APICS Newsletter Addresses BioTerrorism Preparedness and Response Act
BatchMaster Software, Inc. has provided advanced ERP solutions for over two decades with more than one thousand five hundred installations worldwide. BatchMaster’s customers can be found in every formula or recipe-based business, including food, beverage, cosmetic, personal care, paint, coating, nutraceutical, pharmaceutical, and specialty chemical industries. Flexible, easy to learn and use, and scalable to grow with a process manufacturing business, BatchMaster is the definitive solution for the challenges facing small to midsize process manufacturers. BatchMaster has more than a hundred technical staff numbers of highly-qualified software professionals.
Preston Blevins, vice-president with BatchMaster (www.batchmaster.com) received the APICS (Association for Operations Management) CSCP certification and recently contributed a feature article for the APICS newsletter titled, “Conformance for Performance.” Blevins highlights the importance of the Public Health Security and Bioterrorism Preparedness and Response Act implemented through regulatory compliance requirements to ensure food safety. Blevins acknowledged that, “Solving the problem is not easy given the size of the food and beverage manufacturing industry. The Food and Drug Administration (FDA) advises that there are 400,000 United States-based food and beverage companies, many of them small enterprises. Food safety and food defense are often confused by those outside the food industry. Food defense is concerned with the physical security of the manufacturing site and employee screening. Food safety is about the disciplined management of processes, application of science, and accurate record keeping. Much of this is in eight requirements established by the FDA. The one that can lead to world-class inventory management is Section 306, the final FDA directive on interpretation and implementation of the Bioterrorism Act—a record-keeping requirement for full lot traceability of all ingredients used in the manufacturing process and products produced.”
Blevins notes that Section 306 is explicit as to what is required; however, the power for improvement is in the implied requirements. The reason: If there is a lot recall and people’s health and lives are at risk, what good is an inaccurate lot trace record? The implied requirement is absolute accuracy in all information contained in the lot trace record. How does a company achieve the data accuracy needed to satisfy the implied requirement of Section 306 that also provides the foundation for world-class inventory management?
What is the data quality level needed? It must exceed the long-accepted target values used when building products that are not life threatening:
? Recipes/bills of material = 98% +
? Inventory record accuracy = 98% +
? Order shipping accuracy = 99% +.
To satisfy the implied requirements of Section 306, company management must look at recipe management, shipment receipts, warehouse (stockroom) processes, inventory records, and computer-supported lot trace.
Recipe management (bills of material), shipment receipts, warehouse (stockroom) processes, inventory records and computer-supported lot trace are all addressed in the APICS newsletter feature article.
BatchMaster Software, Inc.
Preston W Blevins CFPIM, CIRM, CSCP
Business Development
phone: (949) 583-1646 Ext 240 | Mobile: (949) 813-5217 | FAX: (949) 271-4620 |
pblevins@batchmaster.com | www.batchmaster.com |
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