Bms protocol

Installation/Operation Qualification Protocol
Protocol No.:
Hikma Pharmaceuticals-APIs Sterile BMS System
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Hikma Pharmaceuticals-APIs Sterile BMS
System
Name Company Title Date Signature
Prepared by: Eng. Omar Jarwan Ideal Control Systems Co.LLc Project Manager 12/3/16 O.M.J
Reviewed by:
Approved by:
Approved by:
Approved by:
Approved by:

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Table of Contents
1 INTRODUCTION...................................................................................................................3
2 PURPOSE ............................................................................................................................3
3 SCOPE .................................................................................................................................3
4 RESPONSIBILITIES.............................................................................................................3
5 SAFETY PROCEDURES AND GENERAL CONSIDERATIONS: .......ERROR! BOOKMARK
NOT DEFINED.
6 DEFINITIONS AND ABBREVIATIONS ................................................................................5
7 IDENTIFICATION & SIGNATURES LOG FOR PROJECT TEAM.......ERROR! BOOKMARK
NOT DEFINED.
8 INSTALLATION QUALIFICATION (IQ)................................................................................7
8.1 DOCUMENTATION.......................................................................ERROR!BOOKMARKNOT DEFINED.
8.2 VISUAL CHECKS AND INSPECTIONS ............................................................................................9
8.2.1 OUTSIDE CHECKS.................................................................................................ERROR! BOOKMARK NOT DEFINED.
8.2.2 INSIDE CHECKS.....................................................................................................ERROR! BOOKMARK NOT DEFINED.
8.3 LAYOUTS AND CHECKS .......................................................................................................... 10
8.3.1 SENSORS LAYOUT................................................................................................ERROR! BOOKMARK NOT DEFINED.
8.3.2 DDCS LAYOUT......................................................................................................ERROR! BOOKMARK NOT DEFINED.
8.4 VERIFICATION OF DDC PANEL ................................................................................................ 13
8.5 VERIFICATION OF COMMUNICATION AND CONTROL CABLES TYPES ................................................ 14
8.6 VERIFICATION OF COMMUNICATION AND CONTROL CABLES STATUS............................................... 15
8.7 DDC / POINTS CHECKS.......................................................................................................... 16
8.8 CALIBRATION STATUS ........................................................................................................... 16
8.8.1 LIST OF ITEMS TO BECALIBRATED:......................................................................ERROR! BOOKMARK NOT DEFINED.
8.8.2 LIST OF ITEMS TO BE VERIFIED:...........................................................................ERROR! BOOKMARK NOT DEFINED.
8.9 INSTALLATION QUALIFICATION DISCREPANCYREPORT......................ERROR!BOOKMARKNOT DEFINED.
9 OPERATION QUALIFICATION (OQ).................................................................................19
9.1 OPERATION SOPS AVAILABILITY............................................................................................. 19
9.2 CHALLENGE TESTING:........................................................................................................... 20
9.2.1 SUDDEN SHUTDOWN RESPONSE:........................................................................ERROR! BOOKMARK NOT DEFINED.
9.2.2 NETWORK FAILURE RESPONSE..................................................................................................................................21
9.2.3 SOFTWARE TESTING:...........................................................................................ERROR! BOOKMARK NOT DEFINED.
9.2.4 CHALLENGE TESTING...........................................................................................ERROR! BOOKMARK NOT DEFINED.
9.3 OPERATION QUALIFICATION DISCREPANCYREPORT.........................ERROR!BOOKMARKNOT DEFINED.
9.4 MATERIALS & EQUIPMENT USED.............................................................................................. 37
9.4.1 MEASURING INSTRUMENTS........................................................................................................................................37
9.4.2 MATERIALS OR TOOLS................................................................................................................................................38

