Tip #309: Understand the Fundamentals of an Effective Traceability System

Take action to protect your business against the threat of a product recall by better understanding the fundamentals of an effective traceability system from Dean Hornsby of Redimark. This article was originally published in RCI's Kettle Talk magazine.

In 2018, a total of 382 food product recalls were registered between the U.S. Food and Drug Administration (FDA), as well as the U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS). What were the leading reasons for the recalls? Undeclared allergens accounted for 160 recall cases; milk, tree nuts, eggs, peanuts, soy and wheat representing the largest offenders. (foodsafetymagazine.com)

If you produce confectionery products, you are most likely sourcing ingredients from multiple suppliers that are derived from local and even international sources. You rely on your suppliers to keep track of these ingredients and provide the documentation for batch or lot identification. You would expect your suppliers to notify you if they had a quality or safety recall, but what about you? Would you know what products of yours would fall under that same product recall?

THE IMPORTANCE OF TRACEABILITY

An effective product traceability system involves the use of tracking and tracing systems and processes to record the movement of incoming goods to outgoing product. Whatever system you use, it is important to capture the data of incoming ingredients quickly and accurately. The packaged products that you produce and ship need to be identified all the way back to the batches of ingredients used.

• Once product is outside of your four walls, what now?
• Did you track where the product lot was shipped to?
• What about your customers or consumers?
• Would they be able to identify the offending batch of product?

This is the importance of product coding and identification.

Above: Key areas of consideration for a traceability system

HOW TO TRACK PRODUCTS

Not only should your product traceability system capture the data of incoming goods to outgoing shipments, it needs to index all production activities to a unique batch lot number such as a kettle or oven number, mixer, packaging line, etc. This primary-level batch lot number is the license plate that travels with the product all the way to the customer and consumer. If a supplier notifies you of an ingredient safety issue, your traceability system should support a “where-used” function that allows you to enter the secondary-level batch numbers of the ingredients used and all parent level batch numbers should show as a result. The same holds true for the production process activities. Should a metal mixing blade break, all batches produced from the last inspection date of the mixing blade up until the new inspection that found the failure must be identified.

CODING REQUIREMENTS

The primary-level batch code must be visible on your product packaging. It should not be printed on parts of the packaging that can be discarded such as a tear-away opening or throwaway cap. It should be printed onto the permanent section of the packaging so that a consumer can locate the code for identification. Printing of the batch code can be performed by many different technologies. Inkjet coders offer the most flexible way to date and batch code products by jetting the ink drops that form printed characters onto the product as it travels down a product conveyor or through a flow wrapper. Labels can be printed inline using a print-and-apply system, or offline in batches that are hand-applied onto the product. Thermal Transfer Over printers (TTO) print directly onto the film in the flow wrapping process—Label and TTO technologies use wax ribbons for printing onto the label or plastic packaging substrate.

More expensive coders, like lasers, can be used to vaporize the package’s pre-printed ink surface to reveal contrasting date codes with the natural packaging material color underneath.

FSMA’S IMPACT ON TRACEABILITY

The Food Safety Modernization Act (FSMA) impacts small manufacturers (fewer than 500 full-time equivalent employees) as of September 18, 2017 and very small businesses (less than $1,000,000 in sales) on September 17, 2018.

The FSMA is a law that enforces preventative control measures and enables the FDA to perform unscheduled inspections and force product recalls instead of issuing voluntary recalls. The law can even allow the FDA to force closure of production operations should improper preventative control measures be found regarding food safety.

An effective product traceability system delivers what your business needs to protect brand image, provide consumer trust, and meet your product quality and safety goals.

LEARN MORE ABOUT TRACEABILITY Register now to join RCI for Regional Conference in Nashville August 19-21, 2019. Dr. Bob Strong, with SAI Global Assurance, will lead education on the importance of traceability. Understand traceability and requirements for businesses of all sizes, as well as consequences facing both your business and public health, if not done properly. Register today!

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Throwback Tip #230: Refresh Your FSMA Knowledge

It has been eight years since the Food Safety Modernization Act (FSMA) was signed into law, which also means if you manufacture food and operate with less than $1 million in sales, September 2018 was the deadline to comply with the FDA's regulations. This week's tip offers a refresher on FSMA in an excerpt from an article written by Michael Koch of Morley Candy Makers/Sanders Candy for RCI's Kettle Talk magazine, plus tips for next steps.

