Factory Acceptance Testing (FAT)/Vendor commentary 1
From LabAutopedia
A LabAutopedia invited article
Commentary on FAT by technology providers
Authored by: Kevin F. Keras, Business Unit Manager, Caliper Life Sciences - A.C.E.S. - Automation, Consulting, Engineering & Services
Information provided to The LabMan for the September 2009 blog.
- How is FAT unique in the process of developing an automated system?
Automated systems are by nature unique, and rarely are any two systems identical. We use the FAT process as a tool to ensure that the product that we are creating is functionally identical to the concept we have proposed and quoted to our user.
- Who should attend a FAT?
We suggest that the actual user(2) attend as they can use the FAT process to get a leg up on running the system when it is delivered. The more the merrier, from our perspective. In your experience, is there a single critical factor that leads to a successful FAT Yes, a signed mutually agreed upon FAT document well in advance of the FAT is essential. We try to have a customer kickoff meeting within days of accepting a system order and our main goal is make sure that we have detailed agreement that constitutes what the FAT will consist of. We want our customer to be an active part in creating this agreement so that they will be confident and knowledgeable when the testing begins.
- What specific categories of things should be evaluated during FAT
Well, obvious things should be the physical configuration of the system as well throughput of specified assays. Less obvious things might be aesthetics (condition of third party equipment, table tops…etc) or documentation. It is much easier to fix a problem on our integration floor than it is in the customer’s lab.
- What should be the product of a FAT?
We utilize the FAT as a green light to ship the system to our customer’s site. The only way this can happen is if the customer agrees that the product that we have created meets the criteria of our quotation and the test metrics we have mutually agreed upon for FAT during our kickoff meeting.
- How much of the FAT protocol should be repeated once the system is on-site (SAT)?
We typically repeat the entire FAT process during the SAT. This helps us ensure our customer that the product performs in their lab exactly as it did at our integration facility. For a variety of environmental and permitting reasons, we do not perform actual chemistry during FAT’s, however the SAT is an ideal time to run live chemistry through the system, just as our customer will be using the system.
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