SOP on Calibration Policy
SOP on Calibration Policy
1.0 What
This document details the Calibration Policy of equipment/ instrument of the Company.
2.0 Why
It is the policy of the Company that the written procedure shall be followed for calibration of all Equipment / Instrument at suitable interval based on manufacturer’s recommendation, historical experience and criticality of use, used in the process of Manufacturing, Packing, Analytical division,Q.C., Maintenance and Warehouse other than those Equipment / Instrument that are calibrated with each use.
3.0 When
This procedure is to be applied at the time of preparation of calibration schedule once in a year for both In house calibration and out side party Calibration. The instrument / equipment are to be calibrated as per their individual frequencies stated in the calibration schedule.
4.0 RESPONSIBILITY
Persons along with their responsibilities are given below:
| S. No | Designation | Responsibility |
| 01 | Executive – Corporate Quality Assurance | To prepare procedure and coordination for calibration with Outside party and concerned department. |
| 02 | Executive – Quality Assurance | To prepare In house and outside calibration schedule |
| 03 | Executive – Quality Assurance | Execution and overall responsibility for calibration with Outside party and concerned department |
| 04 | Manager – Quality Assurance |
To ensure that calibration is being done accordingly. |
| 05 | Manager – Corporate Quality Assurance | To ensure implementation of SOP |
5.0 PROCEDURE
5.1.1 Separate calibration programs for in house calibration and outside party calibration shall be prepared in the beginning of each year for all instrument / equipment to be calibrated on dates as per their individual frequencies.
5.1.2 Calibration of Equipment / Instrument shall be carried out at suitable intervals based on manufacturer’s recommendation, historical experience and criticality of use.
5.1.3 Calibration standards for in-house or contract service must be traceable to a recognized National Standard and within calibration validity period.
5.1.4 All traceability certificates shall be checked by department Head and reviewed by person responsible for calibration activities.
5.1.5 Both In house and outside calibration schedule shall be prepared by the concerned departments as per Annexure I (Format for Outside Party Calibration Schedule) and Annexure II (Format for In house Calibration Schedule) and shall be handed over to Quality assurance Department.
5.1.6 Quality assurance Department on receiving schedules from different department will prepare a composite Schedule for calibration and will send a copy of the same to all concerned department.
5.1.7 On installation of new equipment, during qualification all instruments need to be calibrated shall be identified based on manufacturer recommendation and criticality of use. User department will inform to Quality assurance Department about the same for inclusion in the calibration schedule on Appendix – I.
5.1.8 On procurement of new measuring instruments like, thermometers, Thermo hygrometers etc. the user department will inform to Quality assurance Department for inclusion in the calibration schedule on Appendix-I.
5.1.9 Once the instrument is included in the calibration schedule, Quality assurance Department will allot new ID no. of that series based on the type of instrument and will inform to concerned department.
5.1.10 User department will inform to Quality assurance Department about 30 days prior to due date of calibration for out side party calibration so that necessary arrangements can be made on Appendix-III.
5.1.11 All concerned departments are required to intimate Quality assurance Department whenever any instrument is replaced, out of use, damaged, out of calibration or when there is no calibration status label.
5.1.12 Calibration schedule (both In-house and outside) will be live document and any inclusion can be made
5.1.13 Although all efforts will be made to calibrate the instrument / equipment on or before/after due dates the following grace periods will be accepted based on the criticality and frequency of calibrations :
Monthly : 1 Week
Quarterly : 1 Week
Half yearly : 2 Week
Yearly : 4 Week
5.1.14 The schedule shall have the following information:
5.1.14.1 Names of instrument / equipment
5.1.14.2 Identification Nos. (ID Nos.)
5.1.14.3 Location
5.1.14.4 Name of outside party
5.1.14.5 Frequency of calibration
5.2 Outside Party Calibration
5.2.1 In case of outside party calibration, a technical contract shall be signed with the party specifying the general conditions of calibration using agreed methods.
5.2.2 Calibration shall be carried out at the site in presence of a supervisor/ officer of the concerned department.
5.2.3 If calibration is not possible at the site, shall be send to the site of outside agency.
5.2.4 Calibration of Equipment / Instrument shall be carried out as per the Standard Operating Procedure.
5.2.5 HOD of the concerned department shall ensure that calibration is being carried out as per SOP.
5.2.6 If any equipment / instrument found out of calibration, label it as “UNDER MAINTENANCE” , update the Instrument History Card as per Appendix II and inform to Quality Assurance for appropriate action.
5.2.7 In case the instrument is out of calibration it gets promptly reported and steps taken to remove it from service.
5.2.8 Instrument/equipment shall not be further used till complies the calibration requirements.
5.2.9 The acceptance criteria for calibration of instrument / equipment shall be provided by the company to the outside party agent based on the cGMP requirements.
5.2.10 On successful calibration of any equipment / instrument the calibrating agency personnel shall label the instrument with a green coloured calibration sticker.
5.2.11 Calibration sticker shall have information like date of calibration, Instrument ID No., Calibration date, signature of the person who carried out the calibration and next due date of calibration.
5.2.12 The calibrating agency shall issue a certificate of calibration in respect of each instrument / equipment calibrated.
5.2.13 Calibration certificate shall have details like identification of the instrument, the range of calibration, standard calibrators used and their traceability, the date of calibration, the actual values obtained, the date on which the next calibration is due and the signatures of the person who carried out the calibration activity.
5.2.14 Each certificate of calibration of instrument / equipment shall be reviewed by concern Department.
5.2.15 Along with these calibration certificates the calibrating agency shall also provide copies of the calibration certificates of the standard calibrators used, traceable to National Standards.
5.2.16 All traceability certificates shall be checked by department Head and reviewed by person responsible for calibration activities.
5.2.17 Ensure that resolution (least count) of calibrator should be less than the resolution of equipment/instrument to be calibrated.
5.2.18 The certificates shall be documented & maintain the record.
5.3 In house Calibration
5.3.1 A calibration schedule shall be prepared in the beginning of each year for all instruments / equipment which to be calibrated as per their individual frequencies.
5.3.2 Calibration of instruments shall be done as far as possible in the location of its use.
5.3.3 In case the instrument / equipment is found out of calibration, it shall be immediately labeled “UNDER MAINTENANCE”, update the Instrument History Card as per Appendix II and inform to Quality Assurance for appropriate action.
5.3.4 In case the instrument is out of calibration it gets promptly reported and steps taken to remove it from service.
5.3.5 Instrument/ equipment shall not be further used till complies the calibration requirements.
5.3.6 After successful calibration, the instrument shall be labelled with a Green calibration sticker indicating the Instrument name, date of calibration, Tag No. / ID No., signature of the person who carried out the calibration and next due date of calibration.
5.3.7 Calibration reports shall be prepared by the person carrying out the activity and shall be reviewed by designated person and documented.
5.3.8 Maintenance or moving of an instrument can alter calibration status and accuracy of data. Hence after any such activity with the instrument shall be assed and recalibrated (whenever required) and document the calibration record.
5.3.9 Re-calibration shall be done in case of any maintenance or re-installation of instrument / equipment (wherever applicable) and record shall be maintained.
5.4 FOLLOW-UP FOR OUT OF CALIBRATION
5.4.1 The details of ‘Out of Calibration’ shall be recorded in the logbook of respective instrument / equipment and inform to Quality assurance Department.
5.4.2 Fill the form on JOB ORDER attached in Appendix IV and send it to engineering department.
5.4.3 HOD – Engineering shall take the corrective action accordingly.
5.4.4 The QA Officer shall assess the number of Sample affected or the number of analysis affected and the impact of the same on the quality or system.
5.4.5 Record the maintenance details in the log of instrument / equipment.
5.4.6 Calibrate the instrument/ equipment after rectification as per the respective calibration SOP.
5.4.7 Record the calibration in the log of the instrument / equipment.