Irena Ograjensek

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Poul Thyregod
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ISO 9000:2000
ISO 9000
International quality
Quality circles
Quality management system
(QMS)
Statistical methods
Demings !" #oints
$m#loyee education %
training
&otal Quality Management
(&QM)
Quality Progress ' 200" (anuary )) bac*
Qualitative Vs. Quantitative Methods
by Irena Ogra+ense* and ,oul &hyregod
In 50 Words or Less
Statistics- .hile necessary /or quality- are a /requently neglected com#onent o/
quality management systems0
&his is not sur#rising since ISO 9000:!99" mentioned statistics only brie/ly and
didnt lin* to statistical standards until !9990
&he situation has im#ro1ed .ith ISO 9000:2000- but organi2ational- national
and international e//ort is still needed0
&he use o/ statistical methods in certi/ied quality management systems (QMSs)
has been a /requently discussed to#ic e1er since the total quality management
(&QM) and ISO 9000 certi/ication boom in the 30s and 40s0
5y the 90s- many o/ the e6#erts re/erenced at the end o/ this article .ere noting
that statisticians /requently stood aside and .atched the quality mo1ement hy#e
or o1erem#hasi2e the qualitati1e as#ects o/ quality management0
7lthough M0&0 82arnec*i claimed the quality mo1ement re#resents an im#etus /or
measurement-
!
it is clear ISO 9000 certi/ied com#anies /ocus #rimarily on &QMs
#hiloso#hy .ithout really embracing statistical methodology0
&hus- .hile conce#ts such as quality circles and 90 $d.ards Demings !" #oints
ha1e been .idely acce#ted and used- statistical as#ects o/ quality management
ha1e usually remained the neglected com#onent o/ QMSs0
&here are t.o reasons /or this state o/ a//airs: measurement di//iculties and
quantitati1e illiteracy o/ em#loyees0 O/ the t.o #roblems- quantitati1e illiteracy is
doubtless the more di//icult to o1ercome0
Quantitati1e literacy includes not only statistical literacy (the ability to select- use
and inter#ret the results o/ #ro#er statistical methods to sol1e a #roblem)- but also
com#uter literacy (the ability to use the #ro#er statistical so/t.are to sol1e a gi1en
#roblem) and online literacy (the ability to /ind and access data and in/ormation
online)0
$uro#ean e6am#les o/ #roblems created by statistical illiteracy abound0 Slo1enian
com#anies lac* #ersonnel .ith /ormal statistical training and e6#ertise0
2
7n
interesting study on the use o/ statistical methods in S.edish small and
medium:si2ed com#anies #resents clear e1idence o/ #oor utili2ation o/ statistical
quality control in manu/acturing0
;
In his /are.ell Quality ,rogress <Statistics 8orner< column in !994- 5ert =unter
bluntly said:
ISO:mania is sym#tomatic o/ an e1er more #er1asi1e decline in the quality
#ro/ession 000 : the retreat /rom quantitati1e methodology to so/t quality 000
>.hich? em#hasi2es human relations- #ersonnel organi2ation- communications
#rocedures- meeting conduct and the li*e0
7@$A7=$ A7&IB=
Out o/ ! Aatings
Aate this article
@ie. comments
8omments C7Q
Related rti!les
8olumn: Standards
Outloo*: Im#lementing
ISO 900!:2000
8olumn: $merging
Sectors: 9hy an
association became
ISO 900! certi/ied0
8olumn: Standards
Outloo*: 7uditing ISO
900!:20000
Related "is!ussions
Quality ,rogress
Discussion 5oard
Members Dog In Bo.
#$R%&

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1 o ! 1"#11#2011 2:$1
I do not .ish to dismiss this stu// as uselessE some is both necessary and
im#ortant0 Fo.e1er- .ithout the core quantitati1e disci#lines that actually
measure and e//ect real im#ro1ement- it ends u# being mere /lu// and
distraction::all /orm and no substance0 000 I belie1e that the /light /rom
quantitati1e methodology in general::and statistical methodology in
#articular::is basically a ca#itulation0 000
It is a lot easier to send e1eryone through a class on ho. to hold better
meetings or im#ro1e interde#artment communication than it is to learn S,8 or
e6#erimental design0 So by dismissing quantitati1e methods as inadequate and
ine//ecti1e- one a1oids ha1ing to e6#end that e//ort0
"
It is no sur#rise quantitati1e methods ha1e not been a #riority0 Older 1ersions o/
the ISO 900! standard address the issue o/ statistical analysis in +ust t.o brie/
#aragra#hs (see Cigure !)- and the necessary lin*s to international statistical
standards .erent #ublished until much later in ISO'&A !00!3:!999- Guidance on
Statistical Techniques for ISO 9001:19940
In ISO 900!:2000- a more #rocess based structure has been introduced- together
.ith an increased /ocus on continuous quality im#ro1ement and customer
orientation0 &he ne. 1ersion stresses an e1idence based a##roach to decision
ma*ing and- accordingly- deals .ith issues o/ measurement- analysis and
im#ro1ement in much more detail in its clause 4 (see Cigure 2 /or the general
requirements in 40!)0
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7#art /rom the general requirements #ro1ided in 40!- clause 4 also includes
guidelines on measurement o/ customer satis/action- internal audits- and
monitoring and measurement o/ both #rocesses and #roducts0 &he clause also
addresses the control o/ measurement systems- noncon/orming #roducts and the
issue o/ data analysis0
Des#ite the heroic e//ort to u#date the ISO'&A !00!3:200; guidance document to
align it .ith ISO 900!:2000 clause by clause and des#ite an identi/ication o/ need
/or quantitati1e data and a##ro#riate statistical techniques associated .ith the
im#lementation o/ the clauses- it is questionable .hether this re1ision o/ the
standard and the guidance document can result in ra#id #ositi1e changes o/
attitudes to.ard the use o/ the statistical toolbo6 in com#anies .ith ISO 900!
certi/ied QMSs0
Some may not consider this a #roblem because o/ a.areness that com#anies
.hose #roduction 1itally de#ends on statistical trials (the chemical-
#harmaceutical and /ood industries- /or e6am#le) ha1e not decreased their use o/
statistical methods0
O1erall- ho.e1er- the neglect o/ statistical methods at both micro (com#any) and
macro (national and international) economic le1els that started during the &QM
and ISO 9000 certi/ication boom has continued to this day0
&o' To %hange Things
&his state o/ a//airs needs to change at com#any- national and international
le1els0 7mong the .ays at the com#any le1el are the /ollo.ing:
,ro/essional statisticians should #artici#ate in regular audits on the use o/
statistical methods in quality im#ro1ement #rocesses at the com#any le1el0 It
is 1itally im#ortant they not act as hostile e1aluators but instead assume the
role o/ /riendly consultants- thus o1ercoming the em#loyee a1ersion to the
use o/ statistical methods0
&his idea .as im#lemented by a leading G0S0 #harmaceutical giant- and the
results .ere im#ressi1e0
H
Criendly consultations can also be im#lemented in
a business to business mentoring scheme- as sho.n in a re#ort /rom the
Gnited Iingdom0
J
&o# managements in1ol1ement in the #rocess o/ integration o/ statistical
methods into the quality system is critical- along .ith a##ointment o/ a
statistical coordinator .hose #rimary tas* is harmoni2ation o/ statistical
acti1ities .ithin a com#any0
3
Si6 Sigma- aimed at the near elimination o/ de/ects /rom e1ery #roduct-
#rocess and transaction- has /ound broad acce#tance at the com#any le1el0
Si6 Sigma is a disci#lined quantitati1e a##roach /or im#ro1ement o/ de/ined
indicators (called metrics) in all ty#es o/ business #rocesses0 Quality
im#ro1ements are seen as leading to huge cost sa1ings0 Initially introduced
by Motorola and .idely used by giants such as =eneral $lectric- the initiati1e
has a broad business character0
Other statistical acti1ities and #ro#osals at the micro le1el are scarce0 9ithout the
micro le1el initiati1es- it is questionable .hether signi/icant #rogress in the use o/
statistical methods can be achie1ed at the national and international le1el0
Be1ertheless- /ollo.ing are some #ossibilities:
Quality associations such as the $uro#ean Organi2ation /or Quality ($OQ)
and its national counter#arts could #ay more attention to the use o/ statistical
methods- lessening their /ocus on standardi2ation alone0
7t its annual congresses in the #ast- $OQ usually dedicated only a single
session to the use o/ statistical methods in QMSs0 9hile sessions on
statistics ha1e recently increased- some o/ the congresss industrial
character has been lost- .ith attention no. shi/ted to to#ics such as quality
in the ser1ice sector- customer satis/action and customer loyalty0
Bational and international societies and associations o/ statisticians should
#romote the use o/ statistical methods in quality im#ro1ement #rocesses0
&he same could also be claimed /or national and international statistical
o//ices and agencies com#iling statistical data- although they seem to ha1e
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$ o ! 1"#11#2011 2:$1
other #riorities0 ,arado6ically though- they embraced the &QM #hiloso#hy
and ha1e been engaged in continuous quality im#ro1ement o/ their internal
#rocesses /or the last /e. years0
Bational chambers o/ commerce and similar organi2ations should become
more in1ol1ed0 5ut initiati1es such as the establishment o/ com#any a.ards
/or e6cellent achie1ements in integration o/ statistical methods into QMSs
and /or continuous em#loyee training in #ro#er use o/ statistical methods
seem unrealistic and .ould #robably only add to the already enormous
bureaucratic strain on ISO 900! certi/ied com#anies0
7dditionally- in 1ie. o/ some recent studies o/ organi2ational learning- it
seems clear that unless initiati1es to use statistical methods in quality
im#ro1ement #rocesses originate /rom .ithin the com#any- they .ill ne1er be
/ully embraced by em#loyees- much less carried out 1igorously and
energetically0
4
$uro(ean Initiative
Since $uro#ean statisticians shared res#onsibility /or such a state o/ a//airs- it
became 1itally im#ortant to establish a #ro/essional net.or* to connect theoretical
and a##lied statisticians and statistical #ractitioners0 &he $uro#ean Bet.or* /or
5usiness and Industrial Statistics ($B5IS) .as /ounded in December 2000- and
its mission- goals and accom#lishments .ere described in a later article in Quality
Progress0
9
Cunctioning as a .eb based society- $B5IS connects members .ho belie1e
statistics are 1ital /or economic and technical de1elo#ment- and consequently-
im#ro1ed com#etiti1eness o/ $uro#ean com#anies0
,ro:$B5IS- the /undraising arm o/ $B5IS- obtained a grant /rom the $uro#ean
8ommission- and $B5IS recently concluded its success/ul third annual
con/erence0 &he con/erences #rimary goal .as to share e6am#les o/ good
#ractice in the use o/ quantitati1e methods to sol1e business and industry
#roblems0
In the /uture- $B5IS and ,ro:$B5IS .ill continue to su##ort the systematic
rea//irmation o/ the quantitati1e as#ects o/ quality management by #romoting the
.ides#read use o/ sound and science dri1en a##lied statistical methods in
$uro#ean com#anies0
9e belie1e an ongoing research #ro+ect across countries and industries should
be established to e//ecti1ely address and e1aluate .hether the #lanned
systematic rea//irmation o/ the quantitati1e as#ects o/ quality management can be
more easily achie1ed in com#anies .ith QMSs certi/ied to ISO 900! than in
com#anies not limited by the standard0
&hose interested in learning more about $B5IS and other initiati1es to reduce
quantitati1e illiteracy in business and industry are in1ited to 1isit ...0enbis0org0
%)*OWL$"+M$*T *" "I#%LIM$R
&he #re#aration o/ this article .as su##orted by /unding under the $uro#ean
8ommissions Ci/th Crame.or* <=ro.th< ,rogram 1ia the &hematic Bet.or*
<,ro:$B5IS< (contract re/erence: =JA&:200!:0H0H9)0 &he authors are solely
res#onsible /or the content0 &he content does not re#resent the o#inion o/ the
community- and the community is not res#onsible /or any use that might be made
o/ data therein0
R$,$R$*%$#
Mar* &0 82arnec*i- Managing y Measuring: !o" To I#$ro%e &our
Organi'ation(s Perfor#ance Through )ffecti%e *ench#ar+ing-
7macom- !9990
!0
Irena Ogra+ense*- <On the Im#ortance o/ Statistical Quality 8ontrol in a
Quality Management System-< Proceedings of the ,-nd Session of the
International Statistical Institute- @ol0 ;- !999- ##0 H;:H"0
20
Aichard =ar1are and FK*an 9i*lund- <Cacilitating the Gse o/ Statistical ;0
Qualitative vs. Quantitative Methods http://asq.org/data/subscriptions/qp/2004/0104/qp0104ograjensek.html
4 o ! 1"#11#2011 2:$1
Methods in Small and Medium Si2ed $nter#rises-< Proceedings of the
41st .ongress of the )uro$ean Organi'ation for Quality- @ol0 ;- !993-
##0 2!!:2200
5ert =unter- <Care.ell Cusillade-< Quality Progress- 7#ril !994- ##0
!!!:!!90
"0
(ohn S0 Iim and Michael D0 Darsen- <Integration o/ Statistical
&echniques Into Quality Im#ro1ement Systems-< Proceedings of the
41st .ongress of the )uro$ean Organi'ation for Quality- @ol0 2- !993-
##0 233:24"0
H0
Iim ,earce- Shirley 8oleman- Matt Dinsley- CrLydis 5+er*e- Desley
Cairbairn and Da1e Ste.ardson- <Small to Medium:Si2ed Industries and
the Im#ortance o/ Aeliable Measurement-< Proceedings of the Second
/nnual )0*IS .onference- Aimini- Italy- Se#t0 2;:2"- 2002- 8D:AOM0
J0
,Mter 9in*ler and INroly Da*at- <Integration o/ Statistical Methods Into
Quality 7ssurance Systems-< Proceedings of the 41st .ongress of the
)uro$ean Organi'ation for Quality- @ol0 ;- !993- ##0 2";:2H!0
30
Ien Irons- The 1orld of Su$erser%ice: .reating Profit Through a
Passion for .usto#er Ser%ice- 7ddison:9esley- Farlo.- !9930
40
SLren 5isgaard- Aonald Does and Da1e Ste.ardson- <$uro#ean
Statistics Bet.or* =ro.s Aa#idly-< Quality Progress- December 2002-
##0 !00:!0!0
90
-I-LIO+RP&.
$aston- =eorge S0- <7 5aldrige $6aminers 7ssessment o/ G0S0 &otal Quality
Management-< in A0$0 8ole- ed0- The 2eath and 3ife of the /#erican Quality
Mo%e#ent- O6/ord Gni1ersity ,ress- !99H- ##0 !!:"!0
Morita- 8hi*a/umi- <Status o/ ISO 9000 8erti/ication and &QM in (a#an-<
4a+o%ost- @ol0 2- !99J- ##0 !;:!H0
IR$* O+R/$*#$) is an assistant $rofessor of econo#icis at the 5ni%ersity
of 36ul6ana in Slo%enia7 She earned a doctorate in usiness and organi'ation
fro# the sa#e institution8 "riting her dissertation on the to$ic of custo#er loyalty
sche#es7
PO0L T&.R$+O" is a #e#er of the faculty of infor#atics and #athe#atical
#odeling at the Technical 5ni%ersity of 2en#ar+7 !e earned a doctorate in
#athe#atical statistics fro# the 5ni%ersity of .o$enhagen8 2en#ar+7 Thyregod
is a Senior Me#er of /SQ7
#o!ial -ook1arking
Digg- delicious- Be.s@ine- Curl- =oogle- S#url- 5lin*Dist- Sim#y- StumbleG#on-
5logMar*s- Caceboo*
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