Tuesday, August 25, 2015

25/08/2015: Added value of Early Warning System (EWS)

by Johan den Hartog, Managing Director, GMP+ International

Most of the feed and food safety assurance systems are focussed on prevention of contamination of feed and food materials with undesirable substances or microbiological agents. A certification scheme has three main components: the normative references, the assurance and corrective action tools, and the rules of certification.

The normative references determine what is considered as a safe product for consumption, or what is sustainable or responsible related to environment or society. The rules of certification are about the certification process of companies applying for a certificate against the involved certification scheme, which the certification bodies have to apply and comply with.

The assurance and corrective action tools are the instruments and procedures, which the company obtaining a certificate have to apply in the daily business operations. The assurance tools are focused on preventive actions and measurements in order to avoid the occurrence of contamination.

A starting point for the control of potential risk is the application of prerequisite programs in order to create a basic level of control. The Hazard Analysis Critical Control Points (HACCP) approach is important to identify in advance the remaining risks in the process and operations and to determine appropriate control measures, as well as a monitoring plan.

The purchased/supplied ingredients could be a risk. For feed or food safety, a full control of the supply chain is a relevant option, which is followed in the GMP+ Feed Safety Assurance certification. Application of a quality management system makes it possible to ensure control measures and monitoring plan in the daily operations in a consistent way.

Besides the preventive measures, also corrective actions need a company to apply in the event of the occurrence of a contamination of a certain consignment. In that case, it is about traceability; recall procedures, and early warning. The aim of these measurements is to reduce the distribution of contaminated lot(s) of feed or food material in the market or withdraw it in order to limit the negative impact on feed safety in the production chain as much as possible.
Within the GMP+ Feed Safety Assurance (FSA) certification, the Early Warning System (EWS) is essential to reduce the impact of a contamination and operates as follows. It is not alone a matter of the primary involved company, but also of other companies. If a certified company determines a level of undesirable substance(s) exceeding the maximum permitted level, it is obliged – besides taking the appropriate control and corrective measurements and informing its customers – to notify GMP+ International as well as the involved certification body and the competent official authority if applicable.

This notification has a relevant reason. GMP+ International assesses each EWS notification and decides, together with involved participants, if and which measures are necessary to prevent or limit damage in subsequent chains. These may include measures taken by GMP+ International.

The primary focus of the company is to inform involved suppliers and customers, blocking contaminated batches, investigate the cause of contamination and take corrective measures.

The primary focus of GMP+ International is to alert the other GMP+ FSA participants about the occurrence of a concrete contamination event in the market, if the contaminated lots are delivered by supply chain partner(s), or the contaminated lots are or can be delivered to other companies in the market.

In that case, GMP+ International informs all other GMP+ FSA participants about the involved product (generic name), the kind of undesirable substance(s), the detected level(s), and the country of origin. The company involved will not be published. When other GMP+ FSA participants are also buying or dealing with the reported product from the mentioned origin, they can take the right control measures, like sampling and analysing or asking guarantees of his supplier. The primary focus of the certification body is to monitor the application of the appropriate actions and measurements by the involved feed company.

Facts about 2013-2014
At this moment GMP+ International is preparing an evaluation of the EWS notifications of 2013 and 2014. In general the figures show that there have been more notifications in 2013 and 2014 than the years before. This increase in the number of notifications was related to mycotoxins. It is also good to realise that sometimes more than one EWS message has been related to the same case.

Most of the reported issues are controlled in an early stage. Only a limited number were related to a more or less serious feed safety emergency. In 2013 this was aflatoxin in maize and in 2014 this was furazolidon in in soymix. Because of these two safety issues, the requirements to notify have become stricter.

Before 2015, GMP+ FSA certified companies were only obliged to notify contamination levels above maximum permitted level, in case the situation was not fully under control of the involved company and could affect other companies too. End 2014, we introduced the obligation to notify every exceeding of the maximum permitted level of an undesirable substance to GMP+ International as well as the certification body. This notification as well as informing the customers is considered so crucial for the effectiveness of the control of a safety incident, that non-compliance is classified as a critical non-conformity with withdrawal of the GMP+ FSA certificate as a consequence.

GMP+ International always tries to find out the source and cause of contamination, because that could be relevant for the risk assessments and could contribute to avoid occurrence in the future. The GMP+ FSA certified companies observe these EWS messages as worthwhile, because it increases their alertness regarding specific risks.

It adds also value in comparison of the Rapid Alerts System Feed & Food (RASFF) of the European Union, due to more details and quick publication. The most important causes of contamination (figure 2) are natural exposure and genesis during processing. Process aids can also be a source, which need to be considered in the risk assessments.   

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