All measuring devices become less precise with time. And devices providing imprecise measurements can hamper product quality. This is therefore a matter that demands special attention. Equipment must be kept calibrated and validated in order to guarantee the final quality of your product. But what is the difference between calibrating and validating equipment?
Normal wear is usually why measuring devices, instruments and equipment become less precise. However, electrical or mechanical shocks or a hazardous manufacturing environment (with oils, metal shavings, etc.) can also cause changes in precision. Depending on the type of instrument and on the environment in which it is being used, degradation can occur quickly or take a long time.
What is equipment calibration?
Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. This is a comparison between a known (standard) measurement and the measurement given by your instrument. Standard precision should normally be ten times greater than the precision of the measuring device that is being tested. Nevertheless, a precision rate of 3:1 is acceptable for most standard organizations.
There are two goals when calibrating measuring instruments:
- Verification of the instrument’s precision;
- Determination of the measurement’s traceability.
In practice, calibration also includes repairing the device if it is not calibrated. A report is provided by a calibration specialist showing the error in measurements taken with the measurement device before and after calibration.
Types of calibration
Instrument calibration can be done for different types of instruments, in every area of the company. Some of the most frequently performed calibration services are:
- Pressure calibration;
- Temperature calibration;
- Flow calibration;
- Pipette calibration;
- Electrical calibration;
- Mechanical calibration.
The exact process used to calibrate equipment should vary according to the type of instrument, how critical it is to the operation and the standards followed for calibration purposes.
What is equipment validation?
Equipment validation provides wide-ranging and documented evidence that the instrument is functioning precisely.
A validation process provides proof that the components critical to the precise functioning of the equipment consistently meet predefined specifications and operational attributes.
This process involves identifying and quantifying each element related to the result produced during analytic measurement. Validation is a guarantee that any internal malfunction in the equipment will not negatively affect the quality of the result.
The validation process is guided by the validation protocol:
The validation protocol is a written plan expressing the validation method. The main characteristics considered are the testing parameters, the product’s attributes, production equipment and decisive stages that define the scope of acceptable test results.
Why do I need to validate equipment?
Equipment validation is the trademark of the warranty. It attests to the precise functioning of an instrument within the range prescribed for the operating conditions and environment, while also strictly adhering to the correct operating specifications.
For instance, failure to comply with regulatory requirements can make a company’s instruments ineligible for use in the sector. This can result in significant losses for the company, further reinforcing the need for validation.
The difference between calibrating and validating equipment
Equipment calibration concerns assessment of the precision of the results provided by a piece of equipment, measuring variation in relation to the standard defined. Equipment is adjusted according to the precision of its performance, in line with acceptable standards or specifications.
Validation of equipment is a documented guarantee that each component of the equipment is compliant with the manufacturer’s specifications. This is obtained by verifying performance in relation to traceable standards of control. This provides absolute assurance of analytical measurements and guarantees that the equipment’s precision, reliability and perfection are not compromised in any way. Nevertheless, to maintain the precision of an instrument that is being used, it must be calibrated.