Laboratories have a professional obligation to provide accurate and reliable analytical results to customers. The Laboratory should to justify the customer’s trust by providing the correct answer to the analytical part of the problem, in other words, results that have demonstrable ‘fitness for purpose’ Analytical method validation is one of the measure universally recognised by laboratory as a necessity for a comprehensive system of quality assurance.
Reliable analytical results are required for compliance with international regulations in almost all areas of analysis.. Method validation is an essential component of the measure that laboratories should employ to ensure that they produce accurate and reliable results, hence ensuring business continuity.
International organizations like ISO, AOAC AND IUPAC have published guidelines for method validation techniques. It is important that laboratories should adopt these guidelines and incorporate them into their method validation procedures. Method validation should, if possible, have means of involving the customers that will be using the results. The involvement of customers ensures that method performance, as required by customers, is incorporated early before a method is developed
This paper discusses in details the conceptual aspects of method validation and its management, method validation processes, highlight method validation key performance characteristics and discusses method validation schemes. It uses as an example, statistical method validation techniques to establish if the is any significance (0.05) difference between gaseous fluoride results, form Mozal pot rooms roofvent, obtaining using Boreal Laser HF analyser and Isokinetic Sampling techniques (ISO 9096).
The results indicate that there is no significant (0.05) difference between HF Results obtained using the two methods.