CONTENTS 1.0 Scope of the Q!"#t$ M!%!&e'e%t S$(te' !t Wo"(te%ho"'e I%te)%!t#o%!" L#'#te* 1.1 Statement of Quality Policy 2.0 Q!"#t$ M!%!&e'e%t S$(te' Doc'e%te* +)oce*)e( 2.1 Document Control 2.2 Control of Quality Records 2.3 Internal Quality Audits 2.4 Control of Nonconforming Product 2. Correcti!e Action 2." Pre!entati!e Action ,.0 Q!"#t$ M!%!&e'e%t S$(te' +)oce((e( !%* I%te))e"!t#o%( 3.1 #rganisation C$arts 3.2 Res%onsi&ilities 3.3 Interrelation of Processes 3.4 Processes 1.0 Scope of the Q!"#t$ M!%!&e'e%t S$(te' !t Wo"(te%ho"'e I%te)%!t#o%!" L#'#te* 'olsten$olme International (imited is a Com%any )it$ a long*standing successful $istory of su%%lying metal %o)ders+ %astes+ %ellets+ !arnis$+ o,set in-+ .e/ogra%$y in- and ot$er related %roducts for use in a large range of a%%lications+ on a )orld)ide &asis. 0$e sco%e of t$e Quality 1anagement System encom%asses all acti!ities on t$e Dar)en Site. 0$e 1etallic Po)ders #%eration at Dar)en is res%onsi&le for t$e manufacture and su%%ly of metal %o)ders and %igments mainly in aluminium+ co%%er and &rass 2&ron3e4 &ased alloys+ for use in %rinting+ in-s+ %lastics and ot$er industrial and engineering a%%lications. 0$e In- #%eration at Dar)en is res%onsi&le for t$e manufacture of a )ide range and ty%e of %rinting in-+ 5one*%ac-5 gold in-+ !arnis$ and related %rinting %roducts. All %roduction %rocesses at Dar)en are !alidated &efore lea!ing t$e site and as suc$ su&*clause 6..2 is e/cluded. 0$e o!erall o%eration at Dar)en is controlled &y t$e In- 7 Print &usiness unit and t$e Industrial &usiness unit. 0ec$nical Ser!ice and Researc$ and De!elo%ment are !ital to t$e future de!elo%ment of t$e Com%any+ toget$er )it$ understanding and de!elo%ing ne) %roducts and a%%lications for our customers. 0$e manufacturing+ tec$nical and administration functions of t$e Com%any are &ased in Dar)en+ (ancas$ire+ 8ngland and em%loy some 219 sta, at t$at location. 0$roug$ t$e a%%lication of Quality 1anagement Systems and Com%any )ide training %rogrammes+ 'olsten$olme International (td. is committed to ensuring continuous im%ro!ements to &ot$ its %rocesses and %roduct tec$nology. WOLSTENHOLME INTERNATIONAL LTD. QUALITY +OLICY 'olsten$olme International (imited is committed to t$e %ro!ision of customer satisfaction. Quality in e!eryt$ing )e do is t$e central ingredient in t$e a&o!e commitment. #ur commitment goes &eyond maintaining a :uality system )$ic$ fully com%lies )it$ t$e re:uirements of ;S*8N*IS# <991. 'e are committed to ac$ie!ing+ maintaining and im%ro!ing o!erall organisational %erformance and ca%a&ilities &y t$e a%%lication of t$e %rinci%les outlined in ;S*8N*IS# <994=2999 'e )ill maintain and continuously im%ro!e our :uality management system &y t$e setting of measura&le :uality o&>ecti!es t$roug$out t$e organisation and !igorous internal audits. 'e )ill re!ie) our %erformance at regular management re!ie)s. Additional in%uts to t$ese re!ie)s )ill also include customer feed&ac-+ %rocess %erformance and %roduct conformance. 0$e %rime out%ut of t$e re!ie) )ill &e to ensure continuing customer satisfaction and im%ro!ement of %roducts. As %art of t$is commitment )e )ill identify and meet t$e training needs of our em%loyees+ so ensuring t$at t$e needs of our customers are met. 0$is Policy )ill &e made a!aila&le t$roug$out our organisation to ensure t$at t$e commitment to our customers is clear and )idely understood. Ch)#( R!-e%(c)oft 1anaging Director 2.9 Q!"#t$ M!%!&e'e%t S$(te' Doc'e%te* +)oce*)e( 2.1. Doc'e%t Co%t)o" All :uality system documentation )ill &e made a!aila&le !ia su%er!ision in t$e 0riangle IS# Ac$ie!er Plus data&ases. All documents relating to t$e :uality system )ill &e controlled. C$anges to :uality system documentation may &e %ro%osed &y any mem&er of t$e Com%any. Suc$ %ro%osed c$anges )ill &e re!ie)ed &y t$e 1anagement Re%resentati!e )$o )ill liaise )it$ ot$er :uality system documentation users as necessary. Dead 0riangle IS# Ac$ie!er Plus documents )ill &e arc$i!ed )it$in t$e data&ases. RE.: Co%t)o" of Q!"#t$/ E%-#)o%'e%t!" Doc'e%t(0 WIQS+.1 ISO Document No control ISO Achiever document Other Lotus Notes document AS 400 Document External Origin Document Control WIQSP.1 Automatiic Control Automatic Control Automatic Control Other Documentation Document owner controls document identity and distriution Document Owner controls document! estalishes and maintains" Ade#ucy $rior to issue Document %eview Changes to document and revision status identi&iale Document availaility at 'oint o& use %emoval o& osolete documents Controlled Document ( ( N ( ( N Start N ( N N End Co%t)o" of Q!"#t$ Reco)*( All :uality records )ill &e maintained and controlled. 0$e records )ill &e legi&le and stored in suc$ a manner as to %rotect t$em from damage+ loss and deterioration. Quality records )ill also &e stored and clearly located in suc$ a manner as to facilitate easy retrie!al of information. RE.: Co%t)o" of Q!"#t$/ E%-#)o%'e%t!" Reco)*( 0 WIQS+.2 %ecord Owner Create %ecord Assign title)record numer Securely Store %ecord *se %ecord De&ine %etention $eriod ) +ee' inde&inately %etrieve %ecord Document Control Ends Audit %ecord Control %ecord to e used %etention $eriod Ex'ired %ecord Control to e Audited N N Record Control WIQSP.2 ( ( N ( Start End 2.3 I%te)%!" Q!"#t$ A*#t( Internal audits )ill &e carried out in accordance )it$ Com%any %rocedures and )ill &e conducted for any of t$e follo)ing reasons=* 2i4 #n a sc$eduled &asis. 2ii4 As a result of a customer com%laint 2%art or full audit4 2iii4 As a result of t$e need for ne) %rocedures to accommodate ne) &usiness situations. 2i!4 ?n*sc$eduled Audits as re:uested &y t$e #%erations Director or 1anagement Re%resentati!e. 2!4 @ollo)*u% audits 2%art or full audits4 )ill ta-e %lace in order to esta&lis$ t$e e,ecti!eness of rele!ant audit related Correcti!e Action Re:uests %re!iously raised.0$e management of internal audits )ill &e t$e res%onsi&ility of t$e 1anagement Re%resentati!e+ )$o )ill also &e res%onsi&le for ensuring t$at any necessary correcti!e actions are satisfactorily im%lemented and closed out in t$e rele!ant de%artment &y t$e declared deadline date. Internal audits )ill &e carried out as laid do)n in t$e internal audit sc$edule &y trained %ersonnel $a!ing no direct in!ol!ement )it$ t$e de%artment+ section or function &eing internally