Reviews of Standards and Related Material : Statistical Standards and ISO, Part 1
Reviews of Standards and Related Material : Statistical Standards and ISO, Part 1
Reviews of Standards and Related Material : Statistical Standards and ISO, Part 1
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Reviews of Standards and Related Material*: Statistical Standards and ISO, Part 1
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Reviews of Standards and Related Material : Statistical Standards and ISO, Part 1
Michele Boulanger, Mark E. Johnson, and Stephen N. Luko
3b2 Version Number : 7.51c/W (Jun 11 2001)
File path : P:/Santype/Journals/TandF_Production/LQEN/v24n1/lqen623956/lqen623956.3d
Date and Time : 20/10/11 and 22:48
Quality Engineering, 24:1–8, 2012
Copyright # Taylor & Francis Group, LLC
ISSN: 0898-2112 print=1532-4222 online
DOI: 10.1080/08982112.2012.623956
KEYWORDS Q1
30
INTRODUCTION
It may come as a shock when a traveler ventures abroad and discovers
that the electrical outlets differ from those at home. The utility line frequency
(50 Hz or 60 Hz typically) can also vary from that used at home and can even 35
vary within a country (e.g., western and eastern Japan, which has inhibited
the recovery from the tsunami of 2011). Lack of standardization with regards Q3
to left- and right-traffic sides is another example of undue duplicity and a
circumstance in which correction to a single mode would likely be cost pro-
hibitive (although Samoa switched from right to left in 2009 to match neigh- 40
boring Australia and New Zealand). Standardization is perhaps best
appreciated when it is absent. The International Organization for Standardi-
zation (abbreviated ISO from the Greek isos meaning equal) was founded in
1947 to deal with standardization issues across many sectors.
Edited by Stephen N. Luko. Standardization has been recognized since the time of the Chinese Zhou 45
Address correspondence to Stephen Dynasty (11th to 8th century B.C.) as a means for efficient and economical
N. Luko, Hamilton Sundstrand empire governance (Quipeng et al. 1995). At the heart of standardization
Corporation, 1 Hamilton Road,
Windsor Locks, CT 06096, USA. E-mail: is metrology (the science of measurement), which in turn necessitates stat-
[email protected] istical methods to cope with uncertainty in measurement as well as in
1
50 characterizing a population on the basis of a sample organization—the International Electrotechnical Com-
of items. Issues related to ordnance in World War II mission (IEC), which pioneered standardization in 95
(shortage of inspectors) prompted the development electrotechnology (electrical, electronic, and related
of acceptance sampling methods that could quickly technologies) in the early 20th century. In brief, a
identify very good or very bad lots based on rela- new international standard comes about first through
55 tively small samples and could prompt another the approval of a new work item with at least five
round of sampling for intermediate quality lots. member countries supplying experts to write the pro- 100
Boulanger et al. (1999) provided a concise history posed document and a designated project leader
of standardization and couched international statisti- under the aegis of a working group that has a desig-
cal standards in the context of the life cycle of pro- nated convenor. This step of identifying project lea-
60 ducts and services. They further delineated the ders and=or convenors can take place within the
following benefits of standardization: plenary meetings at international standards meetings 105
typically held yearly. Recent meetings have occurred
. Enhanced product quality and reliability at a in Berlin (2011); Paris (2010, 2005); Kuala Lumpur,
reasonable price Malaysia (2009); Beijing (2008); Helsingør, Denmark
. Improved health and safety (2007); Sun City, South Africa (2006); Stockholm
65 . Improved environmental protection and reduction (2004); Kansas City (2003); and Tokyo (2002). 110
of waste With the approval of a new work item (via a ballot
. Greater compatibility and interoperability of goods with a majority of the participating member coun-
and services tries), the proposed document goes through various
. Reduction in the number of models, which in turn stages starting from a working draft (WD), to a com-
70 reduces costs mittee draft (CD), to a draft international standard 115
. Increased distribution efficiency (DIS), and, finally, to a final draft international stan-
. Ease of maintenance dard (FDIS).Another class of documents that are
guidelines rather than standards are technical reports
Statistical methods contribute to these areas, for (TRs), with prior stages being draft technical reports
example, through assessing measurement uncertainty (DTRs). One other type of document is a technical 120
75 and for calibrating, monitoring, and improving mea- specification (TS) document, which could be pub-
surement processes in production (Perruchet 2008). lished, for example, if the technical committee was
Perruchet further noted that some agencies call for unable to reach sufficient support for the material
statistical methods in testing, verifying conformance, as an international standard but nevertheless wanted
and validating the producer’s quality and environ- the document to be published. At each stage, mem- 125
80 mental management systems. The description above ber countries can vote outright approval, approval
provides a rationale for the official scope of ISO TC69: with comments, disapproval with comments, or
abstain. The process is extremely rigorous and the
Standardization in the application of statistical meth- comments can be extensive, with each comment
ods, including generation, collection (planning and
Q4 design), analysis, presentation and interpretation of data. from each member body requiring a specific 130
response prepared by the working group. Upon ulti-
85 The official scope actually applies broadly to stat- mate publication, the international standards are sub-
istical methods but covers the previously mentioned ject to periodic review, revision, and renewal.
