Factory and Site Acceptance Test (FAT/SAT) Protocol

This is a ready-to-use FAT and SAT protocol. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, attach the engineering drawings and the supplier test plan, and route it through your normal document control, review, and approval. A worked filled specimen follows the template so you can see how a completed version reads. Verify each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This protocol defines how <<FILL: COMPANY NAME>> runs and documents the Factory Acceptance Test (FAT) at the supplier site and the Site Acceptance Test (SAT) after installation, for <<FILL: equipment / system name>>. FAT confirms the equipment was built and performs to the purchase specification and the user requirements before it ships. SAT confirms it arrived undamaged, was installed correctly against the right utilities, and performs in its final location. Both tests generate evidence that can be reused to shorten Installation Qualification (IQ) and Operational Qualification (OQ) when the reuse rules in section 9 are met.

2. Scope

This protocol applies to the equipment listed in the header at <<FILL: site / area>>. It covers mechanical and dimensional build, utilities and connections, functional operation, safety interlocks and emergency stops, the control system and alarms, and, where applicable, software and data integrity behavior. It does not replace IQ, OQ, or Performance Qualification (PQ), which are governed by <<FILL: cross-reference qualification SOP-ID>>. FAT and SAT are commissioning activities; this protocol uses a risk-based, science-based approach consistent with ASTM E2500 so that verification effort follows product and process risk.

3. Responsibilities

4. Definitions

• FAT (Factory Acceptance Test): structured testing at the supplier site, before shipment, to confirm the equipment meets the purchase specification and the user requirements.
• SAT (Site Acceptance Test): testing after delivery and installation, in the final location, to confirm no transit damage, correct installation, and correct performance on site utilities.
• Punch list: the running register of open items, defects, and deviations found during FAT or SAT, each with an owner, a classification, and a resolution before acceptance.
• Critical test case: a test that verifies a function with direct product, patient, or data impact (for example a safety interlock, a sterilization cycle parameter, a control limit, an alarm, or an audit trail behavior).
• Reuse of evidence: crediting a documented commissioning result toward IQ or OQ rather than repeating it, allowed only when the conditions of section 9 are satisfied.
• GEP (Good Engineering Practice): established engineering methods, applied so that commissioning is documented well enough to support reuse into qualification.

5. Prerequisites

Confirm and record each prerequisite before testing starts. FAT does not begin until the left column is met; SAT does not begin until the right column is met.

6. Test cases

Number every test case, state the requirement it verifies (trace to the URS line), state the method, state the acceptance criterion before testing, and record the actual result, the pass or fail, and the witness. A test case with no pre-stated acceptance criterion is not a test; it is an observation. The categories below are the minimum set; add equipment-specific cases.

6.1 Mechanical, dimensional, and build verification

6.2 Utilities and connections

6.3 Functional operation

6.4 Safety: interlocks, guards, and emergency stop

6.5 Controls, alarms, and (where applicable) software and data integrity

Tests that depend on the final location, the site clock, or site utilities are repeated at SAT even when passed at FAT. Tests with no site dependence may be reused per section 9.

7. Punch list

Every defect, open item, or deviation found during FAT or SAT is logged on the punch list, classified, assigned, and resolved or formally risk-accepted before acceptance. Do not accept the equipment with open critical items.

8. Deviations

Any test result outside its acceptance criterion, any departure from this protocol, and any test that cannot be executed as written is recorded as a protocol deviation, given an impact assessment, and dispositioned before the affected result is accepted. Where the issue is also an equipment defect, it is cross-listed on the punch list. A failed critical test case is investigated per <<FILL: deviation SOP-ID>> and is not re-tested into a pass without a documented root cause and fix.

9. Reusing FAT and SAT evidence to reduce IQ and OQ

FAT and SAT are commissioning activities, but their documented results can be credited toward IQ and OQ instead of being repeated, which is the main reason a well run FAT pays back. Reuse is allowed only when all of the conditions below are recorded and approved by Validation and QA. This is the controlled bridge between commissioning and qualification described in ASTM E2500 and ICH Q9 risk thinking.

A FAT or SAT result may be credited to IQ or OQ only when:

1. The test was executed against a pre-approved acceptance criterion traced to the URS, not a free-form observation.
2. The test was witnessed by the named SME, and QA witnessed every GxP-critical test case.
3. The measuring instruments were calibrated and traceable at the time of test, with certificates attached.
4. The equipment configuration and software version at test are recorded and are identical to the version installed on site (reconciled at SAT).
5. The result, the raw data or printout, and the pass or fail are retained and retrievable as a controlled record.
6. The protocol, results, and reviewer signatures meet the same data integrity standard expected of a qualification record under ALCOA+ thinking: each result is traceable to the person who recorded it, readable, captured at the time the work was done, kept as the first or a true certified copy, factually correct, with nothing missing, free of contradictions, durable for the retention period, and retrievable when needed.

Typical reuse pattern: build, material, and configuration checks from FAT credit into IQ; functional and control test cases from FAT credit into OQ, provided they have no site dependence; safety, utility, and clock-dependent cases are confirmed or repeated at SAT and credited from there. Record each credited test in the IQ/OQ traceability so an inspector can follow the line from URS to FAT/SAT result to qualification credit. Where a test cannot meet all six conditions, repeat it in qualification rather than crediting it.

10. Acceptance criteria

FAT is accepted when all of the following are true:

• Every critical test case (sections 6.3 to 6.5) passed against its pre-stated acceptance criterion and was witnessed and documented.
• All Class A punch items are closed; Class B items are closed or risk-accepted with QA approval and a due date.
• The software version, configuration, and drawing set tested are recorded for reconciliation at SAT.
• All deviations are recorded and dispositioned.
• The FAT report is complete, signed, and approved.

SAT is accepted when all of the following are true:

• No transit damage; delivered scope reconciles to the manifest.
• Installation matches the approved drawings, and site utilities are connected, verified, and within spec.
• The on-site software version reconciles to the FAT version.
• All site-dependent and clock-dependent test cases passed in the final location.
• All Class A punch items are closed; remaining items are tracked with committed dates.
• The SAT report is complete, signed, and approved, and IQ readiness is confirmed.

11. Reports

On completion of FAT, the project engineer issues the FAT report summarizing test results against criteria, the punch list status, all deviations and their disposition, the recorded software and configuration version, and the explicit list of results proposed for reuse into IQ or OQ. The SAT report does the same for the on-site test and confirms IQ readiness. Both reports are approved by QA.

12. Attachments

13. References

21 CFR 211.63 (equipment design), 211.65 (construction), 211.68 (automatic, mechanical, and electronic equipment). EU GMP Annex 15 (Qualification and Validation), 2015 revision. EU GMP Annex 11 (Computerised Systems), where the equipment has GxP software. ASTM E2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. ICH Q9, Quality Risk Management (for the risk-based test scope and reuse decisions). ISPE Baseline Guide Volume 5, Commissioning and Qualification (second edition). ISO 12100 (safety of machinery, for interlock and emergency stop test design), where applicable.

Confirm the current version and clause numbers of each reference before issue.

14. Revision history

15. Approvals

Filled specimen

The following shows representative test cases, a punch item, and the reuse decision completed for an example autoclave / steam sterilizer, so you can see the level of detail an inspector expects. The company, system, and numbers are illustrative; replace them with your own.

Selected test results:

Punch list extract:

Reuse decision:

In this example the team set acceptance criteria before testing, had QA witness every GxP-critical case, recorded the firmware version for reconciliation, closed the Class B probe defect before shipment, and credited only the FAT results that met all six reuse conditions while deferring the site-dependent ones to SAT. That sequence, criteria first, witnessed, version-controlled, defects closed, evidence credited under stated rules, is exactly what a reviewer is expected to see.

Common inspection findings this protocol prevents

• Test cases run with no pre-stated acceptance criterion, so the record shows an observation, not a verified pass or fail.
• GxP-critical functions (interlocks, alarms, audit trail) tested at FAT but not witnessed, so the result cannot be credited.
• FAT results reused into IQ or OQ with no record that the on-site software version matched the FAT version.
• Site-dependent tests (utilities, clock synchronization, transit damage) credited from FAT and never repeated on site.
• A failed critical test re-run into a pass with no documented root cause or fix.
• The equipment accepted and used with open Class A punch items, or with the punch list never closed out.
• Calibration of the test instruments not recorded, so measured FAT results have no traceability.
• No traceability from the URS line to the FAT/SAT result to the qualification credit, so an inspector cannot follow the reuse claim.

How to adapt this protocol

1. Set your document number, owner, equipment ID, supplier, and effective date in the header.
2. Replace the test cases in section 6 with your equipment-specific cases, each traced to a real URS line and given a pre-stated acceptance criterion. Keep the safety and controls categories; add process-specific cases.
3. Match the punch list classification in section 7 to your engineering and quality conventions, and point the deviation cross-reference in section 8 to your real deviation procedure.
4. State which FAT and SAT results you intend to credit into which IQ and OQ protocols in section 9, and confirm each one meets all six reuse conditions before you claim the credit.
5. Point the qualification cross-references to your real IQ, OQ, and PQ protocols, and confirm IQ readiness at SAT acceptance.
6. Confirm every regulation in section 13 against the current published version before issue.