REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCE .

3y ago
115 Views
20 Downloads
556.82 KB
16 Pages
Last View : 19d ago
Last Download : 3m ago
Upload by : Francisco Tran
Transcription

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - 2017Protocol NumberIOPQ-RFR-xxx-xxx-PRevisionIssued Date0dd-mm-yyyyCOMPANY NAME:XXXXXXXASSET :SURGICAL STORE REFRIGERATOR (-25 C to -15 C)LOCATION:XXXXXPROTOCOL PREPARED BYNAMESIGNATUREDATEName:dd-mm-yyyyTitle:Company: Vacker GlobalPROTOCOL APPROVED BYNAMESIGNATUREDATEName:dd-mm-yyyyTitle:Company: Vacker GlobalPROTOCOL APPROVED & REVIEWED BYNAMESIGNATUREDATEName: xxxxxxxTitle:Company:Name: xxxxxxxTitle:Company:Name: xxxxxxxTitle:Company:CHANGE HISTORYNAMEAll rights reserved Vacker LLCFile: IOPQ-RFR-xxx-xxx-PREASON FOR CHANGEREVISIONISSUED DATE(dd-mm-yyyy)New document0dd-mm-yyyyPage 1 of 14Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol NumberRevisionIOPQ-RFR-xxx-xxx-P0Issued Date10-10-2016SCOPE OF THIS PROTOCOL :Study typeTemperature Mapping study & QualificationClient nameXxxxxxxAsset TypeRefrigeratorDescription and LocationSurgical store Refrigerator,Xxxxx .Temperature range to be mappedLow limit -25 CHigh limit -15 CDuration of testing3-4 daysDate of testingReference Standards : This mapping study is carried out as per WHO Technical Report Series, No.961, 2011.All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 2 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol NumberIOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016TABLE of CONTENTS1IDENTIFICATION OF THE QUALIFICATION TEAM .42DEFINITIONS AND ACRONYMS .53SCOPE .74OBJECTIVE .75RATIONALE .86APPLICABILITY .97RESPONSIBILITY .98QUALIFICATION DOCUMENTATION .10MANUAL ENTRIES IN PROTOCOL .10DEVIATION REPORTS .10DATA SHEETS .118.3.18.3.28.3.38.3.4IQ SECTION .11OQ SECTION .12PQ SECTION .12INSTALLATION / OPERATIONAL / PERFORMANCE QUALIFICATION REPORT .13CHANGE CONTROL .13ANALYSIS .149EQUIPMENT INSTALLATION/OPERATION DESCRIPTION .15All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 3 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number1IOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016IDENTIFICATION OF THE QUALIFICATION TEAMIn order to identify the persons who have participated in the execution of this qualification, a specimen of theirsignature and initial is shown below, beside their name and title.NameAll right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PTitleSignatureInitialPage 4 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number2IOPQ-RFR-xxx-xxx-PRevisionIssued Date010-10-2016DEFINITIONS AND ACRONYMSIn order to facilitate the comprehension of terms and acronyms used in this document, a brief technicaldefinition is shown below.TermsDefinitionsAuxiliary EquipmentEquipment mostly used in conjunction with the equipment to be qualified butnot included in the qualification package.Change PartsParts to fit different size / format or application.ComponentAny major piece, part or assembly of the main equipment or sub-equipmentthat does not have its own power supply and could not operate as a standaloneunit (valves, switches, etc.).ControllerA device that interprets a mechanical, digital or analog signal, generated by asensor, to control an equipment or component.Controller, criticalA controller for which control have a direct impact on the quality of the productor proper operation of the equipment.Controller, non-criticalA controller for which control have no direct impact on the quality of the productor proper operation of the equipment.For IQ:DeviationAny discrepancy between the installation specifications and theactual (as found) installation.For OQ: Any discrepancy between the protocol and the actual performed test,test function methodology, testing equipment, testing material etc.InstrumentA device that interprets a mechanical, digital or analog signal generated by asensor, and converts it into engineering units ( C, % RH, mA, etc.) throughscaling.Instrument, criticalAn instrument for which measurements have a direct impact on the quality ofthe product or proper operation of the equipment.Instrument, non-criticalAn instrument for which measurements have no direct impact on the quality ofthe product or proper operation of the equipment.Key OperatingParametersParameters that must be maintained to process or produce products withconsistent quality attributes and those that may have an impact on the properoperation of the equipment.Main EquipmentMajor equipment to be qualified.SensorA mechanical device (pressure switch, bimetal temperature switch, etc.), adigital or analog transducer (limit switch, pressure sensor, temperature sensor,etc.) that generates an electrical or mechanical signal to an instrument or acontroller in order to be interpreted.Sensor, criticalA sensor for which detection has a direct impact on the quality of the productor proper operation of the equipment.Sensor, non-criticalA sensor for which detection has no direct impact on the quality of the productor proper operation of the equipment.Sub-equipmentPiece of equipment, part of major equipment that possesses its own powersupply that could usually operates as a standalone unit (pump, conveyor etc.).All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 5 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol NumberIOPQ-RFR-xxx-xxx-PRevisionTermsIssued lation QualificationIOPQInstallation / Operational / Performance QualificationN/Ap.Not ApplicableN/Av.Not AvailableN/Sp.Not SpecifiedNISTNational Institute of Standards and TechnologyOQOperational QualificationPQPerformance QualificationPMPreventive MaintenanceQAQuality AssuranceQCQuality ControlS/NSerial numberSOPStandard Operating ProcedureAll right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-P10-10-2016Page 6 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number3IOPQ-RFR-xxx-xxx-PRevisionIssued Date010-10-2016SCOPEThe Installation / Operational / Performance Qualification protocol is a comprehensive document, which will beused to guide the executants, in the verification of the proper installation and operation of the Refrigeratorlocated at Xxxxx.4OBJECTIVEThe purpose of this Installation / Operational / Performance Qualification is to: Temperature mapping study to analyze distribution of temperature inside the whole area. Briefly describe the equipment, its major components and their roles. Verify that the Refrigerator is properly installed according to the manufacturer and Xxxxxxxspecifications thus permitting operation as per design specifications. Ensure that appropriate identification and documentation are in place. Ensure that the physical characteristics are compatible with planned equipment utilization. Ensure that appropriate operation procedures and training program are in place. Ensure that all features of the equipment described are functioning in the