Standard Operating Procedure Rev. Dt.

01/11/2020
Document No. QUA-PRO-002-00 Page 1 of 4
Review before
SOP for Calibration 01/11/2022
1. OBJECTIVE:

To lay down the procedure for calibration of instruments.

2. SCOPE:

This procedure is applicable to calibration of critical and non-critical instruments.

3. RESPONSIBILITY:

Department / Designation Responsibility

Concerned Department Executive/  To monitor the due date for calibration as per the
Officer/ Operator identification tag.
 To intimate Quality person for arranging calibration.
Quality Executive/Officer  To arrange for Calibration of equipment through external
agency.
 To provide calibration tags on the equipment.
 To update the list of Monitoring and Measuring Equipment.
Head - Quality Control (QC)/  To review and approve calibration reports from external
Designee agencies.

4. PROCEDURE:

4.1. List of Monitoring and Measuring Equipment:

4.1.1. All monitoring and measuring equipment, like analytical and testing equipment/
instrument; equipment/instrument used for processing, monitoring and inprocess
testing of products and areas; equipment/instrument used for monitoring of
engineering/utility systems; equipment/instrument used for weighing; etc. shall be
listed down department wise by concerned department executive/officer in the
Annexure – I List of Monitoring and Measuring equipment.
4.1.2. Quality Head/ Designee; Production Head/Designee and Engineering Head/Designee
shall define the frequency of calibration of the equipment/instrument, based on:
– Criticality of monitoring and measuring equipment/instrument.
– Manufacturer recommendations.

4.2. Preparing monthly Calibration schedule:

4.2.1. Based on the frequency of calibration and due date of calibration, Concerned
department Executive/ officer shall prepare in last week of every month, the list of
equipment/instrument due for calibration in next month.
4.2.2. Concerned Department executive/officer shall forward the list of equipment/
instrument due for calibration to Quality Executive/Officer.
4.2.3. After receiving the above list from all departments, Quality executive/officer shall
prepare a consolidated list of equipment/instrument due for calibration.

Date: Prepared By Reviewed By Approved By

 Standard Operating Procedure Rev. Dt. 01/11/2020
Document No. QUA-PRO-002-00 Page 2 of 4
Review before
SOP for Calibration 01/11/2022
4.2.4. Quality Executive/officer shall then arrange to get the equipment/instrument calibrated
inhouse/externally through respective external agencies.

4.3. Performing Calibration:

4.3.1. External Agency shall calibrate equipment/instrument in presence of Quality

Executive/ Designee. (When calibration is performed inhouse)
4.3.2. External Agency shall submit the calibration report along with raw data. (When
calibration is performed inhouse)
4.3.3. Quality Head/Designee shall review the calibration report with respect to the
acceptance criteria and accordingly approve the calibration report.
4.3.4. External Agency shall provide master equipment calibration report ensuring
traceability to national/international standards.
4.3.5. Wherever national/international standards are not available for calibration of
equipment/ instrument, the basis used for calibration shall be documented.
4.3.6. The calibration of the equipment/instrument shall ideally cover the minimum,
maximum and operational range of the equipment/instrument. However, when it is not
possible to do so, the calibration shall cover at least the minimum range and
operational range of the equipment/instrument.
4.3.7. The record shall contain the details of the standards used for calibration indicating
traceability, instrument serial number, validity, and the details of the instrument under
calibration indicating the name of the instrument, make, ID number, least count,
accuracy and range.
4.3.8. If the instrument/equipment fails in calibration test, stop usage of the instrument
/equipment and put “UNDER MAINTENANCE” label duly filled.
4.3.9. In case the critical instrument/ equipment fails in calibration, such failure shall be
reported to the Quality Head/Designee.
4.3.10. After investigating the reason for failure, the instrument shall be repaired/ replaced as
appropriate and calibration shall be performed. If the instrument is not repairable,
make the instrument unusable and send it to scrap yard for disposal.

