ולידציה – Testing Process Automation Systems
Testing Responsibilities Supplier and User
Where a Supplier has been assessed and its quality management system found to be acceptable, the User may benefit from the testing already carried out as part of the product development life cycle in order to minimize additional testing.
Similarly, the User may benefit from the testing carried out by the Supplier as part of the application, for example, to allow a small sample of tests to be repeated at witnessed FAT.
Example of Life Cycle for a Custom Application
Supplier Product Life Cycle
For example in a life cycle where a new application is developed for an embedded control system, the Supplier's product may be SW or tools used to develop the User specific application. The Supplier of the control system has been assessed and its quality management system found to be acceptable. Thus, the User does not need to repeat the testing of product functionality. The testing should instead concentrate on the application of the control system
End User Application Life Cycle
Assuming that the application is critical to product quality and includes a custom sequence coded as a sequence function chart, a test approach could be agreed :that includes the following elements
Supplier's module testing of the sequence function chart program.
Supplier's integration testing (100% test) and FAT (sampled) to demonstrate correct interaction configuration of the control system and correct operation of the process equipment.
SAT and IQ/OQ/PQ of the control system as part of the process equipment.
Example of Life Cycle for a Standard Application
Supplier Product Life Cycle
In the case of a life cycle where a standard application is purchased containing an embedded control system, the control system Supplier has been assessed and its quality management system found to be acceptable. Thus, the User does not need to repeat the testing of product functionality (including mature library functions such as standard control modules) or of the standard application. The testing has to cover only the setup and use of the application.
End User Application Life Cycle
Assuming that the application is still critical to product quality, there is now much lower risk associated with the application development, as the configuration is limited to selecting the required functions and entering setup parameters. A test approach could, therefore, be agreed including the following elements:
FAT to demonstrate correct setup of the control system and correct operation of the process equipment.
SAT and IQ/OQ/PQ of the control system as part of the process equipment.