals, production managers, and production workers.     Some of our most popular courses include:   PCQI Online Training: Comprehensive training to help you become a Preventive Controls Qualified Individual. Work on developing FDA-compliant Food Safety plans and earn an official FSPCA certificate.   SQF Practitioner Training & Implementation: Fulfill SQF Edition 9 requirements for SQF Practitioners. Course takers learn to document, implement, and audit SQF systems and earn a certificate of completion.   HACCP Certification: International HACCP Alliance-approved certification course. This course teaches HACCP requirements and how to write a HACCP guide step by step.   Keep Up With Medical Device Regulations   Medical devices come with stringent compliance regulations worldwide. By stocking up on industry online training, you can better prepare to comply with US and international requirements.    Registrar Corp’s medical device course offerings include:   Implementing ISO 13485: Introduction to the requirements of ISO 13485. This course teaches medical device industry professionals to build an ISO 13485-compliant quality management system.   European Medical Devices Regulations (EU MDR) Training: Get an overview of European medical device requirements. Learn about the expanded regulations, device classification and labeling, and more.   Introduction to 21 CFR 11: Introductory course on Part 11 of Title 21 of the Code of Federal Regulations. Establish an understanding of FDA’s requirements for electronic records and signatures.   Prepare for MoCRA Enforcement   Cosmetics facilities have been anticipating FDA’s upcoming deadlines for the Modernization of Cosmetics Regulation Act (MoCRA) enforcement. From facility registration to product listing and labeling, there are a lot of new regulations, steps, and processes to learn.   Registrar Corp now has a range of cosmetics and MoCRA-focused courses to help you comply with FDA.    We offer an 8-course library on MoCRA regulations as part of our Online Training platform. It covers topics such as:   Facility Registration and U.S. Agent Responsibilities   Cosmetic Product Listings and the Responsible Person   FDA Cosmetic Labeling Guidance with MoCRA Updates   Cosmetics Registration and Listing Portal   Prepare for MoCRA enforcement by having all the information on cosmetics requirements, compliance deadlines, and more.   Why Use Your Training Budget With Registrar Corp?     We offer hundreds of courses that have served over 25,000 global professionals across industries.  Our self-paced online training courses are designed to help you comply with a wide range of FDA regulations. We work with professional auditors, consultants, trainers, assessors, and business executives with decades of international experience to develop and instruct each course. We also partner with many industry organizations to provide approved and certified training.  Thanks to the quality of our courses and global professional partnerships, Registrar Corp’s Online Training platform has earned a 4.7/5 rating on TrustPilot.   Save 20% on Online Training During Our End of Year Sale     This year, Registrar Corp is offering an end-of-year discount for companies that want to “stock up and save” on online training before 2024. Stretch your training budget even further by saving 20% on our food safety, medical device, and cosmetics courses (some exclusions apply) from now through December 31.  Choose single courses or invest in a team or company training package for 2024. Courses are available 24/7 for 12 months from the date of purchase, so you and your staff will have all year to access and pass your online training.   To save 20% on your next end-of-year online training purchase, use the promo code SAVE20FOR2023 during checkout. 
