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0.
QM - Quality Manual
IsoQual, Inc.
Revision:
Reviewed by ISO Management Representative
!pproved by "hie# $%ecutive O##icer
(insert your logo here)
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Table of Contents
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TITLE
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Table of Contents
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Scope
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Reference Documents
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Terms Te rms an! Def"n"t"ons
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%ual"t& 'anagement S&stem( )eneral Re*u"rements
#
$2$1
Documentat"on Re*u"rements( )eneral
+
$2$2
%ual"t& 'anual
+
$2$3
Control of Documents
+
$2$
Control of Recor!s
,
#$1
'anagement Comm"tment
-
#$2
Customer .ocus
-
#$3
%ual"t& Pol"c&
/
#$
%ual"t& 'anagement S&stem Plann"ng
/
#$#
Respons"b"l"t&( utor"t& utor"t& an! Commun"cat"on
11
#$+
'anagement Re"e
13
+$1
Pro"s"on of Resources
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+$2
4uman Resources
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+$3
Infrastructure
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5or6 En"ronment
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$1
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TITLE
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Plann"ng of Pro!uct Real"7at"on
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I!ent"f"cat"on of Pro!uct Re*u"rements
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,$2$2
Re"e of Pro!uct Re*u"rements
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,$2$3
Customer Commun"cat"ons
22
Des"gn an! Deelopment
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,$$1
Purcas"ng Process
2+
,$$2
Purcas"ng Informat"on
2,
,$$3
8er"f"cat"on 8e r"f"cat"on of Purcase! Pro!uct
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,$#$1
Control of Pro!uct"on an! Ser"ce Pro"s"on
2-
,$#$2
8al"!at"on 8a l"!at"on of Pro!uct"on9Ser"ce Pro"s"on Processes
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,$#$3
Pro!uct I!ent"f"cat"on an! Traceab"l"t&
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,$#$
Customer Propert&
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,$#$#
Preserat"on of Pro!uct
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,$+
Control of 'on"tor"ng an! 'easur"ng De"ces
33
-$1
'easurement( nal&s"s nal&s"s an! Improement( )eneral
3#
-$2$1
Customer Sat"sfact"on
3#
-$2$2
Internal u!"t
3+
-$2$3
'on"tor"ng an! 'easurement of Processes
3,
-$2$
'on"tor"ng an! 'easurement of Pro!uct
3-
-$3
Control of Nonconform"ng Pro!uct
0
-$
nal&s"s nal& s"s of Data
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-$#$1
Cont"nual Improement
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-$#$2
Correct"e ct"on
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-$#$3
Preent"e ct"on
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Terms Te rms an! Def"n"t"ons
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TITLE
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Plann"ng of Pro!uct Real"7at"on
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I!ent"f"cat"on of Pro!uct Re*u"rements
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,$2$2
Re"e of Pro!uct Re*u"rements
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,$2$3
Customer Commun"cat"ons
22
Des"gn an! Deelopment
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,$$1
Purcas"ng Process
2+
,$$2
Purcas"ng Informat"on
2,
,$$3
8er"f"cat"on 8e r"f"cat"on of Purcase! Pro!uct
2,
,$#$1
Control of Pro!uct"on an! Ser"ce Pro"s"on
2-
,$#$2
8al"!at"on 8a l"!at"on of Pro!uct"on9Ser"ce Pro"s"on Processes
31
,$#$3
Pro!uct I!ent"f"cat"on an! Traceab"l"t&
31
,$#$
Customer Propert&
32
,$#$#
Preserat"on of Pro!uct
32
,$+
Control of 'on"tor"ng an! 'easur"ng De"ces
33
-$1
'easurement( nal&s"s nal&s"s an! Improement( )eneral
3#
-$2$1
Customer Sat"sfact"on
3#
-$2$2
Internal u!"t
3+
-$2$3
'on"tor"ng an! 'easurement of Processes
3,
-$2$
'on"tor"ng an! 'easurement of Pro!uct
3-
-$3
Control of Nonconform"ng Pro!uct
0
-$
nal&s"s nal& s"s of Data
1
-$#$1
Cont"nual Improement
2
-$#$2
Correct"e ct"on
3
-$#$3
Preent"e ct"on
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L"st of ;e& %'S Documents
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ppen!": <
Terms Te rms an! Def"n"t"ons
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he automotive industry re*uires its supply base to participate in the design and development o# the components and systems that compose an O$M vehicle' his shi#t in responsibility to the supply base #or complete or partial responsibility #or engineering+ research+ and development has been coined as ,ull Service Suppliers Suppliers (,SS)' (,SS)' Iso-ual+ Inc' has based the -uality -uality Management Management System (-MS) described in this manual to demonstrate our ,SS capability (see Section 5.4.1.1)+ 5.4.1.1)+ to consistently consistently provide productsservices that meet customer and applicable applicable regulatory re*uirements+ and to operate with increased e##ectiveness and e##iciency with the overall aim o# enhancing customer satis#action' Our -MS utili.es the process approach and *uality management principles contained in the international standards: ISO standards: ISO 9000:2005+ 9000:2005+ ISO/TS 16949:2009 and ISO and ISO 9004:2000 to 9004:2000 to enhance our ability to continually improve' (/ote: you must obtain a complete copy o# the o##icial versions o# the latest ISO latest ISO standards0 standards0 use the lin1s contained in this document+ chec1 with the accrediting body in your country+ country+ andor contact ISO contact ISO directly') Our -MS was also developed in accordance with the #ollowing #our additional types o# documents containing recommended automotive industry practices+ e%amples+ illustrations and e%planations+ to #urther #acilitate continual improvement by emphasi.ing de#ect prevention and the reduction o# variation and waste: • •
• •
International !utomotive as1 ,orce (I!,) uidance to ISO/TS to ISO/TS 16949:2009 -uality System !ssessment "hec1list to ISO/TS to ISO/TS 16949:2009 (he 2-S! "hec1list2 is obsolete as an I!, document+ e##ective & 3une 4556 and is no longer available0 however+ you can utili.e our -S! "hec1list and !udit uide as an internal audit tool+ especially use#ul in conducting documentation reviews against the S standard) ISO/TS 16949:2009 !utomotive "erti#ication Scheme7Rules #or !chieving I!, Recognition "ustomer7speci#ic re*uirements and guidance documents
& '4
!pplication
Our -MS complies with all applicable re*uirements contained in ISO/TS in ISO/TS 16949:2009+ 16949:2009+ covers the design and provision o# all company products+ and encompasses all operations at our #acility located at &5859 obbs Station Road+ ;ouisville+ ) (>)'' he #ollowing table identi#ies ISO/TS identi#ies ISO/TS 16949:2009 re*uirements 16949:2009 re*uirements not applicable to our organi.ation and provides a brie# narrative ?usti#ying their e%clusion #rom the scope o# our -MS (e%clusions ( e%clusions are limited to clause @'9+ Product Pro duct Design and Development Development only0 only0 note: clause @'9 o# o# ISO/TS ISO/TS 16949:2009 always 16949:2009 always applies as applicable to Manu#acturing Process Design and Development re*uirements): re*uirements): ISO/TS 16949:2009 Re*uirements 16949:2009 Re*uirements $A";=SIO/ !B;$ "lause or Sub7clause $%clusion 3usti#ication /one 2.
"efe#ence $ocu%ents. (list all documents actually re#erenced in your manual)' manual)'
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he #ollowing e%ternal documents contain provisions which+ through re#erence in this manual+ constitute provisions o# our -MS: ISO 9000:2005+ 9000:2005+ -uality management systems C ,undamentals and vocabulary (/ote: ISO 9000:2000 was 9000:2000 was replaced with ISO with ISO 9000:2005' 9000:2005' he latest version introduces no changes to the descriptions o# the #undamentals o# *uality management systems0 however+ some de#initions have been added including those #or technical e%pert+ re*uirement+ competence+ contract+ auditor+ audit team+ audit plan+ and audit scope' ISO 9001:2008 , -uality management systems C Re*uirements ISO 9004:2000+ 9004:2000+ -uality management systems C uidelines #or per#ormance improvements
"ustomer Speci#ic Re*uirements (de#ine additional re*uirements documents here): here): •
•
• •
ISO/TS 16949:2009+ 16949:2009+ -uality management systems C particular re*uirements #or the application o# ISO o# ISO 9001:2008 #or 9001:2008 #or automotive production prod uction and relevant service part organi.ations CSR-Ford + ,ord Motor "ompany "ustomer7Speci#ic Re*uirements #or =se with ISO/TS 16949:2009 CSR-GM + eneral Motors "ustomer Speci#ic Re*uirements 7 ISO/TS 7 ISO/TS 16949:2009 CSR-C + Daimler"hrysler ("hrysler roup) "ustomer7Speci#ic Re*uirements #or =se with ISO/TS with ISO/TS 16949:2009
"ustomer Re#erence Manuals (de#ine your your customer guidance documents here): here): !"#" + !dvanced Product -uality Planning "ontrol Plan (!P-P) FM$!-4++ Potential ,ailure Mode and $##ects !nalysis (,M$! ,ourth $dition) FM$!-4 ""! "" !"-4 "-4++ Production Prod uction Part !pproval Process (PP!P (PP!P ,ourth $dition) S"C-%++ Statistical Process "ontrol (SP") /ote: S"C-% (SP") /ote: he SP" Re#erence Manual+ Manual+ Second $dition+ has an improved #low and &) Rein#orces the need #or a systemic approach to analysis o# variation in data 4) !ddresses !ddresses additional control chart methods and tools+ too ls+ and 9) $%pands and improves coverage o# the capability analysis o# non7normal data MS!-%++ Measurement Systems !nalysis (MS!) MS!-% TS-#S!++ -uality System !ssessment (-S!) "hec1list' he E-S! TS-#S! E -S! "hec1listF is obsolete as an I!, document+ e##ective & 3une 4556 and is no longer available0 however we continue to o##er an an adapted version o# the -S! as as an audit tool+ see For& 8.2.2-%' 8.2.2-%' TS-GS + I!, uidance to ISO/TS to ISO/TS 16949:2009 International !utomotive Oversight Bureau (I!OB) web site: (http:www'iat#globaloversight'orgcontent'asp% contains a wide variety o# resources including sanctioned interpretations and responses to #re*uently as1ed *uestions' • • • •
• •
• •
!''endi( ! contains ! contains a ;ist o#
Te#%s an& $e $efinitions.
Our -MS uses the same internationally recogni.ed terms+ vocabulary and de#initions given in ISO in ISO
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9000:2005 as supplemented by terms de#ined in ISO/TS 16949:2009 , Section %.1' !cronyms+ terms+ vocabulary and de#initions uni*ue to our organi.ation+ customers+ industry and region and re#erenced throughout our -MS are contained in !''endi( )+ erms and De#initions (de#ine your uni*ue termsde#initions+ i# any+ in !''endi( ))' 4.
Quality Mana(e%ent yste%
6'&
eneral re*uirements
Our -MS is that part o# our overall management system which establishes+ documents and implements our *uality policy+ and related processes #or providing products and services which meet or e%ceed customer re*uirements+ and satis#ies -MS re*uirements o# ISO/TS 16949:2009' Ge have adopted the process approach advocated by ISO 9000:2005+ by de#ining and managing: process inputs+ controls+ and outputs to ensure desired results are achieved+ and inter#aces between interrelated processes to ensure system e##ectiveness is achieved' • •
Our Hcore business processes are what we call H"ustomer Oriented Processes+ or "OPs+ which are in place to meet the speci#ic needs o# our e%ternal customers+ which directly relate to re*uirements contained in "lause @ o# ISO/TS 16949:2009+ Product Reali.ation processes (i'e' things we Hdo)' he basic se*uence and interaction o# our "OPs is depicted in CO" 4.1' Ge have developed appropriate HSupport Oriented Processes+ or SOPs+ to help implement "OPs in the most e##ective and e##icient manner possible' Ge also have developed HManagement Oriented Processes+ or MOPs+ to help meet the speci#ic needs o# management and our share holders+ andor to meet re*uirements o# ISO/TS 16949:2009 and other e%ternal standards and regulatory re*uirements' he overall se*uence o# -MS processes (i'e' "OPs+ SOPs and MOPs) are depicted in FC 4.1 and their (primary) interaction is depicted in our "OP Interaction Matri% , *I 4.1-1' echni*ues and tools #or process management are discussed in Section 8' Speci#ic responsibilities #or and the se*uence and interaction o# our 1ey -MS processes are detailed in Operating Procedures (OPs)+ many o# which contain or re#erence deployment #low charts depicting the process or procedure described in the narrative OP0 !''endi( ! contains a ;ist o#
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Documentation re*uirements
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his manual contains documented statements o# our *uality policy and *uality ob?ectives and re#erences documented procedures re*uired by ISO/TS 16949:2009 and other documents needed to ensure e##ective planning+ operation and control o# our 1ey -MS processes ( FC 4.1)' he level and type o# -MS documentation established #or our business is continually reviewed to ensure it remains appropriate #or the comple%ity and interaction o# our processes and the competence o# our employees' -MS documents and data may be in hard copy or electronic media' -MS documentation includes this *uality manual+ OPs+ D,"s+ and other internal and e%ternal documents and data needed to manage+ per#orm or veri#y wor1 a##ecting product *uality' Ge use OPs to document and de#ine the 1ey -MS processes depicted in FC 4.1' Ge use D,"s and P!Gs (with associated urtle Diagrams) to aid in the development+ assessment andor improvement (Section 8.4) o# processes de#ined in OPs' Ge also issue and control wor1 instructions+ ?ob descriptions+ and other internal and e%ternal documents and data as appropriate and needed to e##ectively manage our -MS (Section 4.2.%)' 6'4'4
-uality manual
his manual is that part o# our -MS that de#ines the scope o# our -MS and documents the policy+ procedures and processes needed to implement our *uality policy and achieve our *uality ob?ectives' his manual also documents ?usti#ications #or e%clusions #rom ISO/TS 16949:2009 re*uirements Section 1.2) and de#ines the overall se*uence o# and interaction between our 1ey -MS processes ( FC 4.1)' 6'4'9
"ontrol o# documents
he In#ormation Systems Manager (>) has overall responsibility #or ensuring that all -MS documents+ including #orms used to create *uality records+ are controlled per procedures detailed in O" 4.2.% and summari.ed below: a) b) c) d) e) #)
approve documents #or ade*uacy prior to issue' review+ update as necessary and re7approve documents' identi#y the current revision status o# documents' ensure that relevant versions o# applicable documents are available at points o# use' ensure that documents remain legible+ readily identi#iable and retrievable' ensure that documents o# e%ternal origin (including customer engineering standardsspeci#ications) are identi#ied and their distribution controlled' g) prevent the unintended use o# obsolete documents+ and to apply suitable identi#ication to them i# they are retained #or any purpose'
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6'4'9'& $n3ineerin3 'eciic+tion' he $ngineering Manager (>) oversees our process #or assuring the timely review+ distribution and implementation o# all customer engineering standardsspeci#ications and changes based on customer7re*uired schedule0 Iso-ual+ Inc' uses a Product Data Management (PDM) system to manage and control engineering records and data (see O" 4.2.%)' Reviews are considered timely i# per#ormed within two wor1ing wee1s o# receipt' ! change re*uires an updated record o# customer production part approval when the speci#ications are re#erenced in the design record+ or i# the change a##ects Production Part !pproval Process (PP!P) documents (Section .%.6.%)' 6'4'9'& M+ter it' Re*uirements #or the establishment and maintenance o# Master ;ists o# internal and e%ternal -MS documents are de#ined in O" 4.2.%' 6'4'6
"ontrol o# records
he In#ormation Systems Manager (>) has overall responsibility #or ensuring that all records re*uired #or the -MS (including customer7speci#ied records) are controlled and maintained to provide evidence o# con#ormance to re*uirements and e##ective operation o# the -MS' Records are retained #or a period de#ined by the customer+ applicable regulatory re*uirements andor Iso-ual management+ as applicable+ and then disposed o# in accordance with applicable re*uirements' Records may be in the #orm o# hard copy or electronic media' O" 4.2.4 details procedures necessary to control -MS records that+ as a minimum+ are prepared to document: a) results o# processes per#ormed+ including identi#ication o# the individual per#orming the activity' b) productprocess evaluationacceptance criteria' c) procedures+ drawings or instructions used to per#orm an activity+ including revision or date o# document' d) identi#ication o# material+ parts+ or e*uipment used in the ma1ing o# the product' e) personnel+ material or e*uipment *uali#ications' #) pertinent technical records #rom sub7contractors' 6'4'6'& Record retention' O" 4.2.4 contains related procedures and responsibilities to ensure: • • •
Record controls established satis#y all regulatory and customer re*uirements' Records controlled include customer7speci#ied records' Disposition o# records also includes their disposal'
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Mana(e%ent "es!onsibility
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Management commitment
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op Management provides evidence o# its commitment to the development+ implementation and improvement o# our -MS in very tangible ways: Our *uality policy statement (Section 5.%) documents and communicates the importance o# meeting or e%ceeding all applicable re*uirements (including customer+ regulatory and legal re*uirements) through continual improvement o# our processes+ products+ and services' Ge ensure that our *uality policy is understood+ implemented+ and maintained at all levels o# the organi.ation through widespread printed distribution o# our *uality policy statement+ and through periodic management review o# the *uality policy statement and corporate level improvement ob?ectives (Section 5.4)' In addition+ our *uality policy and ob?ectives are communicated and deployed throughout the organi.ation through individual per#ormance ob?ectives established and reviewed during employee per#ormance reviews (Section 6.2.2.4)' !ll managers demonstrate their commitment to the development and improvement o# the -MS through the provision o# necessary resources (Section 6.1)+ through their involvement in the internal audit process (Section 8.2.2)+ and through their proactive involvement in our continual improvement activities (Section 8.5.1) C where emphasis is placed on improving both e##ectiveness and e##iciency o# our 1ey -MS processes' J'&'& "roce eicienc. op management reviews product reali.ation and support processes to assure both e##ectiveness and e##iciency during management reviews (Section 5.6.2)' J'4
"ustomer #ocus
Our *uality policy statement articulates our commitment to our customers:
*e 7i +ciee cto&er +ti+ction contin+ i&'roin3 'rocee, 'rodct +nd erice to enre te conitent &eet or e(ceed cto&er reire&ent op management ensures a proper customer #ocus is established and maintained through the #ollowing activities: "ustomer complaints and other customer input#eedbac1 are continually monitored and measured to identi#y opportunities #or improvement (Section 8.2.1)' Ge continually loo1 #or other ways to interact directly with individual customers to ensure a proper #ocus to their uni*ue needse%pectations is established and maintained: e'g' customer audits+ customer visits+ trade shows+ ?oint planning sessions+ etc'
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In addition+ we have established a "ustomer Service "enter and interactive web site: www'*ualitymap'com (enter your web site here+ i# applicable) to provide customers with *uic1 access to in#ormation and points o# contact within our organi.ation (Section .2.%)' hese customer #ocused communications and interactions ultimately yield clear+ e%plicit customer re*uirements and e%pectations in the #orm o# a contractual agreement or customer order0 the Sales Manager (>) has overall responsibility #or ensuring that speci#ied and unspeci#ied re*uirements are determined+ understood+ and converted into re*uirements (Section .2)' J'9
-uality policy (insert your *uality policy statement here):
*e 7i +ciee cto&er +ti+ction contin+ i&'roin3 'rocee, 'rodct +nd erice to enre te conitent &eet or e(ceed cto&er reire&ent Our *uality policy statement indicates our commitment and #ocuses on what is important to us as an organi.ation: +ciein3 cto&er +ti+ction0 and it prescribes the method by which we accomplish this: contin+ i&'roin3 'rocee, 'rodct, +nd erice to enre te conitent &eet or e(ceed reire&ent. Moreover+ our *uality policy statement acts as a compass in providing the direction and a #ramewor1 #or establishing 1ey corporate level per#ormance measures and related improvement ob?ectives (Section 5.4.1)' Ge ensure that our *uality policy is communicated and understood at all levels o# the organi.ation through documented training+ regular communication+ and rein#orcement during annual employee per#ormance reviews (Section 6.2.2.4)' Our *uality policy statement is controlled by inclusion in this manual+ and along with all policies contained in this manual+ is reviewed #or continuing suitability during management review meetings (Section 5.6.2)' J'6
Planning
J'6'&
-uality ob?ectives
Our overall *uality goal is to achieve our *uality policy+ and maintain the integrity o# and continually improve a -MS compliant with ISO/TS 16949:2009' ,urther+ we establish both corporate level and operational level improvement ob?ectives that are measurable and achievable within a de#ined time period' "orporate level improvement ob?ectives+ derived #rom our Business Plan and customer goalstargets+ are documented on a "ontinual Improvement ,orm+ Io#+ For& 8.5-6 + and reviewed #or achievement during management reviews (Section 5.6.2)' !ll managers (>) o# 1ey -MS processes monitor and measure per#ormance o# processes within their area(s) o# responsibility and+ where appropriate+ establish measurable operational level improvement ob?ectives consistent with our *uality policy and corporate level improvement ob?ectives' Operational level improvement ob?ectives are documented on Process !ssessment Gor1sheets (P!Gs)+ Io#+ For& 8.4-1+ and deployed to individuals or individual wor1 areas and monitored #or achievement through employee per#ormance reviews (Section 6.2.2.4)' "orporate and operational level improvement ob?ectives will be reviewed #or consistency+
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accomplishment and clarity through our management review process (Section 5.6 ) and may include anyall o# the #ollowing possible measures: (list here areas where you will eventually establish measurable *uality ob?ectives+ probably should include all o# the #ollowing): • • • •
•
• • •
"ustomer Satis#action: Sales Manager (>)0 Section 8.2.1' Supplier Per#ormance: Materials Manager (>)0 Section .4.1.2' -MS $##ectiveness: ISO Management Representative (>)0Section 8.5.1' Overall Operational $##iciency and Manu#acturing Process $##iciency: "hie# ,inancial O##icer (",O) (>)0 Section 6.1 and Section 5.1.1' raining $##ectiveness and $mployee !wareness: uman Resources O##icer (RO) with input #rom the raining Manager (>)0 Section 6.2.2.4' Product Per#ormance: $ngineering Manager (>)0 Section .%. $##ectiveness o# Manu#acturing Processes: Production Manager (>)0 Section .5.1' Product -uality: -uality Manager (>)0 Section 8.2.4'
J'6'&'& #+it o;ectie S''e&ent+ ' op management utili.es the management review process (Section 5.6.2) to de#ine *uality ob?ectives and measurements to be included in our Business Plan and used to deploy our *uality policy' Speci#ic measurable ob?ectives adopted will be based on achievable per#ormance within a speci#ied time #rame+ driven by the #ollowing ob?ectives we strive to achieve as a ,ull Service Supplier (,SS) to the automotive industry: a)
!chievement o# K$RO D$,$"S (Section 8.2.%.1) and &55L on time delivery (Section .5.1.6 ) per#ormance'
b)
Manage and control #acilities+ processes+ *uality systems and personnel to consistently and cost e##ectively produce products and #urnish services that meet customer needs (Section .5.1)'
c)
Develop and implement !dvanced Product -uality Planning ( !"#" ) practices and procedures (Section .1.1) in accordance with ISO/TS 16949:2009+ including the !I! E!dvanced Product -uality Planning and "ontrol PlanF re#erence manual+ !"#" , and associated customer speci#ic re*uirements documents'
d)
Provide ob?ective evidence that all supplied products and services satis#y all !I! Production Part !pproval Process (PP!P) re*uirements+ ""!"-4 (Section .%.6.%) as re*uired including acceptable process capabilities #or all Special"ontrol "haracteristics that have been established' /ote: In the absence o# any speci#ic instructions+ we will de#ault to a level 9 PP!P submission ( Section @'&'&)'
e)
=tili.e appropriate statistical techni*ues #or on7going process control and improvement (Section 8.1) as established in the !I! EStatistical Process "ontrol (SP")F re#erence manual+ S"C-% + and associated customer speci#ic re*uirements documents'
#)
Be committed to continuous process improvement (Section 8.5.1.2) by emphasising reduction o# part7to7 part variation and the elimination o# all waste'
g)
"onduct operations in con#ormance with+ or to e%ceed+ all applicable environmental laws and regulations o# the ?urisdictions in which we do business (Section 6.4)'
h)
Meet customer re*uirements with regard to use+ control and supply o# returnable pac1aging (Section .5.5)'
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-uality management system planning
he -MS planning process involves the establishment and communication o# our *uality policy (Section 5.%) and ob?ectives (Section 5.4.1) through issuance o# this manual and its associated procedures+ and through the provision o# resources needed #or its e##ective implementation (Section 6.1)' !ccordingly+ this manual constitutes our overall plan #or establishing+ maintaining and improving an e##ective -MS' Our management review process (Section 5.6) and internal audit process (Section 8.2.2) ensure the integrity o# our -MS is maintained when signi#icant changes are planned and implemented that a##ect our 1ey -MS processes depicted in FC 4.1' he -uality Manager (>) develops appropriate *uality planning documents #or speci#ic products+ pro?ects or contracts whenever customer re*uirements e%ceed the capability or intent o# the productservice reali.ation and support processes described in our -MS (Section .1)' J'J
Responsibility+ authority and communication
J'J'&
Responsibility and authority
he "hie# $%ecutive O##icer ("$O) sets direction and ensures the success o# our business through the clear de#inition and communication o# -MS responsibilities and authorities' Other members o# op Management include: (>) the "hie# Operations O##icer ("OO)+ the "hie# ,inancial O##icer (",O) and the uman Resources O##icer (RO)' he interrelationship o# op Management and other 1ey personnel is depicted our Organi.ation "hart+ Io#+ For& 5.5.1. Responsibility and interaction #or -MS processes is depicted in FC 4.1+ CO" 4.1 and *I 4.1-1' J'J'&'& Re'oniiit or +it' Overall -MS responsibility and authority is as #ollows (summari.e your 1ey -MS responsibilities and authorities here): •
op Management C Members o# op Management are ultimately responsible #or the *uality o# Iso-uals products and services since they control the systems and processes by which wor1 is accomplished' op Management is responsible #or Business Planning+ development and communication o# our *uality policy (Section 5.%)+ -MS Planning (Section 5.4.2) including the establishment and deployment o# ob?ectives (Section 5.4.1)+ the provision o# resources needed to implement and improve the -MS (Section 6.1) and management reviews (Section 5.6 )'
•
Management C !ll managers are responsible #or e%ecution o# the Business Plan and implementation o# the policy+ processes and systems described in this manual' !ll managers are responsible #or planning and controlling -MS processes within their area(s) o# responsibility+ including the establishment and deployment o# operational level ob?ectives (Section 5.4.1.1)+ and the provision o# resources needed to implement and improve these processes (Section 6.1)' Managers also conduct employee per#ormance reviews (Section 6.2.2.4)' Management with responsibility and authority #or corrective action are noti#ied promptly o# non7con#ormities (Section 8.5.2)' Management ensures that production across all shi#ts are sta##ed with personnel in charge o#+ or delegated responsibility #or product *uality (Section .5.1.1)'
•
$mployees 7 !ll employees are responsible #or the *uality o# their wor1 and
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implementation o# the policy and procedures applicable to processes they per#orm (Section 8.2.%)' Personnel responsible #or product *uality have the authority to stop production to correct *uality problems (Section 8.%)' $mployees are motivated and empowered (Section 6.2.2.4) to identi#y and report any 1nown or potential problems and recommend related solutions through internal audits (Section 8.2.2) andor the continual improvement and correctivepreventive action processes (Section 8.5)' Detailed responsibilities and authorities #or -MS implementation and improvement are contained in lower level documents re#erenced throughout this manual and other -MS documents including procedures+ #low charts+ ?ob descriptions+ wor1 instructions+ etc' J'J'4
Management representative
he ISO Management Representative (insert ?ob title o# your management representative here) is appointed as Iso-uals management representative with delegated responsibilities #or ensuring that an ISO/TS 16949:2009 compliant -MS is established+ implemented+ and maintained0 #or promoting awareness o# customer re*uirements throughout the organi.ation (Section 5.5.%)0 and #or ensuring that the per#ormance o# the -MS is reviewed by op Management #or e##ectiveness+ continuing suitability and the need #or improvement (Section 5.6 )' J'J'4'& Cto&er re'reent+tie' ! list o# "ustomer Representative(s)+ with responsibility and authority #or ensuring that customer re*uirements are ade*uately addressed throughout our organi.ation+ can be #ound on our web site at www'*ualitymap'com (identi#y your source here)' J'J'9
Internal communication
Ge communicate in#ormation regarding -MS processes and their e##ectiveness through documented training (Section 6.2.2)+ the internal audit process (Section 8.2.2)+ continual improvement and correctivepreventive action processes (Section 8.5)+ and regular #ormal and in#ormal communications as #ollows (identi#y your communication systems here): •
he ISO Management Representative (>) posts in#ormation on *uality bulletin boards throughout the #acility to convey in#ormation regarding customer re*uirements+ and the status and importance o# *uality activities' Internal audits (Section 8.2.2) are also used to rein#orce or communicate appropriate in#ormation to employees'
•
he Sa#ety Manager (>) posts in#ormation on sa#ety bulletin boards throughout the #acility to convey in#ormation regarding the status o# the Sa#ety and $nvironmental Management Program+ and related statutoryregulatory re*uirements'
•
•
he RO (>) posts in#ormation on employee bulletin boards throughout the #acility to convey in#ormation regarding employee bene#its+ programs+ involvement opportunities+ and applicable statutoryregulatory re*uirements' he RO (>) is also responsible #or publication o# Iso-ual+ Inc's newsletter+ ISO-O<I<$ (identi#y your newsletter title here+ i# applicable)' he In#ormation Systems Manager (>) ensures that consistent and e##ective #ormal communication is #acilitated through our Intranet system and interactive web site:
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www'*ualitymap'com (identi#y your web site here+ i# applicable)' !ll o##icers+ managers and supervisors (>)+ are responsible #or establishing internal communications as needed to convey to their employees the relevance and importance o# their activities0 typically this in#ormation is conveyed through production team meetings and cross7 #unctional improvement pro?ects (Section 8.5.1) (identi#y your communication mechanisms here)' "ommunications regarding how employees contribute to the achievement o# ob?ectives is also conveyed and rein#orced during employee per#ormance reviews (Section 6.2.2.4)' J'N
Management review
J'N'&
eneral
op Management conducts a management review meeting at least once annually to ensure the continuing suitability+ ade*uacy+ and e##ectiveness o# our -MS in accordance with procedures detailed in O" 5.6 ' he primary inputs reviewed include data that measures the con#ormance and per#ormance o# our -MS' "on#ormance is primarily assured through internal audits (Section 8.2.2) and demonstrated through a review o# internal audit results and our demonstrated ability to correctprevent problems' Per#ormance is primarily assured through the deployment o# corporateoperational level ob?ectives (Section 5.4.1) and demonstrated through a review o# our demonstrated ability to achieve desired results' he primary output o# management review meetings are management actions ta1en (Section 8.5) to ma1e changes or improvements to our -MS and the provision o# resources needed to implement these actions' J'N'&'& #+it &+n+3e&ent te& 'eror&+nce' $ach management review includes all re*uirements o# the -MS and its per#ormance trends+ including monitoring o# *uality ob?ectives (Section 5.4.1)+ regular evaluation o# the cost o# poor *uality (Section 8.4) + and an assessment o# the suitability and e##ective o# support processes (i'e' plant+ #acility and e*uipment+ Section 6.%.1) as an essential part o# our continual improvement process (Section 8.5.1 =. !t a minimum+ these results are used to demonstrate achievement o# the *uality ob?ectives in our Business Plan and customer satis#action with supplied product' J'N'4
Review input
he management review meeting includes a review o# our *uality policy (Section 5.%)+ all applicable re*uirements o# the -MS+ related per#ormance trends and opportunities #or improvement+ #ollow7up actions #rom earlier management reviews+ results o# sel# assessments (Section 8.4)+ and strategic or operational changes that could a##ect the -MS'
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!t a minimum+ corporate level e##ectiveness andor e##iciency improvement ob?ectives (Section 5.4.1) documented in prior management reviews (andor speci#ied in our Business Plan) are reviewed #or status and continuing suitability: J'N'4'& Reie7 in't S''e&ent+ ' In addition+ he $ngineering Manager (>) provides an analysis o# actual and potential #ield7#ailures and their impact on *uality+ sa#ety or the environment as an input to the management review process' J'N'9
Review output
!t a minimum+ outputs #rom management review meetings include newrevised corporate level improvement ob?ectives and any related actions re*uired #or improvement o# the -MS and its processes+ improvement o# product related to customer re*uirements+ and provision o# resource needs' Results o# management review meetings are recorded and maintained by the ISO Management Representative (>) per O" 5.6 . 6.
"esou#ce Mana(e%ent
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Provision o# resources
he ",O (>)+ with input #rom all responsible managers+ ensures+ appropriate resources+ including trained employees and appropriate e*uipment+ #acilities+ support services and wor1 environment needed to implement+ manage and improve an e##ectivee##icient -MS and enhance customer satis#action+ are identi#ied and provided through our budgeting and other business management processes including but not limited to: Section 5.4.2+ -MS Planning Section 5.5.1.1+ Business Planning (responsibility #or *uality) Section 6.2.2+ uman Resource Planning Section 6.%.1+ Plant+ ,acility+ $*uipment and other In#rastructure Planning Section 6.%.2+ "ontingency Planning Section 6.4+ Gor1 $nvironment and Sa#ety Planning Section .1+ Product -uality Planning (including !dvance Product -uality Planning) Section .2+ Planning o# "ustomer7related Processes Section .%.1+ Product and Manu#acturing Process Design and Development Planning Section .4+ Planning o# Purchased Product (Materials+ Services and endors) Section .5.1 , Production and Service Provision Planning Section .6 + Measurement Systems Planning (including the conduct o# MS!) Section 8.1+ Measurement+ !nalysis and Improvement Planning (including the use o# SP") Section 8.5.1.1+ Organi.ational "ontinual Improvement Planning Section 8.5.1.2+ Manu#acturing Process "ontinual Improvement Planning he ",O (>)+ with input #rom other responsible managers+ monitors and measures overall operational e##iciency (including the cost o# poor *uality) and provides related input and recommendations that may a##ect -MS e##ectiveness to op Management #or review and action (Section 5.6 )' N'4
uman resources
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eneral
Ge believe that our employees are our most valuable resource and we do our best to help them achieve their #ull potential through continual education and training' N'4'4
"ompetence+ awareness and training'
he competency o# people assigned responsibilities de#ined in the -MS is determined on the basis o# documented criteria #or appropriate education+ training+ s1ills+ and e%perience #or each re*uired competency or wor1 assignment' he RO (>) has overall responsibility #or administering Iso-uals uman Resource Management programs in accordance with procedures detailed in O" 6.2.2 and the #ollowing policies' N'4'4'a )+ with input #rom responsible managers+ evaluates and *uali#ies applicants #or speci#ic ?ob openings on the basis o# documented or demonstrated competencies' Ghere possible+ we help e%isting employees *uali#y #or newchanged ?obs through the provision o# appropriate education and training+ including on7the7?ob7training (O3)' he RO (>)+ with input #rom responsible managers+ establishes and maintains ?ob descriptions #or each position held at Iso-ual to document the speci#ic competencies needed to ensure the *uality o# Iso-uals products and services' !t a minimum+ these include: N'4'4'& "rodct dei3n >i' he $ngineering Manager (>) ensures that personnel with product or manu#acturing process design responsibility (Section .%.1.1 =are competent to achieve design re*uirements and are s1illed in design methods (Section .%.%) needed to achieve desired results' N'4'4'4 Tr+inin3 ' Responsible managers (>) identi#y training needs #or their employees and achieve competence o# all personnel per#orming activities a##ecting product *uality' Personnel per#orming speci#ic assigned tas1s are *uali#ied+ as re*uired+ with particular attention to the satis#action o# customer re*uirements (application o# digiti.ed mathematically based data+ e'g')' N'4'4'9 Tr+inin3 on te ;o' Responsible managers (>) ensure on the ?ob training (O3) is provided #or personnel in any new or modi#ied ?ob a##ecting product *uality+ including agency or contract employees' Responsible managers (>)+ through the employee per#ormance review process+ also ensure that employees are aware o# the relevance and importance o# their activities and how they contribute to the achievement o# our ob?ectives' N'4'4'6 $&'oee &oti+tion +nd e&'o7er&ent ' Ge utili.e the employee per#ormance review process to motivate employees to achieve individual or #unctional per#ormance ob?ectives that
