PROTOCOLREFERENCE OUTLINE

Factory Acceptance Test (FAT) Protocol

FAT protocol template for verifying equipment at the vendor works before shipment — prerequisites, functional and performance test matrix, the documentation-review checklist that makes FAT results leverageable in C&Q, punch-list disposition, and formal acceptance.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)GAMP 5 (2nd ed.)
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

The protocol that verifies equipment at the vendor before it ships, and — through a documentation review as rigorous as the testing — makes those results usable later instead of repeated on site. The characteristic failure is a FAT executed well and documented loosely, so nothing survives the journey. Whether vendor testing may be leveraged rather than repeated is your organisation’s determination, made against your own risk assessment.

What's Inside

✓Purpose, scope and system identification, including the serial or tag numbers of what was actually tested
✓Test prerequisites and readiness checklist — calibrated instruments, approved drawings, utilities available at the vendor
✓Functional and performance test matrix with acceptance criteria approved before the vendor demonstrates anything
✓Documentation-review checklist for the vendor handover set, examined line by line rather than merely transmitted
✓Actual recorded results rather than pass ticks, because a tick cannot be leveraged as evidence
✓Punch list with dispositions separated into fix-before-ship and acceptable-to-ship, each carrying an owner
✓Acceptance and sign-off record, with any test deferred to site named explicitly rather than assumed

How to Use It

1Confirm prerequisites — calibration, approved drawings, utilities — before testing starts, or the results will not be leverageable later
2Approve acceptance criteria before the vendor demonstrates the equipment; criteria agreed in the room match what was demonstrated
3Record actual values rather than pass ticks, because the value is what a later reviewer can use as evidence
4Review the vendor documentation set line by line against the checklist; a complete transmittal is not a complete set
5Categorise every punch item and settle its disposition before shipment, since leverage on the vendor drops sharply after despatch
6Name any test deferred to site explicitly, and file the executed protocol in the verification evidence set
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and System Identification
2Test Prerequisites
3Functional and Performance Test Matrix
4Documentation-Review Checklist
5Punch-List and Disposition
6FAT Acceptance and Sign-Off
REGULATORY CONTEXT

ASTM E2500-25 and the ISPE Baseline Guide Vol. 5 (2nd ed.) allow well-documented vendor testing to be leveraged as verification evidence rather than repeated, which is why the documentation review carries as much weight as the tests. For automation and computerised elements, GAMP 5 (2nd ed.) supplies the lifecycle that vendor evidence has to fit. None of them decides whether a particular vendor’s testing is good enough to rely on — that assessment, and its consequences, stay with your organisation.

MAPPED STANDARDS
ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)GAMP 5 (2nd ed.)
Browse the standards catalog →