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9.5 QUALIFICATION ACCEPTANCE CRITERIA.........................................ERROR!BOOKMARKNOT DEFINED.
1- Introduction:
Thisdocumentprovidedby Ideal Control SystemsCo.LLc,as the installerof the BMS system
, controllingAndmonitoringThe SterileAHU,AnditsCoveredArea.
2- Purpose:
The BuildingManagementSystem(BMS), Providedtocontrol andmonitor,Sterile AHUand
itsarea, to Achieve optimumHVAC,AndIsolationBetweenRooms.
Andthisdocument, made tovalidate thissystem, with HikmaPharmaceuticals
Requirements andcodes.
3- Scope:
Ideal Control SystemsCo.LLcScope of Work is,the (BMS) Control System Design,supply,install,and
operation,andall the systemrelatedComponents,mentionedinthe providedoffer.
4- Responsibilities:
Department/Party Responsibilities
Validation/HikmaPharmaceuticals - APIs  Review/Approve protocol
 Assist in protocol implementation
 Monitor protocol completion
Maintenance/HikmaPharmaceuticals - APIs  Review /Approve Protocol
 Assistin protocol implementation
 Prepare required SOP’s
 Prepare required layouts and lists
Production/ HikmaPharmaceuticals - APIs  Review /Approve Protocol
 Assistin protocol implementation
 Prepare required SOP’s
 Operate system as per SOP
QA/HikmaPharmaceuticals - APIs  Review/Approve Protocol
Agent/ Ideal systemIntegrator  Prepare/review protocol
 protocol implementation
 provide necessary documents

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5- Safety precisionsandGeneral Considerations:
Responsible Persononusingthe BMS System shoulddiscussthe following withIdeal Control Engineers:
• Your needsandrequirementsforphysical andnetworksecurityof the BASanditscomponents,such
as devices,computers,andnetworkingequipment.
• Your needsandrequirementsforaccessingthe systemoutsideof yourinternal networks,suchasusing
the Internetora VPN.
• Your organization’scurrentknowledge level andcapabilitiesinmaintainingsecurityof the system.
Rememberthatwhile aBASmight notnecessarilybe the primarytargetof an attack, itmightbe
targetedas a wayto access othersystems.
- Disaster recovery planning:
Developingadisasterrecoveryplanaspart of your securitystrategy,define acomprehensive backup
and restore policy fordisasterrecovery.
- Backup andrecovery strategy:
Performingbackupsisone of the mostimportantriskmitigationtasksforsecuringyourCompass
system.If backupsof importantdata are not made,thendata will be lostif a hardware or software
failure occurs,if configurationfilesare deleted,if the systemisinfectedwithavirusorworm, or inthe
eventof a natural disasterlike fire orflood.Choosinganappropriate backupstrategyallowsyouto
minimize downtime due tosituationsthatcause loss of data. Whendeterminingyourbackupstrategy,
considerthe typesof situationsthatcanoccur:
• Mediafailure:If one ormore diskdrivesfail,there isapotential foracomplete lossof dataunlessthe
systemwasproperlybackedup.
• User error:If a usermakesinvalidmodificationstoconfigurationdata,thenaneffective waytoundo
these changesisto restore the datafrom backup.
• Permanentlossof aserver:If a serverbecomespermanentlyunusable,thenthe systemanddatahave
to be reconstructedunlessyouhave abackup.
• Virusor worminfection:If avirusinfectsthe Compassworkstation,thenitcoulddeleteorcorrupt
filesmakingitdifficultorimpossible torestore the systemconfiguration.
Alsoconsider:
• CD and DVDare not consideredtobe reliable backupmediums.

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• Backupscan be CPU- anddisk-intensive operationsonalarge system.Performbackupsattimesthat
do nothave a lotof systemload.
• Do notstore backupimagesonthe Compassprimaryworkstationor,if used,the SQL Servercomputer.
• Do notstore backupimagesonthe same computerbeingbackedup.
• Backupimagesshouldbe storedonnetworkdrives.
• If networkdrivesare notavailable,thenstore backupimagestoaconnecteddrive usingUSB.
• Notall backup productssupportbackingup SQL Server,especiallywhenSQLServerisrunningwith
openfiles.
• Configure yourbackupsoftware producttodo a full backupweeklyandincrementalbackupsnightly
to lowerthe loadandperformance impactfrombackupactivities.
• Ensure that youhave enoughfile storage space toholdall backups.
• Ensure that verificationisperformedafterthe backuphascompletedtoguarantee thatthe datawas
backedup correctly.Aneffective DisasterRecoveryPlanmustbe documentedandall personnel
involvedmustbe knowledgeableof itscontentandstorage location.
6- DefinitionsandAbbreviations:
BMS : BuildingManagementSystem.
DDC : Direct Digital Control.
T&C : Testingandcommissioning
AI : Analogue input.
AO : Analogue Output.
DI : Digital input.
DO : Digital Output.
WS : Work Station
BAS : BuildingAutomationSystem.
BACnet : communicationsprotocol forbuildingautomationandcontrol networks

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ATC : AutomaticTemperature Control.
AHU : Air HandlingUnit
HVAC : HeatingVentilatingandAir-Conditioning.
MCC : Motor Control Center.
SOP : Standard OperatingProcedure
VCD : Volume Control Damper.
ΔP : Differential Pressure.
Failure : Terminationorstopthe abilityof afunctional unit,device orcontrollertoperformarequired
function/process.
Error : Discrepancybetweenacomputedobservedormeasured(monitored) value orconditionand
the true specifiedortheoreticallycorrectvalue orconditionthatistobe set.
Instrument : Apparatususedinperforminganaction
Note : Instrumentedsystemsin the processsectorare typicallycomposedof sensors(Pressure
Sensor,flowSensor,temperaturetransmitters),logicsolversorcontrol systems(DDCs),and
final elements(ContactorControl valves).
7- Signature List:
The individual(s)executingthis Installation/OperationQualificationProtocol mustprinttheir
name withtheirtitle,signtheirname andentertheirinitialsinthe table below. Thisserves
to identifythe individual(s) executingeachunittestaseachunittest onlyrequiresrecording
of the individual(s) initialsatthe completionof the unittest:
Name of Tester Company Title Initials Signature

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8- InstallationQualification(IQ):
8.1. Documentation:
Basedon the BMS function/design,fill the documentationrequiredforinstallation
qualificationstudy.
No. Document Reference
1 Purchase order
2 invoice
3 Installationmanuals
4 Operationandmaintenance manual
5 Software manual
6 Complementarydocument
7 SensorsandDDCs layout
8 DDCs and SensorsDatasheet
9 Software License File
10 Sequence of operation
11 ProjectsDocumentationandPrintouts(foreachModule)
12 CalibrationProcedure(s) withTrainingDocuments
13 SensorsCalibrationDocuments
Acceptance Criteria: All documentsare available.

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RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
COMMENTS:

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8.2. Visual ChecksandInspections:
8.2.1 Outside Checks:
Objective:Verifythe well-beingof the overall system.
Procedure:Performthe followingvisualchecksonthe system:
Test Procedure Result
1. Checkthe finishingensuringthereare no damagesor sharp edges.
2. Checkmetalwork:hingesondoors,flushdoors,opening andclosingof doors,
no saggingor droopingof doorswhenopen,interlockingof doors.
3. Checkdoor sealsandglandplate gasketsare inplace and are securelyfixed.
4. Checkcommonkeyfor all panels.
5. Checkthat safe accessto the control equipmentis possible withoutisolating
the control panel where specified.
6. Checkfor locationandlabelingof switchesandindicators(includingcolor).
Checkthat plasticrivetsorscrewsare usedto mountlabels.
8.2.2 Inside Checks:
Objective:Verifythe well-beingof the overall system.
Procedure:Performthe followingvisualchecksonthe system:
Test Procedure Result
1. All DDC panel componentsare fixedproperly(noloose component).
2. Incomingcablesaccessto the panel properly
3. Access for outgoingpowerandcontrol cables.
4. Provisionof suitableglands.
5. All doors/glandstobe earthedbycable links.
6. Bus bars andpowercablingas specified.
7. Ventilationgrilles,filtersandfansare includedandcorrectlysetwhere
specified.

