SOP For Out of Calibration (OOC) of Laboratory Instruments

1. PURPOSE:

      To lay down a procedure for the handling out of calibration (OOC) results of Quality Control Laboratory Instruments and Equipment.

• SCOPE:

This SOP is applicable to all the Laboratory Instruments and Equipment.

• RESPONSIBILITY:
• Officer-QC, Sr. Officer-QC,Executive-QC, Sr Executive-QC, Head Quality Control, Head Quality Assurance

• DEFINITION:
• Calibration- the act of marking units of measurement on an instrument so that it can be used for measuring something accurately.
• PROCEDURE:
• 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.
• ABBREVIATIONS:

SOP    :            Standard Operating Procedure

QC       :            Quality Control

QA       :           Quality Assurance 

NA       :           Not Applicable 

OOC     :            Out of Calibration

• REFERENCES:

In-house.

1. ANNEXURES:

NA

1. REVISION HISTORY: