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Posts Tagged ‘Recall Management’

Pet Food Distributors Require Wholesale Distribution Software with Strong Product Recall Management and Lot Traceability Functionality

Saturday, September 18th, 2010 by admin

In recent months and years, we’ve seen substantial issues with product recalls for peanuts, pistachios, and a variety of other food products consumed by humans.  Lately, there has been a lot of activity focused on the recall of pet food due to salmonella. Read More…

For those pet food distributors with strong wholesale distribution software like Enterprise 21, they are well positioned to manage this difficult situation as efficiently as possible.  When pet food is received by the distributor, the associated vendor lot numbers are recorded in the system as part of the inventory transactions.  At each step in the process, when the product is moved, picked, packed, and shipped, the given products and associated lot numbers are recorded.  Should the need arise, the complete scope of affected product can be identified through lot traceability – either forward traceability (when a vendor provides data about specific products and lots) or backward traceability (when a customer provides data about specific products and lots).

Likewise, having a comprehensive, well-defined, system-enabled recall management plan enables pet food distributors to manage the process efficiently with customers, vendors, and governmental agencies.  This includes having documented and repeatable processes and procedures and associated data available to define the scope of and execute the product recall.

Beyond strong lot traceability and recall management capabilities, pet food distributors will also appreciate Enterprise 21’s functional strengths in managing:
•    Multiple facilities for territory assignments and intra-company transfers,
•    Customer segmentation for sales analysis and customer pricing methodologies,
•    Pricing and promotions management by various units of measure, including rotation allowances and promotions with complex rule sets,
•    Order management with manual, EDI, and Web-based entry methods, and efficient customer returns processing,
•    Purchasing by managing vendors with multiple ship-from locations, vendor promotions and rebates, and vendor returns processing,
•    Inventory management and warehouse management with shelf life management, stock rotation, and multiple picking methods to support pallets, layers, and eaches,
•    Transportation management supporting route delivery plus common carrier shipping, and
•    Accounts receivable and receipt of payment including processing checks from parent organizations to pay off multiple child invoices concurrently and integrated credit card processing.

Pet food distributors will derive tremendous benefits from strong distribution management systems like Enterprise 21, including efficient management of lot traceability and recall management, while simultaneously improving operational efficiency and customer service.


Reportable Food Registry – Food and Beverage Processors Must Now Report Issues within 24 Hours via the FDA’s RFR Electronic Portal

Monday, September 21st, 2009 by admin

As of September 9, 2009, food and beverage processors are mandated to report all reportable food incidents to the FDA’s Reportable Food Registry when, “there is reasonable probability that an article of food will cause serious adverse health consequences.”  This mandate applies to all food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.  Details of this program are available via the FDA’s Reportable Food Registry resource Web page. Read More…

The program includes reporting key data during an initial disclosure and via follow-up reports including items such as the date the article of food was determined to be reportable, a description of the food including quantity and amount, the extent or nature of the adulteration, the result of investigation to determine the cause of the adulteration, disposition of the article of food, and product information typically found on packaging sufficient to identify the article of food.

Once the submission is completed, a confirmation page identified via an Individual Case Survey Report ID (ICSR), including all submitted information, is produced.  This report can be saved as a PDF file and associated with key data elements in the food and beverage processor’s Enterprise 21 ERP system, including customer incident reporting, lot traceability data, and associated customer shipments.

Food and beverage processors are strongly encouraged to review their Comprehensive Recall Management plans and make appropriate adjustments based on the FDA’s Reportable Food Registry mandate.  For an overview of the Reportable Food Registry, please review the FDA’s “Reportable Food Registry (RFR): At a Glance” document.


Establishing and Maintaining a Comprehensive Recall Management System

Friday, June 5th, 2009 by admin

What do pistachios, cough and cold medicine, cheese, dietary supplements, cookies, fruit and nut blend, and alfalfa sprouts all have in common?  They all appeared on the US FDA’s recalls, market withdrawals, and safety alerts list during April 2009. Read More…

Many companies that believed they were immune to this process have recently had to initiate recalls.  Some of these companies were so ill-prepared they had to close their doors due to poor preparation for such a possibility.

So, what do companies in life sciences and food and beverage industries need to do to make certain they are well prepared for a potential recall initiation?  Companies need to have automated lot tracking software functionality and a comprehensive recall management system in place.  At the core of a comprehensive recall management system are well-defined policies and procedures to be followed in the event of a recall.

The Ohio State University Extension published an excellent article on this subject titled, “What Can You Do to Be Ready for a Recall?” which overviews what companies can do to avoid the potential need for a recall and a high-level summary of the procedures that should be followed in the event that it becomes necessary to initiate a recall respectively.

Key points made about how to avoid a recall include having a Hazard Analysis and Critical Control Point (HACCP) plan in place, complying with the FDA’s current Good Manufacturing Practices (cGMP) regulations, developing and maintaining quality management systems, developing a food security and tampering prevention program consistent with the FDA’s Bioterrorism/Food Safety Security Act of 2003, and ensuring quality of raw materials by working with credible suppliers.  When defining a recall plan, one must pay special attention to the key element of such a plan which is fact gathering about the defective product.  This includes both internal and external discovery.

In TGI’s Enterprise 21 ERP system, service and support functionality can be used as a coordination point for external discovery.  This includes logging of all support calls, routing to appropriate resources for investigation, and documenting and tracking the associated resolution.  A recall coordinator would be alerted should the problem be determined to be of sufficient nature and require immediate action.

Enterprise 21 manages internal discovery by supporting complete chain of custody tracking through lot traceability of inbound ingredients, their consumption in manufacturing processes which can yield intermediates, and ultimately to finished goods which are shipped to customers.  In addition, quality data is recorded for each lot during this process.  Enterprise 21 supports both forward and backward lot traceability.

Through a combination of policies and procedures, along with strong system functionality for quality management and lot traceability, TGI customers leverage the Enterprise 21 ERP system as a key element of their comprehensive recall management systems.


Integrated Lot Traceability: A Critical Ingredient for Today’s Small Business Food Processor

Thursday, May 7th, 2009 by Alex Smith

I received a call recently from a small business owner who made a statement that I found to be quite profound, alarming, and unfortunately, characteristic of far too many small business food manufacturing and distribution companies. He said, “This whole situation with the peanut epidemic has really woken everybody up around here and made us realize it’s time to get a lot tracking software solution that will protect us in case of a recall. Is that something you guys might be able to help us with?” Read More…

This small business owner, despite being in the business of processing various nuts and fruits, was fortunate enough to have avoided the existing peanut crisis and was not forced to recall any of the company’s products. Nonetheless, he did say that the current peanut situation had made many of his existing customers call and inquire as to the company’s ability to manage any unforeseen recall. These customer inquiries, then, led the small business owner to call TGI.

My conversation with this particular small business owner only made me more aware of what many of us who develop and sell food manufacturing software have been aware of for some time now – there are a lot (no pun intended) of small food processing companies who do not have an adequate lot tracking software solution to protect themselves in the unlikely possibility of a recall. Smaller food processors frequently resort to entering raw ingredient and finished good lot numbers manually in Excel spreadsheets. Aside from the obvious problem of an employee entering a lot number incorrectly, the task of tracking the specific raw ingredient lot numbers used in specific manufacturing runs to produce multiple products that were eventually shipped to multiple customers is a near impossible feat to accomplish without data entry errors using Excel. Consequently, organizations of all sizes turn to food ERP software solutions with complete forward and backward lot traceability, such as Enterprise 21, to arm the company with the management and tracking tools necessary in the event of a food epidemic and subsequent product recall. While this type of software functionality is a must for any sizeable food processor, more and more food processing companies of all sizes are recognizing the need to migrate to a software solution that can account for the company’s lot tracking needs. As the small business owner I spoke with told me, “If we had been hit by the peanut recall, we would have gone from a small business to out of business.”

