1、BS ISO 13053-2:2011Quantitative methods in process improvement Six SigmaPart 2: Tools and techniquesraising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 13053-2:2011 BRITISH STANDARDNational forewordThis British Standard is
2、the UK implementation of ISO 13053-2:2011.The UK participation in its preparation was entrusted to TechnicalCommittee MS/6, Methodologies for business process improvementusing statistical methods.A list of organizations represented on this committee can beobtained on request to its secretary.This pu
3、blication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68912 3ICS 03.120.30Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the
4、authority of theStandards Policy and Strategy Committee on 30 September 2011.Amendments issued since publicationDate Text affectedBS ISO 13053-2:2011Reference numberISO 13053-2:2011(E)ISO 2011INTERNATIONAL STANDARD ISO13053-2First edition2011-09-01Quantitative methods in process improvement Six Sigm
5、a Part 2: Tools and techniques Mthodes quantitatives dans lamlioration de processus Six Sigma Partie 2: Outils et techniques BS ISO 13053-2:2011ISO 13053-2:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
6、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 ISOs member body in the country of the requester. ISO copyright office Case postale 56 g120 CH-1211 Geneva 20 Tel. + 41 22 749 0
7、1 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedBS ISO 13053-2:2011ISO 13053-2:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword . vg3Introduction vig31 Scope 1g32 Terms and definitions . 1g33 Symbols and abbrevi
8、ated terms 4g33.1 Symbols 4g33.2 Abbreviated terms . 5g34 DMAIC process sequence 6g34.1 Define phase 6g34.1.1 Objectives 6g34.1.2 Steps . 6g34.2 Measure phase . 7g34.2.1 Objectives 7g34.2.2 Steps . 7g34.3 Analyse phase . 9g34.3.1 Objectives 9g34.3.2 Steps . 9g34.4 Improve phase . 10g34.4.1 Objective
9、s 10g34.4.2 Steps . 11g34.5 Control phase 12g34.5.1 Objectives 12g34.5.2 Steps . 12g3Annex A (informative) Factsheets . 15g3Factsheet 01 ROI, costs and accountability 16g3Factsheet 02 Affinity diagram . 17g3Factsheet 03 Kano model 18g3Factsheet 04 CTQ tree diagram 19g3Factsheet 05 House of quality 2
10、0g3Factsheet 06 Benchmarking . 21g3Factsheet 07 Project charter . 22g3Factsheet 08 Gantt chart . 23g3Factsheet 09 SIPOC . 24g3Factsheet 10 Process mapping and process data . 25g3Factsheet 11 Prioritization matrix 26g3Factsheet 12 Cause and effect diagram 27g3Factsheet 13 Brainstorming . 28g3Factshee
11、t 14 Failure mode and effects analysis (FMEA) . 29g3Factsheet 15 Measurement system analysis (MSA) . 30g3Factsheet 16 Data collection plan 31g3Factsheet 17 Determination of sample size 32g3BS ISO 13053-2:2011ISO 13053-2:2011(E) iv ISO 2011 All rights reservedFactsheet 18 Normality testing .33g3Facts
12、heet 19 Descriptive statistics visualization tools 34g3Factsheet 20 Indicators .35g3Factsheet 21 Waste analysis .36g3Factsheet 22 Value stream analysis (VSM) .37g3Factsheet 23 Services delivery modelling .38g3Factsheet 24 Hypothesis testing 39g3Factsheet 25 Regression and correlation 40g3Factsheet 2
13、6 Design of experiments (DOE) 41g3Factsheet 27 Reliability .42g3Factsheet 28 RACI competencies matrix .43g3Factsheet 29 Monitoring / control plan 44g3Factsheet 30 Control charts 45g3Factsheet 31 Project review 46g3Bibliography 47g3BS ISO 13053-2:2011ISO 13053-2:2011(E) ISO 2011 All rights reserved v
14、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 technical committees. Each member body interested in a subject for which a t
15、echnical 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 with the International Electrotechnical Commission (IEC) on all matters
16、 of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulate
17、d 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 document may be the subject of patent rights. ISO shall not be held responsible
18、for identifying any or all such patent rights. ISO 13053-2 was prepared by Technical Committee ISO/TC 69, Applications of statistical methods, Subcommittee SC 7, Applications of statistical and related techniques for the implementation of Six Sigma. ISO 13053 consists of the following parts, under t
19、he general title Quantitative methods in process improvement Six Sigma: g127 Part 1: DMAIC methodology g127 Part 2: Tools and techniques BS ISO 13053-2:2011ISO 13053-2:2011(E) vi ISO 2011 All rights reservedIntroduction Six Sigma1)is an approach developed for businesses and organizations seeking to
20、gain a competitive advantage. Six Sigma practices are designed to be instrumental in g127 driving process improvement and making statistically based decisions, g127 measuring business results with a level of reliance, g127 provisioning for uncertainty and error, g127 combining high returns and benef
21、its in the short, medium and long run, and g127 removing the waste from any process. The sigma score (written Zvalue) is an indicator of process quality that expresses process performance in terms of an ability to provide a product or a service that meets customer and third party specifications and
22、expectations. It is directly related to either a) the proportion of good or positive outputs (yield) provided by a process, or b) the proportion of poor or negative outputs %, ppm or defects per million opportunities (DPMO) from a process. The following table translates the Zvalueas the proportion o
23、f defects that might be expected. Table 1 Sigma scores Calculated value of DPMO (YDPMO) Sigma score (Zvalue)308 538,0 66 807,0 6 210,0 233,0 3,4 2 3 4 5 6 NOTE 1 A full table of sigma scores can be found in ISO 13053-1:2011, Annex A. NOTE 2 Calculations are based on a 1,5 sigma shift of the mean. 1)
24、 Six Sigma is a trade mark of Motorola, Inc. BS ISO 13053-2:2011INTERNATIONAL STANDARD ISO 13053-2:2011(E) ISO 2011 All rights reserved 1Quantitative methods in process improvement Six Sigma Part 2: Tools and techniques 1 Scope This part of ISO 13053 describes the tools and techniques, illustrated b
25、y factsheets, to be used at each phase of the DMAIC approach. The methodology set out in Part 1 of ISO 13053 is generic and remains independent of any individual industrial or economic sector. This makes the tools and techniques described in this part applicable to any sector of activity and any siz
26、e business seeking to gain a competitive advantage. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 benchmarking method for comparing the performance of the leading organizations in a market segment 2.2 brainstorming group creativity techniqu
27、e designed to generate a large number of ideas 2.3 cause and effect diagram Ishikawa diagram fishbone diagram visual tool often used with brainstorming for the logical organization of potential causes of a problem 2.4 common cause source of process variation that is inherent in a process over time 2
28、.5 confidence interval interval within which a parameter to be estimated can be expected to lie with a probability of g116 1 g16g3g68, e.g. generally 95 % or 99 % 2.6 continuous data data that have been measured on a scale and that can be subdivided BS ISO 13053-2:2011ISO 13053-2:2011(E) 2 ISO 2011
29、All rights reserved2.7 critical-to-quality CTQ critical characteristics, the quality performance requirements which must be met to satisfy the customer 2.8 customer organization or person that receives a product NOTE The customer can be internal or external to the organization. ISO 9000:2005, 3.3.5
30、2.9 defect non-fulfilment of a requirement related to an intended or specified use ISO 9000:2005, 3.6.3 2.10 defect opportunity any measurable event creating a possible defect 2.11 defective unit unit with one or more defects ISO 3534-2:2006, 1.2.16 2.12 design of experiments DOE systematic methodol
31、ogy for collecting information to guide improvement of any process NOTE 1 Statistical models are developed to represent the process under analysis. NOTE 2 Simulation tools and optimization can be applied to test and confirm specific improvements. 2.13 discrete data data that can be classified, but n
32、ot subdivided NOTE 1 Continuous data, by grouping or otherwise classifying, can be regarded as discrete. NOTE 2 Data classified according to different attributes are discrete and are called “attribute data”. NOTE 3 Discrete data come from nominal or ordinal scales. 2.14 environmental aspect activity
33、, product or service that could possibly interact with the environment 2.15 gate review project review led by a sponsor each time a DMAIC stage is completed in order to validate the conclusions of that stage 2.16 input resources or data, or both, required to execute a process BS ISO 13053-2:2011ISO
34、13053-2:2011(E) ISO 2011 All rights reserved 32.17 Kano model quality management tool used to prioritize customer requirements 2.18 measurement system analysis MSA series of studies that explains how a measurement system performs NOTE Validating measurement systems makes it possible to ensure data c
35、onsistency and data stability. 2.19 mistake proofing poka yoke prevention method designed as a simple technique to prevent either g127 anyone from making unplanned or unwanted changes to a system, or g127 any errors from negatively impacting on a system 2.20 objective target value of a process, dete
36、rmined by the customer 2.21 operational definition clear, concise description of a measurement and the process used to derive it 2.22 output products or services generated through a process 2.23 Pareto analysis methodology used to drill into discrete data to assess the frequency of defects by classi
37、fication factors 2.24 process set of interrelated or interacting activities that transforms inputs into outputs 2.25 process map graphical display of a process 2.26 project charter document that states the problem to be solved, the improvement goals, the project scope, the project milestones and the
38、 project roles and responsibilities 2.27 quality function deployment QFD method to translate customer requirements into design characteristics and, ultimately, into process control requirements NOTE The “house of quality” is a tool used by this method. 2.28 sampling plan plan that describes how samp
39、les are to be selected BS ISO 13053-2:2011ISO 13053-2:2011(E) 4 ISO 2011 All rights reserved2.29 scorecard customer-specified evaluation device used to track performance in satisfying customer requirements 2.30 special causes sources of process variation other than inherent process variation NOTE Sp
40、ecial causes are due to known or exceptional factors, sometimes called assignable causes. 2.31 third party person or body concerned or impacted by the performance issue in question 2.32 top Y primary CTQ for both customer and organization 2.33 unit item produced or handled 2.34 voice of the customer
41、 VOC information from the customer that expresses his expectations NOTE This can require the customer concerned to state targets he needs and will assist the producer to know the customers position and to understand his or her expectations. 3 Symbols and abbreviated terms 3.1 Symbols b0intercept in
42、a regression equation b1coefficient in a regression equation C criticality number used in FMEA c number of defects (nonconformities) D detection ranking used in FMEA d accuracy (associated with confidence interval) L lower specification limit N population size n sample size nCTQCnumber of critical t
43、o quality characteristics O occurrence ranking used in FMEA p proportion BS ISO 13053-2:2011ISO 13053-2:2011(E) ISO 2011 All rights reserved 5r correlation coefficient g54 summation g86 estimated population standard deviation S severity ranking used in FMEA s sample standard deviation U upper specif
44、ication limit X random variable (independent) X mean value of X Y random variable (dependent) Y mean value of Y Y predicted value of Y YDPMOcalculated value of DPMO Yppmcalculated value of ppm Zvaluesigma score or value 3.2 Abbreviated terms ANOVA analysis of variance COQ cost of quality COPQ cost o
45、f poor quality CTQ critical to quality CTQC critical to quality characteristics DMAIC define, measure, analyse, improve and control NOTE 1 The DMAIC method for improving an existing process and its output has five phases: define, measure, analyse, improve and control. DPMO defects per million opport
46、unities NOTE 2 DPMO can be used to determine the sigma score. FMEA failure mode and effects analysis FMECA failure mode, effects and criticality analysis GRR gauge repeatability and reproducibility study ppm parts per million BS ISO 13053-2:2011ISO 13053-2:2011(E) 6 ISO 2011 All rights reservedRACI
47、responsible, accountable, consulted, informed ROI return on investment RPN risk priority number SIPOC flowchart showing (S)upplier, (I)nputs, (P)rocess, (O)utputs, (C)ustomer relationships 4 DMAIC process sequence 4.1 Define phase 4.1.1 Objectives The objectives of this step are to a) identify the r
48、equirements and expectations of the stakeholders, b) identify the voice of the customer and third parties (CTQC, etc.), c) select the project team, d) develop a process map (SIPOC), visualize the data (Pareto), and e) create a project charter. 4.1.2 Steps 4.1.2.1 Define: Step 1 Identify the customer
49、s and the third parties, understand their demands and translate them into measurable requirements. Set improvement objectives. Techniques Factsheet or International Standard Customer claims, market feedback, surveys Factsheet 04, ISO 9001 or other management standards Third party expectations, ethics surveys Factsheet 04, ISO 14001 or other management standards ROI, costs and accountability Factsheet 01 Six Sigma indicators Factsheet 20 Affinity d
