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AUDIT CHECKLIST

NO 1. 2. 3. 4. 5. ELEMENT 4.1 MANAGEMENT RESPONSIBILITY What are your duties and responsibility in this department? Do you have a do umented !ob des ription? "ay # see your or$ani%ational stru ture &re you a'are o( the )uality *oli y? +an you e,plain the )uality *oli y. What are the s ope- responsibility and authority o( your (un tion to ensure produ t or servi e .uality or to a hieve the orporate .uality ob!e tive? /o' an you ontribute or support (or the su ess and implementation o( this poli y? Do you have department $oals? 0,plain the on ept is this relevant to the )uality *oli y? Do you ondu t veri(i ation a tivities su h as veri(i ation o( resour es and personnel? /o' 0,plain? Do you have an e,istin$ poli ies and ob!e tives in your o'n department relevant to the )uality *oli y

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FINDINGS

6. 7. 8. 9.

NO 1.

Element 4.2 Q !l"t# S#$tem What are your pro esses in this department? What are your transa tions in per(ormin$ your !ob? /o' do you per(orm your a tivities? Do you have a do umented pro edure (or this transa tions1a tivities? /o' 'ill you ensure that all o( this pro edures are e((e tively implemented and bein$ (ollo'ed at all levels in your department? Do you have a )uality *lan? +an you e,plain ho' the re.uirements (or .uality an be met? /o' do you per(orm the (ollo'in$ a tivities? - 2he preparation o( the )uality *lan - 2he identi(i ation and a .uisition o( any ontrols- pro essin$e.uipment- 3in ludin$ inspe tion and test e.uipment4 (i,turesresour es and s5ills that may be needed to a hieve the re.uired .uality? - 0nsurin$ the ompatibility o( desi$n- the produ tion pro essinstallation- servi in$- inspe tion and test pro edures and the appli able do umentation. - 2he updatin$ o( .uality ontrol- inspe tion and testin$ te hni.ues- in ludin$ the development o( ne' instrumentation

FINDINGS

2. 3. 4. 5.

AUDIT CHECKLIST
NO ELEMENT 4.2 QUALITY SYSTEM 2he identi(i ation o( any measurement re.uirement involvin$ the apability that e, eeds the 5no'n state o( the art- in su((i ient time (or the needed apability to be developed. 2he identi(i ation o( suitable veri(i ation at appropriate sta$es in the reali%ation o( the produ t. 2he lari(i ation o( standards o( a eptability (or all (eatures and re.uirements- in ludin$ those 'hi h ontain a sub!e tive element.

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FINDINGS

6.

Does the )uality *lan de(ine6? a4 2he ob!e tives to be de(ined 3e.$. hara teristi s or spe i(i ations- uni(ormity- e((e tiveness- aestheti s- y le timeost- natural resour es- utili%ation- yield- and dependability. b4 2he steps in the pro ess that onstitute the operatin$ pra ti e o( the or$ani%ation 3a (lo' hart or similar dia$ram an be used to demonstrate elements o( the pro ess4. 4 2he spe i(i allo ation o( responsibilities- authority and resour es durin$ the di((erent phases o( the pro!e t. d4 2he spe i(i do umented pro edures and instru tion applied e4 7uitable testin$- inspe tion- e,amination and audit pro$rams at appropriate sta$es. (4 & do umented pro edure (or han$es and modi(i ations in a .uality plan that pro!e t pro eed. $4 & method o( measurin$ the a hievement o( the .uality ob!e tives. Element 4.% C&nt'!(t Re)"e* Do you per(orm submission o( tender? #( so- /o'?- e,plain the pro ess- #s this (ound on your relevant pro edures- Do you ondu t tender revie' be(ore submission? #( so-e,plain. /o' do you handle a eptan e o( a ontra t or order. 0,plain the pro ess steps. Do you a ept verbal means o( order? #( so- e,plain ho' do ondu t ontra t revie'? /o' do you handle amendments to a ontra t? 0,plain the pro ess. Who are responsible (or the ontra t revie'? 0,plain the role o( ea h member. Do you have a ontra t revie' pro edure? Does the pro edure ontain the (ollo'in$ (eatures? a4 &ll interested parties have an opportunity to revie' to revie' the ontra t. b4 & he 5list or some other means is available (or revie'ers to veri(y that they have revie'ed and understood the re.uirements o( the ontra t. 4 & method is available (or revie'ers to .uestion the re.uirement o( the ontra t and to have their .uestions FINDINGS

NO 1.

2. 3. 4. 5. 6.

addressed.

AUDIT CHECKLIST
NO ELEMENT 4.% CONTRACT RE+IE, d4 #( appropriate- a dra(t .uality plan is developed to havean understandin$ o( ho' to implement the ontra t su ess(ully. e4 2here is a provision (or revie's in the event that the ontra t is han$ed. 7. "ay # see re ords o( ontra t revie'. Does the re ords maintain and ade.uate. Element 4.- D&( ment !n. D!t! C&nt'&l Who is responsible (or do ument and data a4 &pproval b4 #ssuan e 4 Distribution d4 &dministration e4 8emoval o( obsolete opies 0,plain ho' bein$ done? Do you have a masterlist o( do uments identi(yin$ all ontrolled do uments and its urrent status and lo ation? /o' 'ill you ensure that pertinent issues o( appropriate do uments are available at all lo ations 'here essential operations are per(ormed? /o' 'ill you ensure that invalid and1or obsolete do uments are promptly removed (rom all points o( issue or use- or other'ise assured a$ainst unintended use? +an you dis uss the methods o( ontrol (or do ument and data han$es at the sta$e o( preparation- handlin$- issuan e and re ordin$ o( han$es. Do you have uni.ue identi(i ation (or internal and e,ternal do uments? 9y 'hat means? What is the importan e o( do umentation revie' durin$ revision?

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FINDINGS

NO 1.

FINDINGS

2.

3.

4.

5.

6.

7.

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AUDIT CHECKLIST
NO 1. ELEMENT 4./ PURCHASING Do you ondu t evaluation o( sub ontra tor? 0,plain ho'. :n 'hat basis? /o' o(ten on 'hat interval? 0,ample6 - a revie' o( previous per(orman e in supplyin$ similar produ ts- pro ess .or servi es. - & satis(a tory assessment to an appropriate .uality system standard by a body onsidered to be ompetent (or the purpose. - &n assessment o( the sub ontra tor by the supplier to an appropriate .uality system standards. /o' 'ill ensure that pur hased- sub ontra ted produ ts 3in ludin$ servi es4 on(orm to spe i(ied re.uirements? 7u h as6 - assessment and sele tion o( sub ontra tor lear and unambi$uous spe i(i ation o( the pur haser re.uirements - the per(orman e o( suitable veri(i ation - inspe tion pro edure :n 'hat type and e,tent o( ontrol are you e,er isin$ over sub ontra tors? Does the e,istin$ system establish an e((e tive 'or5in$ relationship and (eedba 5 system 'ith ea h sub ontra tor? Does the e,istin$ .uality system (or pur hasin$ in ludes6 - the appli able issue o( spe i(i ations- dra'in$s- pur hase do uments and other te hni al data - sele tion o( a eptable sub ontra tor - a$reement on .uality assuran e - a$reement on veri(i ation method - provisions (or settlement o( disputes - re eivin$ inspe tion pro edure - re eivin$ ontrols - re eivin$ .uality re ords Does the pur hasin$ do uments ontains lear des ription o( the produ ts ordered and re.uirements. #n ludin$6 - the type- lass- $rade or other pre ise identi(i ation - the title or other positive identi(i ation- and appli able issues o( spe i(i ations- dra'in$s- pro ess re.uirements- inspe tion- and other relevant te hni al data- in ludin$ re.uirements (or approval or .uali(i ation o( produ t- pro edures- pro ess e.uipment and personnel Who is responsible (or the revie' and approval o( pur hasin$ produ t FINDINGS

2.

3. 4. 5.

6.

7.

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AUDIT CHECKLIST

NO 8.

ELEMENT 4./ PURCHASING /o' do you per(orm sele tion o( a eptable sub ontra tors? Des ribe the methods used to establish apability 0,6 - on<site evaluation o( sub ontra tors apability and1or .uality system - evaluation o( produ t sample - past history and test results o( similar produ ts - published e,perien e o( other users. Do you have a lear a$reement 'ith sub ontra tors (or the assuran e o( produ ts supplied su h as any o( the (ollo'in$? - relian e on the sub ontra tors .uality system - submission o( spe i(ied inspe tion1test data and pro ess ontrol re ords 'ith shipment - 1;; = inspe tion and testin$ by the sub ontra tor - implementation o( a (ormal .uality system by the sub on - periodi evaluation o( sub on .uality pra ti es by the or$ani%ation or third party - #n<house re eivin$ inspe tion or sortin$ Do you have an a$reement 'ith sub ontra tors re$ardin$ the veri(i ation methods o( pur hased produ ts. #( so- does the pur hasin$ do uments spe i(y the veri(i ation arran$ements and the method o( produ t release? Do you have an a$reement (or ustomer (or ustomer veri(i ation o( sub ontra ted produ t. #( so- is this spe i(ied in the ontra t? Do you have provisions (or settlement o( disputes 'ith sub on re$ardin$ .uality? 0,plain- #s there provision (or dealin$ (or both routine and non<routine matters? Does the system ontains provision o( improved ommuni ation hannels bet'een the or$ani%ation and the sub on onmatters a((e tin$ .uality? Does the .uality re ords relatin$ to pur hasin$ maintained? Does the re ords maintain has identi(i ation (or the purpose o( tra eablity? Element 4.0 PRODUCT IDENTIFICATION 1 TRACEABILITY /o' do you implement a produ t identi(i ation and tra eability system? Does the produ t tra eability has the ability to tra e the historyappli ation- lo ation o( an item or a tivity by means o( re orded identi(i ation? Does the identi(i ation o( produ t appropriate 3le$ible- durable4 and maintained throu$hout the pro ess- (rom re eipt and durin$ all sta$es o( produ tion- delivery and installation?

FINDINGS
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9.

1;.

11. 12.

13.

NO 1. 2.

FINDINGS

3.

AUDIT CHECKLIST

NO 4.

ELEMENT 4.0 PRODUCT IDENTIFICATION 1 TRACEABILITY Does the materials or produ t ontains uni.ue identi(i ation (rom the time o( initial re eipt- to delivery and installation at the (inal destination? Does the identi(i ation in a ordan e 'ith the do umented pro edures and re orded? Does the e,istin$ system is apable o( identi(yin$ a parti ular produ t in the event that a re all or spe ial inspe tion be omes ne essary? Element 4.2 PROCESS CONTROL Do you have a plan (or your produ tion pro esses 'hi h dire tly a((e t .uality? What are those pro esses or produ t hara teristi s that an have a si$ni(i ant e((e t on produ t .uality? *lease an you identi(y? /o' 'ill you ensure that these riti al pro esses a((e tin$ .uality are arried out under ontrol onditions? Does the ontrolled onditions in ludes the (ollo'in$6 - do umented pro edures de(inin$ the manner o( produ tioninstallation and servi in$- 'here the absen e o( su h pro edures ould adversely a((e t .uality - use o( suitable produ tion- installation- and servi in$ e.uipment and a suitable 'or5in$ environment omplian e 'ith re(eren e standards1 odes- .uality plansand1or do umented pro edures - monitorin$ and ontrol o( suitable pro ess parameters and produ t hara teristi s - the approval o( pro esses and e.uipment as appropriate riteria (or 'or5manship- 'hi h shall be stipulated in the learest pra ti al manner 3e.$. 'ritten standards- representative samples or illustration4 - suitable maintenan e o( e.uipment to ensure ontinuin$ pro ess apability Does the plannin$ o( pro ess ensure that those pro eed under ontrolled onditions in the spe i(ied manner and se.uen e? Does the ontrolled onditions in ludes appropriate ontrol (or materials- approved produ tion- installation and servi in$ e.uipment- do umented pro edure or .uality plans omputer so(t'are- re(eren e standards odes- suitable approval o( pro ess and personnel- as 'ell as asso iated supplies- utilities and environments? Does the operation o( pro esses spe i(ied to the ne essary e,tent by the do umented 'or5 instru tions? Do you ondu t pro ess apability studies? What veri(i ation method bein$ used?

FINDINGS
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5. 6.

NO 1. 2. 3.

FINDINGS

4. 5.

6. 7.

AUDIT CHECKLIST
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NO 8. 9.

ELEMENT 4.2 PROCESS CONTROL Does the veri(i ation o( pro ess in lude material- e.uipmentomputer system and so(t'are- pro edures and personnel? Do you ondu t veri(i ation o( pro ess variables? Where does the veri(i ation depends on? 3 in<pro ess produ t hara teristi s or (inal produ t hara teristi s4 Do all in<pro ess and (inal veri(i ations planned and spe i(ied? #s this do umented in ludin$ test and inspe tion pro edures (or ea h .uality hara teristi s to be he 5ed- spe i(y e.uipment to per(orm su h test and he 5s and the spe i(ied re.uirements and 'or5manship riteria? /o' 'ill you distin$uish (inished produ t hara teristi s (rom measurable in<pro ess hara teristi s? Does the pro ess .uali(ied in advan e by test to ma5e sure that the pro ess an meet the spe i(ied re.uirements. Do you have a do umented pro edures1instru tions o( the ommon pra ti e bein$ applied in the operations? Does the pro edure1instru tions des ribe the riteria (or determinin$ satis(a tory 'or5 ompletion and on(ormity to spe i(i ation and standard o( $ood 'or5manship? Does the 'or5manship riteria is stipulated in the learest pra ti al manner by 'ritten standards- illustrations and1or representative samples? &re you employin$ the use o( statisti al pro ess ontrol- ontrol harts and statisti al samplin$ pro edures and plans (or pro ess ontrol e,plain? Does the monitorin$ o( ontrol and pro esses relates dire tly to (inished produ t spe i(i ations or to internal re.uirements? Does the e,istin$ system1pro edures ontains appropriate methods (or leanin$- preservin$ and the details o( pa 5a$in$ in ludin$ moisture elimination- ushionin$- blo 5in$ and ratin$? Does important produ t .uality hara teristi s- au,iliary materials and utilities- su h as 'ater- ompressed air- ele tri al po'er and hemi als used (or pro essin$ ontrolled and veri(ied periodi ally to ensure uni(ormity o( e((e ts on the pro ess? Does environmental onditions- su h as temperature- humidity and leanliness important to produ t .uality is ontrolled and veri(ied thru spe i(ied appropriate limits? "&208#&> +:?28:> a4 Does all materials and parts on(orm to spe i(ied re.uirements be(ore bein$ introdu ed into a pro ess

FINDINGS

1;.

11.

12. 13.

14.

15.

16. 17.

18.

19

2;

AUDIT CHECKLIST
NO ELEMENT 4.2 PROCESS CONTROL b4 Does all in<pro ess produ t in ludin$ that in<pro ess inventory sto 5rooms are appropriately stored- se$re$ated- handled and preserved to maintain its suitability? 4 Does spe ial onsideration $iven to shel(<li(e and deterioration ontrol- in ludin$ assessment o( produ t in sto 5 at appropriate intervals? 21 Does all e.uipment- in ludin$ (i,ed ma hinery- !i$s- (i,tures toolin$- templates- patterns- and $au$es proved (or a ura y prior to use? Does all e.uipment appropriately stored and ade.uately prote ted bet'een use- and veri(ied or alibrated at appropriate intervals to ensure that re.uirements on ernin$ a ura y- trueness and pre ision are (ul(illed? Do you have a preventive maintenan e pro$ram to ensure ontinued pro ess apability? Does pro ess variables monitored- ontrolled and veri(ied at appropriate (re.uen ies to ensure - the a ura y and variability o( e.uipment used - the s5ills apability and 5no'led$e o( the operators - the a ura y o( measurement results and data used to ontrol the pro ess - pro ess environment and other (a tors a((e tin$ .uality- su h as time- temperature and pressure - appropriate do umentation o( pro ess variables- e.uipment and personnel When- ho' or in 'hat point in time you determine that there is a pro ess de(i ien y? #n ase- it is apparent only a(ter the produ t is (inished or in use@ do you ondu t pro ess pre<.uali(i ation3validation4 to ensure pro ess apability and ontrol o( all riteria variables durin$ pro ess operation? Does the veri(i ation status o( pro ess output identi(ied su h as unveri(ied- on(ormin$ or non on(ormin$ in ludin$ the or$ani%ational unit responsible (or the veri(i ation? Does the identi(i ation suitable su h as stamps- ta$s- notation or inspe tion re ords that a ompany the produ t - or by omputer entry or physi al lo ation? Who is responsible (or the authori%ation o( pro ess han$e. Do you see5 ustomer approval (or the han$e 3'here ne essary4? #n ase o( desi$n han$es- does all han$es to produ tion toolin$ or e.uipment materials or pro esses do umented and ommuni ated? #s this overed in the pro edure?

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FINDINGS

22

23 24

25 26

27

28

29 3;

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AUDIT CHECKLIST
NO 31 ELEMENT 4.2 PROCESS CONTROL Does the produ t evaluated a(ter any han$es to veri(y that the han$e instituted had the desired e((e t upon produ t .uality? Element 4.13 INSPECTION AND TESTING FINDINGS FINDINGS

NO

1. 2.

Does the a tivities (or inspe tion and testin$ are in a ordan e 'ith the .uality plan or do umented pro edures? 80+0#A#?B #?7*0+2#:? &?D 2072#?B a4 Does all in omin$ produ ts- materials- parts is not used or pro essed until it has been inspe ted or other'ise veri(ied as on(ormin$ to spe i(ied re.uirements? b4 Does appropriate a tions arried<out in the event o( non on(ormities? /o'? 4 Where in omin$ produ t is released (or ur$ent produ tion purposes prior to veri(i ation@ does the produ t positively identi(ied and re orded in order to permit immediate re all and repla ement in the event o( non on(ormity? ?ote6 #tems should only be released sub!e t to re all i(6 an ob!e tive evaluation o( .uality status and solution o( non on(ormities an still be implemented orre tion o( non on(ormities annot ompromise the .uality o( ad!a ent- atta hed or in orporated items

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d4 Does the pro edure de(ine the responsibility and authority o( personnel 'ho may allo' in omin$ produ ts to be used 'ithout prior demonstration o( on(orman e? e4 Does the pro edure de(ine ho' su h produ t3s4 'ill be positively identi(ied and ontrolled in the event that subse.uent inspe tion (inds non on(ormities?

3.

#?<*8:+077 #?7*0+2#:? &?D 2072#?B a4 Does the produ t is hold until re.uired inspe tion and tests have been ompleted or ne essary reports have been re eived and veri(ied e, ept 'hen produ t is released under positive< re all pro edures. b4 Does the inspe tion and test allo's the early re o$nition o( non on(ormities and timely disposition o( the non on(ormin$ items? 4 Do you apply statisti al ontrol te hni.ues to identi(y trends (or both produ t and pro ess be(ore non on(ormities a tually o ur?

d4 Does the pro edure or .uality plan ensure the ob!e tivity o( the inspe tion and test results- in ludin$ situations 'here in< pro ess inspe tion is arried out by produ tion personnel?

AUDIT CHECKLIST

NO 4.

ELEMENT 4.13 INSPECTION AND TESTING C#?&> #?7*0+2#:? &?D 2072#?B a4 Does the .uality plan and1or do umented pro edures (or (inal inspe tion and testin$ re.uire that all spe i(ied inspe tion and tests in ludin$ those spe i(ied either on re eipt o( produ t or in<pro ess@ have been arried out and that the results meet the spe i(ied re.uirements? b4 Does all dispat hed produ t under$one all the veri(i ation a tivities spe i(ied in the .uality plan and1or do umented pro edures and had been satis(a torily ompleted? 4 Who has the inspe tion authority and responsibility (or produ t release? Does all asso iated data and do umentation used are available and authori%ed?

FINDINGS
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d4 Does all repaired and1or re'or5ed produ ts re<inspe ted or retested? 9y 'hom? NO 1. Element 4.11 CONTROL OF INSPECTION4 MEASURING AND TEST EQUIPMENT Does all inspe tion- measurin$- and test e.uipment that an a((e t the spe i(ied hara teristi s o( a produ t or pro ess suitably ontrolled- alibrated and maintained? #s the pro ess ontained in a do umented pro edure? #s there a ontrol bein$ e,er ised over $au$es- instruments- sensorsspe ial test e.uipment and related test so(t'are? &nd alsomanu(a turin$ !i$s- (i,tures- su h as test hard'are- omparative re(eren es and pro ess instrumentation that an a((e t the spe i(ied hara teristi s o( a produ t or pro ess suitably ontrolled. Does statisti al methods bein$ used in a hievin$ and demonstratin$ (ul(illment o( re.uirement that D#nspe tion- measurin$ and test e.uipment shall be used in a manner 'hi h ensures that measurement un ertainty is 5no'n and is onsistent 'ith the re.uired measurement apabilityE? Does test so(t'are or omparative re(eren es su h as test hard'are bein$ used as suitable (orms o( inspe tion are he 5ed to prove that they are apable o( veri(yin$ the a eptability o( produ t- prior to release (or use durin$ produ tion- installation or servi in$? Does the test so(t'are or omparative re(eren es bein$ re he 5ed at pres ribed intervals in ludin$ the e,tent and (re.uen y o( su h he 5s 'ith supportin$ re ords as eviden e o( ontrol? Does the ontrol *ro edure? a4 Does the ontrol pro edure determine the measurement to be made and the a ura y re.uired- and sele t the appropriate inspe tion- measurin$ and test e.uipment that is apable o( the ne essary a ura y and pre ision? FINDINGS

2.

3.

4.

5.

6.

AUDIT CHECKLIST

NO

ELEMENT 4.11 CONTROL OF INSPECTION MEASURING AND TEST EQUIPMENT b4 #denti(y all inspe tion- measurin$ and test e.uipment that an a((e t produ t .uality and alibrate and ad!ust them at pres ribed intervals or prior to use a$ainst erti(ied e.uipment havin$ a 5no'n valid relationship to internationally or nationally re o$ni%ed standards? Where no su h standards e,ist the basis used (or alibration shall be do umented. 4 De(ine the pro ess employed (or the alibration o( inspe tionmeasurin$ and test e.uipment in ludin$ details o( e.uipment type- uni.ue identi(i ation- lo ation- (re.uen y o( he 5she 5 method- a eptan e riteria- and the a tion to be ta5en 'hen results are unsatis(a tory.

FINDINGS
Qualitest International

d4 #denti(y inspe tion- measurin$ and test e.uipment 'ith a suitable indi ator or approved identi(i ation re ord to sho' the alibration status. e4 (4 "aintain alibration re ords (or inspe tion- measurin$ or test e.uipment &ssess and do ument the validity o( previous inspe tion and test results 'hen inspe tion measurin$ or test e.uipment is (ound to be out o( alibration.

