To define the general requirements for an effective calibration control system to ensure that applicable measuring and test equipment is calibrated and maintained within accuracy limits sufficient for their intended purpose.
This procedure is applicable for calibration of all equipment /instrument/ measuring devices.
- Follow up: Concern Department Officer/Executive
- Overall responsibility: Concern Department head.
- Head QA: To approve the SOP & calibration planner.
- Classification of Instruments:
- All calibrated instruments will be tagged with an identification number for tracking purposes as per Annexure –II : Calibration status. This tag will also indicate the date of last calibration and the due date of the next calibration.
- Instruments deemed not to require calibration due to the nature of the instrument or its application will be tagged as “NO CALIBRATION REQUIRED”.
- When any instrument is out of calibration limits, it should be immediately labeled as “OUT OF CALIBRATION” and intimated to Head -Engineering and get the same recalibrated, repaired, replaced as the case may be before proceeding further.
- The intimation of the same shall be given to Head QA to assess the impact of such out of calibration instrument on product quality, if instrument has been used, and during this period out of calibration has been observed.
- Classification of Instruments:
- Calibration Intervals
- Calibration Intervals will be assigned to each type of instrument to attain a desired probability that the instrument will be within calibration limits at the time of use.
- All instruments will be assigned calibration frequency as mentioned in below table.
|Sr. No.||Calibration / Validation Frequency||± Limit|
|01||1 Month (Monthly-Once in a month)||± 3 working days|
|02||3 Months (Quarterly-Once in three month)||± 7 working days|
|03||6 Months (Half yearly-Once in six month)||± 15 working days|
|04||12 Months (Yearly-Once in year)||± 30 working days|
- Initial interval of calibration for new equipment will be based on the manufacturer’s recommendation and judgment of engineering department.
- Calibration intervals may be adjusted as necessary on the basis of calibration data or other information which may support for change. These changes can be done as per procedure of Change control.
- The date of calibration shall be put on the calibration label/ documents however the next due date of calibration will be the one day before on which calibration can be performed, for example current date of calibration is 10 Jan 2022 then the due date of calibration for 12 months period shall be 09 Jan 2023.
- Maintain the Master List of Calibration Status of Measuring Devices of Equipments/ Instruments/Utilities as per Annexure –I in soft copy and hard copy.
- When the need for repair/ adjustment is determined, the instrument repaired or adjusted by in-house or outside contractor will be re-calibrated prior to returning to service.
- When the need for repair/ adjustment is determined, the instrument will be tagged as “OUT OF CALIBRATION”.
- The “OUT OF CALIBRATION” tag will not be removed until the repair is completed and the instrument has been re-calibrated.
- The calibration system will provide the means to trace assigned values of measurement to nationally recognized standards (i.e. NABL). Documentation will include calibration agency and certification data.
- The use of calibration standards which are not traceable to National standards, such as standard reference materials or internal standards will require adequate documentation as to the validity of the standards used.
- Outside Contractor Control
- It is the responsibility of company Engineering Department in co-ordination with QA to ensure that the contractor’s calibration system complies with all, requirements.
- The Head QA and Head Engineering Department will review the outside contractor’s procedure and will approve.
- All documentation supplied by contractor will be reviewed and dully signed.
- Calibration ofinstruments/equipments/measuring devices shall be done as per standard operating procedures of respective instruments.
- Calibration Process Limits shall be defined for each equipment /instrument/ measuring device.
- There shall be a means of readily determining the calibration status of each equipment / instrument / measuring devices. The instrument/equipmentmeasuring devices shall be properly labeled with “calibration status label” as described in respective standard operating procedures of calibration. Wherever the calibration of equipment / instrument / measuring devices is coordinated by outside calibration agency then calibration status label will be supplied by outside calibration agency. Calibration label shall be as per Annexure-II: Calibration status.
- Calibration Certificate should contains following details:
- Instrument/equipment/measuring device name
- Instrument/equipment/measuring device Identification Number
- Range of instruments under calibration
- Name of Standard Instrument and its range used in calibration process
- Calibration Certificate of standard Instrument used in calibration process and validity period of calibration
- Date and time of calibration
- Calibration status
- Calibration due date
- Acceptance criteria
- Master List of Calibration Status of Measuring Devices of Equipments/ Instruments/Utilities shall prepare separately and updated by engineering department. This document shall contain name and identification number of instrument /equipment/ measuring device, location of instrument/equipment/measuring device, date of calibration, due date of calibration.
Note: Measuring devices which are in spare shall be calibrated as per calibration frequency. These calibrated measuring devices shall be used as replacement in case of urgency like mal-functioning of measuring devices or if calibration validity of measuring devices provided to equipments /systems/areas is immediately due.
- All QC instruments shall calibrate as per standard calibration procedure of respective instrument.
- Any out of calibration instrument/measuring devices shall labeled as ‘OUT OF CALIBRATION’ and shall intimate to HOD of concern department, Head Engineering and Head QA. Such instruments/measuring devices shall not use till the satisfactory recalibration of the same. In case of critical instruments which have direct impact on product quality / analysis results found out of calibration, the products/samples which analyzed by using instrument within the period of previous calibration date and date on which instrument found out of calibration shall reassessed.
Trainer : Head – Quality Assurance
Trainees : All Departmental / Sectional Heads
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Production
Controlled Copy No.3 : Head of Department – Quality Control
Controlled Copy No.4 : Head of Department – Warehouse / Stores
Controlled Copy No.5 : Head of Department – Engineering / Maintenance
Controlled Copy No.6 : Head of Department – Microbiology
Original Copy : Head – Quality Assurance
Annexure I : Calibration Calendar
Annexure II : Calibration label
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||———–||New SOP||New SOP|