Procedure for Calibration Policy of QC Instruments

1. OBJECTIVE:

To lay down a procedure for calibration policy for QC Instruments.

• SCOPE:

This procedure is applicable for procedure for calibration policy for QC Instruments.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager

• PROCEDURE:
  • All the instruments associated with the testing of materials and products shall be calibrated.
  • All the instruments are to be calibrated once in three months or as mentioned in the respective instrument SOP.
  • An annual calibration schedule shall be prepared at the beginning of the every calendar year as per “Quality control Instrument calibration schedule for the year” as per Format.
  • Operation and Calibration SOP shall be prepared for all Instruments.
  • All the instruments should be calibrated as per respective standard operating procedure.
  • The results of calibration shall be recorded in calibration record of individual instruments.
  • Calibration shall be carried out within ± 14 days of calibration due date if calibration frequency is yearly, ± 7 days if calibration frequency is half yearly, ± 3 days if calibration frequency is every four month and three month & ± 1 days if calibration frequency is every month or should be completed next working days.
  • The instruments having daily calibration schedule must be calibrated on the same working day.
  • If the calibration due date of instruments falls on holidays then the calibration shall be done on the day before or on the next day of the scheduled due date.
  • During calibration of the instrument, put the duly filled “UNDER CALIBRATION” label.
  • Any instruments labeled with “UNDER CALIBRATION” shall not be used for analysis.
  • If the instrument is complying with established acceptable tolerance, remove the under calibration label board and update the details on “CALIBRATION STATUS” label.
  • Equipments used for calibration of instruments shall be either calibrated in-house or from certified outside agency, which is traceable to NIST Standards or any other applicable agency.
  • Pharmacopoeia reference standards shall be used for calibration wherever applicable.
  • Reference materials used for calibration of instruments shall have manufacturers certificate of analysis.
  • If the Instrument is not complying with established acceptable tolerance limit, person who calibrated should inform to Department Head.
  • If the instrument fails in calibration, put the duly filled “UNDER MAINTAINANCE” label and Calibration failed label (Annexure) and the instrument shall not be used for analysis before it is repaired or replaced.
  • If the instrument fails in calibration, the analytical data of previous sample analyzed on the instrument shall be reviewed by Head-QC and Head-QA. If any discrepancy is found in the obtained results, necessary action shall be taken.
  • After repair, replacement of parts, such instrument shall be re-calibrated (particular part) before regular use.
  • In case the calibration is performed due to breakdown, repair, or replacements of major parts before the next schedule date of calibration, the same shall be recorded in the respective instrument calibration record.
  • The same servicing/breakdown details shall be recorded in “Instrument History record” as per Annexure.
  • The “Instrument History Record” shall be maintained separately for each instrument.
  • The scheduled date of calibration shall not be disturbed due to any calibration performed before the schedule date of calibration in case of break down, repair, or change of parts.
  • In case of new instruments installation, the calibration schedule shall be updated by including the new instrument in schedule.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees: Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• REFERENCES:

In-House