To lay down the procedure for the calibration of measuring instruments of manufacturing.
1.0 PURPOSE
To lay down the procedure for the calibration of measuring instruments of manufacturing.
2.0 SCOPE
2.1 This SOP is applicable for Engineering department for the calibration of measuring instruments related to manufacturing other than QC testing equipments.
3.0 RESPONSIBILITY
3.1 Personnel –Engineering department.
4.0 ACCOUNTABILITY
4.1 Manager – Engineering department
4.1 Manager – Quality Assurance
5.0 PROCEDURE
5.1 All the measuring instruments shall be calibrated as per their respective SOPs
5.2 Instrument shall be calibrated against Reference Instruments which should be traceable to the national standards.
5.3 Reference instrument, used for calibration instrument shall be with in its calibration period.
5.4 Engineering department is responsible for the calibration of reference instruments by accredited calibration laboratory within the due date of recalibration.
5.5 Engineering department shall have the copy of calibration traceability certificate of all reference instruments.
5.6 List of reference instruments shall be maintained with engineering department as per the specimen format given in Annexure I
5.7 Engineering Department shall maintain list of measuring instruments with their criticality and calibration frequency as per the specimen format given in Annexure II
5.8 Instrument shall be categorized as critical, Monitor or Indicator as per their criticality.
5.8.1 Critical: Instrument with direct impact on the product quality
5.8.2 Monitor: Instrument with no direct impact on product quality but related to the performance of the equipment to which it is attached.
5.8.3 Indicator: Instrument required only for indication
5.9 Frequency of recalibration: The instrument calibration frequency should be based on the type of instrument and criticality of instrument. Minimum frequency of recalibration shall be once in 6 months for critical material and once in year for other instruments.
5.10 Instruments shall be checked for calibration within ±7 days of the schedule date for yearly calibration, ±5 days for half yearly calibration, ±4 days for quarterly calibration and ±2 days for monthly calibration.
5.11 Engineering department shall maintain the record of calibration as per Annexure III
5.12 Calibration status of the instrument shall be indicated by Calibration tag as per Annexure IV. Calibration tag is to be placed near the instrument.
5.13 Instrument, which cannot be calibrated in house, shall be sent to the external laboratory, which is accredited to NPL or ETDC or any international accredited Calibration Lab.
5.14 In case of any parameter not meeting the limit, engineering department to raise deviation.
5.15 QA department shall evaluate the criticality of the instrument with respect to its impact on product quality and shall decide for the further actions.
5.16 The incidence of out of calibration shall be handled as per the deviation control procedure.
5.17 Action shall be taken to prevent the reoccurrence of failure.
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Calibration, quality assurance, measuring instruments