October 9, 2023
A Global Food Safety Initiative (GFSI) recognized food safety certification, FSSC 22000 Version 6 is a food safety management system certification scheme governed by “Foundation FSSC.” Foundation FSSC is a foundation whose mission is creating a better world through the GFSI-recognized food safety management system FSSC 22000 and the social management system FSSC 24000.  The food safety management system certification requirements provide a rigorous system to manage food safety risks and provide safe products for use by consumers and companies in the food industry.  Here’s are some of the key changes since FSSC 22000’s version 5.  What Did FSSC 22000 Version 6 Change?  The FSSC declares that this updated version of the standard aims to incorporate the stipulations of ISO 22000 and bolster requirements to assist organizations in advancing UN Sustainable Development Goals (SDGs);  This updated edition enhances the scheme requirements for facilities seeking certification by adding new requirements. Five of the biggest changes are the addition of these requirements:   Food Safety and Quality Culture  This latest inclusion specifically mandates that institutions must possess a recorded strategy for food safety and quality culture, complete with objectives and schedules that demonstrate ongoing enhancement and assessment in management review.  It states that top management should establish, implement, and maintain food safety and quality culture objectives.  Equipment Management   In order to buy new equipment or its components, it is now essential to possess recorded specifications that give information about the equipment. This includes the sanitary finish design conditions and surface traits that meet the application or end use.  It's also crucial to conduct a risk evaluation on alterations in machinery or its structure to guarantee that the commissioning has been executed correctly and that it won't affect the operations.  Quality Control   This addition necessitates a structured quality assurance process, which includes setting up, executing, and sustaining quality standards in line with the final product specifications and product launch.   Additionally, the outcomes of the quality control parameters should be examined and evaluated, and these findings should be used for management review. The procedure for quality control should also be incorporated into the internal audit processes.  Communication Requirements  This new section necessitates that the certification body is notified within a three-day timeframe about events or circumstances that could impact food safety, legality, compliance, and/or integrity of the certification.  Examples include:  War & Natural Disasters  Labor Strikes  Fire & Flood  Crime & Terrorism  Recalls & Withdrawals Outbreaks, etc  Food Loss and Waste  This new addition stipulates that a company's strategy to diminish food loss and waste within the associated supply chain should be outlined by a policy and recorded objectives.  The statement further emphasizes that food donated to non-profit entities, staff, and other groups must be safe. This contribution needs to be regulated, and the items should be managed in accordance with food safety standards.  Companies should also implement management strategies for excess items or secondary products intended for animal consumption to avoid cross contamination.  When Will FSSC Begin Auditing For the New Changes?  FSSC 22000 Version 6 was published on April 1, 2023, and organizations will be given a one-year timeframe to meet and comply with the new requirements.  Between April 1, 2024, and March 31, 2025, all previously certified entities will undergo audits based on the new Version 6.  Despite the provision of a 12-month transition phase, it is recommended to begin implementing the new changes as early as possible. This is due to the fact that some of the recent changes require comprehensive critical analysis and risk evaluation for efficient implementation.  How to Prepare For FSSC 22000 Version 6  Equipping your teams with the knowledge required to help maintain a culture of quality and food safety in the daily routine of your organization is an invaluable process.   Online Courses that cover the new FSSC 22000 Version 6 can give you confidence in the risk analysis, documentation, and verification during your internal and certification audits. All while being 100% self-paced and easily accessible.   Everything You Need to Meet the New Requirements  Get your teams up to date with Registrar Corp’s FSSC 22000 Version 6 online training.   We’ve spent over 20 years as industry leaders in the regulatory compliance space and help more than 30,000 businesses across 180+ countries achieve compliance each year.   We know what it takes to meet rigorous standards like the FSSC 22000 certification and we have developed a line of new comprehensive online courses to get your business ready for the new audits.  
