Tracing a Path to Manufacturing Success
SAP Business One + Customized Softengine WMS Deliver Complete Traceability to Ensure FDA Compliance
SAP Business One and Softengine team up to deliver winning formula for nationally acclaimed manufacturer of liquid-filled swab applicators.
Established in 1998, Swabplus, Inc. (located in Rancho Cucamonga, California), is a Current Good Manufacturing Practice (cGMP)-compliant, FDA-registered, ISO 9001-certified manufacturer of liquid-filled swab applicators that contain formulas designed for medical, personal care, OTC, health care, fragrance and beauty aid uses. The company serves as a contracted OEM manufacturer for several world-class cosmetic companies and Fortune 500 medical companies. Swabplus is registered as a drug establishment with the FDA, operating under a drug manufacturing license from the State of California Food and Drug Branch of the Department of Health Services.
Swabplus operates out of its state-of-the-art 60,000 sq. ft. facility, which includes a laboratory where comprehensive testing is conducted in support of its rigorous Quality Assurance Program (QAP). Currently, Swabplus is nearing release of the third generation of its delivery system, pending patent approval. In addition, the company is evaluating potential expansion into other product lines, including sprays and wipes. In order to accommodate this proposed expansion, a state-of-the-art clean-room facility would be added to their existing plant.
“FDA regulatory standards require traceability, which includes not only the components and finished goods, but the ability to audit the entire process from cradle to grave.”
– Justin Ku, Administration & Operations Coordinator
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Uncompromising Commitment to Lofty QA Goals Challenged by Inefficient, Manual Processes
Swabplus is a manufacturer that leaves “no stone unturned” in its quest to deliver products that are unparalleled in quality and safety. Every raw material and component integrated into its liquid-filled swab applicators is monitored and tested to the most stringent standards, ensuring that its finished products meet or exceed all applicable FDA requirements. According to Justin Ku, Administration & Operations Coordinator for Swabplus, “80% of our focus is on QA. We check our production processes every hour to ensure the highest quality and to uncover any issues that may arise. Manufacturers who perform inspections just once each day risk seeing their entire production wiped out because of an issue that wasn’t caught sooner. With hourly inspections, we can diagnose and resolve an issue immediately and minimize the risks of long delays and wasted production.”
Now, one would think that this level of performance could only be achieved with the support of fully automated and integrated business systems, but that was not always the case at Swabplus. For a few years, the company relied upon manual data entry and spreadsheets to manage all of its business processes, most notably, production and inventory control. This, in turn, created significant challenges for management and staff.
For example, tracing the movement of lots and batches through inventory and production was accomplished through multiple versions of spreadsheets across numerous departments. Due to these time- and labor-intensive manual processes, it often took weeks to assemble data required to produce a report and there was always that lingering concern of human error due to manual input and the lack of proper spreadsheet version control. A better way forward was needed.
Third Time’s the Charm … Softengine Intervenes to Deliver Successful Implementation of SAP Business One. A New Partnership Is Born
Andy Ku, COO for Swabplus, was determined to find an automated system that would eliminate the existing issues, while offering the power, flexibility and cloud-based platform upon which to take the company into the next phase of growth. Ku’s research led him to SAP Business One.
“From the outset, the most compelling attraction to SAP Business One was its utilization of cloud-based technology, “said Justin Ku. “This demonstrated to us how ambitious and innovative SAP was and it piqued our interest in the program. Another virtue was the program’s flexibility and modularity. The SAP Business One core system can expand and grow with us for the long term — we can add modules and third-party extensions that are a good fit for a manufacturing business like ours.”
Swabplus decided to invest in SAP Business One, but they encountered an unexpected setback as the SAP Business One reseller tasked with the implementation failed twice to complete the job. It would have been easy for Andy Ku and his team to cut their losses and switch to a competitive product, but their belief in the system led them to try again. To help achieve success the next time, Ku sought SAP’s assistance in locating a top-notch SAP Business One partner.
SAP recommended Softengine (www.softengine.com), an SAP Gold Partner that had established a longstanding track record of excellence in helping businesses get the most out of SAP Business One. It also helped that Softengine had developed its own line of SAP Business One “extensions” that were specially designed to augment the core system and adapt to the needs of businesses in a wide array of industries, including manufacturing. The Softengine team, upon learning of the two previous failed attempts at implementation, was determined to make sure the “third time was the charm.”
Softengine’s project manager set the tone from the initial meeting, taking the time to fully understand the company’s business processes and achieve rapport with Andy Ku and his team. It immediately became clear that Softengine meant business and there would be no “hiccups” this time around. Softengine’s credibility was bolstered by its long and respected track record in the food industry, along with a comprehensive knowledge of traceability and how the SAP Business One system and extensions can facilitate adherence to strict FDA guidelines.
SAP Business One + Customized Softengine WMS Deliver Complete Traceability to Ensure FDA Compliance
“FDA regulatory standards require traceability, which includes not only the components and finished goods, but the ability to audit the entire process from cradle to grave,” said Justin Ku. “We needed the new system to be able to batch-trace everything in our warehouse so that we can run reports on what gets received and what gets issued. This includes tracing every movement of an item through all our physical/virtual warehouses on its journey from raw material to subassembly in a finished product. SAP Business One facilitates all of this, giving us the visibility we need to achieve our rigorous QA standards and meet all FDA guidelines. Plus, the system provides verifiable documentation in the unlikely event of a product recall.
The Softengine team was able to tailor SAP Business One to deliver all the traceability Swabplus needed, including all the applicable reports. Softengine enhanced the core system to enable creation of new batch numbers if components don’t already have them and the option of batch-costing. They also added fields for escalation dates, expiration dates and additional inspection data (e.g., who inspected and when), which could be incorporated into each Certificate of Analysis (detailed below).
