1.0 OBJECTIVE :
- To describe a procedure for calibration of devices / instruments from external authorized agencies.
2.0 SCOPE :
- This procedure is applicable for calibration of devices / instruments of all the departments.
3.0 RESPONSIBILITY :
- Engineering Head for the selection of Government approved calibration agency
- Quality Assurance Head,
- Production Head,
- Quality Control Head and
- All other concerned departments Head
- For identification of items to be calibrated and to ensure that all instruments, weighing and measuring devices are calibrated.
4.0 ACCOUNTABILITY:
- Quality Assurance Head
5.0 PROCEDURE :
5.1 Calibration of instrument and other measuring devices is comparison of the observed value with reference standard valve. The difference between the measured value and standard value helps to determine the instrument performance. The tolerance limit for each device is set for acceptance.
5.2 All the devices / instruments associated with the processing, monitoring and testing of products, materials and areas which do not have internal procedure to perform calibration shall be identified and shall be calibrated through government approved outside agencies and same shall be endorsed by Engineering Head and Quality Assurance Head.
5.3 All devices/ instruments shall be calibrated for entire range.
5.4 Respective department head shall forward the list of device/instruments due for calibration to Quality Assurance and Engineering department 30 days in advance.
5.5 Engineering department shall call for the agency for onsite calibration.
5.6 Some small instrument/ devices like Vernier calipers, Hardness tester etc. can be taken at agency’s place for calibration.
5.7 A calibration planner shall be prepared by concerned department specifying the device / instrument name, identification number, calibration done on, next calibration due on etc., The same information shall be available on label of calibration tag attached to the device.
5.8 External agency shall calibrate each instrument / device using calibrated master Instrument / Device. Collect the copy of the traceability certificate of the instrument / device used for calibration. After receipt of the calibration report the same shall be verified for information like calibration standard, name, report No., device identification number, calibration done on, next calibration due on and other relevant information if any.
5.9 The calibration certificates obtained from outside agency shall be evaluated for its adequacy and tolerance limit and countersigned personnel of above officer level by Engineering department and concerned department.
5.10 The original countersigned certificate / report shall be submitted to Quality Assurance department.
5.11 Q.A. Department shall send one photocopy of individual certificate of calibration to respective department and file the original copy for future reference.
5.12 If any instrument is sent to outside for calibration, necessary documents / delivery challan shall be prepared by concerned department mentioning correct instrument code. Ensure that device is received after calibration from external agencies is duly packed to avoid any damages.
5.13 Calibration shall be carried out within 10 days from the calibration due date or earlier.
5.14 If the device fails it shall be replaced / repaired. In such case Engineering department shall inform the same to the head of concerned department, who in turn along with Head of Quality Assurance shall investigate the impact of this failure on production and quality made in between the date of failure and earlier date of calibration. Quality Assurance shall maintain report of this.
5.15 Calibration Frequency
- Once in Year or as indicated in External calibration calendar or as recommended by manufacturer of device whichever is earlier.
- The frequency is dependent on criticality of device/ instrument.
- The list of device is updated in case of receipt of new item.
- Calibration frequency should be increased when:
- Any instrument, measuring device or sensor is found out of the tolerance limit during the routine calibration.
- Any error in measurement by instrument or device could lead to the quality issue of the batch or any safety issue.
- Any instrument or sensor is being used in critical process where error in result may cause any harm.
- Calibration frequency should be decreased when:
- The calibration results are found with the specified limits during calibration from a long period of time.
- The instrument or measuring device is used in any non critical process.
- Keep copy of traceability certificate in record.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| No. | Number |
7.0 ANNEXURES:
| Annexure No. | Title |
| 01 | List of device / instrument to be calibrated through external agency |
8.0 SOP REFERENCES
- In-House
END OF THE SOP
ANNEXURES :
Annex. No. 01 List of device / instrument to be calibrated through external agency