August 21, 2023
U.S. FDA regulations require that specific food safety tasks, such as writing up food safety plans, must be undertaken by a Preventive Controls Qualified Individual (PCQI). It’s an important role and one that cannot be performed by just anyone on the team.  PCQIs aren’t just food safety professionals. They are individuals who have either completed training in the overall development and application of risk-based preventive controls in food safety. Or, they otherwise have the qualified and extensive job experience to handle the development and implementation of a food safety system.  Training to be an Animal Food PCQI is the quickest route an individual or a company can take to assure they have the regulatory staff they need to cover these important tasks.   What is PCQI Animal Food Training?  Official courses approach this PCQI Animal Food training by addressing the rule provisions within the Food Safety Modernization Act (FSMA). Specifically, they cover the rules regarding CGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.  Individuals can expect to be introduced to FSMA requirements for:   Staff and personnel   Holding and distribution  Facilities and grounds   Equipment and operations  Sanitation practices  Plumbing and water supply  Who Benefits From the FSPCA Preventive Controls for Animal Food?  There is little question that the person who will hold the responsibilities of being PCQI will benefit most. However, anyone interested in learning more about how to write a Food Safety Plan according to FSMA requirements will also greatly benefit.  In either case, PCQI training for animal food profits both facilities and individuals that seek to comply with U.S. FDA’s food safety compliance requirements.   Does FDA Require PCQI Training?  As mentioned above, only a PCQI can execute certain activities required under FSMA, but the official training itself is not mandatory though it is the quickest and easiest way to satisfy this requirement.   However, if you, someone on staff, or an individual you can hire has the sort of extensive experience FDA requires, then you can bypass taking the official course. This option can become far more costly and risk FDA Notice of Actions if this individual isn’t as qualified as originally thought.  FSPCA PCQI Animal Food Training Made Easy  With Registrar Corp, you can get the training you need to become a Preventive Controls Qualified Individual (PCQI) for animal food.   With our quick and user-friendly course, you’ll learn to develop and implement an FDA-compliant Food Safety Plan for pet food, animal feed, or raw materials and ingredients.   It’s convenient, self paced, and 100% online for the working professional with a busy schedule.  Learn more or start today. 
August 8, 2023
 A Complete Guide to the Global Food Safety Initiative (GFSI)  GFSI Certification is a powerful tool for a business looking to push food and beverage products across borders. It’s a glowing stamp of approval that highlights your dedication to a higher standard of food safety and is often required by many potential customers of your business.  What Is GFSI & What Does It Stand For?   The Global Food Safety Initiative, or GFSI, is a nonprofit initiative designed to promote the development of food safety management systems and to help ensure food facilities are processing safe food for consumers.   The GFSI oversees and approves different auditing platforms that meet their food safety criteria. This criterion also provides recognition of superior standards for certain food safety audits and schemes.  It differs from SQF, ISO, and others in that GFSI establishes standards and benchmarks that SQF and other schemes must adhere to in order to be globally recognized as a structured, comprehensive, and effective food safety program.  A Brief History of GFSI  GFSI started in 2000 following a series of food safety issues and various changes to regulatory laws in the food industry, including food laws of the European Union. With legal obligations imposed on their supply chains, and overall compliance tied to their liability, European retailers elected to use a set of technical standards to help comply with the new changes. Since then, global industry experts have been collaborating to tackle food safety issues defined by various GFSI stakeholders.  Today, GFSI Certification represents the gold standard of food safety and recognizes various food safety management programs such as:  BRC Global Standard (BRCGS) Safe Quality Food Code (SQF) International Featured Standards (IFS) Freshcare FSQ  FSSC 22000  And several others  How to Become GFSI Certified  When it comes to GFSI, many individuals in the food and beverage industry are still first introduced to its existence when a potential client asks to see their GFSI-benchmarked certificate.   GFSI can be a complicated institution to initially grasp, but the simple fact is that, regardless of which scheme or program you decide to pursue, everything starts with HACCP.  Hazard Analysis Critical Control Points (HACCP) sets you up to be successful in your food safety program, as it’s not only extremely helpful for food safety, but HACCP training is often required under several GFSI-recognized schemes.  Once you find and complete your HACCP training online, you can take the next steps in pursuing a GFSI-Benchmarked Certification.  Step 1 - Select the Appropriate Scheme  When choosing a recognized scheme under GFSI Certification, you should first check with the retailers, suppliers, further processors, or other potential clients you’re looking to do business with. In many cases, they’ll tell you which certifications they either accept or require.  If you’re still unclear or were given too many options, consider your business and its potential needs. For example, if you have a larger international operation, the advantages of seeking the Food Safety Management System Certification FSSC 22000 may outweigh that of more product-focused certifications like SQF.    Step 2 - Access the Right Training  Training is a critical part of the process. The person in charge of the project needs a good understanding of the scheme requirements and how to implement them as well as of HACCP.   Your team and management need to understand the requirements involved and internal Auditors need to be trained on both the requirements and on the auditing process. Even employees need to get in on the training regarding food safety and their role in maintaining compliance.  Your chosen scheme will come with specific requirements that will determine which training and courses will not only be the most effective, but also essential in obtaining your GFSI Certification.  Step 3 - Implement Plans & Procedures  As you begin implementation, you want to be sure to assign an individual or an entire team to oversee and document the entire process. You should equip them with the appropriate training and then provide them with the procedure templates, plans, and gap information.  This individual or team will then take this information and help identify necessary changes that you can refine and continue to refine through regular internal audits until — and after — you’re ready for review.  Step 4 – Undergo the Certification Audit  After a few rounds of internal audits and necessary adjustments, you will be ready to work with  the certification body you chose for GFSI who will conduct your certification audit.   The review process will scrutinize every detail of their required standards to ensure your operations are in compliance. Once approved, you’ll earn your GFSI-benchmarked Certification.  Global Food Safety Initiative FAQ  With how broad GFSI can be, it’s fair to call it a bit complicated. We’ve put together a small FAQ that answers some of the more Common questions about GFSI:    How Much Does A GFSI Certification Cost?   The answer honestly depends on what you need, how much time it will take you, and what scheme you’re pursuing. You also need to consider internal costs (such as staff), consultancy or software fees, training programs, and the certification audits and accreditation costs themselves.   The certification body you choose will charge for its audits. These costs will obviously vary depending on the overall size and complexity of your business and other factors.   Is A GFSI Certification Worth It?   You can think of GFSI Certification as a type of food safety passport. Your commitment to food safety is recognized everywhere with this certification and global retailers will be more than willing to accept your product on their shelves. In fact, major retailers require a GFSI-recognized certification.   If you’re looking to boost your reach and your revenue, then GFSI is more than worth it.     What Is the Difference Between GFSI & SQF?  GFSI is a private nonprofit organization that exists to ensure higher standards across different food management systems. SQF, or Safe Quality Food, is one of these systems your company can implement in order to achieve GFSI Certification.  What Is the Difference Between GFSI & ISO?   Similar to SQF or any other food management system, ISO, or International Organization of Standardization, is a broader approach to food safety that by itself is not recognized by GFSI.   ISO 22000 is that it does not have specific requirements for prerequisite programs. Instead, it requires that the organization identifies and implements the appropriate programs making it more flexible as food organizations of any type can implement and be certified to ISO 22000.  It’s important to note that ISO 22000 is part of the FSC22000 scheme which qualifies for GFSI Certification. ISO 22000 can be a starting point for GFSI for many organizations.   Online GFSI Certification Training By Registrar Corp  Obtain global recognition for your commitment to food safety with GFSI Certification through Registrar Corp’s online training. We offer a host of courses that will help you master various food management systems the Global Food Safety Initiative recognizes and stands behind.   Discover how our comprehensive and specialized GFSI training can open doors to your business that would have otherwise remained shut.     
