11. Personnel Qualifications

All personnel (calibration technician or engineer) that performs test or calibration should have proper training, in short, should be competent enough where he can demonstrate the required calibration procedure when prompted.

They must have attended or been oriented regarding calibration awareness as the first part of the training or exposure to calibration basics. Calibration awareness is one of the most important training that an organization should take regardless of the area you are in (like in production, planning, purchasing, and others). Of course, this is under quality surveillance.

Their competency is supported by their qualifications (experience, education, training, etc). Moreover, all of his training must be included in a record control file for proper monitoring.

To support Personnel Qualifications, we need the competence requirements such as:

1. Authorizations

2. Training records

3. List of responsibilities and Job description

4. Competency Level

Monitoring personnel competency (example: Training)  is a continuous process and required to be updated or refreshed regularly.

To read more about this topic, visit my other post in this link >> Competence Requirements

Another important requirement under Personnel is to ensure that every personnel is observing Impartiality during the performance of calibration work, specifically those activities that have an effect or risk on the results of calibration done. A procedure that identifies this risk is called Risk to Impartiality procedure. 

12. Data Retention (how long do we need to keep a record)

Data retention is important for every records control procedure, in calibration, data retention is very meaningful. Compare to other records, calibration records should be accessible easily even it is an old record, we need to collect and tabulate data specifically the data of reference standards for our history file.

This will provide a reference regarding the performance of a certain instrument, past data will help you to decide on how you adjust or provide a proper disposition specifically in determining the calibration interval of your instrument.

Usually, records retention is 5 years or longer.

13. Quality Control 

What Quality Controls should be implemented to ensure the reliability of the reference standards used?

Reference standards are always used for measurement either inside the laboratory or outside the lab (on-site calibration).  It is exposed to different environments and the handling of personnel.

Because of these factors, we must ensure that our reference standards are still in good condition outside and inside.

Below are the methods that we can implement for this:

1. Intermediate Check – implemented every time the reference standard is sent out of the lab, during preventive maintenance or  exposure to harsh environments.

2. Preventive Maintenance – a scheduled maintenance

3. Performing Measurement System Analysis

4. Re-Calibration and verification

5. Performing different methods of calibration and verification (replicate test)

Also, measurement results should be monitored and analyzed if the below situations are encountered:

1. If there is an out of tolerance during calibration and verification or an out of tolerance is suspected.

2. If a new instrument or standard has arrived from a third party calibration

3. During a scheduled maintenance

4. During the extension of the calibration interval

5. If new equipment is installed or transferred from different locations