WHAT IS FSMA?

FSMA was designed to shift the focus on food safety from responding to contamination issues to a more proactive approach of preventing contamination before it happens. Through the passing of this law the FDA has gained more leverage in its ability monitor and control the safety of our food supply chain.

In September of 2015 the FDA published its "Preventive Controls for Human Food" guidelines. As part of FSMA, it outlines the mandatory requirements being placed on all food manufacturers to have and implement a written food safety plan. FSMA requires that your plan be written and managed by a qualified individual. Individuals must complete a certification course to become a qualified food safety administrator.

PREVENTATIVE CONTROLS

Hazard Analysis and Risk-Based Preventive Controls (HARPC) is a documented food safety program that addresses hazard risks with preventive controls for every food product you handle in your facility to ensure it will not become contaminated and unfit for human consumption.

VERIFY EFFECTIVENESS

Continuing to verify the effectiveness of your plan ensures preventive controls are consistently implemented and sufficient. Verification includes evaluating the accuracy of process monitoring, calibrating instruments, such as thermometers, and reviewing records to verify monitoring and corrective actions are completed. Product testing and environmental monitoring by a certified third party are also reliable verification methods.

RECALL PROCEDURES

Your plan must contain details on your recall procedures. If a contaminated product is shipped, you must be able to identify where the product has gone and have the ability to perform a recall. A recall plan should include the procedures for identifying the contaminated product. Having important contact information in the plan will help move the process forward. Contacts should include the local health department, local FDA office, news media and anyone else that you may deem important to the process.

FSMA covers a much greater spectrum of the food chain and more details than covered in this brief post. The realm of information and procedures that you are responsible for also cover such things as your supply chain management, good manufacturing practices, corrective actions and etc. The FSMA is no small task and it is designed to protect the consumer from obtaining contaminated products.

WHAT NOW?

Co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, Joann Givens shares next steps for food facilities now that compliance dates have passed for most small businesses.

“The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.”

Joann also stresses the importance of a thorough system for documenting what you do. “The better the records, the more a company can demonstrate that it is meeting the legal standard.” With the right processes and procedures in place you’re better equipped to prevent problems before they arise. Joann recommends creating some redundancy in your system, “if one measure fails, another can take its place.”

In order to operate a successful candy making business, it is essential that you are knowledgeable on federal regulations and take the proper action to ensure you are in compliance with FSMA guidelines. Click here for more resources and updates.

Crave more? If you like what you read here, look for the "Subscribe now" box on the right to enter your email address and start receiving weekly tips, like this, delivered straight to your email inbox. Plus, review past blog posts for quick and actionable tips to apply to your business. RCI's Tip of the Week blog is just one of the many resources we offer to help candy makers refine their craft and build upon their business and marketing practices.

Not a member? Click here to learn how RCI can help you build your sweet business.

Throwback Tip #230: Refresh Your FSMA Knowledge

It has been seven years since the Food Safety Modernization Act (FSMA) was signed into law, which also means if you manufacture food and operate with less than $1 million in sales, September 17, 2018 is the deadline to comply with the FDA's regulations. This week's tip offers a refresher on FSMA and its requirements in an excerpt from an article written by Michael Koch of Morley Candy Makers/Sanders Candy for RCI's Kettle Talk magazine.

Click here for further clarification on compliance dates.

WHAT IS FSMA?

FSMA was designed to shift the focus on food safety from responding to contamination issues to a more proactive approach of preventing contamination before it happens. Through the passing of this law the FDA has gained more leverage in its ability monitor and control the safety of our food supply chain.

In September of 2015 the FDA published its "Preventive Controls for Human Food" guidelines. As part of FSMA, it outlines the mandatory requirements being placed on all food manufacturers to have and implement a written food safety plan.

Before putting a plan together, first, identify the individual or individuals in your organization that are going to administer your program. FSMA requires that your plan be written and managed by a qualified individual. Currently the only way to verify that an individual is qualified is to have your food safety administrator attend a certification course.

IDENTIFY HAZARDS

Hazard Analysis and Risk-Based Preventive Controls (HARPC) is a documented food safety program that you need to develop and implement for your facility. The first step toward developing a HARPC is to conduct a hazard analysis for every food product you handle in your facility—this is not limited to the items that you manufacture. The second step is to put in place preventive controls for each food product to ensure it will not become contaminated and unfit for human consumption.

VERIFY PLAN’S EFFECTIVENESS

Verifying the effectiveness of your plan ensures preventive controls are consistently implemented and sufficient. Verification includes evaluating the accuracy of process monitoring, calibrating instruments, such as thermometers, and reviewing records to verify monitoring and corrective actions are completed. Product testing and environmental monitoring by a certified third party are also reliable verification methods.

CREATE RECALL PROCEDURES

Your plan must contain details on your recall procedures. If a contaminated product is shipped, you must be able to identify where the product has gone and have the ability to perform a recall. A recall plan should include the procedures for identifying the contaminated product. Having important contact information in the plan will help move the process forward. Contacts should include the local health department, local FDA office, news media and anyone else that you may deem important to the process.

FSMA covers a much greater spectrum of the food chain and more details than covered in this brief post. The realm of information and procedures that you are responsible for also cover such things as your supply chain management, good manufacturing practices, corrective actions and etc. The FSMA is no small task and it is designed to protect the consumer from obtaining contaminated products.

In order to operate a successful candy making business, it is essential that you are knowledgeable on federal regulations and take the proper action to ensure you are in compliance with FSMA guidelines. Click here for more resources and updates.          

Stay connected with RCI through Facebook for more tips and inspiration dedicated to the retail candy maker. Not a member? Click here to learn how RCI can help you build your sweet business.

Tip #230: Refresh Your FSMA Knowledge

If you are in the food industry, chances are you are well aware of the Food Safety Modernization Act (FSMA). Now that Halloween…Thanksgiving…Christmas…Valentine’s Day…Easter is now over, this is a great time for a refresher in this excerpt from RCI's Kettle Talk, written by Michael Koch of Morley Candy Makers/Sanders Candy.

FSMA was designed to shift the focus on food safety from responding to contamination issues to a more proactive approach of preventing contamination before it happens. Through the passing of this law the FDA has gained more leverage in its ability monitor and control the safety of our food supply chain.

In September of 2015 the FDA finally published its “Preventive Controls for Human Food” guidelines. As part of the FSMA it outlines the mandatory requirements being placed on all food manufacturers.

The most important aspect of the law that everyone needs to realize is that it applies to all food manufacturers. If you think your company is too small and these regulations don’t apply to you, please understand you could be making a costly mistake.

As with many of the guidelines that the FDA enacts they have set forth a specific time frame for companies to comply. The timeline is as follows:

Prior to putting a plan together you must identify the individual or individuals in your organization that are going to administer your program. The FSMA requires that your plan be written and managed by a qualified individual. Currently the only way to verify that an individual is qualified is to have your food safety administrator attend a certification course.

Hazard Analysis

Hazard Analysis and Risk-Based Preventive Controls (HARPC) is a documented food safety program that you need to develop and implement for your facility. The first step toward developing a HARPC is to conduct a hazard analysis for every food product you handle in your facility—this is not limited to the items that you manufacture. The second step is to put in place preventive controls for each food product to ensure it will not become contaminated and unfit for human consumption.

Verification

Verifying the effectiveness of your plan ensures preventive controls are consistently implemented and sufficient. Verification includes evaluating the accuracy of process monitoring, calibrating instruments, such as thermometers, and reviewing records to verify monitoring and corrective actions are completed. Product testing and environmental monitoring by a certified third party are also reliable verification methods.

Recall Procedure

Your plan must contain details on your recall procedures. If a contaminated product is shipped, you must be able to identify where the product has gone and have the ability to perform a recall. A recall plan should include the procedures for identifying the contaminated product. Having important contact information in the plan will help move the process forward. Contacts should include the local health department, local FDA office, news media and anyone else that you may deem important to the process.

The FSMA covers a much greater spectrum of the food chain and more details than covered in this brief article. The realm of information and procedures that you are responsible for also cover such things as your supply chain management, good manufacturing practices, corrective actions and etc. The FSMA is no small task, it is designed to protect the consumer from obtaining contaminated products.

In order to operate a successful candy making business, it is essential that you are knowledgeable on federal regulations and take the proper action to ensure you are in compliance with FSMA guidelines. Visit fda.gov for more resources and updates.          

Stay connected with RCI through Facebook for more tips and inspiration dedicated to the retail candy maker. Not a member? Click here to learn how RCI can help you build your sweet business.