July 13, 2023
Regulatory professionals need the highest quality and current food safety courses to help keep operations in compliance with FDA. Courses that aren't time-consuming. When it comes to finding regulatory compliance training online, courses that cover concepts like detentions and import alerts, or how to prepare for and conduct recalls are staples for a healthy supply chain.   That said, food safety regulatory compliance courses that help prevent detentions and recalls are even more essential. Understanding one of the most common causes for FDA Actions —Labeling Errors— will help keep you compliant and assure the product keeps moving.  That’s why we put together this list of the most effective courses that experts in the food safety industry insist will keep your business in FDA compliance and avoid crippling detentions and recalls.  Food Facility Registration  For facilities engaging in manufacturing, processing, packing or storing food intended for consumption within the United States, sourcing a quality course that covers how to register with the U.S. FDA is essential for business.  Failing to accurately register and file appropriate documents can lead to major setbacks and violations.   Food Labeling for Allergens To protect individuals with food allergies and other food sensitivities, FDA enforces various regulations that require businesses to list their ingredients on each packaged food and beverage.  Sourcing courses that discuss major food allergens that must be declared on US food labels and mandatory labeling declarations is key to ensuring food safety compliance. Knowing when and why advisory labeling is used, is just as important.   Detention & Import Alerts Courses that detail Import Alerts, as it relates to foods and dietary supplements, is another critical subject for regulatory staff.   If you are a manufacturer in a country outside of the USA who wishes to export your products to the United States, or you are a US importer who wishes to import products from non-US suppliers, sourcing courses on this topic will equip you with the knowledge needed to navigate and avoid detentions.  Labeling Dietary Supplements Labeling requirements for dietary supplements differ from those for conventional foods and beverages. Ensuring your supplement labels are in compliance with these regulations is of vital importance for your product reaching market.  To assure compliance, you’ll want to find courses that cover what goes on the label. You'll also want to find courses that explain why these required items on the label are necessary and how they differ from traditional food labels.  Preparing For & Conducting Recalls When it comes to FDA Recalls, you will want to find courses that equip you with key considerations you need before, during and after an incident.   Courses like these teach you how to obtain, analyze and use information to take quick action to benefit both the public health and the health of your business.  Nutrition Fact Labeling When sourcing regulatory compliance training online, one of the most frequently violated safety issues is the proper labeling of nutrition facts.   You’ll want to find quality courses that discuss how FDA determines the serving size for foods, specify which nutrient values are to be included in the nutrition facts labeling, and how these are calculated and prepared.    You also want to look for training that discusses how to approach the development of your nutrition facts label while ensuring it is compliant with FDA regulations.  Food Additive Regulation Courses that cover food additive regulations will introduce you to the way FDA regulates ingredients added to conventional foods and beverages.    Understanding the status of each ingredient is crucial when you’re a domestic producer or even a non-US entity exporting food products to the United States.   Labeling Health Claims Labeling requirements for making claims about a food in relation to a reduction in the risk of certain health conditions are very stringent.   Ensuring your claims are in compliance with these regulations is paramount in compliance, whether you are a domestic producer or a non-US entity exporting food products to the United States.  Color Batch Certification When it comes to color batch certification, you will want a course that will introduce you to the way certain color additives must be batch certified by FDA prior to their use in food and beverages.  Understanding which color additives require this certification and the process by which it can be achieved is vital to maintaining compliance and keeping products out of detention.  Simplify Training for Food Safety Professionals With RegiLearn  With RegiLearn Libraries by Registrar Corp, regulatory professionals have easy access to a full catalog of quality courses specific to individual needs. Whether you need HACCP courses for management, GMP trainings for production workers, or specialized FDA compliance modules for your regulatory staff, RegiLearn equips your team with up-to-date training from top industry experts that cover the above courses and more.  Discover how you can gain and maintain FDA compliance with RegiLearn.
