Action To Be Taken For Unusual Observation For Instrument During Calibration

1.0 OBJECTIVE:

To lay down the procedure for action to be taken during unusual observation for instrument during calibration.

2.0 SCOPE:

This procedure is applicable to instrument which are calibrated in Q.C dept.

3.0 RESPONSIBILITY:

3.1 Doing: Tech. Asst.

3.2 Checking: Executive/ Manager.

4.0 ACCOUNTABILITY:

4.1 Head of the Q.C Department.

5.0 PROCEDURE:

5.1 Q.C Assistant calibrating the instrument shall inform to the concerned Executive regarding the out of calibration incidence of the instrument.

5.2 Q.C Executive shall go through the problem aroused and shall try to rectify the problem if possible within available parameters and guideline received from manufacturer.

5.3 Q.C Executive shall inform to maintenance dept. if the problem is not rectified or solved.

5.4 If the problem is aroused of other technical nature and cannot be rectified, Q.C Executive shall inform with details of the problem to the authorized service center or manufacturer regarding the nature of the problem and intimate them to send the service engineer to rectify the problem at the earliest.

5.5 After servicing the instrument by service engineer, re-calibrate the instrument as per respective SOP’s and keep the record of the same. Note down the details in respective instrument history card.

5.6 Analyse the product/ batch which was last analyzed on that particular instrument to confirm the result.

5.7 The difference between the initial result & the new result after re-calibration should not differ by more than 1%.

5.8 If the result of the last analyzed batch/ product is not within ±1% of initial result then select second last batch/ product for analysis and continued doing testing of the batches/ product in reverse order till the results are found within the ±1% of the initial result.

5.9 List out the batches not comply with the ±1% criteria and ensure that the revised results comply with specified limit as per release specification.

5.10 In case if does not comply with release specification, ensure that it complies with regulatory specification.

5.11 In case it is not complies with regulatory specification then inform to manager Q.C for further action.

5.12 In case of raw material/ list out the RM if the revised results not comply with ±1% criteria.

5.13 Ensure that the revised results of listed RM are complies with laid down specifications.

5.14 In case if it is found not complies, immediately instruct RM store to stop the further use through proper channel and inform to Q.C in-charge for further action.

5.15 List out the batches manufactured using the particular RM.

5.16 Follow step 5.9 to 5.12 for the listed out batches.

6.0 REVISION LOG: