Equipment qualification and its application to conductivity measuring systems
It is only possible to obtain analytical results that are suitable for their intended purpose if the equipment used is capable of producing measurements of the required quality. To ensure that this requirement is met, analysts should define the performance criteria required from the instruments, ensure that only suitable instruments are selected for analytical measurements, and confirm that these instruments continue to meet these criteria for their entire operational life. This process should be conducted on a formal, documented basis, known as equipment qualification. In addition to describing the key elements of equipment qualification for all analytical instruments, this paper gives specific guidance on its application to conductivity systems that has never previously appeared in the literature. The benefits of performing equipment qualification are highlighted and guidance is given on the selection of control standards and why the equipment vendor performing stages of equipment qualification can be of benefit to the user. The relationship between equipment qualification and method validation is discussed, including how these activities play a major role in determining the quality control measures that should be applied to routine analysis.
KeywordsEquipment qualification Conductivity User requirement specification Design qualification Installation qualification Operational qualification Performance qualification
The authors wish to extend their gratitude to all of their colleagues who assisted with the production of this article – particularly Ms. V. Byrne for her assistance in compiling this article and Mr. L. Geary and Ms. R. Cooney for proofing this article.
- 1.Huber L (1999) Validation and qualification in analytical laboratories. CRC Press LLC, Boca Raton, FloridaGoogle Scholar
- 3.Barron JJ, Ashton C (2005) The effect of temperature on conductivity measurement. TSP-07, Issue 3, available at www.reagecon.com/supportarticles.shtmlGoogle Scholar
- 4.Barron JJ, Ashton C (2005) The selection and use of instruments for accurate conductivity measurement. TSP-04 Issue 1, available at www.reagecon.com/supportarticles.shtmlGoogle Scholar
- 5.ISO 9001 (2000) Quality management systems – requirements. ISO. Geneva, SwitzerlandGoogle Scholar
- 6.Barron JJ, Ashton C (2004) The selection, use, care and maintenance of sensors for accurate conductivity measurement. TSP-08, Issue 1, available at www.reagecon.com/supportarticles.shtmlGoogle Scholar
- 7.IS0/IEC 17025 (2005) General requirements for the competence of testing and calibration laboratories. ISO. Geneva, SwitzerlandGoogle Scholar
- 8.Barron JJ, Ashton C (2005) The application of good laboratory practice in the selection and use of accurate, traceable conductivity standards. TSP-10, Issue 2, available at www.reagecon.com/supportarticles.shtmlGoogle Scholar
- 9.Gingerella M, Jacanin JA (2000) Cal Lab – Int J Metrol, July–August 2000:29–36Google Scholar
- 10.Barron JJ, Ashton C (2005) Cal Lab – Int J Metrol 12.1:24–29.Google Scholar
- 12.Eurachem Guide (1998) The fitness for purpose of analytical methods: a laboratory guide to method validation and related topicsGoogle Scholar