IATF16949 {7.1.5.2.1} CALIBRATION/VERIFICATION RECORDS - Explained

 IATF16949 {7.1.5.2.1} CALIBRATION/VERIFICATION RECORDS

A. Calibration

A list of organization owned inspection measuring Instruments & Gauges is maintained by Quality Head which describes the details like name of the instrument / gauge, Range, Least count, Model, Make, Calibration frequency & acceptance criteria of instruments etc.

At the time new instrument purchase, determine the measurement to be made by studying the customer specifications:

• Study the customer requirements for their products.

• Determine the measurement to be made and the accuracy required for those measurement.

• Select appropriate monitoring and measuring equipments that is capable of necessary accuracy and precision.

Select & Qualify an instrument for use based on:

• Instrument Accuracy > Required Accuracy (Acceptance Criteria)

• LC at least < 1/10th * Measurement Tolerance (most critical amongst different uses of the instrument) or as specified by customer. 

• Range


Frequency of calibration shall be decided considering following points-

 Frequency of use, 

 Accuracy required, 

 Reliability of equipment,

 Past experience


Calibration service is availed from approved external agencies. The calibration agency will be chosen based on any of the following:

• The agency should be accredited to National / International Laboratory standard (i.e. NABL approved).

• The agency can be the manufacturer of the instrument/test equipment.

• Customer approved agency


On receipt of Calibration certificates from outside calibration agency, verify below details: - 

a) Measurement standards Traceable to international or national measurement standards.

b) Verify observed error in instruments as per Instruments Acceptance chart. If it is ok then sign on Calibration Certificate for its verification evidence.


Measuring instruments / gauges are identified with code numbers. Calibration status is indicated on the instruments / gauges using suitable label / stickers.


All instruments are carefully handled during use & kept in suitable location to prevent damage / deterioration to them. If non-standard gauge design by Quality Department and use for inspection, then these type gauges are calibrated / validated by master instrument & record the details in Gauge validation report. 


All calibration will be carried out as per decided frequency     


OUT OF CALIBRATION: -

Whenever any inspection, measuring and test equipment is found to be defective, the products cleared shall be verified and ensured that conforming products only accepted for further processing / delivery to customer. 

Under such circumstances previous inspection and test results shall be assessed and validated.

Suitable actions are taken to rectify the defects among instruments/ gauges. Where repair /reconditioning is not possible, same will be kept in scrap box. The same will be withdrawn from using. This will be indicated in the history card of the instrument / gauge. 


MEASUREMENT SYSTEM ANALYSIS 

 MSA Plan is prepared indicating applicable MSA studies to be conducted for each type of measurement system identified in the control plan.


MSA study shall be conducted as per the frequency defined in the MSA Plan. The frequency of MSA Study is decided based on the following criteria

A. New Equipment Introduced

B. The extent of usage of instrument


MSA studies are carried out and based on the results obtained actions are initiated. Records of MSA study are maintained by Quality Head.

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