7.5.2 Validation Of Processes For Production and Service Provision

Purpose

Where processes cannot be fully verified immediately, using normal inspection and testing processes, the actions taken to validate these processes are identified in this procedure.

This may be the case where testing would destroy the product such as destructive tests to confirm the strength of a weld. Or where the final strength of a product such as concrete, which may take 28 days to cure, cannot be determined immediately after the pouring process.

Procedure

• Where processes cannot be fully verified by our normal inspection and testing processes, [enter-your-company-name-here] identifies these in its quality plan and develops and implements procedures to ensure that the product specifications are achieved.
• [enter-your-company-name-here]’s top management undertake to ensure that, wherever such processes are carried out, providers or personnel, responsible for such processes and for ensuring the conformance of outcomes, are adequately qualified and that their skills are periodically reviewed through adequate sampling.
• Any equipment, used for the validation process, is approved by top management after it has been verified as fit for purpose and is subject to periodic calibration and review.
• The methods and procedures used for validation of the process or service will be dependant upon the type. Expansion is required here to detail specific instances where this will apply.
• The validation process is documented in the form of a report, citing the methodology used and any supporting data that was obtained, such as temperature, humidity, process times, machine settings etc. 
• The documentation is stored in accordance with the procedure 4.2.4 – Control of records
• Whenever the sampling results show excessive variation, the process is re-validated.