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. | Instrument | Service agency |
7.2 Format for “Annual Maintenance Plan”.
| Sr. No. | Month | Jan | Feb | Mar | Apr | May | Jun | …….. Dec |
| — | Instrument Name | Instrument Code/ID. No. | ||||||
| Due Date | ||||||||
| Performed Date | ||||||||
| Prepared By & Date | Checked By & Date | Checked By & Date | Approved By & Date |
| Quality Control | Quality Control | Quality Assurance | Quality Assurance |
7.3 Specimen for “Annual Maintenance Contract Label”.
AMC STATUS
INSTRUMENT NAME :
MAKE :
MODEL :
IDENTIFICATION NO.:
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 Name | Instrument / Equipment Code | Annual Maintenance Due Date | Annual Maintenance Performed On |
| – | Prepared By | Checked By | Verified By |
| Signature | |||
| Date | |||
| Name | |||
| Department | Quality Control | Quality Control | Quality Assurance |
7.5 Format for “AMC activity review checklist”.
Instrument /Equipment Name;
Instrument / Equipment ID: Issued By (sign/Date):_______
| Other check points (if any) checked: |
| Comment (If any): |
Checked By (service engineer): Verified By (QC person):
(Sign/ Date) (Sign/ Date