DANSK DSF/IEC TR 62737 ED1 PDF

This IEC Technical Report is a general guide to the principles and methods used for the calibration and validation (verification) of process (on-line) analysers. It covers the principles of initial calibration and correlation, in the factory or on the plant, and initial validation. The detailed guidance is focussed on continued (routine) validation (in-service checking) and calibration adjustment (only if required, based on appropriate validation results) including the use of control charts. The content and presentation of this IEC Technical Report recognises that the effort available for routine validation and calibration adjustment is limited. The simplified approaches recommended are therefore intended to require only a reasonable expenditure of effort in order to maintain assurance that the initial calibration and correlation of the analyser to the reference method is still valid. In some cases the simplified approaches will produce procedures, which although adequate, may be less rigorous than could be evolved on purely technical and theoretical grounds. The approaches should be amended to ensure that they meet the individual business needs of the manufacturing or other process to which they are applied. It should be noted that this Publication is primarily intended for use by those directly involved with supplying, using and maintaining on-line/process analysers. These individuals are generally not specialists in quality measurement principles and the associated statistical calculations. Therefore, as far as possible, this IEC Technical Report avoids the explicit use of statistical methods and favours descriptions and explanations of a more practical nature. In order to remain consistent with the theoretical approach these practical approaches are assumed to exhibit random statistical behaviour with a normal/Gaussian distribution. This Publication is not intended to cover Continuous Emissions Monitoring Systems (CEMS). These systems have calibration, validation, on-going quality assurance (routine validation and calibration adjustment) and the associated statistical tools defined by other standards, e.g. EN 14181 – Stationary source emissions: quality assurance of automated measuring systems(1). This IEC Technical Report is not intended to cover automatic or semi-automatic instruments used mainly in laboratories to analyse discrete samples. However, the principles and techniques described can also be applied to laboratory instruments. For consistency with EN 60359 – Electrical and electronic measurement equipment expression of performance(2), this Publication treats the definitions of validation and verification as equivalent.