iso9001 manual with procedure
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QUALITY MANUAL
DATE: June 06, 2005
REVISION 01
UNCONTROLLED COPY
CONTROLLED COPY
Serial !!00"!!!!!!!
I##ue$ T%: !!!!!!!!!!!!!!!!!!!!!!!!!!! Da&e: !!!!!!!!!!!
Worksmart, Inc.Po Box 442 - Paw Paw, Michigan 49079
Voice: 00-!"!-##47 - 2"9-#4$-9!29 %acsimi&e: 2"9-#4$-9!#0WWW.Worksmartinc.net - ra'ar0$()o*ager.net
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Worksmart, Inc.
ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2 O- 105
Table of Contents
APPROVALS......................................................................................................................................6
REVISION AND APPROVAL RECORD.............................................................................................7
1. !ENERAL................................................................................................................................"
1.1 INTRODUCTION................................................................................................................................................. "
1.# E$CLUSIONS..................................................................................................................................................... %
1.& SCOPE..............................................................................................................................................................1
1.' QUALITY POLICY STATEMENT................................................................................................................. ..... 11
#. COMPANY (ISTORY............................................................................................................1#
&. COMPANY CONTACT IN)ORMATION.................................................................................1#
'. QUALITY MANA!EMENT SYSTEM....................................................................................1&
'.1 !ENERAL REQUIREMENTS........................................................................................................................... 1&
'.# DOCUMENTATION REQUIREMENTS.............................................................................................................164.2.$ +/..................................................................................................................................................... $"4.2.2 1/I3 M//.......................................................................................................................................$74.2.# 5636 6% 65M38.......................................................................................................................$7
4.2.#.$ 5ontro& o ocments Proce're.........................................................................................................$4.2.4 5636 6% 1/I3 568............................................................................................................2$
4.2.4.$ 5ontro& o 1a&it* ecor's Proce're..................................................................................................22
*. MANA!EMENT RESPONSI+ILITY......................................................................................#'
*.1 MANA!EMENT COMMITMENT.......................................................................................................................#'
*.# CUSTOMER )OCUS........................................................................................................................................ #*
*.& QUALITY POLICY............................................................................................................................................ #*
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7.& DESI!N AND DEVELOPMENT........................................................................................................................*7.#.$ esign an' e)e&o>ment P&anning...............................................................................................................!07.#.2 esign an' e)e&o>ment In>ts................................................................................................................... !07.#.# esign an' e)e&o>ment 6t>ts................................................................................................................ !$7.#.4 esign an' e)e&o>ment e)iew................................................................................................................. !$7.#.! esign an' e)e&o>ment Veriication........................................................................................................... !$7.#." esign an' e)e&o>ment Va&i'ation............................................................................................................. !27.#.7 5ontro& o esign an' e)e&o>ment 5hanges..............................................................................................!27.#. esign an' e)e&o>ment 5ontro& Proce're................................................................................................!#
7.' PURC(ASIN!.................................................................................................................................................. *"7.4.$ Prchasing Process...................................................................................................................................... !
7.4.2 Prchasing Inormation................................................................................................................................. !97.4.# Veriication o Prchase' Pro'ct................................................................................................................. !97.4.4 Prchasing Proce're..................................................................................................................................."0
7.* PRODUCTION AND SERVICE PROVISION................................................................................................... .667.!.$ 5ontro& o Pro'ction an' 8er)ice Pro)ision.................................................................................................""
7.!.$.$ Process 5ontro& Proce're.................................................................................................................."77.!.$.2 8er)icing Proce're............................................................................................................................. "9
7.!.2 Va&i'ation o Processes or Pro'ction an' 8er)ice Pro)ision......................................................................707.!.2.$ Process Va&i'ation Proce're...............................................................................................................7$
7.!.# I'entiication an' 3racea<i&it*........................................................................................................................ 727.!.#.$ I'entiication an' 3racea<i&it* Proce're..............................................................................................7#
7.!.4 5stomer Pro>ert*........................................................................................................................................ 74
7.!.4.$ 5ontro& o 5stomer-8>>&ie' Pro'ct Proce're................................................................................7!7.!.! Preser)ation o Pro'ct.................................................................................................................................7"7.!." Aan'&ing, 8torage, Packaging, Preser)ation, an' e&i)er* Proce're.........................................................77
7.6 CONTROL O) MONITORIN! AND MEASURIN! DEVICES...................................................................... ....7%7.".$ 5ontro& o Monitoring an' Measring e)ices Proce're.............................................................................0
". MEASUREMENT, ANALYSIS, AND IMPROVEMENT.........................................................."&
".1 !ENERAL........................................................................................................................................................."&.$.$ P&anning........................................................................................................................................................ #
".# MONITORIN! AND MEASUREMENT.............................................................................................................."&
.2.$ 5stomer 8atisaction................................................................................................................................... #.2.$.$ Measring an' Monitoring 5stomer 8atisaction................................................................................4
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.2.2 Interna& /'it................................................................................................................................................. 7.2.2.$ Interna& /'its Proce're.....................................................................................................................
.2.# Monitoring an' Measrement o Processes..................................................................................................90.2.4 Monitoring an' Measrement o Pro'ct an'or 8er)ice..............................................................................90
.2.4.$ Ins>ection an' 3est Proce're.............................................................................................................9$.2.4.2 Ins>ection an' 3est 8tats Proce're..................................................................................................94
".& CONTROL O) NONCON)ORMIN! PRODUCT.............................................................................................. %*.#.$ 5ontro& o onconorming Pro'ct Proce're..............................................................................................9"
".' ANALYSIS O) DATA........................................................................................................................................ %".4.$ 8tatistica& 3echni@es Proce're.................................................................................................................. 99
".* IMPROVEMENT..............................................................................................................................................1.!.$ 5ontina& Im>ro)ement............................................................................................................................... $00
.!.$.$ 5ontina& Im>ro)ement Proce're.....................................................................................................$0$.!.2 5orrecti)e /ction.........................................................................................................................................$0#.!.# Pre)enti)e /ction........................................................................................................................................ $0#
.!.#.$ 5orrecti)e an' Pre)enti)e /ction Proce're......................................................................................$04
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/PP6V/8
APPROVED +Y
Michae& P. Mc+arr*, Presi'ent ate
enise Brasch, Vice Presi'ent ate
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VI8I6 / /PP6V/ 56
Re23s3on Des453t3on A5o2e +8 Date
$ 6rigina& e&ease 0"0"0!
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1. !ENERAL
1.1 INTRODUCTION
Worksmart, Inc. recogni?es its res>onsi<i&it* as a >ro)i'er o @a&it* ser)ices. 3o this en',Worksmart, Inc. has 'e)e&o>e' an' 'ocmente' a @a&it* management s*stem. 3he @a&it*
s*stem com>&ies with the internationa& stan'ar' I86 900$:2000, 1a&it* managements*stems C e@irements. 3he @a&it* s*stem a&so com>&ies with the o&&owing stan'ar's:
/merican 8ociet* or 3esting an' Materia&s
3he >r>ose o this mana& is to >ro)i'e com>rehensi)e e)i'ence to a&& cstomers,s>>&iers an' em>&o*ees o what s>eciic contro&s are im>&emente' to ensre ser)ice@a&it*. 3his mana& a&so go)erns the creation o @a&it* re&ate' 'ocments. It wi&& <ere)ise', as necessar*, to re&ect the @a&it* s*stem crrent&* in se. It is isse' on acontro&&e' co>* <asis to a&& interna& nctions aecte' <* the @a&it* s*stem an' on anncontro&&e' co>* <asis to cstomers an' s>>&iers. It ma* <e isse' to cstomers on a
contro&&e' co>* <asis >on cstomer re@est. 3his mana& is 'i)i'e' into eight main sections. 8ections 4- are mo'e&e' on the sectiona&organi?ation o the I86 900$:2000 stan'ar'. 8ections are rther s<'i)i'e' into se)era&s<sections re>resenting main @a&it* s*stem e&ements or acti)ities.
DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDD Michae& P. Mc+arr*, Presi'ent
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1.# E$CLUSIONS
!ene5al Pol348
3he Worksmart, Inc. @a&it* s*stem is tai&ore' to or >rocesses, inc&'ing a&& cstomer an'reg&ator* re@irements. e@irements o I86 900$ that are not a>>&ica<&e to the natre oor <siness are exc&'e' rom the sco>e o or @a&it* s*stem.
P5o4e95e
$.0 +enera&
$.$ xc&sion o an I86 900$ re@irement is >ermissi<&e on&* when <oth o theo&&owing con'itions are satisie':
• 3he re@irement mst <e &imite' to I86 900$ 5&ase 7, Pro'ct
ea&i?ation an'
• xc&sion o the re@irement wi&& not aect or a<i&it* or res>onsi<i&it* to
>ro)i'e >ro'ct that meets cstomer an' a>>&ica<&e reg&ator*re@irements.
2.0 es>onsi<i&ities
2.$ 3he 1a&it* Manager is res>onsi<&e or i'enti*ing those re@irements o I86900$ that are not a>>&ica<&e to or <siness, an' to recommen' theirexc&sions rom the Worksmart, Inc. @a&it* s*stem.
2.2 3he Presi'ent has res>onsi<i&it* or e)a&ation an' a>>ro)a& o the exc&sions.3his e)a&ation an' a>>ro)a& o exc&sions are norma&&* con'cte' 'ring themanagement re)iew >rocess. 3he 'etai&s are ex>&aine' in the Managemente)iew Proce're.
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#.0 I'entiication
#.$ /n* exc&'e' re@irements are i'entiie' in this section o the @a&it* mana&an' reerence the a>>&ica<&e c&ases in the I86 900$ stan'ar'. In each case,there is a&so an ex>&anation as to wh* the exc&sion is a>>&ica<&e.
L3st of E:4l9s3ons
3he Worksmart, Inc. 1a&it* 8*stem satisies a&& the re@irements o I86 900$:2000E
thereore, no exc&sions are c&aime'.
1.& SCOPE
3he Worksmart, Inc. @a&it* s*stem a>>&ies to the 'esign, 'e)e&o>ment, an' ser)ice o orser)ices. 8er)ices inc&'e' in the sco>e o registration are:
• +ron' Penetrating a'ar 8canning
• 8race Penetrating a'ar 8canning
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1.' QUALITY POLICY STATEMENT
Worksmart, Inc. acce>ts res>onsi<i&it* or the com>&ete satisaction o its cstomers. We
exercise this res>onsi<i&it* throgh a'e@ate training o or em>&o*ees, a'herence to
>ro)en >roce'res, tota& commitment to meeting an' excee'ing cstomer re@irements,
an' maintaining a com>an* c&tre that osters continos im>ro)ement. 6r o<=ecti)e is to
'e&i)er 'eect ree ser)ices on time, e)er* time.
DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDD Michae& P. Mc+arr*, Presi'ent
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#. COMPANY (ISTORY
Worksmart, Inc. >ro)i'es remote sensing, s<srace imaging ser)ices.
Worksmart, Inc. was esta<&ishe' in $99 an' incor>orate' in $999 to >ro)i'e s<sracescanning an' &ocating ser)ices to in'str*, constrction, en)ironmenta& an' >ri)ate concernsaron' the nite' 8tates. 6r mission statement is sim>&e FPro)i'e the highest &e)e& o
@a&it* an' >roessiona&ism or the <est )a&e to the cstomer in e)er* area o or <siness.F
&. COMPANY CONTACT IN)ORMATION
Worksmart, Inc. is &ocate' at:
"#444 5ont* oa' 2$!
awrence, Michigan 490"4
Mai&ing a''ress:
P6 Box 442PawPaw, Michigan 49079
Phone: 00-!"!-##47
2"9-#4$-9!29
%ax: 2"9-#4$-9!#0
-mai& : ra'ar0$()o*ager.net
We< 8ite: www.worksmartinc.net
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ISO '001 (UALITY )ANUAL
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'. QUALITY MANA!EMENT SYSTEM
'.1 !ENERAL REQUIREMENTS
Worksmart, Inc. has 'e)e&o>e', 'ocmente', im>&emente' an' maintains its @a&it* s*stem
in accor'ance with the re@irements o I86 900$:2000, 1a&it* management s*stems Ce@irements. Worksmart, Inc.Gs @a&it* s*stem is <ase' >on a F>rocess a>>roachH to@a&it* management an':
a i'entiies the >rocesses nee'e' or the @a&it* s*stemE< 'etermines the se@ence an' interaction o these >rocesses Jsee 3a<&e $.Ec 'etermines criteria an' metho's re@ire' to ensre the eecti)e o>eration an'
management o these >rocessesE' ensres the a)ai&a<i&it* o resorces an' inormation necessar* to s>>ort the
o>eration an' monitoring o these >rocessesEe monitors, measres an' ana&*?es these >rocesses, an' im>&ements actions
necessar* to achie)e >&anne' res&ts an' contina& im>ro)ement.
Worksmart, Inc. contina&&* maintains an' im>ro)es these >rocesses in accor'ance withre@irements o I86 900$:2000, 1a&it* management s*stems C e@irements.
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Table 1.Se;9en4e an Inte5a4t3on of -o5<s=a5t, In4. Q9al3t8 Mana>e=ent S8ste=
? P5o4ess Relate P5o4e95es ISO%1
Cla9se
$. 5stomeree' isI'entiie'
- Measring an' Monitoring 5stomer 8atisaction .2
2. Pro'ct8er)ice isesigne'e)e&o>e'
- 5ontro& o Monitoring an' Measring e)ices Proce're- 5ontro& o onconorming Pro'ct Proce're- esign an' e)e&o>ment 5ontro& Proce're
7.".#7.#
#. 1otations are8ent an'6r'ers areecei)e'
- 5ontract e)iew Proce're 7.2.2
4. 8er)iceP&anning
- %aci&it* Management Proce're- Pro'ct ea&i?ation P&anning Proce're
".#7.$
!. Materia&s are
Prchase'
- 5ontro& o onconorming Pro'ct Proce're
- I'entiication an' 3racea<i&it* Proce're- Prchasing Proce're
.#
7.!.#7.4
". 8er)ice,Veriication,8hi>ment
- 5ontro& o 5stomer-8>>&ie' Pro'ct Proce're- 5ontro& o Monitoring an' Measring e)ices Proce're- 5ontro& o onconorming Pro'ct Proce're- %aci&it* Management Proce're- Process 5ontro& Proce're- Process Va&i'ation Proce're- 8tatistica& 3echni@es Proce're- Aan'&ing, 8torage, Packaging, Preser)ation, /n' e&i)er*- Ins>ection an' 3est Proce're
- Ins>ection an' 3est 8tats Proce're
7.!.#7.".#".#7.!.$7.!.2.47.!.!.2.4
.2.47. 5stomer8er)ice
- Measring an' Monitoring 5stomer 8atisaction .2
. 8er)icing - Measring an' Monitoring 5stomer 8atisaction- Process 5ontro& Proce're- Process Va&i'ation Proce're- 8er)icing Proce're- 8tatistica& 3echni@es Proce're
.27.!.$7.!.27.!.$.4
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ISO '001 (UALITY )ANUAL
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Cont3n9al I=5o2e=ent of -o5<s=a5t, In4. Q9al3t8 Mana>e=ent S8ste=PDCA Relate P5o4e95es ISO
%1Cla9se
P&an - 5ontro& o ocments Proce're- 8tatistica& 3echni@es Proce're- Pro'ct ea&i?ation P&anning Proce're
- 3raining Proce're
4.2.#.47.$
".2.2o - 5ontro& o 1a&it* ecor's Proce're- 8tatistica& 3echni@es Proce're- 3raining Proce're
4.2.4.4".2.2
5heck - 5ontro& o 1a&it* ecor's Proce're- Measring an' Monitoring 5stomer 8atisaction- Ins>ection an' 3est Proce're- Interna& /'its Proce're- Management e)iew Proce're- Process Va&i'ation Proce're- 8tatistica& 3echni@es Proce're
- 3raining Proce're
4.2.4.2.2.4.2.2!."7.!.2.4
".2.2 /ct - 5ontina& Im>ro)ement Proce're- 5orrecti)e an' Pre)enti)e /ction Proce're- 8tatistica& 3echni@es Proce're- Interna& 5ommnication Proce're
.!.$.!.2.4!.!.#
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'.# DOCUMENTATION REQUIREMENTS
'.#.1 !ENERAL
Worksmart, Inc.Ks @a&it* s*stem 'ocmentation is com>rise' o:
a this 1a&it* Mana&, which inc&'es a&& the >roce'res re@ire' <* the I86900$ stan'ar'E
< 'ocmente' >roce'res re@ire' <* a>>&ica<&e stan'ar's an' reg&ationsEc 'ocments nee'e' to ensre the eecti)e o>eration an' management o the
>rocesses Ji.e., where a>>&ica<&e, >rocess ma>s, @a&it* >&ans, workinstrctions, sam>&es, 'rawings, an' <i&&s o materia&s.
' recor's re@ire' <* the I86 900$ stan'ar' an' an* other a>>&ica<&estan'ar's an' reg&ations
3he extent o Worksmart, Inc.Ks 'ocmentation 'e>en's on the:
a organi?ationa& nee'sE< com>&exit* an' interaction o the >rocessesEc com>etence o >ersonne& >erorming the tasks.
ocments are maintaine' on )arios me'ia sch as >a>er, e&ectronic, )i'eo, etc.
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ISO '001 (UALITY )ANUAL
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'.#.# QUALITY MANUAL
3he 1a&it* Mana& is the >rinci>a& 'ocment that 'eines the @a&it* s*stem atWorksmart, Inc.. It inc&'es:
a the sco>e o the @a&it* s*stem, inc&'ing 'etai&s o, an' =stiication or, an*exc&sionsE
< 'ocmente' >roce'resEc reerences to 'ocmente' >roce'res an' externa& 'ocments not inc&'e' in
the @a&it* mana&E' a 'escri>tion o the se@ence an' interaction o the >rocesses inc&'e' in the
@a&it* s*stem.
'.#.& CONTROL O) DOCUMENTS
Worksmart, Inc. i'entiies an' contro&s 'ocments re@ire' <* the @a&it* s*stemaccor'ing to the 5ontro& o ocments Proce're. It ensres that 'ocments:
a are re)iewe' an' a>>ro)e' or a'e@ac* >rior to isseE< are >'ate', re)iewe', an' a>>ro)e' or re-isse as necessar*E
c are i'entiie' with their crrent re)ision statsE' are a)ai&a<&e at >oint o seEe are &egi<&e, rea'i&* i'entiia<&e, an' retrie)a<&eE o externa& origin are i'entiie' an' their 'istri<tion is manage'Eg that are o<so&ete are >re)ente' rom ninten'e' se an' are sita<&*
i'entiie' i the* are retaine' or an* >r>ose.
ocments 'eine' as @a&it* recor's are manage' >er the 5ontro& o 1a&it*ecor's Proce're.
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'.#.&.1 Cont5ol of Do49=ents P5o4e95e
!ene5al Pol348
/&& 'ocments an' 'ata are re)iewe' an' a>>ro)e' <* athori?e' >ersonne& >rior to isse.ach 'e>artment isses an' maintains its own 'ocments. 5rrent re)isions o a>>ro>riate'ocments are a)ai&a<&e at &ocations where the* are se'. 6<so&ete 'ocments areremo)e' rom >oints o se.
P5o4e95e
$.0 +enera&
$.$ 3he o&&owing t*>es o 'ocments are contro&&e' <* the 'ocment contro&>roce're:
• 1a&it* Mana&, >roce'res an' orms, 1a&it* P&ans, Pro=ect P&ans, 3est
P&ans, an' 8er)ice P&ans
• Work instrctions Ji.e., conigration instrctions, >ro'ction contro&
>&ansrotings, insta&&ation instrctions, ins>ectiontest instrctions, etc.
• 8tan'ar's an' other reerence materia&
• Pro'ct re@irements, co'es, s>eciications, 'rawings, an' Bi&&s o Materia&
JB6Ms
2.0 ocment an' ata I'entiication, />>ro)a&, an' Isse
2.$ /&& 'ocments are i'entiie' with a tit&e, re)ision &e)e& Ji re@ire', an' wherea>>&ica<&e, a co'e or >art nm<er. 5ertain work instrctions Ji.e., 'irections>oste' in work areas or 'is>&a*e' <* other means 'o not ha)e to ha)e are)ision &e)e&. 6n&* origina& orms, which are store' on i&e, are i'entiie' withthe issing athorit*. /&& 'ocments are re)iewe' an' a>>ro)e' Jsigne' an''ate' >rior to isse.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 1' O- 105
2.2 Prior to isse an' re&ease, 'ocments are re)iewe' or correctness an'com>&iance to @a&it* re@irements. / 'ocment is consi'ere' to <e orma&&*isse' when it is athori?e' an' a>>ro)e' <* the issing athorit*.ocments that re@ire more than one a>>ro)a& signatre in'icate how man*an' which signatres are re@ire' or a>>ro)a& an' isse.
2.# %or e&ectronic 'ocments, on&* a>>ro)e' 'ocments ma* <e >oste' on thecom>an* network. 3he s*stem a'ministrator is res>onsi<&e or re)iewing a&&the re@ire' a>>ro)a& signatres.
2.4 3he 1a&it* Manager is res>onsi<&e or ensring that the 1a&it* Mana& isre)iewe', a>>ro)e', an' 'istri<te' as re@ire'. 5o>ies o this mana& wi&& <eseria&i?e' an' isse' on a contro&&e' 'istri<tion <asis. ncontro&&e' co>ieswi&& <e marke' F5636H an' wi&& <e >ro)i'e' or se otsi'e o thecom>an*, a&thogh a contro&&e' co>* can <e isse' to cstomers >oncstomer re@est.
2.! 5stomer engineering 'ocments Ji.e., stan'ar's, s>eciications, 'rawings,sam>&es, etc. an' externa& 'ocments Ji.e., changes recei)e' romcstomers are re)iewe' <* ngineering, the +enera& Manager, an' the1a&it* Manager. I an* am<igities or errors are 'etecte', the cstomer is
notiie'. 6n&* 'ocments a>>ro)e' <* the 'esignate' Worksmart, Inc.>ersonne& ma* <e se' or engineering>ro'ctionser)ice o>erations.
2." ach 'e>artment isses an' maintains its own 'ocments an' a Master In'exo a&& a>>&ica<&e 'ocments an' their crrent re)ision. 5rrent re)isions oa>>ro>riate 'ocments are a)ai&a<&e at &ocations where the* are se'.
#.0 ocment an' ata 5hanges
#.$ /n* em>&o*ee can re@est a change to a 'ocment, <t the re)iew an'a>>ro)a& mst <e >erorme' <* the same nctions that >erorme' the origina&re)iew an' a>>ro)a&. e)ise' >ortions o 'ocments are 'istri<te' with a
5hange Brie, an' o<so&ete 'ocments are remo)e'. Work instrctions thatare not marke' with a re)ision &e)e& are 'estro*e' an' re>&ace' with new,a>>ro)e' instrctions.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 20 O- 105
4.0 6<so&ete ocments
4.$ 6<so&ete 'ocments that are retaine' or reerence or &ega& o<&igations aremarke' F6B863H an' are ke>t se>arate rom acti)e 'ocments. %i&ingca<inets containing o<so&ete 'ocments are segregate' an' &a<e&e'F6B863H. 6<so&ete e&ectronic 'ocments are remo)e' rom the networkan' are store' in me'ia that are on&* accessi<&e to athori?e' >ersonne&. /n*o<so&ete 'ocments that nee' to <e reacti)ate' Ji.e., or s>are >arts, mst <ere)iewe', a>>ro)e', an' re&ease' in the same manner as new&* esta<&ishe''ocments.
!.0 ncontro&&e' ocments
!.$ 5o>ies o 'ocments isse' to Worksmart, Inc. >ersonne& an' otsi'e >artiesor inormation on&* Jare not aecte' <* the 'ocments are stam>e'L5636L across the ront >age. 8ch 'ocments are not n'erre)ision contro&. ncontro&&e' co>ies o 'ocments ma* not <e isse' to>ersonne& or otsi'e >arties who manage, >erorm, or )eri* work that is'irect&* aecte' <* the 'ocment.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 21 O- 105
'.#.' CONTROL O) QUALITY RECORDS
Worksmart, Inc. has esta<&ishe' an' maintains @a&it* recor's to >ro)i'e e)i'ence o conormance to re@irements an' o eecti)e o>eration o the @a&it* s*stem. 3he5ontro& o 1a&it* ecor's Proce're ensres >ro>er i'entiication, storage, retrie)a&,>rotection, retention time, an' 'is>osition o @a&it* recor's.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 22 O- 105
'.#.'.1 Cont5ol of Q9al3t8 Re4o5s P5o4e95e
!ene5al Pol348
3o 'emonstrate the im>&ementation o the @a&it* s*stem, Worksmart, Inc. a'heres to strictcontro& o @a&it* recor's. /&& recor's are maintaine' <* the 'e>artment that is res>onsi<&eor the acti)it* on recor' an' are store' in a secre an' easi&* accessi<&e &ocation to >re)ent&oss or 'amage. 3he retention >erio' an' 'is>osition >rocess or recor's are 'eine'.
P5o4e95e
$.0 +enera&
$.$ 1a&it* recor's are maintaine' to attest to the && im>&ementation o the@a&it* s*stem. 3he recor's are store' as secre' com>ter i&es or in'esignate' i&ing ca<inets to >re)ent 'eterioration an' 'amage. 8ch recor'sare easi&* accessi<&e or se an' are ma'e a)ai&a<&e or re)iew >oncstomer, interna&, or externa& a'itor re@est.
$.2 3he o&&owing 'ocments are acce>ta<&e recor's: orms, re>orts, mintes omeetings, signe' or stam>e' 'ocments, com>ter i&es, or 'ata<ases.
2.0 es>onsi<i&it*
2.$ 1a&it* recor's are generate' an' maintaine' <* the 'e>artments res>onsi<&eor their creation. /&& recor's mst contain sicient 'ata to attest tosatisactor* com>&etion o the recor'e' acti)it* an' at minimm, mst <esigne' an' 'ate' <* the in'i)i'a& res>onsi<&e or com>&eting the recor'.
2.2 %or com>teri?e' recor's, a>>ro>riate <ack > >roce'res are esta<&ishe'.ngineering is res>onsi<&e or <acking > com>ter i&es.
#.0 8torage, ocation, an' etention 3ime
#.$ /&& recor' ca<inets, containers, an' 'e)ices are c&ear&* marke'&a<e&e' toi'enti* their contents. ecor's are in'exe' an' gro>e' or ex>e'ientretrie)a&. ecor's mst not <e store' in em>&o*ees >ersona& i&ing'e)ices&ocations.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2" O- 105
#.2 3he retention >erio' or @a&it* recor's is 'etermine' <* contracta&re@irements, warrant* >erio's, >ro'ct &ie c*c&es, &ega& consi'erations, etc.3he o&&owing are @a&it* recor's that are store' at Worksmart, Inc., at the'esignate' &ocations or the s>eciie' retention time:
T3tleSto5a>eLo4at3on
Retent3onPe53o
Management e)iews 2 ears
/'it e>orts ! ears5stomer 5om>&aints 2 ears
Ins>ection an' 3est e>orts ! ears
8>>&ier 1a&iicationPrchasing ! ears
onconormance e>orts ! ears
Pro'ct I'entiication3racea<i&it* ! ears
5orrecti)e /ction e>orts ! ears
3raining $0 ears
8er)icing $0ears
esign an' e)e&o>ment e)iews,Veriication, N Va&i'ation
$0 ears
5ontract6r'er e)iews ! ears
8>ecia& Processes 1a&iication $0 ears
5a&i<ration ! ears
Pro'ction 5ontro& P&ansotings ! ears
4.0 is>osition
4.$ 3he 1a&it* Manager is res>onsi<&e or the 'is>osition o @a&it* recor's thatexcee' their s>eciie' retention time.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2. O- 105
*. MANA!EMENT RESPONSI+ILITY
*.1 MANA!EMENT COMMITMENT
Worksmart, Inc.s management >ro)i'es its commitment to the 'e)e&o>ment,im>&ementation an' contina& im>ro)ement o the @a&it* s*stem <*:
a commnicating to the organi?ation the im>ortance o meeting cstomer, reg&ator*,an' &ega& re@irementsE
< esta<&ishing an' 'ocmenting the @a&it* >o&ic* an' @a&it* o<=ecti)es as 'escri<e' inthe Management e)iew Proce'reE
c con'cting management re)iews as 'escri<e' in the Management e)iewProce'reE
' ensring the a)ai&a<i&it* o necessar* resorces.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 25 O- 105
*.# CUSTOMER )OCUS
3he management o Worksmart, Inc. wi&& ensre that cstomer nee's an' ex>ectations arei'entiie', transorme' into re@irements, an' &i&&e' with the intent o achie)ing an'excee'ing cstomer satisaction. 5stomer nee's an' ex>ectations are i'entiie' )ia theMeasring an' Monitoring 5stomer 8atisaction Proce're, an' 5ontract e)iewProce're, an' trans&ate' )ia the esign an' e)e&o>ment 5ontro& Proce're. Worksmart,
Inc. com>&ies with a&& re&e)ant reg&ator* an' &ega& re@irements.
*.& QUALITY POLICY
3he @a&it* >o&ic* is esta<&ishe' <* to> management an' is a>>ro)e' <* the Presi'ent. 3hemanagement o Worksmart, Inc. ensres that the 'ocmente' @a&it* >o&ic*:
a is a>>ro>riate to the >r>ose o Worksmart, Inc.E< inc&'es a commitment to meeting re@irements an' to contining im>ro)ement o
the @a&it* s*stem >er the 5ontina& Im>ro)ement Proce'reE
c >ro)i'es a ramework or esta<&ishing an' re)iewing @a&it* o<=ecti)esE' is commnicate' an' n'erstoo' at a>>ro>riate &e)e&s o the organi?ation >er the
3raining Proce're, an' in a''ition it is >oste' throghot )isi<&e areas o thecom>an*E
e is re)iewe' or contining sita<i&it* >er the Management e)iew Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2/ O- 105
• Q9al3t8 s8ste= ob@e4t32es /re o<=ecti)es that >ertain to the im>ro)ement o
@a&it* s*stem >rocesses an' >erormance.
*.'.# Q9al3t8 Mana>e=ent S8ste= Plann3n>
3he management o Worksmart, Inc. ensres that @a&it* management s*stem>&anning is execte' to meet the re@irements >ro)i'e' in 8ection !.4.$, as we&& asthe @a&it* o<=ecti)es. 1a&it* >&anning inc&'es:
a the >rocesses o the @a&it* s*stem, inc&'ing >ermissi<&e exc&sionsE< the resorces nee'e'Ec contina& im>ro)ement o the @a&it* s*stem.
3a<&e $ in 8ection 4.$ 'e>icts the @a&it* management s*stem >&anning >rocessot>t at Worksmart, Inc. an' 'escri<es the se@ence an' interaction o the>rocesses o the @a&it* management s*stem. Worksmart, Inc.Gs @a&it* s*stem is<ase' >on a F>rocess a>>roachH to @a&it* management. %or each instance o@a&it* management s*stem >&anning, the ot>t is 'ocmente' accor'ing&*, an'changes are con'cte' in a contro&&e' manner.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2 O- 105
*.* RESPONSI+ILITY, AUT(ORITY, AND COMMUNICATION
*.*.1 Resons3b3l3t8 an A9to53t8
Worksmart, Inc. has 'eine' a&& nctions an' their res>onsi<i&ities within theorgani?ation. es>onsi<i&ities an' athorities are 'eine' an' commnicate' in or'er
to aci&itate eecti)e @a&it* management.
*.*.1.1 O5>an3Bat3on
Worksmart, Inc. 6rgani?ation 5hart
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Michae&P.Mc+arr*Presi'ent
enise BraschVice Presi'ent
%ie&' 3echnician8a&es 6ice 3echnician
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2' O- 105
*.*.1.# Mana>e=ent Resons3b3l3t3es
• 3he Presi'ent orm&ates the @a&it* >o&ic*, initiates the @a&it* s*stem,
>ro)i'es the necessar* resorces to maintain the @a&it* s*stem, an'con'cts anna& management re)iews o the @a&it* s*stem.
• Marketing8a&es con'cts market research an' ana&*sis to 'eine market
'eman' as to the gra'e, >rice range, an' >otentia& @antitiesE esta<&ishes the'esire' @a&it* characteristics o ser)ices inc&'ing nstate' ex>ectations,esta<&ishes s>eciications or >ro'cts an' associate' ser)ices, commnicatesa&& cstomer re@irements an' ex>ectations c&ear&* an' accrate&* within thecom>an*, a')ertises an' >romotes com>an*s >ro'cts, monitors the @a&it*o com>etitors >ro'cts an' ser)ices, carries ot contract an' or'er re)iews,>rocesses contracts an' or'ers, >ro)i'es cstomer &iaison an' ser)ice, an'han'&es cstomer com>&aints.
• ngineering >re>ares >ro'ct nctiona& s>eciications rom Marketing
s>eciications or cstomer-s>eciie' re@irements, 'esigns an' 'e)e&o>s>ro'ctsser)ices, initiates 'esign an' 'e)e&o>ment re)iews an' assres that'esign an' 'e)e&o>ment ot>t meets the 'esign an' 'e)e&o>ment in>t,)eriies an' tests the 'esigns, co&&ects ie&' >erormance an' re&ia<i&it* 'ata,an' >artici>ates in the 'is>osition o nonconorming >ro'cts.
• Pro'ction 'etermines >ro'ction >ersonne& an' e@i>ment re@irements,
contro&s an' monitors >rocesses, 'eines workmanshi> stan'ar's, maintains>ro'ction e@i>ment, a'ministers storage areas, >erorms >ro'ctionengineering, >re>ares >ro'ction >&ans, >re>ares @a&it* >&ans, an'>artici>ates in the 'is>osition o nonconorming >ro'cts.
• Prchasing se&ects @a&iie' s>>&iers an' s<contractors, >re>ares an'
a>>ro)es >rchasing 'ocments, monitors an' assesses s>>&ier>erormance, an' >artici>ates in the 'is>osition o nonconorming >ro'cts.
• 8er)ice >rocesses ser)icing or'ers, >erorms ser)icing, an' co&&ects ie&'
>erormance an' re&ia<i&it* 'ata.
• Personne& 'eines >ersonne& @a&iication re@irements, im>&ements em>&o*ee
incenti)e >rograms, im>&ements training >rograms, an' maintains trainingrecor's.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE "0 O- 105
• 1a&it* esta<&ishes an' maintains the @a&it* management s*stem, a'its
im>&ementation o the @a&it* s*stem, initiates re@ests or, an' o&&ows > oncorrecti)e actions, maintains an' ca&i<rates measring an' test e@i>ment,carries ot s>>&ier @a&it* sr)e*s an' a'its, 'etermines statistica&techni@es, >erorms ins>ections an' testing in accor'ance with the @a&it*>&ans, han'&es an' >artici>ates in the 'is>osition o nonconorming >ro'cts,coor'inates 'ocment contro& acti)ities, an' maintains ins>ection recor's.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE "1 O- 105
*.*.# Mana>e=ent Re5esentat32e
Worksmart, Inc. 'esignates the 1a&it* Manager as the Management e>resentati)e.8he or he, irres>ecti)e o other res>onsi<i&ities, has the athorit* an' res>onsi<i&it*or:
a ensring that the >rocesses o the @a&it* s*stem are esta<&ishe',im>&emente' an' maintaine'E
< re>orting to to> management on the >erormance o the @a&it* s*stem,
inc&'ing an* nee's or im>ro)ementEc ensring >romotion o awareness o cstomer re@irements throghot the
organi?ationE' acting as &iaison with externa& >arties on matters re&ating to the @a&it* s*stem.
*.*.& Inte5nal Co==9n34at3on
Worksmart, Inc. management ensres that commnication regar'ing theeecti)eness o the @a&it* management s*stem is aci&itate' throghot theorgani?ation )ia the Interna& 5ommnication Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE "2 O- 105
*.*.' Inte5nal Co==9n34at3on P5o4e95e
!ene5al Pol348
Worksmart, Inc. commnicates a&& matters regar'ing the eecti)eness o the @a&it* s*stemsto the entire organi?ation. 3his inc&'es @a&it* re@irements, o<=ecti)es, an' achie)ementsas we&& as >ro'ct an' >rocess >erormance.
P5o4e95e
$.0 5ontina& 5ommnication
$.$ Interna& inormation >ertaining to the Worksmart, Inc. @a&it* s*stems iscommnicate' )ia ser an' >ro'ct mana&s, >roce'res, work instrctions,'rawings, s>eciications, @a&it* recor's re>ortsE an' throgh on-the-=o<training, orma& instrction, an' @a&it* re&ate' meetings.
$.2 3he 1a&it* Manager has the o)era&& res>onsi<i&it* or ensring that
inormation an' 'ata a<ot @a&it* >erormance an' the eecti)eness o the@a&it* s*stem are re>orte' to management. 3his inc&'es the 'istri<tion oa&& a>>&ica<&e 'ocments, re>orts, an' recor's to a>>ro>riate nctions.
$.# Interna& commnication &ows two wa*s:
a Managements 'irection on @a&it* is commnicate' to the organi?ationthrogh: the @a&it* >o&ic* an' o<=ecti)esE cstomer an' reg&ator*re@irementsE >ro'ct an' >rocess s>eciicationsE )eriication an' )a&i'ationre@irementsE an' instrctions on how to im>&ement an' se the @a&it*s*stem.
< 3he organi?ation re>orts 'ata an' inormation re&ati)e to cstomersatisaction, @a&it* ex>ectations o >ro'cts an' ser)ices, @a&it*>erormance o >ro'cts an' >rocesses, o>>ortnities or im>ro)ement, an'the eecti)eness o the @a&it* s*stem to management on a contina& <asis.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE "" O- 105
2.0 5ommnication Meetings
2.$ %orma& commnicationre)iew meetings ser)e an im>ortant ro&e in ensring>ro>er commnication <etween management an' the organi?ation.Management con'cts @arter&* commnication meetings or the entireorgani?ation. In a''ition, management re)iews >ro)i'e the ramework or theorgani?ation to re>ort on the stats o @a&it*-re&ate' isses an' acti)ities, an'or the management to orm&ate >o&icies an' 'irecti)es to change an'orim>ro)e the @a&it* s*stem. 3he 1a&it* Manager has the o)era&&res>onsi<i&it* or coor'inating strctre' commnication meetings. %or
'etai&s, reer to the Management e)iews Proce're.
*.6 MANA!EMENT REVIE-
*.6.1 !ene5al
3he management o Worksmart, Inc. con'cts re)iews o the @a&it* s*stem each6cto<er, as 'escri<e' in the Management e)iew Proce're. 3he re)iews e)a&atethe s*stems contining sita<i&it*, a'e@ac*, eecti)eness an' the nee' or an*>otentia& changes.
*.6.# Re23e In9t
In>ts to management re)iews ma* inc&'e, <t not <e &imite' to, crrent>erormance 'ata an' >otentia& im>ro)ement o>>ortnities re&ate' to:
a a'it res&tsE< cstomer ee'<ackE
c >rocess >erormance an' >ro'ct conormanceE' stats o correcti)e an' >re)enti)e actionsEe o&&ow-> actions rom >re)ios management re)iewsE changes that ma* aect the @a&it* s*stem, an'g recommen'ations or im>ro)ement
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE ". O- 105
*.6.& Re23e O9t9t
6t>ts rom management re)iew inc&'e conc&sions reache' an' action itemsre&ate' to:
a im>ro)ement o the @a&it* s*stem an' its >rocessesE< im>ro)ement o >ro'ct re&ate' to cstomer re@irementsE an'c necessar* resorces.
es&ts o management re)iews are recor'e' as 'escri<e' in the Management
e)iew Proce're an' maintaine' >er the 5ontro& o 1a&it* ecor's Proce're.
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ISO '001 (UALITY )ANUAL
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*.6.' Mana>e=ent Re23e P5o4e95e
!ene5al Pol348
Management re)iews o the @a&it* s*stem are con'cte' anna&&*. 3he >r>ose o there)iews is to 'etermine the contining sita<i&it* an' eecti)eness o the s*stem, inc&'ingthe @a&it* >o&ic* an' o<=ecti)es.
P5o4e95e
$.0 8che'&ing an' /tten'ance
$.$ 3he com>an*s Presi'ent, with s>>ort rom the 1a&it* Manager, con'ctsanna& re)iews o the @a&it* s*stem each 6cto<er. In res>onse to changing<siness con'itions or >erormance 'ata, the Presi'ent ma*, at his or her'iscretion, ca&& or nsche'&e' re)iews.
$.2 /tten'ance is man'ator* or a&& 'e>artment managers. In the e)ent a
manager cannot atten', he or she mst sen' a re>resentati)e. /ter re)iewingthe mintes o the meeting, the a<sent manager mst s<mit written in>twithin two weeks o recei)ing the meeting mintes. 6n&* one manager >ermeeting ma* <e a<sent.
2.0 Meeting In>ts an' 6t>ts
2.$ 3he 1a&it* Manager is res>onsi<&e or >re>aring the meeting agen'a. 3hePresi'ent is res>onsi<&e or a>>ro)ing the agen'a an' 'istri<ting it to a&&'e>artment managers no &ess than two weeks >rior to the meeting.
2.2 3he in>ts or re)iews inc&'e the o&&owing inormation:
• /53I6 I3M8 %6M /83 M3I+: 3he 1a&it* Manager o>ens the
meeting <* re>orting on the stats o action items rom the &ast meeting.Isses that were not com>&ete' remain on the &ist as o>en action items,an' are recor'e' as sch in the mintes o the meeting.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE "6 O- 105
• P6588 P%6M/5 / P653 56%6M/5: 3he
1a&it* Manager >resents @a&it* >erormance 'ata. 3hese inc&'e>rocess >erormance an' >ro'ct conormancenonconormance, s>>&ier@a&it* >erormance, on-time 'e&i)er* >erormance, an' >ro'cti)it* 'ata.
• I3/ 1/I3 /I38: 3he 1a&it* Manager >resents the res&ts
o interna& @a&it* a'its. 3his inc&'es @a&it* s*stems a'its, >rocessa'its an' >ro'ct a'its, inc&'ing smmaries o im>ortant in'ings.
• 5653IV / PV3IV /53I68: 3he 1a&it* Manager
>resents the o)era&& stats o im>ortant correcti)e an' >re)enti)e actionsim>&emente', an' the stats an' im>ortance o o>en isses.
• 5836M %B/5O / 56MP/I38: Marketing8a&es >resents
smmaries o cstomer com>&aints, inc&'ing ana&*sis o tren's or>artic&ar categories.
• 5836M 8, P53/3I68, / 8/3I8%/53I6: Marketing
>resents cstomer ee'<ack, cstomer nee's, an' ex>ectations <ase' oncstomer satisaction 'ata, an' 'iscsses 'e)e&o>ing tren's in this area.
• 3/II+: 3he Personne& Manager re>orts on the stats o training>rograms an' the eecti)eness o training >ro)i'e'.
• 563I/ IMP6VM3: 3he 1a&it* Manager >resents the stats o
crrent an' com>&ete' im>ro)ement >ro=ects, an' >resents 'atas>>orting the >rogress ma'e towar' achie)ing contina& im>ro)ementgoa&s.
• 5A/+8 3A/3 56 /%%53 3A 1/I3 883M: 3he 1a&it*
Manager >resents inormation on the changes in @a&it* acti)ities,>ro'cts, >rocesses, ca>acit*, or an* other o>erationa& or organi?ationa&
changes that wi&& ha)e an im>act on the @a&it* s*stemE an' >ro>osess>eciic actions to re)ise the s*stem in res>onse to these changes.
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2.# 3he ot>ts rom re)iews inc&'e 'eine' im>ro)ement actions that wi&& ha)e a>ositi)e eect on continos im>ro)ement o >ro'cts, ser)ices, an' the@a&it* s*stem. 3hese im>ro)ement actions are orm&ate' into @a&it*o<=ecti)es as nee'e', with s>eciic measra<&e targets, com>&etion 'ates,assignments o res>onsi<i&ities, an' the re@ire' resorces or their sccess&im>&ementation. 6<=ecti)es that ha)e <een achie)e' ma* either <e >gra'e'to a higher >erormance &e)e&, or <e c&ose' ot. 6<=ecti)es that were notachie)e' wi&& <e in)estigate' to 'etermine the cases or the ai&re.
#.0 ecor's
#.$ 3he res&ts o the re)iews are 'ocmente' in meeting mintes <* the 1a&it*Manager, 'istri<te' to com>an* management or a>>ro>riate action, an'maintaine' >er the 5ontro& o 1a&it* ecor's Proce're.
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6. RESOURCE MANA!EMENT
6.1 PROVISION O) RESOURCES
Worksmart, Inc. management is committe' to >ro)i'e a'e@ate resorces to:
a im>&ement an' im>ro)e the >rocesses o the @a&it* s*stem, an'< >romote cstomer satisaction.
6.1.1 !ene5al
3he re@ire' resorces or im>&ementation an' im>ro)ement o the @a&it* s*stem,an' or a''ressing cstomer satisaction, ma* inc&'e an* o the o&&owing:s>>&iers, inormation, inrastrctre, work en)ironment, an' inancia& n's. 3he>rinci>a& means or 'etermining an' commnicating resorce re@irements are
management re)iews o the @a&it* s*stem. %or 'etai&s, reer to the Managemente)iew Proce're.
6.1.# Resons3b3l3t3es fo5 Dete5=3nat3on of Re;935e Reso954es
3he 1a&it* Manager an' a&& management >ersonne& aecte' <* the @a&it* s*stemare res>onsi<&e or 'etermining resorce re@irements or the im>&ementation an'im>ro)ement o the s*stem.
6.1.& P5o23s3on of Reso954es
• 3o> management has the res>onsi<i&it* an' athorit* or >ro)ision o resorces.
• esorces or 'esignate' acti)ities are integrate' with the >rocess o 'eining
an' initiating the acti)it*. 3he* ma* take the orm o >ersonne& assignments,a&&ocation o s>ace or e@i>ment, training, >rocrement 'ecisions, <'gets, etc.
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• /&&ocation o resorces ma* <e 'ocmente' in the @a&it* mana&, o>erationa&
>roce'res, an' mintes o meetings, memoran'a, or an* other orm. />>ro)a&so resorce a&&ocations ma* a&so <e commnicate' )er<a&&*.
6.# (UMAN RESOURCES
6.#.1 !ene5al
Worksmart, Inc. se&ects an' assigns @a&iie' >ersonne& to ensre that those whoha)e res>onsi<i&ities 'eine' in the @a&it* s*stem are com>etent on the <asis oa>>&ica<&e e'cation, training, ski&&s, an' ex>erience.
6.#.# Co=eten4e, Aa5eness, an T5a3n3n>
Worksmart, Inc. has esta<&ishe' an' maintains a 3raining Proce're to:
a i'enti* com>etenc* nee's or >ersonne& who >erorm tasks aecting @a&it*E< >ro)i'e training to a''ress these nee'sEc assess the eecti)eness o the training >ro)i'e'E' ensre that >ersonne& are aware o the re&e)ance an' im>ortance o their
acti)ities an' how the* contri<te to the achie)ement o the @a&it* o<=ecti)esEan'
e maintain recor's o e'cation, ex>erience, training, an' @a&iications >er the5ontro& o 1a&it* ecor's Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE .0 O- 105
6.#.& T5a3n3n> P5o4e95e
!ene5al Pol348
Worksmart, Inc. regar's em>&o*ees as its greatest asset. 3o this en', the com>an*maintains an esta<&ishe' em>&o*ee @a&iicationtraining >rogram. /&& >ersonne& arec&assiie' on the <asis o a>>ro>riate e'cation, training, ski&&s, or ex>erience. ecor's oa&& training acti)ities are ke>t in each em>&o*ees i&e.
P5o4e95e
$.0 3raining e@irements e)iew
$.$ 3he res>onsi<i&it* or i'enti*ing em>&o*ee-training re@irements &ies with each'e>artment managers>er)isor. 3he >r>ose or the re)iew is to i'enti*com>etenc* nee's or a&& >ersonne& >erorming acti)ities aecting @a&it*. Qo<re@irements, interna& a'it re>orts, an' correcti)e action acti)ities 'etermineem>&o*ee-training nee's. In a''ition, an anna& re)iew is con'cte' with
each em>&o*ee, at which time the em>&o*ees training nee's, as we&& as theeecti)eness o the >re)ios training are 'iscsse'. ach em>&o*ee is ma'eaware o the re&e)ance an' im>ortance o their acti)ities an' how the*contri<te to the achie)ement o the @a&it* o<=ecti)es.
2.0 %orma& an' Inorma& 3raining
2.$ /&& em>&o*ees recei)e inorma& Fon-the-=o<H training <* the res>onsi<&e areas>er)isor. /ter a "0-'a* tria& >erio', a&& newtranserre' em>&o*ees aree)a&ate' against the >osition re@irements an' i >erormance is on' to <esatisactor*, @a&iication or the a>>&ica<&e >osition is awar'e'.
2.2 ew em>&o*ees recei)e in'octrination into the @a&it* s*stem rom the 1a&it*Manager.
2.# esignate' em>&o*ees ma* recei)e orma& o-siteon-site trainingseminars in)arios =o<-re&ate' 'isci>&inesto>ics, as 'etermine' <* the res>onsi<&es>er)isormanager. 3his inc&'es certiication in s>ecia&i?e' ski&&s sch aswe&'ing an' so&'ering.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE .1 O- 105
2.4 Worksmart, Inc. s>>orts contining e'cation >rograms <* reim<rsingtition or =o< re&ate' corses.
#.0 1a&iication3raining ecor's
#.$ 3he Personne& Manager maintains recor's o e'cation, ski&&s, ex>erience,training, an' @a&iications or each em>&o*ee.
6.& IN)RASTRUCTURE
3o ensre that or inrastrctre is sita<&e or achie)ing conormance to >ro'ctre@irements, Worksmart, Inc. has esta<&ishe' an' maintains a %aci&it* ManagementProce're. /ssessment an' maintenance o inrastrctre inc&'es:
a works>ace an' associate' aci&itiesE< e@i>ment, har'ware an' sotwareE an'c s>>orting ser)ices.
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REV* 1 DATE: 06+06+05 PAE .2 O- 105
6.&.1 )a43l3t8 Mana>e=ent P5o4e95e
!ene5al Pol348
8ita<&e aci&ities an' work en)ironment are >ro)i'e' as re@ire' to assre >ro'ct @a&it*.3his inc&'es >&anning, >ro)ision, an' maintenance o em>&o*ee aci&ities, works>aces,e@i>ment, sotware, an' associate' ser)ices.
P5o4e95e
$.0 %aci&it* Management P&anning
$.$ P&anning or new an'or mo'iication o existing aci&ities is norma&&* con'cte'with ca>acit* or work orce ex>ansions an' >ro'ct or >rocess changes.%aci&ities ma* a&so <e ex>an'e' or mo'iie' to im>ro)e >ro'cti)it*, @a&it*,an' the work en)ironment.
$.2 ach nctiona& manager is res>onsi<&e or i'enti*ing the nee' an'
re@irements or new, or mo'iication o existing, aci&ities in their areas. /&&re@ests or mo'iications or ex>ansions o aci&ities mst <e re)iewe' an'a>>ro)e' <* the +enera& Manager an' 1a&it* Manager at a minimm.e@ests or signiicant mo'iications or ex>ansions mst a&so <e re)iewe'an' a>>ro)e' <* the Presi'ent.
2.0 Maintenance o @i>ment, %aci&ities, an' 8>>orting 8er)ices
2.$ Maintenance o e@i>ment, <i&'ings, an' aci&ities is >erorme' <* theMaintenance %nction or externa& contractors. 3his inc&'es reg&ar&*sche'&e' maintenance o >ro'ction e@i>ment, &ighting s*stems, aircon'itioning an' heating s*stems, &an'sca>ing, an' c&eaning. e>airs o
<i&'ings an' other sch aci&ities are contracte' as nee'e'. Prchasing isres>onsi<&e or coor'inating an' managing maintenance contracts.
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ISO '001 (UALITY )ANUAL
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2.2 /&& maintenance is >erorme' >er the recommen'ations >ro)i'e' <* thee@i>mentKs manactrers an' is recor'e' on the @i>mentMaintenance8er)ice ecor' or each >iece o e@i>ment. 3he accrac* an'>erormance o the e@i>ment is continos&* monitore'. 8>ecia& attention isgi)en to e@i>ment eatres that contri<te to ke* >ro'ct @a&it*characteristics.
#.0 Work n)ironment
#.$ 3he Personne& Manager an' 'e>artmenta& managers are res>onsi<&e or
ensring sita<&e working en)ironment or >ersonne&. 3his inc&'es hman aswe&& as >h*sica& actors.
#.2 3he +enera& Manager an' the 1a&it* Manager are res>onsi<&e or i'enti*ingo>erations with extreme en)ironmenta& con'itions that ha)e a >otentia& orim>acting @a&it* >erormance o >ersonne& an' >ro'ct>rocess @a&it*.Where a>>&ica<&e, &imits o ex>osre Ji.e., extreme&* &ow or high tem>eratre,excessi)e noise, etc. or mitigating measres Ji.e., &imiting ex>osre time,increasing the re@enc* o <reaks, s>>&*ing >rotecti)e gear, atomating>rocesses, etc. sha&& <e 'eine' an' im>&emente' or aecte' o>erations.
6.' -OR ENVIRONMENT
Worksmart, Inc. has im>&emente' an' maintains a %aci&it* Management Proce're tomanage the hman an' >h*sica& actors o the work en)ironment that are necessar* orachie)ing conorming >ro'ct. 8ch actors inc&'e, <t are not &imite' to:
a saet* an' ergonomicsE< &ightEc c&ean&iness
' heat an' hmi'it*Ee s>ace, an' &angage
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ISO '001 (UALITY )ANUAL
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7. PRODUCT REALI/ATION
7.1 PLANNIN! O) PRODUCT REALI/ATION
Worksmart, Inc. has esta<&ishe' an' maintains a 'ocmente' Pro'ct ea&i?ation P&anningProce're to ensre that >rocesses an' s<->rocesses are con'cte' n'er contro&&e'con'itions. P&anning o the rea&i?ation >rocesses is consistent with the other re@irementso the organi?ations @a&it* s*stem. Pro'ct rea&i?ation >&ans 'etermine the o&&owing:
a @a&it* o<=ecti)es or the >ro'ct, >ro=ect or contractE< the nee' to esta<&ish >rocesses an' 'ocmentation, an' >ro)i'e resorces,
inrastrctre, an' work en)ironment necessar* to >ro'ce conorming >ro'ctEc )eriication an' )a&i'ation acti)ities, an' the criteria or the 'etermination o
acce>ta<&e >ro'ctE' the recor's that are nee'e' to >ro)i'e e)i'ence that the >rocesses an' res&ting
>ro'ct conorm to s>eciie' re@irements.
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7.1.1 P5o94t Real3Bat3on Plann3n> P5o4e95e
!ene5al Pol348
Pro'ct rea&i?ation >&anning encom>asses 'etermination o >ro'ct>rocess @a&it*o<=ecti)es, 'e)e&o>ment o re@ire' >rocesses, an' >rocess 'ocmentation an' recor's.
P5o4e95e
$.0 Pro'ct 1a&it* 6<=ecti)es
$.$ Pro'ct @a&it* o<=ecti)es are 'eine' in 'rawings an' s>eciications,contracts, stan'ar's, sam>&es, workmanshi> stan'ar's, an' a>>&ica<&e &ega&an' reg&ator* re@irements.
$.2 3he 1a&it* Manager is res>onsi<&e or i'enti*ing >ro'ct @a&it* o<=ecti)esan' re@irements. 3his ma* <e inc&'e' in the >rocess o 'eterminingcstomer an' >ro'ct re@irements.
2.0 Pro'ct ea&i?ation P&anning
2.$ Pro'ct rea&i?ation >&anning inc&'es the o&&owing:
• einition an' e)a&ation o >ro'ctionser)ice >rocesses
• e)e&o>ment o sita<&e an' ca>a<&e >rocesses
• I'entiication o s>ecia& >rocesses an' consi'eration o associate' risks
an' conse@ences
• e)e&o>ment an' im>&ementation o a>>ro>riate >rocess contro& measres
• e)e&o>ment o instrctions Jwhere a>>&ica<&e an' training or >rocess
>ersonne&
• I'entiication o the recor's re@ire' to 'emonstrate >ro'ct>rocess
@a&it*
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2.2 Pro'ct rea&i?ation >&ans are generate' co&&ecti)e&* <* the Pro'ction8er)ice,ngineering, an' 1a&it* %nctions. 3he >&ans are 'eine' in associate'>ro'ctionser)ice 'ocments Ji.e., >rocess &owcharts, >ro'ctionser)icework or'ers, >rocess contro& >&ans, o>eratorinsta&&ation instrctions, >rocess)a&i'ation re>orts, etc..
7.# CUSTOMER0RELATED PROCESSES
7.#.1 Dete5=3nat3on of Re;935e=ents Relate to te P5o94t
Worksmart, Inc. has esta<&ishe' a esign an' e)e&o>ment 5ontro& Proce're an' a5ontract e)iew Proce're or i'enti*ing cstomer re@irements. 3hese >rocesses'etermine:
a >ro'ct re@irements s>eciie' <* the cstomer, inc&'ing the re@irements ora)ai&a<i&it*, 'e&i)er*, an' >ost-'e&i)er* s>>ortE
< >ro'ct re@irements not s>eciie' <* the cstomer <t necessar* orinten'e' or s>eciie' seEc o<&igations re&ate' to >ro'ct, inc&'ing reg&ator* an' &ega& re@irementsE' 5stomer re@irements are conirme' <eore acce>tance in sitations where
the cstomer >ro)i'es no 'ocmente' statement o [email protected] 3he res&ts o the re)iews, >ertinent re&ate' corres>on'ence, an' necessar*
o&&ow-> actions are 'ocmente' <* Worksmart, Inc. or'er nm<er an'cstomer name.
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ISO '001 (UALITY )ANUAL
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7.#.# Re23e of Re;935e=ents Relate to te P5o94t
Worksmart, Inc. re)iews the i'entiie' cstomer re@irements together with a''itiona&re@irements that are not s>eciie' <t are necessar* or itness or se an'go)erne' <* &aws an' reg&ations, an' re@irements or a)ai&a<i&it*, 'e&i)er*, an's>>ort. 3his re)iew is con'cte' >rior to commitment to s>>&* a >ro'ct to thecstomer >er the 5ontract e)iew Proce're. 3he re)iew >rocess ensres that:
a >ro'ct re@irements are 'eine'E
< where the cstomer >ro)i'es no 'ocmente' statement o re@irement, thecstomer re@irements are conirme' <eore acce>tance an' a recor' o)er<a& or'er is maintaine'E
c contract or or'er re@irements 'iering rom those >re)ios&* ex>resse' in aten'er or @otation are reso&)e'E
' Worksmart, Inc. has the a<i&it* to meet the cstomer re@irements.