realms that are featured prominently in the overall Throughout the process, ISO maintains a ‘‘clock’’
portfolio of ISO standards. regarding the progression of the document through 135
its various stages. Delays in meeting the schedule
STANDARDS CREATION AND can lead to the cancellation of projects, requiring
later resuscitation as a new work item if the parties
90 PROGRESSION TO PUBLICATION involved or new groups wish to continue. Note that
The production of standards proceeds through a the bulk of the work in writing the standards is 140
well-defined process subject to detailed directives done by volunteer experts whose other duties can
published jointly by the ISO and a sister standards intervene with the completion of projects.
M. Boulanger et al. 2
Q5 Subcommittee or working group Title Secretariat Chair(s) or convenor Secretary
Subcommittee 1 of TC69 is responsible for termin- design, and quality function deployment (QFD) that
160
ology and symbols. For many of the technical com- are not currently present in the ISO 3534 series.
mittees of ISO, the first numbered subcommittee
deals with terminology. Clearly defined terms are
ISO TC69/SC4
essential to achieving harmony and consensus with Subcommittee 4 of TC69 covers the area of statisti-
165 the other standards produced by a technical commit- cal process control (SPC) including control charts, 195
tee. TC69 has three published standards on termin- cumulative sum (CUSUM) charts, and process capa-
ology with the series designation ISO 3534. The bility and performance. The current set of SC4
parts are as follows: published documents is as follows:
ISO 3534-1:2006: Statistics—Vocabulary and sym- ISO 22514-1:2009: Statistical methods in process
170 bols—Part 1: General statistical terms and terms management—Capability and performance— 200
used in probability Part 1: General principles and concepts
3 Reviews of Standards
ISO 22514-3:2008: Statistical methods in process 105D on acceptance sampling was the forerunner Q6
management—Capability and performance— to the ISO 2859 series of documents. Documents
Part 3: Machine performance studies for measured have been developed to standardize acceptance 250
205 data on discrete parts sampling methods involving sampling by attributes,
ISO=TR 22514-4:2007: Statistical methods in process by variables, and for cases where the items are in
management—Capability and performance— lots. Attention is also given to achieving various cri-
Part 4: Process capability estimates and teria with respect to the acceptance of parts or lots.
