Factory acceptance testing FAT

2 The most important part of the FAT is to have a well defined, well written and well structured test procedure that defines how to test the application logic and what to look for after each step. 

Personnel that will be operating the process should attend the FAT since it will give them some early training on the operation of their SIS. Often, they can also provide good suggestions or enhancements to the test procedure that were not foreseen during the design. 

5 During the FAT, interfaces should be tested (for example, communications between the BPCS and SIS). 

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1 The objective of a factory acceptance test (FAT) is to test the logic solver and associated software together to ensure it satisfies the requirements defined in the safety requirement specification. By testing the logic solver and associated software prior to installing in a plant, errors can be readily identified and corrected. 

NOTE The factory acceptance test is sometimes referred to as an integration test and can be part of the validation. 

1 The need for a FAT should be specified during the design phase of a project. 

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DQ is performed by the supplier of the equipment or system at the supplier s factory as part of the factory acceptance test (FAT). IQ (based on site acceptance test—SAT), OQ, and PQ are performed on-site at the GMP facility. For a GMP manufacturing facility, the validation activities include the facility design, FTVAC system, environment control, laboratory and production equipment, water system, gases and utilities, cleaning, and analytical methods. Validation protocols (IQ, QQ, and PQ) are prepared for each item, listing all critical steps and acceptance criteria. Deviations are reviewed and resolved before the validation activity proceeds to the next phase. 

Is the equipment to be used newly acquired If so, has it undergone requisite IQ, OQ, and PQ activities If so, how good are the completed packages Before the equipment was received from the vendors, were vendor equipment qualifications (also known as factory acceptance tests—FAT) conducted and were the results satisfactory Are there any outstanding issues requiring resolution Some assumptions will of course be made. These assumptions are listed in Table 5. 

The FDS will also form the basis for contractual acceptance testing, both at the supplier s premises (factory acceptance test, FAT) and on delivery to the site (site acceptance test, SAT). With suitably compiled test procedures these traditional contractual acceptance tests may be incorporated with the qualification testing required by the validation life cycle. 

Factory Acceptance Test (FAT) An acceptance test in the supplier s factory, usually involving the customer (IEEE). 

Factory Acceptance Tests (FATs) are performed at the site of manufacture of a piece of equipment before it is shipped to the customer. These ensure that the equipment meets the DQ precisely. 

The prerequisite requirements for testing should be clearly defined (e.g., interlocks and utility systems). It is a good idea to coordinate Factory Acceptance Testing (FAT) along with the mechanical system checkout. Consider using the same testing approach for both in-house developed systems and vendor-provided packaged systems in situations when both types of systems exist on the project. 

Factory Acceptance Testing (FAT) is conducted within a simulated environment to demonstrate that the system meets the URS and FDS. The FAT will only be conducted if the software is a new development or major adaptation of the standard product. The FAT is the first opportunity for the pharmaceutical manufacturer to test the system in its entirety. The scope of the testing should be wide enough to ensure that most problems can be identified and rectified within the development enviromnent. Where tests are not dependent on the operating environment as, for example, in data entry validation, the FAT may serve as the validation record for that function. However, in order to adopt this approach, formal test specifications must be developed and approved prior to executing the tests, and results must be clearly recorded. 

A factory acceptance test (FAT) should be performed. The report should cover at least a check against Customer Order for completeness, visual check for appearance and identification, the record of serial numbers of filters, dimensional check, electrical installation and safety check, functional check, including operation of interlocks and alarms and documentation 216 217... 

Before the equipment is delivered to the site it will normally undergo the type and routine tests in the factory. These tests are often referred to as the factory acceptance tests (FAT). Some documents are required before the FAT and others afterwards. Those required before are usually the inspection reports as part of the quality assurance plan, instruction manuals for transportation, storage, installation and commissioning routine maintenance. 

In the development of the process automation and control system, the required testing of that control system and the factory-assembled components, and the process simulation program must be established with the general functional specifications. In an API facility, many of the control systems perform process functions that require strict validation. The functional description for the automation system should require a complete factory acceptance test (FAT). This test should simulate the entire process and process failures and alarms. The FAT should also check and verify that the control system cabinets and controllers operate as designed. The factory acceptance testing of the process automation system prior to shipment and installation in the field is a critical step in the validation and start-up of the facility. 

If the SIS has already been through a Factory Acceptance Test (FAT), this may be taken into consideration during the validation. The validation team should review the results of the FAT to ensure that all of the application software was successfully tested and all problems found during the FAT have been corrected. 

The system validation documentation includes but is not limited to Quality Assurance Plan (QAP), Operation and Maintenance Manual (O M), and Factory Acceptance Test (FAT) reports. A properly developed QAP and its supporting documentation help to reduce cost, boost product quality, ensure regulatory compliance and increase profitability. The FAT validation is the first verification step of the customer s validation process, which may include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

Although the manufacturer will build a chosen machine with standard components, the final result will be more or less unique. The manufacturer will often only accept limited liability for the performance of the machine in a specific situation. Agreement on a so-called Factory Acceptance Test (FAT) is recommended and it should be executed at the site of the manufacturer when the apparatus has reached the ready for testing status. At this stage it is possible to solve any unforeseen problems that would be either impossible to solve, or only against huge costs after installing at the final destination. 

Carry out a factory acceptance test (FAT) and a site acceptance test (SAT), if applicable. 

Clause 13 - Factory acceptance test (FAT) informative not normative L R A R R P ... 

At the time of writing the system had been successfully passed through factory acceptance testing (FAT). This means that the system had been demonstrated to be able to communicate with the control system and had been able to monitor the performance of a simulated process. The process is being installed in November 2002 and is expected... 

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