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We must implement controlled conditions for production and service operations, including delivery and post-delivery activities. Controlled conditions include: • the availability of documented information that defines the characteristics of the products and services, • the availability of documented information that defines the activities to be performed and the results to be achieved, • monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met, • the use, and control of suitable infrastructure and process environment, • the availability and use of suitable monitoring and measuring resources, • the competence and, where applicable, required qualification of persons; • the validation, and periodic revalidation, of the ability to achieve planned results of any “Special Process” for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, • the implementation of actions to prevent human error, • the implementation of products and services release, delivery and post-delivery activities. Special Processes must be identified and validated. A special process is defined as a process for a product or service that cannot be inspected to determine conformance. An example of a special process would be: • A welding joint, where the strength cannot be tested without destroying the product. • The result of a test, where test data is the product. You cannot inspect the item and determine if it is correct. • Instead of inspecting, you must ensure the accuracy by making sure that the process is reliable, monitoring product characteristics and making sure the person performing the process is qualified.