An Spc Case Study on Stabilizing Syringe Lenghts

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Quality Engineering, 12(1), 65-7 1 (1999-2000) AN SPC CASE'STUDY ON STABILIZING SYRINGE LENGTHS LeRoy A. Franklin Rose-Hulman Institute of Technology 5500 Wabash Avenue Terre Haute, Indiana 47803 Samar N. Mukherjee Statistical Consultant Quality Council of Indiana P.O. Box 360 West Terre Haute, Indiana 47885 Key Words Process capability; Process stability; Statistical process control; Supplemental runs rules; f and R charts; Process center: Process variation. Introduction A Midwest pharmaceutical company manufactures (in two stages) individual syringes with a self-contained, single . dose of an injectable drug. In the first stage, sterile liquid drug is filled into glass cartridges and sealed with a rubber stopper. The remaining stage involves insertion of the cartridge into plastic syringes and the electrical "tacking" of the containment cap at a precisely determined length of the syringe. If the cap is "tacked" at a shorter than desired length (less than 4.920in.), this leads to pressure on the cartridge stopper and, hence, partial or complete activation of the syringe. Such syringes must then be scrapped. If the cap is "tacked" at a longer than desired length (4.980in. or longer), the "tacking" is incomplete or inadequate, which a can lead to cap loss (and potentially a cartridge loss) in shipment and handling. Such syringes can be "reworked" manually to attach the cap at a lower position. However, this requires a 100% inspection of the "tacked" syringes and results in increased cost for the items. This final production step seemed to be producing more and more scrap and reworked syringes over successive weeks. At this point, the authors became involved in an attempt to solve this problem, and implementation of SPC procedures for the purpose of improving the tacking operation was recommended to management. The lenglh was targeted by the

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