Final Link

	Scenario #6: Improving Recall Procedures
	A formalized system for subsidiary quality data and activity allows faster response and less effort in problem resolution, and limits the extent and financial impact of recalls.

	Situation The recall imposed on the confectionery manufacturer was not going too well, but was cancelled by the FDA after four days of intensive effort. The consumer complaint had proved to be unfounded and erroneous. "We dodged a bullet on that one!" was the QC Manager's verdict. “But we need better approaches in case there is a next time!” Like the recall process of most companies in the food and pharmaceutical industries, the QC Manager, assisted by the Marketing Administrator and Production Control Manager used their systems to backtrack from the lot number and customer shipment through distribution, inspection, packaging, production, to inventoried materials and purchasing. These applications traced product and material disposition by lot ID, with some "paper clip" attachments of subsidiary information and documents to orders and other records. The problems arose when the Production Control Manager reported that all the associated and sometimes critical supporting production and materials records and specifications were spread across several departments, on unconnected PCs and various manual and other records from notebooks to process logs. As a result, getting access to supplier provided details posed similar problems. “The supporting information decides the extent of the recall” was the QC Manager’s comment. “Yes, and the magnitude of lost revenues” added the Marketing Administrator. It had been a long time since the company had been inflicted with a recall procedure. Four days of uncompleted work on all the dispersed and unconnected information on material and process quality, product specifications and inspection results had never been foreseen. Fortunately this recall had been canceled just as the enormity of the required effort had been realized. Summary: Ineffectual controls; high manual effort; slow response; loss of revenue. With Final Link The appropriate processes and essential records are stored in the Final Link™ central repository and referenced by product number, with the lot number and the purchase or production order numbers as secondary keys to facilitate easy lookup ability. Sales, production, and all personnel involved from purchasing and receiving through production, QC, packaging and shipping use the Final Link™ Activity Workbench. Internal procedures are modified so that the information and the events to be entered into Final Link™ are properly defined, and familiar to all employees. The QC Manager, Marketing Administrator and Production Control Manager decide to carry out a test recall. Based on lot identities in the enterprise system, filtered or selective Final Link reports are used to collate details and any subsidiary data that was involved. All the supporting information needed for recall, or to resolve quality questions, is now available almost instantaneously. No longer is it necessary to use one system for an initial search and then a massive human effort to collect substantiating information. A rigorous test recall was completed in two days. Six months afterwards, apparent packaging imperfections or tampering is discovered on a retailer’s shelves in the Mid-West. The same team initiates a full recall procedure. The problem is identified and narrowed down to just one implicated batch of product to be recalled. The comprehensive investigation and communications to the FDA authorities is completed in less than 24 hours. Summary: Fast response; minimal effort; reputation enhanced; minimized revenue impact.


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