proper manner as required toperform all operations associated with its use. Specific tests are designed to verify that the equipmentoperates within all applicable design. Hot and Cold points of the Refrigerator will be identified. Locations for placing sensors for continuous monitoring will be recommended based on the hot andcold points. This mapping study will be carried out for summer season. The recommendations issued in first climaticstudy will be reviewed and revised. The results of summer will be considered as worst case scenarioand the final recommendations will be considered accordingly. Number of data loggers are determined based on the volume of the Refrigerator and as per relevantWHO Standards.Detailed technical information can be found in the technical documents supplied by the manufacturer (refer toSection 12.1: Documentation for Installation).All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 7 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number5IOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016RATIONALEInstallation / Operational / Performance Qualification is the establishment of documented evidence that theRefrigerator is installed in accordance with manufacturer's specification and consistently performs according todesign specifications and intended use.The Installation / Operational / Performance Qualification protocol is designed to allow technical analysis of allapplicable installation requirements and operational functions. Proper installation and operation will beestablished based on the following characteristics: Proper installation as per manufacturer Xxxxxxx specifications. Proper operation of temperature controller buttons as proposed by manufacturer. Temperature alarms verification System Start-Up Verification Proper temperature control and distribution under empty conditions Power failure under empty condition. Proper temperature recovery following a door opening empty conditions. Proper temperature control and distribution under 70% loaded conditions. Power failure under 70% loaded condition. Proper temperature recovery following a door opening under 70% loaded conditions.One data logger will be placed outside the Refrigerator for recording external temperature.All tests must be conducted by trained and experienced technical personnel and must be documented in ascientific manner using this established format.Any test function that does not have results which support the parameters defined in the approved protocolmust be conclusively rationalized for their deviation and approved or the qualification will be considered invalid.This protocol is only applicable for the Refrigerator.Note: We will use any equivalent data loggers with calibration certificate as per actual site conditions and testschedule.All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 8 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number6RevisionIOPQ-RFR-xxx-xxx-PIssued Date010-10-2016APPLICABILITYAll Vacker Global and Xxxxxxx personnel, when performing the Installation / Operational / PerformanceQualification of the Refrigerator shall follow this qualification protocol.7RESPONSIBILITYThis qualification protocol must be respected by all Vacker Global and Xxxxxxx employees during processing.The responsibility of the Installation / Operational / Performance Qualification of the Refrigerator is attributed tothe following:ResponsibilitiesTaskVacker GlobalMake available all documentation required for theInstallation / Operational / Performance Qualification forthe Refrigerator.Collect information.Write the protocol.Review and approve the protocol. Arrange loading and unloading goods for the testCoordinate activity.Execute the test described in the protocol. Write the final report.Issue the final report.All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-P Log door openings during testing.Compile and analyze data.Xxxxxxx Page 9 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number8IOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016QUALIFICATION DOCUMENTATIONMANUAL ENTRIES IN PROTOCOL All manual entries will be written in edible ink. Any error must be crossed out with a single line stroke, and the correct information must be enteredbelow or above the error. All corrections must be initialed and dated. Data applicable in the shaded areas will be gathered during protocol execution.DEVIATION REPORTSAny discrepancy between the installation specifications and the actual (as found) installations, any discrepancybetween the protocol and the actual performed test (test methodology, testing equipment, testing material etc.)or failure of the application to meet the test function acceptance criteria specified in the OQ section of thisprotocol must be documented on a Deviation Report.The Deviation Report numbers are to be indexed according to the section of the protocol to which they pertain.For example, reports pertaining to OQ Test Verification in section 13.1 of this protocol will be sequentiallynumbered D13.1-1, D13.1-2, etc.All Deviation Reports associated with the execution of this protocol are to be enclosed in Attachment 1 of thisprotocol.All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 10 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol NumberIOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016DATA SHEETS8.3.1IQ SectionInformation pertaining to the Installation Qualification will be directly recorded in the IQ section of this protocol.Here is a brief description of each section.SectionDescriptionSpecifiedItem that should be in place in order to satisfy the specified condition as stated bythe manufacturer or regulation (if any). If no specified condition is stated bymanufacturer, then «Not specified» should be written in the corresponding field.As FoundItem found at the time of qualification. Should meet or exceed the specifiedcondition. If condition is not specified, «As Found» data will then be consideredfor information purpose.Pass / FailIndication that the item found is compliant with specifications or specifiedconditions.- A «Pass» result indicates that the item is found compliant with specified condition.- A «Fail» result indicates that the item is found not compliant with specifiedcondition and therefore will be reported as deviation.Deviation ReportNumberReference to Deviation Report number (if applicable) pertaining to the test.CommentsDiscussion of any unusual observations during the test or significant test conditionsnot defined in the test procedure.Documented bySignature and corresponding date for the person performing the test.Verified bySignature and corresponding date for the person verifying the test data. .(Byrepresentatives from Vacker Global and Xxxxxxx )All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 11 of 16Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com

TITLE:REFRIGERATOR INSTALLATION / OPERATIONAL/ PERFORMANCEQUALIFICATION PROTOCOL - SUMMER 2016Protocol Number8.3.2IOPQ-RFR-xxx-xxx-PRevision0Issued Date10-10-2016OQ SectionInformation pertaining to Operational Qualification will be directly recorded in the OQ Section «Test Data Sheet»of this protocol. Here is a brief description of each section:SectionDescriptionObjectiveDefine the purpose of the test.Acceptance CriteriaDescription of the acceptance criteria.PrerequisiteConditions, files, equipment, diagrams, tables. Any supporting documents orequipment needed to execute the test, which are not obvious in the standardoperation of the equipment.MethodologyDescription of the course of actions that need to be executed in order to producethe expected result.Pass / FailIndication that the functionality tested is compliant with specifications.- A «Pass» result indicates that the functionality tested is found compliant withspecifications.- A «Fail» results indicates that the functionality tested is found not compliantwith specifications and therefore will be reported as deviation.Deviation ReportNumberReference to Deviation Report Number (if applicable) pertaining to the test.CommentsDiscussion of any unusual observations during the test or significant testconditions not defined in the test procedure.Tested bySignature and corresponding date for the person performing the test.Verified bySignature and corresponding date for the person verifying the test data.8.3.3PQ SectionInformation pertaining to Performance Qualification will be directly recorded in the PQ Section «Test DataSheet» of this protocol. Here is a brief description of each section:SectionDescriptionObjectiveDefine the purpose of the test.Acceptance CriteriaDescription of the acceptance criteria.PrerequisiteConditions, files, equipment, diagrams, tables. Any supporting documents orequipment needed to execute the test, which are not obvious in the standardoperation of the equipment.MethodologyDescription of the course of actions that need to be executed in order to producethe expected result.Pass / FailIndication that the functionality tested is compliant with specifications.- A «Pass» result indicates that the functionality tested is found compliant withspecifications.- A «Fail» results indicates that the functionality tested is found not compliantwith specifications and therefore will be reported as deviation.Deviation ReportNumberReference to Deviation Report Number (if applicable) pertaining to the test.All right reserved to Vacker GlobalFile: IOPQ-RFR-xxx-xxx-PPage 12

