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What Keeps You Up at Night? 2014 in Review for Medical Device Companies

Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.

Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"

Recalling the Difference

Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or at the request of the FDA is irrelevant. The difference is important as a recall requires the submission of a correction and removal report to the FDA. These reports become part of public record and thus may not put the company in a positive light. What may be considered recalls can include updates to instructions or changes to components or labeling.

Continue reading "Recalling the Difference"

An Introduction to Supply Chain Traceability and Recalls

Unlike twenty years ago, manufacturers today no longer relinquish responsibility for a product once it is delivered. Now, consumer recalls are weekly occurrences: problems like bacterial contaminations, sterility assurance risks, undeclared ingredients, metal / glass / plastic particles, and oversized tablets have highlighted the need for Life Sciences manufacturers to know exactly where ingredients came from, where they went, and even what machinery they were processed on.

Perhaps this was best summed up by Susan J. Wilkinson, a Smarter Food Supply Networks Subject Matter Expert, with IBM Global Business Services, who wrote “Consumers and governments now hold brand owners fully responsible for everything related to their products,” (, May 2012.)

Here's the bottom line: traceability is an essential aspect of the modern manufacturing environment. Also known as “track and trace,” if it isn't already, traceability should be an integral part of a Life Sciences organization's quality management system.

What does traceability mean?

In its simplest terms, traceability means knowing where a product came from and where it went. It's achieved by giving each unit of production a unique identification code – often a batch or lot number – and logging that through the manufacturing process. Extending the use of these codes to suppliers and customers results in what's often referred to as “one up, one down,” traceability across the supply chain.

Since manufacturers by definition “assemble,” the material or source information has to be linked to the recipe or bill of material. Thus traceability requires an ERP system with the ability to link suppliers, deliveries, and product identification codes to the manufacturing batches and eventual process output.

Regulation and Granularity

In the early days of traceability, lot or batch-level record-keeping was sufficient. However, in many industries, and especially the Life Sciences, a combination of consumer demand and government regulation are driving an increasing level of granularity, down to the individual item.

For an example, look at the Guidance Note on Medical Device Tracking issued by the FDA in January 2010. Addressing the requirements of the Safe Medical Devices and other Acts, this states that “Device tracking is intended to ensure that the Food and Drug Administration (FDA) can require a manufacturer to promptly identify product distribution information and remove a device from the market.”

Traceability and Recalls

When a processing fault or error is discovered, the responsible manufacturer halts production and quarantines goods that might be affected. In many cases though, this is not sufficient to protect the end customer as short lead times and minimal supply chain inventory mean every product is made and shipped as quickly as possible. As a result, if a processing or production problem is discovered the affected goods could be many miles from their origin.

At this point the manufacturer is into a recall situation. All those customers who may have received defective goods have to be contacted and the items recovered. The expense of performing a recall can be huge but easily outweighed by the cost, in terms of reputation damage and lost business, of doing nothing. As a result, many recalls are carried out voluntarily, although agencies such as the FDA have the power to force a recalcitrant manufacturer's hand if necessary.

Importance of Traceability

Traceability lets a manufacturer minimize the size and scope of a recall by providing detailed information about the source, processing and distribution of raw materials and finished goods. The more granular the record-keeping - even down to the discrete item level - the smaller a recall can be. Traceability out to the end-user or customer also helps the manufacturer verify that every affected item has been retrieved, providing a measure of recall effectiveness.

When track and trace thinking is integrated within a single ERP and Quality Management System, an organization can respond quickly, minimizing possible adverse consequences. In turn, this protects the brand, showing that traceability is good for business.

No one chooses to get into a recall situation, but occasionally errors are made. An effective traceability system minimizes negative business impacts while protecting end-users and satisfying regulatory authorities. Learn about the Top 6 Benefits of Supply Chain Traceability in a Recall Situation.