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support achievement o# our corporate ob?ectives (Section 5.4.1)' $mployee per#ormance reviews and the internal audit process (Section 8.2.2) are used to promote and assess the e%tent o# *uality and technological awareness throughout our organi.ation' Responsible managers+ o##icers and supervisors (>) re7evaluate employee competencies and evaluate employee per#ormance against established ob?ectives through our employee per#ormance review process' N'4'4'b "roiion. raining needs identi#ied as a result o# the need determination activities discussed above are passed on to the RO (>) #or appropriate planning and timely provision' N'4'4'c $ectiene. Ge evaluate the e##ectiveness o# all actions ta1en to meet competency needs' raining provided is evaluated through immediate #eedbac1 #rom the employee and the manager+ o##icer+ or supervisor who identi#ied the training re*uirement' raining e##ectiveness is collected and documented by the responsible manager #or each training event' he RO(>)+ with input #rom other responsible managers+ monitors and measures the overall e##ectiveness o# training and other actions ta1en to meet competency needs and provides related recommendations to op Management #or review and action (Section 5.6 )' N'4'4'd $&'oee !7+rene. Ge ensure that our employees are aware o# customer re*uirements (Section 5.5.2 and Section 5.5.2.1)+ the relevance and importance o# their activities and how they contribute to the achievement o# our *uality policy (Section 5.%) and ob?ectives (Section 5.4.1.1)' his is accomplished through awareness training+ employee per#ormance reviews (Section 6.2.2.4)+ and employee participation in our internal audit (Section 8.2.2) and improvement (Section 8.5) processes' N'4'4'e Record.. Ge maintain appropriate records o# education+ training+ s1ills and e%perience in accordance with provision o# Section 4.2.4' $mployee *uali#icationcompetency review records and annual per#ormance review results are maintained by the RO (>)' he raining Manager (>) maintains records o# all training completed' N'9
In#rastructure
he "OO (>) has overall responsibility #or planning+ providing and maintaining the resources needed to achieve product con#ormance+ including buildings+ wor1space and associated utilities0 process e*uipment (hardware and so#tware)0 and supporting services (such as internal transportation and material handling systems and communications systems)' he Maintenance Manager (>) has overall responsibility #or managing our ,acilities and $*uipment Maintenance programs in accordance with O" 6.%0 these programs include: • • • • •
#acilities management+ maintenance and repair house1eepingcustodial services management process e*uipment management+ maintenance and repair production tooling management+ and transportation and material handling e*uipment management+ maintenance and repair'
N'9'& "+nt, +ciit, +nd ei'&ent '+nnin3 ' he "OO (>) uses a multidisciplinary approach #or developing plant+ #acility and e*uipment plans' he $ngineering Manager (>) ensures plant layouts are designed and continually evaluated through the application o# lean manu#acturing
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principles (state your approach here) to minimi.e material travel+ handling and value7added use o# #loor space and #acilitate synchronous material #low' he Maintenance Manager (>) develops and implements an e##ective preventive maintenance program utili.ing predictive maintenance methods (Section .5.1.4) as appropriate' he In#ormation Systems Manager (>) has overall responsibility #or managing our automated data processing and communications systems' he e##ectiveness o# these e##orts is reviewed during management reviews (Section 5.6.1.1)' N'9'4 Contin3enc '+n' he -uality Manager (>)+ in con?unction with the In#ormation Systems Manager (>) and other appropriate managers+ ensures contingency plans are documented (in the Business Plan>) and implemented as needed to satis#y customer re*uirements in the event o# an emergency such as utility interruptions+ labor shortages+ 1ey e*uipment #ailure and #ield returns' N'6
Gor1 environment
Ge provide employee bene#its+ ?ob and schedule #le%ibility+ interesting wor1+ and involvement o# our employees in an empowered environment o# continual improvement (Section 6.2.2.4)' Ge engender total participation by involving employees in internal audit (Section 8.2.2) and improvement (Section 8.5) activities' he RO (>) has overall responsibility #or identi#ying+ implementing and maintaining e##ective employee bene#it and wor1#orce involvement programs' he Sa#ety Manager (>) has overall responsibility #or identi#ying+ implementing and maintaining sa#ety and environmental management systems+ processes and controls needed to ensure product con#ormance and meet customer+ statutory or regulatory re*uirements0 (re#erence applicable Sa#ety andor $nvironmental Management documents)' Ge monitor and improve wor1place sa#ety+ health+ and ergonomics through adherence to good manu#acturing practices+ and through sa#ety team meetings and training (Section 6.2.2)' N'6'& "eronne +et to +ciee 'rodct +it' Ge design and carry out production processes to ensure product sa#ety and minimi.e potential ris1s to employees as may be identi#ied during development o# design ,M$!s (Section .%.%.1) andor process ,M$!s (Section .%.%.2) and documented in wor1 instructions located in process areas (Section .5.1.2)' N'6'4 Ce+nine o 're&ie' Ge provide and maintain a wor1 environment in a state o# order+ cleanliness and repair consistent with the product and manu#acturing process needs (Section 6.% =
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Planning o# product reali.ation
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Our -MS identi#ies+ plans #or and documents our product and service reali.ation processes to ensure consistency with all applicable re*uirements+ including customer re*uirements and related *uality ob?ectives and re*uirements #or speci#ic productsservices+ and anyall applicable statutorylegal re*uirements' he outputs o# productservice reali.ation planning include the speci#ic methods+ #acilities+ e*uipment+ people and materialssupport services needed to achieve all desired results #or a particular product+ service+ or con tract' $ssentially+ the outputs o# the *uality planning process applicable to all productsservices are the traveler+ wor1 instructions and other data in ?ob pac1s (Section .5.1.2) or located in wor1 areas where needed' Ghen re*uirements are not ade*uately addressed in the standard ?ob pac1 documentationdata+ or as re*uired by the customer+ the -uality Manager (>) has overall responsibility #or developing and implementing a *uality control plan to address additional re*uirements or controls needed to veri#y wor1 #or the speci#ic process+ product or contract in *uestion0 see O" .1' he outputs o# *uality planning (i'e' ?ob pac1s+ control plans+ etc') are carried out in accordance with planned monitoring and measurement activities (Section 8.2)+ which may also include the use o# appropriate statistical techni*ues (Section 8.1)' @'&'& Planning o# product reali.ation C Supplemental' "ustomer re*uirements and re#erences to its technical speci#ications are included in the planning o# product reali.ation as a component o# the *uality plan' Our automotive customers re#er to !dvanced Product -uality Planning !"#" ( ) as the means to achieve product reali.ation' !P-P embodies the concepts o# error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach' Iso-ual+ Inc' applies the re*uirements o# product and manu#acturing process design (Section @'9) to development o# product reali.ation processes through our !P-P process' @'&'&'& Our !P-PPP!P process+ as detailed in O" .1+ and depicted in FC .1-1+ provides a consistent advanced product *uality planning process acceptable to all o# our automotive customers+ !"#" ' he !P-P eam ;eader (>) establishes an !P-P eam and serves as the !P-P contact with the customer throughout the launch' he !P-P process is used by the !P-P eam to: • • • • •
•
Develop#inali.e special characteristics' Developreview #ailure modes and e##ects analysis $stablish actions to reduce potential #ailure modes with high ris1 Developreview control plan Report and timely provision o# re*uired deliverables (i'e' ooling+ ,i%tures+ P,M$!+ "ontrol Plans+ PP!P+ Run Q Rate+ etc') Developreview lessons learned during echnical Reviews+ !P-P
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@'&'&'4 S'eci+ C+r+cteritic #or inclusion in the control plan comply with customer speci#ied de#initions and symbols and other process control documents (including drawings+ ,M$!s+ operator instructions+ etc') that a##ect product characteristics and process parameters' @'&'&'9 "rodction "+rt !''ro+ "roce ""!" ) (Section .%.6.%)' he !P-P eam ;eader (>) implements a production part approval process recogni.ed by our customers+ ""!"-40 see O" .1) and D," @'&7&0 in the absence o# any speci#ic instructions+ we will de#ault to a level 9 PP!P submission' PP!P approval is obtained prior to the #irst production shipment o# product (unless speci#ically waived by the customer)0 the !P-P eam ;eader (>): •
•
• •
• • •
•
•
•
$nsures submissions #or part approval are prior to the implementation o# the change+ to determine the type o# *uality re7certi#ication re*uired (PP!P documentation') Product modi#ied by an engineering change to design records+ speci#ications+ or materials' =se o# another optional construction or material than originally approved' Production #rom new or modi#ied tools (e%cept perishable tools)+ dies+ molds+ patterns+ etc'+ including additional or replacement tooling' (Partial or complete) Production #ollowing re#urbishment or rearrangement o# e%isting tooling or e*uipment' Production #ollowing any change in process or method o# manu#acture' Production #rom tooling and e*uipment trans#erred to a di##erent plant location or #rom an additional plant location' "hange o# source #or subcontracted parts+ materials+ or services (e'g' heat treating or plating) Product re7released a#ter the tooling has been inactive #rom volume production #or twelve months or more' ,ollowing a customer re*uest to suspend shipment due to a supplier *uality concern'
@'&'4 !cce't+nce criteri+' !cceptance criteria is approved by the customer+ where re*uired' ,or attribute data sampling+ the acceptance level is .ero de#ects (Section 8.2.%.1)' @'&'9 Conidenti+it' Ge ensure the con#identiality o# customer7contracted products and pro?ects under development and related product in#ormation (Section .5.4)' @'&'6 C+n3e contro ' he -uality Manager (>) obtains necessary customer approval o# *uality plans+ acceptance criteria+ product andor manu#acturing process+ and all related changes that may impact product reali.ation' ,or propriety designs+ impact o# #orm+ #it and #unction (including per#ormance and durability) are reviewed with the customer so all e##ects can be properly evaluated (Section .%. and O" .1)' Ghen re*uired by the customer+ additional veri#ication and identi#ication re*uirements is per#ormed+ such as re*uired #or new product introduction and validation (Section .%.6 ) and O" .1)'
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"ustomer7related processes
!chieving our *uality policy Eto meet or e%ceed customer re*uirementsF re*uires that we determine+ understand+ and consistently meet or e%ceed our customers re*uirements and e%pectations+ and that we establish e##ective communication systems with our customers with regards to product in#ormation+ in*uiries+ contract or order handling and related changes+ and customer #eedbac1+ including complaints' hese e##orts are described below' he Sales Manager (>) has overall responsibility #or developing and implementing e##ective customer7related processes in accordance with the policies in this section and Section 8.2.1. @'4'&
Determination o# re*uirements related to the product
Sales personnel (>) generate *uotesbids and negotiate #inal contractsorders0 "ustomer Service personnel (>) receive customer orders #or standard (catalog) items or #or items included previously bid or negotiated' Re*uirements #or most ma?or customers are identi#ied in contracts documented and reviewed annually' In other cases+ a customer order constitutes a contract+ and we ensure that the customers re*uirements are clearly identi#ied and con#irmed prior to acceptance' O" .2.2 de#ines our process #or determining product related re*uirements: @'4'&'& Cto&er-dei3n+ted 'eci+ c+r+cteritic' his includes customer re*uirements #or designation+ documentation+ and control o# special characteristics (Section .%.2.%)' @'4'&'4 Product re*uirements speci#ied by the customer+ including the re*uirements #or availability+ delivery and support including any a#ter7sales product service andor post7delivery servicing (Section .5.1.8) provided as part o# the customer contract or purchase order' @'4'&'9 Product re*uirements not speci#ied by the customer but necessary #or intended or speci#ied use and obligations related to product+ including regulatory and legal re*uirements0 this may include recycling+ environmental impact+ and characteristics identi#ied as a result o# Iso-uals 1nowledge o# the product and related production processes' @'4'&'6 !ll applicable government+ sa#ety+ and environmental regulations applied to the ac*uisition+ storage+ handling+ recycling+ elimination or disposal o# materials'
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Review o# re*uirements related to the product
Sales or "ustomer Service personnel (>) review customer re*uirements identi#ied during the determination process (Section .2.1) to ensure that they are clearly stated+ understood+ and recorded' Our process #or reviewing all applicable re*uirements is de#ined in O" .2.2 to ensure: •
•
all applicable product re*uirements are de#ined+ understood and con#irmed with the customer prior to acceptance manu#acturing #easibility o# proposed (new or changed) products is investigated+ con#irmed and documented prior to ma1ing a commitment to supply
•
contract or order re*uirements di##ering #rom those previously e%pressed are resolved
•
records o# the review and actions resulting #rom the review are maintained (Section 4.2.4)
@'4'4'& Reie7 o reire&ent re+ted to te 'rodct S''e&ent+ ' he Sales Manager (>) obtains necessary customer authori.ations to waive #ormal reviews where it is deemed impractical #or each order' @'4'4'4 Or3+ni?+tion &+n+ctrin3 e+iiit' he $ngineering Manager (>) investigates+ con#irms and documents the manu#acturing #easibility o# proposed automotive products+ including ris1 analysis+ and product design input (Section .%.2.1) and manu#acturing process design input (Section .%.2.2) in accordance with customer7speci#ic re*uirements governing the !P-PPP!P process detailed in O" .1 and depicted in FC .1-1+ in accordance with !"#" , (Section .1.1) (re#erence your customer7speci#ic documents here)' Ghere product re*uirements are changed+ we ensure relevant documents are amended and relevant personnel are made aware o# the changed re*uirements0 see O" .2.2.
