Clause 7.5.2 Validation of processes for production and service provision

Verification/inspection of products before they are provided to the customer is a valuable opportunity to prevent delivery of product that does not meet customer's requirements. However, sometimes it is not possible to fully verify the quality of the product without using or destroying it. For example, it is not possible to fully verify the strength of a weld unless a destructive test is performed or the product is actually used. Similarly, for many service industries, the service provided is instantaneous, which does not readily allow verification before delivery of that service.

For example, a lawyer who defends a client in court is obviously not able to verify his service before delivery. Failure to represent the client correctly will only be detected when the judge rules.

In these cases the activities can only be controlled (validated) with the use of qualified personnel, qualified equipment, and qualified processes based on specific procedures. A process can be qualified, for example, by doing a destructive test on a sample of the products. The results of this destructive test can then represent other products with the same characteristics.
ISO 9001 requires that record be maintained for activities that require validation it should be noted that validation is only necessary if there is a risk of providing product that does not meet customer's requirements. For example, aesthetic welding may not have to be validated if it does not affect the quality of the product.
 
Records (4.2.4) relating to validation of process shall be maintained. These records should provide evidence that process validation is done periodically (by keeping at least last 3 process validation records) and records relating to following:

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  Qualification of personnel performing the process


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  Qualification of equipment used to perform the process


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  Evidence of adherence to specified process parameters or characteristics when process is performed.

External Document Reference: Documentation Kit

Standard Procedure for Process Validation

Additional Key words: special process, special processes