The calibrated equipment process is considered a crucial procedure in quality management.
It ensures that all measurement and test instruments used in the design, manufacture, and testing of components, in-process sub components and finished products or devices are accurate and effective.
In order to verify product and process conformity, it is often necessary to have inspection and test equipment that is calibrated. This means that all the measuring equipment needs to be tested regularly for accuracy and the tolerances checked against any applicable #referencestandards or measures to ensure the measurements taken are accurate.
A calibrated equipment procedure describes the process that tests and records the accuracy of all measuring, testing, and monitoring equipment.
It details how calibration activities should be performed, the responsibilities for each task and any other conditions or limitations to the calibration.
It is a legal requirement that organizations meet the calibration schedule for all measuring equipment.
This is to ensure that the integrity of the organization’s work is within an allowable tolerance range at all times.
What’s Included in the Calibrated Equipment Procedure?
The calibrated equipment procedure includes details such as the frequency of calibrations and the people responsible for carrying them out.
It also provides any other information or conditions regarding calibration that may have been agreed upon when purchasing equipment.
When writing the procedure, it’s crucial to ensure that any relevant standards, are mentioned so that employees don’t doubt the accuracy of tests and measurements.
The quality assurance department is responsible for designing, implementing, and maintaining the calibrated equipment procedure. They are also responsible for calibration administration responsibilities as defined by this document.
To establish a calibrated equipment procedure, please follow these steps:
1. IDENTIFY WHICH EQUIPMENT NEEDS TO BE TESTED
2. IDENTIFY INSPECTION AND MEASUREMENT PROCESSES
3. DECIDE ON THE CALIBRATION FREQUENCY
4. ASSIGN RESPONSIBILITIES
5. DECIDE ON THE CUSTODY OF CALIBRATION TOOLS
6. IDENTIFY THE RELEVANT STANDARDS/REGULATORY REFERENCES
All monitoring and measurement equipment and software performance data is reviewed by the Quality Manager.
Audits of software and equipment maintenance procedures and records should evaluate the adequacy of safeguards, change controls, and other controls necessary to maintain software quality and proper performance of associated equipment.
The audits must be documented, important results are reviewed with management, and corrective action taken as appropriate.
