To lay down a standard procedure for calibration of all instruments used in Quality control Department.
This SOP is applicable for calibration of all instruments used in Quality control Department
Officers / Executive – Quality Control shall be responsible for complies of this SOP
Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
Instrument Calibration Schedule Attachment-I
Under Calibration label Attachment-II
Calibration label Attachment-III
Calibration failed label Attachment-IV
Under maintenance label Attachment -V
- All the major instruments associated with the testing of materials and products shall be calibrated.
- An annual calibration schedule shall be prepared at the beginning of the every calendar year as per “Calibration Schedule” (Attachment-I).
- 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.
- The instruments having monthly calibration schedule shall be calibrated a day before due date or within three days of due date of calibration.
- The instruments having quarterly, half –yearly and yearly calibration schedule shall be calibrated a day before due date or within seven days of due date of calibration.
- The instruments having weekly calibration schedule shall be calibrated on the same day.
- The instruments having daily calibration schedule must be calibrated on the same working day.
- If the calibration due date of weekly calibrated instruments falls on holidays then the calibration shall be done on the day before of the scheduled due date or on the consecutive working day.
- During calibration of the instrument, duly filled “UNDER CALIBRATION” label shall be displayed. (Attachment-II).
- 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. (Attachment-III) Equipments used for calibration of instruments shall be either calibrated in-house or from certified outside agency, which is traceable to NABL / NPL / ETDC Standards or any other applicable agency.
- Reference materials used for calibration of instruments shall be of AR / GR /Spectroscopy grade and 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 board (Attachment-V) and “CALIBRATION FAILED LABEL” (Attachment-IV) 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 Manager-QC and Manager-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 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.
- After Completion of calibration of instrument respective instrument calibration record shall be maintained.
- REFERENCES :
- ABBREVIATIONS :
SOP: Standard Operating Procedure
QC: Quality Control
NABL: National Accreditation Board for Testing and Calibration Laboratories
NPL: National Physical Laboratory
ETDC: Electronic Testing and Development Centre
QA: Quality Assurance
- DISTRIBUTION LIST :
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION: