Category

FSMA

When it comes to food safety, leave nothing to question

By | ERP, Food and Beverage, FSMA | No Comments

The Food Safety Modernization Act (FSMA) is having a profound impact on food and beverage manufacturers. In order to help food and beverage manufacturers understand the law and ensure they are in compliance, we recently hosted a webcast with Richard Ross, the CEO and Founder of PathTracer™ Laboratory and Consulting Services. With over 40 years in the food manufacturing industry, Richard has the practical experience to help food companies through the FSMA compliance process.

Richard shared the following story on the importance of leaving nothing to question when it comes to food safety:

Food safety is receiving more attention today than ever before with the regulations associated with the Food Safety Modernization Act (FSMA).

A case in point: An attorney relayed a story to me about a food company in Texas that was sued by a family whose son allegedly got sick from consuming food produced by the company. The company was completely prepared to fight the lawsuit with documentation – they had both HACCP and Food Safety Plans in place and employees had completed food safety training.

The company also had documentation proving that they had tested the ingredients for pathogens and tested again during the manufacturing process. However, they did not test the finished product. It made perfect sense that if the ingredients and production process had tested clear, that the finished product would be clear, too. The jury did not agree and found for the family.

Although the FDA states that product and environmental testing needs to be “scientifically based,” they do not provide explicit instructions because every food business is unique. What should be done is to scientifically demonstrate, over time, that the Standard Operating Procedure (SOP) for environmental and product testing is effective and that the results are documented and retained.

It wasn’t that the company didn’t test the finished product as much as they didn’t have proof that they had made the appropriate decision based on the results of testing. They appeared to be negligent. It is important to leave nothing to question.

To learn out more on FSMA, watch our webinar featuring Richard Ross: “Food Safety Modernization Act Compliance for the Food Industry.”

ERP solutions

Does your CAPA plan address FSMA regulations?

By | ERP, Food and Beverage, FSMA, Sage X3 | No Comments
ERP solution

Corrective and Preventative Action software can dramatically improve the ease of FDA inspection prep.

Is your food or beverage manufacturer ready for new federal regulations that can bring added scrutiny to your corrective and preventative action (CAPA) system?

If not, your company could face increased Food and Drug Administration (FDA) scrutiny, including an FDA violation and additional inspections. The reason is a new rule as part of the Food Safety Modernization Act, which gives the FDA broader inspection powers. Companies the FDA deems as “high risk” can be subject to FDA inspection once in the next five years and then at least every three years thereafter.

Does your CAPA plan address FSMA regulations? The answer, as seen in the recent post, “The food manufacturer’s strategic guide to technology,” may mean making smart decisions about software tools for operations.

Let’s take a closer look at some best practices to use in your CAPA plan and what FDA inspectors are looking for to determine FSMA compliance.

Your CAPA plan provides an opportunity to identify and recommend solutions to potential problems. When an incident occurs, the CAPA provides the detailed solution and the steps necessary to implement. It’s a road map for companies to ensure consistent remediation and compliance with FSMA regulations.

The basic components of a robust CAPA plan include:

  • Identification of the problem. The root problem needs to be clearly identified and articulated.
  • Evaluation and review. It’s necessary to determine the scope of the problem, the implications of the problem for consumers and suppliers, and the severity of the consequences of the problem.
  • Investigation. A plan to research the problem and its causes is paramount.
  • Analysis. All potential causes of the problem should be explored. It is recommended that several different methodologies are used to ensure thorough analysis.
  • Action plan. The list of probable causes is developed.
  • Implementation. The action plan is put into motion.
  • Review. Verify the mitigation was done properly and review the entire incident and CAPA process.

CAPA documentation and the FDA

Many food and beverage companies are still using word processing and spreadsheet programs to track their CAPA compliance. With the implementation of the FSMA, the FDA is looking for companies to have integrated, digital solutions that are less apt to have errors and inconsistent data.

