SOP FOR CALIBRATION OF EQUIPMENT/ INSTRUMENTS FROM OUTSIDE AGENCY
PURPOSE: To lay down a procedure for calibration of equipment’s /instrument by outside agency
SCOPE: This sop applicable to all the equipment’s/ instruments.
RESPONSIBILITY:
Preparation of SOPs: Officer/ Executive of Concerned Departments
Checking and Review of the SOPs: Next Level of the Concerned Department
Approval of the SOPs: Head of Concerned Department
Authorizing of SOP: Head QA/ His or her Designee
Concerned /user department shall prepare the list of calibration planner of their department.
Concerned /user department head shall be responsible for checking of calibration planner.
IPQA/QA personnel shall be responsible for approval of the calibration planner.
QA Head/designee shall be responsible for approval of the calibration planner.
Engineering department personnel shall be responsible for intimating the outside agency for the calibration of equipment’s/instruments for calibration as per planner.
Concerned department personnel and IPQA personnel shall be responsible for monitoring of the due date for calibration of equipment’s/instruments.
ACCOUNTABILITY:
The accountability of implementation and compliance of the SOP is of concerned department Head/ QA Head.
PROCEDURE:
Definition: Calibration: A comparison of two instruments or measuring devices one of which is a standard of Known accuracy (traceable to national standards) to detect correlate, report or eliminate by adjustment, any discrepancy in accuracy of the instrument measuring device being compared to the standard.
Common Calibration Terms:
Out of Tolerance Conditions: If the results are outside of the instrument’s performance specifications it is considered an OOT (Out of Tolerance) condition and will result in the need to adjust the instrument back into specification.
Calibration Tolerance: Every calibration should be performed to a specified tolerance. The terms tolerance and accuracy are often used incorrectly. In ISA’s The Automation, Systems, and Instrumentation Dictionary, the definitions for each are as follows:
The ratio of the error to the full-scale output or the ratio of the error to the output, expressed in percent span or percent reading, respectively.
Tolerance: Permissible deviation from a specified value; may be expressed in measurement units, percent of span, or percent of reading.
Calibration may be called for but not limited for:
A new instrument
After an instrument has been repaired or modified
when a specified time period has elapsed
when a specified usage (operating hours) has elapsed
Before and/or after a critical measurement
After an event, for example
After an instrument has had a shock, vibration, or has been exposed to an adverse condition which potentially may have put it out of calibration or damage it
Sudden changes in weather
Whenever observations appear questionable or instrument indications do not match the output of surrogate instruments
As specified by a requirement, e.g., customer specification, instrument manufacturer recommendation.
Calibration Procedures:
Based on the yearly calibration planner, QA shall review the calibration planner on monthly basis and list out the instruments/equipment’s which are due for calibration on next month in word or excel sheet and inform the engineering department to communicate with outside agency for calibration.
All the equipment’s and instruments shall be calibrated as per the calibration planner as per ‘Calibration Planner of Equipment & Instrument of VMP.
Calibration of all equipment’s/instruments shall be performed by outside agency as per the guidelines or respected SOPs.
After calibration of equipment’s /instruments shall affix the calibration tag which mentioning the calibration status and details of equipment’s.
If any equipment is found out of calibration, then it shall be handled as per the SOPOut of calibration.
Outside agency shall be perform the calibration and submit the calibration report along with the raw data (where available).
After the calibration of instrument/equipment update the calibration planner manually for done date and next due date.
Concerned Department personnel, engineering department personnel and QA personnel shall be responsible for the verification of the external party calibration report and raw data”
The following shall be the tolerance criteria for the calibration of instrument and equipment’s:
| Frequency | Tolerance limit |
| Quarterly | ± 7 days Half Yearly |
| Half Yearly | ±15 days Yearly |
| Yearly | ±3Odays |
Preparation of Calibration Planner for Equipment’s/instruments:
The calibration planner shall be prepared on a yearly basis ‘Calibration Planner of Equipment & Instrument of VMP.
When any new instrument/equipment are introduced in the facility it shall be acknowledge through the format for calibration planner of equipment’s/instruments.
Whenever calibration planner is revised all addendums shall be club in main calibration planner.
Calibration planner shall contain instrument name, calibration date, due date, calibration done date, next due date, make of instrument, serial number, instrument ID, location.
Calibration Planner shall be approved by Head QA/ Designee.
The outside agency selected for the calibration shall be NABL certified.
Engineering department personnel shall communicate at least one week in advance to the user department and outside agency for calibration of instruments / equipment’s.
REFERENCE:
SOP for SOP (SOP/C/QA-001)
VMP (KPL/VMP/005)