ECC Status.pptx ggggggggggggggggggggggggg

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1. ARPL ECC - CURRENT MAINTENANCE PROCESS EVALUATION & HAND OVER CHALLENGES

2. Below are the factors considered for evaluating the current maintenance practice. The observed gaps provided in detail in further slides 1.Equipment Master List 2.Mapping Failure last one year 3 .Temperature/RH Offset issues 4 .Stability chamber condition 5.Yokowaga AMC issue 6.AMC issues 7.Equipment Master List Vs AMC 8.Summary Challenging Factor – ECC Conditions

3. 1.Equipment Master List Total ECC Equipment's 153 no's NON BAS PROJECT EQUIPMENTS Equipment Name Nos. Vacuum Oven 7 Laboratory Oven 4 Steam Pot 2 Lab Oven 2 Hot Air Oven 2 Tray Drier 1 Refrigerator 14 Muffle Furnace 2 Autoclave 4 MasterClave 2 Walkin Frezeer 2 Incubator 3 DEEP FREEZER 34 Photostability chamber 2 Walkin cold chamber 1 Oven 2 Humidity chamber 1 Cold Chamber 3 Cold Room 2 Total 90 BAS PROJECT EQUIPMENTS Equipment Name Nos. BOD Incubators 9 Cold Chamber 14 Combi Unit BOD & CC 1 Deep Freezer 1 Humidity Chamber 3 Ultra low deep freezer 1 Walk in BOD Incubator 4 Walk In Cold Chamber 8 Walk In Stability Chamber 22 Total 63

4. The mapping failure was due to the following reasons which has been identified on the root cause, And CAPA also processed for the same. The list of mapping failure has been captured in the following Effective periodic PM is not performed Electromechanical component's failure Manual intervention OFFSET Various Mapping failure due to ineffective maintenance 2.Mapping Failure Last one year

5. No. AQRS No Eq/Area ID Topic Details DATE OF INCIDENT Observed/AQRS initiated on Final Closure date PR Status ROOT CAUSE CATEGORY Root Cause CAPA No. CAPA SCOPE 1 56569 09/E/404 Temperature excursion in Vacuum Oven (09/E/404) 05-Oct-15 05-Oct-15 30-Nov-15 Closed Equipment/Facility/System - Inadequate Maintenance Direct Cause: From the above investigation findings and conclusion, the direct cause for this deviation is attributed to the tiny gasket leakage in The Equipment . Root Cause: The root cause for this deviation is Instrument periodic maintenance not performed. 59202 Inst to be added in Cal., Remapping, List of vacuum oven to be done, If AMC no, PM to be done 2 56572 09/E/812 Temperature excursion in Steam Pot (09/E/812) 05-Oct-15 05-Oct-15 04-Nov-15 Closed Procedure/Process/Specs - Incomplete-Incorrect Based on the investigation it was observed that the deficiency in the protocol No. # ARI/05/QUA/PAR/797/A” due to providing increased mapping duration than the actual usage without considering the steam loss during boiling cycles that might have resulted in the variation in steam pot temperature mapping 57975 & 57976 ARI/09/SOP/CAL/66/C revision to modify the mapping duration PRT/767/A shall be revised to change the mapping duration 3 59005 09/E/095 Temperature excursion in refrigerator 21-Nov-15 26-Nov-15 01-Mar-16 Closed Equipment/Facility/System - Inadequate Maintenance From the Investigation it is concluded that the Preventive maintenance of the refrigerator was not performed and Existing refrigerator is not suitable for industrial usage. 312846 Equ shall be decommissoned, Ind Ref shall be procured 4 59581 02/E/272 Temperature excursion in refrigerator 01-Dec-15 08-Dec-15 30-Mar-16 Closed Equipment/Facility/System - Inadequate for intended purpose Based on the outcome of the engineering investigation, No fault was found , this equipment will not provide uniform temperature distribution throughout the chamber . 62760 60390 Decommissioning of 02/E/272 Procured new walk in cold chamber and ready for installation 5 60799 09/E/404 Temperature excursion in Vacuum Oven (09/E/404) 05-Oct-15 05-Oct-15 30-Nov-15 Closed Equipment/Facility/System - Inadequate Maintenance Direct Cause: From the above investigation findings and conclusion, the direct cause for this deviation is attributed to the tiny gasket leakage in The Equipment. Root Cause: The root cause for this deviation is Instrument periodic maintenance not performed. 59203 Inst to be added in Cal., Remapping, List of vacuum oven to be done, If AMC no, PM to be done 2.Mapping Failure Last one year Details

6. No. AQRS No Eq/Area ID Topic Details DATE OF INCIDENT Observed/AQRS initiated on Final Closure date PR Status ROOT CAUSE CATEGORY Root Cause CAPA No. CAPA SCOPE 6 306294 RM No. 46 & 27 Relative Humidity excursion in IN PROCESS QUARANTINE (Room No.46) and JANITOR ROOM (Room No.27). 08-Feb-16 12-Feb-16 07-Apr-16 Closed Other - Unknown Cause Inadequate fixing of data loggers and Individual area doors would have been kept open for particular time. 332493 1.AHU # 05/E/017 Performance qualification protocol and report # ARI/05/QUA/PAR/395 shall be revised to remove temperature and Relative humidity mapping activity for Janitor room [since in janitor room only cleaning agents, cleaning solutions are stored], and the revised document shall be submitted to QA Documentation team. 2.Mapping shall be performed for the area as per the revised protocol and report. 3.Relative Humidity sensor & transducer shall be captured in External calibration schedule. 4.Awareness training shall be provided to the concern IIME personnel & Engineering personnel on following points: •To ensure proper fixing of data Loggers •For Ensuring frequent monitoring of area during mapping activity. 7 320338 09/E/133 Cold chamber temperature excursion 11-Mar-16 11-Mar-16   Investigation Equipment/Facility/System According to the vendor investigation the temperature excursion  is due to compressor relay defecti ve.     8 332470 09/E/843 Relative Humidity excursion in Walk-In Stability Chamber_09/E/843 07-Apr-16 07-Apr-16 07-May-16 Opened Equipment/Facility/System During mapping water tank cleaning was performed, and due to that water level become low in steam generator     9 332471 09/E/822 Relative Humidity excursion in Walk-In Stability Chamber_09/E/822 07-Apr-16 07-Apr-16 07-May-16 Opened Procedure/Written Instruction Due to more manual intervention for samples loading/unloading     10 332473 02/E/212 Temperature excursion in Hot Air Oven _02/E/212 07-Apr-16 07-Apr-16 07-May-16 Opened Equipment/Facility/System Temperature controller PID output is not working as required, equipment is neither covered under AMC nor under inhouse PM     2.Mapping Failure Last one year Details

7. User Says Yakogawa Recorder is the master sensor, & they document the report through Yakogawa only. In order to match the Temperature/RH values of Stability chambers( Allyone ) with respect to yakogawa recorder – Frequently Allyone service Engineers were intimated to put Offset to Allyone sensors by User dept . This was leaded to thermal mapping failures 3.Temperature/RH offset issues

8. There are 63 Environmental control chambers & below listed equipment's components found with worn-out/unusable status, which may need replacement 4.Stability Chamber Condition

9. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 1 09/E/822 Walkin Stability Chamber 60,000 Ltr ALLY ONE LVMP(Basement) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available boiler tank problem,compressor 1nos yes Relative Humidity excursion in Walk-In Stability Chamber_09/E/822 AQRS No- 332471 2 09/E/840 Walkin Stability Chamber 60,000 ltr ALLY ONE LVMP(Basement) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available boiler tank problem yes N.A N.A 3 09/E/841 Walkin Stability Chamber 60,000 ltr ALLY ONE LVMP(Basement) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available boiler tank problem yes N.A N.A 4 09/E/842 Walkin Stability Chamber 60,000 ltr ALLY ONE LVMP(Basement) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available boiler tank problem yes A1 alarm observed for Relative Humidity for the walk in stability chambers 09/E/842 and 09/E/843. AQRS No- 397141 5 09/E/843 Walkin Stability Chamber 60,000 ltr ALLY ONE LVMP(Basement) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available boiler tank problem yes Relative Humidity excursion in Walk-In Stability Chamber_09/E/843 AQRS No- 332470 4.ECC Needs Up gradation

10. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 6 11/E/111 Walkin Humidity Chamber 42,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available chamber motor yes N.A N.A 7 11/E/112 Walkin Humidity Chamber 72,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available utility & pannel , chamber motor yes N.A N.A 8 11/E/116 Walkin Humidity Chamber 60,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available utility & pannel , chamber motor yes Temperature excursion in Walk-In Stability Chamber _11/E/116 AQRS No- 358515 9 11/E/117 Walkin Humidity Chamber 60,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available utility & pannel , chamber motor yes N.A N.A 10 09/E/353 Walkin Humidity Chamber 38,000 ltr MACK PLC BEC (CSL 2F stability Room) connected No issues Calibration offset option available chamber motor yes N.A N.A 4.ECC Needs Up gradation

11. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 11 09/E/354 Walkin Humidity Chamber 30,000 ltr MACK PLC BEC (CSL 2F stability Room) connected No issues Calibration offset option available chamber motor yes Calibration failure of Temperature & Humidity controller with sensor(09/E/354) AQRS No- 312167 12 09/E/355 Walkin Humidity Chamber 30,000 ltr MACK PLC BEC (CSL 2F stability Room) connected No issues Calibration offset option available chamber motor yes N.A N.A 13 09/E/356 Walkin Humidity Chamber 50,000 ltr MACK PLC BEC (CSL 2F stability Room) connected No issues Calibration offset option available chamber motor yes N.A N.A 14 09/E/031 Walkin Humidity Chamber 15,000 ltr MACK PLC SVMP (Basement Stability room) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available condensing unit,utility yes     15 09/E/028 Humidity Chamber 2000 Ltr MACK PLC SVMP (Basement Stability room) connected No issues Calibration offset option available condensing unit yes N.A N.A 4.ECC Needs Up gradation

12. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 1 09/E/949 Walkin Cold Chamber 25,000ltr ALLY ONE LVMP(Basement) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 2 09/E/950 Walkin Stability Chamber 25,000ltr ALLY ONE LVMP(Basement) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 3 09/E/951 Walkin Stability Chamber 25,000ltr ALLY ONE LVMP(Basement) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 4 09/E/952 Walkin Stability Chamber 25,000ltr ALLY ONE LVMP(Basement) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 5 09/E/1052 Walkin Cold Chamber 21,000ltr ALLY ONE LVMP(Basement) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 4.ECC Needs Up gradation

13. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 6 09/E/548 Walkin Cold Chamber 16,000ltr ALLY ONE LVMP (2F microbial entry) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 7 09/E/539 Walkin BOD Incubator 16,000 ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Temperature excursion in Walk-In BOD Incubator _ 09/E/539 AQRS NO- 358516 8 09/E/540 Walkin BOD Incubator 14,000 ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A   9 09/E/541 Walkin BOD Incubator 14,000 ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Temperature excursion in Walk-In BOD Incubator _09/E/541 AQRS NO- 358522 10 09/E/542 Walkin BOD Incubator 8,000 ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Temperature excursion in Walk-In BOD Incubator09/E/542 AQRS NO- 357826 11 09/E/543 Walkin Cold Chamber 6,000 ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Temperature excursion observed in Yokogawa recorder for walk in cold chamber 09/E/543 in microbiology laboratory AQRS NO- 354630 4.ECC Needs Up gradation

14. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 12 09/E/790 Cold Chamber 1600 Ltr ALLY ONE LVMP (2F corridor microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 13 09/E/791 Cold Chamber 1600 Ltr ALLY ONE LVMP (2F corridor microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 14 09/E/765 Combi Unit BOD & Cold   ALLY ONE LVMP (3F balance room QC) connected   Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 15 09/E/818 BOD Incubator 565 Ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 16 09/E/819 BOD Incubator 565 Ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 17 09/E/820 BOD Incubator 565 Ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 18 09/E/821 BOD Incubator 565 Ltr ALLY ONE LVMP (2F MEZ microbial) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Temperature excursion observed in Yokogawa data for BOD incubator 09/E/821 AQRS No- 345944 19 09/E/880 Cold Chamber 2000 Ltr ALLY ONE LVMP (2F packing material testing area) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 4.ECC Needs Up gradation

15. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 20 09/E/881 Cold Chamber 2000 Ltr ALLY ONE LVMP (2F entry packing material testing area) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 21 11/E/109 Walkin Humidity Chamber 12,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 22 11/E/110 Walkin Cold Chamber 12,000 LTR MACK NON PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 23 11/E/304 Walkin Cold Chamber 20,000 LTR MACK PLC BEC (PES 1F Stability Room) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 24 11/E/045 Deep Freezer 400 Ltr MACK NON PLC BEC (PES 1F Instrument Room) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 25 11/E/039 Cold Chamber 400 Ltr MACK NON PLC BEC (PES 1F Instrument Room) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 26 09/E/352 Walkin Cold chamber 16,000 ltr MACK PLC BEC (CSL 2F Corridor) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 27 09/E/359 Cold Chamber 1000 Ltr MACK PLC BEC (CSL 2F store) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes 09/E/359_ Cold chamber Temperature was not recorded for more than 4hrs AQRS No- 413199 4.ECC Needs Up gradation

16. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 28 09/E/239 Walkin Humidity Chamber 11,000 ltr MACK PLC 1100 SVMP (Basement Stability room) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes Relative Humidity excursion in Walk-In Stability Chamber_09/E/239 AQRS No- 357828 29 09/E/240 Walkin Humidity Chamber 11,000 ltr MACK PLC 1101 SVMP (Basement Stability room) connected CONVERTOR/SENSOR/P.S issue Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 30 09/E/427 Walkin Humidity Chamber 20,000 ltr MACK PLC SVMP (Basement Stability room) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 31 09/E/428 Walkin Cold Chamber 10,000 ltr MACK PLC SVMP (Basement Stability room) connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 32 02/E/063 Cold Chamber 400 Ltr ALLY ONE SVMP (1F AD) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 33 02/E/026 Cold Chamber 400 Ltr ALLY ONE SVMP (1F AD) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 34 02/E/022 Cold Chamber 400 Ltr ALLY ONE SVMP (1F AD) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 35 02/E/296 Humidity Chamber 200 Ltr ALLY ONE SVMP (1F AD) Not connected No issues Calibration offset option available No major problems, during PM/AMC will observe & process yes N.A N.A 4.ECC Needs Up gradation

17. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 1 09/E/133 Cold Chamber   NEWTRONIC LVMP (3F Instrument room QC) connected No issues Calibration offset option available N.A No N.A N.A 2 09/E/265 Humidity Chamber   NEWTRONIC LVMP (2F packing material testing area) Not connected No issues Calibration offset option available N.A No N.A N.A 3 09/E/025 cold chamber 150 Ltr MACK NON PLC BEC (CSL 2F store) Not connected No issues Calibration offset option available N.A No N.A N.A 4 09/E/027 Cold Chamber   MACK PLC BEC (CSL 2F stability Room) Not connected No issues Calibration offset option available N.A No N.A N.A 5 09/E/266 Walkin Humidity Chamber 8,000 ltr NEWTRONIC SVMP (Basement Stability room) connected No issues Calibration offset option available N.A No N.A N.A 6 09/E/024 BOD Incubator 150 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 7 09/E/142 Cold Chamber 200 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 8 09/E/145 BOD Incubator 600 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 4.ECC Which is not under AMC

