Factory Acceptance Testing (FAT)
The Factory Acceptance Test (FAT) is a major project milestone in a laboratory automation project where the equipment and/or system integrator demonstrates that the system design and manufacturing meets the contract or Purchase Order (P.O.) specifications (derived from the Functional Requirements Document (FRD), created by the system 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 of discrepancies and non conformities and how they are to be handled. Many purchasing companies do not allow the automated system to ship w/o completing a successful FAT.
Unfortunately some vendors are often poorly prepared for FAT, and the FAT is often rushed though in order to ship the equipment as soon as possible, realize a milestone payment in the vendors's financial casino reporting period, or move expensive inventory off a vendor's books. But a poor FAT can delay observation of non conformities until after the 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.
Incude the project teams Functional Requirements Document, as part of any contract or purchase order with the system vendor or integrator.
Include in the contract / purcahse order the requirement for a FAT and that:
- The FAT must be witnessed by the system owner, project manager or designee.
- The equipment should be fully pretested by the vendor before the witnessed FAT.
- The FAT include all equipment being supplied by the vendor.
- The FAT procedure is to be presented to the system owner for approval at least two weeks before the witnessed FAT, and should be derived from validation specifications as laid out in the Functional Requirements Document.
- The testing included in a FAT procedure should be largely derived from the performance criteria defined in the Functional Requirements Document (FRD), which is created by the project team early in the project planning process. The FRD should be the focal point for discussions when interviewing potential system integrators / vendors and should be included in the contract/purchase order package. These requirements 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 FAT procedure well in advance of the FAT. This procedure should be reviewed and approved by the system owner/project manager. It should attempt to include testing of as much functionality as is practical in the factory, and check of all interfaces among equipment and systems. Where possible the procedure should show pass/fail criteria or desired results for each item.
- The vendor should also provide a schedule for the FAT showing all timing and sequence of testing.
- Prior to FAT all design approvals should be complete. This is to remove technical ambiguity from the FAT and prevent disputes over work that continues after FAT.
- The vendor should prepare a test facility that can be effectively used to conduct the FAT testing, including calibrated test equipment and any special test equipment.
- The vendor should compile a document set that can support the testing and serve as a reference for the test results, including:
- Contract specifications and copies of all references called out in the specification.
- All drawings for the project, including drawings received from other 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 a prolonged extension of FAT while fixes are effected.
- If the system in question is large enough to impact the system owners facilities, laboratory layout or utilities or if there are any questions regarding moving the system into the owners facility, it is highly recommened that a person responsible for for the owners physical plant/facility be invited to attend FAT.
Attendance by vendor/system integrator, and by the system owner and/or project manager. Depending on the scope of the project, the owners FAT team could include owners site facilities staff, informatics staff or other techncial staff that may be involved in daily operation of the system. Inspection of the equipment is an important step that can be done at any convenient point. The inspection is generally
- Review the specification line by line while checking the equipment 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 vendor’s 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 Activities
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 vendor’s schedule for completing all documentation.
- All discrepancies and non conformities of the system should be compiled into a Non Conformities List, including a “time to complete” column, for example, before shipment. Items incomplete, or not available for inspection or FAT are to be included on the Non-Conformities List.
- The Non-Conformities List should be issued to the vendor at the end of FAT for discussion to confirm agreement with the “time to complete”.
- The Non-Conformities List helps to prioritize and focus work to complete 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 vendor’s eligibility to receive the full FAT progress payment. Project management should review this on a case by case basis.
Download This Document
- Commentary from Caliper Life Sciences
- Commentary from Treis Technology
- Commentary from technology users at Amgen Inc.
- GE Healthcare Factory Acceptance Testing
- ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, International Society for Pharmaceutical Engineering / 2001 / ISBN: 19318790
- IEEE Std 829-1998 IEEE Standard for Software Test Documentation
- Microsoft Acceptance Test Engineering Guide, Vol. I - RC1
- Black, Rex (August 2009). Managing the Testing Process: Practical Tools and Techniques for Managing Hardware and Software Testing. Hoboken, NJ: Wiley. ISBN 0470404159.
- The Skinny on FATs
- The Decline of Acceptance Testing, from Electrical Construction & Maintenance (EC&M) magazine.
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