To lay down a procedure for the handling out of calibration (OOC) results of Quality Control Laboratory Instruments and Equipment.
- Officer-QC, Sr. Officer-QC,Executive-QC, Sr Executive-QC, Head Quality Control, Head Quality Assurance
- Calibration- the act of marking units of measurement on an instrument so that it can be used for measuring something accurately.
- Handling Out of Calibration (OOC) Results:
- Perform calibration of instrument or measuring device as per the procedure given in respective SOP of the instrument.
- During calibration if the results are found to be out of calibration (OOC), then immediately stop using the same and label it as “OUT OF CALIBRATION”.
- Immediately inform to supervisor for the further action.
- The supervisor shall raise an out of calibration (OOC) Evaluation form.
- The calibration team including the Head of the Department and Head Quality Assurance or their designee shall review the following:
- Degree of out of calibration (OOC) and criticality of the result (impact on product).
- Any supporting data like system suitability, system performance or back up data.
- Impact analysis for the product or process that was analyzed/measured during the period between the last calibration and the current calibration.
- The Head-QA shall design the action plan based on the review and make report that includes:
- The calibration findings, instrument used for the calibration and its calibration status, instrument traceability.
- The degree of failure (the level of out of calibration (OOC) from standard).
- The degree of failure shall be decisive for finalization of further the action plan.
- The impact of failure on products, which were analyzed, and or process, which were measured.
- This can be done by reviewing but not limited to sequential log, instrument equipment / usage log.
- Analysis of control sample or in-process sample (if the process is on going) for the specific tests using the instrument or device.
- In case other supporting data are available which can justify the impact, it may not be necessary to analyze the entire impacted product.
- This needs to clearly mentioned in the action plan and justified.
- The Head-QA shall implement the action plan.
- After completion of implementation of plan, the team shall review the data and appropriate action shall be decided for the affected product.
- This may be but not limited to the product recall, information to customer, etc.
- Out of calibration (OOC) incidence shall be closed out by Head QA after thorough review of action plan, execution, data review, and action based on the findings.
- The section Head shall initiate a parallel activity to rectify the instrument/measuring device and recalibration shall be performed before putting in actual practices.
- Record the out of calibration (OOC) evaluation.
SOP : Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
NA : Not Applicable
OOC : Out of Calibration
- REVISION HISTORY:
|S. No.||Document No. with Version No.||Superseded Document No. with Version No.||Reference Change Control No.||Page no.||Point No./Section||Description of Change|