18. S No Eq ID Equipment Type CAPACITY Make LOCATION Connected through Yokogawa Yokogawa Issues Temeperature/RH values matching with yokogawa recorder Chamber conditions utilities like heater ,boiler tanks, compressors condensers and door leakeages,control systems,HMI,PLC AMC Status History of Complaints Reference no 9 09/E/146 BOD Incubator 600 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 10 09/E/147 BOD Incubator 400 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 11 09/E/148 BOD Incubator 400 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 12 09/E/151 Cold Chamber 600 Ltr MACK PLC BEC (1F PEAS µBio) connected No issues Calibration offset option available N.A No N.A N.A 13 09/E/442 Ultralow Freezer   MACK NON PLC BEC (1F PEAS µBio) LVMP µ Not connected CONVERTOR/SENSOR/P.S issue Calibration offset option available N.A No N.A N.A 4.ECC Which is not under AMC

19. AMC Issues AMC scope not defined as required (Yakogawa Data logger AMC performed , Major components like Sensors/transmitters , convertor, power supply is not covered). Note :- These major components failure which were not covered in AMC, leaded to frequent breakdowns/complaints/deviations Unavailability/Uncontrolled data backup Unable to retrieve missed out data's (As Data backup is only accessible by IS team) Note:- But data retrieval request is given to Engineering (required to access Data backup path) 5.Yakogawa Issues with AMC

20. At present there is AMC for 50 chambers ( BAS related Equipment's) The scheduled frequency is Quarterly(once in 3 months) At present the Scheduling , following & Ensuring Execution of External AMC for Equipment’s is performed by User dept , AMC will be done by Vendor in presence of QA as per AMC contract – In this case the Efficiency & Operation parameter of chambers is not completely verified( eg . Sensor offsets, PLC – control panel – electrical components) Also Internally PM is performed Quarterly by Engineering team – which is the repeated activity 6 . AMC Issues

21. BAS PROJECT EQUIPMENTS Equipment Name Nos. AMC covered AMC Not covered BOD Incubators 9 4 5 Cold Chamber 14 9 5 Combi Unit BOD & CC 1 1 Deep Freezer 1 1 Humidity Chamber 3 2 1 Ultra low deep freezer 1 1 Walk in BOD Incubator 4 4 Walk In Cold Chamber 8 8 Walk In Stability Chamber 22 21 1 Total 63 50 13 7 . Equipment Master List Vs. AMC

22. BAS PROJECT EQUIPMENTS (Location wise) Location Name Nos. AMC covered AMC Not covered LVMP 27 25 2 BEC PE & AS 9 9 CSL 8 6 2 SVMP QC 15 6 9 SVMP AD 4 4 Total 63 50 13 7 . Equipment Master List Vs. AMC – Location Wise

23. 7. Equipment Master List Vs. AMC NON BAS PROJECT EQUIPMENTS Equipment Name Nos. AMC covered AMC Not covered Vacuum Oven 7 5 2 Laboratory Oven 4 1 3 Steam Pot 2 2 Lab Oven 2 2 Hot Air Oven 2 2 Tray Drier 1 1 Refrigerator 14 6 8 Muffle Furnace 2 2 Autoclave 4 4 MasterClave 2 2 Walkin Frezeer 2 2 Incubator 3 3 DEEP FREEZER 34 34 Photostability chamber 2 2 Walkin cold chamber 1 1 Oven 2 1 1 Humidity chamber 1 1 Cold Chamber 3 1 2 Cold Room 2 2 Total 90 70 20

24. 7. Equipment Master List Vs. AMC NON BAS PROJECT EQUIPMENTS (Location wise) Location Name Nos. AMC covered AMC Not covered LVMP (QC + Micro + QA ) 16 10 6 BEC PE & AS 5 3 2 BEC CSL 4 2 2 SVMP AD 16 13 3 BEC(Clinical + Bio analytical) 49 43 6 Total 90 71 19

25. 8.Summary Following issues to be close before handing over 1. Yokowaga AMC Scope to be revised 2. Offsets to be cleared and calibration to be done Allyone AMC Scope to be check , Non covered AMC to be discuss. Stability chamber up gradation to be complete AMC/Internal Preventive Maintenances to be revised to one maintenances. AMC Cost Budget clarification to be required. 7.Manpower for Documentations and Execution to be consider

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