QM: 7.6 Control of monitoring and measuring equipment (Calibration)

NIST-F1 Cesium Fountain Atomic Clock (http://www.nist.gov/)

Introduction

Measuring and monitoring devices includes measuring and test equipments, comparative reference hardware (such as gauges and templates), and test software used for:

Setup and monitoring of production processes,

Monitoring of environmental conditions,

Verification of product conformity, and

Operations where defined accuracy of a measurement is required to assure product conformity.

7.6	Control of monitoring and measuring equipment (Calibration)

7.6 Control of monitoring and measuring equipment

The company has a defined process for the control of measuring and monitoring devices needed to provide evidence of conformity of the product to specified requirements. This includes details of equipment type, unique identification, location, and frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory.

Quality assurance is responsible for calibration and maintaining measuring and monitoring devices. All active devices are inventoried in a controlled list, indicating their calibration status and location. Instruments that are used for reference only (not verification) are not included in the calibration system and are labeled with ‘DO NOT USE, FOR VERIFICATION ONLY’ stickers warning that is not in calibration plan.

Calibration is either performed by external calibration laboratory or internally. When external services are utilized, they are incorporated into the approved vendor list after successful vendor qualification program and rated accordingly. All internal calibration is performed in accordance with the written instructions.

The company determines the measurement to be made and the accuracy required to assure conformity of the product to specified requirements. Equipment is selected that is capable of functioning with the required accuracy and precision. Software used for measuring and monitoring of specified requirements shall be checked periodically and validated prior to use.

Measurement and monitoring devices are used in a manner that ensures that measurement capability is consistent with the measurement requirements (accuracy and precision). This includes ensuring that the environmental conditions are suitable for the calibration, inspection, measurements and tests being carried out. The company control all measuring and monitoring devices that can have an effect on product quality.

Periodic Calibration: The Company has identified the measuring and monitoring devices that can affect product quality and calibrate and adjust them at prescribed intervals. Calibration is performed against certified standard traceable to international or national standards.

Where no such standard exist, the basis used for calibration is documented.

If any adjustments or readjustments are required the same are performed and reported in calibration report. Recalibration is performed after adjustments.

Identification of Calibration: Measuring and monitoring devices are identified with unique identification numbers. Calibration status of measuring and monitoring devices is shown on the calibration sticker on the equipment and/or by the information in the calibration database.

Safeguard from Adjustment: The Company ensures that measuring and monitoring devices are safeguarded from adjustments that would invalidate the calibration.

Protection from damage: The Company ensures that handling, maintenance and storage of measuring and monitoring devices is such that accuracy and fitness for use are maintained.

Validity re-assessment: If it is confirmed that the equipment is out of calibration, validity of the measurements for which the equipment was previously used is investigated and assessment of the acceptance status of all the affected products is made. If applicable, all nonconforming products are identified and appropriate action taken to address the situation.

Calibration records: The Company maintains appropriate calibration records for measuring and monitoring devices. Each instrument is traceable to its own calibration history record which contains it identification number, storage location, make or type, frequency of calibration, reference standards used, actual calibration findings including date, and actions to be taken in case of unsatisfactory results.

Software: Test software (developed or purchased) that is used for inspection and testing and/or monitoring of process performance is validated before it is used for verification of products. Standard software purchased from commercial sources is ordered with validation certificates. Software that is developed in-house are validated and approved in accordance with its documentation, which contains instructions for validation of proper functioning. Software is re-validated at prescribed intervals of whenever a change from the original release in introduced. 

Calibration Labels

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