Tuesday, April 08, 2008

can you exclude Process Validation from your QMS?




YES

Process validation can be excluded if you can provide sufficient justification

clause 7.5.2: Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

NOTE: the following processes must be considered as special processes:

casting and forging and welding

reason: ageing takes place and strain age embrittlement

painting and powder coating and plating

reason: inadequate surface preparation will give rise to defects when in use that will affect the life of the surface treated product

and cathodic protection

Food business operations must preferably be certified to ISO 22000

However if certified to ISO 9001, the CODEX guielenes must be followed and validation of control measures must be done (Refer clause 8.2 of ISO 22000)

- see also sanctioned interpretations

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