Attribute Test Method Validation Protocol - CASE EXAMPLE (Technical Series on Process Validation Principles and Practices)

This document uses validation of a visual inspection method for seal integrity of flexible packaging to illustrate how to perform an attribute test method validation (TMV).

An attribute TMV is used to assure that tools, procedures and training provided to operators are sufficient to enable them to discern nonconforming products to protect the consumer (the patient). Attribute TMV also intends to demonstrate that the operators do not reject conforming products, and so also protects the producer (the manufacturer).

This protocol also provides a statistical approach by which the attribute test method (go, no-go inspection method) is validated with a confidence level, indicating that the inspection method reliability is at least above a certain percentage. The minimum performance indicators for the test method in terms of confidence and reliability are based on risks.

The approach presented in this protocol can be used to validate most attribute inspection methods. It can also be used to qualify operators or inspectors involved in inspection of critical quality characteristics that are reported as attribute data (pass or fail, go or no-go, etc).