FDA inspectors are expected to look at these 10 steps when conducting a CAPA assessment:

  1. Procedure definitions and documentation. Inspectors are expected to check that management has detailed definitions and interpretation of key phrases, such as “nonconforming product,” “prevention,” “timely” and “correction.”
  2. Consistent information collection and review.   Customer complaints, returned products, quality records and audits, installation reports and litigation must all be cataloged.
  3. Data usage. FDA staff will look at your trending data, corrective actions, acceptance work and quality systems documentation to ensure you are interpreting data correctly.
  4. Data entry accuracy. Inspectors will spot check data sources to ensure accuracy, thoroughness, and timeliness.
  5. Data analysis. This assessment examines whether statistical and non-statistical methods are being used to identify recurring issues.
  6. Investigation procedures. Inspectors can ask about the procedures used to investigate an incident followed by a review of the records to determine if they match your description.
  7. Double-checking. Inspectors will look at corrective actions taken to determine if more could have been done.
  8. Verify documentation. Corrective actions will be spot-checked to ensure actions are documented correctly.
  9. Validation of actions. Your past actions will be assessed to determine their efficacy.
  10. Management roles. Inspectors will check to make sure problems and corrective actions are communicated properly to appropriate managers.
ERP solutions

CAPA is a critical component of FDA inspections under new food safety rules.

To ensure proper FSMA compliance and better communication and data integration, many food and beverage makers deploy an enterprise resource planning (ERP) solution. An ERP solution integrates key functions – finance, sales, management, operations, and distribution – to help companies make better decisions faster.

At NexTec, we help food and beverage makers find the ERP solution that fits their enterprise. We work with partners like Sage X3 to implement solutions that transform companies.

Sage X3 is a powerful ERP that integrates and automates. With NexTec add-ons designed specifically for the Sage X3 platform, companies can have an automated CAPA solution. Inspections no longer take days of prep time with the commitment of many resources. Instead, automated CAPA functionality means documentation can be generated in minutes.

To learn more about the power of Sage X3 and the role of an ERP in CAPA compliance, download our infographic – Don’t think CAPA is important? The FDA does.

Manufacturing ERP software

Record-keeping with FSMA: one more reason for robust ERP

By | ERP, Food and Beverage, FSMA, Sage X3 | No Comments
Manufacturing ERP software

Accurate record-keeping of procedures is essential for compliance with new federal food safety guidelines.

Under the federal Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has wide latitude to access records and inspect facilities to prevent or investigate safety issues. As mentioned in the recent post entitled “How FSMA impacts modern food and beverage manufacturers today”, for food and beverage manufacturers, these new guidelines around record-keeping require comprehensive procedures and technologies to ensure compliance and sound procedures required by the FSMA provisions.

Enterprise resource planning (ERP) software allows manufacturers to tie together the myriad operational and back-office functions within the organization to ensure prompt and accurate compliance. The need for accurate record-keeping with FSMA is one more reason for robust ERP.

Scope of FSMA record-keeping

The FSMA gives the FDA new tools to use for inspections and compliance. Among the new provisions are:

  • Mandated facility inspections, the frequency of which is based on risk. For high-risk domestic sites, inspections must be completed within five years and then at least every three years thereafter. Non-high-risk facilities are to be inspected within seven years and at least every five years thereafter. In the first year, the FDA is directed to inspect 600 foreign facilities, with double the foreign inspections every year for the next five years.
  • Access to records, including FSMA-mandated food safety plans and records that document how those plans are implemented.
  • Testing carried out by accredited laboratories.
Manufacturing ERP software

Food safety guidelines give the FDA wide latitude to inspect records and facilities and use external labs for sample analysis.

Targeted facilities

The final FSMA guidelines indicate the FDA will characterize high-risk sites based on:

  • Known safety risks for the food made, processed, packed, or stored at a facility.
  • The facility’s compliance history related to recalls, foodborne illness outbreaks, or violations of food safety standards.
  • The strength (“rigor and effectiveness” according to the FDA) of a facility’s hazard analysis and risk-based preventive controls.

Record-keeping is an obvious essential element of FSMA compliance. The number of records required to be kept is significant and includes measurement of:

  • Hazards and potential hazards
  • Preventive controls
  • Suppliers for each food ingredient
  • Corrective actions taken
  • Verification of the corrective actions
  • Training of employees

Records need to be originals and must include measurements and observed values and be created concurrent with the activity measured or observed. Records must include the facility’s name and location, date and time, person doing the recording, and the product name and production code.

Preparing for records and inspections

The key for food manufacturers is to be prepared, with the proper procedures and recording systems in place. Compliance tracking software, used in tandem with manufacturing ERP software, helps ensure that companies remain in compliance, can track and retrieve required documents, and are following determined procedures fully.

At NexTec Group, we help identify the right compliance tracking and food processing software packages that ensure full FSMA compliance. Some available packages provide automated tracking functionality that helps not only with compliance but improves operational efficiency, too.

With NexTec as your trusted FSMA compliance partner, you will have access to expert advice about the vendors, products, and features that best meet your company’s needs. To learn more about how NexTec and Sage X3 can help with your compliance challenges, download the NexTec Food Brochure.

Sage Authorized Partner


Food processing software

FSMA standards for warehouse management. Are you compliant?

By | Food and Beverage, FSMA, Inventory control, Sage X3, Warehouse management | No Comments
Technology is transforming warehouse management and compliance.

Technology is transforming warehouse management and compliance.

With the implementation of key provisions of the Food Safety Modernization Act (FSMA) now in play, food and beverage manufacturers need better technologies and tools to monitor and manage their supply chain. Warehouse management is a critical component of food safety. As a food manufacturer, there is an important question you should ask yourself regarding FSMA standards for warehouse management: Are you compliant?

FSMA addresses prevention, inspection, compliance, response, and import management. At each step, the act’s provisions are focused on accurate measures that will drive better oversight of the entire food supply chain.

Many consider the FSMA to provide an opportunity to shift from reaction to prevention. New technologies in the warehouse are one key way to ensuring companies can comply, while also improving food safety and providing functionality that improves efficiency.

Warehouse management has traditionally been a predominantly manual system. That is changing as companies embrace new technologies and integrate warehouse management systems into enterprise resource planning (ERP) platforms that facilitate multiple functions.

These technologies ensure better accuracy in picking, mixed SKU pallets, and other areas of warehouse management. In turn, these innovations help ensure food safety and FSMA compliance.

For example, the growth of the Internet of Things can connect objects in the warehouse that can track, monitor, record, and transmit information as inventory moves in and out of the warehouse, a major boon to the food and beverage industry.

Food processing software

Technology makes for more accurate picking and safer warehouse conditions.

Consider some of these other new technologies that are transforming warehouse management…

Paperless processes. For far too long, the picking process has relied on paper. Today, with the new federal guidelines in play and more demanding specificity by customers, warehouses need more accurate tools. For example, a customer may insist on products that have an expiration date that is no more than X days away. With electronic picking, it is easier for warehouses to manage such specifics.

Voice commands. Voice-activated controls provide far more inventory accuracy, order accuracy, and better warehouse control. Such systems are optimal in cold environments where gloves and cold fingers can lead to more mistakes.

Laser-guided pallet trucks. These systems move automatically to the proper picking location within the warehouse and move the appropriate pallets to the shipping dock, often with little to no need for a picker. The tool offers more accuracy and saves time by eliminating the need for drivers to enter and exit repeatedly.

RFID technology. This technology is semi-automated, relying on a mapped route to bring a truck to the right location and a lift that ascends to the proper height automatically. Routes are optimized, saving time.

Electric trucks. Electric vehicles have a dual benefit. They reduce the level of emissions and lower the risks of permeating increasingly thin plastic wraps on product. They also make the warehouse a safer environment for workers.

To be successful, food processing manufacturers need robust warehouse management systems that integrate warehouse functions with data from purchasing, operations, distribution, sales, marketing, accounting and billing. Sage X3 is an ERP that delivers exactly that at a fraction of the cost and complexity of typical ERP systems. NexTec has the largest, most experience Sage X3 team with deep experience implementing ERP for food and beverage manufacturers. To learn more about how NexTec and Sage X3 can help your food and beverage company, download NexTec’s Food Brochure


fsma compliance

Are you ready for the 2017 FSMA rule changes?

By | Food and Beverage, FSMA | No Comments
Food and beverage industry regulation

New guidelines related to food safety and foodborne illness prevention will affect a large number of food manufacturers and processors in 2017.

For food and beverage processing companies, 2017 is a year for significant change regarding important components of the federal Food Safety Modernization Act (FSMA).

Are you ready for the 2017 FSMA rule changes? Here is a detailed look at the seven core changes and how to ensure regulatory compliance.

1. Preventive controls for human food

  • Large facilities were required to prepare specific food safety plans by September 2016.
  • Manufacturers or processors that rely on raw materials or ingredients from suppliers must ensure their supply chain programs are FSMA-compliant by March 17.
  • Small businesses need to have food safety plans in place by September 17, 2017.

This rule and the next are designed to reduce the incidence of foodborne illnesses.

2. Animal food safety controls

Large facilities must have food safety plans in place by September 17, 2017. Those facilities needed to comply with federal current good manufacturing practices (CGMP) by September of last year.

Food and beverage industry regulation

New FSMA guidelines cover transportation, foreign suppliers and transportation.

3. Produce safety

FSMA regulations covering most farms take effect on January 26, 2018, which makes 2017 an important preparation year. The FSMA requirements relate to water quality and testing, use of manure and stabilized compost, the use of grazing or working animals, worker training and hygiene, equipment, tools, and buildings. Additional regulations apply to sprout farmers.

4. Sanitary transportation

The new rules apply to carriers, loaders, and shippers, requiring those transporting food to use sanitary practices. The guidelines require vehicles and equipment to be designed and used to keep cargo safe, proper temperature controls, protection from cross-contact, and protection from contamination from non-food items. Rules take effect April 6, with smaller businesses having an additional year.

5-6. Foreign imports

Food importers need to establish verification programs that ensure food from foreign facilities or farms is produced within safety standards, effective May 27. A related optional program allows for expedited entry for importers that meet certain supply chain requirements and agree to an independent third-party audit.

7. Intentional adulteration

Food manufacturers need to have risk-reduction strategies in place by July 2019, including a vulnerability assessment; mitigation strategies including monitoring, corrective actions, and verification systems; training; and recordkeeping.

Ensuring compliance

With so many new guidelines and requirements going into effect, there is a more urgent need for thorough and persistent documentation. Companies that have better records will be more easily able to show they are compliant and meet legal standards.

Compliance includes a number of core considerations:

  • Identifying risks
  • Identifying controls to mitigate those risks
  • Deploying those controls
  • Monitoring that controls are working

Maintaining compliance with all these food and beverage industry regulations means having integrated software platforms. Today’s compliance environment means your enterprise resource planning (ERP), business intelligence (BI) and customer relationship management (CRM) tools need to share, combine and analyze data in real time.

At The NexTec Group, we understand the complexities facing manufacturers when it comes to food and beverage industry rules. Our national team of consultants provides advice on systems and processes to ensure FSMA 2017 guidelines are followed and the right measures in place. To learn more about how NexTec Group can keep your company in compliance, download the NexTec Food Brochure.

Food Benefits

By | Compliance, ERP, Food and Beverage, FSMA, Inventory control, Process Manufacturing, Product recall management, Sage X3 | No Comments

Top benefits of ERP | CRM | BI Software
for food and beverage

Avoid delays caused by inventory shortages

Balancing stock levels is a major challenge. With ERP you can easily manage food and beverage warehouse inventory and stock levels. ERP allows you to optimize inventory levels and meet your needs without overstocking and tying up working capital.

Lower inventory costs and eliminate waste

Perishable products have a have a limited shelf life and waste is costly. ERP enables a faster, more efficient distribution process to improve quality and reduce waste.

Improve food safety, track inventory and initiate food recalls

Quality is critical in the food industry and recalls can be a major headache. Linking to your warehouse allows you to keep track of your products lots, dates, quantities and movement in your distribution supply chain in real-time. Food is fresher and if there is a recall you are quickly able to initiate the recall.

Take corrective action earlier and continuously improve processes

Access to real-time information improves your sourcing decisions, provides better control and increases visibility over your manufacturing or production process so you can provide consistent, superior quality.

Reduce labor and other costs

By automating operations, you can eliminate redundant tasks and enable your staff to focus on the most meaningful tasks. The ability to aggregate all your financial, production and other data, will give you the ability to understand what areas could benefit from increased efficiencies.

Comply with health codes and other government regulations

Track ingredient and raw materials origins so you can provide accurate food labeling, stay compliant with changing health codes, and create summarized reports that give you an overview into regulatory compliance.

Real-time intelligence to respond to customers and management

If management wants to know how a change will impact business you have answers at your fingertips. Customers expect a quick response — generate and deliver immediate quotes, make appointments, track customer cases in real-time and enable customer engagement on multiple channels, from web and mobile to chat and social.

How food & beverage manufacturers can capitalize on the gluten-free market

By | Compliance, Distribution / Supply Chain, Food and Beverage, FSMA, OTHER | No Comments
With new suggested labeling requirements, the FDA is asking manufacturers to be more diligent with their gluten-free practices.

With new suggested labeling requirements, the FDA is asking manufacturers to be more diligent with their gluten-free practices.

Gluten-free foods are all the rage, and not just for those who have adverse reactions to the ingredient. For the food and beverage industry, the rise of attention on gluten has an added layer of complexity: compliance with the FDA’s recommendations on labeling. Despite those concerns, there is ample opportunity for F&B companies to seize on the emerging demand for gluten-free foods. Here’s how food & beverage manufacturers can capitalize on the gluten-free market.

Understand the Perspective

One tack for manufacturers to take is to look downstream at what restaurants are doing to respond to the growth in gluten-free. Restaurants are being encouraged to work more closely with their suppliers to ensure gluten-free products. While manufacturers may use several organizations to verify the absence of gluten, a recent post on restaurant.org urges restaurants to go further.

“The safest approach is to ask your supplier to verify an item is gluten-free because many gluten sources aren’t readily identified in the ingredient list. Beware of vague ingredient descriptions like ‘flavorings.’ Request a written statement that verifies ingredients are gluten-free or ask for a certificate of analysis.”

The same post encourages restaurateurs to be more proactive with suppliers by requesting to be notified whenever a product’s ingredients change, at least quarterly reconfirmations, and limiting allowable substitutions. Another article suggests chefs ask for “bake in the bag” products that can reduce cross-contamination from cooking vessels and other food.

A Look at Labels

In 2014, the FDA issued optional guidelines related to gluten on product labels. According to the agency, a gluten-free food cannot include an ingredient that contains a gluten-containing grain such as wheat, rye, barley or spelt; be derived from a gluten-containing grain that hasn’t been processed to remove the gluten; or, if the gluten is removed, contain more than 20 parts per million in the food.

The guidelines also place the phrases “no gluten,” “free of gluten” and “without gluten” under the same scrutiny.

Gluten-free products are a burgeoning opportunity for F&B companies.

Gluten-free products are a burgeoning opportunity for F&B companies.