$4 0nsure that the environmental onditions are suitable (or the alibration- inspe tions- measurements and tests bein$ arried out. h4 0nsure that the handlin$- preservation and stora$e o( inspe tion measurin$ and test e.uipment in su h that the a ura y and (itness (or use are maintained. i4 7a(e$uard inspe tion- measurin$ and test (a ilities- in ludin$ both test hard'are and test so(t'are- (rom ad!ustments 'hi h 'ould invalidate the alibration settin$.

NO 1.

Element 4.12 INSPECTION AND TEST STATUS Does the inspe tion and test status o( produ t identi(ied by suitable means- 'hi h indi ate the on(orman e or non on(orman e o( produ t 'ith re$ards to the inspe tion and tests per(ormed? Does the identi(i ation o( inspe tion and test status maintained and de(ined in the .uality plan and1or do umented pro eduresthrou$hout produ tion- installation and servi in$?

FINDINGS

2.

AUDIT CHECKLIST
NO 1. ELEMENT 4.1% CONTROL OF NONCONFORMING PRODUCT Does the do umented pro edure de(ine and ensure that produ t that does not on(orm to spe i(ied re.uirements is prevented (rom unintended use or installation? What are the a tions ta5en to prevent the unintended use or installation o( non on(ormin$ produ t? Does the ontrol pro edure provide ade.uate identi(i ationdo umentation- evaluation- se$re$ation and disposition o( non on(ormin$ produ t and (or noti(i ation o( the (un tions on erned? Does the non on(ormin$ produ t bein$ revie'ed by desi$nated persons to determine 'hether it an be a epted 'ith or 'ithout repair by on ession- repaired- re'or5ed- re$raded or s rapped? Does the persons arryin$ out the revie' are ompetent to evaluate the e((e t o( the de ision on inter han$eability- (urther pro essin$per(orman e- demonstrability- sa(ety and aestheti s? Who is responsible and authori%ed (or the disposition o( non on(ormin$ produ t? Does the de ision to a ept the use o( non on(ormin$ produ t do umented- to$ether 'ith the reason (or doin$ so- in authori%ed 'aivers- 'ith appropriate pre autions? Does the repaired and1or re'or5ed produ t re<inspe ted in a ordan e 'ith the .uality plan and1or do umented pro edures? Does the established pro edures meet the (ollo'in$ purposes? - to determine 'hi h produ t units are involved in the non on(ormin$- (or e,ample 'hat produ tion time interval-. :r produ tion ma hines or produ t lots are involved to mar5 the non on(ormin$ produ t units to ma5e sure that they an be distin$uished (rom on(ormin$ produ t units to do ument the e,isten e o( the non on(ormity and (or e,ample 'hi h produ t units- produ tion ma hines or produ t lots are involved to evaluate the nature o( the non on(ormity to onsider the alternatives (or the disposition o( the non on(ormin$ produ t- to de ide 'hat disposition shall be made and to re ord this disposition. *hysi ally to ontrol the movements- stora$e ands subse.uent pro essin$ o( the non on(ormin$ produ t onsistent 'ith the disposition de ision 2o noti(y other (un tions that may be a((e ted by the non on(ormity- in ludin$ 'here appropriate the pur haser
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FINDINGS

2.

3.

4.

5.

6. 7.

AUDIT CHECKLIST
NO 1. ELEMENT 4.14 CORRECTI+E AND PRE+ENTI+E ACTION Does the orre tive and preventive a tion ta5en to eliminate the auses o( a tual or potential non on(ormities shall be to a de$ree appropriate to the ma$nitude o( problems and ommensurate 'ith the ris5 en ountered? Does the pro edure and implementation o( orre tive a tion in lude6 a4 the e((e tive handlin$ o( ustomer omplaints and reports o( produ t non on(ormities b4 investi$ation o( the ause o( non on(ormities relatin$ to produ t pro ess and .uality system and re ordin$ the results o( investi$ation 4 determination o( the orre tive a tion needed to eliminate the ause o( non on(ormity d4 appli ation o( ontrols to ensure that orre tive a tion is ta5en and that is e((e tive Does the pro edure and implementation o( preventive a tion in ludes6 a4 the use o( appropriate sour es o( in(ormation su h as pro esses and 'or5 operations 'hi h a((e t produ t .uality- on essionsaudit results- .uality re ords- servi e reports and ustomer omplaints to dete t- analy%e and eliminate potential ause o( non on(ormity b4 determination o( steps needed to deal 'ith any problems re.uirin$ preventive a tion 4 initiation o( preventive a tion and appli ation o( ontrols to ensure that it is e((e tive d4 ensurin$ that relevant in(ormation on a tions ta5en is submitted (or mana$ement revie' Does the auses o( dete ted3or potential4 non on(ormities promptly identi(ied so that orre tive a tion may be ta5en and re urren e 3or o urren e4 may be prevented? Does the pro edure identi(ies the responsibility (or ta5in$ orre tive a tion and ho' this a tion 'ill be arried out and the veri(i ation o( the e((e tiveness? Element 4.1- HANDLING4 STORAGE4 PACKAGING4PRESER+ATION 1 DELI+ERY /&?D>#?B a4 Does handlin$ o( produ t done in an ade.uate methods to prevent dama$e or deterioration. Does the system de(ined is a do umented pro edure overin$ the in omin$- in<pro ess and (inal produ t onsiderin$ also the method o( delivery and the time o( bein$ put into use b4 Does the methods (or handlin$ o( produ t provides a orre t sele tion and use o( suitable transportation units 3su h as pallets- ontainers- onveyors- vessels- tan5s- pipelines and vehi les4 so that dama$e- deterioration or ontamination 3 due to vibration - sho 5- abrasion- orrosion- temperature variation

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FINDINGS

2.

3.

4.

5.

NO 1.

FINDINGS

AUDIT CHECKLIST
NO ELEMENT 4.1- HANDLING4 STORAGE4 PACKAGING4 PRESER+ATION AND DELI+ERY 8adiation or any other onditions o urin$ durin$ handlin$ and stora$e4 may be prevented 4 does the maintenan e o( handlin$ e.uipment bein$ onsidered 2. 72:8&B0 a4 &re desi$nated stora$e areas identi(ied? Does the desi$nated stora$e areas or sto 5rooms ade.uate to prevent dama$e or deterioration o( produ t? b4 #s there an appropriate method (or authori%in$ re eipt to and dispat h (orm su h areas? 4 Does the stora$e (a ilities- suitable and onsiderin$ not only physi al se urin$ but also environmental onditions 3e.$. temperature and humidity4? d4 #s there as appropriate and periodi he 51assessment o( items in stora$e to dete t possible deterioration- loss or dama$e? e4 Does the method (or mar5in$ and labelin$ $ives le$ible and durable in(ormation in a ordan e 'ith the spe i(i ation? (4 Does the e,istin$ system ontains administrative pro edure (or e,piry dates- and sto 5 rotation and lot se$re$ation? /o' is this implemented? $4 Does the stora$e and pa 5a$in$ re.uirements onsider the tierin$- layerin$ or sta 5in$ o( produ t as part o( the desi$n parameters? *&+F&B#?B a4 Does the pa 5a$in$ pro edure- materials- pa 5a$in$ and labelin$ desi$ns provide appropriate prote tion a$ainst dama$e- deterioration or ontamination durin$ stora$etransportation or any later period until the suppliers responsibility eases? b4 Does the various (orms o( stora$e and the types o( transportation that an be en ountered bein$ onsidered? 4 Does the pa 5a$in$ provides a lear des ription o( the ontents or in$redients 'here re$ulations or ontra t spe i(y? d4 Does the e,istin$ system provides a provisions (or he 5in$ the e((e tiveness o( the pa 5a$in$. *80708A&2#:? a4 does the do umented pro edure spe i(y appropriate methods (or preservation and se$re$ation o( produ t? D0>#A08G a4 Does the e,istin$ system in ludes provisions (or prote tion o( the .uality o( produ t a(ter (inal inspe tion and test and e,tended durin$ all phases o( delivery to destination? b4 Does the system ontains pro edure to ensure that deteriorated produ t is not shipped and put into use and those produ t 'ith limited shel(<li(e or re.uirin$ spe ial prote tion durin$ transport or stora$e identi(ied? 4 #s there a delivery lead time in onsideration to various types o( delivery and variations in environmental onditions that may

Qualitest International

FINDINGS

3.

4.

5.

be en ountered to meet the delivery time?


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AUDIT CHECKLIST
NO 1. ELEMENT 4.1/ CONTROL OF QUALITY RECORDS #s there a do umented pro edures (or identi(i ation- olle tioninde,in$- a ess (ilin$- stora$e- maintenan e and disposition o( .uality re ords? Does the .uality re ords is apable o( providin$ eviden e that the .uality system is satis(a torily implemented- i( not does the .uality re ords indi ate 'hat orre tion 'as made? Does all .uality re ords le$ible- stored and retained in su h a 'ay that they are readily retrievable in (a ilities that provide suitable environment to prevent dama$e or deterioration- unauthori%ed a ess- loss- and alteration? What is the retention period o( the .uality re ords? FINDINGS

2.

3.

4.

NO 1. 2.

