How can we establish that a process works and will continue to work? A product life cycle-based process validation strategy is a stepwise approach that begins with understanding of the process design, followed by commercial manufacturing qualification, and then finally by continued process verification.
An attribute test method validation (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).