TITLE: COLD ROOM INSTALLATION / OPERATIONAL / PERFORMANCE .
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL - 2017Protocol NY NAME:xxxxxSITECOLD ROOMLOCATION:xxxxxx/PERFORMANCEIssued Datedd-mm-yyyyPROTOCOL PREPARED BYNAMESIGNATUREDATEName:dd-mm-yyyyTitle:Company: Vacker GlobalPROTOCOL APPROVED cker GlobalPROTOCOL APPROVALNAMESIGNATUREDATEName: xxxxTitle:Company:Name: xxxxTitle:Company:Name: xxxxTitle:Company:CHANGE HISTORYNAMEREASON FOR CHANGEREVISIONISSUED DATE(dd-mm-yyyy)New document0dd-mm-yyyyAll right reserved to Vacker GlobalFile: IOPQ-CDR-xxx-xxxx-PPage 1 of 17Part of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ed DatePERFORMANCEdd-mm-yyyySCOPE OF THIS PROTOCOL :Study TypeTemperature & Humidity - Mapping Study &QualificationClient nameXxxxxxAsset TypeCold RoomDescription and LocationCold Room,XxxxxxTemperature range to be mappedLow limit 2 CHigh limit 8 CHumidity range to be mappedDuration of testing4-5 daysDate of testingReference Standards : This mapping study is carried out as per WHO Technical Report Series,No. 961, 2011.All right reserved to Vacker GlobalPage 2 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ed DatePERFORMANCEdd-mm-yyyyTABLE of CONTENTS1IDENTIFICATION OF THE QUALIFICATION TEAM .42DEFINITIONS AND ACRONYMS .53SCOPE .74OBJECTIVE .75RATIONALE .86APPLICABILITY .107RESPONSIBILITY .108QUALIFICATION DOCUMENTATION .118.1MANUAL ENTRIES IN PROTOCOL .118.2DEVIATION REPORTS .118.3DATA SHEETS .128.3.18.3.28.3.38.3.49IQ SECTION .12OQ SECTION .12PQ SECTION .13INSTALLATION / OPERATIONAL / PERFORMANCE QUALIFICATION REPORT .138.4CHANGE CONTROL .148.5ANALYSIS .15EQUIPMENT INSTALLATION/OPERATION DESCRIPTION .16All right reserved to Vacker GlobalPage 3 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol FORMANCEIssued Datedd-mm-yyyyIDENTIFICATION OF THE QUALIFICATION TEAMIn order to identify the persons who have participated in the execution of this qualification, a specimenof their signature and initial is shown below, beside their name and title.NameAll right reserved to Vacker GlobalTitleSignatureInitialPage 4 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ed DatePERFORMANCEdd-mm-yyyy2 DEFINITIONS 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 astandalone unit (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 theproduct or proper operation of the equipment.Controller, non-criticalA controller for which control have no direct impact on the quality of theproduct or 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 performedtest, test function methodology, testing equipment, testing materialetc.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 qualityof the 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 & Humidityswitch, etc.), a digital or analog transducer (limit switch, pressure sensor,Temperature & Humidity sensor, etc.) that generates an electrical ormechanical signal to an instrument or a controller 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 theproduct or proper operation of the equipment.All right reserved to Vacker GlobalPage 5 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol /Issued iece of equipment, part of major equipment that possesses its own powersupply that could usually operates as a standalone unit (pump, tion QualificationIOPQInstallation / Operational / Performance QualificationN/Sp.Not SpecifiedNISTNational Institute of Standards and TechnologyOQOperational QualificationPQPerformance QualificationPMPreventive MaintenanceQAQuality AssuranceQCQuality ControlS/NSerial numberSOPStandard Operating ProcedureAll right reserved to Vacker GlobalPage 6 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ed DatePERFORMANCEdd-mm-yyyy3 SCOPEThe 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 ofthe Cold Room located at Xxxxxx.4 OBJECTIVEThe purpose of this Installation / Operational / Performance Qualification is to: Temperature mapping study to analyze distribution of Temperature inside the whole area. Humidity mapping study to analyze distribution of humidity inside the whole area. Briefly describe the equipment, its major components and their roles. Verify that the Cold Room is properly installed according to the manufacturer and Xxxxxxspecifications 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 appropriate calibration (if necessary) and maintenance program are in place. Ensure that all features of the equipment described are functioning in the proper manner asrequired to perform all operations associated with its use. Specific tests are designed to verifythat the equipment operates within all applicable design. Hot and Cold points of the Cold Room will be identified. Maximum and Minimum percentage of the humidity zones of the Cold Room will be identified. Locations for placing sensors for continuous monitoring will be recommended based on thehot and cold points. This mapping study will be carried out for two seasons.ie, summer and winter. Therecommendations issued in first climatic study will be reviewed and revised after the secondclimatic study. The results of summer will be considered as worst case scenario and the finalrecommendations will be considered accordingly. Number of data loggers are determined based on the volume of the Cold Room and as perrelevant WHO Standards.Detailed technical information can be found in the technical documents supplied by the manufacturer(refer to Section 12.1: Documentation for Installation).All right reserved to Vacker GlobalPage 7 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ORMANCEIssued Datedd-mm-yyyy5 RATIONALEInstallation / Operational / Performance Qualification is the establishment of documented evidence thatthe Cold Room is installed in accordance with manufacturer's specification and consistently performsaccording to design specifications and intended use.The Installation / Operational / Performance Qualification protocol is designed to allow technicalanalysis of all applicable installation