Standard Operating Procedure for Calibration of Quality Control Instruments

1.0 Purpose:

To lay down a procedure for Calibration of Quality Control Instruments.

2.0 Scope:

The scope of this SOP is applicable for carrying out Calibration of Quality Control Instruments in quality control department and microbiology department. It also provides the procedure for Monitoring the Calibration Schedule in quality control department at [company name].

3.0 Responsibility:

3.1 QC Personnel

To Calibrate the Instrument.
To Prepare the Calibration Record and Certificate of Calibration.
To update the Calibration Status.
To make necessary entries in the Instrument Usage Logbook.

3.2 Section Head QC/ Designee:

To check the correctness of the Calibration Data entered into the Calibration Record and entry in the Instrument Usage Logbook.
To Check the Calibration Status.
To Check the Certificate of Calibration.

3.3 Head QC/Designee:

To Approve the Calibration Record and Certificate of Calibration.
To monitor the activity.

4.0 Definitions:

Not applicable

5.0 Procedure:

5.1 Calibration shall be performed in case of followings;

5.1.1 Procurement of new Instrument/ Instrument Accessory

5.1.2 As per the Annual Calibration Schedule

5.1.3 After Instrument Maintenance

5.1.4 Calibration shall be started as per given frequency (Provided grace period) or as per the due date.

5.1.5 Post evaluation of instrument, as per predefined acceptance criteria shall be release for routine use If calibration shall be started after due date. Deviation shall be filled for delay and impact assessment if any.

5.1.6 In case of laboratory incident/ Breakdown/ OOC remark shall be mentioned in the Calibration planner for better clarity for delay in calibration.

5.2 Calibration of the Instrument can also be done before the due date with respect to the Frequency given within Provided grace period.

5.3 Instrument, which does not require Calibration, shall be labelled as “Need not to be calibrated”.

5.4 Monitoring of Calibration of Instrument with respect to Calibration Schedule:

5.4.1 Follow Calibration Schedule of each Instrument as per the frequency mentioned in the individual Instrument Calibration SOP.

5.4.2 Review the Calibration Schedule at the beginning of each month to track the Instrument due for Calibration.

5.4.3 Calibration Schedule shall act as ready reference for Calibration Status during the entire period of year.

5.4.4 In case any new Instrument needs to be added in the Calibration Schedule, make entry in it manually and subsequently incorporate in next revision.

5.4.5 The annual Calibration Schedule shall track through LIMS.

5.5 Calibration Procedure:

5.5.1 QC Person shall follow the respective Calibration SOP for the Calibration of the Instrument.

5.5.2 He / She shall record all the observation in the “Calibration Record” and relevant Calibration Data, Spectra, Chromatograms to it (If any).

5.5.3 Any other QC Person shall check the “Calibration Record” along with relevant Calibration Data, Spectra, Chromatograms and “Certificate of Calibration”.

5.5.4 After the completion of the Calibration, QC Person shall enter the details in the “Calibration Status” Tag of the Instrument.

5.5.5 Head QC shall approve the Calibration Record and Certificate of Calibration.

5.6 Out of Calibration Procedure:

5.6.1 In case the Calibration of Instrument is not Satisfactory, it shall be labelled as “OUT OF CALIBRATION” and follow the procedure as per “SOP for Handling of Out of Calibration”.

6.0 Acceptance Criteria:

Not Applicable

7.0 Frequency:

Monthly: “- 3 Days”
Quarterly: “- 5 Days”
Half Yearly: “- 15 Days”
Yearly: “- 30 days”

8.0 Format for recording:

8.1 Calibration Status Tag

CALIBRATION STATUS

Instrument Name:

Make:

Model:

Identification No.:

Ref. SOP. No.:

Done On:

Done By:

Next Due Date:

8.2 Certificate of Calibration

CERTIFICATE OF CALIBRATION

Instrument Name:

Instrument Id:

Model No. Make :

Calibration Date: Next Due Date :

Sr. No.	Parameter	Result	Acceptance Criteria
1
2
3
4

Remarks:

——	Prepared By	Checked By	Approved By
Sign & Date
Name
Department	Quality Control	Quality Control	Quality Control