Softengine’s Warehouse Management System (WMS) extension works in concert with SAP Business One to deliver mobile scanning capabilities that streamline the receipt of goods and the movement of items between warehouses. Any time material arrives in the warehouse, Swabplus QA staff utilizes the WMS scan gun to receive the material and automatically generate a goods receipt. As Justin Ku notes, “With the WMS mobile device, we can walk around the warehouse and scan every ingredient into SAP Business One as it moves through the process. This enables us to transfer inventory on the go between all of our warehouses rather than having to do it from a workstation. You can imagine how much time this saves vs. having to go back to the office every time we want to initiate a transfer.”
The Batch Number Transaction Report Improves Visibility
“This report is the bread and butter for our batch-tracing efforts as it enables us to trace all inventory transfers between warehouses,” said Justin Ku. “It’s very important that every item is assigned a batch number. With SAP Business One, checking previous batches and how they moved between warehouses is a breeze and our QA staff is able to view this movement in a single report. The fact that everything in our warehouse is now batch-traced means that we can run reports on what gets issued and received and that gives us the visibility we need.”
SAP Business One Helps Swabplus Achieve Ambitious QA Goals
Swabplus goes the extra mile to reach its lofty QA goals. “All ingredients and processes have to be ‘QA’d’ and tested prior to approval and release,” said Justin Ku. “Our QA team pulls a sample of the product and sends it to our lab for testing. A Certificate of Analysis (COA) is produced if the sample passes inspection and the COA is attached to that sample as it moves to the next stage of production. In addition, every product includes a COA when completed and ready for shipment.”
Because they are using SAP BO to track production, Swabplus personnel can print out hard copies of the COA’s to attach to each item. In addition, they can electronically attach a .pdf or Word document to a sales order, purchase order or work order, which can then be added to the library for future reference. Having access to the library of documents and images is especially handy in the event of a recall. The idea of having to physically search for all these documents would be a rather daunting task.
Multi-layered BOMs Provide Real-time Updates
Bills of materials (BOMs) are a critical part of the production process at Swabplus and prior to the implementation of SAP Business One, they had relied on a single-level BOM, which compromised their ability to trace all their materials. While a single-level BOM lists all the components that go into the “parent” item, this approach is limited in that it makes no distinction for subassemblies, thus making it challenging to find components that may be floating around different locations during production. As Justin Ku noted, “We used to create single-layer BOMs on a sheet of paper. Unfortunately, with this approach, we had no visibility into production until the whole process was complete.”
Once SAP Business One was on-board, Swabplus was ready to leverage the multi-level BOM capabilities of the system. According to Justin Ku, “Utilizing a multi-layered BOM, we can bring together all the different layers into one production order, which, in effect, delivers a real-time progress report on all the work produced for that day.”
QA, Inventory Control and Overall Efficiency Receive Big Boost from SAP Business One. Swabplus and Softengine Revel in the Success.
For Swabplus, the third attempt at implementing SAP Business One has paid multiple dividends — all of its business processes are more efficient and accurate and they have found a true long-term partner in Softengine.
SAP Business One has transformed the way Swabplus conducts its business — from production to inventory management to inter-departmental communications and more. “Previously, not only did we enter all of our data manually, we also generated all of our analysis reports by hand,” commented Justin Ku. “Although there are still a few forms that we have to complete manually to comply with existing regulations, at least now we can leave the calculations and analysis reports to SAP Business One, which provides real-time data with just a single mouse-click. Company-wide, communications have greatly improved as a result of our enhanced visibility into critical data and our staff is now much more efficient and self-sufficient.”
“Perhaps the biggest contribution of the new system is its powerful inventory control capabilities,” added Justin Ku. “Now, everything has the correct item/serial number and the fact that meaningful batch numbers are assigned to every receipt in our system is priceless. The availability of the Batch Number Transaction Report, the Summary section on the Production Order and multi-layered BOMs/PDOs has already made a huge improvement in our ability to reassess our workflow and overall production procedures. We can now access valuable, real-time information such as how many components were issued and how many goods were produced.”
Swabplus management and staff are also bullish about the value Softengine has brought to the partnership from day one. “Softengine employed a decidedly different approach than the previous SAP reseller,” claimed Justin Ku. “Softengine’s mission is clear through their actions — customer success and satisfaction at all costs. From our first interaction, we knew they were committed to making this SAP Business One implementation a success. To that end, the entire Softengine team worked closely with Andy Ku, our COO, to make sure that both parties were on the same page in terms of designing a system to fulfill our objectives and supporting us in every way possible to achieve that outcome. From that foundation, they have earned our trust and confidence, which has grown and blossomed along the way.”
“The Softengine team possessed all the qualities we were seeking in a partner,” added Justin Ku. “They took the time to fully comprehend our unique business processes and then offered suggestions as to how we could customize the system to maximize its ROI. They were open to our input and even though we had a few debates during the process, there was a mutual understanding and respect that resulted in progress and productivity. Their project manager made the effort to understand both the regulatory requirements and workflow procedures that define our business and the results of the new system speak volumes about the value of his efforts.”
“As we speak, Softengine is continually seeking ways to improve our system and, to be honest, that is hard to come by nowadays,” continued Justin Ku. “On a personal note, I came into this project after it was already underway and, from the beginning, Softengine’s project manager took me under his wing and taught me not only how SAP works, but also how I could tweak the system to make it work the way we do business and not vice versa. We view our relationship with Softengine as a long-term partnership, and we believe that it will continue to be mutually beneficial.”