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1、Reference number ISO 11462-1:2001(E) ISO 2001 INTERNATIONAL STANDARD ISO 11462-1 First edition 2001-06-15 Guidelines for implementation of statistical process control (SPC) Part 1: Elements of SPC Lignes directrices pour la mise en uvre de la matrise statistique des processus (MSP) Partie 1: lments
2、de MSP Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11462-1:2001(E) PDF disclaimer This PDF file may cont
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7、office Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2001 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980
8、755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11462-1:2001(E) ISO 2001 All rights reservediii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .2 4SPC applications2 4.1Process cha
9、racteristics 2 4.2Production characteristics .2 4.3Techniques for control and models of processes .3 5SPC objectives and organization.3 5.1SPC objectives.3 5.2Financial motive for SPC 4 5.3Relationships .4 5.4SPC organization.5 6Conditions for statistical process control 5 6.1Management support 5 6.
10、2Understanding of SPC tools and methods .6 6.3Quality management system6 7Elements of a statistical process control system6 7.1Process documentation and control plan.6 7.2Definition of process targets and limits7 7.3Measurement system evaluation and control.7 7.4Documented work instructions8 7.5Empl
11、oyee training and involvement in process data.8 7.6Process data recording and collection .9 7.7Traceability and production sequence identification 10 7.8Subcontractor performance evaluation 10 7.9Process input sequencing10 7.10Process logs.11 7.11Process reliability11 7.12Process output monitoring s
12、ystem .12 7.13Process control system 12 7.14Short-term variability assessment.12 7.15Long-term variability assessment13 7.16Communicating the results of process analyses.14 7.17Customer information system14 7.18Internal SPC audits14 7.19SPC projects and teams15 7.20Process improvement, optimization
13、and troubleshooting15 Annex A (normative) Terms and definitions 16 Bibliography23 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without licen
14、se from IHS -,-,- ISO 11462-1:2001(E) iv ISO 2001 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO techni
15、cal committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely w
16、ith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to th
17、e member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 11462 may be the subject of patent rights. ISO shall not be held responsibl
18、e for identifying any or all such patent rights. International Standard ISO 11462-1 was prepared by Technical Committee ISO/TC 69, Applications of statistical methods, Subcommittee SC 4, Applications of statistical methods in process management. ISO 11462 consists of the following parts, under the g
19、eneral title Guidelines for implementation of statistical process control (SPC): Part 1: Elements of SPC A catalogue of tools and techniques will be the future subject of part 2 to ISO 11462. Annex A forms a normative part of this part of ISO 11462. Copyright International Organization for Standardi
20、zation Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11462-1:2001(E) ISO 2001 All rights reservedv Introduction ISO 11462 provides guidelines for the implementatio
21、n of a statistical process control (SPC) system. These guidelines are aimed primarily at increasing production efficiency and inherent capability, and reducing interval and cost. This part of ISO 11462 provides elements to guide an organization in planning, developing, executing, and/or evaluating a
22、 statistical process control system. By implementing those elements deemed applicable and appropriate by customer and supplier, an organization may satisfy a requirement to adopt a comprehensive and effective SPC system. By also deploying a quality system with the aim of ensuring that products and s
23、ervices meet customer requirements (such as the system defined by ISO 9001), an organization can improve the infrastructure so as to help hold the gains from its SPC system. This part of ISO 11462 extends the definition of process control to integrate the traditional definitions of statistical proce
24、ss control, algorithmic process control, and model-based control methods. These are different approaches with the same purpose of reducing variation in both products and processes. This part of ISO 11462 also extends the definition and usage of the term parameter to apply to a process parameter or a
25、 product parameter; and to recognize that a product parameter can be either an in-process product parameter or a final-product parameter. Under specified conditions of measurement, a product parameter can be equivalent to a product characteristic. Some considerations given in the formulations of ISO
26、 11462 are the following: a)Elements of part 1 of ISO 11462 guide an organization in how to implement an SPC system. Specific tools and techniques that experience has shown useful in applying these elements within processes will be listed in part 2 of ISO 11462. b)Users of ISO 11462 should be aware
27、that the use of “should” throughout both parts of ISO 11462 indicates that 1)among several possibilities, one or more are recommended as being particularly suitable and effective, without mentioning or excluding others; 2)a certain course of action is preferred but not necessarily required for a pro