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8. Tightnessof all connections,boltedpowerconnectionsandbus-barbolts
tightenedtothe correcttorque.
9. Neatnessof cable loomswithnopinching.
10. Sufficientspare capacityinall cable trunksto complywithBS7671(13).
11. Colorcodingand numbering of all cableswhere specifiedandcorresponding
withnumberingof terminals.
12. Numberingof all terminals.
13. Shroudingandlabelingof non-isolatedequipment.
14. Shroudingof switches,lampsetc.ondoorsif low voltage.
15. Segregationof powercablingfrom control cablingandelectronic
equipment.
16. Drawingholderavailability.
17. Fuses(type andratings) matchfuse chart.
18. Ensure spare back panel space isprovidedasspecified.
19. Ensure no equipmentismountedonthe bottomorsidesof the panel
(similarlyterminations) unlessback/sideplatesare fitted.
20. Labelingof equipmentinpanel
21. Screenandearth connectionsassociatedwiththe control systemequipment
complywiththe Manufacturer’sinstallationrequirements.
22. All powerandservice LEDs in the BMS panels’modulesindicate the
healthystatuses.
Acceptance Criteria: All testsabove passed.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
COMMENTS:

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NAME: DATE:
8.3. Layoutsand Checks:
Objective:Checkthatthe layoutsmatchthe actual installation.
Procedure:check the followinglayoutsforthe followingpoints
8.3.1 RoomSensorsLayouts
# Procedure Reference Result
1 Checkthat all the sensorslocationscomplywiththe
designatedcorresponding approveddrawings
2 Checkthat the detailsshownin the layoutsare matchingwith
actual executedinstallations
8.3.2 AHU SensorsLayouts
1 Checkthat all the sensorslocationscomplywiththe
designatedcorresponding approveddrawings
8.3.3 DDCs Layouts
1 Checkthat all DDCs locationscomplywiththe designated
correspondingapproveddrawings, alsocheckthe correctness
of the notesonthe DDC layout
3 Checkthat all wire labelingmatchesthe layouts.
Acceptance criteria: layoutsincludingthe informationwithinmatchthe actual installation.

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RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
COMMENTS:

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8.4. Verificationof DDCPanels
Objective:IdentifyDDCspecifications
Procedure:Fill the followingtable withthe correspondinginformationandattachtables
reflectingthe followingdetailsforeachDDC panels(transformeroutputvoltage,address,
numberof usedpointsandtotal capacity of the panel (AI,AO,DIand DO))
No. Panel Location Model Serial # Supply
voltage (V)
1 DDC-Sterile-01
2 DDC-Sterile-02
3 DDC-Global-03
4
Acceptance Criteria: N/A
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
COMMENTS:

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8.5. Verificationof CommunicationandControl CablesTypes:
Objective:Toidentifytypesof cablesusedinthe installationforeachtype of connection.
Procedure:Checkthe typesof cableswithsupplierrecommendedspecifications
Source Destination Cable Type Actual result Remarks
Acceptance criteria: cablestypesmatch the supplierrecommendedspecifications
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
COMMENTS:

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8.6. Verificationof CommunicationandControl CablesStatus:
Objective:Verificationof the cablesstatus/condition
Procedure:All Input/Outputcablesshallbe labeledproperlyandeachcable shall be tested
as detailedhereafter:
1- Disconnecteachwire frombothends,test wire forshort circuitFault.
2- Short the wire at one endand testthe continuityfromotherend,if bothsteps1 and2
pass markwire ok? Withyes(Y) if no fill no(N)
3- Checkthat the input/outputsignal type jumperof eachpointisplacedonthe correct
position
4- In the computersoftware checkthatthe settingforeach inputoutputare correctly
configured
5- Checkthe label foreach cable.
6- Recordthe results
Acceptance criteria:
1- The wire short circuittestresultshall be anopencircuit(no shortcircuitFault).
2- The wire continuitytestresultshall be ashortcircuit(nocut wire fault)
3- The jumperpositionshouldcorrespondtothe input/outputtype
4- On the computerthe inputoutputshouldconformthe inputoutputtype andthe input
outputnumbershouldcorrespondtothe physical locationof inputoutput
5- All cablesare labeledcorrectly
6- All resultsmustbe recorded
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
COMMENTS:

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NAME: DATE:
8.7. DDC / PointsChecks
Objective:Inordertoassure proper operationof DDC controllersfollowingchecksshall be
carriedout forall terminationsandmodules:
Procedure:Performthe followingpower&installationstaticchecks:
Test Result
1. Checkif powersource of the DDC and IOmodulesare terminated.
2. Check the fuse forthe 24V AC powersupply.
3. Double checkthe jumperconnecterbetweenthe modules.
4. Checkthe rating of all fusesforthe 24V circuitsand 220V circuit.
5. Checkthe rated outputvoltage of the transformers.
6. Checkthe Installationof the DDC and IO modulesondinrail orscrews
and make sure that the DDC is fixed.
7. Checkthe CablesColorsandtagging
Acceptance Criteria: All testsabove passed.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
COMMENTS:

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8.8. CalibrationStatus
Calibration/verificationdocumentsforeachsensorare attachedto thisdocument
8.8.1. List of Itemsto be Calibrated:
# Item Code Calibration Date Next Calibration
Date
Calibration Documentation
1
2
3
4
8.8.2. List of Itemsto be Verified:
# Item Code Validation Date Next Validation
Date
Validation Documentation
1
2
3
4
Acceptance Criteria: All instrumentsare calibrated,calibrationisstill effective andall documentationis
attached.

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RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
8.9. Deviations
DeviationNo.:…………………………………. Date:………………………..
Equipment#:…………………………………… Page:……… from……….
Anydiscrepancies betweenspecifiedandactual on the installedequipment,piping,utilities,
controls,etc.determinedduringthe executionof thisprotocol mustbe documented.
COMMENTS:

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Describe belowall informationrelatingtothe deviation,listspecifiedversusactual resultin
detail.”
Deviation
Observedby: Date:
Investigation
Observedby: Date:
Action taken
Conductedby: Date:
Reviewedby: Date:
QA Approval: Date:
9- OperationQualification(OQ):
9.1 OperationSOPsAvailability:
Objective:Ensure the compliance of BMSthe operationSOPsandavailabilitypersonnel
training

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Procedure:checkthe compliance of the BMS operationSOPsandsigneachsection.
SOP # SOP Title Reference Date Signature
Acceptance Criteria: operationSOPscomplieswiththe BMSsystemandtrainingformsare available.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2 Challenge Testing:
9.2.1 SuddenShutdownResponse:
Objective:To ensure properoperationincase of powerfailure.
COMMENTS:

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Procedure:
1. Recordset value forsensorsmeasurementrate (intime).
2. DisconnectDDCpanel powersupply.
3. Recorddisconnectiontime.
4. Checkthat the last measurementsbefore disconnectionare presentonthe station.
5. Reconnectpowersupplyandrecordtime.
6. Repeatthose stepsforeachpanel.
Acceptance Criteria: DDC panel isworkingproperlyandthe connectionisupandback to normal
automatically.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.2 Networkfailure response
Objective:To ensure properoperationincase of networkfailure.
Procedure:
COMMENTS:

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1. Change sensorsrate to one minute (orMaximumrate)
2. Disconnectnetworkcable frompanel’sprocessor.
3. Recordtime of disconnection.
4. Wait for3-5 measurementperiods.
5. Reconnectthe networkcable andrecordreconnectiontime.
6. Revertsettingbackto original.
7. Repeatsteps2.1 to 2.7 for all panels.
8. Testresultsandrecords shall be documentedin properforms
Acceptance Criteria: On the station,all measurements(includingmeasurementstakenduring
disconnection) are present.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.3 Software Testingand SystemRequirements:
Objective:toensure that station’shardware meets/exceedsminimumsystemrequirementsof
CompassSoftware.
Procedure:
COMMENTS:

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1. Checkthat stationspecificationsmeetall systemrequirementsfor Compasssoftware
(Attachment#CompassCompass-Data-Sheet-083115.pdf)
2. Stationsuddenshutdown:
3. Reduce measurementtime tominimum.
4. Disconnectstationpowersupplyandrecordtime.
5. Wait for3-5 measurementperiodsthenreconnectpowersupply
6. Recordsystemstartuptime.
Acceptance Criteria: all readings includingthose takenduringpower cutoff are presentinstation.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.4 Testingof Digital InputswithScreens,AlarmsandAlarmEvents
Objective:To verifythe normal operationof digital inputsafterturningonthe controller.
Tools required:BMS StationSoftware
Procedure:
1. Turn panel powertoOn Position.
2. Put Auto/ManswitchinAutoPosition.
COMMENTS:

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3. Simulate eachDigital Inputsignal by
 Shorting/Openingthatsignal tocontrollerinput.
 Operatingrespective fieldinstrument.
4. Verifyandrecordthe statusof that Digital Inputof the controller.
5. Checkfor eachdigital inputthatthe statusis displayedcorrectlyonsoftware screensand
alarmswill be generatedwhereapplicable.
Acceptance Criteria: Aftercorrect power-up,eachcomponentshall be operational.Statusof Individual
Digital inputsignalson BMS stationscreens,andsummaryscreenshall reflectactual statusof the
system.Aftersimulatingdigital inputs,alarmiconwill flashandthe alarmshouldshow upon the alarms
screenandshouldbe recordedinthe eventslogger.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.5 Testingof Digital OutputswithScreens andActual Physical Actions
Objective:To verifythe normal operationof digital outputafterturningonthe controller.
Procedure:
1. Put Auto/ManswitchinAutoPosition.
COMMENTS:

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2. On the central station computerscreen,seteachDigital outputsignal to“ON”thenverify
the status of that output,thenswitchto“OFF” position,verifyandrecordthe statusagain.
Verifythe actual physical conditionof the fielddevicethatiscontrolledbythatoutput.
Acceptance Criteria: Aftercorrect power-up,eachcomponentshall be operational.Statusof individual
Digital OutputsignalsonBMS stationscreens,individual systemscreenandsummaryscreenshould
reflectactual physical statusof thatoutput.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.6 Testingof AnalogInputswithScreens,AlarmandAlarmEvents
Objective: To verifythe normal operationof analoginputsafterturningonthe controller.
Procedure:
1. Turn panel powertoON Position.
COMMENTS:

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2. Checkthat all analoginputare correctlydetectedanddisplayedonthe central station
screens.Simulate alarmsandverifythatthe systemgeneratesthe correspondingpoints
alarms.
3. Attach the offsetvalue table forall analoginputpoints.
Acceptance Criteria: Aftercorrect power-up,eachcomponentshall be operational.Analoginputsignals
are displayedcorrectlyon BMSstationscreens,individual systemscreens,andsummaryscreens.All
valuesoutside the acceptablerange shouldshow analarmonthe alarmsscreen
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.7 Testingof AnalogOutputswithScreens andActual Physical Actions
Objective:To verifythe normal operationof analogoutputsafterturningonthe controller.
Procedure:
COMMENTS:

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2. Change the analogoutputvalue manuallyusingthe central station.Verifywiththe actual
physical conditionof thatoutputinthe field.
3. Recordthe results.
Acceptance Criteria: Aftercorrect power-up,eachcomponentshall be operational.Analogoutput
valuesare displayedcorrectlyon BMSstationscreens,individual systemscreen,summaryscreenand
actual physical statusof the fielddevice shall reflectactual valuesof the system
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.8Verificationof SetParameterswithScreens,ControllerDataTable Values,Powerand
CommunicationFailure Condition
Objective: To verifythatsetparametersare conservedinboththe BMS stationand the controllerin
case of poweror communicationfailure.
COMMENTS:

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Procedure:
2. Usingthe BMS station modifysome of the setpointsvaluesandcheckthat the values
have changedinall BMS station screensandeventsare loggedinthe AuditLog.
3. SwitchOFFthe BMS stationand switchitON again. Recheckthe setpointsandmake sure
theydidnot change due to powerfailure onthe BMS station.
4. Disconnectthe communicationbetween BMSstationandDDC controllers.Switchoff any
DDC controllerandthenswitchiton again.Checkthat the controllerresumesthe same
control program withoutbeingconnectedtothe DDC network. Connectthe
communicationbetween BMSstationand DDC controllersagain.Now,checkthatall set
pointsdidnotchange on the BMS station screens.
Acceptance Criteria: The control programand setpointvaluesare conservedandunchangeddue to
poweror communicationfailure becausetheyare savedonthe controller.
COMMENTS:

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RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.9 Verificationof Min.andMax. Entry Valuesof SetParameters
Objective: Toverifythatsetparameterscannotbe setoutside the acceptable range.
Toolsrequired:BMSStationSoftware
Procedure:
2. Usingthe BMS station,clampone of the setpointsfortemperature tobe inthe range
from15 to 25 C°.

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3. Go to that setpointand try to change it to 25.1 C°.
4. Try to change it to 14.9 C°.
Acceptance Criteria:Anysetpointvalue thatisoutside the predefinedacceptable range forthatset
pointwill notbe accepted.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.10 Testingof SystemOperation
Objective:Toverifythe systemoperation.
Procedure:
2. Loginas Managerthengo to selectedsystemgraphicstobe tested.
3. Testthe control loopsand switchinglogicsasfollows.
COMMENTS:

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4. Testeach type of the switchinglogicsbysimulating the inputconditionsmanuallythen
checkwhetheroutputactionsare as specified.
5. Testeach type of the control loops bychangingthe setpoint(s)value and checkwhether
the systemresponse isasspecifiedinsequence of operation.
Acceptance Criteria: All control loops andswitchinglogicsare workingproperlyandasspecifiedinthe
sequence of operation.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.11 Testingof SystemSchedule
Objective:To verifythatthe systemfollowsthe assignedtime program(schedule).
Procedure:
2. Loginas Manager. Change the time programfor any equipmenttoswitchonand off at a
selectedtime withinreasonable time intervalfortesting.
COMMENTS:

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3. Wait forthe selectedtimesandcheckwhetherequipmentisswitchingonandoff as per
the time schedule.
Acceptance Criteria: All equipmentcontrolledbytime programisrespondingtothe time program
assigned.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.12 Testingof SystemSecurity
Objective:To verifythe system’ssecurity andadvancedpasswordfeatures.
Procedure:
1. Try to loginto the BMS stationwiththe correct username andwrongpassword.The login
attemptwill fail andfail loginmessage will appear.
COMMENTS:

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2. Try to loginwiththe wrongusername andcorrect password.The loginattemptwillfail and
fail loginmessage will appear.
3. Loginusingthe correct username andpassword formanageraccount,the loginattemptwill
be accepted and the mainscreenwill appear.
4. Create newuseraccount andcheck all passwordstrengthpolicyterms:
a. To preventeasilyexpectedpasswords.
b. Force change forpasswords.
5. Checkthe privilegesforeachaccesslevel,Manager,Service,Keeper&Viewer.
Acceptance Criteria: All securities required foreachaccesslevel are achieved,andnoalterationcan
be done by anyuser withoutregistrationandclearrecord.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.13 Testingof AuditTrails/EventsReporting
Objective: To verifythe correctloggingof eventsandgeneratingeventreports.
Procedure:
1. Loginto the systemas Manager and go to the propermenuto display UserActivityreport.
2. Checkthat all the events are correctlyloggedanddisplayed withtime-stamp.
COMMENTS:

Protocol No.:
Page 34 of 39
Rev.:Org
3. Loginas operatorand make sure that the operatorcannot change or stop the User Activity
report.
Acceptance Criteria: All eventsare correctlyloggedinthe UserActivity showingcorrectaction,
username,location,date andtime.Andaudittrial loggingcannotbe stoppedbythe operator.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.14 Verificationof TrendDataReports
Objective:To verifythe integrityof retrievedtrenddate andreports.
Procedure:
1. Loginto the systemas Manager and go to Trendspage.
2. Choose several pointstoshow theirhistorical date (Tending).Checkthatall the points
have beencorrectlyloggedanddisplayed.
COMMENTS:

Protocol No.:
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Rev.:Org
3. Go to Reportspage and choose the trendreport.
4. Printthe reportand attach it to thisprotocol.
5. Checkthat the printedreportconformstothe data on screen.
Acceptance Criteria: Trendingdatacan be viewedandprinted.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.2.15 Verificationof systemDatabase Backup/Restore
Objective: To verifythe integrityof retrievedhistorical database.
Procedure:
1. Logoff the systemandshoutdownthe WebServer.
2. Go to the database storage locationonthe systemharddisk.
3. Copythe database to CD or anyotherstorage media.
COMMENTS:

Protocol No.:
Page 36 of 39
Rev.:Org
4. Checkthe contentsof copieddatabase.
5. Go to the data base storage locationonthe systemharddiskagainand delete the
database folder.
6. Copythe database storedon CD or storage mediato the properlocationonthe system
hard disk
7. Start the central stationsoftware again.
8. Checkthat all trend,audittrail and alarmsdata are notchangedand the systemisfully
operational.
Acceptance Criteria: The backup of database foldercontainsall requireddataforTrends, AuditLogsand
Alarms.
RESULT:
TESTER SIGNATURE:
NAME: DATE:
WITNESSSIGNATURE:
NAME: DATE:
9.3 Deviations
“DeviationNo.:…………………………………. Date:………………………..
Equipment#:…………………………………… Page:……… from……….
Anydiscrepanciesbetweenspecifiedandactual on the installedequipment,piping,utilities,controls,
etc.determinedduringthe executionof thisprotocol mustbe documented.Describebelow all
informationrelatingtothe deviation,listspecifiedversusactual resultindetail.”
COMMENTS:

Protocol No.:
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Rev.:Org
Deviation
Observedby: Date:
Investigation
Observedby: Date:
Actiontaken
Conductedby: Date:
Reviewedby: Date:
QA Approval:
9.4 Materials& EquipmentUsed
Fill the bellow tablestoindicate Materialsandequipmentthathave beenusedduringthe installation
qualification:
Measuring Instruments
No. Code Calibration Date Next Calibration Date

Protocol No.:
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Rev.:Org
Materials or tools
No. Description
9.5 QualificationAcceptance Criteria
No. Acceptance criteria Result
(Pass/Failed)
Test
Reference
Date Signature

Protocol No.:
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Rev.:Org
1 All testingrequiredbythe approvedprotocols
are conductedasper approved protocolsor
applicable procedures.
2 Acceptance criteriaof all testsare met without
deviation.

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