3.16 Rework means action taken on a non-conforming product that will fulfill the specified Device Master File requirements before it is released for distribution. 3.17 Specification means any requirement with which a product, process, service, or other activity must conform. 3.18 Validation means confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. 3.18.1 Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.