Template for Design Qualification Protocol + OBJECTIVE + To esign, engineer and supply the Name of Equipment anc to provide assurance thatthe machine is manufacture a5 per the URS: oc Number and it complies withthe Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there inthe document, are the same at uimest transparency + score + The scope ofthis qualification document is limited to the Design Qualification of Name of Equipment. This qulfcation cuments part of validation activity forthe Name of Equipment. ‘RESPONSIBILITIES + cunt 1 To Check and Approve the design qualiction ‘ MANUFACTURER: «To esign, engineer and prove the complete technical details ofthe equipment pertaining tots sign qualification vr. + Machine verion, «+ Genera arrangement drawing «+ Equpment onentaton wath yout + Spectcaton tthe sub components bought outtems andthe make, model 8. quantity. and backup record brochures, + Deas of Utes, + Ientfcaton of components for altration + Material of constuction ofl components «safety features and alarms «+ Toensure the prope intaltion andcommisioning ofthe equipment (To ensure that no ur-suthorzed and or unrecorded design modifications shall tke place. fat any point in time, any changes ested in the mutually agreed design Chenge control procedure shal be folowed and documented. + To confirm the safe delivery of the equipmentto the use st, ‘+ MACHINE DESCRIPTION + (Data of Equipment shallbewrttan here) ‘TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB COMPONENTS USED / BOUGHT OUTS. Description Speciation‘(Note:The rows shal be increased / decreased as per requirement.) ‘CHANGE CONTROL PROCEDURE «change in the agreed design sal be adressed through the wel-defined Change control procedure ‘DESIGN QUALIFICATION REPORT ‘LIST OF ABBREVIATIONS(The rows shall be increased / decreased as per requirement)