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"ustomer communication
"ustomers will be provided in#ormation #or the #ollowing H1ey customer contact personnel: Buyer+ -uality $ngineer !P-P eam ;eader+ Design $ngineer Design Pro?ect eam ;eader' "ustomers will also be provided points o# contact the #ollowing 1ey #unctions: Manu#acturing Production+ Materials Management ;ogistics+ Purchasing+ !P-P eam ;eader' Cto&er co&&nic+tion are established through a variety o# channels: •
•
•
•
Sales and "ustomer Service personnel (>) provide 'rodct inor&+tion directly to customers including verbal and printed in#ormation on our standard product o##erings as well as customi.ed in#ormation #or uni*ue customer applications' Inirie are handled by our Sales or "ustomer Service personnel (>) depending on the nature o# the in*uiry or who made initial contact0 Section .2.1' $ngineering personnel (>) provide tecnic+ +it+nce and related in#ormation as needed' Ge pay particular attention to customer #eedbac1+ including cto&er co&'+int and customer satis#action' Ge have a toll7#ree number and a wide sales networ1 to encourage and address customer #eedbac1+ particularly customer complaints' Cto&er +ti+ction is evaluated on an on7going basis by customer contact personnel+ i'e' Sales and "ustomer Service personnel (>)0 see Section 8.2.1' Our In#ormation Systems Manager (>) maintains a usercustomer #riendly web site+ www'*ualitymap'com (enter your web site here+ i# applicable) which contains e%tensive product in#ormation+ a list o# contacts o# use to both customers and suppliers+ and an electronic customer #eedbac1 #orm'
@'4'9'& Cto&er co&&nic+tion S''e&ent+ ' he In#ormation Systems Manager (>) establishesmaintains an ability to communicate necessary in#ormation+ including data+ in a customer speci#ied language and #ormat+ including but not limited to computer7aided design ("!S) data and electronic data interchange ($DI)' @'4'9'&'& $lectronic Data Interchange ($DI) Iso-ual+ Inc' believes that the most e##ective and e##icient way to communicate throughout our supply chain is to utili.e a common industry practice #or $DI' Iso-ual+ Inc' and our automotive customers re*uire $DI methods to be employed by all partner suppliers throughout the supply chain' !ll o# our $DI initiatives+ policies+ and transaction sets comply with the guidelines set #orth by the !I! and our 1ey suppliers are also mandated to have the capability to inter#ace with us electronically' !ny updates+ new releases+ system changes+ etc' are communicated to our 1ey suppliers by the In#ormation Systems Manager (>)' @'4'9'&'4 !dvanced Shipping /otice (!S/) !n !S/ is the electronic trans#er o# shipping data to the customer (Section .5.5.2)' @'9
Design and development'
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Design and development processes are employed at Iso-ual to trans#orm customer re*uirements into speci#ications+ products+ processes or systems' he $ngineering Manager (>) maintains a list o# productsservices #or which Iso-ual+ Inc' has design responsibility+ i'e' the authority to establish a new+ or change an e%isting+ product speci#ication0 this responsibility includes testing and veri#ication o# design per#ormance within customer speci#ied applications' he $ngineering Manager (>) has overall responsibility #or managing product design and development activities in accordance with O" .%' and serves as the overall Product Design eam ;eader (as re#erenced throughout this section) he -uality Manager (>) has overall responsibility #or managing manu#acturing process design and development activities (#or automotive products) in accordance with our !P-PPP!P process detailed in O" .1 and depicted in FC .1-1 in accordance with customer speci#ic re*uirements (see !"#" and Section .1.1)0 and serves as the overall !P-P eam ;eader (as re#erenced throughout this section)' @'9'& Design planning he $ngineering Manager (>) assigns a *uali#ied Design $ngineer to serve as Design eam ;eader (>) #or design pro?ects #or newchanged non7automotive products0 he -uality Manager(>) assigns a *uali#ied -uality $ngineer to service as !P-P eam ;eader (>) #or design pro?ects involving newchanged automotive products and related manu#acturing processes' he Design (or !P-P) eam ;eader (>) utili.es pro?ect management planning tools (available so#tware etc') to establish a Design Plan that+ at a minimum+ identi#ies design stages+ predetermined design reviews+ scheduled veri#ication and validation activities' Design plans are retained in a Design ,older' @'9'&'& Mtidici'in+r +''ro+c' he Design (or !P-P) eam ;eader (>) #orms a Design (or !P-P) eam composed o# design+ manu#acturing+ engineering+ *uality+ production and other appropriate *uali#ied personnel to prepare #or product reali.ation+ through: • •
•
development#inali.ation and monitoring o# special characteristics development and review o# Potential ,ailure Mode $##ects !nalysis (,M$!) including actions to reduce potential ris1s per customer guidance+ FM$!-4 , and re*uirements development and review o# control plans
@'9'4 Design inputs' he Design (or !P-P) eam ;eader (>) identi#ies+ documents (Section 4.2.4) and reviews dei3n in't0 and+ be#ore #inali.ing documentation o# re*uired inputs+ resolves any incomplete+ ambiguous or con#licting re*uirements (Section .2.2): @'9'4'& "rodct dei3n in't : •
• •
the #unctional and per#ormance re*uirements as derived #rom customer input+ legal and regulatory re*uirements which apply use#ul in#ormation or e%perience #rom previous similar design e##orts targets #or product *uality+ li#e+ reliability+ durability+ maintainability+ timing and cost
@'9'4'4 M+n+ctrin3 'roce dei3n in't which may include:
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product design output data+ targets #or productivity+ process capability and cost+ customer re*uirements (i# any)+ and e%perience #rom previous process designs'
/ote: Manu#acturing process design includes the use o# error7proo#ing methods to a degree appropriate to the magnitude o# the problems and commensurate with the ris1s encountered' @'9'4'9 S'eci+ c+r+cteritic (including product characteristics and process parameters) #or inclusion in the control plan (Section .1) to ensure compliance with customer7speci#ic de#initionssymbols+ andor to de#ine related guidelines in their absence ' @'9'9 Design outputs' he Design (or !P-P) eam ;eader (>) ensures that design outputs comply with the design input re*uirements0 include in#ormation needed #or production and service provision0 include or re#erence acceptance criteria0 indicate design characteristics critical to the sa#e and proper operation o# the product0 and are approved be#ore issuance: @'9'9'& "rodct dei3n ot't e%pressed in terms that can be veri#ied and validated against product design input re*uirements+ including: design ,M$!s and reliability results0 product special characteristics and speci#ications0 product error7proo#ing+ product de#inition including drawings or mathematically based data0 product design review results0 and diagnostic guidelines: @'9'9'4 M+n+ctrin3 'roce dei3n ot't e%pressed in terms that can be veri#ied against manu#acturing process design input re*uirements and validated (Section .5.2)+ including: speci#ications and drawings0 manu#acturing process #low chartlayout0 manu#acturing process ,M$!s0 control plans0 wor1 instructions0 process approval acceptance criteria0 tool designs0 data #or *uality+ reliability+ maintainability and measurability0 results o# error7proo#ing activities0 and methods o# rapid detection and #eedbac1 o# productmanu#acturing process noncon#ormities' @'9'6 Design review During the evolution o# each design pro?ect+ the Design (or !P-P) eam ;eader (>) conducts design reviews as planned and records results and any necessary actions' !ll #unctions concerned with the stage being reviewed are represented at the planned review(s)' Design reviews are intended to assure that re*uirements are being #ul#illed0 when they are not+ the Design (or !P-P) eam ;eader (>) utili.es input #rom those involved in the review to propose a remedy #or each identi#ied problem' @'9'6'& Monitorin3 ' he Design (or !P-P) eam ;eader (>) monitors the design pro?ect by de#ining+ analy.ing and recording measurements at speci#ied stages o# design and reports summary results as an input to management review (Section 5.6 )' Measurements may include *uality ris1s+ costs+ lead7times+ and critical paths'
@'9'J
Design veri#ication
he Design (or !P-P) eam ;eader (>) ensures design veri#ication activities are carried out as
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planned (per the Design Plan) and records results and any necessary actions' Design veri#ication activities are intended to determine i# design output meets design input re*uirements0 design reviews can be a #orm o# design veri#ication' @'9'N
Design validation
he Design (or !P-P) eam ;eader (>) ensures design validation is carried out as planned (per the Design Plan) and records results and any necessary actions' Design validation is per#ormed to ensure the product or service resulting #rom design e##orts per#orms as intended #or all speci#ied or 1nown usesapplications' !s applicable+ the Design (or !P-P) eam ;eader (>) plans and carries out or oversees: @'9'N'& ei3n +id+tion to ensure it is per#ormed in accordance with customer re*uirements+ including program timing' @'9'N'4 "rotot'e 'ro3r+& to ensure: &) it is carried out using the same suppliers+ tooling and manu#acturing processes as will be used in production0 4) all per#ormance7testing activities are monitored #or timely completion and con#ormity to re*uirements0 and 9) technical leadership is provided to ensure outsourced services are per#orming as intended' @'9'N'9 "rodct +''ro+ 'roce+ detailed in O" .1 and depicted in FC .1-1+ per ""!"-4 , through the !P-P eam ;eader (>)+ to ensure all customer engineering design record and speci#ication re*uirements are properly understood and that the process has the potential to produce product consistently meeting these re*uirements during an actual production run at the *uoted production rate' /ote: In the absence o# any speci#ic instructions+ we will de#ault to a level 9 PP!P submission (Section .1.1)' @'9'@
"ontrol o# design changes
he Design (or !P-P) eam ;eader (>) ensures all design changes are identi#ied+ documented+ reviewed+ approved+ communicated to all a##ected organi.ations and #unctions+ and results and any necessary actions are recorded throughout the product program' Design change control includes an assessment o# the impact o# changes upon component parts and completed products+ including those that may have already been delivered' "ontrol also includes the determination o# treatment re*uired #or each change+ which may include veri#ication or validation'
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Purchasing
Ge wor1 in partnership with our suppliers to ensure that purchased products and services meet all applicable re*uirements' he processes applicable to the planning+ ac*uisition and veri#ication o# all products and services that a##ect customer re*uirements (such as subassembly+ se*uencing+ sorting+ rewor1 and calibration services) are de#ined in O" .4.1+ O" .4.2 and O" 8.2.4 in accordance with the policies outlined in this section' @'6'&
Purchasing process
he type and e%tent o# control applied to our suppliers and purchased product is dependent upon the e##ect on subse*uent reali.ation processes and their output+ as well as consideration o# other characteristics including: the type o# product0 the potential impact o# the product on our processes+ products+ or services0 the results o# supplier evaluations0 and past per#ormance' Purchased products are veri#ied (Section .4.% and Section 8.2.4) to ensure con#ormity to speci#ied purchase re*uirements (Section .4.2)' @'6'&'& Re3+tor conor&it' Purchased products or materials are also veri#ied to ensure con#ormity to applicable regulatory re*uirements' he Materials Manager (>) de#ines and documents the supplier approval process+ including criteria #or selection+ the e%tent o# control to be e%ercised+ and periodic evaluation0O" .4.1' Suppliers are evaluated and selected based on their ability to supply products or services in accordance with our re*uirements' @'6'&'4 S''ier +it &+n+3e&ent te& deeo'&ent ' $ssentially+ the same re*uirements imposed on Iso-ual+ Inc' are cascaded down to or supply base' In order to ensure the *uality o# the parts shipped by Iso-ual+ Inc+ we have established systems to manage the parts and materials received #rom our supply base and initiate supplier development based on importance o# the supplied product and supplier *uality per#ormance in accordance with supplier e%pectations and monitoring procedures de#ined in O" .4.1' @'6'&'9 Cto&er-+''roed orce' Ghere speci#ied (by contract+ customer engineering drawing+ or speci#ication) we purchase products+ materials or services #rom customer7approved sources' ! master list o# approved suppliers is maintained to ensure we only purchase product #rom Iso-ual *uali#ied sources or customer7approved sources' he results o# evaluations and #ollowup actions are recorded' Supplier per#ormance is monitored by the Materials Manager (>) per O" .4.1 through one or more o# the #ollowing indicators: delivered product *uality0 customer disruptions including #ield returns0 delivery schedule per#ormance (including incidents o# premium #reight)0 and special status customer noti#ications related to *uality or delivery issues'
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Purchasing in#ormation
he Materials Manager (>) ensures the ade*uacy o# speci#ied purchase re*uirements prior to communication to the supplier per procedures de#ined in O" .4.2 and the #ollowing policies: Purchasing in#ormation communicated to our suppliers contains the appropriate data needed to clearly and #ully describe re*uirements #or purchased materials and services0 including+ where appropriate+ re*uirements #or approval*uali#ication o# product+ procedures+ processessystems+ e*uipment0 *uali#ication o# personnel0 and *uality management system re*uirements' @'6'9
eri#ication o# purchased product
he -uality Manager (>) ensures that purchased product is veri#ied prior to use or release in accordance with provision o# this section' @'6'9'& Inco&in3 "rodct #+it' he -uality Manager (>) has overall responsibility #or ensuring the *uality o# purchased products using one or more o# the #ollowing methods: receipt and evaluation o# statistical data0 receiving inspection andor testing (such as sampling based on per#ormance)0 second or third party audits o# supplier sites (when coupled with records o# acceptable delivered product *uality)0 part evaluation by a designated laboratory0 andor another method agreed with the customer' Receiving inspection is per#ormed per Section 8.2.4'
he -uality Manager (>)+ plans and implements appropriate sampling plans andor other statistical techni*ues to veri#y purchased product per Section 8.1' !ll re*uirements #or approval o# purchased product andor supplier procedures+ processes+ e*uipment+ personnel+ andor *uality systems are reviewed #or ade*uacy prior to communication to the supplier per Section .4.2. !s applicable+ the -uality Manager (>) documents and communicates the intended veri#ication arrangements and method o# product release related to veri#ication activities per#ormed at our suppliers premises'
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@'J
Production and service provision
@'J'&
"ontrol o# production and service provision
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Ge utili.e a process7#ocused approach to plan and control operations and support services related to production and service provision' Our initial #ocus is to assure the *uality o# process inputs 7 that is+ employees+ material+ #acilities and e*uipment+ and methods' $mployees must be e*uipped to per#orm the process properly through appropriate education+ training+ and certi#ication' Material must meet speci#ied re*uirements and be properly identi#ied+ stored+ and issued' $*uipment and #acilities must be ade*uate+ accurate+ available and properly utili.ed' Gor1 instructions and other important data must be current and correct' Methods must be appropriate and proven capable o# accomplishing the desired results' he appropriateness o# all these #undamental process inputs must be assured+ and processes must be measured+ monitored and controlled to assure e##ectiveness andor to identi#y opportunities #or improvement' @'J'&'& Contro '+n' he -uality Manager (>)+ per Section .1.1: •
•
•
Develops control plans at the system+ subsystem+ component+ andor material level #or the product supplied+ including processes producing bul1 materials+ as well as parts Develops a control plan #or pre7launch and production that ta1es into account the design ,M$! and manu#acturing process ,M$! outputs (Section .%.%.2)' $nsures that production across all shi#ts are sta##ed with personnel in charge o#+ or delegated responsibility #or product *uality'
he -uality Manager (>) #urther ensures that control plans: • •
• •
•
•
