Validation Resources Blog

FAT Optimisation

FAT or Factory Acceptance Testing is a valuable task particularly when bespoke or new “once-off” equipment is being introduced to a factory. The purpose is to ensure the equipment has been manufactured according to design specifications (DS) and all User requirement specifications (URS) are incorporated into the equipment.

Testing Functionality

It is important to challenge as much of the functionality of the equipment as possible, especially critical processes. Equipment should also be challenged outside of normal operating conditions. In the past this has been often termed ‘provoke testing’. Other broad terms such as Disaster recovery, Utility Failures or business continuity testing are also used. 

This type of testing can be completed at FAT stage by safely removing or interrupting utilities such as compressed air or electrical supply etc. At this point, the equipment or systems response to the interrupted utility supply can be verified. With reference to the design of the equipment, the response can be observed as to whether alarms are triggered or can the equipment recover on re-supply of the utilities.

Documentation

Many vendors supply user/owner manuals specific to the customers’ requirements. This documentation is important for training of staff and as a knowledge resource in the future. It is also critical to support the qualification efforts once the equipment is onsite. A user manual can provide the basis of testing for the Equipment Installation and Operational Qualification Protocol.

There is also an advantage of reviewing all documentation (P&ID, Electrical drawings, manuals etc) while onsite at the vendors facility. Face-to-face, a manual can be reviewed and queried more efficiently. Any omissions or errors can be dealt with there and then.

Be prepared by bringing design documentation and any supporting documents. Where possible, a FAT Protocol be approved in advance of the FAT so it is ready for completion.