SOP for handling of Out of Calibration (OOC) results.
1.0 Purpose:
To lay down a procedure for handling of out of calibration (OOC) result.
2.0 Scope:
This procedure is applicable for handling of out of calibration (OOC) result in Quality Control laboratory.
3.0 Responsibility:
QC Officer/ Designee :
•To follow calibration procedure.
QC Executive/ Designee
• To ensure Calibration procedure.
QC Head/Designee :
• To investigate out of calibration result.
• To review, implement and ensure compliance of SOP.
QA Head/Designee:
• To review the impact of OOC results on the analytical results and the product and recommend corrective actions.
• To approve, implement and ensure compliance of SOP.
4.0 Procedure:
4.1 QC Officer/Executive shall calibrate all the instruments as per the respective calibration SOP at pre-defined schedules.
4.2 If any instrument fails to meet the specified tolerance limit, immediately inform to QC Head /designee.
4.3 Tag the instrument with status indicating Do not use –Instrument is out of calibration”.
4.4 QC Head /designee investigate the OOC results and if no assignable cause established, repeat the calibration for that particular parameter and find out the degree of non-conformance.
4.5 If the results of recalibration are same, inform the service engineer.
4.6 Prepare a list of samples analyzed and tests performed using the instrument during the period in between last calibration and OOC date.
4.7 QC Head and QA Head shall study the impact of OOC results on the analytical results and the product and recommend corrective actions.
4.8 Quarantine the materials / products where the impact on the results is appeared to be significant.
4.9 This investigation has to be completed within three days from the date of OOC results.
4.10 Retest samples after the investigation on other instrument with different dates of affected period and arrive to the conclusion.
4.11 Recheck the performance of repaired equipment through calibration and repeat the analysis of quarantine materials /products/control sample.
4.12 The retested results are to be discussed with QA Head and decision is taken for Release / Reject of quarantined batches after thorough evaluation.
4.13 Frequency of calibration of this instrument shall be increased to minimize such incidents.
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