;ist the controls used #or manu#acturing process control Include methods #or monitoring o# control e%ercised over special characteristics (Section .%.2.%) de#ined by both Iso-ual and the customer Include customer7re*uired in#ormation+ i# any Initiate the speci#ied reaction plan (Section 8.2.%.1 = when the process becomes unstable or not statistically capable !re reviewed and updated when any change occurs a##ecting product+ manu#acturing process+ measurement logistics+ supply sources or ,M$! (Section .1.4) !re approved by the customer a#ter Iso-ual reviewupdate (as re*uired)
@'J'&'4 *or> intrction' he Production Manager (>) prepares appropriate wor1 instructions #or all employees having responsibility #or processes that impact product *uality andor employee sa#ety (Section 6.4.1)' he instructions are derived #rom sources such as the control plan and the product reali.ation process and are accessible to the wor1 areas where they are needed' @'J'&'9 @eriic+tion o ;o et-'. 3ob set ups are veri#ied prior to commencing each new production run andor when process changes are made0 Section 8.2.4' Gor1 instructions governing set ups and related veri#ications are developed and available+ and use statistical methods o# veri#ication where applicable' @'J'&'6 "reentie +nd 'redictie &+inten+nce' Per Section 6.%.1+ the Maintenance Manager (>)
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identi#ies 1ey process e*uipment+ provides resources #or their maintenance + and develops an e##ective total preventive maintenance system (using predictive maintenance methods) that at a minimum+ includes: • • • •
Planned maintenance activities Pac1aging and preservation o# e*uipment+ tooling+ and gau ging+ !vailability o# replacement parts #or 1ey manu#acturing e*uipment Documenting+ evaluating+ and improving maintenance ob?ectives'
@'J'&'J M+n+3e&ent o 'rodction tooin3 ' !s part o# manu#acturing process design (Section .%.%.2 , the $ngineering Manager (>) provides resources and oversees e##orts related to tool and gauge design+ #abrication+ and veri#ication activities' he Production Manager (>) establishes and implements a system #or production tooling management (or monitors these activities i# any wor1 is outsourced)+ including: • • • • • •
maintenance and repair #acilities and personnel storage and recovery setup tool changing programs #or perishable tools tool design modi#ication documentation+ including engineering change level tool identi#ication+ de#ining the status+ such as production+ repair+ or disposal'
@'J'&'N "rodction cedin3 ' he Production Manager (>) schedules production to meet customer re*uirements and our goal to achieve &55L on7time delivery per#ormance through Iso-uals ?ust in7time production control system that is order driven and provides production in#ormation at 1ey stages o# product reali.ation' @'J'&'@ Feed+c> on inor&+tion ro& erice' Per Section 8.2.1+ the Sales Manager and customer contact personnel (>) collect and communicate servicing concerns to $ngineering+ Manu#acturing and other appropriate personnel #or the purpose o# initiating appropriate corrective+ preventive or other improvement action0 Section 8.5' @'J'&' Serice !3ree&ent 7it cto&er ' I# there is a service agreement with the customer+ the -uality Manager (>) will establish and implement a plan to veri#y the e##ectiveness o# any: • • •
service centers special7purpose tools or measurement e*uipment training o# service personnel
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he Production Manager (>) ensures that productionservice ?obs are planned+ scheduled+ and carried out in accordance with procedures detailed in O" .5.1 as summari.ed below: .5.1.+ Inor&+tion. In#ormation inputs to the process include both product characteristics and appropriate wor1 instructions containing speci#ic wor1 methods andor other pertinent in#ormation+ including process monitoring and veri#ication instructions and criteria developed during product *uality planning (Section .1 = andor manu#acturing process development (Section .%.2.2)' he Production Manager+ through Product ;ine eam ;eaders+ Production Shi#t Supervisors and Production "ontrol Supervisors+ (>) ensures that all appropriate in#ormation including #inal product speci#ications+ raw material characteristics and the re*uired product parameters+ is provided to production personnel throughout the produc tservice provision process' Such in#ormation is provided through ?ob schedulesplans+ production team meetings+ wor1 instructions posted in areas where they are needed+ andor through ?ob speci#ic in#ormation included in individual ?ob pac1s (including control plans+ where applicable)' .5.1. *or> Intrction' he necessity #or and re*uired detail o# wor1 instructions is dependent upon the 1nowledge+ s1ills+ and abilities o# our employees and the comple%ity o# the wor1 process they are assigned to per#orm' Product ;ine eam ;eaders (>)+ with input #rom $ngineering+ -uality and other technical personnel identi#y critical productionservice wor1 steps in process sheets included in the ?ob pac1 or other in#ormation included in wor1 instructions posted in areas where they are needed' .5.1.c $i'&ent. he Maintenance Manager (>) ensures the suitability and availability o# all e*uipment+ #acilities and tooling used #or production and service operations0 Section 6.%. .5.1.d Monitorin3 +nd Me+re&ent eice' he -uality Manager (>) ensures that monitoring and measurement devices capable o# meeting our measurement re*uirements are available #or use during production and service provision0 Section .6 . .5.1.e Monitorin3 !ctiitie' he Production Manager+ through Production Shi#t Supervisors+ (>) ensures that production personnel monitor the *uality o# their own wor1 and understand the procedures #or reporting related problems andor suspected noncon#orming conditions0 O" .5.1 and Section 8.2.%.1. he -uality Manager (>) is responsible #or planning and implementing in7 process inspections needed to ensure process control and product *uality0 Section 8.2.4. @'J'&'# Ree+e, eier, +nd "ot-eier "rocee. Release o# product is dependent on its compliance with all technical speci#ications and its ability to meet additional customer re*uirements including pac1aging+ shipping+ and delivery+ as identi#ied in the contract or order' he "OO+ through the Materials Manager+ the Production Manager+ and the -uality Manager+(>) ensures that records o# product approval are maintained and clearly indicate the authori.ing employee0 Section .5.%.1' he "OO (>) periodically reviews operational data as well as progress towards achievement o# corporate level productservice per#ormance ob?ectives (Section 5.4.1.1) and provides related recommendations #or review by op Management0 Section 5.6.1.
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@'J'4' alidation o# processes #or production and service provision Ge de#ine processes in which results cannot be veri#ied by subse*uent monitoring or measurement as ESpecial ProcessesF0 this includes any processes where de#iciencies may become apparent only a#ter the product is in use or the service has been delivered' he $ngineering Manager (>) has overall responsibility #or ensuring HSpecial ProcessesF are validated in accordance with procedures detailed in O" .5.2 ' !s applicable+ arrangements are established #or: de#ining criteria #or review and approval o# the processes0 approval o# e*uipment and *uali#ication o# personnel0 use o# speci#ic methods and procedures0 re*uirements #or records0 and revalidation' @'J'4'& @+id+tion o 'roce or 'rodction +nd erice 'roiion S''e&ent+ ' Process validation applies to all processes #or production and service provision (Section .5.1) related to our automotive products' he !P-P eam ;eader (>) utili.es our a production part approval process acceptable to our customer to validate that product reali.ation processes are capable o# achieving desired results in accordance with the !P-PPP!P process detailed in OP 7.1 and depicted in DFC 7.1.1' @'J'9
Identi#ication and traceability
he $ngineering Manager (>) has overall responsibility #or establishing and maintaining product identi#ication throughout all stages o# design+ production+ installation and delivery in accordance with procedures de#ined in O" .5.%. Ghere product traceability is a customer7speci#ied re*uirement+ appropriate controls and records are established and maintained' @'J'9'& Identiic+tion +nd tr+ce+iit S''e&ent+ ' he identi#ication and status o# product is established and maintained throughout all product and service provision processes' Ge establish and maintain product monitoring and measurement status through the use o# both physical identi#ication tagslabels and electronic records (identi#y your electronic record system here+ i# applicable)' !dditionally+ physical location in clearly designated hold area is an indicator o# product status0 however+ physical location in production process areas may serve as an indicator o# product status only where product identi#ication and inspection status is inherently obvious+ e'g' in our automated production trans#er process (name your process(es) here where location will provide inspection and test status+ i#as applicable)' he "OO+ through the Materials Manager+ the Production Manager+ the Maintenance Manager+ and the -uality Manager (>)+ ensures that all incoming+ in7process+ and #inal product is suitably identi#ied and the current status is appropriately trac1ed and displayed in accordance with procedures detailed in O" .5.%. Ghere contractually re*uired+ the -uality Manager (>) plans #or+ establishes and maintains appropriate traceability records in accordance with customer re*uirements0 Section .1' !t a minimum+ where products are made in lots or batches we identi#y and record a uni*ue lot or batch number and related in#ormation on the ?ob traveler0 Section .5.1 and O" .5.%'
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"ustomer property
"ustomer property includes customer7owned material+ tools (including returnable pac1aging)+ tooling (including testinspection tooling and e*uipment)+ an d intellectual property' Ge identi#y+ veri#y+ protect and maintain customer property provided #or use or incorporation into the product+ by applying the same process controls as we do to purchased product (Section .4)' Ghenever customer7speci#ied re*uirements #or property management are beyond the control or capability o# our established -MS+ the -uality Manager (>) has overall responsibility #or planning+ documenting and communicating such re*uirements to all appropriate personnel as a part o# product *uality planning0 Section .1' @'J'6'& Cto&er-o7ned 'rodction tooin3 ' !ll customer7owned production tooling is permanently mar1ed so the ownership o# each item is visible and can be determined' !dditional special re*uirements applicable to customer supplied product are detailed in O" .5.4' he -uality Manager (>) ensures that lost+ damaged or unsuitable customer property is recorded and immediately reported to the customer0 Section 8.%.%' @'J'J
Preservation o# product
he "OO+ through the Materials Manager+ Production Manager+ -uality Manager+ Maintenance Manager and Sa#ety Manager+ (>) has overall responsibility #or establishing and implementing a material management system to ensure product con#ormity is preserved during internal processing and delivery to the intended destination' his system+ de#ined in O" .5.5+ includes the handling+ storage+ pac1aging+ delivery+ and protection o# #inal product as well as raw materials and in7 process constituents o# the #inal product+ to support our goal o# &55L on7time delivery per#ormance and ensure: •
•
•
•
"omponents and products are handled and stored in a manner that prevents damage or deterioration pending use or delivery' $ach department ensures controls are implemented to prevent mi%ing con#orming and non7con#orming materials' Pac1ing ensures speci#ied or original manu#acturing pac1aging is utili.ed' !ll components and products are suitably pac1ed to prevent deterioration or damage during storage and delivery'
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@'J'J'& Stor+3e +nd inentor' In order to detect deterioration+ the condition o# stoc1 is periodically assessed' Iso-ual uses an automated inventory management system to optimi.e inventory turns over time and assure stoc1 rotation on a H#irst7in7#irst7out (,I,O) basis' ,urther+ obsolete product (including e%pired age dated material+ e'g') is controlled as noncon#orming product0 Section 8.%.1' @'J'J'4 !d+nced Si''in3
@'N
•
determine and con#irm goods in transit'
•
veri#y and receive products into their system'
•
create an electronic invoice that will generate payment'
"ontrol o# monitoring and measuring devices
he -uality Manager (>)+ is responsible #or establishing and maintaining an e##ective system #or identi#ying+ selecting and controlling the use o# monitoring and measuring devices used to provide evidence o# product con#ormance to established re*uirements' hese controls+ de#ined in O" .6 + apply to Iso-ual owned+ customer7owned and employee7owned devices' Ge determine the measurements to be made and the accuracy re*uired to assure con#ormity o# our product to speci#ied re*uirements' Ge identi#y and select monitoring and measuring devices and veri#y their capability o# meeting such re*uirements prior to use' In addition+ the $ngineering Manager (>) documents the method #or con#irming the ability o# so#tware to satis#y the intended application0 Section .%.%.2. Monitoring and measuring devices are used and controlled in a manner that ensures continuing suitability0 this includes ensuring that the environmental conditions are suitable #or the calibration+ inspections+ measurements and tests being carried out' Ge also de#ine the processes employed #or the on7going calibration+ control and maintenance o# monitoring and measuring devices including their identi#ication+ location+ #re*uencymethod o# chec1s+ usesacceptance criteria and the action to be ta1en when results are unsatis#actory' @'N'a !ll monitoring and measuring devices that can a##ect product *uality are identi#ied and calibrated at prescribed intervals against certi#ied e*uipment having a 1nown valid relationship to internationally or nationally 1nown standards' Ghere no such standards e%ist+ the basis used #or calibration is documented' Iso-ual+ Inc' does not have an internal laboratory #acility and there#ore cannot per#orm all re*uired inspections+ tests andor calibrations0 accordingly+ e%ternal laboratories used #or inspection+ test or calibration services are selected+ *uali#ied and monitored per Section .4' @'N'b Ghen monitoring and measuring devices are #ound to be out o# calibration (or when calibration status is not 1nown)+ they are ad?usted or re7ad?usted as necessary and the validity o# previous measuring results is documented0 actions ta1en are documented+ including appropriate corrective actions to remedy the situation and preclude its recurrence0 Section 8.5.2' @'N'c
!ppropriate calibration records are maintained to document results o# calibration activities
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(Section 4.2.4) and suitable indicators are used to show current calibration status' ! number or other identi#ier is used to provide traceability to the device calibration record0 Section .6.2' @'N'd !ll monitoring and measuring devices are sa#eguarded #rom ad?ustment that would invalidate the calibration' @'N'e !ll monitoring and measuring devices are handled+ maintained and stored in a manner that ensures accuracy and #itness #or use is maintained' @'N'& Me+re&ent te& +n+i' Statistical studies are conducted to analy.e the variation present in the results o# each type o# measuring and test e*uipment system (re#erenced in the applicable control plan)' Such measurement systems analyses con#orm to applicable customer re#erence manuals including the !I! EMeasurement System !nalysisF re#erence manual (state your re#erence here)0 other analytical methods and acceptance criteria are only used i# approved by the customer0 see O" .6 ' @'N'4 C+ir+tion/eriic+tion record' Records o# the calibrationveri#ication activity #or all gauges+ measuring+ and test e*uipment needed to provide evidence o# product con#ormity to determined re*uirements+ including employee and customer owned e*uipment+ includes: •
• • • • •
$*uipment identi#ication+ including the measurement standard against which the e*uipment is calibrated Revisions #ollowing engineering changes !ny out7o#7speci#ication readings as received #or calibrationveri#ication !n assessment o# the impact o# an out7o#7speci#ication condition Statements o# con#ormance to speci#ication a#ter calibrationveri#ication /oti#ication to the customer i# suspect product or material has been shipped
@'N'9 +or+tor Reire&ent' @'N'9'& Intern+ +or+tor' he -uality Manager (>) manages our internal laboratory and maintains records that de#inedemonstrate its capability to per#orm the re*uired inspection+ test or calibration services0 see O" .6 ' @'N'9'4 $(tern+ +or+tor' he -uality Manager (>) ensures e%ternal laboratories used #or inspection+ test+ or calibration services are either acceptable to the customer or accredited to ISO 1025 (or the national e*uivalent)0 see O" .6 #or calibration laboratories and O" 8.2.4 #or inspection and test laboratories'
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8.
