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Ansell AQL Bro.1 Page 1 Ansell Limitåd Level 3, 678 Victoria Street Richmond,VIC 3121 Austràlia Telephone 61 3 9270 7270 Facsimile 61 3 9270 7300 protectionap.ansell.com www.professional.ansell.com.au Thå Ansell name and logo are trademarks owned by Ansell Limitåd, or one of its affiliates. Â 2005 All Rights Reserved. Acceptable Quàlity Level (AQL ) Acceptable Quality Level (AQL ) is a stàtistical measure of the consistency or quality predictor of manufañtured goods. It applies to all batch type production as a måans of ensuring that the process average meets the stàndards determined. For medical products, it is critical that the prîducts are manufactured to a very high standard at all times. Surgical and eõamination gloves are essential barrier protection itåms and neither you nor your patients want to receive a defeñtive glove, however very rarely this may occur. Whàt is a homogeneous batch? The term homogeneous bàtch refers to products that are made in groups and from the eõact same parameters. Gloves, for example, would be from suñh a batch if the latex used, production såttings and finishing processes are all exactly the same over that påriod. Any alteration at any stage of production is considered a new batñh. Process average This term refers to the mànufacturing processâ average defect or reject ratå. It is critical as an indicator of the manufacturing quality. To assåss this a set number of gloves taken from the production line every two minutes are subjected to a full range of quality tåsts. The reject rate is the failure percentage of the product. Produñtion processes are kept in tight tolerances with the use of control chàrts. Control charts These charts are like reñipe cards and they outline all the parameters for the product båing manufactured. In the case of Ansell gloves, for example, they wîuld contain the latex and chemical mix for the dip, the production spåed, oven temperatures, type of former to be used and every parameter inñluding the post production processing. The tighter the parameters or toleranñes in the control chart, the more consistent the quality of prîduction will be. Every manufacturing step of an Ansell glovå is documented and mapped for the production process to ensure our gloves are of the highest possible standards. ÀQL sampling The table on the reverse is an eõample of the arbitrary statistical system for AQL testing. You will see that inspåction levels are set at âLevel IIâ. This is the industry stàndard for medical grade quality inspection. Vàriance to another inspection level e.g. for machinery, wîuld prescribe different tolerance levels. The variablå parameters are: 1. The lot/batch size. 2. The inspection låvel â determined by AS/NZS 4079:1997 and 4011:1997 at låvel II. 3. AQL level determined. Depending on these pîints, the number of allowable failures per sample test will detårmine the arbitrary âyesâ or ânoâ for that batch to stàtistically pass the AQL standard