ANAB at Pittcon: Method Validation

Instructor Deanne Emory – ANSI National Accreditation Board

Method validation must be planned activity where it is necessary to have confidence in the results produced by the method, including, but not limited to, laboratories, manufacturing organizations and petroleum facilities. The scope of the method being validated, and acceptance criteria, must be defined before method validation is initiated. Validation activities must consider the entire scope of the method and the extent of validation necessary to meet the needs of a given application, field of application, or specific customer needs. Methods then must meet the specified acceptance criteria to be considered fit for intended use. From an accreditation or certification perspective, robust method validation provides confidence that the methods employed by the organization are fit for the intended purpose and produce valid, reliable, and consistent analytical results. Appropriate method validation not only ensures that the organization can accurately and adequately perform a method, but ultimately it ensures confidence in the measurement process. This course reviews the accreditation requirements for method validation, defines method validation and verification, and gives direction on creating a validation plan. Participants will be given practical guidance on creating and carrying out a validation plan and will have the opportunity to apply the guidance through interactive exercises. The course will include discussions on when the organization needs to verify a method, validate a method, validation before introducing a method, validation when changes to a method occur, validation of standard methods that need to be modified, as well as validation records to be retained.