SOP For Maintenance of laboratory Instrument

1. OBJECTIVE:

The purpose of this SOP is to lay down a procedure for Maintenance of Laboratory Instrument / Equipments in Quality control department.

2. SCOPE: 

This SOP is applicable to Quality Control Department at manufacturing facility 

3. RESPONSIBILITY:
   1. Analyst or his designee shall be responsible for follow the SOP.
   2. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
4. PROCEDURE:

1. Install the Instrument / Equipment as per Manufacturer’s recommendation in laboratory.
2. Include Instrument / Equipment in laboratory Instrument / Equipment list as per Annexure-I. 
3. Assign identification number to each of the Instrument / Equipment in the laboratory as per SOP for Instrument coding system (QC030)
4. Qualify the Instrument / Equipments before use. Qualification shall be carried out by the service engineer of Manufacture/Supplier of the instrument/Equipment.
5. Prepare standard operating procedure for the operation and calibration. This shall include Calibration frequency.
6. Prepare Instrument / Equipment History Card as per Annexure-II
7. Carry out preventive maintenance as per preventive maintenance schedule (Annexure III) by external service engineer.
8. In case of malfunctioning / break down of Instrument / Equipment following action plan to be followed:
   1. If instrument / Equipment is under warranty period the QC section head shall be raise the job order to site Engineering Dept. to evaluate & resolve the problem by disturbing the Warranty terms & conditions.
   2. If instrument / Equipment is not under warranty period the QC section head shall be raise the job order to site Engineering Dept. to evaluate & resolve the problem internally.
   3. After evaluation by Site Engineering personnel, if help from specific service Engineer is needed then Engg. Dept. shall write such remark on Maintenance Job order copy & share such copy to QC Dept.
   4. Based on the remark of Site Engineering, QC head shall contact to Service providing agency by email or telephone.
9. Record the preventive and breakdown maintenance in Instrument / Equipment History Card.  
10. Prepare Instrument / Equipment preventive maintenance schedule for every year as per Annexure III.
11. Every year prepare calibration schedule for laboratory Instrument / Equipments format for calibration schedule as per Annexure IV. Perform calibration as per the scheduled date and after completion, add performed date in the same planner.
12. Changes like Addition & deletion in calibration or maintenance schedule, Annexure-III (Instrument/Equipment Preventive maintenance schedule) and Annexure-IV (Instrument/Equipment Calibration schedule) shall be updated timely by using same formats.
13. After completion of activity (Preventive maintenance or Calibration), the Actual date shall be written and updated the planner. 
14. In case of malfunctioning of Quality impacting instruments/ Equipments, the Incident shall be raise & failure investigation shall be carried out as per SOP “Laboratory incidents” QC089. 
15. TRAINING:

 Trainer : Head – Quality Control 

 Trainees             : Quality Control chemist / Sectional Heads

6. DISTRIBUTION:

Controlled Copy No.1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Quality Control

Original Copy               :  Head – Quality Assurance

7. ANNEXURE:

            Annexure I : Instrument / Equipment List 

Annexure II : Instrument / Equipment History record

Annexure III : Instrument / Equipment preventive maintenance Schedule

            Annexure IV : Instrument / Equipment Calibration Schedule

8. REFERENCES(S):

SOP “Laboratory incidents” QC089 

9. REVISION HISTORY:

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	—-	New SOP	New SOP