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TITLE TITLE STSSTS C CALIBRATIONALIBRATION GENERALGENERAL PROCEDUREPROCEDURE 1 1 PURPOSEPURPOSE To define the procedure of calibration in STS Plant 2 2 SCOPESCOPE This procedure is eligible for all the measuring testing equipment and manufacturing equipment with measuring testing function 3 3 REFERENCEREFERENCE DOCUMENTSDOCUMENTS Calibration Procedure 0076600 Quality Assurance Requirements For Measuring Equipment ISO 10012 1 Quality System Requirements ISO TS 16949 General Requirements For The Competence Of Testing And Calibration Laboratories ISO IEC 17025 4 4 DEFINITIONSDEFINITIONS Calibration A set of operations that establish under specified conditions the relationship between values indicated by a measuring instrument or measuring system and values represented by a reference material or the corresponding standard or known values derived from the standard Measuring testing equipment All devices used to measure gauge test inspect or otherwise examine items to determine compliance with specifications Primary standards reference Standards of the highest metrological quality from which measurements made are derived Secondary standards transfer Standards used as an intermediary to compare standards Working standards standards that is used routinely to calibrate or check material measures measuring instruments of reference materials Traceability Property of the result of a measurement or the value of a standard whereby it can be related to stated references usually national or international standard through an unbroken chain of comparisons all having stated uncertainties ECN Equipment Control Number 5 5 GENERALGENERAL Calibration Laboratory hereafter refers to Cal Lab should maintain calibration database of all measuring and testing equipment Each operation organization maintains database for manufacturing equipment 5 15 1 CalibrationCalibration ScopeScope Category o Manufacturing equipment with measuring testing function o IPC In Process Control equipment o Measuring meter instrument o Standard OwnershipScopeReportLabel Cal Lab Callipers Micrometer Force Gauge Dial Tension Gauge Bond Tester Sensor Dage4000 XYZTEC PTS 30 CO2 Bubbler Thermometer and temperature sensor High Temperature Oven Calibration report Calibration label Production Manufacturing equipment with measuring and test function P Bonder Ball Au Water Temp Control PM reportPM label End user All the measuring testing equipment which STS are not able to calibrate Dial Multimeter Digital Multimeter Graphical Multimeter or 8 Digits Analyzer Oxygen Standard Weight Block Calibration report Calibration label Form 1 5 25 2 CompetencyCompetency 5 2 1 STS Cal Lab only certificated personnel are allowed to perform calibration 5 2 2 External Lab Only certificated organization is allowed to provide calibration service 5 35 3 EnvironmentEnvironment ControlControl Cal Lab temperature humidity 180C 26 0C RH 40 65 5 45 4 CalibrationCalibration IntervalInterval 5 4 1 Interval Calibration interval is established in sequence of o Manufacturers recommendations o Reference of ISO GB standard o Reference of certified external lab o Customer specific requirement 5 4 2 Alteration of Interval In case of interval change the alteration should be documented with approval of Status Change Notice 5 55 5 Storage Storage Management Management CalibrationCalibration andand ReportReport RecordRecord forfor StandardStandard GageGage andand EquipmentEquipment All standard gage and equipment o Are stored in Cal Lab under the specific environment conditions 5 3 o Are managed by Cal Lab unauthorized use is not allowed o Are calibrated by certificated Calibration Organization o Calibration reports are recorded and archived in Cal Lab 5 65 6 PrecisionPrecision requirementrequirement ofof standardstandard The master standard for internal calibration should has adequate capability i e 10X higher resolution 6 6 SAFETYSAFETY REQUIREMENTSREQUIREMENTS Calibration personnel must strictly follow all safety requirements according to relative equipment instruction manual 7 7 PROCEDUREPROCEDURE 7 17 1 EquipmentEquipment DatabaseDatabase 7 1 1 Registration All equipment should be registered in Cal Lab by end use with below information refer to figure 1 o Equipment info o Calibration info o Calibration manual or non calibration declaration o Import license info 7 1 2 Database ECN database is maintained by Cal Lab PM Calibration database schedule for manufacturing equipment is maintained by end user 7 1 3 Database Update For ECN database any in or out inactive reactive and dismissal end user should inform Cal Lab to update database followed with relevant label For PM Calibration database schedule should be updated by each owner defined in Form 1 For external calibration end user should inform Cal Lab to update database once external calibration report received Database schedule update should be done immediately after calibration report issued 7 1 4 Dismissal Inactive If equipment is determined to be dismissed transferred out written off damaged broken and can not be repaired or inactive temporarily useless and calibration overdue end user should inform Cal Lab in time and submit approved Status Change Notice report to Cal Lab 7 1 5 External Calibration External calibration report should be submitted and archived in Cal Lab Figure 1 7 27 2 CalibrationCalibration ProcedureProcedure GuidanceGuidance 7 2 1 Calibration Procedure The procedure shall indicate work flow calibration items interval deviation tolerance and acceptance criteria This procedure should be documented in ADCS system For manufacturing equipment calibration procedure should be included in PM procedure with all above information 7 2 2 Calibration Guidance Calibration guidance is established in sequence of o Manufacturers recommendations o Reference of ISO GB standard o Reference of certified external lab o Customer specific requirement 7 37 3 CalibrationCalibration FlowFlow 7 3 1 Calibration Due Notice Calibration due notice shall be issued by Cal Lab to equipment end user 2 weeks before calibration due date Each owner should scheme to perform calibration when receiving the due notice 7 3 2 Calibration Cal Lab shall follow the calibration procedure and guidance and do the calibration before Due Date Relevant record shall be made accordingly 7 3 3 Equipment Gauge Out Of Tolerance Notice If any equipment gauge is out of tolerance during the calibration Cal Lab shall issue inactive label until recalibrate At the mean time Owner should inform production and QA engineers to take related action which we can see the detail referring to ADCS 0076600 Clause 5 9 7 3 4 Re calibration refer to figure 2 All measuring and testing equipment adjusted or repaired need to perform re calibration Re calibration is also required for the equipment whose performance is potentially affected by any change 7 3 5 Over due Notice Any equipment is still not calibrated on due date Cal Lab shall inform end user to sign status change notice report refer to Appendix 2 and issue inactive label At the mean time Calibration should be arranged immediately until calibration completed Over due is not allowed Figure 2 7 3 6 Manufacturing Equipment Calibration For manufacturing equipment whose calibration is included in PM it should follow PM procedure and use the same sticker of PM the report format refer to Appendix 3 7 3 7 External Calibration For any equipment whose calibration is not able to be done by STS external calibration is required The external Lab should be authentically certified and able to provide qualified calibration report External lab should submit calibration report to Cal Lab then Lab should update equipment calibration status based on that 7 47 4 CalibrationCalibration LabelLabel referrefer toto AppendixAppendix 4 4 7 4 1 Label Issuance For Calibration of manufacturing equipment included in PM referring to PM label For calibration done by Cal Lab or external Lab 5 labels are applicable o Label for the calibrated The non overdue measuring and testing equipment whose calibration done by Cal Lab and external Lab then should stick this label o Label for the inactive The calibration failed or the equipment broken need to be fixed then owner should fill in Status Change Notice and stick this label o Label for the dismissed The measuring and test equipment is not able to fix or it s not used any more then owner should fill in Status Change Notice and stick this label o Label for the restricted To indicate the restriction use of equipment of which the performance is within specification on certain functions or ranges only then stick this label o Label for the no need To indicate no need to do Calibration per supplier s certification All label sticking should be owner s responsibility 7 57 5 CalibrationCalibration ReportReport 7 5 1 Report Submit a For manufacturing equipment done by end user referring to PM procedure b For measuring equipment done by Cal Lab report should be documented within 2 working days after calibration done no extension to due date is allowed Cal Lab should stamp on the report c For any calibration done by external Lab report should be documented within 5 working days after calibration done no extension to due date is allowed Cal Lab should stamp on the report 7 5 2 The following information will be recorded on the calibration report refer to Appendix 1 a Equipment name b Equipment control number ECN c Model No Serial No d Calibration Date Due Date Cal Interval weeks e Manufacturer f End user Location g Calibrated in accordance to h Standard or measuring equipment used including Standard ECN i Temperature and relative humidity during calibrat