requirements and operational functions. Proper installation andoperation will be established based on the following characteristics: Proper installation as per manufacturer Xxxxxx specifications. Proper operation of Temperature & Humidity controller buttons as proposed by manufacturer. Temperature & Humidity alarms verification Proper Temperature & Humidity control and distribution under empty conditions Power failure under empty condition. Proper Temperature & Humidity recovery following a door opening under emptyconditions. Proper Temperature & Humidity control and distribution under 40% loaded conditions. Proper Temperature & Humidity recovery following a door opening under 40% loadedconditions. Power failure under 40% loaded condition. Proper Temperature & Humidity control and distribution under 70% loaded conditions. Proper Temperature & Humidity recovery following a door opening under 70% loadedconditions. Power failure under 70% loaded condition.One data logger will be placed outside the Cold Room for recording external temperature.All tests must be conducted by trained and experienced technical personnel and must be documentedin a scientific manner using this established format.IMINITemperature & Humidity & humidity data loggers will be used to measure and recordtemperature. Each data logger has been calibrated and calibration certificates are included in eachAll right reserved to Vacker GlobalPage 8 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ed DatePERFORMANCEdd-mm-yyyyreport generated (included in this document). These electronic instruments are verified and calibrationreports will be part of the final report.Any test function that does not have results which support the parameters defined in the approvedprotocol must be conclusively rationalized for their deviation and approved or the qualification will beconsidered invalid.This protocol is only applicable for the Cold Room.Note: We will use any equivalent data loggers with calibration certificate as per actual site conditionsand test schedule.All right reserved to Vacker GlobalPage 9 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ORMANCEIssued Datedd-mm-yyyy6 APPLICABILITYAll Vacker Global and Xxxxxx personnel, when performing the Installation / Operational / PerformanceQualification of the Cold Room shall follow this qualification protocol.7 RESPONSIBILITYThis qualification protocol must be respected by all Vacker Global and Xxxxxx employees duringprocessing.The responsibility of the Installation / Operational / Performance Qualification of the Cold Room isattributed to the following:ResponsibilitiesTaskVacker GlobalMake available all documentation required for theInstallation / Operational / Performance Qualificationfor the Cold Room. Review and approve the protocol. Verify that all critical instrument of the equipment havea valid calibration date. Collect information.Write 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 Global Log door openings during testing.Compile and analyze data.Xxxxxx Page 10 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ORMANCEIssued Datedd-mm-yyyy8 QUALIFICATION DOCUMENTATION8.1MANUAL 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 beentered below or above the error. All corrections must be initialed and dated. Data applicable in the shaded areas will be gathered during protocol execution.8.2DEVIATION REPORTSAny discrepancy between the installation specifications and the actual (as found) installations, anydiscrepancy between 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 specifiedin the OQ section of this protocol must be documented on a Deviation Report.The Deviation Report numbers are to be indexed according to the section of the protocol to which theypertain. For example, reports pertaining to OQ Test Verification in section 13.1 of this protocol will besequentially numbered D13.1-1, D13.1-2, etc.All Deviation Reports associated with the execution of this protocol are to be enclosed in Attachment 1of this protocol.All right reserved to Vacker GlobalPage 11 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol NumberIOPQ-CDR-xxx-xxxx-P8.3DATA SHEETS8.3.1IQ SectionOPERATIONALRevision0/PERFORMANCEIssued Datedd-mm-yyyyInformation pertaining to the Installation Qualification will be directly recorded in the IQ section of thisprotocol. 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 specifiedcondition.- 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 testconditions not 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 Xxxxxx )8.3.2OQ SectionInformation pertaining to Operational Qualification will be directly recorded in the OQ Section «TestData 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 toproduce the expected result.All right reserved to Vacker GlobalPage 12 of 17File: IOPQ-CDR-xxx-xxxx-PPart of VackerGlobal GroupOur Offices: UAE, KSA, India, Oman, Kuwait, USAwww.vackerglobal.comEmail: sales@vackerglobal.com
TITLE:COLD ROOMINSTALLATION /QUALIFICATION PROTOCOL 2017Protocol ORMANCEIssued Datedd-mm-yyyyPass / 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 t
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 Cold Room located at Xxxxxx. 4 OBJECTIVE The purpose of this Installation / Operational / Performance Qualification is to:
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The Installation / Operational 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 walk-in cold room (ID number: Cold Room 1 (DIP) ) located into the warehouse of Dubai DIP.
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USING INQUIRY-BASED APPROACHES IN TRADITIONAL PRACTICAL ACTIVITIES Luca Szalay1, Zoltán Tóth2 1Eötvös LorándUniversity, Faculty of Science, Institute of Chemistry, Pázmány Pétersétány1/A, H-1117 Budapest, Hungary, luca@chem.elte.hu 2University of Debrecen, Faculty of Science and Technology, Department of Inorganic and Analytical Chemistry,, Egyetem tér1., H-4010 Debrecen, Hungary,