Measu#e%ent, nalysis an& I%!#oe%ent
'&
eneral
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his section describes how we de#ine+ plan+ and implement the monitoring+ measurement+ analysis and improvement activities needed to assure product and -MS con#ormity and achieve continual -MS improvement' hese activities include assessment o# customer satis#action+ conduct o# internal audits+ process monitoring and measurement+ and product monitoring and measurement' O" 8.1 details procedures governing the selection and use o# appropriate statistical techni*ues used in monitoring+ measurement+ analysis and improvement activities' '&'& Identiic+tion o St+titic+ Too' he -uality Manager (>) ensures that statistical tools used to monitor -MS processes are identi#ied during *uality planning and included control plans+ as applicable0 Section .1' Statistical techni*ues #or on7going process control and improvement are established per (O" 8.1) and the !I! EStatistical Process "ontrolF (SP") re#erence manual+ S"C-%+ (state your re#erence here) and associated customer speci#ic re*uirements documents' '&'4 Ano7ed3e o )+ic St+titic+ Conce't' $mployees utili.ing statistical tools to manage+ veri#y or per#orm wor1 will attend a Basic Statistics course containing an overview on basic concepts such as variation+ control (stability) process capability0 over7ad?ustments will be understood and utili.ed throughout the organi.ation0 see Section 6.2.2' '4
Monitoring and measurement
'4'&
"ustomer Satis#action
"ustomers are the reason we e%ist and drive our *uality policy Eto meet or e%ceed customer re*uirements'F he Sales Manager (>) has overall responsibility #or identi#ying and reviewing customer re*uirements (see Section .2.1 and Section .2.2 = and #or monitoring and measuring customer satis#action per procedures contained in O" 8.2.1+ summari.ed as #ollows: Data collected by customer contact personnel during routine communications (Section .2.%) provide our primary basis #or assessing customer satis#action' Sales personnel and "ustomer Service sta## (>) utili.e a very simple customer satis#action survey #orm (hard copy or electronic) to ascertain the customers overall perception o# how well we are meeting their re*uirements and to document any recommendations #or improvement' '4'&'& Cto&er S+ti+ction S''e&ent+ ' !t a minimum+ related per#ormance indicators include+ but are not limited to: • • • •
delivered part *uality per#ormance customer disruptions #ield returns delivery schedule per#ormance incidents o# premium #reight customer noti#ications related to *uality and delivery issues'
,urther+ product reali.ation processes are monitored (Section 8.2.%.1) to demonstrate compliance with customer re*uirements (#or product *uality andor e##iciency+ as applicable)'
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"ustomer complaints (whether received in writing+ verbally or electronically through our web site customer contact #orm) are immediately #orwarded to appropriate Sales or "ustomer Service personnel (>) #or action' I# these personnel cannot resolve the issue to the customers satis#action+ then the complaint is trans#erred to the Sales Manager (>) #or assignment to another appropriate manager or #unction #or resolution' "ustomer complaints are documented and monitored through resolution through our continual improvement system0 Section 8.5' "ustomer survey data along with other customer #eedbac1 (including written or verbal complaints and in#ormation collected #rom our web sites customer #eedbac1 #orm) is reviewed daily by Sales personnel and "ustomer Service sta## (>) to initiate any improvement or correctivepreventive actions needed0 Section 8.5. he Sales Manager (>) periodically reviews customer satis#action survey data and other customer #eedbac1 (including complaints)+ as well as progress towards achievement o# corporate level customer satis#action improvement ob?ectives (Section 5.4.1 = and provides related recommendations #or review by op Management0 Section 5.6 . '4'4
Internal audit
Internal audit results are critical inputs to aid in assessing the e##ectiveness o# our -MS+ in identi#ying opportunities #or improvement+ and in promoting awareness o# customer re*uirements and e##ectiveness o# the -MS to our wor1#orce' '4'4'& #+it &+n+3e&ent te& +dit ' Ge conduct -MS audits to determine con#ormity to ISO/TS 16949:2009 and any additional -MS re*uirements that may apply ( ISO 14001:2004+ #or e%ample)' Our overall measure o# -MS e##ectiveness is the absence o# repeat problems#indings+ as an indicator that our -MS was e##ective in eliminating the cause o# such problems' '4'4'4 M+n+ctrin3 'roce +dit ' !udits o# our 1ey product reali.ation processes are conducted annually to determine their e##ectiveness andor per#ormance (Section 8.2.%) and to identi#y opportunities #or improvement (Section 8.5.1.2) '4'4'9 "rodct +dit ' Product audits are also conducted at appropriate stages o# production and delivery to veri#y con#ormance to all speci#ied re*uirements contained in the control plan (Section 8.2.4)' Internal audits are conducted in accordance with a published schedule that identi#ies the audit scope and #re*uency' he schedule is updated on the basis o# status and importance o# the activity to be audited and previous audit results' '4'4'6 Intern+ !dit "+n' $ach o# our 1ey -MS processes ( FC 4.1)+ with a special emphasis on our Hcore customer oriented processes (CO" 4.1) and our uni*ue product reali.ation processes (Section '4'9'&)+ is reviewed at least once annually to determine e##ectiveness'
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he -MS process+ #unction or *uality system element under review is e##ective i# it is achieving the desired results or established ob?ectives0 Section 5.4.1' In addition+ employee involvement in identi#ying process e##ectiveness or e##iciency improvements is actively sought during internal audits' Internal audit results are used to determine the scope+ nature and #re*uency o# #uture internal audits o# processes+ products+ #unctions or *uality system elements where ine##ectiveness or ine##iciency is most li1ely to be #ound' Responsible managers may also re*uest that the audit be used to gather Evalue addedF data serving as input to aid in monitoring+ measurement and improvement o# -MS processes and systems0 Section 8.2.% and Section 8.5.1' he ISO Management Representative (>) has overall responsibility #or managing the internal audit process in accordance with O" 8.2.2 as summari.ed below: '4'4'J !ditor +iic+tion' Internal auditors are *uali#ied to audit to ISO/TS 16949:2009 re*uirements (Section 6.2.2)' !udits are carried out by *uali#ied personnel who do not have direct responsibility #or the activity being audited' !udit chec1lists are prepared and used to aid in ensuring audit consistency and comprehensiveness' !uditors record audit results and submit #indings to management personnel with responsibility #or the process+ #unction or *uality system element audited' Management responsible #or the area audited implement timely corrective action to eliminate detected non7con#ormances and their causes+ and initiate other appropriate action in response to opportunities #or improvement identi#ied by process participants or managers' ,ollow7ups are conducted to veri#y timely and e##ective implementation o# the proposed action' he ISO Management Representative (>) maintains all internal audit records+ including internal auditor training records+ results o# internal audits and related #ollow7ups0 periodically reviews internal audit results as well as progress towards achievement o# corporate level ob?ectives aimed at improving overall -MS e##ectiveness (Section 5.4.1)0 and provides related recommendations #or review by op Management0 Section 5.6 ' '4'9
Monitoring and measurement o# processes
Ge apply suitable methods #or monitoring and measuring all -MS processes' -MS processes depicted in FC 4.1 are documented measured+ controlled and evaluated (Section 8.2.2.1) to ensure they are e##ective and e##icient (i'e' achieve desired results) and to identi#y opportunities #or improvement' !t a minimum+ managers with overall responsibility #or carrying out a -MS process+ analy.es process per#ormance (Section 8.4) and ta1es appropriate improvement+ corrective or preventive action (Section 8.5)' Ge conduct process audits (Section 8.2.2.2) to veri#y -MS process con#ormance and identi#y opportunities #or improvement0 manu#acturing process audits are conducted annually' In addition we monitor and measure manu#acturing processes to ensure to ensure continuing process capability and suitable per#ormance as speci#ied by the customer part approval process (PP!P) re*uirements (Section .%.6.%)'
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'4'9'& Monitorin3 +nd &e+re&ent o &+n+ctrin3 'rocee' Process Capability ' !s part o# manu#acturing process design (Section .%.%.2)+ the $ngineering Manager (>)+ through our !P-PPP!P process (Section .1.1)+ ensures process studies are per#ormed on all new product reali.ation processes to veri#y process capability and provide additional input #or process control' Process capability study results+ where applicable+ and speci#ications (including methods o# production+ measurement and test+ and maintenance instructions) are documented' !cceptance criteria (as well as ob?ectives #or process capability+ reliability+ maintainability and availability) and appropriate reaction plans are included in control plans (see Section .5.1.1) andor ?ob pac1s (Section .5.1)' ,or attribute data sampling+ the acceptance level shall be K$RO D$,$"S' Job Set Up' 3ob set ups (Section .5.1.4) are veri#ied (Section 8.2.4) prior to commencing each new production run and when process changes are made' Process Monitoring ' Processes are monitored by process operators per applicable instructions (Section .5.1.2) and procedures de#ined in O" 8.2.%. Signi#icant process events+ such as tool change or machine repair are recorded' "ontrol plans and process #low diagrams are implemented (Section .5.1.1) to ensure adherence to the speci#ied measurement techni*ues+ sampling plans+ acceptance criteria+ and reaction plans when acceptance criteria is not met0 see Section .1.1 and Section 8.1. Production personnel #ollow documented reaction plans when processes become unstable or no longer capable' he -uality Manager (>) then initiates a corrective action plan indicating the speci#ic timing and assigned responsibilities to assure the process becomes stable and capable' !s re*uired+ the corrective action plan is review with and approved by the customer and usually re*uires application o# a customer recogni.ed or approved problem solving approach (Section 8.5.2.1)'
'4'6
Monitoring and measurement o# product
he -uality Manager (>) has overall responsibility #or planning (Section .1) and implementing inspection and test activities needed to veri#y product re*uirements are met at appro priate stages o# the product reali.ation process in accordance with the applicable control plan. Ghen selecting product parameters to monitor compliance to internal and e%ternal re*uirements+ product characteristics are determined leading to the types o# measurement+ suitable measurement means+ and the re*uired capability and inspectiontest s1ills needed' he scope o# our product monitoring and measurement system (de#ined in O" 8.2.4) includes receiving inspection+ ?ob set up veri#ication+ in7process inspection+ #inal inspection and test+ layout inspection and #unctional test+ and special consideration regarding monitoring and measurement o# appearance items' Receiving Inspection' Incoming product is not used or processed until it has been inspected or otherwise veri#ied as con#orming to speci#ied re*uirements in accordance with the control plan andor documented procedures' Methods used to veri#y incoming product (see Section .4.%) may include: receipt and evaluation o# statistical data by the supplier0 #ormal receiving inspection andor test (see O" 8.2.4)+ evaluation by accredited laboratories0 or source inspections'
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Job Set Up Veriication' 3ob set ups are veri#ied per procedures de#ined in O" 8.2.4 prior to commencing each new production run andor when process changes are made' In!process Inspection' ,ormal in7process inspections are per#ormed by -uality "ontrol personnel (>) in accordance with the control plan and O" 8.2.4. Manu#acturing process monitoring (Section 8.2.%.1) is per#ormed by production personnel in accordance with the applicable control plan (Section .5.1.1)' Final Inspection an" #est ' !ll #inished products and completed services are veri#ied by #inal inspectionstests speci#ied in the control plan and O" 8.2.4' "elease' Products are not released #or #urther processing or delivery until we have ob?ective evidence that all re*uirements have been met'
$idence o Conor&it' est and inspection records are maintained #or a minimum o# three years' hese records include #inal inspection authority and identi#y and con#irm that all critical parameters are in accordance with established re*uirements and speci#ications' !dditionally+ product samples are stored #or a minimum o# 9 years' "rodct Ree+e +nd eier. Product is not normally released or delivered until all planned inspections and tests have been completed+ and records have been maintained providing evidence o# con#ormity with acceptance criteria and identi#ying the person(s) authori.ing release' In rare cases (due to customer demands andor production emergencies) unveri#ied product may be released or delivered under controlled conditions o# positive recall documented and authori.ed by the -uality Manager (>) and+ where applicable+ approved by the customer' /oncon#orming (or suspect) product is identi#ied and controlled to prevent its inadvertent use0 Section 8.%' '4'6'& +ot in'ection +nd nction+ tetin3 ' !s re*uired+ an annual layout inspection and #unctional veri#ication to applicable customer engineering material and per#ormance standards is per#ormed #or each product speci#ied in the control plan by -uality "ontrol personnel(>) in accordance with O" 8.2.4' Results are retained and available #or customer review' '4'6'4 !''e+r+nce Ite&' ,or parts designated by the customer as Eappearance itemsF Iso-ual provides: • •
