Standard Operating Procedure for External Calibration of Instrument or Equipment in Quality Control Lab

1.0 Purpose:

To lay down a procedure for External Calibration of Instrument / Equipment in Quality Control Department.

2.0 Scope:

The scope of this procedure is applicable for External Calibration of Instrument / Equipment in Quality Control Department [company name].

3.0 Responsibility:

3.1 QC Personnel:

To prepare the annual external temperature mapping schedule.
To check the temperature mapping report.
To prepare master list of weight box and sieve.

3.2 Engineering Personnel:

To prepare the annual external calibration schedule.
To co-ordinate with the external calibration agency during the calibration.
To approve the external calibration certificate.
To monitor the activity.

3.3 Section Head Engineering/ Designee: To check the annual external calibration schedule.

3.4 Section Head QC/ Designee:

To check the annual external temperature mapping schedule.
To monitor the activity.

3.5 Head QC/ Designee:

To verify the external temperature mapping report.
To check the master list of weight box & sieve.
To approve the annual external temperature mapping schedule.
To monitor the activity.

3.6 Head QA / Designee:

To approve the master list of weight box & sieve.
To approve annual external calibration schedule.

4.0 Definitions:

5.0 Procedure:

5.1 External calibration/temperature mapping shall be done by an approved external agency (approved by [company name]).

5.2 External calibration/temperature mapping shall be performed as per the “Annual External Calibration/Temperature Mapping Schedule”.

5.3 The external agency personnel shall bring the necessary accessories required for the instrument/equipment due for calibration/temperature mapping.

5.4 If any new instrument needs to be added to the “Annual External Calibration Schedule”, Engineering Personnel shall make an entry in SAP and subsequently incorporate it in the next revision.

5.5 If any new agency needs to be added to the list of “External Calibration Agencies”, Engineering Personnel shall make an entry in it manually and subsequently incorporate it in the next revision.

5.6 Any newly procured weight box shall be enlisted in the format for the “Master List of Weight Boxes”.

5.7 Any newly procured sieve shall be enlisted in the format for the “Master List of Sieves”.

5.8 Engineering Personnel shall prepare an “Annual Calibration Plan”. QC Personnel shall prepare an “Annual Temperature Mapping Schedule” as per their respective formats at the beginning of the calendar year, and a copy of the same shall be given to the external agency for their reference.

5.9 Engineering Personnel shall review the calibration at the beginning of each month and track due for calibration in SAP.

5.10 QC Personnel shall review the temperature mapping schedule at the beginning of each month and prepare a list of instruments/equipment due for temperature mapping.

5.11 Engineering Personnel shall communicate with the external agency for calibration.

5.12 QC Personnel shall communicate with the external agency for temperature mapping as per the list.

5.13 Engineering Personnel shall accompany external agency personnel during calibration.

5.14 QC Personnel shall accompany external agency personnel during temperature mapping.

5.15 The external agency shall send a certificate of calibration of lab instruments (in case of calibration) and a temperature mapping report and certificate (in case of temperature mapping), duly signed by the performer and checker.

5.16 Engineering Personnel shall approve the certificate of calibration (in case of calibration), and Head QC/Designee shall verify the temperature mapping report and certificate (in case of temperature mapping) and sign them.

5.17 After Temperature Mapping activity, the external agency shall tag the external mapping label.

6.0 Acceptance Criteria:

Not applicable.

7.0 Frequency:

Instrument / Equipment	Frequency
Thermometer Hygrometer, Vernier caliper, Micrometer Scale, Stop Watch, Sieve of sieve shaker, Conductivity sensor kit, Digital tachometer, Wobble gauge, Depth gauge, Digital protractor, Centering kit, Basket validation gauge, Standard 25mm gauge	06 months- 30 Days
Data logger, Wall clock, Micro pipette (Finn pipette), Digital flow meter, Temperature and Humidity Oven Mapping	06 months- 30 Days
Temperature Controller, Temperature Sensor, Humidity Controller, Humidity Sensor, Timer, Pressure Gauge, Safety Controller	6 Month – 30 Days
Weight Box, Stability Humidity Chamber (Temperature Mapping), Humidity Chamber (Temperature Mapping), Vaccum Oven, Drying Oven, Hot Air Oven	1 Year – 30 Days
Cooling Cabinet (Temperature Mapping), Deep Freezer (Temperature Mapping), Dual Chamber (Temperature Mapping), Muffle Furnace (Temperature Mapping)	1 Year – 30 Days

8.0 Format for recording:

8.1 Format for “Annual Temperature Mapping Schedule”.

Sr. No.	Equip. Name	Equip.Code	Frequency	Schedule Date	Jan	Feb	…..	Nov	Dec
				Due date
				Performed Date

—	Prepared By	Checked By	Approved By
Signature
Date
Name
Department	Quality Control	Quality Control	Quality Control

8.2 Format for “List of the Instrument /Equipment due for Temperature Mapping”.

Sr. No.	Instrument / Equipment Name	Instrument / Equipment Code	Due Date	Performed on

—	Prepared By	Checked By	Approved By
Signature
Date
Name
Department	Quality Control	Quality Control	Quality Control

8.3 Format for “Master List of Weight Box”.

Sr. No.	Weight Box	Make	Weight Box No.	Range

—	Prepared By	Checked By QC	Approved By QA
Signature
Date

8.4 Format for “Master List of Sieve”.

Sr. No.	Serial number of Seive	Mesh size	Make

—	Prepared By	Checked By QC	Approved By QA
Signature
Date