Tips for Manufacturers

For manufacturers looking to enter the gluten-free zone, here are some things to consider:

• Your supply chain. You need to work with your providers to understand how their fields and farms are growing, harvesting and storing food. While grains are the source of gluten, you need to be sure that other products, such as meat, spices and dairy, are not contaminated.

• Your facility. A shared facility creating gluten and gluten-free products has a whole range of complexities. Equipment must be sanitized after each use, and care must be used that gluten traces do not settle back onto work areas. Workers need to be trained to not cross-contaminate via clothing or equipment moves.

• Test early. Ingredients should be tested upon arrival. Surfaces should be tested before work begins on gluten-free products. And finished foods should be tested.

• Managing a Gluten-Free Manufacturing Process. With the NexTec Group, you gain a proven partner in finding solutions for managing gluten-free manufacturing. With the right food manufacturing ERP, you can focus on food safety, accurate labeling, quality control, compliance monitoring, and improved productivity as well as incorporate full traceability.

At NexTec Group, we work with a range of suppliers to find the comprehensive food distribution software solution for your manufacturing facilities. We have extensive experience in the F&B sector and with multiple providers. To learn how we can help with the complexities of your food manufacturing business, download the NexTec Food Brochure.

Ensuring FSMA compliance in food distribution

By | Compliance, ERP, Food and Beverage, FSMA | No Comments

FSMA rules for food distribution will affect railways, trucking companies, and those that use heavy equipment for food distribution.

It’s easy to become frustrated with the growing body of regulations governing food manufacturing, food transportation, food quality, food handling, and related issues. It’s easy to believe that the government is just down on the food industry and looking for ways to make life harder. But the flipside of all those rules and regulations is that the United States enjoys one of the safest food, drug, and water supplies in the entire world. In fact, even the food we feed our pets and livestock is safer and of better quality than some of the food delivered and served to people in some parts of the world.

What’s FSMA compliance?

So, get ready to be thankful, as the brand new FSMA rules are ready to go. Slated for taking effect in April of 2017, the Sanitary Transportation of Human and Animal Food Rule focuses specifically on avoiding risks during the transportation of food, as opposed to strict focus on food quality issues. It is designed to respond to more than 200 comments the FDA received, most from inside the food transportation industry.

FSMA rules for food distribution apply to four main areas:

  1. The equipment and vehicles that transport food
  2. The operations of food transportation
  3. The training of personnel responsible for food transportation
  4. Record keeping on the food transportation processes

As profit margins become ever slimmer for food manufacturers and food transportation companies, additional requirements like these don’t make things easy. However, the right food distribution software can tremendously help, both in terms of staying compliant with laws and regulations like FSMA and in keeping operations efficient and productive to maximize profits.

How food distribution software helps you stay FSMA compliant

The benefits of these laws are that the US enjoys some of the safest, highest quality foods in the world. The downside is that these regulations drive up operational costs.

Food distribution software can help your food transportation company remain FSMA compliant, and also:

  • Find the most efficient shipping routes. You will be able to give your customers your guarantee that you will be able to fulfill their order precisely and on time for the lowest possible cost.
  • Improved lot control means you will be able to manage to stick within even the strictest of FSMA compliance and other regulations. You will be able to perfectly track the path of your stock via RFID and EDI technologies.
  • Simpler, easier management of food recalls means you can quickly and easily remove products that have been classified as unsafe by using automated product lot numbers.
  • Improved, enhanced inventory management means you can see accurate, current numbers in real time so that you can make the right decisions about your inventory on the spot, even if your inventory is in flux.
  • When your customers are running promotions, you will be able to manage and track those using the system’s streamlined trade promotions features.
  • Improved quality control means that you can keep track of expiration dates and proactively test products to assure that they are within compliance regulations and determine whether or not they contain potential allergens.
  • Increased visibility into operations means that you can get valuable insight into all your business processes via business intelligence tools.

Are you ready to get the food distribution software you need to remain FSMA compliant and improve your profit margins? Download the NexTec Food Brochure to find out more now.