1、BRITISH STANDARD BS ISO 11462-1:2001 Guidelines for implementation of statistical process control (SPC) Part 1: Elements of SPC ICS 25.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS ISO 11462-1:2001 This British Standard, having been prepared under the direction of t
2、he Management Systems Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 September 2001 BSI 07-2001 ISBN 0 580 38293 1 National foreword This British Standard reproduces verbatim ISO 11462-1:2001 and implements it as the UK national standard. T
3、he UK participation in its preparation was entrusted to Technical Committee SS/4, Statistical Process Control, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement in
4、ternational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to i
5、nclude all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/Eu
6、ropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page,
7、 pages ii to v, a blank page, pages 1 to 23 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsReference number ISO 11462-1:2001(E) INTERNATIONAL STANDARD ISO 11462-1 First edition
8、 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 de MSPii ISO 11462-1:2001(E)iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative
9、 references 1 3 Terms and definitions .2 4 SPC applications2 4.1 Process characteristics 2 4.2 Production characteristics .2 4.3 Techniques for control and models of processes .3 5 SPC objectives and organization.3 5.1 SPC objectives.3 5.2 Financial motive for SPC 4 5.3 Relationships .4 5.4 SPC orga
10、nization .5 6 Conditions for statistical process control 5 6.1 Management support 5 6.2 Understanding of SPC tools and methods .6 6.3 Quality management system6 7 Elements of a statistical process control system 6 7.1 Process documentation and control plan.6 7.2 Definition of process targets and lim
11、its 7 7.3 Measurement system evaluation and control.7 7.4 Documented work instructions8 7.5 Employee training and involvement in process data.8 7.6 Process data recording and collection .9 7.7 Traceability and production sequence identification 10 7.8 Subcontractor performance evaluation 10 7.9 Proc
12、ess input sequencing10 7.10 Process logs.11 7.11 Process reliability 11 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 assessment13 7.16 Communicating the results of process analyses.14 7.17 Customer infor
13、mation system14 7.18 Internal SPC audits14 7.19 SPC projects and teams15 7.20 Process improvement, optimization and troubleshooting15 Annex A (normative) Terms and definitions 16 Bibliography23ISO 11462-1:2001(E) iv Foreword ISO (the International Organization for Standardization) is a worldwide fed
14、eration of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that comm
15、ittee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accorda
16、nce with the rules given in the ISO/IEC Directives, Part 3. Draft International 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
17、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 responsible for identifying any or all such patent rights. International Standard ISO 11462-1 was prepared by Technical Committee ISO/TC 69, Applications of statist
18、ical methods, Subcommittee SC 4, Applications of statistical methods in process management. ISO 11462 consists of the following parts, under the general title Guidelines for implementation of statistical process control (SPC): Part 1: Elements of SPC A catalogue of tools and techniques will be the f
19、uture subject of part 2 to ISO 11462. Annex A forms a normative part of this part of ISO 11462.ISO 11462-1:2001(E)v Introduction ISO 11462 provides guidelines for the implementation of a statistical process control (SPC) system. These guidelines are aimed primarily at increasing production efficienc
20、y 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 statistical process control system. By implementing those elements deemed applicable and appropriate by customer and su
21、pplier, 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 services meet customer requirements (such as the system defined by ISO 9001), an organization can improve the infrastruct
22、ure 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 process control, algorithmic process control, and model-based control methods. These are different approaches with the same p
23、urpose 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 product parameter; and to recognize that a product parameter can be either an in-process product parameter or a final-p
24、roduct parameter. Under specified conditions of measurement, a product parameter can be equivalent to a product characteristic. Some considerations given in the formulations of ISO 11462 are the following: a) Elements of part 1 of ISO 11462 guide an organization in how to implement an SPC system. Sp
25、ecific 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 that the use of “should” throughout both parts of ISO 11462 indicates that 1) among several possibilities, one or more
26、 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 the economic control of production. This choice of language does not indicate requirements whi
27、ch are to be strictly followed in order to conform to this International Standard and from which no deviation is permitted.INTERNATIONAL STANDARD ISO 11462-1:2001(E)1 Guidelines for implementation of statistical process control (SPC) Part 1: Elements of SPC 1 Scope Statistical process control (SPC)
28、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 parameters, or in o
29、ther 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. NOTE 1 SPC opera
30、tes 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 to the next d
31、ownstream suppliers process. NOTE 2 Although 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 guidelines
32、 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 certification use
33、. 2 Normative 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 to agreement
34、s 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 registers of curr
35、ently valid International Standards. ISO 3534-1:1993, Statistics Vocabulary and symbols Part 1: Probability and general statistical terms.ISO 11462-1:2001(E) 2 ISO 3534-2:1993, Statistics Vocabulary and symbols Part 2: Statistical quality control. ISO 3534-3:1999, Statistics Vocabulary and symbols P
36、art 3: Design of experiments. ISO 9000:2000, Quality management systems Fundamentals and vocabulary. 3 Terms 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. NOTE
37、Annex A provides a glossary 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. 4 SPC applications 4.1 Process characteristics It is intended that elements in this part of ISO 11462 be selected base
38、d on their applicability and 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 bei
39、ng served, nature of product 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
40、service-specific) and quality 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
41、 any specific process, industry 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 appropr
42、iate”,a n d“where applicable” are used to highlight those elements whose particular application is expected to be more process-dependent or more market-sensitive. 4.2 Production characteristics This part of ISO 11462 can be used in circumstances when: variation or deviation from either product requi
43、rements or performance to 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
44、 are not limited to: a) design 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 communica
45、tions;ISO 11462-1:2001(E)3 g) manual or automated technologies for production, assembly, test, or communications; h) first pass or loops for rework, repair, reprocessing, or purging. In this part of ISO 11462, references to a product include service, hardware, processed material, software, or a comb
46、ination thereof, such as an information or communications transaction. 4.3 Techniques for control and models of processes SPC elements extend to techniques applied on-line within the operation of the process; and off-line either outside the operation of the process, or on the outputs at the end of t
47、he process. These elements are not limited to traditional control charting techniques, to specific models of process data involving specific distributions or to specific patterns of correlation. The SPC elements can be applied to control processes regardless of the tactics used. Applications include
48、 automatic controllers for continuous and batch processes, automated editors for data inputs, control algorithms for timing or spacing of resource inputs, manual maintenance procedures for low volume outputs, and analytical procedures such as control charts. A supplier may use statistical, algorithm
49、ic or model- based methods, or a combination of such methods. The choice of these methods will depend on process data availability, model availability, business needs, as well as the relative frequency of random, unknown, and assignable causes of variation. 5 SPC objectives and organization 5.1 SPC objectives 5.1.1 General Statistical process control as stated in clause 1 has one or more objectives, distinct from those of statistical quality control and important to emphasize: a) to increase knowledge about the process; b) to steer a process