4.4. Calibration of New Equipment/Instrument:

4.4.1. Whenever any new equipment/instrument is purchased, manufacturers calibration

certificate shall be made available, before the equipment/instrument is put into use.
4.4.2. In case manufacturers calibration certificate is not available or the date of calibration
is more than 6 months, the equipment/instrument shall be re-calibrated before put into
use.

4.5. Tolerance criteria:

4.5.1. Following shall be the tolerance criteria for calibration of Equipment/instrument:

– Monthly calibration: ± 3 working days.
– Bi-monthly calibration: ± 5 working days.
– Quarterly calibration: ± 7 working days.
– Half yearly calibration: ± 10 working days.

Date: Prepared By Reviewed By Approved By

 Standard Operating Procedure Rev. Dt. 01/11/2020
Document No. QUA-PRO-002-00 Page 3 of 4
Review before
SOP for Calibration 01/11/2022
– Yearly calibration: ± 20 working days.

4.6. Post Calibration:

4.6.1. Once Calibration of equipment/instrument is completed and reports are reviewed and
accepted; Quality Executive/officer shall ensure that new calibration tags duly filled
are put on the equipment/instrument.
4.6.2. All equipment/instruments shall be safeguarded from adjustments, damage or
deterioration that would invalidate the calibration status and subsequent
measurement results.

4.7. Action to be taken for unusual observation for instrument during calibration:

4.7.1. Q.C. Executive calibrating the instrument shall inform the concerned Executive
regarding the out of calibration incidence of the instrument.
4.7.2. Q.C. Executive shall go through the problem arisen and shall try to rectify the problem
if possible within available parameters and guideline received from the manufacturer.
4.7.3. He/She shall inform to maintenance department if the problem is not rectified or
solved.
4.7.4. If the problem is arisen of other technical nature and cannot be rectified, he shall
inform with the details of the problem to the authorized service center or manufacturer
regarding the nature of the problem and intimate them to send the service engineer to
rectify the problem at the earliest.
4.7.5. After servicing the instrument by service engineer re-calibrate the instrument as per
respective SOP’s and keep the record of the same. Note down the details in
respective instrument history card.
4.7.6. Analyse the product/batch which was last analysed on that particular instrument to
confirm the result.
4.7.7. The difference between the initial result & the new result after re-calibration should
not differ by more than 1%.
4.7.8. If the result of the last analysed batch/product is not within this ±1% of initial result
then select second last batch/product for analysis and continued doing testing of the
batches/product in reverse order till the results are found within the ±1% of the initial
result.
4.7.9. List out the batches not complying the ±1% criteria and ensure that the revised results
comply with a specified limit as per release specification.
4.7.10. In case of raw material/list out the RM if the revised results do not comply with ±1%
criteria.
4.7.11. Ensure that the revised results of listed RM comply with laid down specifications.
4.7.12. In case, if it is found not, complies, immediately instruct RM store to stop the further
use through proper channel and inform to QC Incharge for further action.
4.7.13. List out the batches manufactured using the particular RM.
4.7.14. Follow step 4.7.9 to 4.7.12 for the listed out batches.

5. DISTRIBUTION:

Date: Prepared By Reviewed By Approved By

 Standard Operating Procedure Rev. Dt. 01/11/2020
Document No. QUA-PRO-002-00 Page 4 of 4
Review before
SOP for Calibration 01/11/2022
5.1. This SOP (Controlled Copy) shall be distributed to following Department of the
Plant.

5.1.1. Quality.
5.1.2. Warehouse.
5.1.3. Production.
5.1.4. Engineering
5.1.5. HR & Admin

5.2. Master Copy remains with Quality Department.

6. ANNEXURES:

Annexure – I List of Monitoring & Measuring Equipment

7. FORMATS:

Sr. No. Document No. Title

1.

8. REFERENCE DOCUMENTS:

Sr. No Reference Detail

1.

9. REVISION HISTORY:

Revision No. Effective Date Details of changes

00 01/11/2020 New SOP

Date: Prepared By Reviewed By Approved By