Factory Acceptance Testing (FAT)/Technology user 1
From LabAutopedia
A LabAutopedia invited article
Commentary on FAT by technology users
Authored by: Daniel Cinacola, Amgen Inc.
Information provided for the September 2009 LabMan blog.
- What is FAT testing and how is it unique in the process of developing an automated system.
The FAT is unique because it is frequently the first time that the team/individual have the chance to see and use the instrument/system in its completed and operational state.
- Who should attend a FAT?
In my opinion as many members of the team that wre responsible for the system as possible. At a minimum, particularly in these tough economic times, the project lead, technical lead, and the primary end user should be present. I've also found it helpful to have a direct link to purchasing setup ahead off time for those last minute issues.
- In your experience, is there a single critical factor that leads to a successful FAT?
Open Communication regarding both positive and negative issues and an understanding by all parties regarding the expectations of the instrument/system including performance, throughput, error recovery and final output prior to the start of the FAT.
- What specific categories of things should be evaluated during FAT
a. A well documented and understood FAT document.
b. Confirm that procedure that was agreed upon in the FAT is actually performed by the system.
c. Confirm the desired throughput of the system is attained in the time frame desired.
d. Error Recovery (module to system level) is understood by the end user and it works.
- What should be the product of a FAT?
a. At the end of a successful FAT, there should be a document signed by both parties that the system has successfully passed all the agreed upon tests of the FAT.
b. Any exception agreed upon during the FAT should be documented clearly so it is understood that the system will not be accepted without their successful completion prior to the end of the FAT or SAT.
c. It is preferred to have the milestone payments part of the purchase agreement with references in the FAT/SAT/BAT.
- How much of the FAT protocol should be repeated once the system is on-site (SAT)?
I normally repeat the agreed upon process (which should use all of the modules of the instrument/system). This process is usually meant to run the maximum number of samples across the desired timeframe, over a three successive days with out an issue or with an agreed upon number of manual intervention. Forced errors should be generated to test a number of errors from a module level to a system level. Depending on the system, the SAT is then followed by the BAT, to confirm that the biological test that the system was design to reproduce actually works.
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