So, they wonder where to start for their implementation of new process manufacturing software.  Two key elements to be considered to be able to answer these questions are what metrics the process manufacturer wants to be able to track and what they want to accomplish relative to system-enabled production scheduling.

Regarding the question about metrics, it is very common for companies to want to be able to measure and analyze a variety of things.  What is my throughput rate?  How much product is scrapped during production?  What is the yield of various ingredients going into each product?  Do we consistently have to add additional ingredients to the production of some products so they ultimately meet a customer’s specifications when completed?

The only way to be able to analyze and track these metrics is to measure and record data during the production process.  It is often comical to have discussions with potential new clients who want to be able to analyze and track key data – such as lot traceability – who in the same breath argue that they can’t possibly take the time in their operations to record such data.  It’s as if they believe a new process manufacturing system will somehow discern this information without anyone or anything recording the data.  Again, to be able to analyze and track data from a production process requires that data to be measured and recorded – either by human intervention via a keyboard, touch screen, or scanning process or directly from a production manufacturing machine via a data interface.

As for production scheduling, every process manufacturer’s business has certain idiosyncrasies or business rules by which it lives.  First, a given product must go through a series of steps or processes to be produced.  Similarly, each work center in a given production facility has a maximum production capacity or throughput rate.  Next, the amount of time to setup (the preparation time required for a given process step), run time (the actual time to perform the production of a given quantity of a product), and queue time (the amount of time a product must be delayed for cooling or other purposes before it is permitted to move to the next step in the process) needs to be known and documented for each product at each step in the process.

At a deeper level, one must know what products can be run together in a sequence (called scheduling groups) in a given work center so adverse results aren’t produced by running two products through the same work center in succession, and what scheduling groups should be run in what sequences through various work centers to minimize setup time, thus yielding a higher total throughput.  And finally, what classes of products cannot be run simultaneously on two adjacent production work centers as there will be a reaction between the two products causing resulting quality issues.

While there are a number of other details beyond the ones documented above, these items are intended to help depict the process necessary to create a series of business rules required to enable the creation of a system-generated production schedule that can be used by a process manufacturer for the scheduling of their production facilities.

By asking themselves what metrics do I want to be able to track and analyze, and to what extent do I want to be able to perform system-enabled production scheduling, process manufacturers will help define the scope and ultimate success of their implementations of strong process manufacturing systems like Enterprise 21.

First, there needs to be control in the ingredients being acquired for use in the manufacturing processes.  Suppliers need to be qualified and held to high standards.  Good ERP systems like Enterprise 21 enable companies’ purchasing organizations to establish criteria for the qualification of vendors and suppliers.  Once given vendors become approved, they can be enabled in Enterprise 21 as valid suppliers for the manufacturer to do business with while monitoring supplier performance over time.

As ingredients go through various processes, Enterprise 21 documents and time stamps each of these transactions and their associated operators for complete traceability of those parties involved at every step in the chain.  These processes include:

• Receiving,

• Movement to a quality control holding area,

• Quality control evaluation, approval, and release for use,

• Product putaway,

• Manufacturing picking and staging,

• Consumption in manufacturing, and

• Putaway of any excess inventory not consumed in manufacturing.

Before manufacturing occurs, authorized personnel can establish one or more manufacturing processes by which to produce a given product and the product’s associated formulation and recipe.  The identities of the personnel who establish the production routings and associated formulations are documented in the system, as are the identities of all personnel involved in the workflow process to review and approve these items prior to their release for production.

When a product is being produced, the manufacturing personnel involved in the processes associated with that production are recorded in Enterprise 21.  Also, electronic signatures can be used for supervisory personnel and management to sign off at key points during the manufacturing processes acknowledging the product has been made in accordance with documented procedures and associated safety standards.

As the product is produced, it too will undergo a series of quality assurance tests in order to gain approval for shipment to customers.  The individuals who perform the QA tests are documented in the system, as are the warehouse personnel who move and put away the finished goods inventory.  Finally, as sales orders are entered for given items, the personnel who pick, pack, and ship the finished goods to fulfill those customer orders are also documented in the system.

In addition to the documented controls of all individuals involved in the complete process from ingredients to customer shipments, all associated lots are recorded in Enterprise 21 to enable complete womb-to-tomb lot traceability.  Ingredient lots from suppliers flow into manufactured lots of produced products, which are ultimately shipped to customers.

Strong ERP systems like Enterprise 21 enable process manufacturers to meet cGMP guidelines through the complete product and process flow throughout the manufacturing enterprise.

After the batch is produced, the product can either be moved immediately to filling operations or placed in drums and stored in the warehouse for some period of time.  Once the formula is in the filling operation, finished goods are produced in various sized containers with associated product labeling to meet customer demands.

So, how does Enterprise 21’s process manufacturing software functionality enable these batch process manufacturers to perform their jobs efficiently?  First, one can establish a scalable batch formula that consists of the various ingredients needed to produce the intermediate formulation.  The formulation can be setup as a recipe, where the ingredients and associated process instructions are combined in an order of operations to produce the desired output.  Where necessary, the recipe can also have electronic signatures required for individuals to sign off at various checkpoints during the process for compliance and quality assurance purposes.

The formulation may have certain ingredients that are generally over consumed as part of the production process.  Let’s say that a given production process may require a standard of 100 pounds of a given ingredient to produce a given batch size; however, if that process is not 100% efficient, the system can enable the planning of consumption of more than 100 pounds of that ingredient – say 102%, or 102 pounds of that ingredient for the given batch size in consideration.  In this situation, Enterprise 21’s yielding functionality within the formulation is used in the procurement and production staging processes to account for the fact that 102 pounds of the given ingredient are needed to perform the given operation.

Once the intermediate formulation is produced, there may be a period of time necessary for cooling required before the output can be packaged into a drum or moved to the filling operations.  In this case, one can build queue time into the end of the given production routing step so the associated cooling time is accounted for prior to scheduling and ultimate performance of that next operation.  This is done within Enterprise 21’s manufacturing routing functionality.

Finally, the filling operations can be scheduled as a series of work orders to produce the ultimate finished goods.  The bills of material for the various finished goods would, at a minimum, be comprised of the intermediate formulation produced as described above, the appropriate container for the given product, and its associated label.

In addition to the functionality described above, Enterprise 21 also manages product costing – average, standard, LIFO, or FIFO – on a product-by-product basis, all of the associated inventory and warehouse transactions including complete womb-to-tomb lot traceability to support recall management, and all associated financial accounting transactions in a real-time, fully-integrated system.

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.

Almost all manufacturing companies with whom we talk share the following characteristics:
•    They are capacity constrained in at least some portion of their production environment.
•    They run a mix of make-to-stock and make-to-order production.
•    There are certain products that may be produced on a very short lead time (as hot orders) that could be thrown into the production schedule the same day they’re ordered by customers.
•    There are complexities to process changeover in such a manner that producing all products of a given family or with certain shared characteristics (i.e., all products of the same color in a painting operation) is imperative to maximize production throughput and minimize off-spec production and process changeovers.

One of the first questions that a manufacturer should ask potential software vendors is whether their system performs finite capacity scheduling or infinite capacity scheduling.  With finite capacity scheduling, one can establish process and machine capacities which can be taken into account.  By doing so, the manufacturer who is capacity constrained can establish a realistic tentative production schedule by not allowing the system to produce a scenario that couldn’t possibly be performed.  If, for example, you only have production capacity within a given work center or have associated labor availability to produce 300 units of a given item per hour, it makes absolutely no sense to have your ERP system generate an unconstrained production schedule with 3-4 fold that amount of production per hour being assumed to run through that work center or with the given number of laborers.

Next, what capabilities does the given ERP system have to manage both make-to-stock and make-to-order production?  Make-to-stock production would generally be scheduled based on a signal – either traditional time-phased inventory management processes like MRP or via an electronic signal of similar nature.  Make-to-order production would be done by enabling business rules within the system to evaluate the given finished good’s bill of materials or formula, determine whether or not all required raw materials and ingredients were available, and if not, when they could be available via supply chain management, what available production capacity exists to produce the given item, and having the system schedule the production while concurrently generating any required purchase requisitions.  Within Enterprise 21, this description of capabilities embodies the collective functionality of Available and Capable to Promise plus Make-to-Order and Automated Supply Chain processing.

Assuming your organization runs with make-to-order processing and allows customers to place such orders on short cycle times (i.e., produced the same day they’re ordered), then it is imperative to leave production capacity available for the placement of these make-to-order items on the same day’s production schedule.  For example, if your organization runs two, eight-hour production shifts, and typically has four hours of short-cycle make-to-order production to perform each day, then it makes sense to set up your finite capacity scheduling processes to assume a maximum of twelve hours for make-to-stock production for the given day.

Finally, ERP systems like Enterprise 21 enable scheduling using schedule groups.  In this case, products with like scheduling characteristics can be placed in the same scheduling group and these items would be placed in the production schedule consecutively.  As well, one can establish scheduling group rules such that certain scheduling groups would follow the completion of other scheduling groups. As an example, in a painting operation where products being produced were white, red, and blue respectively, this would be a likely ordering of production to try to minimize the production of pinks and purples as color changeover occurred.

Similarly, where applicable, manufacturers should be able to build machine “clean out” or “wash down” time into the production schedule between the production of two different schedule groups. For example, a food manufacturer who produces certain items that contain peanuts or other food allergens followed by other items that cannot contain peanuts on the same production machine will need to have machine clean out time built into the production schedule between those two respective schedule groups.

So, if you’re a manufacturer with any reasonable level of complexity in your manufacturing processes, don’t be drawn like a moth to the flame during software demonstrations.  Dig deeper into ERP systems’ manufacturing scheduling functionality so you have a broader set of requirements beyond, “Does your production scheduling system support drag and drop functionality?”

One of the ways in which businesses work to protect themselves and those with whom they do business is by receiving and making readily available certificates of analysis (commonly referred to as COA’s) from suppliers along with the ingredients they buy for use in manufacturing operations. COA’s are documents which provide a quantitative analysis across a series of properties for the associated item. For example, a COA for soya lecithin powder or ginger extract would generally include microbiology results for properties such as total plate count, E.coli, and salmonella levels, as well as a variety of other properties.

Life sciences and food and beverage companies will typically receive ingredients and automatically place them on quality hold upon receipt. Then, these businesses will alert quality control (QC) specialists that there are items that need to be inspected prior to their release for use.

The QC department will run a series of tests on samples of the given product received and verify that the properties on the COA match up with the properties of the product being tested. Assuming these tests pass muster, the product is then released for further consumption in a manufacturing process. Should the product not pass the QC tests, laboratory personnel will then run further tests while involving the supplier’s QC personnel to help evaluate potential issues with the ingredients before determining what to do next.

These same types of QC tests are performed on finished goods which are manufactured by life sciences and food and beverage companies prior to their release for shipment to their customer base. Again, a COA is created to accompany the specific lot of produced product to the manufacturing company’s customers.

Another document which is becoming more prevalent in the life sciences industry is a pedigree document. A pedigree document traces the complete chain of custody of the given end item from original manufacturer through various distributors until it finally reaches a retailer for sale. State governments such as Florida have a predefined prescription drug pedigree document which must be passed along the supply chain with each associated company adding its information and signing off on the document throughout the channel.

Strong business management systems like TGI’s Enterprise 21 ERP system can be used by life sciences and food and beverage companies to automate and maintain strong product safety and control procedures including the creation of certificates of analysis and drug pedigree documents.

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.

Given the current state of the economy, it is certainly common for companies to scale down their normal trade show calendar. It is also highly likely that in addition to fewer exhibitors, overall attendance at trade shows across the country will be lower in 2009 compared to prior years. Trade shows require a significant investment in employees’ time and company money for both exhibitors and attendees; however, unlike many industries, the food and beverage industry has been largely unaffected by the downturn in the economy in 2008 and 2009. If you think about it, food is one of life’s absolute necessities – people are always gonna have to eat! Unlike new cars, flat screen TV’s, and other “luxury” items (like my girlfriend’s weekly, and unnecessary, manicure and pedicure), food is a must no matter what the state of the economy may be. In fact, numerous studies have shown that in times of economic downturn, people actually eat more! I recently read an article in the May 2009 issue of Food Processing magazine that stated that despite the economy, food processors are increasing their overall dedication to new product development compared to prior years, a clear sign that food companies are making strategic moves to differentiate themselves from the competition.

As I result, I anticipate attendance at this year’s IDDBA show to be relatively strong despite the existing economic climate. The IDDBA show provides an ideal avenue for cheese, dairy, deli, and bakery companies to showcase their new products to thousands of attendees at a time when food consumption and new product development is on the rise.

For more information on the 2009 IDDBA show, please visit www.iddba.org. If you are attending the IDDBA show, please feel free to stop by and visit us at booth 4070.

For process manufacturers, two of the most common challenges are formula and recipe management and scalable batches. Experienced processors recognize that regardless of the product produced, one size does not fit all. A can of soup, a box of detergent, and a bottle of cough syrup are all packaged and sold in multiple types of shapes and sizes. The need for flexible units of measure, formulas, and batch sizes have united food, chemical, and pharmaceutical companies into a process community focused on improving the capabilities and processing options at all steps of the production process. This unification has taken the historically discrete-focused ERP software industry and brought about a number of strong process-based ERP software packages.

A key differentiator for process manufacturing software is the ability to take a standard bill of materials and craft it into a sophisticated and scalable formula that is comprised of a variety of ingredients, units of measure, yields, and by-products or co-products. This formula or recipe can be dynamically scaled to match the ideal batch size, thus meeting current demand levels, optimizing vat and ingredient usage, tracking all ingredient costs, and blending in the appropriate manner to facilitate a finished good that is within specification and acceptable for final sale.

While the idea of a scalable batch may appear rudimentary for ERP software packages, it is not functionally feasible in the original, discrete manufacturing ERP software solutions. In fact, it is not even feasible in all of the ERP software solutions that are marketed to process manufacturers. A recipe with ingredients, yields, and instructions is not the same as a discrete bill of materials. The recipe needs to accommodate ingredient-based instructions and be able to scale up or down based on a given demand level. The recipe or formula needs to be able to manage intermediates, ingredient level yields, and support private label requirements if necessary. The software needs to provide operational control while allowing for a high level of flexibility and scalability.

How does a process manufacturer select the right process manufacturing software solution? The most reliable means of doing so would be a thorough evaluation of potential software packages demonstrated with real data via an onsite scripted demonstration. Even with the advancements in process manufacturing ERP software, not all software packages can perform at the same level. The best technique for separating and comparing one package from another is through reviewing the definition and processing of a sample formula that is scaled for a specific batch or production run. If the ERP vendor cannot demonstrate the software’s ability to manage this process, the software will struggle in a real production environment.

TGI offers free software selection tools and resources for both process and discrete manufacturers. Please visit TGI’s available online resources or TGI’s online request form to order the free Software Selection Tool Kit.

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 processing 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.