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SOP for Equipment for Calibration By External Agency
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
l Engineering Head for the selection of Government approved calibration agency.
l Quality Assurance Head, Production Head, Quality Control Head and all other concerned
Department Heads 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 should be calibrated for the entire range.
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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
the 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 an outside agency shall be evaluated for their
adequacy and tolerance limit and countersigned personnel of above officer level by the
Engineering Department and concerned Department.
5.10 The original countersigned certificate/report shall be submitted to Quality Assurance
Department.
5.11 QA 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 outside for calibration, necessary documents/delivery challan
shall be prepared by concerned department mentioning correct instrument code. Ensure that
the 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 devices is updated in case of receipt of new item.
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Calibration frequency should be increased when:
o Any instrument, measuring device or sensor is found out of the tolerance limit
during the routine calibration.
o Any error in measurement by instrument or device could lead to the quality issue of
the batch or any safety issue.
o Any instrument or sensor is being used in critical process where error in result may
cause some harm.
Calibration frequency should be decreased when:
o The calibration results are found with the specified limits during calibration from a
long period of time.
o The instrument or measuring device is used in any non-critical process.
o Keep a copy of traceability certificate in record.
6.0 ABBREVIATIONS
Abbreviation Expanded form
SOP Standard Operating Procedure
QA Quality Assurance
No. Number
7.0 ANNEXURES
Annexure No. Title
01 List of device/instrument to be calibrated through external agency
8.0 REFERENCES
1. SOP…
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ANNEXURE:
Annex. No. 01. List of device/instrument to be calibrated through external agency
