Resource Maintenance Software to Aid Manufacturers in Preventing Recalls
In light of the increasing number of manufacturer recalls, Valdata Systems has launched a campaign focusing on educating manufacturers on ways to ensure proper maintenance of equipment and prevent future recalls.
Valdata has developed an integrated set of modules within its Chemical Management System (“CMS”) which enforcesresource maintenance rules. The result is a higher level of protection from quality issues resulting in product recalls.
CMS manages the maintenance of resources throughout the facility which can include anything from scales, tanks / vessels, hoses, equipment (mixers / homogenizers/ etc), rooms (vessels and tanks get assigned to rooms), meters and even people. When a resource is associated with an order, unless the scheduled resource maintenance is performed, that order cannot be executed. In other words, unlike a standalone asset management programs, CMS prevents recalls due to contamination or lack of maintenance.
Just this month it was discovered that a faulty tank was responsible for glass fragments in a generic Lipitor recall. “Glass that lined one of the tanks, or reactors, where some of the drug's active ingredient is made in the North Indian city of Toansa may have splintered, according to Ranbaxy officials, who provided the first details about the circumstances surrounding the recall.” (1)
Having a system in place to enforce vessel inspection which is policed through the manufacturing system helps to prevent these types of recalls, savings companies millions of dollars. The cost of a recall does not stop at the cost of the actual product being recalled – it also includes lost future business due to lack of confidence. According to a study by Vigilistics, Inc., an average of 57% of customers will not purchase a product perceived as having been part of a recall for at least six months.(2)
With all this at stake, a system that protects against contamination is critical. Valdata Systems' CMS system has the option to prevent any further production activities until the required maintenance has been performed. The software allows maintenance to be scheduled based on a number of criteria including number of batches and elapsed time (daily / weekly / annually / etc). During the execution of the scheduled maintenance, users have the ability to record pre-defined data points. In addition to recording data by the person performing the maintenance, the system has the option of requiring a second user to confirm that the data is accurate.
(1) Jonathan D. Rockoff and Peter Loftus, Wall Street Journal, December 5, 2012.
(2) “The High Cost of Product Recall”, Vigilistics, Inc., August, 2010
About Valdata Systems
Headquartered in Fairfield, NJ, Valdata Systems is a premier provider of Chemical Management solutions specifically targeting the Pharmaceutical, Flavor & Fragrance, Nutraceutical and Chemical Manufacturing industries.
Source: Valdata Systems