Kaye 安装运行性能培训.ppt

IQ/OQ +What is IQ/OQ?+Why IQ/OQ – value to customer?+What do I have to do?+How much effort is IQ/OQ? Why IQOQ? Why IQOQ? Regulations / Guidelines Regulations / Guidelines What does it mean? What does it mean? How much effort? How much effort? Preparations IQOQ protocols need to be approved by several persons at customer site in signing on first page of each protocol before starting IQOQ execution suitable PC must be available with from GE Sensing recommended Operating System and Office package in dependence of the age of the unit (Validator 2000 or ValProbe Reader) the PC should have a real RS232 or USB com port and a floppy disk drive Admin access to the PC to install the Software and needed patches and to create PC User Groups if necessary Preparations Special for Validator 2000. Needed parts and documents: Validator 2000 with all SIMs; one SIM with 12 TCs IRTD* LTR*, HTR* or CTR* all calibration certificates SOPs for the system Quote, purchase order and other documents related to the system (*)IRTD and a temperature reference (LTR, HTR or CTR) should be available to perform the standalone calibration tests of the protocol. If an IRTD and/or a temperature reference are not available, this protocol chapter cannot be executed. Preparations Special for ValProbe. Needed parts and documents: - ValProbe Std Reader, Reader 2 or Single Reader and all Loggers - IRTD* - CTR-40* - all calibration certificates - SOPs for the system - Quote, purchase order and other documents related to the system (*)IRTD and a CTR-40 or other suitable oil bath should be available to perform the temperature logger calibration verification. If an IRTD and/or a temperature reference are not available, this protocol chapter cannot be executed. * IQ/OQ Validation Process Validation is establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and qualit