Module 22

Process requirements – Method selection,

verification and validation
Clause 7 (part 2)

Presenter: Tim Alcock

www.Qualimetric.co.uk
7.2 Method selection, verification & validation
• Appropriate methods: NOTE: Published methods can be used
if sufficient information is provided,
– Sampling, preparation otherwise supplemental or additional
documentation is required.
– Test/Calibration methods/procedures
– Quality Control procedures
– For determination of measurement uncertainty
– Application of statistical techniques for analysis of data
• Up-to date (latest version unless inappropriate/not possible)
• Readily available
 7.2 Method selection, verification & validation
• Notification of customer as to the method if not chosen
• Where possible use national, international or from reputable bodies.
 Verification vs Validation NOTE: The item may be a process,
measurement procedure, material,
compound or measuring system
Verification
Provision of objective evidence that a given item fulfils specified requirements
• Confirmation that a given reference material as claimed is homogeneous for the quantity value and
measurement procedure concerned, down to a measurement portion having a mass of 10 mg
• Confirmation that performance properties or legal requirements of a measuring system are achieved
• Confirmation that a target measurement uncertainty can be met

Validation
Verification, where the specified requirements are adequate for an intended use.
• A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in
water, may be validated for measurement of mass concentration of nitrogen in human serum
 7.2 Method selection, verification & validation
• Verification before introduction and changes/records
• Method development process
• Authorization of deviations
Design Specification

Validation