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Control of Monitoring and Measuring Devices
DOC ID: 1043


1.0              Purpose

To ensure all inspection, measuring and test equipment used to verify the quality of products is properly controlled and maintained with documented evidence.

 

2.0              Scope

This procedure applies to all inspection, measuring and test equipment used during assembly process.

 

3.0              Responsibility

3.1              Quality Assurance

The Quality Assurance Representative is responsible for:

    identifying all inspection, measuring, and test equipment that can affect product quality, and calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards;

        defining the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory;

        documenting the actions to be taken when equipment is found to be out-of-calibration;

        identifying inspection, measuring and test equipment with a suitable indicator to show the calibration status;

        maintaining calibration records for inspection, measuring and test equipment per PTD-4.2.4 (Control of Records);

        assessing and documenting the validity of previous inspection and test results when inspection, measuring and test equipment is found to be out-of-calibration:

        determine the magnitude of out-of-tolerance condition;

        review all inspections since last acceptable calibration;

        determine delta between out-of-tolerance condition and inspections;

        review with Engineering Manager to determine action to be taken;

        review with Facility/Operations Manager when out-of-tolerance condition effects product already shipped;

        maintain a record of the discussion and actions taken, and issue a corrective or preventive action request, as necessary.

        ensuring that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out (Maintain temperature of 50 100 F and humidity of 10 95%);

        safeguarding inspection, measuring and test equipment, as necessary;

        ensuring that the handling, preservation, and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained;

        verifying a recalling system exists: having the ability to identify equipment-requiring recall when it is due for re-calibration.

 

3.2              Maintenance Representative

Maintenance Representative is Responsible for:

        calibrate equipment and devices, adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards;

        defining the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory;

        notifying Quality Representative when equipment is found to be out-of-calibration;

        identifying inspection, measuring and test equipment with a suitable indicator to show the calibration status;

        completing calibration records for inspection, measuring and test equipment per PTD-4.2.4 (Control of Records);

        safeguarding inspection, measuring and test equipment, as necessary;

        ensuring that the handling, preservation, and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained;

 

3.3              Engineering Manager or Engineering/Configuration Representative

Engineering is responsible for:

        determining the measurements to be made and the accuracy required;

        documenting the specific inspection, measuring and test equipment to be used, when appropriate;

        assessing the validity of previous inspections or tests when equipment is found to be out-of-calibration:

        determine the magnitude of out-of-tolerance condition;

        review all inspections since last acceptable calibration;

        determine delta between out-of-tolerance condition and inspections;

        review with Quality Assurance Representative to determine action to be taken;

        review with Facility/Operations Manager when out-of-tolerance condition effects product already shipped;

        maintain a record of the discussion and actions taken, and issue a corrective or preventive action request, as necessary.

 

 

 

 

 

 

 

3.4              Facility/Operations Manager

The Facility/Operations Manager is responsible for assessing the validity of previous inspections or tests when equipment is found to be out of calibration and the out-of-tolerance condition effects product already shipped:

        determine the magnitude of out-of-tolerance condition;

        review all inspections since last acceptable calibration;

        determine delta between out-of-tolerance condition and inspections;

        review with Quality Assurance Representative and Engineering Manager to determine action to be taken;

        maintain a record of the discussion and actions taken, and issue a corrective or preventive action request, as necessary.

 

3.5              All Employees that Handle Inspection, Measuring and Testing Equipment

All employees are responsible for:

        ensuring that the handling, preservation, and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained;

        notifying the Quality Assurance Representative and/or Maintenance Representative if Inspection, Measuring and Test Equipment are damaged or otherwise found to be out-of-calibration.

 

4.0              References

Section 4.11 of ISO-9001, 1994; Control of Inspection, Measuring and Test Equipment

Section 4.11 of AS9100-2001 (Control of Inspection, Measuring and Test Equipment)

Calibration Record

PTD-4.2.4 Control of Records (AS9100)





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