Installation Qualification Computer

TEM-245 Issue date Installation Qualification Computer (Reference SOP: __________) Prepared by: Date Prepared: Revision No: Page 1 of 16 PROGRAM INDEX 1. OBJECTIVE..................................................................................................................................3 2. ACCEPTANCE CRITERIA............................................................................................................3 3. QUALIFICATION PROCEDURES ................................................................................................3 4. DEMAND SPECIFICATIONS........................................................................................................4 5. EQUIPMENT - MECHANICAL ......................................................................................................4 5.1. List of drawings.....................................................................................................................4 5.2. List of Supplier Quotes & Purchase Orders for Major Components.......................................5 5.3. List of Equipment / Maintenance Manuals. ...........................................................................5 6. EQUIPMENT FEATURES.............................................................................................................6 6.1. Manufacturer’s Specifications...............................................................................................6 6.2. Component Materials in Product Contact..............................................................................6 6.3. Component Materials (as detailed in design spec.) not in Product Contact...........................6 6.4. Filters: ..................................................................................................................................7 6.5. Lubricants.............................................................................................................................7 6.6. Equipment SOP’s .................................................................................................................7 6.7. Spare Parts List Location:.....................................................................................................8 6.8. Can machine adjustment be made without potential for product contamination? ..................8 7. ELECTRICAL INSTALLATION......................................................................................................8 7.1. Electrical Drawings...............................................................................................................8 7.2. Equipment Rating.................................................................................................................9 7.3. Supply Wiring .......................................................................................................................9 7.4. Distribution Details................................................................................................................9 7.5. Instrumentation...................................................................................................................10 7.6. Calibration SOP’s ...............................................................................................................10 7.7. Computerised Systems Verification ....................................................................................11 7.8. Spare Parts List Location:...................................................................................................12 8. AUXILIARY EQUIPMENT / SERVICES LIST..............................................................................13 9. CHANGE PARTS .......................................................................................................................13 10. CLEANING PROCEDURES .......................................................................................................13 10.1. SOP’s.................................................................................................................................13 10.2. Cleaning Records...............................................................................................................13 11. PREVENTATIVE MAINTENANCE..............................................................................................14 11.1. Preventative Maintenance Program Identification:..............................................................14 12. TRAINING RECORDS................................................................................................................14 13. COMMISSIONING OVERVIEW..................................................................................................14 13.1. Equipment Operation..........................................................................................................14 13.2. Process Operation..............................................................................................................14 13.3. Handover of Specifications .................................................................................................14 14. DISCREPANCIES.......................................................................................................................15 15. SIGNATURE LOG ......................................................................................................................15 16. ATTACHMENTS.........................................................................................................................15 TEM-245 Issue date Installation Qualification Computer (Reference SOP: __________) Prepared by: Date Prepared: Revision No: Page 4 of 16 4. DEMAND SPECIFICATIONS The list below indicates the Demand Specifications that have been applied to this project. All Demand Specifications will be filed away with this Installation Report Demand Specifications Available Used in this Project* 1. Equipment Functional Demand Specification Yes/No 2. Mechanical / Design Specification Yes/No 3. Electrical Demand Specification Yes/No 4. Instrumentation Demand Specification Yes/No 5. Operator’s Control Panel Specification Yes/No 6. SCADA Demand Specification Yes/No 7. Technical Documentation Specification Yes/No 8. Environmental, Health and Safety Requirements Yes/No * = Please attach if Yes Yes/No 5. EQUIPMENT - MECHANICAL Complete a list of drawings, P&I’s, specifications, purchase orders & manuals associated with the equipment/system. Document Location of the latest versions.. Verify the accuracy of those drawings which represent the system “as built”. 5.1. List of drawings. 5.1.1. Equipment Drawing ID Rev. No. Description Location As Built Verified Date Verified by Yes No TEM-245 Issue date Installation Qualification Computer (Reference SOP: __________) Prepared by: Date Prepared: Revision No: Page 9 of 16 7.1.3. Termination Are circuit breakers, terminal blocks, controls, etc., properly identified? Drawing ID Rev. No. Description Location As Built Verified Date Verified by Yes No 7.1.4. Control Schematics Drawing ID Rev. No. Description Location As Built Verified Date Verified by Yes No 7.2. Equipment Rating Voltage: Volts Current: Amperes Power: Kilowatts Phases: Main Switch Location: 7.3. Supply Wiring Type Conductor: Conductor Size: Type Connection: Denote any special type of installation required: 7.4. Distribution Details Main Switchboard: Sub-Board: Distribution Board: Circuit Breaker Type: Circuit Breaker Rating: Phases: TEM-245 Issue date Installation Qualification Computer (Reference SOP: __________) Prepared by: Date Prepared: Revision No: Page 14 of 16 11. PREVENTATIVE MAINTENANCE 11.1. Preventative Maintenance Program Identification: Program identification and records. For each piece of equipment list the Task Number and maintenance period: Equipment Task No. Maintenance Period 12. TRAINING RECORDS Personnel Type of Training State SOP/ Training Module delivered Signed by Trainee 13. COMMISSIONING OVERVIEW 13.1. Equipment Operation Equipment EO No. Date run Operation/s & duration Report Doc. No. Operated by: 13.2. Process Operation Process Date run Operation/s & duration OK Report Doc. No. Operated by: Yes No 13.3. Handover of Specifications Specifications File Name(s) Completed User Requirement Specification(s) Functional Specification(s) Software Design Specification(s) Software Module Design Specification(s)

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