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GMP Cleaning Systems for the Pharmaceutical Industries.

E-FAT: IWT brings Factory Acceptance Tests
to a whole new (digital) level!

As the name suggests, FAT - Factory Acceptance Test - is normally performed at the manufacturer’s site. A factory visit and test give the customer the opportunity to verify that the equipment is built and operating in accordance with their tender requirements and design specifications.

During the global pandemic travel has not been possible and the effects will continue to cause challenges for our customers for some time to come. This has meant we have had come up with another solution. This is how the concept of the E-FAT was born.

Thanks to the latest technology, such as remote access via web-based platforms, customers can see the different tests being performed, as well as interact from a distance. Remote FAT is a smart alternative, reducing the time required for staff to be away from the office and the associated costs (travel, accommodation, etc).


FAT: DEFINITION AND SCOPE

It is important to note that the FAT is an opportunity for you to see your equipment in action after months of documentation and design work.

This first step of E-FAT is to run through the process that the manufacturer undertook to arrive at the ‘solution’ (from an “idea” listed in the User Requirement Specification (URS) to “reality”) to ensure both you, the client, and manufacturer are aligned or agree to any necessary changes.

As the machine is still at the IWT site, any modifications can be done with minimal impact on project times and costs. The aim, at the end of a successful FAT, is that you are happy for us to despatch your order.

E-FAT: HOW IS IT PERFORMED?

E-FAT uses a number of communication methods including: a collaboration of digital workspaces that combine chats, real-time meetings, videos and screen sharing, as well as shared file storage.

By using high-quality webcams (at least one static placed in front of the equipment and a mobile one, allowing us to shift focus to different components), managed by software normally intended for video surveillance purposes, clients can effectively experience the same level of interaction that would take place during a face to face FAT.

Some of the software and web-apps in use:

 

To run an E-FAT, we follow the following steps:

  • Before the FAT starts we share the FAT protocol: documentation which describes the agreed tests that will be perform during the FAT day(s).
  • Just prior to the FAT, we organize a 30-minute web call to share the documents, including: the User and Maintenance manual, the PID, the pneumatic diagram, the wiring diagram, the layout, etc. During the call we also introduce all the virtual attendees and define the goals for the FAT.
  • On the day of the FAT we start in front of the machine(s): usually static tests (such as documentation checks/correspondence between the machine and the PID/wiring diagram) are performed, while functional tests (such as the washing challenge test - riboflavin, safety checks and alarms tests) are performed “live”.
    During this phase, the interaction among participants is very high: The Service engineer together with the Validation Manager and the Project Manager run the machine and perform the tests. Whilst the tests are being performed you can ask for further details, view messages on the touch screen, see the water draining during the washing cycle and much more.
    The FAT protocol is filled in as tests are performed: at the end of the live remote FAT, all the documentation is shared with you for review.
  • Finally, one or two days following  the e-FAT, a wrap up meeting is scheduled: this gives you the opportunity to share comments and approval.

For more information about FATs or E-FATs please contact our Project Management Team on 0345 050 4556.

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