| Handling of out of calibration (OOC) results |
| 1.0 OBJECTIVE To lay down the procedure for handling out of calibration results. 2.0 SCOPE This procedure is applicable for Calibration of Handling of out of calibration results in quality control department. 3.0 RESPONSIBILITY QC – Officers/Executive/Senior Executive/Asst. Manager 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Calibrations of all the instruments are to be performed as per the respective calibration SOP and the pre-defined schedules. 5.2 If any instrument fails to meet the specified tolerance limit, immediately inform to Q.C. Head. 5.3 If the instrument/. equipment is out of calibration, the respective instrument/ equipment must be clearly labelled of “Out of Calibration” with date and signature as per Format No.: XXX and label of “Do Not Use”. 5.4 The calibration failure should be noted in the respective equipment logbook and OOC number assign as per format no. XXX. 5.5 The reason for calibration failure to be investigated and appropriate CAPA to be initiated (if applicable), as per format no. XXX. The respective instrument to be re-calibrated and results to be evaluated. 5.6 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. 5.7 If recalibration results found satisfactory, label of “Out of Calibration” and label of “Do Not Use” to be removed and “Calibration label” with sign and date to be affixed to instrument. The Calibration to be recorded on equipment log and the instrument can be release for use. 5.8 Prepare a list of samples analyzed and tests performed using the instrument during the period in between last calibration and OOC date. 5.9 If recalibration results not found satisfactory, other measures such as maintenance, repair from service engineer to be taken. If instrument found “Out of calibration “even after that, the instrument to be discontinued and dispose. 5.10 Q.C. Head and Q.A Head will study the impact of OOC results on the analytical results and the product and recommend corrective actions. Check which analysis results obtained with the instrument/equipment for re-evaluation retrospectively. Typically, any analyses performed since the last acceptable calibration are reviewed to determine if the current out of calibration condition could have had any impact on the results. The measures to be documented in investigation report. 5.11 Quarantine the materials/ products where the impact on the results is appeared to be significant. 5.12 This investigation has to be completed within three days from the date of OOC results. 5.13 Re-test samples after the investigation on other instrument with different dates of affected period and arrive to the conclusion. 5.14 Recheck the performance of repaired instrument through calibration and repeat the analysis. 5.15 The retested results are to be discussed with Q.A. Head and decision is taken for Release / Reject of quarantined batches after thorough evaluation. 5.16 Frequency of calibration of this instrument shall be increased to minimize such incidents. 6.0 ABBREVIATIONS SOP – Standard Operating Procedure BP – Degree British pharmacopoeia USP – United State Pharmacopoeia QC – Quality control IP – Indian pharmacopoeia GR – General reagent AR – Analytical reagent ML – Millilitre |