performance measures Currently, the documents under the purview of SC5 255
210 ISO 21747:2006: Statistical methods—Process perfor- are as follows:
mance and capability statistics for measured
quality characteristics ISO 2859-1:1999: Sampling procedures for inspection
ISO 11462-1:2001: Guidelines for implementation of by attributes—Part 1: Sampling schemes indexed
statistical process control (SPC)—Part 1: Elements by acceptance quality limit (AQL) for lot-by-lot
215 of SPC inspection (with corrections 2001 and 2011) 260
ISO 8258:1991: Shewhart control charts (with a ISO 2859-2:1985: Sampling procedures for inspection
correction in 1993) by attributes—Part 2: Sampling plans indexed by
ISO 7966:1993: Acceptance control charts limiting quality (LQ) for isolated lot inspection
ISO 7873:1993: Control charts for arithmetic average ISO 2859-3:2005: Sampling procedures for inspection
220 with warning limits by attributes—Part 3: Skip-lot sampling procedures 265
ISO=TR 7871:1997: Cumulative sum charts— ISO 2859-4:2002: Sampling procedures for inspection
Guidance on quality control and data analysis by attributes—Part 4: Procedures for assessment of
using CUSUM techniques declared quality levels
ISO 7870-1:2007: Control charts—Part 1: General ISO 2859-5:2005: Sampling procedures for inspection
225 guidelines by attributes—Part 5: System of sequential sam- 270
ISO 7870-4:2011: Control charts—Cumulative sum pling plans indexed by acceptance quality limit
charts (AQL) for lot-by-lot inspection
ISO 2859-10:2006: Sampling procedures for inspec-
Document ISO 7871 is being withdrawn but the tion by attributes—Part 10: Introduction to the
updated material will be incorporated in the ISO ISO 2859 series of standards for sampling for 275
230 7870 series of documents (eventually consisting of inspection by attributes
seven parts including Part 2: Shewhart control charts ISO 3951-1:2005: Sampling procedures for inspection
and Part 3: Acceptance control charts). The series by variables—Part 1: Specification for single sam-
ISO 22514 is also being expanded to additional parts. pling plans indexed by acceptance quality limit
In addition to the published Parts 1, 3, and 4 listed (AQL) for lot-by-lot inspection for a single quality 280
235 above, there will be Part 2: Process capability and characteristic and a single AQL (amended in 2009
perfomance of time-dependent process models, and with revision underway as a CD)
Part 6: Process capability statistics for characteristics ISO 3951-2:2006: Sampling procedures for inspection
following a multivariate normal distribution, and by variables—Part 2: General specification for sin-
Part 7: Capability of measurement processes. Ulti- gle sampling plans indexed by acceptance quality 285
240 mately, the complete set of these documents should limit (AQL) for lot-by-lot inspection of inde-
prove very useful to practitioners. pendent quality characteristics (with revision
underway as a CD)
ISO 3951-3:2007: Sampling procedures for inspection
ISO TC69/SC5 by variables—Part 3: Double sampling schemes 290
As briefly noted in the Introduction, acceptance indexed by acceptance quality limit (AQL) for
sampling has been a staple among international stat- lot-by-lot inspection
245 istical standards dueto its relevance to munitions and ISO 3951-4:2007: Sampling procedures for inspection
other areas of large-scale production requiring by variables—Part 4: Procedures for assessement
inspection procedures. The U.S. standard MIL-STD- of declared quality levels 295
M. Boulanger et al. 4
ISO 3951-5:2006: Sampling procedures for inspection statisticians and physicists. One can discern from
by variables—Part 5: Sequential sampling plans the list of SC6 documents given below that two of
indexed by acceptance quality limit (AQL) for their major efforts went into the production of the
inspection by variables (known standard deviation) ISO 5725 and ISO 11843 series of documents. 345
300 ISO 8422:2006: Sequential sampling plans for Capability of detection is very important in determin-
inspection by attributes ing the presence of toxic materials, for example, and
ISO 8423:2008: Sequential sampling plans for inspec- issues related to accuracy (trueness and precision)
tion by variables for percent nonconforming are fundamental to all laboratory work.
(known standard deviation)
305 ISO=TR 8550-1:2007: Guidance on the selection and ISO 5725-1:1994: Accuracy (trueness and precision) 350
usage of acceptance sampling systems for inspec- of measurement methods and results—Part 1:
tion of discrete items in lots—Part 1: Acceptance General principles and definitions (with correction
sampling 1998)
ISO=TR 8550-2:2007: Guidance on the selection and ISO 5725-2:1994: Accuracy (trueness and precision)
310 usage of acceptance sampling systems for inspec- of measurement methods and results—Part 2: 355
tion of discrete items in lots—Part 2: Sampling by Basic method for the determination of repeatabil-
attributes ity and reproducibility of a standard measurement
ISO=TR 8550-3:2007: Guidance on the selection and method (with correction 2002)
usage of acceptance sampling systems for inspec- ISO 5725-3:1994: Accuracy (trueness and precision)
315 tion of discrete items in lots—Part 3: Sampling by of measurement methods and results—Part 3: 360
variables Intermediate measures of the precision of a stan-
ISO 13448-1:2005: Acceptance sampling procedures dard measurement method (with correction 2001)
based on the allocation of priorities principle ISO 5725-4:1994: Accuracy (trueness and precision)
(APP)—Part 1: Guidelines for the APP approach of measurement methods and results—Part 4:
320 ISO 13448-2:2004: Acceptance sampling procedures Basic methods for the determination of the 365
based on the allocation of priorities principle trueness of a standard measurement method
(APP)—Part 2: Coordinated single sampling plans ISO 5725-5:1998: Accuracy (trueness and precision)
for acceptance sampling by attributes of measurement methods and results—Part 5:
ISO 14560:2004: Acceptance sampling procedures Alternative methods for the determination of the
325 by attributes—Specified quality levels in noncon- precision of a standard measurement method 370
forming items per million (with correction 2005)
ISO 18414:2006: Acceptance sampling procedures by ISO 5725-6:1994: Accuracy (trueness and precision)
attributes—Accept-zero sampling system based on of measurement methods and results—Part 6:
credit principle for controlling outgoing quality Use in practice of accuracy values (with correction
330 ISO 21247:2005: Combined accept-zero sampling 2006) 375
systems and process control procedures for ISO 10576-1:2003: Statistical methods—Guidelines
product acceptance for the evaluation of conformity with specified
ISO 24153:2009: Random sampling and randomiza- requirements—Part 1: General principles
tion procedures ISO 11095:1996: Linear calibration using reference
335 ISO 28801:2011: Double sampling plans by attributes materials 380
with minimal sample sizes, indexed by producer’s ISO 11843-1:1997: Capability of detection—Part 1:
risk quality (PRQ) and consumer’s risk quality Terms and definitions (with correction 2003)
(CRQ) ISO 11843-2:2000: Capability of detection—Part 2:
Methodology in the linear calibration case (with
correction 2007) 385
ISO 11843-3:2003: Capability of detection—Part 3:
ISO TC69/SC6 Methodology for determination of the critical
340 Subcommittee 6 deals with metrology and value for the response variable when no
measurement systems and is populated by both calibration data are used
5 Reviews of Standards
390 ISO 11843-4:2003: Capability of detection—Part 4: use as international standards but would illustrate
Methodology for comparing the minimum detect- sound practice and would draw upon existing inter-
able value with a given value national statistical standards as appropriate. Six tech-
ISO 11843-5:2008: Capability of detection—Part 5: nical guidelines or standards have been published
Methodology in the linear and non-linear with several others in intermediate stages of pro- 440
395 calibration cases duction. The six published technical guideline
ISO=DIS 11843-6: Capability of detection—Part 6: reports or standards are as follows:
Methodology for the determination of the critical
value and the minimum detectable value in ISO=TR 29901:2007: Selected illustrations of full
Poisson distrbuted measurements by normal factorial experiments with four factors (with
400 approximations correction 2009) 445
ISO=DIS 11843-7: Capability of detection—Part 7: ISO=TR 12845:2010: Selected illustrations of
Methodology based on stochastic properties of fractional factorial screening experiments
instrumental noise ISO=TR 14468:2010: Selected illustrations of attribute
ISO 13528:2005: Statistical methods for use in pro- agreement analysis
405 ficiency testing by interlaboratory comparisons ISO=TR 12888:2011: Selected illustrations of gauge 450
(with revision underway with a CD) repeatability and reproducibility studies
ISO=DTR 13587: Three statistical approaches for the ISO 13053-1:2011: Quantitative methods in process
assessment and interpretation of measurement improvement—Six Sigma—Part 1: DMAIC
uncertainty methodology
410 ISO=TS 21748:2010: Guidance for the use of repeat- ISO 13053-2:2011: Quantitative methods in process 455
ability, reproducibility and trueness estimates in improvement—Six Sigma—Part 2: Tools and
measurement uncertainty estimation techniques
ISO=TS 21749:2005: Measurement uncertainty for
metrological applications—Repeated measure- Documents likely to be published within the next
415 ments and nested experiments few years cover the areas of response surface meth-
ISO=TR 22971:2005: Accuracy (trueness and pre- ods (ISO=TR 13195) and contingency table analysis 460
cision) of measurement methods and results— (ISO=TR 16705).
Practical guidance for the use of ISO 5725-2:1994
in designing, implementing and statistically ana-
420 lysing interlaboratory repeatability and reproduci-
ISO TC69/SC8
bility results Subcommittee 8was the most recently established
ISO=TS 28037:2010: Determination and use of subcommittee (2009) in TC69 and was instigated by
straight-line calibration functions the need to produce statistical standards in support 465
of quality management, without overlapping with
the domain of ISO TC176 on quality managment
and quality assurance. Working groups have been
ISO TC69/SC7 established to address robust parameter design and
425 Subcommittee 7 was established in 2008 in sampling associated with voice of the customer and 470
response to a perceived need to provide user- preliminary design issues. Quality function deploy-
friendly documents of use to the Six Sigma com- ment and Design for Six Sigma (jointly with SC7)
munity. In particular, the documents to be produced are also in the development stage.
were planned to include detailed, interesting exam-
430 ples drawn from actual experiments and projects
and would include output from statistical software
ISO TC69/WG3
packages (without suggesting a preference, which TC69 has produced other international standards 475
would violate ISO Directives). With these constraints that are not presently under the aegis of an existing
in mind, SC7 elected to produce technical guideline subcommittee. Subcommittee 2 on applications of
Q7 435 documents that do not have the compulsion for statistics and Subcommittee 3 on bulk sampling were
M. Boulanger et al. 6
disbanded and their work was assumed by TC69 ISO 11648-1:2003: Statistical aspects of sampling 525
480 because the member countries managing these SCs from bulk materials—Part 1: General principles
were no longer willing to make the financial commit- ISO 11648-2:2001: Statistical aspects of sampling
ment to continue. The published documents outside from bulk materials—Part 2: Sampling of
the existing SCs are as follows: particulate materials
7 Reviews of Standards
Boulanger, M., Johnson, M. E., Perruchet, C., Thyregod, P. (1999). Evol- ISO Supplement, Procedures Specific to ISO. (2011). Geneva: International
570 ution of international statistical standards via life cycle of products and Organization for Standardization. Q9 Q8
services. International Statistical Review, 67:151–171. Murphy, T. D., Bzik, T. J., Ullman, N. R. (2011). Statistical standards and
Fortini, P., Luko, S. (2011). Statistical standards and ASTM, Part 4. Quality ASTM, Part 3. Quality Engineering, 23(2):212–216.
Engineering, 23(3):309–313. Neubauer, D. V., Luko, S. (2011). Statistical standards and ASTM, Part 2. 585
ISO=IEC Directives, Part 1: Procedures for Technical Work. (2011). Quality Engineering, 23(1):100–104.
575 Geneva: International Organization for Standardization and Perruchet, C. (2008). The crucial role of statistics. ISO Focus, 33–35. Q11
Q8 Q10 International Electrotechnical Commission. Qiupeng, J., Meidong, C., Wenzhao, L. (1995). Ancient China’s history of
ISO=IEC Directives, Part 2: Rules for the Structure and Drafting managing for quality. In: Juran, J. M., Ed. A History of Managing
of International Standards. (2011). Geneva: International Organiza- Quality. Milwaukee, WI: ASQC Quality Press, 1–31. 590
tion for Standardization and International Electrotechnical Ullman, N. R., Luko, S. (2010). Statistical standards and ASTM. Quality
Q9 580 Commission. Engineering, 22(4):358–363.
M. Boulanger et al. 8