audited. If for any reason an audit cannot &e com%leted as sc$eduled+ t$e 1anagement Re%resentati!e )ill re*sc$edule as re:uired. RE.: I%te)%!" A*#t( 0 WIQS+., Quality Audits WIQSP.3 Start De&ine sco'e and create Audit &rom $ro&ile or inde'endently ,Coordinator- Nominate and Noti&y Auditor ,Coordinator- Acce'ted y Auditor Document %easons ,Auditor- N ." $re'are Audit $lan /" Noti&y Audit 0eam ,i& any- 1" Noti&y Auditee Audit Date Acce'tale y Auditee Change Date Document %easons ,Auditor- N ." Carry out Audit /" Document Audit %e'ort 1" %aise any CA%2s 4" Sign and Com'lete Y Audit %e'ort Acce'tale y Auditee %eview %e#uired ,Coordinator- Document %easons ,Audit- N Y Audit Com'lete Y %eview! Comment! %aise CA%2s and ad3ust Audit $lan i& %e#uired N Y Create Audit Schedule 2.4 Co%t)o" of No%0Co%fo)'#%& +)o*ct( All non*conforming %roducts )ill &e clearly identiAed )it$ t$e rele!ant identiAcation la&el+ or $eld in clearly identiAed areas and remo!ed from normal %roduction or storage areas to a)ait a dis%osal decision. '$ere %roducts are t$oug$t to &e marginally sus%ect+ and re*ins%ection or re*testing re:uired+ t$ey )ill &e clearly identiAed as suc$ and only released for use su&>ect to %assing t$e re*testing stage and a suita&le end use identiAed. '$ere %roducts are found to &e outside s%eciAcation+ t$ey may &e re*)or-ed in accordance )it$ rele!ant %rocedures+ or concession soug$t from t$e customer. Correcti!e and Pe!entiti!e actions )ill &e im%lemented )$ere necessary to determine t$e root cause of t$e non*conformance. Non*conforming %roducts detected at t$e goods in)ard stage )ill &e re>ected+ and t$e :uestion of dis%osal discussed )it$ t$e su%%lier. 0$e su%%lier )ill &e ad!ised of t$e re>ection &y t$e Purc$asing De%artment. RE.:Co%t)o" of No%0Co%fo)'#%& +)o*ct( 0 WIQS+.1!2 13 !%* 1c Start Certi&icate o& con&ormity) analysis 4uarantine Otain Certi&icate 4A 0est 4A $ass)5ail $ac+)Lael 4uarantine rewor+ under 4A control Su''ly under Concession $ac+ ) Lael &or return to Su''lier $roduct 6erchanted $roduct 6anu&actured $roduct 6anu&actured $roduct 6erchanted Control o Aluminium Non!conormin" Product WIQSP.#a 5 N $ N Des'atch END ( ( 7oods %eturned y Customer Start Control o $ron%e Non Conormin" Product WIQSP.#$ 4A 0est $ass)&ail %e#uired y customer $ut into Stoc+room %elend Allocate atch to customer Drum)Lael) Des'atch End $ 5 N ( 7oods %eturned y Customer $owder $aste Arrange O&&8Site Dis'osal Start 4A $roduct $ass Store $roduct within shel& li&e Des'atch to the Customer Drum)lael as re3ect Arrange o&&site dis'osal Can the 'roduct e wor+ed o&& Lael the drum as 9or+ O&& Store in the 9or+ O&& Area %ewor+ under 4C Control ( N End Control o In& Non!conormin" Product WIQSP.