In Enterprise 21, lot traceability occurs for both raw ingredients and finished goods. Enterprise 21 tracks the receipt of raw ingredients and their associated lot numbers from suppliers, the use of these raw ingredient lots in manufacturing runs, and the lot numbers of finished goods (and the lot numbers of the raw ingredients used to produce those finished goods) that were shipped to end customers. This software functionality provides food processors complete lot traceability that begins with the supplier and ends with the customer. Enterprise 21 goes one step further to provide complete recall management, tracks the receipt of recalled goods back into inventory, and allows for any necessary accounting entries to be made for expenses incurred to the business as a result of the recall.

With rising levels of competition in the food processing industry and continuously changing compliance regulations in a global economy, complete lot traceability software functionality is becoming increasingly critical to smaller food processors’ sustained business growth and longevity. For the small business owner, lot traceability is worth more than just peanuts.


Establishing the Complete Chain of Custody of Your Products through Lot Tracking

Thursday, March 19th, 2009 by admin

One of the hottest topics in process manufacturing is lot traceability. The definition of lot traceability is the process of tracking given material lots throughout the enterprise and beyond. Lot traceability includes tracking lots forward from ingredients through manufacturing processes into finished goods, which are ultimately shipped to end customers. This also includes tracking lots backwards from finished goods back into the manufacturing processes and then back to the ingredients consumed in the production processes. Read More…

In ERP systems with strong process manufacturing support like Enterprise 21, companies who have a need to track lots should be able to do so easily and in an automated manner. This is a key element for establishing good system and procedural controls within one’s business, and should the need arise for a product recall, make the isolation process easy and straightforward while minimizing the amount of product necessary for inclusion in the recall.

Most companies without a modern ERP system that includes sophisticated lot tracking software functionality are managing their lot data in a suboptimal manner. Many of these companies may simply be recording lots on hard copy logs, using a series of spreadsheets to key in this data, or a combination of these methods. Not only does this process create a large amount of manual efforts, it leaves operations vulnerable to a significant amount of data entry errors and potential compliance issues.

What a good ERP software package like Enterprise 21 offers is two-fold. First, one can establish and record lot properties, which is a series of corresponding values for a given product’s physical characteristics. This practice is a key element in the quality control (QC) process. Second, one can record the complete chain of custody or pedigree of lots through the enterprise and beyond. Both of these steps are critical requirements for strong lot traceability and compliance.

Relative to system-enabled lot analysis for ingredients, when ingredients are received, the associated lots are recorded. Those received lots would typically be placed on QC hold and the inspectors alerted as to the need to inspect and analyze these lots. The inspectors would perform their analysis and record the values for the associated ingredient lot properties. Assuming the values observed and recorded were within the acceptable range for the various lot property characteristics, then the given lot of ingredients would be released to available inventory for consumption in manufacturing processes.

A similar process can be performed for system-enabled lot analysis for manufactured goods. When manufacturing occurs, the associated lots are recorded. The produced lots can likewise be placed on QC hold and the inspectors alerted to take action. Once the inspectors perform their analysis, the values of the produced goods’ lot properties would be recorded. Assuming all of the lot properties were within spec, the produced goods would be released to available inventory.

While there can be other complexities to one’s operations with packing and repacking of product into various containers with associated lots recorded, the lots shipped to a given customer would be recorded, thus providing complete visibility as to which finished goods lots were shipped to customers associated with given sales orders. This process establishes a complete chain of custody from ingredient lots received, which are consumed in manufacturing yielding manufactured lots, which are then shipped out to customers.

Once this data is recorded in the system, both forward and backward lot traceability can be performed. Forward lot traceability is the tracing of ingredients from suppliers through production processes out to customers in finished goods lots. Backward lot traceability is tracing finished goods lots back from customers into production to determine which other customers received product from those specific produced lots and back to ingredients received from suppliers, if necessary.