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ISO INTERNATIONAL STANDARD 11462-1 First edition 2001-06-15 Guidelines for implementation of statistical process control (SPC) - Part 1: Elements of SPC Lignes directrices pourla mise en ceuvre de la maitrise statistique des processus(MsP) Partie 1: Elements de MSP Reference number ISO 11462-1:2001(E) ISO @ ISO 2001 THS unde Not for Resale ISO 11462-1:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by isO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below @ISO2001 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Casepostale56.CH-1211Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.ch Printed in Switzerland IsO2001-All rightsreserved itted without license from IHS Not for Resale ISO 11462-1:2001(E) Contents Page Foreword. .iv Introduction. 1 Scope. 2 Normative references ... 3 Terms and definitions ... .2 4 SPC applications... 4.1 Process characteristics. 4.2 Production characteristics .... 4.3 Techniquesforcontrolandmodelsofprocesses 5 SPC objectives and organization .. 3 5.1 SPC objectives.. 5.2 Financial motive for SPC 5.3 5.4 SPC organization. 6 Conditions for statistical process control ... 6.1 Management support .. 6.2 Understanding of SPC tools and methods .. 6.3 Quality management system ... .6 7 Elements of a statistical process control system.... 7.1 Process documentation and control plan.... .6 7.2 Definition of process targets and limits... 7.3 Measurement system evaluation and control........ 7.4 Documented work instructions.... 7.5 Employee training and involvement in process data.. 7.6 Process data recording and collection .... 7.7 Traceability and production sequence identification 7.8 Subcontractor performance evaluation . 10 7.9 Process input sequencing.... 10 7.10 Process logs..... 11 7.11 Process reliability... 7.12 Process output monitoring system .... 12 7.13 Process control system.. 12 7.14 Short-term variability assessment...... 12 7.15 Long-term variability assessment... 13 7.16 Communicating the results of process analyses... 14 7.17 Customer information system.... 14 7.18 Internal SPC audits.... 7.19 SPC projects and teams.. 15 7.20 Process improvement, optimization and troubleshooting. 15 Annex A (normative) Terms and definitions ... 16 Bibliography.... 23 ili ense from IHS Not for Resale

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