Analytical instruments- Out of calibration SOP

This Document describes (Standard Operating procedure) Sop for Handling out of calibration result of Analytical Instruments

Sop for Handling out of calibration result of analytical instruments

I. Purpose & Scope:

• The purpose of this SOP is to lay down the procedure for Handling out of calibration result of analytical instruments
• This SOP is applicable in quality control department for handling out of calibration result of analytical instruments.

II. Responsibilities:

• All Quality Control and Quality Assurance personnel’s shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

• PROCEDURE:

  • At the time of calibration of any analytical instrument, if the results are found to be out of limit, the instrument stands out of calibration.
  • Put ‘Under maintenance’ label as per Annexure-I on the instrument immediately duly signed by QC personnel and verified by the QA personnel.
  • Inform the abnormality observed immediately to Head Q.C., Head QA & Instrument engineer.
  • A detailed investigation is to be carried out by the Instrument Engineer & QA Manager as to how and when the instrument has gone out of calibration as per Annexure-II.
  • If the problem in the analytical instrument is minor, the instrument shall be repaired, calibrated and put in use.
  • If the problem in the analytical instrument is major, then all batches analyzed on the instrument (Since last successful calibration) may be retested on another calibrated instrument.
  • Non-compliance if any observed in batch analysis shall be brought to the notice of Head QC and Head QA to recommend additional action if required.
  • After completion of detailed investigation, proper Corrective and preventive measures (CAPA) shall be taken.
  • Evaluation shall be performed on Corrective and preventive Actions (CAPA) on the basis of severity of CAPA to avoid the recurrence.
  • Analytical Instrument Annual calibration scheduled shall be prepared at the end of year for Next year. Refer Annexure –III.
  • It shall be signed and approved by the Quality Assurance Head.
  • After approval of format, Master copy shall be submitted to the Quality Assurance department and controlled copy shall be issued by quality assurance to the Quality control department.
  • Instrument calibration frequency shall be given as per defined in Individual analytical Instrument SOP.
  • All instruments shall be calibrated as per defined frequency in Annual calibration schedule.
  • Frequency of calibration for targeted date can be performed as per mentioned grace period. For Monthly: ± 2 Days, For Quarterly: ± 5 days, for Six Monthly: ± 7 days, For Yearly:  ± 15 days

• FREQUENCY :

As per annual calibration schedule or As and when required

• Annexure:

Annexure I: “Under maintenance:” label for analytical instrument

Annexure II:  Investigation Report for out of Calibration of Analytical Instrument.

Annexure III: Annual calibration Scheduled Quality Control Lab Equipment.

                          ANNEXURE – I

UNDER MAINTEINANCE LABEL FOR ANALYTICAL INSTRUMENT

ANNEXURE – II

INVESTIGATION REPORT FOR OUT OF CALIBRATION OF ANALYTICAL INSRTUMENT

Investigation Report

ANNEXURE-III

ANNUAL CALIBRATION SCHEDULE QUALITY CONTROL LAB EQUIPMENTS – YEAR

*: Due on; **: Done on; *** Daily (Other than weekly off days & holidays)

(Note: Frequency of calibration for targeted date can be performed within grace as mentioned. For Monthly: ± 2 Days, For Quarterly: ± 5 days,

For Six Monthly: ± 7 days, For Yearly:  ± 15 days.)