Hi Simon,
Clause 3.5 is all about the supplier and raw material approval and performance monitoring
clause 3.5.1 is management of suppliers of raw materials and packaging.
the clause 3.5.1.3 says the supplier approval and ongoing monitoring procedure shall define how exceptions are handled (e.g. where material suppliers are prescribed by a customer or where products are purchased from agents and direct audit or monitoring has not been undertaken).
I hope you can help me out,
thanks
SANS
Hi Sans,
Firstly identify and document the exceptions to your supplier approval and monitoring system. As per 3.5.1.3 you need to define how exceptions are handled.
This can be covered in part as in 3.5.2.1 .......a documented procedure for the acceptance of raw materials and packaging.
Based on your risk assessment (3.5.1), Raw material acceptance and its release for use can be based on one or a combination of:
• visual inspection on receipt
• certificates of conformance – specific to each consignment
• certificates of analysis
• product sampling and testing.
You should have a list of raw materials and the requirements to be met for acceptance. The parameters for acceptance and frequency of testing must be defined.
In this situation I would be wanting to be buying to an agreed specification which I would generate if one didn't exist. Incoming materials would be 'held' and subject to 'positive release' once on site inspection/testing had confirmed the material is 'acceptable'.
Kind regards,
Tony