The Installation / Operational / Performance Qualification protocol is a comprehensive document, which will be used to guide the executants, in the verification of the proper installation and operation of the Refrigerator located at Xxxxx. 4 OBJECTIVE The purpose of this Installation / Operational / Performance Qualification is to:

Related Documents:

4 Remove and Replace Refrigerator Doors NOTE: Measure the width of your door opening to see whether or not yo u need to remove the refrigerator doors to move the refrigerato r into your home. If door removal is necessary, see the following instructions. IMPORTANT: If the refrigerator was previously installed and you are moving it out of the home, before you begin, turn the refrigerator

kelvinator . c o m m e r c i a l . commercial freezer/refrigerator . reach-in refrigerator and freezer . refrigerator model: kcbm23r, kcbm48r, kcbm72r

Commercial Refrigerator And Freezer User's Manual - 1 - User Manual Reach-in Refrigerator And Freezer Refrigerator model: 178SS1RHC, 178SS2RHC, 178SS3RHC Freezer model: 178SS1FHC, 178SS2FHC, 178SS3FHC Glass Door Refrigerator model: 178SS1RGHC, 178SS2RGHC Half Door Refrigerator model: 178SS1R2HC, 178SS2R4HC Half Door Freezer model: 178SS1F2HC, 178SS2F4HC .

refrigerator; tear off the protective film on the doors and the refrigerator body.v Keep away from heat and avoid direct sunlight. Do not place the freezer in moist or watery places to prevent rust or reduction of insulating effect. Do not spray or wash the refrigerator; do not put the refrigerator in moist places easy to be splashed

The model and serial number are located on ESR1 1 Door Upright Refrigerator the inside left wall of the reach-in, see Figure ESRH2 2 Half Door Upright Refrigerator 1-1. ESR2 2 Door Upright Refrigerator ESWR2 2 Wide Door Upright Refrigerator b.About Model Numbers ESR3 3 Door Upright Refrigerator Example

4. Plug in refrigerator or reconnect power. 3-5 CONTROL BOX-REFRIGERATOR 1. First, remove all shelves in the refrigerator, than remove the Refrigerator control Box by loosening 2 screws. 2. Remove the Refrigerator Control Box by pulling it downward. 3. Disconnect the lead wire on the right position and separate the lamp sockets. 3-6 MULTI DUCT 1.

Samsung Refrigerator 2020 REFRIGERATOR LINE-UP. Begin by measuring height, depth and width. Make sure to take into account door opening, ventilation, cleaning space and how you'll get the refrigerator in the house and kitchen. Choose a refrigerator with enough cubic feet for your family needs. One Adult - 4-6 cu.ft. A Couple - 12-16 cu.ft .

Tom Sawyer’s observations of his environment and the people he encounters. In addition, students will make their own observations about key aspects of the novel, and use the novel and the journal writing activity to make observations about their own world and the people they are surrounded by. This unit plan will allow students to examine areas of Missouri, both in Hannibal, and in their own .