Early Warning System (EWS)
In several standards of the GMP+ FSA scheme the condition has been included that the GMP+ FSA-certified company must establish a procedure for the (early) signalling and treatment of signals which indicate that the safety of a product does not match the legal standards or the standards laid down in the GMP+ FSA-scheme and which might lead to damage to customers in the chain. These signals must be assessed on this basis and, if desired, control measures must be taken to prevent or to control the hazard. If there is a potential hazard which can not be controlled by the company in question and which may also cause damage to others then the company is obliged to inform GMP+ International. It should be subject to the early warning protocol (GMP+ BA5 Minimum Requirements EWS) established by GMP+ International. Below you will find a blank form for making a report to GMP+ International.
General
The Early Warning System (EWS) is a focal point of the GMP+ FSA scheme, in addition with applying control and precautionary measures. No quality assurance system is able to prevent all incidents arising from natural events, human error or criminal acts. EWS forms therefore a safety net whereby, at an early stage, a (potential) problem can be limited in scope or avoided through proper measures.
Reporting non-standard batches
In addition applies if the batch of a product to be received is refused after checking because it does not comply with the GMP+ FSA scheme standards that the company immediately informs GMP+ International, so we can inform other companies and certification bodies of this. GMP+ International informs all GMP+ FSA-certified companies and approved certification bodies of all relevant EWS reports and reports of rejected batches of products.
RASFF
In addition to this source of information, the information made available by the European Commission within the framework of risk assessment under the Rapid Alert System for Food and Feed (RASFF) is also relevant.
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