SOP FOR CALIBRATION OF INSTRUMENTS IN QUALITY CONTROL

1. OBJECTIVE:

1. To lay down the Procedure for Calibration of Instruments in Quality Control.

2. SCOPE: 

1. This procedure is applicable for Calibration of Instruments in Quality Control Laboratory. 

3. RESPONSIBILITY:

1. Quality Control Officer / Executive is responsible to follow procedure as per the procedure mentioned in this SOP. 

2. QC Head is responsible for implementation and compliance of the procedure as per this SOP.

4. ABBREVIATIONS

1. SOP    :    Standard Operating Procedure

2. QC    :    Quality Control

3. SOP    :    Standard Operating Procedure

4. STP    :    Specification and Testing Procedure

5. HPLC    :    High Performance Liquid Chromatograph

5. PROCEDURE: 

1. Calibration of QC instruments falls into two categories:

2. Prepare annual calibration schedule as per Calibration Schedule of QC Instruments (Annexure I).

3. Before starting the calibration, check availability and validity of the required standards.

4. Ensure that all the standard chemicals /standard instruments are traceable to national / international standards (where applicable).

5. Before starting the calibration go through operation and calibration procedure and protocol.

6. Perform the calibration as per standard procedure.

7. After completion of calibration, write down status of instrument on calibration tag and sign the same as per Annexure-II. 

1. Satisfactory – if instruments are giving expected results (i.e., within specified limits mentioned in protocol).

2. Not satisfactory – if instruments are not giving expected results (i.e., out of specified limits mentioned in protocol).  

8. In case results are not satisfactory immediately inform to Manager (QC).

9. Write down all the observation/results in protocol and take approval of authorized person.

10. Before approval of records authorized person will check all the calculation and ensure that calibration carried out as per standard procedure and result obtained are well within specified limits.

11. Action Plan to be Followed by QC Manager

1. Ensure that standard operating procedure for calibration is followed.

2. Check that all the calculations are correct (if applicable).

3. Ensure that right standard used for calibration and standard is validated at the time of calibration.

4. In case system fails to meet specification try to locate the error. If error is not traceable, tag the instrument with   UNDER MAINTENANCE     label.

5. Inform the concern service engineer regarding the problem.

6. Enter all the data in tabular format for evaluation.

7. Q.C Head should write final conclusion after reviewing the data.

12. Master Calibration Schedule

1. Prepare the master calibration schedule for the major analytical instruments in QC on yearly basis, starting from January to December of the current year.

2. The schedule to contain Instrument name, Id. No., Frequency and dates of calibration (give days of calibration under each month columns) and location of the instrument in the laboratory.

3. If any change is required in the schedule, revise the schedule for the period starting from the current month and up to December of the current year.

13. Allowed Variation in Calibration Schedule

1. The following table is to be followed for the allowed variation in performing the calibrations :

S. No.	Frequency	Allowed variation in days
1.	One day	No variation allowed
2.	Weekly	1 day
3.	15 days	2 days
4.	Monthly	3 days
5.	Quarterly	4 days
6.	Half yearly	5 days
7.	Yearly	10 days

After the calibration is performed with in the above allowed variation, the next date of calibration to be assigned as per the master calibration schedule only.