Element 4.15 INTERNAL QUALITY RECORDS Who is responsible (or plannin$ and implementin$ an sudit? Does the person3auditor4 arryin$<out the audit is independent o(

FINDINGS

the area bein$ audited? 3. 4. 5. Does periodi internal audits per(ormed- on 'hat (re.uen y- on 'hat basis or purpose? Does the results o( the audit re orded and brou$ht to the attention o( the personnel havin$ responsibility in the area audited? Does orre tive and preventive a tion ade.uately ta5en by responsible personnel to orre t the de(i ien ies (ound durin$ the audit? Does tar$et dates established? Does proper veri(i ation implemented durin$ (ollo'<up audit to he 5 the implementation and e((e tiveness o( the orre tive a tion ta5en? Does the results o( internal .uality audits (orm an inte$ral part o( the input to mana$ement revie' a tivities? Does the audit arried out by .uali(ied1 erti(ied auditor? What is their .uali(i ation (or sele tion?
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6.

7. 8.

AUDIT CHECKLIST

NO 1.

ELEMENT 4.10 TRAINING Does the e,istin$ system 1pro edures provides provisions (or identi(yin$ trainin$ needs and provide trainin$ (or all personnel per(ormin$ a tivities a((e tin$ .uality? Does all personnel per(ormin$ spe i(i assi$ned tas5s .uali(ied on the basis o( appropriate edu ation- trainin$ and1or e,perien e? #s there a system (or maintainin$ pro(i ien y o( personnel by ondu tin$ periodi evaluation su h as 6 0valuation o( the Beneral edu ation e,perien e and pro(i ien y o( personnel (or the a tivities to be per(ormed. #denti(i ation o( the individual trainin$ needs a$ainst those re.uired (or satis(a tory per(orman e. *lannin$- or$ani%in$ and arryin$ out o( appropriate trainin$either in<house or by an outside body. 8e ordin$ o( trainin$ and a hievement so that re ords an be updated $aps in trainin$ an readily be identi(ied and (illed.

FINDINGS
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2. 3.

4.

#s there a parti ular attention $iven to .uali(i ations- sele tion and trainin$ o( ne'ly re ruited personnel and personnel trans(erred to ne' assi$nments? #s there a trainin$ $iven to provide e,e utive mana$ement 'ith an understandin$ o( the .uality system to$ether 'ith the tools and te hni.ues needed (or (ull e,e utive mana$ement parti ipation in the operation o( the system? Does the e,e utive mana$ement a'are o( the riteria available to evaluate the e((e tiveness o( the system? Does pro ess 7upervisors and operatin$ and te hni al personnel trained in the pro edure and s5ills re.uired to per(orm their tas5s su h as6 - 2he proper operation o( instruments- tools and ma hinery they have to use? - 8eadin$ and understandin$ the do umentation provided? - 2he relationship o( their duties to .uality? - &nd sa(ety in the 'or5pla e? ?ote6 &s appropriate- personnel should be erti(ied in their s5ills su h as 'eldin$- trainin$ in basi statisti al te hni.ues? Does the personnel a'are o( the advanta$es o( proper !ob per(orman e at all levels- and o( the e((e ts o( poor !ob per(orman e on other people- ustomer satis(a tion- operatin$ ost and the e onomi 'ell<bein$ o( the or$ani%ation? Does the need (or .uality emphasi%ed throu$h an a'areness pro$ramme that 'hi h in lude introdu tion and elementary pro$rammes (or ne' personnel- provision (or personnel to initiate preventive and orre tive a tions and other pro edures? Does appropriate re ords o( trainin$ maintained?

5.

6. 7.

8.

9.

AUDIT CHECKLIST
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NO 1.

ELEMENT 4.23 STATISTICAL TECHNIQUES Does the need (or statisti al te hni.ues re.uired (or establishin$ontrollin$ and veri(yin$ pro ess apability and produ t hara teristi s identi(ied? What are those? 0,ample o( statisti al methods appli ation6 a.4 b.4 .4 d.4 e.4 (.4 mar5et analysis produ t desi$n dependability spe i(i ation- lon$evity and durability predi tion studies o( pro ess ontrol and pro ess apability determination o( .uality levels in samplin$ plans data analysis- per(orman e assessment and non on(ormity analysis $.4 pro ess improvement h.4 sa(ety evaluation and ris5 analysis

FINDINGS

2.

3.

#s there a pro edure to implement and ontrol the appli ation o( the statisti al te hni.ue identi(ied? 7u h as@ a4 desi$ns o( e,periment and (a torial analysis b4 analysis o( varian e and re$ression analysis 4 test o( si$ni(i an e d4 .uality ontrol harts and usum te hni.ues e4 statisti al samplin$ #s there an ade.uate and maintained re ords o( statisti al te hni.ues appli ation?

4.

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