This is a ready-to-use checklist for a Factory Acceptance Test, covering what to confirm before you travel, how to witness in the room, and how to close out so the evidence can be reused into qualification. Replace every <<FILL: ...>> placeholder, mark each item Pass / Fail / NA with a note, and sign it. A filled specimen follows. This is educational reference content, not regulatory advice.
Header
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CL-ID>> |
| Equipment / system | <<FILL>> |
| Vendor / PO | <<FILL>> |
| Planned FAT date / location | <<FILL>> |
| Reuse intended (tests to be used in IQ/OQ)? | Yes / No |
Section A: Before you travel
| # | Item | Reference | Pass / Fail / NA | Note |
|---|---|---|---|---|
| A1 | FAT protocol reviewed and approved (owner QA approval where required) | <<FILL: protocol no.>> | ||
| A2 | Vague acceptance criteria redlined and fixed before approval | |||
| A3 | Software/data-integrity tests present in protocol (access control, audit trail) | |||
| A4 | Vendor confirms pre-FAT / internal dry run complete, machine built to agreed software version | |||
| A5 | Reference set available: URS, FS, DS, P&IDs, electrical drawings, BOM, RTM | <<FILL>> | ||
| A6 | Requirements traceability matrix identifies which tests are intended for reuse | |||
| A7 | Ground rules agreed: who records, who witnesses, punch numbering, classification, sign authority, fail handling | |||
| A8 | Photo / recording permission cleared with vendor | |||
| A9 | Check instruments and calibration status of vendor test gear confirmed |
Section B: During execution
| # | Item | Pass / Fail / NA | Note |
|---|---|---|---|
| B1 | Actual condition forced and observed for each step, not accepted on the vendor’s word | ||
| B2 | Actual results recorded contemporaneously, in ink, by the tester, initialed and dated | ||
| B3 | Boundaries challenged: setpoints to limits, interlocks forced, faults simulated | ||
| B4 | Access levels and user roles actually tested | ||
| B5 | Audit trail capture verified (who/what/when, cannot be disabled or edited at operator level) | ||
| B6 | Software version recorded (printout / screenshot) | ||
| B7 | Materials of construction and BOM verified against certs | ||
| B8 | Every observation logged as a numbered, classified punch item with an owner | ||
| B9 | Supporting paper verified: calibration certs, weld/material certs, pressure test records |
Section C: Closeout
| # | Item | Pass / Fail / NA | Note |
|---|---|---|---|
| C1 | Every step reconciled, no blanks, no gaps in step numbering | ||
| C2 | Each punch item classified and dispositioned | ||
| C3 | No open critical item; no open major item without approved disposition and plan | ||
| C4 | FAT report signed per approval matrix | ||
| C5 | Ship authorization issued only after C3 satisfied | ||
| C6 | Open items carried to SAT with documented disposition |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Witness (C&Q engineer) | <<FILL>> | ||
| Witness (QA, where required) | <<FILL>> |
Filled specimen
Example for a lyophilizer FAT (reuse intended: I/O check and audit-trail test into OQ).
| # | Item | Result | Note |
|---|---|---|---|
| A1 | FAT protocol approved, QA signed | Pass | Rev 2, QA approved 05-Jun |
| A2 | Vague criteria redlined | Pass | 6 steps rewritten with numeric tolerances |
| A3 | Data-integrity tests present | Pass | Added access-control and audit-trail steps in redline |
| A4 | Pre-FAT complete, SW version confirmed | Pass | Vendor pre-FAT report received; SW v4.1.0 |
| B5 | Audit trail capture verified | Pass | Forced operator setpoint change denied and logged with user + timestamp |
| B8 | Observations logged as punch items | Pass | 5 items raised: 1 major, 4 minor |
| C3 | No open critical / uncontrolled major | Pass | Major item (wrong shelf-temp unit) fixed and retested before ship |
| C5 | Ship authorization issued | Pass | Signed after C3 |
The specimen shows the two moves that make a FAT worth the trip: the protocol was fixed before witnessing (A2, A3), and the reused tests (audit trail, I/O) were actually forced and observed, not taken on trust, so they can stand as OQ evidence later.
Common inspection findings this checklist prevents
- Witnessing an unapproved or vague protocol, then the vendor tidies the record afterward.
- Traveling to a FAT on a half-built machine because the pre-FAT was never confirmed.
- Software, access-control, and audit-trail tests skipped because “we will do it in CSV later.”
- Measurements trusted from vendor test gear of unknown calibration status.
- Shipment authorized with an open critical item.
How to adapt this checklist
- Add equipment-specific test items to Sections B and C.
- If you intend to reuse tests, confirm A6 and witness those tests to OQ standard.
- Set your own critical/major/minor rules and reference them in B8.
- Keep the signed checklist with the FAT report and the punch list.