#c 5ree:e $roduct Assign 5inished 7oods Code $ac+)Lael ( N Assign a 9or+ O&& Code ( N 7oods returned y Customer 2. Co))ect#-e Act#o% Correcti!e action )ill &e raised as a result of non*conformances identiAed during internal audits+ )$en su%%liers %ro!ide defecti!e materials or ser!ices+ )$en customers $a!e cause to com%lain or follo)ing in*%rogressB Anal ins%ection. Correcti!e action re:uests may also &e raised in an e,ort to im%ro!e current )or-ing %ractises. Correcti!e actions and customer com%laints )ill &e re!ie)ed at 1anagement Re!ie) 1eetings. '$en non*conforming %roducts or ser!ices are identiAed+ t$e root cause of t$e %ro&lem )ill &e in!estigated+ correcti!e action ta-en and %re!entati!e measures initiated to %reclude a recurrence. RE.: Co))ect#-e Act#o% 0 WIQS+.4 Noncon&ormity identi&ied create)modi&y CA% and send to 'erson assigned to close out Acce'ted y assignee Assignee documents reasons &or re3ection Determine causes o& noncon&ormity Determine ) im'lement action to 'revent reoccurance and close out CA% %ecord results o& actions ta+en Send to originator CA% closed down Correcti'e Action WIQSP.( CA% originator satis&ied N Y Start N Y 2." +)e-e%t!t#-e Act#o% Correcti!e action is ta-en as a result of Product or %rocess nonconformity. It is $ence a reacti!e measure and does not necessarily %re!ent furt$er non conformance. Pre!enti!e action aims to identify %roduct or %rocess conformity &efore suc$ an e!ent $a%%ens and. is t$us a %roacti!e measure. 0$e re:uirement for %re!enti!e action is esta&lis$ed &y t$e analysis and re!ie) of measurement data )it$in t$e Com%any. All suc$ data )it$in t$e Com%any )ill &e su&>ect to e!aluation as to t$e re:uirement for %re!entati!e actions to &e ta-en in order t$at %otential %rocesses or %roduct non conformities are identiAed. RE.: +)e-e%t!t#-e Act#o% 0 WIQS+.5 3.9 Q!"#t$ M!%!&e'e%t S$(te'( +)oce((e( !%* I%te))e"!t#o%( No%0E6ect#-e Ch!#)'!% Paul Rin- M!%!&#%& D#)ecto) C$ris Ra!enscroft +.A. Sandra Cray S7#tch3o!)*/Recept#o% 8ileen Do)son 1argaret 1ayo$ Wo"(te%ho"'e I%te)%!t#o%!" I%c.2 USA 8e%e)!" M!%!&e) 0im Caton 8)op 9(#%e(( De-e"op'e%t D#)ecto) Andre) Rin- Wo"(te%ho"'e A(#! +!c#:c +)e(#*e%t ; M.D. Eeit$ '$eldon Ho%& <o%& O=ce <!"! L'p) O=ce Ros Collins I%te)%!t#o%!" S!"e( D#)ecto) Eeit$ Carter >#ce +)e(#*e%t S!"e( ; M!)?et#%& Denry ;roo-s >#ce +)e(#*e%t A(h"!%* (#te ;rian Eelly Tech%#c!" D#)ecto) I%?( Ron 1cDonald Tech%#c!" D#)ecto) +#&'e%t( Ceo,#rmerod I%?/+)#%t 9(#%e(( De-e"op'e%t D#)ecto) Darry ;o)yer 8e%e)!" M!%!&e) Eeit$ Carter H'!% Re(o)ce ; A*'#%#(t)!t#o% M!%!&e) Deat$er ;ro)n 9(#%e(( De-e"op'e%t D#)ecto) 1i-e Fates Ope)!t#o%( D#)ecto) 1ar- 'est)ell 8)op I.T. M!%!&e) Ceorge 1a-in 8)op .#%!%c#!" Co%t)o""e) Roy;a-er .#%!%ce D#)ecto) Cal!in (ord S!"e( Ette% Le) Ho""!%* MD 9oth Ceep)ee +)o*ct( L#'#te* @40A o7%e*B Ro%!"* 9)#tto% 9(#%e(( U%#t Tech%#c!" S!"e( M!%!&e) 1arc Carland CRM De-e"op'e%t M! %!&e) G ane (a)renson Ope)!t#o%( L#C#* I%?( +e)(o%%e" A((#(t!%t 8!e Rig&y +!$)o"" O=ce) (inda Na%ier Ope)!t#o%( D#)ecto) 1ar- 'est)ell Sec)et!)$ 1elanie 'alton EN8INEERIN8 E%&#%ee)#%& M!%!&e) (es Cam%&ell S$(te'( Tech%#c#!% Andy 'als$ Te!'Le!*e)( Dominic #5Do$erty Allan Potter Sh#ftTe!' 0re!or Car%enter Hincent Cregory Scott 'olsten$olme As$ley Dar)ood D!$ Te!' Peter ;rindle Ryan Duc-)ort$ Een @it3$arris Ceo,Dolden C$arlie Ra)linson Andre) 0odd Roy 'il-inson Darry 'ort$ington +"!%t E%&#%ee) Paul Coo- IN< I%? M!%f!ct)#%& M!%!&e) Stuart Par-er Te!'Le!*e)( Paul Da!en%ort Hernon Roocroft OD(etI%?( Ro&ert ;ryce Adriano @erro G ac- Dine Paul (o)e Arran Ne)ton Da!id Scott Russell 'il-inson L#C#* I%?( Paul S$er)ood Met!(hee% Andre) Ains)ort$ 8d)ard Nic$olson 0$omas ;est Ste!en Crieg I%? +!c?#%& ; De(p!tch 0ony Cartlidge Sallyanne Dalton ;ruce 8lliott @red 1elllor Simon '$ittle 0re!or Daynes R!7M!te)#!" W!)eho(e Cary #rmerod .#%#(he* 8oo*( W!)eho(e 1ar- 'ood S!fet$ !%* Re&"!to)$ AD!#)( M!%!&e) G o$n 1aynard T)!#%#%&/ Q!"#t$ Co0 o)*#%!to) Ray G o$nson Sec)et!)$ Anne Crom%ton Le!% M!%f!ct)#%& +)oEectLe!*e)( Cino Ca%arelli 0ony Dayden 9RONFE 9)o%Ge M!%f!ct)#%& M!%!&e) Duncan 1iller C(to'e) Se)-#ce M!%!&e) (o)ri 0$omas Co0o)*#%!to)( S$aron ;arnes (in3i ;russels 8unice @it3$arris Angela 1cCall (ynne 1aeer C)e*#t Co%t)o""e) Sue Eno)les C)e*#t Co%t)o" A((#(t!%t Susan 1orris A"'#%#' Se%#o) Le!*#%& H!%* ;rian Ro&inson Sh#ftLe!*#%& H!%*( ;arry @it3$arris Dere- Fi$ Sh#ftOpe)!to)( Ray Da)ort$ 0$omas Ro&inson C$ris 'als$ D!$ Ope)!to) Simon 1a$er T.R. 0onyPorter Ste!en 0u-e De(p!tch De(p!tch Co0 o)*#%!to) Se! Ca%arelli Ope)!to)( G imCarr P$ili% Dootson 0ony8nt)istle .o%*)$ Sh#ftA G onat$an C$ad)ic- Paul Du-er G o$n Carson .o%*)$ Sh#ft9 1arcus 8ccles 1ic$ael @a$y Da!id Darrison HAH Sh#ft SCADA 0ec$nician= Dale Cam%&ell SCADA De%uty = 0ony ;ennett #%erators= Andre) 'e&ster Donald ;arlo) H9H Sh#ft SCADA 0ec$nician = Stan Nairey #%erators= Ian Riley HCH Sh#ft SCADA 0ec$nician = (ee Cosling SCADA De%uty = G o$n Creen$alg$ #%erators= @red Smit$ 1ic$ael ;road&ent HDH Sh#ft SCADA 0ec$nician = Paul ;romilo) SCADA De%uty = 1ar- Ains)ort$ #%erators= G o$n Ro&erts (ee Riley +e""et#(#%& Nic- Singleton 9!& +!c?#%& 1ar- Ro&inson C$ris Singleton Q.C. Tech%#c#!%( Andre) Sout$)ort$ +.I. Sh#ft HAH Tech%#c#!%( Ric$ard Seaman Ale/ G e%son +.I. Sh#ft H9H Tech%#c#!%( 'alter (ansom 'inston Sayers
9"e%*#%& HEH Sh#ft Ope)!to)( Ian 1cEie Paul Ro&inson H.H Sh#ft Ope)!to)( Andre) Denderson Paul Nic$olson +!(t#%& Hacancy O6#*#(#%& Ro&ert @is$ PDIB(0S Roland Dic-inson +e)(o%%e" +"!%%#%& M!%!&e) Da!id 8nrig$t I%? +)o*ct#o% +"!%%#%& Ee!in Dearn 9)o%Ge +)o*ct#o% +"!%%#%& 1ic$ael Coodli,e U< .#%!%c#!" Co%t)o""e) G ames 1ac(eod U< +)ch!(#%& M!%!&e) Andrea Pic-ering U< +)oEect Acco%t!%t Hacancy A((#(t!%t M!%!&e'e%t Acco%t!%t (indsay Purslo) 9$e) Sara$ Cood)ill Sto)e?eepe) Peter Dargrea!es Acco%t( A((#(t!%t G oanne 'alton Co''e)c#!" M!%!&e) Eeit$ Carter Ope)!t#o%( A*'#%#(t)!to) Ste-e% D63)$ e0S$(te'( ; Co''%#c!t#o% Co0 o)*#%!to) (ouise (a)rence Net7o)? !%* +C A*'#%#(t)!to 9#"" Atte%3o)o&h) I.T. Ope)!t#o%( ; He"p De(? I.T. Tech%#c!" A%!"$(t De&&ie (ee I.T. +)o&)!''e)/ T)!#%e) G ulie 0$orn&oroug$ De-e"op'e%t Co''e)c#!" D#)ecto) Andre) Rin- Tech%#c!" D#)ecto) +#&'e%t( Ceo, #rmerod Tech%#c!" D#)ecto) I%?( Ron 1cDonald Sec)et!)$ Denise 1iller +)oce(( De-e"op'e%t M!%!&e) Andre) 0$om%son Ne7 Tech%o"o&$ M!%!&e) 1argaret Denderson I%*(t)#!" Tech%#c!" Se)-#ce( M!%!&e) G oanne 1itc$ell I%fo)'!t#o% O=ce) Carol Sim%son +)oce(( De-e"op'e%t E%&#%ee) Paul ;roo-es Tech%c#!%( 1i-e #5Dare Ant$ony Stu&&ens R ; D L!3o)!to)$ Spe)-#(o) Nigel ?ns)ort$ A%!"$t#c!" Che'#(t Stuart 1orison R ; D Che'#(t +)oEect Le!*e) Ro&ert Co%%age Tech%#c#!%( Andre) ;utter)ort$ S$eila Cas-ell Angela 1ason Nigel 8c-ersley I%? !%* +)#%t Tech%#c!" Se)-#ce Stuart Cill L#C#* I%?( Tech%#c!" M!%!&e) Ste!en Clar- I%? R ; D M!%!&e) Hacancy Tech%#c!" Se)-#ce( Tech%#c#!%( 1artin Cunning$am Fogi 1arolia Peter 8dge Nigel 8c-ersley Tech%#c#!% Ayyu& ;$atia U.>. ;Met!(hee% De-e"op'e%t Che'#(t Ryan 1alcolmson Tech%#c!" Se)-#ce( Tech%#c#!% Ro&in 1cDonald M!)?et#%& Se)-#ce( M!)?et#%& Se)-#ce( M!%!&e) G ean Adamson D!t! M!%!&e'e%t ; A*'#% A((t#(t!%t. Cillian ;oot$ .#%!%c#!" D#)ecto) Cal!in (ord Sec)et!)$ Sandra Cray .#%!%c#!" Acco%t!%t ;ren Dutc$inson 8)op .#%!%c#!" Co%t)o""e) Roy ;a-er 8)op I.T. M!%!&e) Ceorge 1a-in Co''e)c#!" D#)ecto) Andre) Rin- Sec)et!)$ Claire 1cCarroll I%te)%!t#o%!" S!"e( D#)ecto) Eeit$ Carter M.D. 9oth >#ce +)e(#*e%t A(h"!%* S#te ;rian Eelly >#ce +)e(#*e%t S!"e( ; M!)?et#%& Denry ;roo-s Tech%#c!" D#)ecto) I%?( Ron 1cDonald Tech%#c!" D#)ecto) +#&'e%t( Ceo, #rmerod A)e! S!"e( M!%!&e) Ette% Le)2 Ho""!%* Quirin !an Steyn E)ope!% S!"e( M!%!&e) Ste!e Cotton S!"e( A*'#%#(t)!t#o% A((#(t!%t 1argot Ee%ers A)e! S!"e( M!%!&e) 1ic$elle Da!ies TECHNICAL DE+ARTMENT O/S I%? De-e"op'e%t De-e"op'e%t Che'#(t Russell 1orris I%? Q.C. Q.C. Spe)-#(o) Sa$ma Dad Q.C. Tech%#c#!% Peter Creen)ood Douglas 'rig$t So"-e%t 9!(e* L#C#* I%?( Tech%#c!" M!%!&e) ;ryan Dancoc- Tech%#c#!%( 1i-e 8llicott Andrea @inn 1.2.2 Res%onsi&ities M!%!&#%& D#)ecto) 0$e 1anaging Director is res%onsi&le to t$e 'olsten$olme International (td ;oard of Directors and $as o!erall res%onsi&ility for all Com%any o%erations suc$ as sales+ :uality+ design and de!elo%ment of t$e %roductsB ser!ices su%%lied to t$e customer. Ope)!t#o%( D#)ecto) 0$e #%erations Director is res%onsi&le to t$e 1anaging Director for all %roduction and engineering o%erations. 0$e #%erations Director also re%orts to t$e ;oard of 1anagement on t$e o%eration of t$e IS# <991 Quality System. SARA @M!%!&e'e%t Rep)e(e%t!t#-eB 0$e SARA 1anager is res%onsi&le to t$e #%erations Director for t$e u%-ee% and maintenance of t$e :uality system to t$e re:uirements of ;S*8N*IS# <991 =2999 0$e SARA 1anager 21R4 re%resents t$e Com%any on all :uality assurance matters+ %ertinent to t$e :uality system as esta&lis$ed &y t$e contract re:uirements+ regulatory re:uirements and :uality %olicies and %rocedures. 0$e SARA 1anager 21R4 $as t$e %rimary res%onsi&ility to structure t$e :uality system )$ic$ )ill in!ol!e all sections and also to ensure com%liance )it$ all :uality system re:uirements. S%eciAcally+ t$e 1anagement Re%resentati!e is in!ol!ed in areas suc$ as=* * Drafting t$e %olicy on :uality assurance of t$e Com%any along )it$ t$e #%erations Director. * Setting t$e :uality management o&>ecti!es of t$e Com%any. * Re%orting on t$e %erformance of t$e Quality System at 1anagement Re!ie) 1eetings. * Determining and re%orting t$e %rinci%le causes of :uality system non*conformances. * 1onitoring t$e :uality system to determine )$ere im%ro!ements are needed and monitoring t$e necessary correcti!e action. * 1aintain contact )it$ t$e e/ternal Registration ;ody on matters relating to t$e o%eration of t$e Quality System. SARA 1anager is res%onsi&le to t$e #%erations Director for t$e u%-ee% and maintenance of all t$e IS# Systems and t$e Com%any Dealt$ and Safety Policy. 0$e SARA 1anager is also res%onsi&le for dri!ing t$e 8+D7S %olicies )it$in t$e Com%any. Tech%#c!" D#)ecto)( 0$e 0ec$nical Directors for %igments and in-s are res%onsi&le to t$e 1anaging Director .. and in- and %rint Director res%ecti!ely for ensuring t$at %rocesses and e:ui%ment are designed and de!elo%ed suc$ t$at %roduct of t$e $ig$est attaina&le :uality is %roduced consistently and eIciently. H'!% Re(o)ce( !%* A*'#%#(t)!t#o% M!%!&e) 0$e Duman Resources and Administration 1anager re%orts to t$e 1anaging Director and is res%onsi&le for managing all as%ects of t$e %ersonnel function+ )$ic$ includes t$e facilitating+ co* ordinating+ recording %ersonnel issues and training+ )it$in 'olsten$olme International (td. I%? M!%f!ct)#%& M!%!&e) 0$e In- 1anufacturing 1anager is res%onsi&le to t$e #%erations Director for t$e control of stoc-s+ man%o)er and t$e %rocess necessary to %roduce %roducts to t$e correct s%eciAcation )it$in a gi!en time. S!"e( D#)ecto)( 0$e Sales Directors are res%onsi&le to t$e 1anaging Director for ensuring t$at customers5 re:uirements for t$e sale of %rintingB industrial %o)ders+ %astes+ %ellets+ in-s+ !arnis$es and related Com%any %roducts are ta-en+ re!ie)ed and dealt )it$ eIciently. U< .#%!%c#!" Co%t)o""e) !%* +)ch!(#%& M!%!&e). 0$e ?E @inancial Controller 7 Purc$asing 1anager is res%onsi&le to t$e @inancial Director for t$e e,ecti!e control and re%orting of manufacturing costs incurred &y t$e manufacturing facility at t$e Dar)en site. 0$ere is also a res%onsi&ility to t$e @inancial Director for t$e e,ecti!e and economic %rocurement of ra) materials and consuma&les used in t$e &usiness of t$e Com%any. Re(e!)ch !%* De-e"op'e%t M!%!&e)( Researc$ and De!elo%ment 1anagers are res%onsi&le to 0ec$nical Directors for managing Researc$ and De!elo%ment %ro>ects+ maintaining customer contact during t$e %ro>ect de!elo%ment stages and t$e general running of researc$ la&oratories. 9)o%Ge M!%f!ct)#%& M!%!&e) / OD(et I%? R;D M!%!&e) 0$e ;ron3e 1anufacturing 1anager and #,set In- R7D 1anager 2in- o%erations4 are res%onsi&le to t$e 0ec$nical Directors for t$e agreement of s%eciAcations )it$ t$e customer+ and ensuring t$at t$ere is a facility to continuously monitor and ins%ect t$e %roduct to ensure t$at all suc$ re:uirements are met. C(to'e) Se)-#ce( M!%!&e) 0$e Customer Ser!ices 1anager is res%onsi&le to t$e #%erations Director for t$e o%eration of Customer Ser!ices toget$er )it$ a team of administrators. +)o*ct#o% Spe)-#(#o% Production is su%er!ised in order to ensure t$at o%erations are carried out in line )it$ %rocess control )or- instructions and t$at customer re:uirements are met &y )ay of our com%liance )it$ sales s%eciAcations. 3.3 Interelation of Processes Sales AR)*+ Customer Ser'ice ,A- Production Plannin" D. *anuacture *W)DC*)SP) $R Des/atch Product De'elo/ment +I0)R*cD Strate"y 1 ,eadershi/ $o* 2uman Resources 2$ I- +A* SARA 3W* Products Satisied customer Pic& 0rder Plant and *aterials a'aila4ility QC)PI DC* Customer 5ocus Customer Re6uirements -echnical Process Control +I0)R*cD 5inished /roduct Payment or Product 5inancial Resources C, .n"ineerin" ,C Purchasin" AP $usiness De'elo/ment 2.$)*3Y)P2 *ar&etin" AR Wolstenholme International Processes and Interrelation 3.4 Processes Start 7oods $urchased $roduction $lanning . 