Engineering SOP -FAT : Factory Acceptance Test & SAT : Site Acceptance Test

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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