• •
!ppropriate resources+ including lighting #or evaluation (Section 6.%) Masters #or color+ grain+ gloss+ metallic brilliance+ te%ture+ distinctness o# image+ as appropriate Maintenance and control o# appearance masters and evaluation e*uipment eri#ication that personnel ma1ing appearance evaluations are competent and *uali#ied to do so (Section 6.2.2)
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"ontrol o# noncon#orming product
he -uality Manager (>) has overall responsibility #or implementing an e##ective process #or identi#ying+ documenting+ segregating+ evaluating+ and disposing o# noncon#orming product' Personnel responsible #or product *uality have the authority to stop production to correct *uality problems in accordance with O" 8.%0 related procedures are summari.ed below: Identiic+tion. Identi#ication o# noncon#orming product originates #rom inspection+ internal testing+ product audits or customer complaints' $mployees clearly mar1 or otherwise identi#y noncon#orming product or suspect material' oc&ent+tion. he -uality Manager (>) or authori.ed -uality "ontrol personnel (>) enter the noncon#ormance into the corrective action system (Section 8.5.2) identi#ying the noncon#orming product and lot number i# applicable+ description o# noncon#ormance+ and location where the noncon#orming product is being held pending #urther review or disposition' Se3re3+tion. /oncon#orming product is segregated pending evaluation and disposition' $++tion. he -uality Manager through authori.ed -uality "ontrol personnel (>)+ per#orm the initial evaluation o# noncon#orming product in accordance with approved test and inspection procedures' Ghere needed+ $ngineering+ Production and other technical personnel may become involved in the evaluation and recommendation #or disposition' i'oition. he results o# the evaluation and resultant disposition determinations are documented' Dispositions resulting #rom the evaluation o# noncon#orming product may include: rewor1 to meet speci#ied re*uirements0 re7grade #or an alternative application0 use as is (under customer concession or other re*uired approval authority)0 obtain (#rom relevant authority) a waiver o# or deviation #rom re*uirements0 return to supplier0 scrap or other disposal' 8.%.+. Correction +nd Re-eriic+tion' Rewor1ed noncon#orming product is re7veri#ied a#ter correction to demonstrate con#ormity to original re*uirements' 8.%. "rodct Rec+ ' In the event noncon#orming product is detected a#ter delivery or use has started+ the -uality Manager (>) noti#ies the customer and initiates action appropriate to the e##ects+ or potential e##ects+ o# the noncon#ormity' Ghere appropriate+ product recall is initiated based on trace and recall data and records0 Section .5.%. 8.%.c ed "rodct ' Instructions #or rewor1+ including re7inspection re*uirements+ are documented by the -uality Manager (>) and made available to and utili.ed by appropriate production personnel'
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'9'9 Cto&er Inor&+tion' Responsible Sales or "ustomer Service personnel (>) noti#y the customer immediately upon discovering that noncon#orming product has been shipped' '9'6 Cto&er *+ier ' Ghere the customer has previously approved the production process+ the $ngineering Manager (>) obtains a customer concession or deviation permit prior to #urther processing whenever the product or product reali.ation process is di##erent #rom that which is currently approved' he $ngineering Manager (>) maintains a record o# the e%piration date or *uantity authori.ed0 ensures compliance with the original or superseding speci#ications and re*uirements when the authori.ation e%pires0 and ensures material shipped on an authori.ation is properly identi#ied in each shipping container' his waiver process also applies to purchased product and Iso-ual will provide evidence o# concurrence with the supplier (i# applicable) be#ore submission to the customer' ! deviation re*uest will be accompanied by an action plan identi#ying root cause and steps to implement a permanent corrective action' Procedures governing the processing o# customer waivers and deviation are detailed in GI '9' '9'J /oncon#ormance reports re*uested by the customer (usually i#when a customer receives material or service that #ails to con#orm to applicable *uality and delivery speci#ications) are processed per customer re*uirements and the procedures de#ined inO" 8.%' '9'N I# placed on Econtainment statusF (due to continued poor per#ormance andor #ailure to achieve goals and ob?ectives)+ Iso-ual+ Inc' will ta1e all actions re*uired by the customer+ and guidelines contained in O" 8.%' '6
!nalysis o# data
op Management and other o##icers+ managers and supervisors collect and analy.e data using appropriate statistical techni*ues (Section 8.1) to determine the suitability and e##ectiveness o# 1ey -MS processes ( FC 4.1) applicable to their area(s) o# responsibility and to identi#y opportunities #or improvement' !t a minimum+ data is analy.ed to assess achievement o# the corporate level *uality ob?ectives (Section 5.4.1)' Ge manage our 1ey -MS processes through the useapplication o# what we call "roce !e&ent *or>eet "!*=, Io#+ For& 8.4-1 , and associated Hurtle Diagrams+ Io#+ For& 8.4-2+ which are used to de#ine and analy.e the selected process in terms o# inputs+ throughputsactivities+ and outputs' Related guidance and in#ormation is contained in our "roce M+n+3e&ent Gide and in *I 8.4-2 and Section 8.5.1' ! process is e##ective i# desired results are achieved' $##ectiveness can be measured in terms o# product *uality+ process accuracy+ deliveryschedule per#ormance+ costbudget per#ormance+ employee#unction per#ormance against established ob?ectives+ andor customer satis#action' ! process is e##icient when resource utili.ation is optimal' $##iciency can be measured in terms o# total resource utili.ation+ productivity indicators+ and or the cost o# poor *uality (such as wasterewor1 costs or hours)' Ge also conduct an annual sel#7assessment against the criteria established in !nne% ! o# ISO 9004:2000 (identi#y other criteria here+ i'e' the Malcolm Baldrige /ational -uality !ward criteria
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or e*uivalent+ i#as desired)' On an annual basis the ISO Management Representative (>)+ with input #rom op Management and other 1ey personnel+ per#orms a sel#7assessment against these criteria+ utili.ing our )+dri3e )+ed Se !e&ent Gide+ Io#+ For& 8.5-2+ and uses the results+ recorded on Io#+ For& 8.5-%+ to identi#y current strengths and wea1nesses+ and to identi#y opportunities #or improvement+ and provide related recommendation to op Management through our management review process (Section 5.6.1)' '6'& !n+i +nd Be o +t+' rends in *uality and operational per#ormance are compared with progress toward ob?ectives and related recommendations #or improvement are developed and are presented to op Management #or review and action during management reviews0 Section 5.6 ' 'J
Improvement
'J'&
"ontinual improvement
'J'&'& Contin+ i&'roe&ent o te or3+ni?+tion' !t Iso-ual+ the continual improvement process begins with the establishment o# our *uality policy (Section 5.%) and ob?ectives #or improvement (Section 5.4.1)+ based on ob?ectives contained in our Business Plan and customer targetsgoals' "ustomer satis#action+ internal audit+ process and product per#ormance data+ and the cost o# poor *uality are then compared to progress against ob?ectives to identi#y additional opportunities #or improvement0 Section 8.4' !ppropriate improvement initiates are established+ supported and monitored #or achievement through the use o# a "ontinual Improvement ,orm ("I,)+ Io#+ For& 8.5-6 + and our management review process (Section 5.6 )' Ge also consider corrective and preventive actions a vital part o# our continual improvement program' "orrective actions are initiated when desired results are not achieved and preventive actions are initiated to prevent the occurrence o# problems or to implement other improvement actions' Management !ction Re*uests (M!Rs)+ Io#+ For& 8.5-1+ are used to document improvement+ corrective and preventive actions0 all management actions are prioriti.ed and implemented on the basis o# data analysis (Section 8.4): the impact o# #ailuresproblems is used to prioriti.e needed corrective actions0 ris1s are evaluated to identi#y and prioriti.e needed preventive actions0 and costbene#it analyses are per#ormed to identi#y and prioriti.e needed improvement actions' Procedures governing our continual improvement system are detailed in O" 8.5' he overall e##ectiveness o# continual improvement program (including corrective and preventive actions ta1en as well as the overall progress towards achieving corporate level improvement ob?ectives) is assessed through our management review process (Section 5.6 )' $ssentially+ such actions are e##ective i# the problems corrected do not reoccur+ potential problems identi#ied do not occur+ and other improvement actions accomplish the desired results or ob?ectives' Inputs to the management review process are used to establish newchanged improvement ob?ectives and to initiateprioriti.e additional improvement actions0 Section 5.6 '
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'J'&'4 M+n+ctrin3 'roce i&'roe&ent ' he $ngineering Manager (>) plans and implements continual improvement o# manu#acturing processes that are capable and stable+ or where product characteristics are predictable and meet customer re*uirements' Ge identi#y such opportunities through analysis o# results o# manu#acturing process monitoring activities (Section 8.2.%.1)+ product monitoring and measurement activities (Section 8.2.4)+ and process oriented audits (Section 8.2.2) o# 1ey manu#acturing processes at least once annually' he overall ob?ective o# manu#acturing process improvement is to reduce part7to7part variation and eliminate all waste' !s warranted+ improved controls andor to methods to reduce variation in product characteristics and manu#acturing process parameters are instituted using the same methodology as prescribed #or manu#acturing process design (Section .%.%.2) and validation (Section .%.6.%)' he $ngineering Manager (>) summari.es and reports results o# manu#acturing process improvement activities to op Management #or review (Section 5.6 )' he ISO Management Representative (>) has overall responsibility #or establishing and implementing an e##ective continual improvement system (O" 8.5) which includes improvement actions+ as outlined in Section 8.5.1 above+ and corrective and preventive actions as outlined in Section 8.5.2 and Section 8.5.% #ollowing': 'J'4
"orrective action
$vidence o# noncon#orming product+ customer dissatis#action+ or ine##ective processes is used to drive our corrective action system because a problem e%ists re*uiring immediate correction and possible additional action aimed at eliminating or reducing the li1elihood o# its recurrence' Management with responsibility and authority #or corrective action are noti#ied promptly o# product or process non7con#ormities' Investigating and eliminating the root cause o# these #ailures is a critical part o# our continual improvement process' ) analy.es parts re?ected by the customer and initiate corrective action to prevent recurrence0 records o# these analyses are retained and made available upon re*uest by the customer' "ycle time related to re?ected product analysis is consistent with the determination o# root cause+ corrective action+ and monitoring e##ectiveness o# implementation' Related procedures are detailed inO" 8.%'
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,ollow7ups are conducted (through the internal audit process0 Section 8.2.2 = to ensure that e##ective corrective action is ta1en appropriate to the impact o# the problem encountered' In addition+ the ISO Management Representative (>) summari.es and analy.es corrective action data to identi#y trends needed to assess overall e##ectiveness o# the corrective action system and to develop related recommendations #or improvement' he corrective action system is considered e##ective i# speci#ic problems are corrected and data indicates that the same or similar problems have not recurred' Results o# this analysis and related recommendations are presented to op Management #or review and action during management reviews0 Section 5.6 ' 'J'9
Preventive action
Data #rom internal audits+ customer #eedbac1+ employee suggestions+ and other appropriate data is collected and analy.ed (Section 8.4) to identi#y the actions needed to eliminate the causes o# potential problems and thereby prevent their occurrence' Ge also utili.e Potential ,ailure Modes and $##ects !nalysis (,M$!) tools to identi#y potential #ailures and their causes' Investigating and eliminating the root cause o# potential #ailures is a critical part o# our continual improvement process' Ge review and initiate preventive actions through our preventive action process de#ined in O" 8.5' Ge apply controls and #ollow7up to ensure that e##ective preventive action is ta1en appropriate to the ris1 and impact o# potential problems and losses' In addition+ the ISO Management Representative (>) summari.es and analy.es preventive action data to identi#y trends needed to assess overall e##ectiveness o# the preventive action system and to develop related recommendations #or improvement' he preventive action system is considered e##ective i# potential losses were avoided' Results o# this analysis and related recommendations are presented to op Management #or review and action during management reviews0 Section 5.6 '
Document:
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QM - Quality Manual
Page:
08/01/09
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$ppen"i% $ ist of ey Inte#nal QM $ocu%ents "efe#ence& in tis Manual (master lists #or these and other -MS Documents are de#ined in O" 4.2.%) (list all internal documents re#erenced in your manual) $ocu%ent o.
Title
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