SOP for Annual Maintenance Contract of Instruments

Standard Operating Procedure for Annual Maintenance Contract of Instruments

Standard Operating Procedure for Annual Maintenance Contract of Instruments

1.0 Purpose:

To lay down a procedure for Annual Maintenance Contract (AMC) for Quality Control Instruments.

2.0 Scope:

2.1 The scope of this SOP is applicable for Annual Maintenance Contract (AMC) for Quality Control Instruments at [Company Name]

3.0 Responsibility:

QC-Personnel: Preparation of AMC schedule, coordination with service agency.

Head QC/Designee: Approval of AMC, To check the “List of Instrument / Equipment due for AMC”.

Head QA & QC/Designee: To verify the “List of Instrument / Equipment due for AMC”.

Purchase Manager: Negotiation with Service Agency.

4.0 Definitions:

Not applicable

5.0 Procedure:

  • AMC shall be effective after the warranty period of respective Instruments by the Manufacturer.
  • AMC shall be valid for one year from the Date of Agreement.
  • Only critical Instruments shall be considered for AMC. Refer to reactive Format.
  • The Frequency for Annual Maintenance Contract of Instruments shall be decided as per the Vendor’s recommendation.
  • The Frequency for renewal of Annual Maintenance Contract shall within 1 month of contract expiry date.
  • QC Person in consultation with Head – QC/Designee shall decide on the Instruments for which AMC is required.
  • QC Person shall prepare an “Annual Maintenance Plan” at the beginning of Financial Year. Refer respective Format.
  • The planner must be prepared in computerized copy with provision of checked by from quality assurance and approved by from quality assurance.
  • QC Person shall Review the “Annual Maintenance Contract Plan” at the beginning of each month. He / She shall prepare the list of Instrument / Equipment due for AMC in the Format “List of Instrument / Equipment due for AMC”.
  • Format for “List of Instrument/ Equipment due for AMC” shall be issued from QA.
  • The initiation of AMC agreement to be initiated before 60 working days.
  • QC Person shall invite quotations from the servicing agencies and select the criteria and the type of AMC with respect to number of calls, and replacement of spares, if any.
  • QC Person shall forward the received quotations, to Manager Purchase, with comments, for commercial negotiations.
  • Manager purchase shall negotiate the AMC and send two copies of AMC from the agency with the criteria as selected by Head QC/Designee and the negotiated price.
  • Manager purchase shall prepare purchase order and shall send to the plant.
  • After Purchase Order generation, AMC shall be confirmed and shall inform to service engineers.
  • If the AMC agreement renewal is pending due to under discussion the AMC should not be stopped and continued with respective to plan prepared.
  • In case of breakdown in Instrument, QC person shall call the service person and shall rectify the problem.
  • In case malfunction or any problem found in instrument analyst shall inform to Head QC/Designee and label it as “UNDER MAINTENANCE” with initial and date.
  • If required, Head QC/Designee shall inform service engineer (Manufacturer) for the rectification.
  • If any Internal Maintenance is required, Maintenance Department rectify the breakdown. 
  • After rectification of instrument Head QC or Designee shall ensure the working of instrument and instruct analyst to check the partial calibration or full calibration (As applicable) as per respective SOP.
  • At the end of every month, Head QC / Designee shall check all instrument / equipment are covered for AMC as per the list “List of Instrument / Equipment due for AMC” and same shall be verified by Head QA & QC / Designee.
  • The AMC of the instruments shall be completed within 30 working days.
  • After completion of AMC Activity, Lab. Support Personnel shall review the activities as per checklist titled as “AMC activity review checklist”. Refer respective Format.

6.0 Frequency:

  • As and when required.
  • Renewal of Annual Maintenance Contract shall within 1 month of contract expiry date.
  • AMC of instruments shall complete within 30 working days.

7.0 Format for recording:

7.1 Format for “List of Instrument and Service Agency”.

Sr. No.InstrumentService agency

7.2 Format for “Annual Maintenance Plan”.

Sr. No.                             MonthJanFebMarAprMayJun…….. Dec
Instrument          NameInstrument Code/ID.     No.           
   Due Date    
   Performed Date    
Prepared By & DateChecked By & DateChecked By & DateApproved By & Date
Quality ControlQuality ControlQuality AssuranceQuality Assurance

7.3 Specimen for “Annual Maintenance Contract Label”.



MAKE                              :

MODEL                           :


REF. SOP NO.                :

DONE ON                       :                             CHECKED BY : NEXT DUE ON              :

7.4 Format for “List of the Instrument / Equipment due for AMC”.

Sr. No.Instrument /Equipment NameInstrument / Equipment CodeAnnual Maintenance Due DateAnnual Maintenance Performed On
                –Prepared ByChecked ByVerified By
Department   Quality Control   Quality ControlQuality Assurance

7.5 Format for “AMC activity review checklist”.

Instrument /Equipment Name;                                                                                                      

Instrument / Equipment ID:                                                           Issued By (sign/Date):_______

Check PointRemark
Whether instrument cleaned properly?Yes/No/Not Applicable
Whether any damage and crack found on the instrument?Yes/No/Not Applicable
Whether instrument alignment was done after completion of AMC?Yes/No/Not Applicable
Whether the silica replaced?Yes/No/Not Applicable
Whether any leakage observed?Yes/No/Not Applicable
Whether the filter was replaced / correctly fitted?Yes/No/Not Applicable
Whether the tubing was replaced / correctly fitted?Yes/No/Not Applicable
Check Internal and External AdjustmentYes/No/Not Applicable
Whether needle wash, seal wash and delta psi found ok?Yes/No/Not Applicable
Whether any spare parts / PM kit are replaced?Yes/No/Not Applicable
Whether HPLC pump seals replacedYes/No/Not Applicable
Whether the condition of optics ok?Yes/No/Not Applicable
Whether all connections are properly connected?Yes/No/Not Applicable
Whether all electrical connections connected and free from carbon deposition?Yes/No/Not Applicable
Whether cleaned or replaced check valve of HPLC pump?Yes/No/Not Applicable
Whether LVPS voltages of HPLC detector verified?Yes/No/Not Applicable
Whether cleaned the flow cell of HPLC detector?Yes/No/Not Applicable
Verify the time zone setting before starting the installationYes/No/Not Applicable
Verify region setting (Date and time format).If below setting are missed during report generation different users will get different formats.Yes/No/Not Applicable
Uninstall third-party software like DELL, Lenovo or HP tools which is causing CPU performance IssuesYes/No/Not Applicable
Disable User account Control Setting.Yes/No/Not Applicable
Switch off all the firewall profiles if it’s not controlled by group policy  Yes/No/Not Applicable
Verify that windows update are as per recommendationsYes/No/Not Applicable
Disable system protection optionYes/No/Not Applicable
Set virtual memory (minimum and Maximum) to 4 times of RAMYes/No/Not Applicable
Disable IPV6 for all network adaptorsYes/No/Not Applicable
Disable all the power option settings. Additionally , Disable below mentioned options if available: i.IPv4 checksum offload ii.TCP checksum offload (IPv4) iii.UDP checksum offload (IPv4)Yes/No/Not Applicable
Disable all the unused network ports in systemYes/No/Not Applicable
Network ports need to be bridged for LAC/e 32 PCYes/No/Not Applicable
Disable windows power saving setting. Set power setting to High performance.Yes/No/Not Applicable
Disable Disk defragmentation scheduleYes/No/Not Applicable
Disable volume shadow copy serviceYes/No/Not Applicable
Disable windows search service and windows defender serviceYes/No/Not Applicable
Disable windows update service.Yes/No/Not Applicable
Disable adobe update service and any other unwanted servicesYes/No/Not Applicable
Run command: comexp.msc/32 and open component settingYes/No/Not Applicable
Make sure to add host file in all the system to avoid any naming resolution issues due to DNS slow response.Yes/No/Not Applicable
Check and confirm the instrument performance after completion of AMC.Yes/No/Not Applicable  
After completion of all above checkpoints, performed other Diagnostics verification from HMI of HPLC system for following: Whether valve leak test (V1 and V2) Performed?Whether static leak test performed?Whether “Carousel” test performend?Whether “Sample heater/Cooler” test performed?Whether “Column heater/Cooler” test performed?      Yes/No/Not Applicable   Yes/No/Not Applicable Yes/No/Not Applicable Yes/No/Not Applicable   Yes/No/Not Applicable
Other check points (if any) checked:  
Comment (If any):  

Checked By (service engineer):                                                  Verified By (QC person):

(Sign/ Date)                                                                                   (Sign/ Date

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