The purpose of this SOP is to lay down a procedure for Maintenance of Laboratory Instrument / Equipments in Quality control department.
This SOP is applicable to Quality Control Department at manufacturing facility
- Analyst or his designee shall be responsible for follow the SOP.
- The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
- Install the Instrument / Equipment as per Manufacturer’s recommendation in laboratory.
- Include Instrument / Equipment in laboratory Instrument / Equipment list as per Annexure-I.
- Assign identification number to each of the Instrument / Equipment in the laboratory as per SOP for Instrument coding system (QC030)
- Qualify the Instrument / Equipments before use. Qualification shall be carried out by the service engineer of Manufacture/Supplier of the instrument/Equipment.
- Prepare standard operating procedure for the operation and calibration. This shall include Calibration frequency.
- Prepare Instrument / Equipment History Card as per Annexure-II
- Carry out preventive maintenance as per preventive maintenance schedule (Annexure III) by external service engineer.
- In case of malfunctioning / break down of Instrument / Equipment following action plan to be followed:
- 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.
- 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.
- 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.
- Based on the remark of Site Engineering, QC head shall contact to Service providing agency by email or telephone.
- Record the preventive and breakdown maintenance in Instrument / Equipment History Card.
- Prepare Instrument / Equipment preventive maintenance schedule for every year as per Annexure III.
- 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.
- 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.
- After completion of activity (Preventive maintenance or Calibration), the Actual date shall be written and updated the planner.
- 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.
Trainer : Head – Quality Control
Trainees : Quality Control chemist / Sectional Heads
Controlled Copy No.1: Head of Department – Quality Assurance
Controlled Copy No. 2: Head of Department – Quality Control
Original Copy : Head – Quality Assurance
Annexure I : Instrument / Equipment List
Annexure II : Instrument / Equipment History record
Annexure III : Instrument / Equipment preventive maintenance Schedule
Annexure IV : Instrument / Equipment Calibration Schedule
SOP “Laboratory incidents” QC089
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||—-||New SOP||New SOP|