How to Implement a Calibrated Equipment Procedure in 6 Simple Steps

To establish a calibrated equipment procedure, please follow these steps:

1. Identify Which Equipment Needs to Be Tested

The most important part of calibration is to know what you are calibrating. As a rule of thumb, it’s best if you make a list with the name and description of any equipment used by your organization.

It is crucial to prioritize the pieces to be tested based on how frequently workers at your company employ them. Once this is determined, it becomes easier to identify who needs training for specific devices so errors don’t happen when using them.

2. Identify Inspection and Measurement Processes

Once you have identified what needs to be calibrated, you can then decide whether this will need to be done as part of an existing process or if there is a separate procedure in place for it.

For example, if you need to calibrate a pH meter, this could be carried out as part of routine maintenance.

You may need to establish a separate procedure to test a different piece of equipment. Each measurement instrument should be traceable through its own calibration record, which contains:

• Identification number

• Manufacturer and model

• Frequency of calibration

• Reference (traceability) standards used

• Validation certificates and calibration findings

• Details of actions taken in case of unsatisfactory results.

For software testing, calibration might include the input of normal and abnormal (limited case) data to test programming performance and error handling to ensure the software and associated equipment meet the specifications.

The test protocol, testing, results, and reviews should be documented, and any changes to the programming should be formally reviewed and approved before final acceptance.

Similarly, validated, automated machine tools such as lathes, printed-circuit drills, and component inserters can be monitored and maintained by conducting a ‘first’ and ‘last-piece’ inspection of representative product lots to assure accuracy.

3. Decide on the Calibration Frequency

You’ll need to decide which frequency calibration should occur, depending on the equipment and its usage. For example, equipment that operates in high-risk fields like food safety may need calibration more frequently than other machines.

The calibration frequency is usually determined by comparing the performance of the measuring equipment to:

• Equipment’s purpose

• Manufacturer’s specifications

• Degree of usage

• Equipment type

• Stability/reliability

4. Assign Responsibilities

The selection and training of competent calibration personnel is an important consideration and the personnel involved with calibration possess the following qualities:

• Technical education and experience in the area of job assignment

• Basic knowledge of metrology and calibration concepts

• Understanding basic principles of metrology, data processing, and acceptance requirements

• Knowledge of the overall calibration program

• Ability to follow maintenance instructions, the use of measurement equipment and standards

• Mental attitude which results in safe, careful, and exacting execution of his or her duties.

Decide who will be responsible for carrying out each calibration process. It’s crucial to assign primary responsibility for specific areas within this procedure. Some of it may be carried out by separate departments. In general, the Quality Manager is required to:

• Select suitable equipment to perform the required measurements with accuracy and precision

• Extend the control of inspection and test equipment to all approved suppliers where applicable

• Ensure inspection and test equipment cannot be used if they are not registered and calibrated

• Ensure inspection and test equipment is calibrated in a suitable environment

• Control all measurement, calibration and maintenance activities

All employees and Process Owners are required to:

• Check that inspection and test equipment is not damaged and is fit for purpose

• Check the calibration status of inspection and test equipment prior to use.

For example, suppose you need to calibrate a piece of equipment used across your organization. In that case, each department should be able to carry out the measurement.

A commercial laboratory accredited to ISO 17025 should be used for calibration when calibration cannot be accomplished in-house.

5. Decide on the Custody of Calibration Tools

The team must decide how they will store calibration tools. They can choose to keep them in one designated place with a lock or two separate locations that are locked and secure at all times, such as the Quality Manager’s office or in close proximity to the technicians on duty.

As appropriate, ensure that environmental controls are established and maintained to ensure that monitoring and measuring instruments are calibrated, and used in conditions that will not adversely affect the accuracy of the measurements.

Consideration must be given to the effects of temperature, humidity, vibration, and cleanliness when purchasing, using, calibrating, and storing instruments.

This way, only authorized personnel can access these items when needed for calibrating equipment during operations hours.

6. Identify the Relevant Standards

Decide which standards and procedures will be used to ensure correct calibration. It may help if you check whether the standards require you to include anything specific in this procedure to meet their requirements. For example, ISO 9001 states that the Quality Manager should administer the calibration procedure.

Benefits of the Calibrated Equipment Procedure

There are many benefits to having a calibrated equipment procedure in place. One of the main advantages is that it shows everyone involved how to maintain accuracy throughout the stages of testing. This means that you will avoid problems with your product or documentation being inaccurate.

Another benefit is that it makes the calibration process easier to carry out. The calibration procedure should serve as a reminder of what needs to be done during each stage and when it’s due. This means that technicians won’t worry about missing deadlines or forgetting essential processes.

It also gives you an audit trail for any future changes, modifications, or additions to the equipment. The procedure should be kept up-to-date if there are any changes. Otherwise, you may run into problems in the event of an audit by the regulator.

Conclusion

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.