A Quality System for Labeling Excellence

Article

Scofield, Eugene L.   (1986, ASQC)   Millipore Corporation, Bedford, MA

40th Annual Quality Congress, May 1986, Anaheim, CA    Vol. 40    No. 0
QICID: 3174    May 1986    pp. 159-161
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Article Abstract

Few quality characteristics have the ability to display excellence or lack of excellence as obviously as labeling characteristics. You don't have to be in the advertising business to appreciate that virtually all items under the broad definition of "labeling" have a significant impact on the customer's perception of product quality.Such a broad definition of labeling includes much more than package labels. It includes many kinds of product enclosures or package inserts, various forms of instructions for installation, operation, calibration, maintenance, retrofit, etc.We are all aware of instances in which the product was perfectly satisfactory -- in fact of excellent quality -- but that the customer was disappointed because of "labeling problems." The operating instructions may have been misleading -- or not included in the package. Promotional literature had little in common with the labeling accompanying the product, and the customer's expectations were not fulfilled. Or, there were "simple" cases of mislabeling in which the right product had the wrong label.Control of labeling has always been on the list of quality management responsibilities. Regulated industries (such as pharmaceuticals and medical devices) have specific labeling requirements and clear quality assurance duties to prevent mislabeling. Product liability is a concern of all companies. Quality of labeling has direct economic consequences; the image of the product and the customer's willingness to buy can be greatly influenced by labeling.To assure the quality of labeling required for excellence, control systems are needed. These consist of physical systems to create, review, revise, publish, store, and distribute product labeling. But as with many quality functions, it is the documentation system which provides the control. Written documents capture the standards for the physical system, procedures to do the tasks required, formal authorization of labeling, and the historical record.Such a labeling control system is used by Millipore Corporation. It consists of fundamental definitions (such as the distinction between product labeling and promotional labeling), several categories of "engineering" documents (such as Product Descriptions, Labeling Specifications, and Purchasing Specifications), and a computerized cross-reference system which can generate "idented bill" and "where used" reports for documents.The documentation system (operated by Quality Assurance) is coordinated with a CAD system in Packaging Engineering, with automated label printing machines at several plants, and with a formal Labeling Review Committee to provide a quality system for excellence in labeling.

Keywords

Biomedical


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