This is a ready-to-use checklist for reviewing the completed FAT documentation package, whether executed on-site or remotely, before it is accepted as evidence that can support the ship decision and, where reuse conditions are met, be credited into IQ/OQ.
It is a package-review gate, run after the FAT is finished, not a witnessing checklist run during the test. Replace every <<FILL: ...>> placeholder, mark each item Pass / Fail / NA with a note, and sign the accept/reject decision. A filled specimen follows. This is educational reference content, not regulatory advice.
Header
| Field | Entry |
|---|---|
| Review number | <<FILL: REV-ID>> |
| Equipment / system and tag | <<FILL>> |
| Vendor / PO | <<FILL>> |
| FAT protocol number and version | <<FILL>> |
| FAT date(s) and location (on-site / remote) | <<FILL>> |
| Package received date | <<FILL>> |
| Reviewer | <<FILL: C&Q engineer or Validation>> |
Section A: Package completeness
| # | Item | Pass / Fail / NA | Note |
|---|---|---|---|
| A1 | Executed protocol received in full, matching the approved protocol number and version | ||
| A2 | Every test step has an actual result recorded; no blank steps, no gaps in step numbering | ||
| A3 | Every step has a pass/fail decision and tester initials and date | ||
| A4 | Punch list included, with every item numbered and classified | ||
| A5 | Deviation records included for any step run outside the approved protocol | ||
| A6 | Table of contents or index matches what was actually supplied; nothing referenced but missing |
Section B: Evidence quality and traceability
| # | Item | Pass / Fail / NA | Note |
|---|---|---|---|
| B1 | Actual results read as contemporaneous entries (in ink or timestamped electronic entry by the tester), not a single retyped summary | ||
| B2 | Material certificates (mill certs / EN 10204 3.1 or equivalent) present and matched to the equipment BOM | ||
| B3 | Weld maps, borescope reports, or pressure test records present where the protocol called for them | ||
| B4 | Software / firmware version recorded as a printout or screenshot, not a verbal note, and matches the DQ / design specification baseline | ||
| B5 | Calibration certificates for every test instrument used are present, current on the test date, state the traceability chain, and state the measured uncertainty | ||
| B6 | Reference-to-tolerance ratio checked for each critical measurement (target 4:1 TAR/TUR or better); any shortfall flagged | ||
| B7 | Every punch item has objective closure evidence (retest step, revised drawing, replaced part with cert, or photo), signed by a verifier independent of the person who performed the fix | ||
| B8 | Requirements traceability: each URS line the FAT was meant to verify is mapped to a specific test step in the package |
Section C: Approvals and reuse readiness
| # | Item | Pass / Fail / NA | Note |
|---|---|---|---|
| C1 | Protocol was approved before execution (approval page or cover sheet dated before the FAT start date) | ||
| C2 | QA witnessing signature present on every GxP-critical test case, or a documented rationale for why QA did not witness it | ||
| C3 | No open Class A / Critical punch item; open Class B / Major items carry an approved disposition and a due date | ||
| C4 | For a remotely witnessed FAT, the ground rules record and remote witness’s signed concurrence are attached | ||
| C5 | Package explicitly states which test results are proposed for reuse into IQ/OQ | ||
| C6 | FAT report is signed per the approval matrix in the protocol |
Accept / reject decision
| Field | Entry |
|---|---|
| Overall completeness (A) | <<FILL: Pass / Fail>> |
| Overall evidence quality (B) | <<FILL: Pass / Fail>> |
| Overall approvals / reuse readiness (C) | <<FILL: Pass / Fail>> |
| Decision | <<FILL: Accept as qualification-grade evidence / Accept as supporting information only / Reject, return to vendor>> |
| Basis for decision | <<FILL>> |
| Reviewer (name, signature, date) | <<FILL>> |
| QA approval (name, signature, date) | <<FILL>> |
Filled specimen
Example for a chromatography skid FAT package received from a European vendor.
| # | Item | Result | Note |
|---|---|---|---|
| A2 | No blank steps, no gaps | Pass | 84 of 84 steps have actual results |
| B4 | Software version recorded, matches DQ baseline | Pass | Firmware v2.7.3, screenshot attached, matches DQ record dated 02-May |
| B5 | Calibration certs present, current, traceable | Fail | Pressure gauge PG-04 certificate expired 3 days before FAT date |
| B7 | Punch items closed with independent verification | Pass | 6 of 6 closed items have retest evidence signed by a verifier other than the fixer |
| B8 | URS traceability | Pass | Traceability matrix maps 41 of 41 in-scope URS lines to a FAT step |
| C2 | QA witnessing on GxP-critical steps | Pass | QA signature present on all 9 interlock and audit-trail steps |
Decision: Accept as supporting information only, conditional. The B5 finding (expired calibration certificate on the pressure gauge used for the interlock trip-point test, TC-14) means the measured result for that step cannot be accepted as qualification-grade evidence on its own. Disposition: request a current calibration certificate for PG-04 covering the test date, or, if unavailable, require TC-14 to be re-executed with a traceable instrument at SAT before that result is credited into OQ. Every other section passes and the remainder of the package is accepted.
This specimen shows the point of the checklist: a package can be largely excellent, complete steps, strong traceability, well-closed punch list, and still fail the accept gate on one instrument-traceability finding, because that single finding undermines the evidentiary basis for one specific measured result, not the whole package.
Common inspection findings this checklist prevents
- A FAT package accepted and used to support ship, and later to support IQ/OQ reuse, without anyone checking that the calibration certificates behind the measured results were current and traceable.
- Punch items marked closed in the summary narrative with no retest, drawing, or photo actually attached in the package.
- A software version recorded in the FAT report that does not match what DQ or the design specification actually approved, discovered only much later.
- A package accepted as complete when steps are missing or blank, because the reviewer read the summary and not the executed protocol itself.
- No documented accept/reject decision at all: the package sits in a project folder and gets used by default rather than by a recorded QA decision.
How to adapt this checklist
- Add equipment-specific evidence items to Section B (for example, biosafety cabinet containment test data, or bioreactor single-use assembly integrity records).
- Set your own TAR/TUR threshold in B6 if your calibration program uses a different ratio than 4:1.
- Use the Accept / reject decision block as the actual gate before the FAT report is filed as a qualification input; a conditional accept always names the specific step and the specific fix required, as in the specimen.
- Keep the completed checklist with the FAT report and the punch list.