Factory Acceptance Test (FAT)

  • Inspection and static &/or dynamic testing of system or major system component to support the qualification of an equipment/system conducted & documented at a supplier site
  • Establishing documented evidence that the vendor fabrication process or material and completed equipment meet vendor & customer specifications.
  • The objective of FAT is to verify that the main equipment or system meets design specification and confirm to agreed performance intentions.
  • The tests will be performed & reported by the supplier.
  • All tests perform during FAT must be in accordance with reviewed & approved protocols and procedures.

Minimum acceptance criteria for FAT

The equipments and system shall comply with:

  • URS/DQ and Purchase specifications
  • Design Drawing
  • Engineering diagrams (wherever it’s applicable)
  • Safety rules (wherever it’s applicable)
  • Trial run (wherever it’s applicable)
  • Software requirement to meet 21CFR part 11
  • User Manual
  • Maintenance manual
  • Piping and installation design
  • Electrical schematic
  • Process and utility diagram
  • Documents for welding
  • Spare part list
  • MOC certificates (Material of Construction)

Applicability of FAT procedure

  • FAT shall be performed for modifiable off-the-shelf equipment or machines.
  • Modifiable off-the-shelf: Developed or customized by a vendor to meet specific user requirements.
  • Off-the-shelf: Used “ as is”

Site Acceptance Test (SAT)

  • Inspection & dynamic testing of systems or major system components to support the qualification of an equipment/system conducted at client site.
  • Establishing documented evidence that during receipt of the items / equipment / system at site, conform with the standard laid in the protocol, purchase order and manufacturer specifications.
  • To ensure that the site of installation is ready.

Minimum acceptance criteria for SAT

The items of equipment and system shall comply with:

  • Major component verification as per FAT report and specifications
  • Packing Material list
  • Physical condition of major components or machine
  • Operation testing / verification shall be perform
  • Manufacturer’s machine identification code / identification number.

Minimum document require for SAT

  • User Manual
  • Maintenance manual
  • Process & utility diagram
  • Electrical Schematics
  • Spare parts list
  • FAT report & specifications
  • Design specifications & drawings
  • Safety Rules
  • Qualification documents (if specify)

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