Calibration for Testing Measurement Procedure | MFG103

Calibration for Testing Measurement Procedure

The Calibration for Testing Measurement Procedure procedure establishes a standard method for the calibration and maintenance of mechanical measuring tools such as micrometers, calipers, etc., and testing instruments. (8 pages, 1484 words)

All measuring tools being used to set specifications or measure conformance to specifications, such as micrometers, calipers, pressure gauges, etc., will be included in the calibration program. This program shall also be mandatory for any personally owned Measuring and Test Equipment used by employees at the company’s facilities. Each tool will be assigned a number and checked every six months (unless otherwise noted) for accuracy.

Calibration for Testing Measurement Definitions:

Calibration – Comparison of a Measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report or eliminate by adjustment any variation in the accuracy of the item being compared.

GMP – Good Manufacturing Practice.

Good Manufacturing Practices (GMP) regulation – Contained in section 520 of the U.S. Food, Drug, and Cosmetic Act, it requires that domestic or foreign manufacturers of medical devices intended for commercial distribution in the United States establish and follow a quality assurance (QA) program.

Measuring and Test Equipment – All devices used to collect data and measure, gauge, test, inspect or otherwise examine items to determine compliance with specifications.

Reference Standard – Standards of the highest accuracy order in a calibration system which establish the basic accuracy values for that system.

Calibration for Testing Measurement Procedure Activities

• Storage, Handling, and Maintenance
• Calibration and Recalibration
• Recordkeeping and Labeling
• Recall System
• Out-of-Tolerance Conditions
• Control of Subcontractor Calibration

Calibration for Testing Measurement Procedure References

• State and Regulatory Requirements

Calibration for Testing Measurement Procedure Forms

• Calibration Record Form