STANDARD OPERATING PROCEDURE FOR HANDLING OF OUT OF CALIBRATION OF ANALYTICAL INSTRUMENTS

1.0 OBJECTIVE

1.1 To lay down a standard procedure for the action to be taken in the event of out Calibration of instruments.

2.0 SCOPE

2.1 This SOP shall be applicable to all instruments used in the Department of Quality Assurance (QAD).

3.0 RESPONSIBILITY

3.1 Head- QA

3.2 QA Personnel (QAP)

4.0 DEFINITIONS

4.1 The instrument shall be considered out of calibration if the data generated by it falls out of the range specified.

5.0 PROCEDURE

5.1 The following actions shall be taken in the event of out-of-calibration status of instruments:

5.1.1 The personnel who has observed the instrument out of calibration shall immediately report the same to the study director / Head of department.

5.1.2 An analysis shall be performed in the presence of the Study director / Head of department to check whether the instrument is out of calibration and the same shall be reported to QA personnel / QA Head.

5.1.3 A status label 'OUT OF CALIBRATION' shall be affixed if the instrument is found out of calibration.

5.1.4 The head of the department shall initiate the internal calibration procedure in the presence of authorized QA personnel as per the calibration procedure mentioned in the respective SOP/user manual of the instrument.

5.1.5 If the internal calibration procedure fails due to some defect/damage in the instrument, authorized technical personnel shall be called for repair and external calibration.

5.1.6 Once the said instrument is repaired then carry out internal calibration and ensure that it is working satisfactorily.

5.1.7 If the external expert performs the servicing satisfactorily, use the instrument after calibration for routine analysis.

5.1.8 In case an instrument is found out of calibration then the results of the previous calibration are reviewed.

5.1.9 If the external expert fails to rectify the instrument, affix a status label ' OUT OF ORDER'.
Arrange to replace the instrument.

6.0 ENCLOSURES

6.1 Formats

Sr. No.	Format Title	Format No.	No. of pages
1.	Record for the out-of-calibration of instruments	F…………………….	01
2.	Instrument out-of-calibration labels	F…………………….	01

FORMAT: RECORD FOR THE OUT-OF-CALIBRATION OF INSTRUMENTS

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1 Nil


                                                           END OF DOCUMENT

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