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3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23190-3 SANS 11462-1:2009Edition 1ISO 11462-1:2001Edition 1SOUTH AFRICAN NATIONAL STANDARD Guidelines for implementation of statistical pr
4、ocess control (SPC) Part 1: Elements of SPC This national standard is the identical implementation of ISO 11462-1:2001 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria
5、 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 11462-1:2009 Edition 1 ISO 11462-1:2001 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 169, Applications of statistical methods, in accor
6、dance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2009. Reference numberISO 11462-1:2001(E)ISO 2001INTERNATIONALSTANDARDISO11462-1First edition2001-06-15Guidelines for implementation of statistical
7、process control (SPC) Part 1:Elements of SPCLignes directrices pour la mise en uvre de la matrise statistique desprocessus (MSP) Partie 1: lments de MSPSANS 11462-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11462-1:2001(E)PDF di
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13、nts of the SABS .ISO 11462-1:2001(E) ISO 2001 All rights reserved iiiContents PageForeword.ivIntroduction.v1 Scope 12 Normative references 13 Terms and definitions .24 SPC applications24.1 Process characteristics 24.2 Production characteristics .24.3 Techniques for control and models of processes .3
14、5 SPC objectives and organization.35.1 SPC objectives.35.2 Financial motive for SPC 45.3 Relationships .45.4 SPC organization .56 Conditions for statistical process control 56.1 Management support 56.2 Understanding of SPC tools and methods .66.3 Quality management system67 Elements of a statistical
15、 process control system 67.1 Process documentation and control plan.67.2 Definition of process targets and limits 77.3 Measurement system evaluation and control.77.4 Documented work instructions87.5 Employee training and involvement in process data.87.6 Process data recording and collection .97.7 Tr
16、aceability and production sequence identification 107.8 Subcontractor performance evaluation 107.9 Process input sequencing107.10 Process logs.117.11 Process reliability 117.12 Process output monitoring system .127.13 Process control system 127.14 Short-term variability assessment.127.15 Long-term v
17、ariability assessment137.16 Communicating the results of process analyses.147.17 Customer information system147.18 Internal SPC audits147.19 SPC projects and teams157.20 Process improvement, optimization and troubleshooting15Annex A (normative) Terms and definitions 16Bibliography23SANS 11462-1:2009
18、This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11462-1:2001(E)iv ISO 2001 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The
19、work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governm
20、ental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (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 In
21、ternational Standards adopted by the technical committees are circulated to the 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
22、 11462 may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 11462-1 was prepared by Technical Committee ISO/TC 69, Applications of statisticalmethods, Subcommittee SC 4, Applications of statistical methods in p
23、rocess management.ISO 11462 consists of the following parts, under the general title Guidelines for implementation of statisticalprocess control (SPC): Part 1: Elements of SPCA catalogue of tools and techniques will be the future subject of part 2 to ISO 11462.Annex A forms a normative part of this
24、part of ISO 11462.SANS 11462-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11462-1:2001(E) ISO 2001 All rights reserved vIntroductionISO 11462 provides guidelines for the implementation of a statistical process control (SPC) syste
25、m. Theseguidelines are aimed primarily at increasing production efficiency and inherent capability, and reducing interval andcost.This part of ISO 11462 provides elements to guide an organization in planning, developing, executing, and/orevaluating a statistical process control system. By implementi
26、ng those elements deemed applicable andappropriate by customer and supplier, an organization may satisfy a requirement to adopt a comprehensive andeffective SPC system. By also deploying a quality system with the aim of ensuring that products and services meetcustomer requirements (such as the syste
27、m defined by ISO 9001), an organization can improve the infrastructureso 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 statisticalprocess control, algorithmic process control, and model-based
28、 control methods. These are different approacheswith 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 processparameter or a product parameter; and to recognize that a product paramet
29、er can be either an in-process productparameter or a final-product parameter. Under specified conditions of measurement, a product parameter can beequivalent to a product characteristic.Some considerations given in the formulations of ISO 11462 are the following:a) Elements of part 1 of ISO 11462 gu
