Understanding Test And Measurement Equipment Performance In The Laboratory
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good Quality Manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality. It is no surprise, therefore, that the need for regular calibration of test and measurement equipment is included as part of most major quality standards and are a commonly reviewed area for auditors, whether they are from an internal department, accreditation body, or a regulator such as the FDA. Most quality systems will also define the actions that must be followed in the case of an instrument being found out of specification during a calibration. What sometimes does not get enough attention is the selection of test equipment to reduce the risk of an out-of-tolerance condition affecting the process.