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ISO '001 (UALITY )ANUAL
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7.#.#.1 Cont5a4t Re23e P5o4e95e
!ene5al Pol348
5ontractor'er re)iew is an integra& >art o the @a&it* s*stem at Worksmart, Inc.. /&&contractsor'ers are re)iewe' an' acce>te' on&* i the re@irements are c&ear an'n'erstoo', an' the com>an* has the ca>a<i&it* an' ca>acit* to assre && cstomerex>ectations.
P5o4e95e
$.0 +enera&
$.$ 6r'er ntr*8a&es recei)es an' >rocesses a&& cstomer e@ests or1otations J%1sor'ers. /&& %1sor'ers are stam>e' with the 'aterecei)e'. Phone or'ers are acce>te' >ro)i'ing the cstomer o&&ows > inwriting within 24 hors. 6r'ers or cata&og >ro'ctsser)ices are re)iewe' an'>rocesse' withot rther in)o&)ement rom s>>orting 'e>artmentsnctions.
%1s or cstomi?e' >ro'ctsser)ices are a&so re)iewe' <* ngineering,Pro'ction, an' 1a&it* <eore an oer is ma'e to the cstomer.
2.0 e)iew
2.$ e)iew o %1sor'ers or >ro'ctsser)ices consists o a )eriication that thecstomers re@irements, inc&'ing re@irements not state' <* the cstomer,are a'e@ate&* 'eine' an' 'ocmente' an' ha)e <een &&* n'erstoo'.8ho&' the %1or'er re@ire c&ariication, it wi&& not <e acce>te' nti& themissing inormation is o<taine' rom the cstomer. 5onsi'eration is gi)en asto whether or ca>a<i&it* an' ca>acit* are a'e@ate to satis* the cstomers
nee's.
#.0 6r'er /cce>tance
#.$ 6nce a&& isses are reso&)e', the or'er is marke' F/55P3H, 'ate', an'initia&e' <* a&& re)iewing >arties.
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4.0 /men'ment to 5ontracts6r'ers
4.$ 5hange 6r'ers are recei)e' an' >rocesse' throgh the same channe&s asthe origina& or'er. 3he 5hange 6r'er orm is com>&ete' an' 'istri<te' to a&&aecte' nctions within the com>an*, an' where a con&ict ma* exist, thecstomer is imme'iate&* notiie'.
!.0 ecor's
!.$ ecor's o contractor'er re)iew are store' on i&e. %or cata&og
>ro'ctsser)ices, the acta& or'er is signe' an' a co>* is store' on i&e. %orcstom >ro'ctsser)ices, a co>* o the @otation, signe' <* athori?e're>resentati)es o a&& >artici>ating nctions, in a''ition to a co>* o the or'er,is i&e'.
7.#.& C9sto=e5 Co==9n34at3on
Worksmart, Inc. has im>&emente' an' maintains >rocesses or commnication withthe cstomers. 5stomer commnications inc&'es:
a >ro'ct>rocess inormation as 'escri<e' in the 5stomer 8atisaction
Proce're, 5ontina& Im>ro)ement Proce're, an' 8er)icing Proce'reE< a''ressing in@iries, contracts or or'er han'&ing, inc&'ing amen'ments as'escri<e' in the 5ontract e)iew Proce'reE
c cstomer ee'<ack, inc&'ing cstomer com>&aints as 'escri<e' in the5orrecti)e an' Pre)enti)e /ction Proce'reE
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7.& DESI!N AND DEVELOPMENT
7.&.1 Des3>n an De2elo=ent Plann3n>
Worksmart, Inc. >&ans an' manages the 'esign an' 'e)e&o>ment o its ser)ice inaccor'ance with the esign an' e)e&o>ment 5ontro& Proce're. esign an'
'e)e&o>ment is )iewe' as a creati)e acti)it* in)o&)ing conce>ta& e&ements. It is not)iewe' as encom>assing minor mo'iications to stan'ar' >ro'cts, or thes>eciication o 'etai&s rom stan'ar' 'ata ta<&es or e@i)a&ent.
3he 'esign an' 'e)e&o>ment >rocess 'etermines:
a stages o the 'esign an' 'e)e&o>ment >rocessE< re)iew, )eriication an' )a&i'ation acti)ities a>>ro>riate to each 'esign an'
'e)e&o>ment stageEc res>onsi<i&ities an' athorities or 'esign an' 'e)e&o>ment acti)ities.
6rgani?ationa& interaces <etween the 'ierent gro>s in)o&)e' in 'esign an''e)e&o>ment are manage' as 'escri<e' in the esign an' e)e&o>ment 5ontro&Proce're to ensre eecti)e commnication an' c&arit* o res>onsi<i&ities. P&anningot>t is >'ate' at a>>ro>riate stages as 'esign an' 'e)e&o>ment >rogresses.
7.&.# Des3>n an De2elo=ent In9ts
In>ts re&ating to ser)ice re@irements are 'eine' >er the esign an' e)e&o>ment5ontro& Proce're. 3hese inc&'e:
a nctiona& an' >erormance re@irementsE
< a>>&ica<&e reg&ator* an' &ega& re@irementsEc a>>&ica<&e inormation 'eri)e' rom >re)ios simi&ar 'esignsE' an* other re@irements essentia& or 'esign an' 'e)e&o>ment.
3hese in>ts are re)iewe' or a'e@ac*. Incom>&ete, am<igos, or con&ictingre@irements are reso&)e'.
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7.&.& Des3>n an De2elo=ent O9t9ts
3he ot>ts o the 'esign an' 'e)e&o>ment >rocess are recor'e' an' ex>resse' interms o re@irements, ca&c&ations, ana&*sis, or other means that can <e )eriie'against in>t re@irements as 'escri<e' in the esign an' e)e&o>ment 5ontro&Proce're. 3his >rocess ensres that 'esign an' 'e)e&o>ment ot>ts:
a meet the 'esign an' 'e)e&o>ment in>t re@irementsE< >ro)i'e a'e@ate inormation to >ro'ction an' ser)ice o>erationsEc contain or reerence >ro'ct acce>tance criteriaE
' 'eine the characteristics o the >ro'ct that are essentia& or its sae an'>ro>er se.
/&& 'esign an' 'e)e&o>ment ot>t 'ocments are re)iewe' an' a>>ro)e' <eorere&ease >er the 5ontro& o ocments Proce're.
7.&.' Des3>n an De2elo=ent Re23e
8*stematic re)iews are >&anne', con'cte', an' 'ocmente' at sita<&e stages o'esign an' 'e)e&o>ment >er the esign an' e)e&o>ment 5ontro& Proce're to:
a e)a&ate the a<i&it* to &i&& re@irementsE< i'enti* >ro<&ems an' >ro>ose o&&ow-> actions.
Partici>ants in the 'esign an' 'e)e&o>ment re)iew inc&'e re>resentati)es onctions concerne' with the 'esign an' 'e)e&o>ment stage n'er re)iew.ecor's o re)iews an' necessar* o&&ow-> actions are maintaine' in accor'ancewith the 5ontro& o 1a&it* ecor's Proce're.
7.&.* Des3>n an De2elo=ent Ve53f34at3on
esign an' e)e&o>ment )eriication are 'eine', >&anne', execte', an' recor'e'
<* com>etent >ersonne& to ensre that the 'esign an' 'e)e&o>ment ot>t meets thein>ts. 3he res&ts o the )eriication an' s<se@ent o&&ow-> actions are recor'e'>er the 5ontro& o 1a&it* ecor's Proce're.
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7.&.6 Des3>n an De2elo=ent Val3at3on
esign an' 'e)e&o>ment )a&i'ation is >erorme' >er the esign an' e)e&o>ment5ontro& Proce're to ensre that res&tant >ro'cts are ca>a<&e o meeting there@irements or the s>eciie' a>>&ication or inten'e' se, where known, >rior tore&ease or 'e&i)er* or im>&ementation. Where it is im>ossi<&e to >erorm &&)a&i'ation >rior to 'e&i)er* or im>&ementation, >artia& )a&i'ation is >erorme' to theextent a>>&ica<&e.
3he res&ts o the )a&i'ation an' s<se@ent o&&ow-> actions are recor'e' >er the5ontro& o 1a&it* ecor's Proce're.
7.&.7 Cont5ol of Des3>n an De2elo=ent Can>es
esign an' 'e)e&o>ment changes are 'ocmente' an' contro&&e' in accor'ance withthe esign an' e)e&o>ment 5ontro& Proce're an' 5ontro& o ocmentsProce're. 3his >rocess inc&'es e)a&ation o the im>act o the changes onconstitent >arts an' 'e&i)ere' >ro'cts. 3he changes are )eriie' an' a>>ro)e'<eore im>&ementation, as a>>ro>riate.
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7.&." Des3>n an De2elo=ent Cont5ol P5o4e95e
!ene5al Pol348
3he 'esign an' 'e)e&o>ment >rocess is carrie' ot n'er contro&&e' con'itions. /&&acti)ities are >&anne' an' 'ocmente'. esigns are re)iewe' at a>>ro>riate stages an'where a>>&ica<&e, )a&i'ate'. 3he 'esign an' 'e)e&o>ment ot>t is )eriie' <eore it isre&ease' to >ro'ction.
P5o4e95e
$.0 +enera&
$.$ ngineering wi&& a'here to this 'ocmente' >roce're that assres a&&'esigne''e)e&o>e' so&tions Jhar'ware, sotware, ser)ice, etc. meet marketre@irements an' >erormance stan'ar's.
2.0 esign an' e)e&o>ment In>t
2.$ Marketing8a&es wi&& i'enti* an' 'ocment the markets nee's or new so&tionin a Market e@irements 8tatement JM8, which wi&& ser)e as the in>t or'esign an' 'e)e&o>ment work. 3he M8 sha&& inc&'e the o&&owing:
• What is re@ire' Jeatresnctions, etc.
• Wh* it is nee'e' Jcstomer 'eman'
• When it is nee'e'
• Market 8egment
• etai&e' >ro'ct re@irements J>erormance stan'ar's, inc&'ing
cstomer re@irements, re&ia<i&it*, stattor* an' reg&ator*re@irements, an' >ro'ctsK &ie nee's
• Pricing 3argets
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2.2 When a ser)ice is to <e 'esigne' or mo'iie' to meet s>eciic cstomerre@irements, ngineering recei)es rom Marketing8a&es a 'esign or'er withcstomer re@irements an' s>eciications. 3he M8 an' 'esign or'er containthe same t*>e o inormation, an' <oth >ro)i'e ngineering with 'esign an''e)e&o>ment in>t.
2.# esign an' 'e)e&o>ment in>t is 'ocmente'. esign an' 'e)e&o>ment in>tcan <e in an* orm, inc&'ing 'ata sheets, cstomer 'rawings an's>eciications, >hotogra>hs, sam>&es, reerences to stan'ar's, etc. /&&'ocments constitting 'esign an' 'e)e&o>ment in>t are recor'e' in the
>ro=ect <ook.
2.4 Marketing8a&es, ngineering, an' the 1a&it* %nctions re)iew an' a>>ro)e a'esign M8 an' 'esign or'er 'ocments >rior to isse an' re&ease. Pro'ctioan' Prchasing a&so take >art in the re)iew as re@ire'.
2.! When its more >ractica& to 'o so, 'esign an' 'e)e&o>ment in>t re)iew ma* <con'cte' at the contract re)iew >hase.
#.0 esign an' e)e&o>ment /cti)ities
#.$ ngineering wi&& trans&ate the nee's an' ex>ectations rom the M8 to technic
s>eciications or materia&s, >ro'cts, an' >rocesses. 3he 'esign is geare'towar's meeting cstomer re@irements, whi&e >ro)i'ing a >ro'ct cost, whichwi&& ena<&e Worksmart, Inc. to ha)e a satisactor* retrn on in)estment.ngineering is res>onsi<&e or >ro)i'ing a 'esign, which is >ro'ci<&e, )eriia<&ean' contro&&a<&e n'er the s>eciie' >ro'ction, insta&&ation, an' o>erationa&con'itions.
#.2 Pro=ect management too&s an' metho'o&ogies are se' to manage the'e)e&o>ment >rocess in or'er to 'e&i)er time&*, >roita<&e so&tions.
#.# ach 'esign an' 'e)e&o>ment acti)it* is >&anne', 'i)i'e' into >hases, an'
tasks are assigne' to @a&iie' >ersonne& e@i>>e' with a'e@ate resorces.P&ans are 'ocmente' an' >'ate' as the 'esign e)o&)es.
#.4 6rgani?ationa& an' technica& interaces <etween 'ierent nctions thatcontri<te to the 'esign an' 'e)e&o>ment >rocess are 'eine' an' thenecessar* inormation 'ocmente', transmitte', an' reg&ar&* re)iewe'.
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#.! esigns an' 'esign changes are 'ocmente', re)ision contro&&e', an'a>>ro)e' <* athori?e' >ersonne&. esign an' 'e)e&o>ment 'ocmentationa''resses a&& 'esign intent re@irements J>erormance, saet*, re&ia<i&it*,reg&ator*, cstomer satisaction, etc., high&ights changes rom the &ast re)isioan' inc&'es <t is not &imite' to:
• e&ease notes or sotware
• 5ritica& 'imensions or >arts
• 5ritica& re&ationshi>s or assem<&ies
• 5ritica& re&ationshi>s an' >erormance criteria or >ro'ct an' s*stem
so&tions.
#." %orma&, 'ocmente' 'esign an' 'e)e&o>ment re)iews are he&' at a>>ro>riatestages o the 'esign an' 'e)e&o>ment acti)it* an' inc&'e re>resentati)es roma&& concerne' nctions. 3he o&&owing e&ements are consi'ere' 'ring 'esignan' 'e)e&o>ment re)iews:
• 5stomer nee's )erss technica& s>eciications
• /<i&it* to >erorm n'er ex>ecte' con'itions o se an' en)ironment
• 8aet* an' >otentia& &ia<i&it* 'ring ninten'e' se an' misse
• 8aet* an' en)ironmenta& consi'erations
• 5om>&iance with a>>&ica<&e reg&ator* re@irements, nationa&, an'
internationa& stan'ar's
• 5om>arison with com>etitorKs 'esign
• 5om>arison with simi&ar 'esigns or ana&*sis o >re)ios @a&it* >ro<&ems
an' >ossi<&e recrrence
• e&ia<i&it*, ser)icea<i&it*, an' maintaina<i&it*
• 3o&erances com>are' to >rocess ca>a<i&ities
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• Pro'ct acce>tancere=ection criteria
• ase o assem<&*, insta&&ation, an' saet* actors
• Packaging, han'&ing, storage, she& &ie, an' 'is>osa<i&it*
• sthetic s>eciications an' acce>tance criteria
• %ai&re mo'es an' eects ana&*sis
• /<i&it* to 'iagnose an' correct >ro<&ems
• I'entiication, warnings, &a<e&ing, tracea<i&it*, an' ser instrctions
• Manactra<i&it*, inc&'ing s>ecia& >rocesses
• 5a>a<i&it* to ins>ect an' test
• Materia&s an' com>onents s>eciications
• e)iew an' se o stan'ar' >arts
ecor's o 'esign an' 'e)e&o>ment re)iews, inc&'ing correcti)e action >&ansan' those in atten'ance, are maintaine'.
#.7 esign an' 'e)e&o>ment )eriication an' )a&i'ation are >erorme' an' a>>ro)eas a>>ro>riate <eore 'esigns are re&ease' to assre each >ro'ct conorms toa&& s>eciie' 'esign an' 'e)e&o>ment re@irements. 3his inc&'es a&ternati)eca&c&ations to )eri* correctness o the origina& ca&c&ations an' ana&*ses, an'>erio'ic e)a&ation o sam>&e >ro'ction mo'e&s. 3he amont an' 'egree otesting is re&ate' to the risk actor i'entiie' in the 'esign an' 'e)e&o>ment >&an3he test wi&& inc&'e e)a&ation o >erormance, 'ra<i&it*, saet*, re&ia<i&it*, an'
maintaina<i&it* n'er ex>ecte' storage an' o>erationa& con'itions an' wherea>>&ica<&e, 'eect an' ai&re ana&*sis. /&& res&ts o tests, e)a&ation, an'ins>ection are 'ocmente' throghot the >ro'ct @a&iication c*c&e. 3he1a&it* %nction )eriies that a&& 'esign eatres meet re@irements an' that a&athori?e' 'esign an' 'e)e&o>ment changes ha)e <een im>&emente'. ecor'o )eriication an' )a&i'ation acti)ities are i&e'.
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4.0 esign an' e)e&o>ment 5hanges
4.$ esign an' 'e)e&o>ment in>t changes ma* <e re@este' 'ring 'esign an''e)e&o>ment >ro=ects <* Marketing8a&es, 8er)ice, Pro'ction, or ngineeringitse&. 6nce a>>ro)e' <* Marketing8a&es, ngineering incor>orates the newre@irements into the 'esign an' a'=sts acti)ities an' sche'&es toaccommo'ate the re)ise' 'esign an' 'e)e&o>ment in>t.
4.2 esign an' 'e)e&o>ment changes to re&ease' >ro'cts are s<mitte' on anngineering 5hange e@est orm J5. ngineering &ogs a&& 5s in the
ngineering 5hange e@est og, >erorms an e)a&ation, an' eithera>>ro)es or 'enies the re@est. Ma=or changes are a&so e)a&ate' <*Marketing, 1a&it*, an' Pro'ction.
4.# /&& 5s ser)e as 'esign an' 'e)e&o>ment in>ts or 'esign an''e)e&o>ment change >ro=ects.
!.0 esign an' e)e&o>ment 3oo&s an' 3echni@es
!.$ /&& sotware that is se' in ca&c&ations an' other 'esign an' 'e)e&o>mentacti)ities is )a&i'ate' an' a>>ro)e'. 8otware 'e)e&o>e' in-hose is )a&i'ate'an' a>>ro)e' >rior to re&ease. 8otware 'ocmentation inc&'es )a&i'ation
s>eciications a>>ro)e' <* the 5hie ngineer an' )a&i'ation recor's attestingto acce>ta<&e >erormance. 8tan'ar'commercia& sotware is acce>te'withot )a&i'ation. 8otware that has <een sccess&&* se' in 'esign an''e)e&o>ment >rior to im>&ementation o this >roce're, an' has >ro)en to'emonstrate sccess& >erormance or at &east one *ear, ma* <e se'withot )a&i'ation testing.
!.2 esign an' 'e)e&o>ment reerence materia&s Ji.e., stan'ar's, cata&ogs, etc.are a)ai&a<&e an' maintaine' <* the ngineering %nction. 6n&* crrentisses an' re)isions o reerence materia& are se'. 8tan'ar's an' reerencemateria&s are contro&&e' <* the 5ontro& o ocments Proce're.
".0 esign an' e)e&o>ment 6t>t
".$ esign an' 'e)e&o>ment ot>t is in the orm o 'ocments that 'eine the>ro'ct, inc&'ing characteristics that aect saet*, itness or se,>erormance, an' re&ia<i&it*, an' >ro)i'e instrctions or manactring Ji.e.,'rawings, s>eciications, >roce'res, workmanshi> stan'ar's, ins>ection>roce'res, etc..
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".2 8>eciications an' >roce'res or >ro'ct >ackaging an' &a<e&ing are a&so>art o the 'esign an' 'e)e&o>ment ot>t.
".# 8>>ort 'ocmentation Ji.e., ca&c&ations, risk ana&*sis, test res&ts, )eriicationan' )a&i'ation re>orts, etc. is a&so >art o the 'esign an' 'e)e&o>ment ot>t.
".4 /&& 'esign an' 'e)e&o>ment ot>t 'ocmentation is re)iewe' <* @a&iie'>ersonne& an' a>>ro)e' <* the 5hie ngineer >rior to re&ease. esign an''e)e&o>ment ot>t 'ocmentation is contro&&e' )ia the 5ontro& o ocmentsProce're.
7.' PURC(ASIN!
7.'.1 P954as3n> P5o4ess
Worksmart, Inc. ensres that the >rchasing >rocess is contro&&e' sch that>rchase' >ro'cts an' s<contracte' ser)ices, which aect >ro'ct @a&it*,conorm to s>eciie' re@irements. 3he t*>e an' extent o metho's to manage the>rchasing >rocess 'e>en's on the eect on s<se@ent rea&i?ation >rocesses an'their ot>t.%or 'etai&s, reer to the Prchasing Proce're.
Worksmart, Inc. e)a&ates an' se&ects s>>&iers as 'escri<e' in the PrchasingProce're. 8e&ection is <ase' on s>>&iers a<i&it* to 'e&i)er >ro'cts that satis* a&&Worksmart, Inc. re@irements. 5riteria or se&ection an' >erio'ic e)a&ation are'eine'. 3he res&ts o e)a&ations an' necessar* o&&ow-> actions are recor'e'.
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7.'.# P954as3n> Info5=at3on
Prchasing 'ocments contain 'ata c&ear&* 'escri<ing the >ro'ct to <e >rchase',inc&'ing, the o&&owing, where a>>ro>riate:
a re@irements or a>>ro)a& or @a&iication o >ro'ct, >roce'res, >rocesses,an' e@i>mentE
< re@irements or @a&iication o >ersonne&E an'c @a&it* management s*stem re@irements.
Worksmart, Inc. ensres the a'e@ac* o s>eciie' re@irements containe' in the>rchasing 'ocments >rior to their re&ease to s>>&iers.
7.'.& Ve53f34at3on of P954ase P5o94t
Worksmart, Inc. has i'entiie' an' im>&emente' )eriication acti)ities or ensring that>rchase' >ro'ct conorms to s>eciie' re@irements. Veriication acti)ities are'eine' in the Ins>ection an' 3est Proce're. Where Worksmart, Inc. or its cstomerre@ests )eriication acti)ities at the s>>&ierKs aci&it*, Worksmart, Inc. s>eciies there@ire' )eriication arrangements an' metho' o >ro'ct re&ease in the >rchasing
'ocments >er the Prchasing Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 60 O- 105
7.'.' P954as3n> P5o4e95e
!ene5al Pol348
Worksmart, Inc. maintains a s>>&ier @a&iication an' rating >rocess. 6r'ers are on&*>&ace' with s>>&iers that are on the />>ro)e' 8>>&iers ist. Prchasing 'ocments arec&ear an' inc&'e && ser)ice 'escri>tions an' @a&it* re@irements. /&& >rchasing'ocments are re)iewe' or accrac* an' a'e@ac*, an' a>>ro)e' >rior to re&ease.
P5o4e95e
$.0 1a&iication o 8>>&iers
$.$ Prchasing an' 1a&it* share res>onsi<i&it* or the @a&iication an' monitoringo s>>&iers.
$.2 8>>&iersK @a&it* ca>a<i&ities are e)a&ate' throgh the se o the 8>>&ier8e&-)a&ation an' where necessar*, on-site sr)e*s, <eore or'ers ors>>&* o materia&s an' ser)ices are >&ace'. 3he eecti)eness o the
s>>&iersK @a&it* s*stem sha&& <e re)iewe' at inter)a&s consistent with thecom>&exit* o the items s>>&ie' an' the s>>&iersK >erormance. Worksmart,Inc.s 8>>&ier 8e&-)a&ation is norma&&* the irst oicia& contact <etweenWorksmart, Inc.s 1a&it* %nction an' a >otentia& s>>&ier. /&& @estions inthe e)a&ation orm sho&' <e answere' as com>&ete&* as >ossi<&e, an' theorm sho&' <e retrne' to Worksmart, Inc. Prchasing within the re@este'time >erio'. 3he 8>>&ier 8e&-)a&ation is a necessar* >rere@isite to an*awar' o <siness rom Worksmart, Inc.. 1a&it* wi&& re)iew the e)a&ationin'ings an' 'etermine whether a site sr)e*, 'escri<e' next, is re@ire'.
$.# 8>>&iers who ha)e <een s>>&*ing Worksmart, Inc. or at &east one *ear >rior
to im>&ementation o this >roce're, an' whose >erormance has >ro)en to <eacce>ta<&e, are exem>te' rom the re@irement or 8>>&ier 8e&-)a&ation,an' ma* <e c&assiie' as F/PP6VH. In this case, on&* the co)er >age othe 8>>&ier 8e&-)a&ation orm is com>&ete', marke' a>>ro)e', 'ate', an'signe' <* the 1a&it* Manager an' Prchasing Manager.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 61 O- 105
2.0 8ite 8r)e*s
2.$ 3he 1a&it* Manager is res>onsi<&e or con'cting the 8ite 8r)e* on>otentia& s>>&iers. 8ite 8r)e*s ma* a&so <e con'cte' <* 1a&it* or <* ateam. I a team is to make a site sr)e*, the team mem<ers are to <e se&ecte'rom 1a&it* Jteam &ea'er, Prchasing, Materia&s, an' ngineering. 1a&it* isres>onsi<&e or re>orting a&& res&ts. 3he 8ite 8r)e* is an on-site in)estigationo a s>>&iers management strctre an' o)era&& <siness o>erations. 8ite8r)e*s wi&& <e ma'e sing the 8>>&ier 8e&-)a&ation orm.
ote: 8>>&iers registere' to I86 9000 stan'ar's ma* <e exem>t rom 8ite8r)e*s.
2.2 3he sr)e* wi&& <egin with a <rie intro'ctor* meeting an' 'iscssion witha>>ro>riate s>>&ier management >ersonne&, an' conc&'e with a )er<a&<rieing on the in'ings. 3he re)iew wi&& inc&'e a 'iscssion o Worksmart,Inc.s 1a&it* >hi&oso>h* an' an assessment o the s>>&iers >h*sica&aci&ities, manactring an' technica& ca>a<i&ities, an' @a&it* s*stem. /s>>&ier mst recei)e a>>ro)a& to <e consi'ere' as a >otentia& <sinesss>>&ier to Worksmart, Inc.. 8ho&' concerns <e note' 'ring the 8ite 8r)e*,con'itiona& a>>ro)a& to >rchase materia& rom a s>>&ier ma* <e gi)en
>ro)i'e' the s>>&ier agrees to take, within the s>eciie' time >erio', an*correcti)e actions re@este'.
2.# 3he 1a&it* Manager wi&& e)a&ate sr)e* in'ings an' generate a 8ite 8r)e*e>ort. /&& >ertinent inormation wi&& <e taken rom the a>>&ica<&e sr)e*orms. / smmar* an' recommen'ation wi&& <e ma'e an', i a>>&ica<&e,correcti)e action re@ests &iste'. 6icia& sr)e* res&ts wi&& <e commnicate'<* &etter within two weeks. 1a&it* wi&& sen' a co>* o the 8ite 8r)e* e>ortto the res>onsi<&e <*er.
2.4 3he res>onsi<&e <*er is res>onsi<&e or sen'ing a co>* o the 8ite 8r)e*e>ort to the s>>&ier.
2.! 3he 1a&it* Manager is res>onsi<&e or entering the sr)e* in'ings, a'it'ate, acti)e or inacti)e stats, an' other >ertinent inormation into the
/>>ro)e' 8>>&ier ist J/8. 6rigina& 8r)e* e>orts wi&& <e store' on i&es.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 62 O- 105
#.0 ating an' 5&assiication o 8>>&iers
#.$ / onconormance e>ort J sha&& <e generate' or a&& nonconormingmateria& recei)e' rom s>>&iers. %or 'etai&s, reer to the 5ontro& oonconorming Pro'ct Proce're. /&& s wi&& <e incor>orate' into the1a&it* Perormance ating 8*stem. 8>>&iers wi&& <e isse' co>ies o theirres>ecti)e s.
#.2 1a&it* an' 'e&i)er* >erormance o a&& s>>&iers is continos&* monitore' )iaa s>>&ier >erormance rating s*stem, an' a month&* s>>&ier >erormance
re>ort is 'istri<te' to a&& concerne' nctions. 8>>&iers whose >erormanceis ina'e@ate are aske' to im>&ement correcti)e actions an' s<mit a writtenres>onse. 8>>&iers that 'emonstrate ina'e@ate >erormance an' show nosign o im>ro)ement are remo)e' rom the />>ro)e' 8>>&ier ist an''iscontine' rom se. %or s>>&iers meeting a minimm 'e&i)er* &ot criteria,Worksmart, Inc.s 1a&it* an' Prchasing %nctions >ro)i'e >erio'ic ee'<ackon how we&& the* are 'oing an' where the* rank in re&ation to s>>&iers>ro)i'ing simi&ar >artsser)ices. 3he rating s*stem is a metho' or gaging as>>&iers >rogress towar' ?ero 'eects an' $00R on-time 'e&i)er*.Worksmart, Inc. c&assiies s>>&iers into one o the o&&owing categories:
•
/PP6V - /n />>ro)e' s>>&ier is a s>>&ier that has an a>>ro)e'@a&it* s*stem an' is acti)e&* 'is>&a*ing acce>ta<&e @a&it* an' 'e&i)er*>erormance. Prchasing ma* or'er >ro'cts or ser)ices rom this s>>&ier
• 56I3I6/ - / 5on'itiona& s>>&ier is a s>>&ier that 'oes not ha)e an
a>>ro)e' @a&it* s*stem an'or 'oes not meet acce>ta<&e @a&it* an''e&i)er* re@irements as 'emonstrate' o)er two consecti)e @arters. Inthe e)ent that a s>>&ier o<tains a 5on'itiona& c&assiication or twoconsecti)e @arters, the Worksmart, Inc. Prchasing %nction ma*a'minister an* or a&& o the o&&owing actions:
$ e@est an imme'iate meeting with the s>>&ier to 'iscss, in 'etai&,the crrent c&assiication an' strategies or im>ro)ement Jreso&tiona>>roaches.
2 )a&ate short an' &ong-term >rchase or'er )o&me re&ati)e to crrent<siness con'itions.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 6" O- 105
# Initiate an imme'iate Free?eH on a&& >rchase or'er )o&me in or'er toassess a s>>&iers crrent ca>a<i&ities in reerence to tre>erormance ex>ectations.
• I8/PP6V - 3he s>>&ier is not @a&iie' 'e to ma=or
nonconormances or other >ro<&ems. Prchasing 3ll not >rchase goo'sor ser)ices rom 'isa>>ro)e' s>>&iers.
#.# / i&e, which inc&'es a&& @a&iication 'ocmentation an' >erormance recor's,is maintaine' or each s>>&ier.
4.0 />>ro)e' 8>>&ier ist
4.$ 3he 1a&it* Manager maintains an />>ro)e' 8>>&ier ist, which is athori?e'<* the 1a&it* Manager an' the Prchasing Manager. 3his inc&'es a&&s>>&iers whose s>>&ies or ser)ices aect the @a&it* o the Worksmart, Inc.>ro'ctsser)ices, an' who ha)e <een sr)e*e'a'ite' an' ha)e'emonstrate', <* >erormance, their a<i&it* to meet the s>eciie' @a&it*re@irements. 6r'ers ma* on&* <e >&ace' with s>>&iers that are on the &ist.mergenc* >rchases rom s>>&iers that are not on the &ist are a&&owe' withwritten >ermission rom the Prchasing Manager an' the 1a&it* Manager
Jse e@est to e)iate rom the />>ro)e' 8>>&ier ist orm. /n >'ate' />>ro)e' 8>>&ier ist is >rinte' an' 'istri<te' month&* to a&& >ersonne& whoare res>onsi<&e or >re>aring an' a>>ro)ing the com>an*Ks >rchasing'ocments.
!.0 Prchasing ata
!.$ /&& >rchasing 'ocments are >re>are' <* Prchasing. 3he 'ocmentsc&ear&* 'escri<e or'ere' >ro'ctsser)ices. 3he* inc&'e >recise i'entiicationo the >ro'ctsser)ices, reerence a>>&ica<&e stan'ar's an' other re&e)anttechnica& 'ata, an' state @a&it* an' com>&iance re@irements, @a&it* s*stemre@irementsE an' where a>>ro>riate, re@irements or @a&iication o
>ersonne&. /&& >rchasing 'ocments are re)iewe' an' a>>ro)e' <* thePrchasing Manager >rior to re&ease.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 6. O- 105
".0 e@est or e)iation
".$ 3o re@est a 'e)iation, the s>>&ier mst com>&ete the e@est or e)iationorm J% with the o&&owing inormation as a minimm: 'ate o the re@estEname, a''ress, >hone an' ax nm<ers o the re@esterE the name o theWorksmart, Inc. <*er who >&ace' the or'er or the >art in @estionE >artnm<erE >art re)ision &e)e&E >art 'escri>tionE >rchase or'er nm<erE @antit*o >arts the 'e)iation wi&& a>>&* toE J>reera<&* in terms o P.6. &ine itemnm<ersE eecti)e 'ate when a>>&ica<&eE the reason or the re@estE a'escri>tion o the 'e)iationE the eect on >rice an'or 'e&i)er* Jre@ire' or a
'e)iation to <e grante'. 8>>&iers are re@ire' to s<mit the re@est to theWorksmart, Inc. Prchasing %nction an' attach >hotogra>hs or sam>&es ocharacteristics that cannot <e @antiie' Jexam>&e: srace im>erections,extent o 'ents, <en's, hair&ine cracks, >orosit*, etc..
".2 3he Worksmart, Inc. <*er orwar's the % to the 1a&it* Manager.
".# 3he 1a&it* Manager &ogs the % in the e)iation og, re)iews the re@estor com>&eteness, an' con'cts a >re&iminar* in)estigation to 'etermine i there@est or a simi&ar one ha' >re)ios&* <een grante' or 'enie'. 1a&it* ma*'en* the re@est or >resent it to the engineer with 'esign res>onsi<i&it* or the
>art.
".4 /ter the in)estigation is com>&ete, the % is a>>ro)e' or 'isa>>ro)e'. I the'e)iation is 'enie', the 'isa>>ro)a& <ox is checke' with an ex>&anation o wh*the re@est was 'enie'. I the 'e)iation is grante', the a>>ro)a& <ox ischecke' an' an* a>>&ica<&e con'itions an'or &imitations are note'. Ia>>&ica<&e, the Lcorrecti)e action re@estL an' L5 is re@ire'L <oxes arechecke'.
".! 3he 1a&it* Manager is res>onsi<&e or o<taining the a>>ro>riate signatresan' entering the 'e)iation re@est into the e)iation og.
"." 3he res>onsi<&e <*er wi&& retrn a co>* o the com>&ete' 'e)iation to thes>>&ier. I the 'e)iation is grante', the s>>&ier mst maintain a co>* or as&ong as it is a>>&ica<&e.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 65 O- 105
7.0 Veriication o Prchase' Pro'ct
7.$ In the e)ent the 1a&it* Manager 'etermines that a )eriication o >rchase'>ro'cts wi&& <e re@ire' at the s>>&iers aci&it*, )eriication arrangements wi&&<e s>eciie' on the Prchase 6r'er.
7.2 6r cstomers are gi)en the right to )eri* >rchase' >ro'cts at ors>>&iers >remises. In this case, Worksmart, Inc. is not re&ie)e' o theres>onsi<i&it* or >ro'cts meeting state' @a&it* re@irements.
.0 8ett&ement o 1a&it* is>tes
.$ 3he 1a&it* Manager an' Prchasing ha)e the res>onsi<i&it* an' athorit* tosett&e a&& 'is>tes with s>>&iers regar'ing the @a&it* o theirmateria&s>ro'ctsser)ices or matters sch as ins>ection an' testingmetho's. 6>en commnication channe&s with a&& a>>ro)e' s>>&iers wi&& <emaintaine' to >ro)i'e or the @ick reso&tion o @a&it* 'is>tes. In the e)entthe 1a&it* Manager an' Prchasing cannot reso&)e a 'is>te, the* wi&&re@est the assistance o the +enera& Manager. is>tes in)o&)ing there=ection o materia&s>ro'cts rom a s>>&ier sha&& <e 'ocmente'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 66 O- 105
7.* PRODUCTION AND SERVICE PROVISION
7.*.1 Cont5ol of P5o94t3on an Se5234e P5o23s3on
Processes that 'irect&* aect @a&it* o interme'iate an' en' >ro'cts are carrie' otn'er contro&&e' con'itions. 3o this en', Worksmart, Inc. has esta<&ishe' an'
maintains a Process 5ontro& Proce're, a Process Va&i'ation Proce're an' a8er)icing Proce're. 5ontro&&e' con'itions inc&'e the o&&owing:
a the a)ai&a<i&it* o inormation that s>eciies the characteristics o the >ro'ctE< where necessar*, the a)ai&a<i&it* o work instrctionsEc the se an' maintenance o sita<&e e@i>ment or >ro'ction an' ser)ice
o>erationsE' the a)ai&a<i&it* an' se o measring an' monitoring 'e)ices >er the 5ontro& o
Monitoring an' Measring e)ices Proce'reEe the im>&ementation o monitoring acti)itiesE the im>&ementation o 'eine' >rocesses or re&ease, 'e&i)er* an' a>>&ica<&e
>ost-'e&i)er* acti)ities.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 6/ O- 105
7.*.1.1 P5o4ess Cont5ol P5o4e95e
!ene5al Pol348
/&& >ro'ctioninsta&&ationser)icing sha&& <e >&anne' an' con'cte' n'er contro&&e'con'itions. 5ontro&&e' con'itions sha&& inc&'e work instrctions, where a>>&ica<&e, se osita<&e >ro'ctioninsta&&ationser)icing e@i>ment, an' working en)ironment. Personne&>erorming com>&ex or critica& o>erations are >ro)i'e' with work instrctions an', whena>>&ica<&e, criteria or workmanshi>. /&& e@i>ment is sita<&* maintaine' to ensrecontining >rocess ca>a<i&it*.
P5o4e95e
$.0 Pro'ction 5ontro& P&an
$.$ / 5ontro& P&an is >re>are' <* the +enera& Manager. 3his 'ocment &ists a&&the re@ire' >ro'ction o>erations, inc&'ing )eriication acti)ities.
2.0 5ontro& o 1a&it* in Pro'ction
2.$ 3he +enera& Manager has >rimar* res>onsi<i&it* or ensring contro& o @a&it*'ring >ro'ction <* se&ecting a>>ro>riate >rocess contro& metho's. Writtenwork instrctions are generate' or com>&ex an'or critica& >ro'ctiono>erations. When 'etermining the nee' or work instrctions, the o&&owingactors are consi'ere':
• 1a&iication o >ersonne&
• 5om>&exit* an' critica&it* o the work to <e >erorme'
• Pre)ios @a&it* histor*
2.2 Where necessar*, criteria or workmanshi> Ji.e., written stan'ar's, workinstrctions, ser mana&s, sam>&es, etc. are ti&i?e'. 8im>&e an' )eriia<&e>rocesses are not orma&&* contro&&e'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 6 O- 105
2.# 3he >&ant en)ironment is monitore' 'ring >ro'ction to ensre those actorssch as tem>eratre, hmi'it*, an' c&ean&iness that can a')erse&* im>act>ro'ct @a&it*, are within s>eciie' &imits. /xi&iar* materia&s an' ti&ities schas water, com>resse' air, e&ectric >ower, an' chemica&s se' 'ring>ro'ction are a&so monitore' to ensre a niorm eect on >ro'ction>rocesses. %or 'etai&s, reer to the %aci&it* Management Proce're.
2.4 /&& reerence stan'ar'sco'es, @a&it* >&ans, an'or 'ocmente' >roce'resare strict&* a'here' to.
2.! 8ita<&e >rocess >arameters an'or >ro'ct characteristics are monitore' an'contro&&e' to assre contining >rocess ca>a<i&it*.
2." 8ita<&e >ro'ction e@i>ment is se' an' its re&ia<i&it* is assre' throghreg&ar maintenance <* the Maintenance %nction accor'ing to assigne'sche'&es. %or 'etai&s, reer to the %aci&it* Management Proce're.
#.0 ecor's
#.$ ecor's o >rocess contro& are maintaine', as a>>ro>riate.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 6' O- 105
7.*.1.# Se52343n> P5o4e95e
!ene5al Pol348
Worksmart, Inc. ser)ices its >ro'cts in accor'ance with the warranties s>eciie' in thecontractscrrent cata&ogs. I contracta&&* s>eciie', ser)icing is exten'e' <e*on' thewarrant* >erio's. 3he 8er)ice %nction carries ot its acti)ities n'er contro& o the @a&it*s*stem an' com>&ies with a&& a>>&ica<&e >roce'res.
P5o4e95e
$.0 +enera&
$.$ 3he 8er)ice e>artment nctions in'e>en'ent&* rom or'er intake, throgh>ro'ct shi>ment.
$.2 8er)icing is the res>onsi<i&it* o the 8er)ice Manager.
2.0 1a&it* 8*stem
2.$ 3he entire @a&it* s*stem o Worksmart, Inc., as 'ocmente' in the 1a&it*Mana&, a>>&ies to the ser)icing o>erations.
2.2 Where necessar*, the @a&it* s*stem is rther 'ocmente' an' maintaine' inwork instrctions or assem<&* an' insta&&ation, commissioning, o>eration,s>ares or >arts &ists, an' ser)icing o an* >ro'ct.
#.0 8>>ort
#.$ %ie&' o>erations are s>>orte' with a'e@ate &ogistics <ack->, technica&
a')ice, s>ares or >arts s>>&*, an' re&ia<&e ser)icing. es>onsi<i&it* or a&&acti)ities is c&ear&* commnicate' to a&& s>>&iers, 'istri<tors, an' sers.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /0 O- 105
4.0 %ee'<ack on Perormance
4.$ / >erormance ee'<ack s*stem is im>&emente' to monitor the @a&it*characteristics o the >ro'cts throghot their &ie c*c&e. 3his s*stem is'esigne' to ana&*?e the 'egree to which the >ro'cts or ser)ices satis*cstomer @a&it*, saet*, an' re&ia<i&it* ex>ectations.
4.2 Inormation is co&&ecte' rom com>&aints, ai&res, cstomer nee's an'ex>ectations, or an* >ro<&em encontere' in se an' is to <e ma'e a)ai&a<&eor 'esign an' 'e)e&o>ment re)iews an' correcti)e action in the s>>&* an'or
se o the items.
7.*.# Val3at3on of P5o4esses fo5 P5o94t3on an Se5234e P5o23s3on
/n* Worksmart, Inc. >ro'ction an' ser)ice >rocesses where the res&ting ot>tcannot <e )eriie' <* s<se@ent measrement or monitoring, are )a&i'ate' inaccor'ance with the Process Va&i'ation Proce're. 3his inc&'es an* >rocesseswhere 'eiciencies ma* <ecome a>>arent on&* ater the >ro'ct is in se or theser)ice has <een 'e&i)ere'.
Process )a&i'ation 'emonstrates the a<i&it* o the >rocesses to achie)e >&anne'res&ts. Worksmart, Inc. has 'eine' arrangements or )a&i'ation that inc&'e theo&&owing, as a>>&ica<&e:
a @a&iication o >rocess >er the Process Va&i'ation Proce'reE< @a&iication o e@i>ment an' >ersonne& >er the Process Va&i'ation Proce're
an' the 3raining Proce'reEc se o 'eine' metho'o&ogies an' >roce'res >er the 5ontro& o ocments
Proce'reE' re@irements or recor's >er the corres>on'ing >roce'resEe re-)a&i'ation >er the Process Va&i'ation Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /1 O- 105
7.*.#.1 P5o4ess Val3at3on P5o4e95e
!ene5al Pol348
/n* >ro'ction an' ser)ice >rocesses where the res&ting ot>t cannot <e )eriie' <*s<se@ent measrement or monitoring Js>ecia& >rocesses are carrie' ot <* @a&iie'>ersonne& an' are s<=ect to continos monitoring an' contro& o >rocess >arametersthrogh the esta<&ishment o >rocess )eriication an' )a&i'ation metho's.
P5o4e95e
$.0 Pro'ctProcess Veriication an' Va&i'ation P&anning
$.$ P&anning o >ro'ct )eriication an' )a&i'ation acti)ities res&ts in the'ocmentation o an ins>ection an' testing >&an or each a>>&ica<&e >ro'ct,an' or materia&s an' com>onents incor>orate' into the >ro'ct. 3hisinc&'es:
• 5riteria or re)iew acce>tance o the >rocess
• I'entiication o ins>ection an' testing >oints
• 8co>e, re@enc*, an' metho's o ins>ection an' testing
• />>ro)a& o re@ire' e@i>ment an' @a&iication >ersonne&
• 8>eciic metho's an' >roce'res
• 3he re@ire' recor's to attest to the >ro'ct @a&it*
• e)a&i'ation
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /2 O- 105
$.2 3he 1a&it* Manager, 5hie ngineer, an' Pro'ction Manager ha)eres>onsi<i&it* or the 'e)e&o>ment o >ro'ct )eriication >&ans. 3he >&ans are'eine' in )arios t*>es o 'ocments Ji.e., 'rawings an' s>eciications,>ro'ction work or'ers, >rchasing 'ocments, ins>ection an' testing>roce'res, etc.. %or critica& >rocesses, a orma& 5ontro& P&an is 'ocmente'or each a>>&ica<&e >ro'ct. 3hese >&ans 'eine the ins>ection an' testing>rocess or a >ro'ct, inc&'ing a&& the re@ire' ins>ectiontest e@i>ment. Ina''ition, the Ins>ection an' 3est Proce're ex>&ains how ot>ts o >ro'ct)eriication an' )a&i'ation >&anning are se'.
7.*.& Ient3f34at3on an T5a4eab3l3t8
Worksmart, Inc. maintains a 'ocmente' >roce're or i'enti*ing the >ro'ct <*sita<&e means throghot a&& stages o >ro'ction, 'e&i)er*, insta&&ation, an' ser)iceo>erations. 3his >rocess i'entiies the stats o the >ro'ct with res>ect tomeasrement an' monitoring re@irements. Where tracea<i&it* is a re@irement,ni@e i'entiication o the >ro'ct is recor'e' an' contro&&e'. Pro'ct i'entiicationan' tracea<i&it* are maintaine' an' contro&&e' throgh Worksmart, Inc.Ks I'entiicationan' 3racea<i&it* Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /" O- 105
7.*.&.1 Ient3f34at3on an T5a4eab3l3t8 P5o4e95e
!ene5al Pol348
/&& >ro'cts are sita<&* i'entiie' <* a >art nm<er=o< nm<er corres>on'ing to a>>&ica<&e'rawings, s>eciications, an' other technica& 'ocments. Where a>>ro>riate, thei'entiication s*stem sha&& a&&ow or tracea<i&it* rom inishe' >ro'cts <ack to incoming
recor's.
P5o4e95e
$.0 es>onsi<i&it*
$.$ ngineering is res>onsi<&e or assigning >art nm<ers=o< nm<ersseria&nm<ers to a&& materia& an' >arts, which are se' in the com>an*Ks >ro'cts,an' or maintaining a&& a>>&ica<&e 'ocmentation an' recor's.
$.2 ecei)ing an' Pro'ction are res>onsi<&e or a>>ro>riate marking o
>rchase' an' manactre' >ro'cts an' or a&& associate' recor's.Preser)ing o the i'entiication is the res>onsi<i&it* o a&& >ersonne& han'&ingthe >ro'cts.
$.# Ins>ection >ersonne& are res>onsi<&e or ensring >ro>er &a<e&smarkings area>>&ie' when re@ire' an' or associate' recor's.
$.4 8tockroomIns>ection >ersonne& ensre that &a<e&s are >ro>er&* store' an'i'entiie' to >re)ent mix->s.
2.0 Pro'ct I'entiication
2.$ /&& >arts>ro'cts, whether >rchase' or manactre', are i'entiie' with >artnm<ers=o< nm<ers, an' where a>>&ica<&e, seria& nm<ers, which &ink the>arts>ro'cts to their 'ocmentation.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /. O- 105
#.0 3racea<i&it*
#.$ When re@ire' <* the cstomer, tracea<i&it* is maintaine' rom recei>t o >artsto 'e&i)er* o the ina& >ro'cts. ngineering maintains recor's that trace >artnm<ers to their corres>on'ing 'rawings, s>eciications, an' an* otherre&e)ant 'ocmentation.
#.2 ngineering maintains >ro'ct conigration recor's that trace seria& nm<erso >ro'cts to their >arts &ists.
7.*.' C9sto=e5 P5oe5t8
Worksmart, Inc. exercises care with cstomer >ro>ert* whi&e it is n'er Worksmart,Inc.Ks contro& or <eing se' <* Worksmart, Inc. as 'eine' in the 5ontro& o 5stomer8>>&ie' Pro'ct Proce're. Worksmart, Inc. ensres i'entiication, )eriicationagainst s>eciie' re@irements, an' >rotection an' saegar'ing o cstomer>ro>ert* >ro)i'e' or se or incor>oration into the >ro'ct. /n* cstomer >ro>ert*that is &ost, 'amage' or otherwise on' to <e nsita<&e or se is recor'e' an're>orte' to the cstomer.
5stomer >ro>ert* ma* inc&'e inte&&ecta& >ro>ert*, sch as inormation >ro)i'e' inconi'ence.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /5 O- 105
7.*.'.1 Cont5ol of C9sto=e50S9l3e P5o94t P5o4e95e
!ene5al Pol348
Worksmart, Inc. 'oes not 'ierentiate <etween cstomer-s>>&ie' >ro'cts an' those thatare >rchase' or incor>oration into the s>>&ies, an' n&ess otherwise s>eciie' <* thecstomer, the* wi&& <e han'&e' throgh or stan'ar' o>erating >roce'res. /n* sch>ro'ct that is &ost, 'amage', or nsita<&e or se is recor'e' an' re>orte' to thecstomer.
P5o4e95e
$.0 es>onsi<i&it*
$.$ Marketing8a&es is res>onsi<&e or a&& coor'ination o cstomer-s>>&ie'>ro'ct with the cstomer.
2.0 ecei)ing, Marking, 8torage, an' Aan'&ing
2.$ ecei)ing, ins>ection, marking, storage, han'&ing, an' >reser)ation ocstomer-s>>&ie' >ro'ct o&&ows the same >roce'res that genera&&* a>>&*to >rchase' >ro'cts, n&ess otherwise s>eciie' <* the cstomer in thecontract.
2.2 Veriication o cstomer-s>>&ie' >ro'ct <* Worksmart, Inc. 'oes not a<so&)ethe cstomer o the res>onsi<i&it* o >ro)i'ing acce>ta<&e >ro'ct.
#.0 oss or amage
#.$ /n* cstomer-s>>&ie' >ro'ct that is &ost, 'amage', or otherwise nsita<&eor se sha&& <e recor'e' an' segregate' >er the 5ontro& o onconormingPro'ct Proce're, an' sha&& <e re>orte' to the cstomer <* the 1a&it*Manager8a&es Manager.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /6 O- 105
7.*.* P5ese52at3on of P5o94t
3o >reser)e conormance o >ro'ct with cstomer re@irements 'ring interna&>rocessing an' 'e&i)er* to the inten'e' 'estination, Worksmart, Inc. has 'e)e&o>e'an' maintains a 'ocmente' Aan'&ing, 8torage, Preser)ation an' e&i)er*Proce're. etai&s or i'entiication o >ro'ct are 'escri<e' in the I'entiication an'3racea<i&it* Proce're. 3hese >roce'res ensre a'e@ate i'entiication, han'&ing,>ackaging, storage an' >rotection an' a&so a>>&* to the constitent >arts o the>ro'ct.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE // O- 105
7.*.6 (anl3n>, Sto5a>e, Pa4<a>3n>, P5ese52at3on, an Del32e58P5o4e95e
!ene5al Pol348
8ita<&e han'&ing, storage, >ackaging, >reser)ation, an' 'e&i)er* metho's are esta<&ishe'to >re)ent >ro'ct 'amage an' 'eterioration. Pro'ct is store' in 'esignate' storage areaswith a>>ro>riate contro& o in<on' recei>ts an' ot<on' re&eases. Pro'ct in storage is
>erio'ica&&* assesse' to 'etect 'eterioration. Packaging is sicient to ensre >ro'ct@a&it*. Protection o the >ro'cts @a&it* is exten'e' to inc&'e 'e&i)er* to the cstomer.
P5o4e95e
$.0 Aan'&ing
$.$ 3he +enera& Manager is res>onsi<&e or esta<&ishing an' enorcing sita<&ehan'&ing metho's to assre >reser)ation o >ro'ct @a&it*. /&& containersti&i?e' or storing >ro'cts are a'e@ate an' in goo' con'ition. /&& e@i>ment
that is se' or interna& trans>ortation o >ro'cts is reg&ar&* maintaine' an'a&& o>erators recei)e the re@ire' &e)e& o training to assre eicient an' saeo>eration.
$.2 /n* items that are sensiti)e an' re@ire s>ecia& han'&ing Ji.e. >rotection rome&ectro-static 'ischarge are i'entiie' an' han'&e' with extreme care.
2.0 8torage an' Preser)ation
2.$ 3he Pro'ction Manager is res>onsi<&e or o>erating an' maintaining thestockroom an' storage areas. 6n&* >ro'cts with the >ro>er i'entiication an'ins>ection stats are acce>te' into an' re&ease' rom storage <* athori?e'
stockroom >ersonne&. %or 'etai&s, reer to the Ins>ection an' 3est 8tatsProce're an' I'entiication an' 3racea<i&it* Proce're.
2.2 imite' she& &ie items are isse' on a Lirst in, irst otL <asis. Pro'cts are>reser)e' with a>>ro>riate rst >re)entati)e chemica&s, where a>>&ica<&e, an'are sita<&* wra>>e'>ackage'. 3he con'ition o materia& in stock is assesse'e)er* three months to >re)ent >ro'ct 'eterioration.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE / O- 105
2.# 5om>&ete' >ro'cts awaiting >ackaging an' shi>>ing wi&& <e >rotecte' so asto >re)ent 'amage rom )i<ration, shock, a<rasion, corrosion, hmi'it*,tem>eratre, or an* other con'itions occrring 'ring han'&ing an' storage.
#.0 Packaging
#.$ Pro'ct <eing >re>are' or shi>ment wi&& ha)e in'ication o ha)ing >asse' aina& ins>ection test. /&& >ro'cts are >ackage' in a manner that wi&& >re)ent'amage 'ring storage an' 'e&i)er*. n&ess otherwise s>eciie' <* thecstomer, ngineering has res>onsi<i&it* or esta<&ishing >ackaging
re@irements.
#.2 Where s>ecia& re@irements are contracta&&* s>eciie', stan'ar' >roce'resare mo'iie' as re@ire' to satis* those re@irements.
4.0 e&i)er*
4.$ Worksmart, Inc. ti&i?es com>an* owne'&ease' an' o>erate' )ehic&es or&oca& 'e&i)eries.
4.2 /&& goo's are trans>orte' ti&i?ing on&* common carriers rom the />>ro)e'8>>&ier ist. /ir i'e )ans wi&& <e s>eciie' where re@ire'. 8hi>>ing
acti)ities wi&& com>&* with a&& a>>&ica<&e shi>>ing an' >ackaging reg&ations toassre sae arri)a& at 'estination.
ote: Where the cstomer s>eciies a s>eciic carrier in the contract, theres>onsi<i&it* or 'e&i)er* wi&& remain with the cstomer.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE /' O- 105
7.6 CONTROL O) MONITORIN! AND MEASURIN! DEVICES
Worksmart, Inc. ensres that the monitoring an' measrement acti)ities are i'entiie', an'that the necessar* monitoring an' measring 'e)ices are a)ai&a<&e to assre conormanceo the >ro'ct to s>eciie' re@irements. Worksmart, Inc.s 5ontro& o Monitoring an'Measring e)ices Proce're is se' to contro& measring an' monitoring 'e)ices so thatmeasrement ca>a<i&it* is consistent with the measrement re@irements. Measring an'
monitoring 'e)ices:
• are ca&i<rate' an' a'=ste' >erio'ica&&* or >rior to se against 'e)ices tracea<&e to the
internationa& or nationa& stan'ar'sE
• are saegar'e' rom a'=stments that wo&' in)a&i'ate the ca&i<rationE
• are >rotecte' rom 'amage an' 'eterioration 'ring han'&ing, maintenance an' storageE
• ha)e the res&ts o their ca&i<ration recor'e'E
• ha)e the )a&i'it* o >re)ios res&ts re-assesse' i the* are s<se@ent&* on' to <e ot
o ca&i<ration an' correcti)e action is taken >er the 5ontro& o onconorming Pro'ctProce're.
8otware se' or monitoring o s>eciie' re@irements is )a&i'ate' accor'ing to 'eine'gi'e&ines >rior to re&ease or se in >ro'ction, insta&&ation, an' ser)icing.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 0 O- 105
7.6.1 Cont5ol of Mon3to53n> an Meas953n> De234es P5o4e95e
!ene5al Pol348
/&& ins>ection, measring, an' test e@i>ment, which are se' in a&& >hases o>ro'ct>rocess )eriication, are contro&&e' an' ca&i<rate' against nationa&&* tracea<&estan'ar's at s>eciie' inter)a&s. 8otware se' to contro& >rocesses sha&& a&so <e )eriie'or >ro>er nctioning. /&& e@i>mentinstrments in the ca&i<ration s*stem are i'entiie'
with stickers that in'icate the ca&i<ration stats. Where a>>&ica<&e, ca&i<ration certiicatesare maintaine'.
P5o4e95e
$.0 8co>e o 5a&i<ration
$.$ 3he 1a&it* Manager has res>onsi<i&it* or contro& an' ca&i<ration acti)ities. /&measring, test e@i>ment, an' test sotware se' or contro&&ing>ro'ctionser)icing >rocesses are ca&i<rate' at >rescri<e' inter)a&s. 3he
ca&i<ration s*stem a&so exten's to manactring =igs, ixtres, too&ing, an'>rocess instrmentation that can aect >ro'ct @a&it*, or is se' to measres>eciie' characteristics. @i>ment that is se' or reerence on&* Jnot)eriication is not inc&'e' in the ca&i<ration s*stem an' is &a<e&e' with L663 8 %6 VI%I5/3I6L stickers warning that it is not ca&i<rate'.
$.2 /&& em>&o*ee-owne' measring instrments se' or )eriication o >ro'ctsare registere' with 1a&it* an' s<=ect to a&& contro&s o the ca&i<ration s*stem.m>&o*ees sha&& not, n'er an* circmstances, se their measrementinstrments i the* are not registere' an' ca&i<rate'.
2.0 @i>ment /ccrac* an' Precision
2.$ />>ro>riate ins>ection, measring, an' test e@i>ment is se&ecte' to satis*the accrac* an' >recision o the re@ire' characteristics. 1a&it* isres>onsi<&e or se&ecting sita<&e e@i>ment to >erorm the measrements.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 1 O- 105
#.0 I'entiication an' Maintenance
#.$ /&& acti)e e@i>ment is entere' on a contro&&e' &ist, in'icating the ca&i<rationinter)a&. /&& ins>ection, measring, an' test e@i>ment se' or )eriication>r>oses are ca&i<rate' to nationa&&* or internationa&&* tracea<&e stan'ar's an'are &a<e&e' with a ca&i<ration sticker. Where >ractica&, the instrments aresea&e' with tam>er >roo sea&s to >re)ent nathori?e' re>air or a'=stment.
#.2 5a&i<ration is either >erorme' <* externa& ca&i<ration &a<oratories or interna&&*.When externa& ser)ices are ti&i?e', the* are incor>orate' into the />>ro)e'
8>>&ier ist an' are monitore' )ia the com>an*Ks s>>&ier rating s*stem to>re)ent the se o &a<s that ai& to meet @a&it* an' >erormance re@irements. /&& interna& ca&i<ration is >erorme' in accor'ance with written instrctions.
4.0 n)ironment
4.$ /&& e@i>ment is ca&i<rate' in a sita<&e en)ironment an' is han'&e' with careto assre 'amage is not sstaine' an' the ca&i<ration is not aecte'.
!.0 5a&i<ration ecor's
!.$ 5ertiicates o ca&i<ration are maintaine' on i&e or a&& instrments that were
ca&i<rate' <* ca&i<ration &a<oratories. ach instrment is tracea<&e to its own5a&i<ration Aistor* ecor' which contains its i'entiication nm<er, storage&ocation, make or t*>e, re@enc* o ca&i<ration, reerence stan'ar's se',acta& ca&i<ration in'ings inc&'ing 'ate, an' actions to <e taken in case onsatisactor* res&ts.
".0 8otware
".$ 3est sotware J'e)e&o>e' or >rchase' that is se' or ins>ection an' testingan'or monitoring o >rocess >erormance is )a&i'ate' <eore it is se' or)eriication o >ro'cts. 8tan'ar' sotware >rchase' rom commercia&
sorces is or'ere' with )a&i'ation certiicates. 8otware that is 'e)e&o>e' in-hose is )a&i'ate' an' a>>ro)e' in accor'ance with its 'ocmentation, whichcontains instrctions or )a&i'ation o >ro>er nctioning. 8otware is re-)a&i'ate' at >rescri<e' inter)a&s or whene)er a change rom the origina&re&ease is intro'ce'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 2 O- 105
7.0 8>>&ier Measrement 5ontro&
7.$ 3he 1a&it* Manager is res>onsi<&e or exten'ing the contro& o measring an'test e@i>ment to a&& a>>ro)e' s>>&iers.
.0 onconorming @i>ment
.$ I it is conirme' that the e@i>ment is ot o ca&i<ration, the 1a&it* Managerin)estigates the )a&i'it* o measrements or which the e@i>ment was>re)ios&* se' an' assesses the acce>tance stats o a&& the aecte'
>ro'ct. I a>>&ica<&e, a&& nonconorming >ro'ct is i'entiie' an''is>ositione' as 'escri<e' in the 5ontro& o onconorming Pro'ctProce're. In the e)ent nonconorming >ro'ct has <een shi>>e', thecstomer is imme'iate&* notiie'.
.2 /n* measring or test e@i>ment that a>>ears to gi)e inaccrate rea'ings ischecke' an' ca&i<rate'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE " O- 105
". MEASUREMENT, ANALYSIS, AND IMPROVEMENT
".1 !ENERAL
Measrement an' ana&*sis acti)ities that are re@ire' to assre >ro'ct @a&it* an'contri<te to contina& im>ro)ement are >&anne', an' 'eine' statistica& techni@es arese' or ana&*?ing measrement 'ata.
".1.1 Plann3n>
Measrement an' ana&*sis acti)ities, to )eri* an' assre >ro'ct @a&it*, are 'eine'in engineering s>eciications an' 'rawings, >ro'ction work or'ers, ins>ection an'testing >roce'res, an' >rocess contro& >roce'res.
".# MONITORIN! AND MEASUREMENT
".#.1 C9sto=e5 Sat3sfa4t3on
/ ke* measre o Worksmart, Inc.s @a&it* s*stem >erormance is the inormationo<taine' on cstomer satisaction. 3he metho'o&ogies or o<taining an' singcstomer satisaction 'ata are 'ocmente' in the Monitoring an' Measring5stomer 8atisaction Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE . O- 105
".#.1.1 Meas953n> an Mon3to53n> C9sto=e5 Sat3sfa4t3on
!ene5al Pol348
Worksmart, Inc. co&&ects an' ana&*?es inormation on the nee's an' ex>ectations o itscstomers. 3his inormation is ti&i?e' to maintain an'or im>ro)e cstomer satisaction.5stomer satisaction inormation is a&so consi'ere' when s>eciic re@irements orim>ro)ing or >ro'cts an' ser)ices are 'e)e&o>e'.
P5o4e95e
$.0 +enera&
$.$ 3he o)era&& metho'o&og* or co&&ecting cstomer satisaction 'ata an'inormation is 'eine' in this >roce're. Aowe)er, the o)era&& a>>roach ma*<e >erio'ica&&* a'=ste' in res>onse to the stats an' im>ortance o cstomersatisaction with res>ect to >artic&ar as>ectsE or in res>onse to new >ro'ct orser)ice &anches, an' changing >riorities.
2.0 Inormation an' ata 5o&&ection Points
2.$ 5stomer satisaction inormation is o<taine' rom cstomer ee'<ack an' <*ana&*?ing cstomer res>onses to:
• 5stomer satisaction sr)e*s
• 5om>&aints
• ecognition an' awar's rom cstomers, associations, an' consmer
gro>s
• Pro'ct retrns
• Warrant* c&aims
• e>eat cstomers
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 5 O- 105
• Market share
#.0 nso&icite' 5stomer %ee'<ack
#.$ 5stomer com>&aints, s>ontaneos ee'<ack on satisaction, an' othernso&icite' cstomer ee'<ack are co&&ecte' an' >rocesse' <* the8a&esMarketing %nction.
#.2 5stomer com>&aints an' ee'<ack are gro>e' <* se&ecte' categories to ai'with statistica& ana&*sis o the 'ata or assessing cstomer satisaction.
#.# 3he cstomer satisaction 'ata is com>i&e' an' ana&*?e' <* the8a&esMarketing Manager an' re)iewe' an' a>>ro)e' <* the 1a&it*Manager. 3he in'ings are re>orte' to management @arter&* an' >resente'an' 'iscsse' at management re)iew meetings.
4.0 etrns an' Warrant* 5&aims
4.$ 8a&esMarketing is res>onsi<&e or coor'inating >ro'ct retrn athori?ationre@ests an' warrant* c&aims. 3he reason or each retrn re@est or c&aim isrecor'e'. Pro'ct retrns are categori?e' an' the 'ata is ana&*?e' <* the8a&esMarketing Manager an' re)iewe' an' a>>ro)e' <* the 1a&it*
Manager.
!.0 ecognition an' /war's
!.$ Worksmart, Inc. seeks to >artici>ate in cstomers awar' an' recognition>rograms, an' a&so encorages cstomers to >ro)i'e ee'<ack on its>erormance. 3his t*>e o recognition an' >erormance rating is consi'ere' to<e the most )a&a<&e ee'<ack on cstomer satisaction or 'issatisaction an'is consi'ere' to <e one o the most im>ortant in>ts or 'etermining cstomersatisaction.
!.2 5stomer ratings an'or awar's an' recognition are ana&*?e' an' se' in thesame wa* as other cstomer ee'<ack. 8a&esMarketing ana&*?es whichas>ects o >ro'cts an'or ser)ices are most res>onsi<&e or achie)ement othe recognition. 3he res&ts are >resente' at management re)iews.
".0 e>eat 5stomers, eerra&s, an' Market 8hare
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".$ 8a&esMarketing >erio'ica&&* ana&*?es sa&es 'ata to track re>eat cstomersan' i'enti* their or'ering >atterns. Where)er >ossi<&e, sa&es inormation isa&so ana&*?e' or cstomer reerra&s.
".2 Marketing is res>onsi<&e or co&&ecting an' ana&*?ing 'ata regar'ingcom>etition, com>etiti)e >ro'cts, an' market share.
".# 3he res&ts o the ana&*sis Ji.e., re>eat cstomers, reerra&s, an' market shareare >resente' an' 'iscsse' at management re)iews.
7.0 5stomer 8atisaction 8r)e*s
7.$ 8a&esMarketing con'cts anna& cstomer satisaction sr)e*s. / sr)e*orm is sent to cstomers or this >r>ose. 6 S8a&esMarketing con'ctscstomer satisaction sr)e*s. / 5stomer 8atisaction 8r)e* is sent tocstomers with each >ro'ct or, at the com>&etion o the ser)ice.T I acstomer 'oes not res>on' within or weeks, a o&&ow-> te&e>hone ca&& isma'e an' a )er<a& sr)e* is con'cte'.
7.2 8a&esMarketing com>i&es an' ana&*?es cstomer satisaction sr)e*s, an'com<ines the res&ts with other cstomer satisaction 'ata to 'raw conc&sionson the @a&it* o >ro'cts an' ser)ices. 3he res&ts are >resente' an'
'iscsse' at management re)iew meetings.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE / O- 105
".#.# Inte5nal A93t
Worksmart, Inc. con'cts >erio'ic interna& a'its, in accor'ance with the Interna& /'its Proce're to ensre that the @a&it* s*stem:
a conorms to the re@irements o the a>>&ica<&e stan'ar's an' reg&ationsE< has <een eecti)e&* im>&emente' an' maintaine'.
Worksmart, Inc. >&ans, con'cts, an' re>orts on interna& a'its in accor'ance with
the Interna& /'its Proce're. 3he a'it sco>e, re@enc* an' metho'o&ogies are'eine'. /'it >&ans take into consi'eration the stats an' im>ortance o theacti)ities an' areas to <e a'ite' as we&& as the res&ts o >re)ios a'its. 3he a'itsare con'cte' <* >ersonne& in'e>en'ent o the acti)ities <eing a'ite'. 3ime&*correcti)e action is taken on 'eiciencies on' 'ring the a'its. %o&&ow-> actionsinc&'e the )eriication o the im>&ementation o the correcti)e actions an' there>orting o )eriication res&ts >er the 5orrecti)e an' Pre)enti)e /ction Proce're.
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".#.#.1 Inte5nal A93ts P5o4e95e
!ene5al Pol348
Interna& @a&it* a'its are >&anne' an' im>&emente' <* >ersonne& in'e>en'ent o a'ite'acti)itiesareas. 3he >r>ose o the a'its is to 'etermine interna& com>&iance with a&&state' @a&it* o<=ecti)es an' >roce'res, as 'eine' in the @a&it* mana& an' associate''ocmentation. /&& nonconormances note' 'ring the a'its are <roght to the attention o the res>onsi<&e managerss>er)isors an' orma& correcti)e action is re@este'.
P5o4e95e
$.0 +enera&
$.$ )er* acti)it* an' area is s<=ect to an interna& @a&it* a'it at &east once a*ear. Where im>ortance o ser)ice @a&it* an' 'eteriorating @a&it*>erormance warrants more re@ent )eriication, the Interna& 1a&it* /'it8che'&e is a'=ste' to ensre that a'its are >erorme' as re@ire'. /
'ocmente' Interna& 1a&it* /'it P&an is >re>are' <eore each a'it.
2.0 es>onsi<i&it*
2.$ 3he 1a&it* Manager is res>onsi<&e or >&anning, coor'inating, an'im>&ementing interna& @a&it* a'its. Ae or she is norma&&* the team &ea'er Jia team is se', exce>t when a'iting @a&it* acti)ities. In this case, the+enera& Manager con'cts the a'it.
2.2 /&& >ersonne& con'cting interna& @a&it* a'its are @a&iie' an' in'e>en'ento the areasacti)ities <eing a'ite'.
#.0 Interna& 1a&it* /'it P&an
#.$ 3he Interna& 1a&it* /'it P&an co)ers the o&&owing items:
a s>eciic areas an' acti)ities to <e a'ite'E
< the 'ates an' times o the a'itsE
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ISO '001 (UALITY )ANUAL
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c a'itors res>onsi<&e or each a'ite' acti)it*areaE
' t*>e o a'it Jrotine or s>ecia&.
4.0 /'it Pre>aration, Im>&ementation, an' e>orting
4.$ In >re>aration or the a'it, a'itors re)iew a&& a>>&ica<&estan'ar'ss>eciications, 1a&it* Mana& an' re&ate' work instrctions,>re)ios a'it re>orts, an' an* other >ertinent 'ocments'ata.
4.2 In execting the a'it, a'itors re)iew @a&it* recor's, o<ser)e >ertinentacti)ities, an' inter)iew a>>&ica<&e >ersonne&. 3he a'itors mst )eri*throgh o<=ecti)e e)i'ence that the re@irements o the 'ocmente' @a&it*s*stem are im>&emente'.
4.# In the e)ent nonconormances are 'etecte', the* are imme'iate&* <roght tothe attention o the res>onsi<&e s>er)isormanager.
4.4 In re>orting the res&ts o the a'its, a'itors wi&& com>&ete the o&&owinginormation on a se>arate Interna& /'it onconormance ecor' or eachareaacti)it* a'ite': res>onsi<&e managers>er)isor, 'ration o the a'itan' com>&etion 'ate, in'ings, nonconormances note', re@ests or correcti)e
action, an' recommen'ations.
4.! /n Interna& 1a&it* /'it e>ort wi&& <e >re>are' <* the 1a&it* Manager an''istri<te' to the com>an* >resi'ent an' a&& aecte' 'e>artmentmanagerss>er)isors.
!.0 /'it %o&&ow->
!.$ In a&& areas where an Interna& /'it onconormance ecor' was isse', theres>onsi<&e managers>er)isor wi&& concr with the in'ings, i'enti* thecorrecti)e action to <e taken, an' set a com>&etion 'ate.
!.2 /&& correcti)e actions wi&& <e re-a'ite' to )eri* com>&iance, at which time the*wi&& <e c&ose' ot. Where the correcti)e actions are on' to <e nsatisactor*the* wi&& <e re-isse'.
".0 ecor's
".$ ecor's o Interna& 1a&it* /'its are maintaine'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE '0 O- 105
".#.& Mon3to53n> an Meas95e=ent of P5o4esses
Worksmart, Inc. a>>&ies sita<&e metho's or measrement an' monitoring o thoserea&i?ation >rocesses that are re@ire' to meet cstomer re@irements. 3hesemetho's are a>>&ie' in accor'ance with the 8tatistica& 3echni@es Proce're an'assre the contining a<i&it* o each >rocess to satis* the inten'e' >r>ose.When >&anne' res&ts are not achie)e', action is taken to correct the imme'iate>ro<&em as s>eciie' in the 5orrecti)e an' Pre)enti)e /ction Proce're.
".#.' Mon3to53n> an Meas95e=ent of P5o94t ano5 Se5234e
Worksmart, Inc. measres an' monitors the characteristics o the >ro'ct to )eri*that re@irements or the >ro'ct are met. 3his is carrie' ot at a>>ro>riate stages othe >ro'ct rea&i?ation >rocess in accor'ance with the Ins>ection an' 3estProce're. Pro'cts are not re&ease'ser)ice 'e&i)er* 'oes not >rocee' nti& a&&>&anne' monitoring an' measring acti)ities ha)e <een satisactori&* com>&ete'.)i'ence o conormance to the acce>tance criteria is 'ocmente' as 'escri<e' inthe Ins>ection an' 3est Proce're an' Ins>ection an' 3est 8tats Proce're.ecor's inc&'e the athorit* res>onsi<&e or re&ease o the >ro'ct.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE '1 O- 105
".#.'.1 Inse4t3on an Test P5o4e95e
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Incoming, in->rocess, an' ina& ins>ectiontesting are con'cte' to )eri* that >ro'ctsconorm to s>eciie' re@irements. Materia&s, com>onents, s<assem<&ies, an' inishe'>ro'cts are >re)ente' rom se, assem<&*, an' 'is>atch nti& the re@ire' ins>ections arecom>&ete'. Mo'iie' >ro'cts sha&& <e &&* re-ins>ecte' an' re-teste'. 3he re@ire'recor's o ins>ectionstests are esta<&ishe' an' maintaine'.
P5o4e95e
$.0 ecei)ing Ins>ection an' 3est
$.$ /&& >rchase' materia& which in&ences the manactre o, or is inten'e' orse as >art o, 'e&i)era<&e >ro'cts is s<=ect to ins>ection an'or testing <*ecei)ing Ins>ection. >on recei>t o >ro'cts, recei)ing >ersonne& )eri* the@antit* o 'e&i)ere' nits, check marking an' i'entiication o >ackages, an'
ins>ect a&& >ackages or an* signs o tam>ering or 'amage. I a&& these checksan' ins>ections are satisactor*, recei)ing >ersonne& signs the 'e&i)er* recei>t.I not, an* shortages or 'amages are note' on a&& co>ies o the 'e&i)er*recei>ts.
$.2 3he recei)e' containers are then mo)e' to the 'esignate' ins>ection area, aco>* o the >rchase or'er is retrie)e', an' the >acking s&i>s are remo)e'rom the containers. >on o>ening the containers, the goo's are )eriie'against the >rchase or'er an' the >acking s&i>, an' are examine' )isa&&* or an* signs o 'amage. 3he >rchase or'er is stam>e' F5IVH an' issigne' an' 'ate' <* the recei)ing ins>ector. /&& recei)ing ins>ections are
&ogge' in the ecei)ing Ins>ection og.
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$.# 6n critica& >arts an' com>onents, as 'etermine' <* the 1a&it* Manager, a>recision ins>ectiontest is >erorme'. 3his t*>e o ins>ection inc&'es:
• e)iew o materia& certiicates, s>>&ier ins>ection recor's, com>&iance
certiicates, an' an* other re&e)ant 'ocmentation 'e&i)ere' with the>ro'ct
• an'om sam>&ing <ase' on statistica& techni@e s>eciie'
• Visa& ins>ection to 'etect an* 'amage or other )isi<&e >ro<&ems
• Perorming measrements an' testing against s>eciie' re@irements as
re@ire'
• ecor'ing the sam>&e si?e, acta& measrements, an' ins>ection test
res&ts on the Ins>ection3est N /'it e>ort
$.4 Where it is not >ractica& to >erorm recei)ing ins>ection >on recei>t,>ro)isions are ma'e to >erorm sorce ins>ection at the s>>&iers aci&it*.
$.! 3he 1a&it* Manager 'etermines the extent an' sco>e o recei)ing ins>ection
<ase' on the im>ortance o the item an' the s>>&iers contro& metho's an'>erormance. 3he 1a&it* Manager ma* re@est that s>>&iers >ro)i'eo<=ecti)e e)i'ence o conormance Ji.e., materia& certiications, certiicates oconormance, test 'ata, irst artic&e ins>ection, an' 8P5 'ata. 6<=ecti)ee)i'ence >ro)i'e' <* s>>&iers ma* <e se' as the <asis or re'cingwai)ingrecei)ing an' sorce ins>ection.
$." >on acce>tance, >ro'cts are i'entiie' with an F/55P3H tag SgreenstickerT an' mo)e' to stock. In the e)ent that >ro'ct which is 'esignate' orrecei)ing ins>ection is re&ease' to >ro'ction 'e to rgenc*, it sha&& <e>ositi)e&* i'entiie' an' recor'e' in recei)ing ins>ection recor's.
2.0 In->rocess Ins>ection an' 3est
2.$ In->rocess ins>ectiontesting is con'cte' to ensre that the >ro'ct>rocessconorms to s>eciie' re@irements. 3he ins>ectiontesting is norma&&* carrie'ot <* >ro'ction >ersonne&. an'om a'its o the in->rocessins>ectiontesting >rocess are con'cte' <* @a&it* contro& >ersonne&.
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2.2 3he 1a&it* Manager 'etermines the extent an' sco>e o in->rocessins>ectiontesting <ase' on the im>ortance o the item, contro& metho's, an'>re)ios >erormance.
