Validation of processes for production and service Sample Clauses

Validation of processes for production and service provision The organization shall validate any production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring. This includes any process where deficiencies may become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of the processes to achieve planned results. The organization shall define arrangements for validation that shall include the following, as applicable: qualification of processes; qualification of equipment or personnel; use of defined methodologies and procedures; requirements for records; re-validation. Note 1: Such processes, where the resulting product and/or service cannot be readily or economically verified, are frequently referred to as special processes. Note 2: The validation of such processes may be achieved by performing product and/or service verification activities not feasible during normal production and service operations. Note 3: Where other methods of process validation are not feasible, it may be suitable to apply the requirements of 7.3 to the development of the process and to demonstrate validation in accordance with 7.3.7.
Sample 1
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