28、cess in order to gain the economic control of production. This choice of language does not indicate requirements which are to be strictly followed in order to conform to this International Standard and from which no deviation is permitted. Copyright International Organization for Standardization Pro
29、vided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/998075510
30、0 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 11462-1:2001(E) ISO 2001 All rights reserved1 Guidelines for implementation of statistical process control (SPC) Part 1: Elements of SPC 1Scope Statistical proces
31、s control (SPC) concerns the use of statistical techniques and/or statistical or stochastic control algorithms to achieve one or more of the following objectives: a)to increase knowledge about a process; b)to steer a process to behave in the desired way; c)to reduce variation of final-product parame
32、ters, or in other ways improve performance of a process. These guidelines give the elements for implementing an SPC system to achieve these objectives. The common economic objective of statistical process control is to increase good process outputs produced for a given amount of resource inputs. NOT
33、E 1SPC operates most efficiently by controlling variation of a process parameter or an in-process product parameter that is correlated with a final-product parameter; and/or by increasing the processs robustness against this variation. A suppliers final-product parameter may be a process parameter t
34、o the next downstream suppliers process. NOTE 2Although SPC is concerned with manufactured goods, it is also applicable to processes producing services or transactions (for example, those involving data, communications, software, or movement of materials). This part of ISO 11462 specifies SPC system
35、 guidelines for use ?when a suppliers capability to reduce variation in processes associated with design or production needs to be proven or improved; or ?when a supplier is beginning SPC implementation to achieve such capability. These guidelines are not intended for contractual, regulatory or cert
36、ification use. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 11462. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties
37、to agreements based on this part of ISO 11462 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain regis
38、ters of currently valid International Standards. ISO 3534-1:1993, Statistics Vocabulary and symbols Part 1: Probability and general statistical terms. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2
39、007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11462-1:2001(E) 2 ISO 2001 All rights reserved ISO 3534-2:1993, Statistics Vocabulary and symbols Part 2: Statistical quality control. ISO 3534-3:1999, Statistics Vocabulary and symbols Part 3: Design of exper
40、iments. ISO 9000:2000, Quality management systems Fundamentals and vocabulary. 3Terms and definitions For the purposes of this part of ISO 11462, the terms and definitions given in ISO 3534-1, ISO 3534-2, ISO 3534-3 and ISO 9000, as well as those given in annex A, apply. NOTEAnnex A provides a gloss
41、ary of explanatory terms and definitions. Some of these terms and definitions given have been based on those given in references 1 and 2 of the Bibliography. 4SPC applications 4.1Process characteristics It is intended that elements in this part of ISO 11462 be selected based on their applicability a
42、nd appropriateness to a specific process. The selection of SPC elements, the order in which an organization implements these elements, and the extent to which the elements are adopted and applied by an organization all depend on factors including: customer needs, market being served, nature of produ
43、ct or service, technology, and the nature and speed of production and transaction processes. It is emphasized that the SPC system guidelines specified in this part of ISO 11462 are complementary (not alternative) to both technical specified requirements (product-, test- or service-specific) and qual
44、ity system requirements. These guidelines specify the elements that are recommended to be included in SPC systems. It is not the purpose of these SPC system guidelines to enforce uniformity of statistical process control systems. These guidelines are generic, independent of any specific process, ind
45、ustry or economic sector. These guidelines are intended to be adopted in their present form by organizations implementing SPC. On occasion, they may need to be tailored by adding or deleting certain SPC system elements for specific circumstances. The phrases, “where appropriate”, and “where applicab
46、le” are used to highlight those elements whose particular application is expected to be more process-dependent or more market-sensitive. 4.2Production characteristics This part of ISO 11462 can be used in circumstances when: ?variation or deviation from either product requirements or performance to
47、a target value may occur; ?confidence in product conformance can be attained by adequate demonstration of a suppliers capabilities in design, development, production, installation, and/or servicing. Production characteristics that benefit from SPC implementation include, but are not limited to: a)de
48、sign and development, production, installation, and/or servicing; b)customized or mass production; c)short runs or long runs; d)small, medium or large-scale production; e)discrete, batch, or continuous processes; f)transactions, as in services, information or communications; Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/16/2007 10:24:04 MDTNo reproduction or networking permitted without license from IHS -,