#.0 %ina& Ins>ection an' 3est
#.$ %or acce>tance o com>&ete' >ro'cts, ina& ins>ectiontesting is ti&i?e'. 3hisinc&'es a )eriication o satisactor* recei)ing an' in->rocessins>ectionstests, as we&& as com>&etion o the remaining ins>ectionstests toassre that the inishe' >ro'cts>rocesses conorm to s>eciie'
re@irements. Pro'cts are not re&ease', an' >rocesses are not a>>ro)e'nti& a&& ins>ectiontest acti)ities ha)e <een satisactori&* com>&ete' an' thea>>ro>riate 'ocmentation is a)ai&a<&e an' athori?e'. /&& ina& ins>ectionsare &ogge' in the %ina& Ins>ection og. 6n critica& >arts an' com>onents, as'etermine' <* the 1a&it* Manager, a %ina& Ins>ection3est N /'it e>ort iscom>&ete'.
#.2 3he 1a&it* Manager 'etermines the extent an' sco>e o ina&ins>ectiontesting <ase' on the im>ortance o the item, contro& metho's, an'>re)ios >erormance.
4.0 Ins>ection an' 3est ecor's
4.$ Ins>ectiontest recor's, which show c&ear&* whether the >ro'ct>rocess has>asse' or ai&e' the 'eine' acce>tance criteria, are esta<&ishe' an'maintaine'.
!.0 onconorming Materia&Pro'cts
!.$ /&& materia&>ro'cts that are on' to <e nonconorming are i'entiie' an'segregate' an'or @arantine', an' a>>ro>riate&* 'is>ositione' >er the5ontro& o onconorming Pro'ct Proce're.
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".#.'.# Inse4t3on an Test Stat9s P5o4e95e
!ene5al Pol348
3he ins>ection an' test stats o a&& >ro'cts is c&ear&* )isi<&e throghot a&& stages o>ro'ction, insta&&ation, an' ser)icing. 6n&* >ro'ct that has >asse' the re@ire'ins>ectionstests is re&ease' or rther >rocessing.
P5o4e95e
$.0 es>onsi<i&it* an' /thorit*
$.$ /&& >ersonne& athori?e' to carr* ot ins>ections an' testing are res>onsi<&eor i'enti*ing the ins>ection stats o >ro'cts an' or the re&ease o >ro'ctsto the next o>eration. 1a&it* has athorit* or re&ease o >ro'cts orshi>ment ater com>&etion o the re@ire' ina& ins>ectionstests. /&& >ersonne&who come in contact with the >ro'cts are res>onsi<&e or >reser)ing thei'entiication.
2.0 5onorming 8tats
2.$ Pro'cts that >ass the re@ire' ins>ectionstests are i'entiie' as conormingwith an F/55P3H tag an' <* the a>>ro>riate ins>ection signatre or initia&son the accom>an*ing >a>erwork Jtra)e&ers, =o< car's, >rocess sheets,ins>ectiontest re>orts, etc.. 6n&* >ro'cts that ha)e >asse' the re@ire'ins>ectionstests are re&ease' or rther >rocessing.
#.0 onconorming 8tats
#.$ /&& materia& that is on' to <e nonconorming is i'entiie' an' where >ractica&,segregate' an'or @arantine' >er the 5ontro& o onconorming Pro'ctProce're.
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ISO '001 (UALITY )ANUAL
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".& CONTROL O) NONCON)ORMIN! PRODUCT
3o ensre that >ro'ct that 'oes not conorm to s>eciie' re@irements is >ro>er&* i'entiie'an' manage', to >re)ent ninten'e' se or 'e&i)er*, Worksmart, Inc. has esta<&ishe' an'maintains a 'ocmente' 5ontro& o onconorming Pro'ct Proce're. onconorming>ro'ct is correcte', where a>>&ica<&e, an' s<=ect to )eriication ater correction to'emonstrate conormance.
Where >ro'ct is acce>te' n'er concession, it is athori?e' or se <* a re&e)ant athorit*sch as, the cstomer, the en' ser, reg&ator* <o'* or other a>>&ica<&e athorit*.
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ISO '001 (UALITY )ANUAL
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".&.1 Cont5ol of Non4onfo5=3n> P5o94t P5o4e95e
!ene5al Pol348
Materia&>ro'ct that 'oes not conorm to s>eciie' re@irements is i'entiie', segregate',an' >re)ente' rom se. 3he res>onsi<i&it* or re)iew an' 'is>osition o nonconormingmateria&>ro'ct is 'eine'. ecor's o nonconormances are ana&*?e' an' orwar'e' tonctions concerne'.
P5o4e95e
$.0 I'entiication an' 8egregation
$.$ /&& >ersonne& at Worksmart, Inc. sha&& imme'iate&* noti* their s>er)isorswhen materia&s, com>onents, assem<&ies, or com>&ete' >ro'ct ai&s to meetthe s>eciie' re@irements 'ring recei)ing, in->rocess, or ina& ins>ection an'testing. /&& nonconorming materia&>ro'ct is i'entiie' with a e=ect 3agan'or a onconormance e>ort J. 3he nonconorming materia&>ro'ct
is then segregate' rom >ro'ction an' where >ractica&, mo)e' to an iso&ate'storage area. /&& s are &ogge' in the onconormance og. /&& e=ect3agss are e)a&ate' or res>onsi<i&it* an' 'eect tren's. 5orrecti)eactions are initiate' as necessar*.
$.2 3he 1a&it* Manager wi&& 'etermine natre an' seriosness o thenonconormance an' 'etermine i >re)ios >ro'ction &ots sho&' <e re-ins>ecte', cstomers sho&' <e notiie', an' 'etermine i a reca&& or stock>rge is in or'er.
2.0 is>osition
2.$ onconorming materia&>ro'ct is 'is>ositione' as o&&ows:
ACC U /cce>t Jnonconormance co&' not <e )a&i'ate'or RTO U etrn 3o 6riginatoror RTS U etrn to 8>>&ieror
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE '/ O- 105
R- U eworkor UAI U se /s Isor S45aan'( U es>onsi<i&it* Aoseor S U es>onsi<i&it* 8>>&ier
2.2 When the 'is>osition o nonconorming materia&>ro'ct is e)i'ent Jscra>,
36 or 38, the +enera& Manager ma* make the a>>ro>riate 'is>osition an'orwar' a co>* o the a>>&ica<&e e=ect 3ag to the 1a&it* Manager. /&&other se=ect 3ags are 'is>ositione' <* the onconormance e)iewBoar' JB an' where re@ire', <* the cstomer. 3he B is com>rise' othe 1a&it* Manager, the +enera& Manager, Prchasing, an' a re>resentati)erom ngineering.
2.# 8>>&iers are isse' co>ies o a&& s that are 'is>ositione' as res>onsi<i&it*8 an' 38 or /I.
2.4 >on com>&etion o the necessar* correcti)e measres, a&& materia&>ro'ct is
re-ins>ecte'. 3he 1a&it* Manager wi&& iso&ate the root case o the >ro<&eman' take a>>ro>riate action to >re)ent recrrence.
#.0 ecor's
#.$ /&& 'is>ositione' e=ect 3ags an' s sha&& <e i&e' an' maintaine'.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE ' O- 105
".' ANALYSIS O) DATA
Worksmart, Inc. has esta<&ishe' an' maintains a 'ocmente' 8tatistica& 3echni@esProce're to co&&ect an' ana&*?e a>>ro>riate 'ata to 'etermine the sita<i&it* an'eecti)eness o the @a&it* s*stem an' to i'enti* im>ro)ements that can <e ma'e. 3hisinc&'es 'ata generate' <* measring an' monitoring acti)ities an' other re&e)ant sorces.
Worksmart, Inc. ana&*?es this 'ata to >ro)i'e inormation on:
a cstomer satisaction >er the 5stomer 8atisaction Proce'reE< conormance to cstomer re@irements >er the esign an' e)e&o>ment 5ontro&
Proce're an' the 5orrecti)e an' Pre)enti)e /ction Proce'reEc >rocess characteristicsE' s>>&ier >erormance >er the Prchasing Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE '' O- 105
".'.1 Stat3st34al Te4n3;9es P5o4e95e
!ene5al Pol348
ecti)e 'ata ana&*sis is an essentia& >art o the @a&it* management s*stem at Worksmart,Inc.. 8tatistica& techni@es are ti&i?e', where a>>ro>riate, an' the 'ata is ana&*?e' <*'esignate' >ersonne& an' ti&i?e' or continos >ro'ct an' >rocess im>ro)ement.
P5o4e95e
$.0 +enera&
$.$ Where a>>ro>riate, statistica& techni@es are ti&i?e' to monitor an' im>ro)e>ro'ct @a&it* an' >rocess ca>a<i&it*.
$.2 8tatistica& techni@es ma* <e se' in: market ana&*sis, >ro'ct 'esign an''e)e&o>ment, re&ia<i&it* s>eciication, &onge)it*'ra<i&it* >rocesscontro&>rocess ca>a<i&it* st'ies, 'etermination o @a&it* &e)e&s, sam>&ing the
@a&it* o recei)e' >ro'ct, >erormance assessment, an' 'eect ana&*sis.
2.0 es>onsi<i&it* an' />>&ication
2.$ 3he 1a&it* Manager 'etermines the nee' or statistica& techni@es.
2.2 When re@ire', statistica& techni@es are em>&o*e' n'er the 'irection o1a&it*. /&& >ersonne& in)o&)e' in the a>>&ication o statistica& techni@es aretraine' in their se an' are >ro)i'e' with the necessar* too&s.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 100 O- 105
".* IMPROVEMENT
".*.1 Cont3n9al I=5o2e=ent
It is the o)era&& res>onsi<i&it* o to> management at Worksmart, Inc. to contina&&*im>ro)e the eecti)eness o the @a&it* management s*stem in accor'ance the
5ontina& Im>ro)ement Proce're. 3his >rocess 'escri<es aci&itation o thecontina& im>ro)ement o the @a&it* s*stem throgh the se o the @a&it* >o&ic*,o<=ecti)es, a'it res&ts, ana&*sis o 'ata, correcti)e an' >re)enti)e action an'management re)iew. ach managers>er)isor is res>onsi<&e or the contina&im>ro)ement o the @a&it* management s*stem in his or her res>ecti)e areas.ecti)eness o contina& im>ro)ement acti)it* is assesse' 'ring the Managemente)iew Process as 'escri<e' in the Management e)iew Proce're.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 101 O- 105
".*.1.1 Cont3n9al I=5o2e=ent P5o4e95e
!ene5al Pol348
Worksmart, Inc. has im>&emente' a contina& im>ro)ement >hi&oso>h* throghot the entireorgani?ation, which is 'ri)en <* goa&s 'ocmente' in the @a&it* o<=ecti)es an' @a&it*>o&ic*. 6>>ortnities or im>ro)ement are i'entiie' an' trans&ate' in im>ro)ement >ro=ects.5ases o nonconormance are i'entiie', in)estigate', an' where a>>ro>riate, correcti)eactions are im>&emente' to ensre there is no recrrence. Pre)enti)e actions areim>&emente' to e&iminate the cases o >otentia& nonconormances.
P5o4e95e
$.0 +enera&
$.$ Worksmart, Inc. has im>&emente' a contina& im>ro)ement >hi&oso>h*throghot the entire organi?ation. 3his >hi&oso>h* is inherent in theWorksmart, Inc. @a&it* s*stem. )er* em>&o*ee in the organi?ation is
encorage' to sggest new i'eas or im>ro)ing >ro'cts, >rocesses, s*stems,>ro'cti)it*, an' the working en)ironment.
$.2 6>>ortnities or im>ro)ement o o>erations an' >rocesses are i'entiie' <*nctiona& managers on a contina& <asis rom 'ai&* ee'<ack on o>erationsan' >erio'ic management re)iews. 6>>ortnities or im>ro)ement o >ro'ctsan' ser)ices are i'entiie' main&* <* 8a&esMarketing an' ngineering.
2.0 8orces or Im>ro)ement 6>>ortnities
2.$ In>ts or im>ro)ement o>>ortnities are o<taine' rom the o&&owing sorces:
• 5stomer satisaction an' an* other cstomer ee'<ack
• Market research an' ana&*sis
• In>ts rom em>&o*ees, s>>&iers, an' other intereste' >arties
• Interna& an' externa& a'its o the @a&it* s*stem
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 102 O- 105
• ecor's o >ro'ct nonconormances
• ata rom >rocess an' >ro'ct characteristics an' their tren's
2.2 6>>ortnities or im>ro)ement ma* a&so <e i'entiie' on a s>ecia& >ro=ect<asis. 3he o&&owing are exam>&es o sch >ro=ects:
• on )a&e-a''e' se o &oor s>ace
• xcessi)e ins>ection testing
• xcessi)e han'&ing an' storage
• xcessi)e ai&re @a&it* costs
• Machine set-> changeo)er times
#.0 )a&ation, Prioriti?ation, an' Im>&ementation
#.$ 6>>ortnities or im>ro)ement rom 'ai&* ee'<ack on o>erationa&>erormance Ji.e., 'is>osition o nonconorming >ro'ct, interna& a'its,
cstomer com>&aints, etc. are e)a&ate' <* the 1a&it* Manager. 3*>ica&&*,the* are im>&emente' throgh the correcti)e an' >re)enti)e action s*stem.
#.2 6>>ortnities or im>ro)ement rom ana&*sis o &onger-term 'ata an' tren'sare e)a&ate' an' im>&emente' throgh the management re)iew >rocess.3he* are >rioriti?e' with res>ect to their re&e)ance or achie)ing @a&it*o<=ecti)es. When o>>ortnities or im>ro)ement are no &onger s>>orte' <*the crrent >o&ic* an' o<=ecti)es, management wi&& esta<&ish new @a&it*o<=ecti)es, an' >ossi<&* change the >o&ic*. 3he >rocess or this e)a&ationan' >rioriti?ing is 'escri<e' in the Management e)iew Proce're. onger-term im>ro)ement >ro=ects are initiate' throgh the management re)iew>rocess, as we&& as the correcti)e an' >re)enti)e action s*stem.
#.# Pro'ct im>ro)ement o>>ortnities are e)a&ate' <* 8a&esMarketing,ngineering, an' the to> management. 3he* are im>&emente' throgh theMarket e@irements statements or ngineering 5hange 6r'ers.
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ISO '001 (UALITY )ANUAL
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".*.# Co55e4t32e A4t3on
Worksmart, Inc. has esta<&ishe' an' maintains a 'ocmente' 5orrecti)e an'Pre)enti)e /ction J5/P/ Proce're or e&iminating the cases o nonconormit* inor'er to >re)ent recrrence. 5orrecti)e actions taken are a>>ro>riate to the im>acto the >ro<&ems encontere'. 3he 5orrecti)e an' Pre)enti)e /ction Proce're'eines re@irements or:
a i'entiication o nonconormities, inc&'ing cstomer com>&aintsE< 'etermination o the cases o nonconormitiesE
c e)a&ation o the nee' or actions to ensre that nonconormities 'o not recrE' 'etermination an' im>&ementation o correcti)e actions nee'e'Ee recor'ing the res&ts o actions takenE re)iewing the correcti)e action taken.
".*.& P5e2ent32e A4t3on
Worksmart, Inc. has esta<&ishe' an' maintains 'ocmente' @a&it* >&ans, a esignan' e)e&o>ment 5ontro& Proce're, an' a 5/P/ Proce're or e&iminating thecases o >otentia& nonconormities to >re)ent occrrence. Pre)enti)e actions takenare a>>ro>riate to the im>act o the >otentia& >ro<&ems. 1a&it* >&ans an' the
>roce'res 'eine re@irements or:
a i'entiication o >otentia& nonconormities an' their casesE< 'etermination an' im>&ementation o >re)enti)e action nee'e'Ec recor'ing res&ts o action takenE' re)iewing o >re)enti)e action taken.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 10. O- 105
".*.&.1 Co55e4t32e an P5e2ent32e A4t3on P5o4e95e
!ene5al Pol348
3he @a&it* s*stem at Worksmart, Inc. is geare' towar' the >re)ention o 'eects. 3o thisen', a orma& correcti)e an' >re)enti)e action s*stem is ti&i?e'. oot cases ononconorming >ro'ct, ser)ices, an' @a&it* s*stem nonconormances are in)estigate',an' correcti)e an' >re)enti)e actions are im>&emente' to >re)ent their recrrence.
P5o4e95e
$.0 Initiation o 5orrecti)ePre)enti)e /ctions
$.$ 5orrecti)e actions ma* <e re@este' when a con'ition, which is a')erse to@a&it* or which has the >otentia& or >ro'ct>rocess im>ro)ement isi'entiie'. 3his inc&'es nonconorming materia& recei)e' rom a s>>&ier.
$.2 Pre)enti)e actions ma* <e re@este' when >otentia& >ro'ct>rocess
>ro<&ems are i'entiie'.
$.# /n* em>&o*ee o the com>an* can initiate a correcti)e>re)enti)e actionre@est <* com>&eting the to> >ortion o the 5orrecti)e /ction e@est J5/orm, <t on&* the 1a&it* Manager can isse a 8>>&ier 5orrecti)e /ctione@est J85/. 3he 1a&it* Manager recor's a&& 5/s in the 5orrecti)e
/ction 8tats og an' 85/s in the 8>>&ier 5orrecti)e /ction 8tats og.
2.0 5stomer 5om>&aints
2.$ Marketing8a&es is res>onsi<&e or recei)ing, >rocessing, an' res>on'ing to
cstomer com>&aints. /&& recei)e' cstomer com>&aints are recor'e' in the5stomer 5om>&aints 8tats og.
2.2 3he 1a&it* Manager e)a&ates e)er* com>&aint an' when re&e)ant, re@estsim>&ementation o correcti)e actions rom the res>onsi<&e nction. 3he1a&it* Manager, in con=nction with the Presi'ent an' 8a&es, 'etermines thea>>ro>riate cstomer res>onse.
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ISO '001 (UALITY )ANUAL
REV* 1 DATE: 06+06+05 PAE 105 O- 105
#.0 Pre)enti)e /ctions
#.$ When correcti)e actions are im>&emente' or when a >otentia& seriosnonconormance is i'entiie', simi&ar >arts, >ro'cts, an' >rocesses areana&*?e' to 'etermine the re@ire' ste>s or eecti)e im>&ementation o>re)enti)e actions.
4.0 /na&*sis an' />>ro)a&s
4.$ / thorogh ana&*sis o a&& re&ate' >rocesses, o>erations, @a&it* recor's, an'
s>eciications, which ma* ha)e contri<te' to the 'eicienc*, is con'cte' <*the res>onsi<&e nction. 3he in)estigation an' ana&*sis o the root case an'>re)enti)e measres sha&& <e &&* 'ocmente' <* the gro> or in'i)i'a&assigne' to the >ro<&em. 3he ana&*sis sha&& inc&'e re)iew o a&& a>>&ica<&e'ata an' examination o >ro'ct scra>>e' or reworke' to 'etermine the extentan' case o the >ro<&em, an' ana&*sis o tren's in >rocesses or >erormanceo work to >re)ent nonconormances.
4.2 /&& >ro<&ems are e)a&ate' in terms o >otentia& im>act on >ro'ction costs,@a&it* costs, >erormance, re&ia<i&it*, saet*, an' cstomer satisaction. /&&>ro<&ems are c&assiie' either minor or ma=or. eso&tions to a&& correcti)e an'>re)enti)e actions are re)iewe' an' a>>ro)e' <* the 1a&it* Manager.Where the res>onse is nsatisactor*, the correcti)e action re@est is re-isse'. 3he 1a&it* Manager con'cts >erio'ic re)iewso&&ow > to'etermine i the correcti)e an' >re)enti)e actions ha)e <een im>&emente' an'are eecti)e.