30、ide an organization in how to implement an SPC system. Specific tools andtechniques that experience has shown useful in applying these elements within processes will be listed inpart 2 of ISO 11462.b) Users of ISO 11462 should be aware that the use of “should” throughout both parts of ISO 11462 indi
31、catesthat1) 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 process in order to gain theeconomic control of production.This choic
32、e of language does not indicate requirements which are to be strictly followed in order to conform tothis International Standard and from which no deviation is permitted.SANS 11462-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 11
33、462-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 11462-1:2001(E) ISO 2001 All rights reserved 1Guidelines for implementation of statistical process control(SPC) Part 1:Elements of SPC1 ScopeStatistical proc
34、ess control (SPC) concerns the use of statistical techniques and/or statistical or stochastic controlalgorithms 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 param
35、eters, or in other ways improve performance of a process.These guidelines give the elements for implementing an SPC system to achieve these objectives. The commoneconomic objective of statistical process control is to increase good process outputs produced for a given amountof resource inputs.NOTE 1
36、 SPC operates most efficiently by controlling variation of a process parameter or an in-process product parameterthat is correlated with a final-product parameter; and/or by increasing the processs robustness against this variation. Asuppliers final-product parameter may be a process parameter to th
37、e next downstream suppliers process.NOTE 2 Although SPC is concerned with manufactured goods, it is also applicable to processes producing services ortransactions (for example, those involving data, communications, software, or movement of materials).This part of ISO 11462 specifies SPC system guide
38、lines for useGbe when a suppliers capability to reduce variation in processes associated with design or production needs to beproven or improved; orGbe when a supplier is beginning SPC implementation to achieve such capability.These guidelines are not intended for contractual, regulatory or certific
39、ation use.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 11462. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agre
40、ements based on this part of ISO 11462 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintainregisters of cu
41、rrently valid International Standards.ISO 3534-1:1993, Statistics Vocabulary and symbols Part 1: Probability and general statistical terms.SANS 11462-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11462-1:2001(E)2 ISO 2001 All righ
42、ts reservedISO 3534-2:1993, Statistics Vocabulary and symbols Part 2: Statistical quality control.ISO 3534-3:1999, Statistics Vocabulary and symbols Part 3: Design of experiments.ISO 9000:2000, Quality management systems Fundamentals and vocabulary.3 Terms and definitionsFor the purposes of this par
43、t of ISO 11462, the terms and definitions given in ISO 3534-1, ISO 3534-2, ISO 3534-3and ISO 9000, as well as those given in annex A, apply.NOTE Annex A provides a glossary of explanatory terms and definitions. Some of these terms and definitions given havebeen based on those given in references 1 a
44、nd 2 of the Bibliography.4 SPC applications4.1 Process characteristicsIt is intended that elements in this part of ISO 11462 be selected based on their applicability and appropriateness toa specific process. The selection of SPC elements, the order in which an organization implements these elements,
45、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 product or service, technology, and the nature and speed ofproduction and transaction processes.It is emphasized that the SPC system guidelin
46、es specified in this part of ISO 11462 are complementary (notalternative) to both technical specified requirements (product-, test- or service-specific) and quality systemrequirements. These guidelines specify the elements that are recommended to be included in SPC systems. It isnot the purpose of t
47、hese SPC system guidelines to enforce uniformity of statistical process control systems.These guidelines are generic, independent of any specific process, industry or economic sector. These guidelinesare intended to be adopted in their present form by organizations implementing SPC. On occasion, the
48、y may needto be tailored by adding or deleting certain SPC system elements for specific circumstances. The phrases, “whereappropriate”,and“where applicable” are used to highlight those elements whose particular application is expectedto be more process-dependent or more market-sensitive.4.2 Producti
49、on characteristicsThis part of ISO 11462 can be used in circumstances when:Gbe variation or deviation from either product requirements or performance to a target value may occur;Gbe confidence in product conformance can be attained by adequate demonstration of a suppliers capabilities indesign, development, production, installation, and/or servicing.Production characteristics that benefit from SPC implementation include, but are not limited to:a) design and development, production, installation, and/or servicing;b) customized or mass
