The system of monitoring and calibration of instruments is a comprehensive system through the Quality Assurance Management System. It is a requirement for registration of the ISO 9001 Quality Management System. Ensuring that your instruments are accurately calibrated is important to maintaining the quality of your process and product. Calibration is a process of comparing the accuracy of an instrument with the known standard accuracy. The accuracy of the tool is usually documented in the tool manual.
When an instrument is calibrated, compare through the entire run of the instrument. Select accuracy data points from the instrument’s low, medium, and high range.
The known standard must be more accurate than the tool. For calibration of dimensional tools, the known standard should be 10 to 1 of the tool’s accuracy.
standard calibrations
There are 3 types of calibration standard for instrument calibration and monitoring system:
Primary Standards: Those units or instruments of a high standard of quality and stability that are calibrated periodically by the National Institute of Technology and Standards (NIST) or by a calibration services contract that is directly affiliated with the National Institute of Technology and Standards (NIST). The surrounding environment is monitored when using the basic calibration at 23 degrees Celsius ± 2 degrees and relative humidity 40% ± 10% (if necessary).
Transfer Standards: Those units or tools with consistency and stability. Calibration is one of the basic standards in monitoring the surrounding environment. Transition standards are stored in a controlled environment of 23°C ±2°C and relative humidity of 40% ±10% (if necessary).
Working Standards: Those units or tools with stability and stability, calibration is one of the transitional standards. Use operating standards to measure process and product quality. Transition standards are used to calibrate operating standards. Which is affiliated with the National Institute of Technology and Standards (NIST). Core standards are usually maintained by the National Institute of Technology and Standards (NIST) or by laboratories maintaining a National Institute of Technology and Standards (NIST) accreditation. All standards must follow the National Institute of Technology and Standards (NIST).
What are the tools that need to be calibrated?
Standards (operational, basic and transitional).
Any tool we may need to measure product quality.
Any measuring instrument used to monitor and measure operations (inbound or outbound operations).
We recommend reviewing all process tools that have continuous analog or digital outputs. If there are other uncalibrated instruments that are used to monitor output, the process equipment needs to be calibrated as well.
Example: An oven has digital readings. Let’s say that the oven needs to operate at 125 degrees Celsius. While the oven was running, the reading was 125 degrees Celsius. But how can we be sure that this reading is correct? If you have calibrated the thermometer, we can make sure that the actual use is 125 degrees Celsius. If you have not calibrated the thermometer, the oven digital readout must be calibrated.
Calibration instrument items and control documents
Main menu of calibration tools.
Process retrieval flow.
How to determine the recovery period.
Determine the calibration procedure for each type of instrument.
Define calibration records that show the requirements and results of calibration.
Discuss flow to ensure that new process tools/equipment are calibrated prior to use.
Coverage of actions taken when the instrument is out of calibration.
Presentation of calibration company labels, which indicate the status of calibration.
Includes use, handling and storage standards.
Define a statement of defect criteria.
Discuss loss standards during the handling process.
main menu
The calibration tools and master checklist should cover these items:
Tool number.
Tool name.
The factory name .
tool location.
Explain the calibration procedure.
Calibration interval.
The standard used to calibrate the instrument.
Tool standard number.
The last day of calibration.
day for the next calibration.
Calibration registration number.
Calibration records
Calibration instruments and control records should cover these items:
Tool number.
Tool name.
The factory name .
tool location.
Explain the calibration procedure.
Calibration interval.
The name of the transition standard used to calibrate the instrument.
Transition standard tool number.
Calibration date.
The next calibration date.
Calibration registration number.
Calibration requirements.
Calibration data.
The employee’s name or signature.
temperature .
Humidity .
The result of acceptance / rejection.
Calibration label recommendations
Calibration labels
Calibration date.
Calibration registration number.
Calibration due date.
The signature of the calibration officer.
Calibration before using the label, used for equipment that must be strictly checked before use.
Reference only, non-calibration label, used for analog and digital readings and monitoring with calibrated equipment.
Do not use label, to be placed on equipment that has not been calibrated or repaired.
Calibration interval
The calibration interval is based on instrument stability, purpose, degree of use, surrounding environment, past history of equivalent instruments and manufacturer’s recommendations. The following can be used as a guide:
