For calibration professionals, integrity is an essential part of every aspect of the calibration laboratory’s activities.
Integrity is the act of adhering to strong moral and ethical principles and values and portraying honesty and truthfulness in all of one’s actions. Integrity means doing the right thing every time, even when it’s not seen or acknowledged by others.
Integrity is about building a foundation of trust and the foremost duty of calibration professionals is to not engage in any activities that may endanger that trust in relation to the calibration activities and measurement results that are provided to their customers.
One of the main outputs of a calibration laboratory is the reliability of the measurement data that is produced and the consistency and accuracy of that data.
The data recorded by calibration professionals confirms the quality of the test equipment and therefore, it becomes mandatory to ensure that the data is protected from intentional or accidental modifications, deletion or any kind of falsification. Implementation of any system that requires storing, processing and retrieving data is impossible without data integrity.
How Loss of Integrity Affects Laboratories
A calibration laboratory’s customers rely on the measurement results from the laboratory and those results affect the decisions and the business of those customers.
The potential consequences for the loss of integrity can be substantial. Each individual’s personal reputation and the reputation of the laboratory depends on developing strong integrity and when that is broken it has the potential to damage the entire laboratory and affect the ability to conduct its business.
Integrity is important for all laboratory personnel from the managers, technicians. support employees and any other members of the laboratory. The laboratory also needs to ensure that all of its suppliers and vendors also follow the same code of integrity.
Types of Integrity Losses
An integrity loss is a deliberate falsification during the taking or reporting of a measurement that failed the calibration requirements but was made to appear to have met those requirements. There are 3 main types of losses that deal with data integrity, omission, manipulation and alteration.
Omission is when data or information is omitted to ensure that the measurements look better, such as when the highest or lowest readings are dropped in a series of calibration measurements to make a graph look better or incomplete record keeping where certain files or measurement data are omitted.
Manipulation is when procedures are not followed properly in the taking of the measurement to produce the desired result, such as not adhering to the required warm-up time or stabilization time to get a better reading or in looking at an analog meter at an extreme angle to have the measurement appear to be within the specifications.
Alteration is when data that already had been taken is changed or altered in a way to benefit the measurement results. Examples of data alteration are when existing data is falsified, files are intentionally overwritten, or computer dates are changed to show that data was taken in a different time period.
Ways to Enforce Integrity in the Laboratory
There are a number of ways that a calibration laboratory can monitor and enforce the level of integrity in the laboratory.
The laboratory should have policies and procedures in place to address the involvement in any activities that would diminish confidence in its ethics and operational integrity; There should be a confidentially or ethics policy that helps employees avoid placing themselves in a situation where integrity may be compromised. Regular training should be provided on those policies to specifically address the laboratory’s position on the matter.
The calibration technicians should not be pressured to calibrate equipment within deadlines. There will always be equipment that is out-of-tolerance or that needs repair and the proper amount of time should be given to ensure that those items are handled correctly.
The calibration procedures need to be followed as they are written. If any deviations need to be made from the procedure those deviations need to be documented.
The laboratory must maintain an openness in the communication in the laboratory so that if issues arise with a calibration the situation can be readily discussed and a proper solution can be developed that meets the needs of the customer.