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Misrak TVET College Training, Teaching and Learning Materials Development yes

MISRAK TVET COLLEGE under

Ethiopian TVET-System INFOM!TION TEC"NOLO#$ %&''OT %EVICE Level I

LEARNING GUIDE # 25 &nit o( Competence) Competence ) Module Title ) L# Code ) TTLM Code )

!ppl* +ualit* %tandards !ppl*ing +ualit* %tandards ICT IT% M-. L-/ 01 ICT IT% TTLM-. -1

LO /) %tud* causes o( 2ualit* deviations

Learning #uide st e evision

Date) -130-/ !uthor) IC ICT, IT 4 Misrak TVET College

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Misrak TVET College Training, Teaching and Learning Materials Development

INTRODUCTION

Learning Guide # 25

This learning guide is developed to provide *ou the necessar* in(ormation regarding the (ollo5ing content coverage and topics 4 

Causes o( deviations (rom (inal products 5ith 5orkplace procedures

This guide 5ill also assist *ou to attain the learning outcome stated in the cover page6 %peci(icall*, %peci(icall*, upon completion o( this Learning #uide, *ou 5ill 7e a7le to 4  

Investigate and report causes o( deviations (rom (inal products in accordance 5ith 5orkplace procedures ecommend suita7le preventive action 7ased on 5orkplace 2ualit* standards and identi(ied causes o( deviation (rom speci(ied 2ualit* standards o( materials or (inal product

Learning Actiitie! 6 ead the speci(ic o78ectives o( this Learning #uide6 06 ead the in(ormation 5ritten in the 9In(ormation %heets : in pages ;316 ;6 !ccomplish the 9%el(3check: in page <6 /6 I( *ou earned satis(actor*, proceed to 9Lap Test on page .6 "o5ever, i( *our rating is unsatis(actor*, see *our teacher (or (urther instructions or go 7ack to !ctivit* =6 16 Do the 9L!' test: >i( *ou are read*? and sho5 *our output to *our teacher6 $our teacher 5ill evaluate *our output either satis(actor* or unsatis(actor*6 I( unsatis(actor*, *our teacher shall advice *ou on additional 5ork6 @ut i( satis(actor* *ou can proceed to Learning #uide 0<6

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$our teacher 5ill evaluate *our output either satis(actor* or unsatis(actor*6 I( unsatis(actor*, *our teacher shall advice *ou on additional 5ork6 @ut i( satis(actor* *ou can proceed to the neAt topic6



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In"r$atin S%eet 1

Quality performance in workplaces

A Standard &rcedure "r 'ua(it) A!!urance Deiatin De iatin Manage$ent *%at i! a Deiatin+ ! Deviation is a departure (rom standard procedures or speci(ications resulting in non3 con(orming material andBor processes or 5here there have 7een unusual or uneAplained events 5hich have the potential to impact on product 2ualit*, s*stem integrit* or personal sa(et*6 sa(et*6

T),e! " Deiatin!Follo5ing are some eAamples o( deviations raised (rom di((erent (unctional areas o( 7usiness) • •

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&rductin Deiatin 3 Deiatin 3 usuall* raised during the manu(acture o( a 7atch production6 'ua(it) I$,re$ent Deiatin 3 Deiatin 3 ma* 7e raised i( a potential 5eakness has 7een identi(ied and the implementation 5ill re2uire pro8ect approval6 Audit Deiatin 3 Deiatin 3 raised to (lag non3con(ormance identi(ied during internal, eAternal, supplier or corporate audits6 Cu!t$er Serice Deiatin 3 Deiatin 3 rose to track implementation measures related to customer complaints6 Tec%nica( Deiatin 3 Deiatin 3 can 7e raised (or validation discrepancies6 For eAample) changes in Manu(acturing Instruction6 Materia( C$,(aint 3 C$,(aint 3 rose to document an* issues 5ith regards to non3con(orming, superseded or o7solete ra5 materialsBcomponents, packaging or imported (inished goods6 S)!te$ Ruting Deiatin 3 Deiatin 3 raised to track changes made to @ill o( materials as a result o( an !rt5ork change6

*%en t Re,rt Deiatin! Deviation should 7e raised 5hen there is a deviation (rom methods or controls speci(ied in manu(acturing documents, material control documents, standard operating procedure (or products and con(irmed out o( speci(ication results and (rom the occurrence o( an event and o7servation suggesting the eAistence o( a real or potential 2ualit* related pro7lems6 ! deviation should 7e reported i( a trend is noticed that re2uires (urther investiga investigation6 tion6 !ll 7atch production deviations >planned or unintended? covering all manu(acturing (acilities, e2uipments, operations, distri7ution, procedures, s*stems and record keeping must 7e reported and investigated (or corrective and preventative action6 eporting deviation is re2uired regardless o( (inal 7atch disposition6 I( a 7atch is re8ected a deviation reporting is still re2uired6 Learning #uide st e evision


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Di""erent Lee(! " Deiatin Ri!/!For the ease o( assessing risk an* deviation can 7e classi(ied into one o( the three levels , 0  ; 7ased on the magnitude and seriousness o( a deviation6 •

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Lee( 1- Critica( Deiatin Deviation (rom Compan* %tandards andBor current regulator* eApectations that provide immediate and signi(icant risk to product 2ualit*, patient sa(et* or data integrit* or a com7inationBrepetition o( ma8or de(iciencies that indicate a critical (ailure o( s*stems Lee( 2- Seriu! Deiatin Deviation (rom Compan* %tandards andBor current regulator* eApectations that provide a potentiall* signi(icant risk to product 2ualit*, patient sa(et* or data integrit* or could potentiall* result in signi(icant o7servations (rom a regulator* agenc* or a com7inationBrepetition o( other de(iciencies that indicate a (ailure o( s*stem>s?6 Lee( .- Standard Deiatin O7servations o( a less serious or isolated nature that are not deemed Critical or Ma8or, Ma8or, 7ut 7ut re2uire correction or suggestions su ggestions given on ho5 to improve s*stems or procedures that ma* 7e compliant 7ut 5ould 7ene(it (rom improvement >e6g6 incorrect data entr*?6

0 t Manage Re,rted DeiatinThe department Manager or delegate should initiate the deviation report 7* using a standard deviation (orm as soon as a deviation is (ound6 rite a short description o( the (act 5ith a title in the ta7le on the (orm and noti(* the +ualit* !ssurance department 5ithin one 7usiness da* to identi(* the investigation6 +! has to evaluate the deviation and assess the potential impact to the product 2ualit*, validation and regulator* re2uirement6 !ll completed deviation investigations are to 7e approved 7* +! Manager or delegate6 +! Manger has to 8usti(* 5ither the deviation is a Critical, %erious or %tandard in nature6 For a deviation o( either critical or serious nature +! delegate has to arrange a Cross Functional Investigation6 For For a standa standard rd t*pe t*pe deviat deviation ion a Cross Cross (uncti (unctiona onall Invest Investiga igatio tion n >CFI? >CFI? is not necessa necessar* r*66 Immediate corrective actions have to 7e completed 7e(ore the (inal disposition o( a 7atch6 Final 7atch disposition is the responsi7ilit* o( +ualit* !ssurance Department6



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*r/,(ace &reentin and Re!,n!e •

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*r/,(ace Vi(ence orkplace violence can 7e an* act o( ph*sical violence, threats o( ph*sical violence, harassment, pressure, or other threatening, disruptive 7ehavior that occurs at the 5ork site6 orkplace violence can a((ect or involve emplo*ees, visitors, contractors, and other non3Federal emplo*ees6 Re!,n!i3i(itie! It is up to ea each ch empl emplo* o*ee ee to help help make make a sa(e sa(e 5ork 5orkpl plac ace e (or (or all all o( us6 us6 The The eApectation is that each emplo*ee 5ill treat all other emplo*ees, as 5ell as customers and potential customers, 5ith dignit* and respect6 $ou can and should eApect management to care a7out *our sa(et* and to provide as sa(e a 5orking environment as possi7le 7* having having preve preventi ntive ve measur measures es in place place and, and, i( necessa necessar* r*,, 7* dealing dealing immedi immediate atel* l* 5ith 5ith threatening or potentiall* violent situations 5hich occur6 &reentin " *r/,(ace Vi(ence ! sound prevention plan is the most important and, in the long run, the least costl* portion o( an* agenc*s 5orkplace violence program6 Identi")ing &tentia(() Vi(ent Situatin! I( *ou ever have concerns a7out a situation 5hich ma* turn violent, alert *our supervisor immediatel* and (ollo5 the speci(ic reporting procedures provided 7* *our agenc*6 It is 7etter to err on the side o( o ( sa(et* than to risk having h aving a situation escalate6 Re!,nding t Vi(ent Incident! No matter ho5 e((ective agenciesG policies and plans are in detecting and preventing incidents, there are no guarantees against 5orkplace violence6 Even the most responsive emplo*ers (ace this issue6 hen a violent incident does occur, it is essential the response 7e timel timel* *, appr approp opri riat ate e to the the situ situat ation ion,, and and carr carrie ied d ou outt 5ith 5ith the the reco recogn gnit ition ion that that emplo*ees are traumatiHed and that the incidents a(termath has 8ust 7egun6 Di!c(!ure " In"r$atin Disclosing in(ormation o7tained (rom emplo*ees 5ithout their 5ritten consent6 !n eAception to this prohi7ition ho5ever, is i( an emplo*ee speci(icall* threatens another person6



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Se("4C%ec/ 1 Name:____________________

*ritten Te!t Date:_________________

Instruction: Answer all the questions listed below, if you have some clarifications- feel free to ask your teacher.

6 It is a departure departure (rom (rom standard standard procedures procedures or speci(ication speci(ications s resulting in non3con(ormi non3con(orming ng material andBor processes 06 IT has to evaluate evaluate the deviation deviation and assess assess the potential potential impact impact to the product product 2ualit* ;6 It is up to each emplo*e emplo*ee e to help make make a sa(e 5orkplac 5orkplace e (or all o( us6 us6 /6 hat hat are Di((erent Levels o( Deviation isks 16 usuall* raised raised during during the the manu(acture manu(acture o( a 7atch 7atch producti production on <6 It is raised raised to track changes changes made to @ill o( material materials s as a result o( an !rt5ork !rt5ork change6 change6

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$our $our teacher 5ill evaluate *our output either satis(actor* or unsatis(actor*6 I(



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&nsatis(actor*, *our trainer shall advice *ou on additional 5ork6 @ut i( satis(actor*, *ou can proceed to the neAt topic6



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