Five Food ERP Features for the Food Safety Modernization Act

The burden of foodborne illness is considerable. Every year, 1 out of 6 people in the United States—48 million people--suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

However, many food and beverage processors are already becoming overwhelmed as they move towards compliance with the major provisions of the FSMA, including:

  • Inspections and Recalls: The FDA now has the sweeping authority to inspect “high-risk” food products annually, and to initiate product recalls of suspected tainted foods. This is a significant transition away from relying on individual producers and distributors to voluntarily issue their own recalls.
  • Penalties and Fines: The FDA has also been given the power to levy heavy fines and limit supplies to food companies that do not cooperate with FDA inspections and recalls.
  • Food Safety Plans: Food processors are now required to develop comprehensive food safety plans, or Hazard Analysis and Critical Control Points plans, that are easily accessible by the government in case of an emergency. These Food Safety Plans need to include analyses of potential biological, chemical, and physical hazards, preventive controls and corrective actions to be taken after an event.
  • Food Traceability: Over the next few years, the U.S. Department of Health and Human Services is required to create a food tracing system to streamline the discovery of contamination sources and accelerate the response times during an outbreak of food poisoning.
In order to meet the document management and traceability requirements of the Food Safety Modernization Act (and other Food Safety regulations), food processors need to choose innovative Food ERP solutions that provide more than just lot traceability and corrective actions. Today’s leading Food ERP solutions go beyond finance, accounting, and supply chain management - they enable you to identify, document, monitor and follow up on critical control points, thereby supporting compliance with even the most stringent regulations and reporting requirements, including FSMA, GFSI, and SQF protocols.

Here are five Food Safety software features that every Food processor must have in their ERP system to ensure that the company maintains the highest levels of quality, safety, compliance and profitability.

  1. Traceability: The increasing demands for regulation and easy access to real-time data have made traceability programs and systems a necessity for any food manufacturing and distribution company. The capability to track (farm to fork) and trace (fork to farm) details per product or per lot is critical. Tracking and tracing is the core of most global regulations. The capability to track a product from farm to fork or using the one up and one down rule combines collecting appropriate information, organizing the information, and retrieving it as required. 
  2. Recall Management: At any given moment, Food companies must be able to quickly and effectively recall products that have been deemed unsafe for the market. Failure to handle a recall successfully (either voluntary or mandatory) can have serious economic and legal consequences. Choosing an industry-specific ERP solution with comprehensive, end-to-end food recall management functionality positions a company to plan their entire recall process in advance, to perform mock recalls proactively or at a customer / regulator’s demands, to constantly measure and improve the recall process and, most importantly, to respond rapidly, accurately, and thoroughly if an actual recall is required.
  3. Quality Management: Food and beverage companies are also required to detect and react to Food Safety incidents and non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA warning letters cite Corrective Action / Preventive Action deficiencies. Using a systematic approach to correcting and preventing issues, measuring the outcome and continuously monitoring the system can ensure that a company is compliant, effective and efficient. And, having a well-thought-out Food Safety Management system can result in successful audits, fewer investigations, less product loss, better customer satisfaction, and an increase in overall operational efficiencies.
  4. Electronic Document Management: Today’s successful food companies are increasingly global. These organizations must sustain global manufacturing and distribution processes while addressing the potential operational risks, as well as overcoming the quality, safety and pricing pressures inherent in an already complex industry. As a result, many food companies seek to implement enterprise-wide food safety and compliance document management solutions that can quickly address customer and regulatory issues consistent with worldwide requirements, while simultaneously being leveraged to automate and enhance business processes. These companies need to manage unstructured data in a controlled manner and according to their food safety compliance programs - and do so efficiently without paper-based and people-intensive processes.
  5. Inventory Control: Every manufacturer must plan production, purchase and manage materials, execute the manufacturing plan, and deliver products. Food process manufacturers however, require a unique set of capabilities, including management of co-products and by-products, multiple packaging configurations, lot traceability, item weight and specification variances, and product shelf life. Food inventory management must enable companies to track and manage raw materials while taking into account the complexities of multiple inventory characteristics such as weight, container type, and expiration date. In addition, companies must be able to define, manage, and cost multiple outputs, such as co-products and by-products, from a single production process.
MAXFood Safety ERP allows organizations to grow their business instead of spending time on manual tasks, redundant data re-entry, and people-intensive processes. It enables food processing companies to simplify compliance with stringent food safety standards - including FSMA, GFSI, and SQF. MAXFood streamlines and automates recalls, and helps companies identify, document, monitor and follow up on critical control points.

And with MAXFood Cloud ERP, employees can have real-time visibility and anytime, anywhere access to the critical business data they need to be successful - without compromising functionality or security.

Life Sciences Materials Control Management Software

As a Life Sciences Manufacturing or Distribution organization, it is your responsibility to track and trace all products from the time they are received or manufactured through delivery to your customer. At any given moment, you can experience a material or quality non-conformance incident that requires you to investigate further.

The bottom line: you don't want to be one of the companies caught without an adequate Materials Control software system! You need to have the prevenative tools and controls in place to quickly and effictively perform investigations and measure the potential impact of any quality incidents. Unfortunately, many companies today do not have adequate systems in place and are putting their company at risk.

Benefits of the MAXLife Materials Control Workbench:

  • Improve efficiency by removing manual or paper-based processes.
  • Adhere to regulatory compliance requirements.
  • Forward and backward traceability for all material lot / serial numbers.
  • Streamline and automate product traceability processes.
  • Improve quality control and customer satisfaction.
  • Quickly notify Customers, Vendors, or employees of potential quality incidents.
The MAXLife Materials Control Workbench enables Life Sciences companies to access and view any material lot and / or serial number, the status of that material, and all of the locations of that material - at the click of a button! And, if you need to notify vendors, customers or internal team members of a potentially adverse situation or investigation, you can quickly send out an email within the MAXLife Materials Control Workbench notification center.

With the MAXLife Materials Control Management Workbench, Life Sciences companies can minimize risk, maximize product safety, and deliver greater value to their customers.

Learn more about MAXLife Life Sciences software.

Food Safety: How Can ERP Make A Difference in a Recall?

Last month, I published a blog article entitled “The Food Safety Modernization Act: One Year Review”. In the article, I talked about the profound impact this historic legislature has had on food producers and processors in the past year.

This month, we want to discuss how a food industry-specific ERP system can help make a difference in a recall or alert situation.

Food safety recalls are not predictable - they can happen at the best of times, or the worst of times. At any given moment, food companies must be able to quickly and effectively recall products that have been deemed unsafe for the market. How a company responds to these situations is critical: failure to handle a recall successfully (either voluntary or mandatory) can have serious economic and legal consequences. With the ever increasing levels of press and public backlash associated with Food Safety and Food Recalls, it is becoming even more important for Food companies to have the proper Recall Management processes in place. Unfortunately, few Food companies today are ready to handle a recall, and are putting their company at risk.

This is not to say that all food companies must have end-to-end food safety ERP or recall management systems. In fact, there are more food companies running on spreadsheets and manual paper processes than on industry-specific ERP. However, as these companies grow, as their business processes become more complex, as top retailers become more demanding, and as food safety protocols like GFSI and SQF keep increasing process standards - it will become more difficult for these companies to manage the two key requirements for a good recall process:

  • Recall Accuracy - Companies need to be able to respond to recalls intelligently, pulling 100% of the tainted product and 0% of products that pose no danger to consumers.
  • Recall Response Times - Companies need to be able to perform recalls and notify clients, vendors, and government agencies in the least amount of time as possible.
So how can food processors solve some of these issues with an industry-specific ERP and recall management system, like MAXFood ERP?

A good recall response requires the right mix of business tools, processes, and employee training. The correct tools (like end-to-end ERP and recall management systems) will make it easier for employees to do their job quickly and accurately. They will enforce workflows and controls that ensure the proper business processes are being followed in accordance to FDA, GFSI, SQF, and other regulations and standards. A lot of legacy systems and paper based systems don’t enforce the correct business processes, and therefore make it extremely difficult for companies to perform accurate, timely recalls. Companies using these systems want to adapt best practices and run their business more efficiently - but they don’t have the systems to support those business process changes. And personnel responsible for identifying failures or food contamination need to have a background of education and experience, or a combination thereof, to provide a high level of expertise necessary for the production and distribution of clean and safe food.

MAXFood ERP and its Recall Workbench streamline and automate the recall process, enabling companies to not only perform effective product recalls, but to provide concrete documentation and proof that your company followed all FDA recall procedures. By using MAXFood ERP, companies are given full transparency into the recall process, allowing them to better track the status of a recall, confirm that all of the recalled product was pulled, and quickly notify the customers affected by the recall.

Choosing an industry-specific ERP solution with comprehensive, end-to-end recall management functionality positions a company to plan their entire recall process in advance, to perform mock recalls proactively or at a customer / regulator’s demands, to constantly measure and improve the recall process and, most importantly, to respond rapidly, accurately, and thoroughly if an actual recall is required.

Recalls are expensive - both in terms of product cost and brand / reputation damage. Having the right ERP and recall management system can enable food processors to minimize the costs of a recall, and prevent further damage.

Food Recall Management for Microsoft Dynamics AX

Customer demands and regulatory requirements relating to food safety are accelerating every day. The bar is going up and everyone in the industry will soon be scrambling to find and implement systems that satisfy these new demands... that is, if they’re not already panicking!

One new requirement is the Food Safety Modernization Act signed by President Obama in January of 2011, which mandates that all food companies must have Food Safety Management systems in place, including document control, HACCP and recall. This is the biggest change to Food Safety legislation in over 60 years.

Another is The Global Food Safety Initiative (GFSI), which is a collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, as well as service providers associated with the food supply chain. It is coordinated by The Consumer Goods Forum, the only independent global network for consumer goods retailers and manufacturers worldwide. It serves the CEOs and senior management teams of nearly 400 members, in over 150 countries. Most major retailers mandate suppliers follow one of the 8 protocols supported by GFSI, which includes SQF and variants of ISO22000. These standards are very similar to the FSMA recently set by the FDA.

The bottom line: you don’t want to be one of the food manufacturers caught without adequate Food Safety and Food Recall ERP systems!

That's why we're so excited about the MAXFood Recall Workbench.

The MAXFood Recall Workbench exists for one purpose – to go beyond lot track and trace to enable extremely fast recall functionality. A common challenge for organizations is the quick response to client requests for “test” recalls. Many companies are making the ability to perform a quick recall a key performance metric for their suppliers. You are probably subject to this testing from your customers. Non-performance during test recalls puts your customer relationship at risk. You could lose your customers if you are unable to perform.

We reduce risk to you if your firm is subject to recall testing from your customers. Imagine being able to answer a test recall within minutes – this should improve your vendor performance score and your customer relationship. The MAXFood Recall Workbench goes beyond the time consuming labor of either paper or system based lot track and trace functionality. It provides a Rapid Food Recall capability for:

  • Recalling product shipped to customers.
  • Stopping production for any affected in-process manufacturing orders.
  • Finding and quarantining any on-hand batches subject to a recall.
  • Quarantine and Vendor notification for problem raw material lots.

Normal lot track and trace works just fine, and is an improvement over paper-based lot tracking systems. But lot track and trace doesn’t save time when customers have to be notified or on hand inventory must be quarantined. It just gives you a list of orders or inventory – then someone has to print the list, and enter transactions.

The MAXFood Recall Workbench saves companies time and money by automating and streamling the entire Food Recall process!

Need Food Safety Cloud ERP?

The Centers for Disease Control reports that as many as 76 million illnesses are caused by food contamination every year in the United States. In addition to the public cost, the impact of food safety lapses can be devastating within the food industry. While many food industry executives think of regulatory penalties as a risk, the major risks are potential shutdowns or, even worse, damage to brands and companies.

MAXFood Cloud ERP enables food manufacturing and distribution companies to meet constantly changing stringent quality and safety compliance regulations while making products faster, safer, and at more competitive costs. MAXFood Cloud ERP provides a complete, enterprise wide business software solution designed to reduce an organization's total cost of ownership and improve profitability.

For companies that need Food Safety ERP, MAXFood Cloud combines built in quality processes and recall procedures with advanced lot tracking capabilities to efficiently manage raw materials and ensure food safety.

  • Forward and Backward Lot Traceability
  • Food Recall Workbench
  • Production Specifications Reporting
  • Support for compliance with HACCP, GFSI, and SQF protocols

Learn more about MAXFood Safety Cloud ERP.