Factory acceptance test

Purchase or specification of a fire pump to support hydrocarbon operations should be in compliance with recognized international standards for such equipment. The most commonly referenced standards are listed below. All of these standards require a factory acceptance test of the unit. 

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. 

Siemens-Westinghouse Power Corporation of Pittsburgh, PA developed and fabricated the first advanced power plant to combine a solid oxide fuel cell and a gas turbine. The microturbine generator was manufactured by Northern Research and Engineering Corporation of Woburn, Mass. The factory acceptance test was completed in April 2000. Southern California Edison will operate the new hybrid plant at The National Fuel Cell Research Center at the University of California-Irvine. A year of testing in a commercial setting will be performed at this site. The system cycle is expected to generate electric power at 55 % efficiency. 

EAT factory acceptance test ISE incorrect sampling errors... 

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. 

For a stand-alone system the computer system normally undergoes factory acceptance testing at the supplier s premises, and as with associated instrumentation and regulating devices is shipped to the site, inspected, and where applicable is stored and then installed with the manufacturing process/plant equipment. 

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

Factory Acceptance Test US Food Drug and Cosmetic Act US Food and Drug Administration US Federal Register... 

The software OQ includes all of the factory acceptance testing and, specifically, the following ... 

Equipment testing Ventilation testing to ensure proper function and operation required. For containment devices, factory acceptance testing and site acceptance testing should be completed... 

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. 

As discussed in the previous section on predelivery testing. Factory Acceptance Tests can be used to supplement formal system qnalification, bnt only where the tests have been well specified, documented, and performed, and nnder controlled conditions. 

Factory Acceptance Tests cannot be nsed in place of OQ tests that clearly need the system to be in the operational environment, e.g., control loop testing, instrument calibration tests, and sequence testing in conjunction with the process eqnipment. Table 27.4 snggests some typical OQ test areas. 

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. 

Linear profiles are the simplest profiles to use for powder compressions. Typically, a sawtooth or v-shaped profile is used where the punch is extended at a constant velocity and retracts at a constant velocity. In theory, during a sawtooth profile, the punch reverses its motion instantaneously between the compression and a decompression strokes. At low speeds (e.g.. <1 mm/sec), the hydraulic response system can easily accommodate this discontinuity. However, at high speeds (>100mm/.sec), the control system may show a small lag in the position-time waveform (<10 milliseconds) as it attempts to rapidly reverse the direction of punch. The sawtooth waveform is commonly used for more fundamental compression studies (e.g.. Heckel analysis), where the desired powder volume reduction is proportional to time. It is also u.seful when evaluating instrument performance during factory acceptance testing. 

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. 

There are two questions most commonly faced by validation organizations "What do we validate " and "How does validation differ from normal project activities such as Factory Acceptance Testing and Site Acceptance Testing " The answers are that we validate GxP critical aspects of the system, i.e., those aspects that can have a direct or indirect impact on product quality, safety and efficacy. Validation is essentiaily a term used to denote the additional rigor applied to the management and documentation of the each phase of the development and operational life cycle of the system. 

---