SOP FOR CALIBRATION OF QC INSTRUMENTS

I.                   PURPOSE

To describe a procedure for calibration of QC instruments.

II.                SCOPE

This procedure is applicable for all the instruments which required periodic calibration in

            Quality Control department,

III.             RESPONSIBILITY

Assistant, Executive- Quality Control

IV.             ACCOUNTABILITY

Incharge –Quality Control

V.                PROCEDURE

1.0              Calibration falls in two categories

1.1              Internal calibration : which is carried out by user / maintenance department of with in house procedures.

1.2              External calibration : which is carried out by third party.

2.0              Annual calibration schedule should be prepared as per 

            Annexure No. AX01/SOPPQC006-00.

3.0              Before starting the calibration, check for the availability and validity of the required standards/equipments/instruments.

4.0             Ensure that all the standards / instruments/equipments are traceable to national / international standards (where applicable).

5.0             Before starting the calibration, go through the calibration procedure and protocol.

5.1              Perform the calibration as per ‘Calibration procedure’.

5.2              The instruments which are covered under daily calibration should be labeled with

                        “DAILY CALIBRATION” label and the calibration details should be entered in                        the respective standard format.

6.0              After completion of Calibration/Validation,

6.1              If the results found satisfactory, label the instrument with calibration status for calibration and validation status label for validation.

6.2              Write down all the observations / results in protocol and take approval of authorized person.

6.3              Before approval of records, authorized person should check all the calculation and ensure that the calibration is carried out as per calibration procedure and the results obtained are well within specified limits.

6.4              If the results are not satisfactory, label the instrument with 

“OUT OF CALIBRATION” label, and for validation,

“OUT OF VALIDATION” label.

6.5              If the results are not satisfactory, inform to incharge Q.C.

6.6              Investigation should be carried out as per ‘Out Of Specification’ (OOS) SOP.

6.7              Action plan to be followed by incharge QC

6.7.1        Ensure that standard procedure is followed for calibration/validation.

6.7.2        Check whether all the calculations are correct. (if applicable).

6.7.3        Ensure that right standards/equipments/instruments are used for

calibration/validation.

6.7.4        Enter all the data in tabular format for evaluation.

6.7.5        Head -QA should write conclusion after reviewing the data.

6.8              Satisfactory

6.8.1        Calibration / validation results are within specified limits as mentioned procedures.

6.9              Not satisfactory

6.9.1        Calibration / validation results are not within specified limits

                  as mentioned in procedures.

7.0       List of Annexures

Annexure  No.	Title
AX01/SOPQC 006-00	Annual calibration schedule

VI.       REVISION SUMMARY

Version No.	Revised on	Reason for Revision
00	NA	NA

 

END OF THE DOCUMENT