5oundry Alloying and Atomising / 5irst Stage 6illing 1 Second Stage 6illing Order %ecei't Invoiced End $ron%e *anuacturin" Process Customer In#uiry Delivery Date Agreed 4 0hird Stage 6illing ; $olished < =lended $aste $rocessed > $ellet $rocessed Des'atched Process7s 1! 8 4uality Control Analysis and ad3ustments carried out ? Oxidised $rocessed @ 0arnish %esistant $rocessed Start 7oods $urchased $roduction $lanning In+ 6ixing In+ $otting In+ $ac+ing Order %ecie't Invoicing End 4uality Control In& *anuacturin" Process Customer En#uiry Delivery Date Agreed Des'atch Start 6anu&actured $roduct $roduction $lanning 7oods $urchased Order %ecei't Invoiced End Aluminium Processes Customer In#uiry Delivery Date Agreed 4uality Control Aacuum dried 4uality Control %e8'ac+ed ) $asted Des'atched Atomised)Cuts )4A 6illed 5ilter $ressed 6erchanted 7oods Stoc+ levels maintained Start New %ecruit Boins Com'any Stage . Induction ,Day .- Stage / Induction ,C. 6onth- *'date %eview chec+s $rogress Com'leted 0raining Evaluated Level . Com'etencies Assessed and Chec+ed Next Level Com'etencies Identi&ied 6ain Develo'ment %eview" Evaluates and Identi&ies Any 5uture 0raining Needs Com'etencies Develo'ed and assessed -rainin" and De'elo/ment %ecords De't o& all coloured stages %ecords I"0" 0raining %e#uested $ersonnel in&orms SA%A De't 8 S'eci&ic E F S 0raining Carried out as A''ro'riate ,C. 6onth- %ecruit on GHG 5actor 6anager In&ormed %ecruit on S+ills =ased $ay 6ain Develo'ment %eview" Identi&ies Any 5uture 0raining Needs De'artmental 0raining using ISO >00. 9or+ Instructions and training chec+ sheets where a''ro'riate" 0raining $lan Com'leted 0raining Needs Com'leted 0raining %e#uisitions Com'leted Start Com'laint %eceived y Anyone 9ithin 9I" Details $assed to %elevant CSC Is 0here Su&&icient In&ormation to 0a+e Action I Details 5lagged to De'artmental 6anager and AS6 to Authorise u' to J/!000 $rovided Claim is 5ully Busti&ied and its Aalue Su''orted" Claims Over this Amount to e Authorised y CA%! CL or AC% CA%2s Standard Letter Sent y CSC Details o& Investigation and $reventative Action 0a+en Sent to CSC Aia Dataase to Include %oot Cause and Costing CSC Otains Customer 5eedac+ to Ensure Satis&action Steering 7rou'4uarterly %eview 6eetings Eeld to Discuss any Outstanding Issues and %oot Causes Com'laint Closed ..Audit o& $rocedure Conducted to Ensure E&&ectiveness End Com'laint logged onto ISO Achiever Contact 6anagement Dataase y CSC K Com'laint $assed to De'artmental Cham'ion &or Action and Co'ied to relevant $arties Is 0here a $otential Claim I CSC See+s 5urther In&ormation Customer In&ormed o& Outcome and Actions 0a+en 9ithin 0arget 0ime Customer Satisaction Procedure 9%4S$"01 (es No (es No Start End Sales &orecast Sales and o'eration ca'acity meeting New 'roduct develo'ment Demand 6anager %eceive order 5it order into 'lan Advise CSC o& des'atch date $rovide 'roduction with 'lan Chec+ des'atch Su&&icient ca'acity Production Plannin" N (
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements: A Comprehensive Guide to Designing a Process-Based Document Control System