fat document

7/28/2019 FAT Document

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Factory Acceptance Testing (FAT)

Preface

The Factory Acceptance Test (FAT) is a major project milestone in alaboratory automation project where the equipment and/or system

integrator demonstrates that the system design and manufacturingmeets the contract or Purchase Order (P.O.) specifications (derived

from the Functional Requirements Document (FRD), created by thesystem owner/project manager/project team). Generally a substantial

financial payment to the vendor is triggered by a successful FAT,therefore the FAT must be conducted formally and be witnessed by

the system owner and/or project manager, with a formal record ofdiscrepancies and non conformities and how they are to be handled.

Unfortunately some vendors are often poorly prepared for FAT, andthe FAT is often rushed though in order to ship the equipment as soon

as possible, realize a milestone payment in the vendors's financialreporting period, or move expensive inventory off a vendor's books.

But a poor FAT can delay observation of non conformities until afterthe equipment is installed when less time is available to correct the

problems without consequences to the project schedule, and when

there is sometimes less flexibility for effecting technical solutions.

This document is an overview of what the system owner/project

manager should consider with respect to equipment FATs.

Contract/Purchase Order

Incude the project teams Functional Requirements Document, as part

of any contract or purchase order with the system vendor orintegrator.

Include in the contract / purcahse order the requirement for aFAT and that:

The FAT must be witnessed by the system owner, projectmanager or designee.

The equipment should be fully pretested by the vendor beforethe witnessed FAT.

The FAT include all equipment being supplied by the vendor.


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The FAT procedure is to be presented to the system owner forapproval at least two weeks before the witnessed FAT, and

should be derived from validation specifications as laid out in theFunctional Requirements Document.

Pre FAT

The testing included in a FAT procedure should be largely derived fromthe performance criteria defined in the Functional RequirementsDocument (FRD), which is created by the project team early in the

project planning process. The FRD should be the focal point fordiscussions when interviewing potential system integrators / vendors

and should be included in the contract/purchase order package. Theserequirements should, therefore, be well known and understood well

before time to develop the actual FAT protocol.

The vendor/system integrator should prepare and submit a FATprocedure well in advance of the FAT. This procedure should bereviewed and approved by the system owner/project manager. It

should attempt to include testing of as much functionality as ispractical in the factory, and check of all interfaces among equipment

and systems. Where possible the procedure should show pass/failcriteria or desired results for each item.

The vendor should also provide a schedule for the FAT showingall timing and sequence of testing.

Prior to FAT all design approvals should be complete. This is toremove technical ambiguity from the FAT and prevent disputesover work that continues after FAT.

The vendor should prepare a test facility that can be effectivelyused to conduct the FAT testing, including calibrated testequipment and any special test equipment.

The vendor should compile a document set that can support thetesting and serve as a reference for the test results, including:

Contract specifications and copies of all references called out inthe specification.

All drawings for the project, including drawings received fromother vendors that describe interfaces. Detailed testing check list, including pass/fail criteria. The vendor is to pretest the system before FAT. Failure to do

this can result in wasted time during FAT, and potentially aprolonged extension of FAT while fixes are effected.


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If the system in question is large enough to impact the system ownersfacilities, laboratory layout or utilities or if there are any questions

regarding moving the system into the owners facility, it is highlyrecommened that a person responsible for for the owners physical

plant/facility be invited to attend FAT.

FAT

Attendance by vendor/system integrator, and by the system ownerand/or project manager. Depending on the scope of the project, the

owners FAT team could include owners site facilities staff, informaticsstaff or other techncial staff that may be involved in daily operation of

the system. Inspection of the equipment is an important step that canbe done at any convenient point. The inspection is generally

Review the specification line by line while checking theequipment or drawings for compliance with the specification,including any change orders.

Inspect for workmanship Inspect for problems that can occur during installation or use of

the equipment, for example, lifting points and safe access to

components for maintenance, etc. Test of the equipment per the vendors approved procedure;

these should include functionality testing and regulatory testing.Ad hoc testing may be required to define any major non-

conformities revealed by testing. Note the software and firmware versions in the equipment being

tested.

Post Testing Activit ies

Check of documentation

Review draft manuals and note any deficiencies. Confirm that the vendor has and will deliver records of hardware

and software sourcing and traceability. Confirm vendors schedule for completing all documentation.

Punch Lists

All discrepancies and non conformities of the system should becompiled into a Non Conformities List, including a time tocomplete column, for example, before shipment. Items


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incomplete, or not available for inspection or FAT are to beincluded on the Non-Conformities List.

The Non-Conformities List should be issued to the vendor at theend of FAT for discussion to confirm agreement with the time to

complete.

The Non-Conformities List helps to prioritize and focus work tocomplete the system with minimum impact on the project critical

path. It needs to be followed up with the vendor periodically to

insure continued attention. Substantial non-conformities can influence the vendors eligibility

to receive the full FAT progress payment. Project managementshould review this on a case by case basis.

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