July 8, 2023
Food safety professionals need quality, up-to-date, courses to help keep their teams in compliance with FDA, GFSI and customer requirements. Like courses that cover concepts around hazard controls, microbiology, and HACCP in order to assure regulatory mastery and effective leadership. Courses like these will help you learn to keep your facility free of violations and assure product stays moving.  When it comes to FDA's FSMA requirements, the last thing manufacturers and food safety managers want is to have poorly equipped teams that lack critical compliance knowledge.  That’s why we assembled this actionable list of the most essential courses that experts in the food safety industry insist will keep your teams in the FDA’s good graces and avoid foodborne illness.   Aseptic Sampling    In short, aseptic sampling is a technique used to prevent contamination by your sampling method through the use of sterile sampling implements and containers.   When you learn to sample with an aseptic technique, your bacteriological findings will accurately reflect the overall condition of the lot at the time of sampling and the original shipment.  Fermentation  In general, fermented foods are arguably the safest for us to eat. However, even though lactic acid kills harmful bacteria during fermentation, if critical errors are made, there is still the risk of food safety hazards.  Botulism, E. coli, and salmonella are the primary risk factors in fermented foods. You’ll want quality training that covers how these bacteria form when sanitation practices are not followed and how to better prevent their growth.  Growth Factors  Preventing growth of unwanted bacteria in the foods you produce is key in food safety and FDA compliance. Courses that offer an in depth view at how food, acidity, temperature, time, oxygen, and moisture affect the growth of bacteria is essential in food safety.  You’ll want to look for training that addresses how these growth factors are used to develop processing techniques to limit microbial growth to achieve safe food products.    Natural Toxins  Taking courses that cover the various types of living organisms that produce toxic chemicals ---known as natural toxins--- and how to deal with them is another excellent way to keep your facility compliant.   Natural toxins are often produced in plants as a defense against predators, insects, or infestation. Though they might not hurt the organisms that produce them, consuming foods and beverages that contain natural toxins can be harmful to the public health and your bottom-line.  HACCP  HACCP courses cover many topics, from histamine in seafood, frozen and dry foods to ready-to-eat foods. HACCP applies to many industries.  Finding courses that not only cover those specific cases but also discuss what it takes to implement a HACCP program in your food facility will set your teams up for success.  The courses should also offer understanding of key terms, the process for creating a HACCP program, and how to monitor it to verify its effectiveness.  Simplify Training for Food Safety Professionals With RegiLearn  With RegiLearn Libraries by Registrar Corp, food safety professionals have easy access to a full catalog of quality courses specific to individual needs. Whether you need HACCP courses for management, GMP trainings for production workers, or specialized FDA compliance modules for your regulatory staff, RegiLearn equips your team with up-to-date training from top industry experts that cover the above courses and more.  Discover how you can gain and maintain FDA compliance with RegiLearn. 
July 5, 2023
When it comes to FDA regulations and their enforcement practices, a business can easily be set back or even crippled by various violations. From detainments at the port of entry and outright product seizures, to recalls and facility registration suspension or debarment, access to food safety training for employees has become critical to assuring continued FDA compliance.   With so much at stake, you want to assure your team is equipped with up-to-date and quality courses that will arm them with the skills and know-how to defend against FDA violations.   That’s why we put together this list of the most recommended courses experts in the food safety industry insist will keep your production teams in the FDA’s good graces.   Going Deep With Good Manufacturing Practices (GMPs)  It should be no surprise that if you want to train your production teams for FDA compliance, GMP food safety training for employees is an absolute must. They will learn the safety protocols and guidelines to prevent contamination during manufacturing and processing throughout every stage of production such as:  Allergen Management  When employees learn allergen management, they learn a process that serves to identify and control the risk and presence of food allergens, whether in raw materials, finished products, and everything in between.  An effective allergen management program will provide structure around identifying allergen risks within your business and also contributes to safe food.  Food Contamination  Whether by ambient dust, hair, or other foreign objects, production teams need to understand how to prevent food contamination by keeping their environment—and themselves—in check.  It is easy to contaminate food, either by subpar personal hygiene or lack of proper education and training. The simple act of wiping nearby surfaces down can send chemicals and other contaminants soaring toward your product.  Learning how to prevent food contamination will set your food production teams up for overall compliance.  Foodborne Illness  The last thing you want is an outbreak traced back to your facility.   With the right food safety training for employees, you can help prevent foodborne illness with techniques like following HACCP plans, cooking and refrigerating to proper temperatures, and how to properly sanitize and rack trays, utensils, and equipment.  Pest Control  It’s safe to say, birds, rodents, and insects don’t belong in the facility. When your team leverages pest control training, they can identify risk areas and how to keep product stored in a way that doesn’t invite unwanted guests or FDA violations.   Understanding where to look and how to shelve products will keep operations clean and sanitary for both your employees and your consumers.  Food Defense  The food and beverage industry has become an intricate web of global complexity and diversity. Though this is a good thing, it has opened up the potential for greater threat from intentional adulteration and contamination from malicious parties intent on affecting public health and the economy.  Responsible manufacturers will want to ensure food safety training for employees that addresses food defense and the strategies necessary to keep product safe.  Simplify Food Safety Training for Employees With RegiLearn  With RegiLearn Libraries by Registrar Corp, your team has easy access to quality courses tailored to every level of your production team. Whether you need HACCP courses for management, GMP trainings for production workers, or specialized FDA compliance modules for your regulatory staff, RegiLearn provides your team with up-to-date trainings from top industry experts.  We not only offer the above courses, but you and your team also gain access to individual libraries specifically tailored to your roles.   Production and Food Safety Managers are even able to purchase only the seats they need for their teams, assign individual training, and track an employee’s progress.  Discover how you can gain and maintain FDA compliance with RegiLearn. 
