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Template for Design Qualification Protocol

  • OBJECTIVE
  • To design, engineer, and supply the Name of Equipment and to provide assurance that the machine is manufactured as per the URS:  Doc Number and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
  • SCOPE
  • The scope of this qualification document is limited to the Design Qualification of Name of Equipment. This qualification document is part of a validation activity for the Name of Equipment.
  • RESPONSIBILITIES
  • CLIENT
  • To Check and Approve the design qualification.
  • MANUFACTURER
  • To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
  • Machine overview,
  • General arrangement drawing,
  • Equipment orientation with layout,
  • Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
  • Details of Utilities,
  • Identification of components for calibration
  • Material of construction of all components
  • Safety features and alarms
  • To ensure the proper installation and commissioning of the equipment.
  • To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
  • To confirm the safe delivery of the equipment to the user site.
  • MACHINE DESCRIPTION
  • (Details of Equipment shall be written here)
  • TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS

 

 

Description Specification
 

 

  • (Note: The rows shall be increased as per no of components.)
  • MATERIAL OF CONSTRUCTION

 

Description Specification
 

 

  •  (Note: The rows shall be increased / decreased as per requirement.)
  • CHANGE CONTROL PROCEDURE
  • Change in the agreed design shall be addressed through the well-defined Change control procedure.
  • DESIGN QUALIFICATION REPORT
  • LIST OF ABBREVIATIONS(The rows shall be increased / decreased as per requirement.)

 

 

 

 

 

 

 

 

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