June 7, 2023
What is the difference between HACCP and PCQI?  Is the food safety plan different than HACCP? I had HACCP training, is that good enough?  Your facilities may already have a HACCP plan in place. Typically, HACCP plans focus on process controls. The food safety plan goes one step further and includes preventive controls.  Supply chain, allergen, and sanitation activities have typically been included in the GMPs or prerequisite programs. In the preventive controls regulation, these may be elevated into the food safety plan as preventive controls.   Sometimes a hazard analysis identifies a specific hazard. For example, recontamination of product after a kill step. Then these activities become more important. In that example, a sanitation control is needed to control the hazard of recontamination. Sanitation is being used to control a hazard identified during the hazard analysis. We need to elevate that to a preventive control.  The sanitation circle overlaps in both GMPs and the food safety plan, showing that sometimes sanitation activities are GMPs, but some may be elevated into the food safety plan. They may become preventive controls. In this example, sanitation to prevent the recontamination of product will become a preventive control, but general sanitation will remain a GMP.  The same thing can happen with allergen controls or supply chain controls. When you see a specific hazard during hazard analysis, we will need to address those with the preventive control. So those activities now become part of the food safety plan. The requirement for becoming qualified to be the PCQI is that you have “successfully completed training in the development and application of risk-based preventive controls, at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA”. HACCP courses do not meet this definition.  View details of PCQI Training  
May 24, 2023
The Preventive Controls Rule for Human Food asks you to implement risk-based preventive controls for food safety hazards. It focuses on prevention, not relying on catching food safety problems after they occur. It is preventive, not reactive. It also focuses on what matters most for food safety. The preventive controls rule builds on other risk-based food safety programs, such as HACCP. HACCP has been in use for a long time and is a proven method of preventing food safety risks. Historically HACCP focuses on the process, and process controls such as CCPs. Hazard analysis identifies hazards associated with the product and process, and critical control points and critical limits are implemented. They are monitored, and corrective action is taken when limits are exceeded. Preventive controls are built on a similar model. But the scope is expanded, the rule includes preventive controls, not only process controls. In addition to process controls, these include allergen, sanitation, and supply chain controls. Because of this, in addition to critical limits, parameters, and values are identified to monitor the controls. Not everything will have an upper and lower limit that can be monitored as with a CCP. Now there will be a variety of parameters that might be used to monitor the control. Process controls and CCPs are one type of control, but the preventive controls rule expands to include more controls. These are allergen controls, sanitation controls, and supply chain controls. There may be other types that companies identify as well. Let's take a look at how the preventive controls rule helps you build a preventive food safety system. The system builds on foundational systems that you have in place in your facility. Most facilities already have GMPs and other prerequisite programs. These are programs that keep your facility clean and sanitary and capable of making safe food. These programs provide a foundation for your food safety plan. The food safety plan and these foundational programs work together to make up your food safety system. The food safety plan is your plan for controlling known or reasonably foreseeable hazards that are associated with your food products through the use of preventive controls. Your facilities may already have a HACCP plan in place. And typically, HACCP plans focus on process controls. The food safety plan goes one step further and includes the other preventive controls I mentioned. Supply chain, allergen, and sanitation activities have typically been included in the GMPs or prerequisite programs. In the preventive controls regulation, these may sometimes be elevated into the food safety plan as preventive controls.