Technology/IT | IDM 10 2016 | international-dairy.com · 27 steering measures or reducing them to an acceptable scope to mitigate the control point (CP). The designation of a CCP is always linked to the corresponding steering measures. For this reason, some operations try not to declare too many of them. However, it is important that a danger analysis according to the Codex Alimentarius is present for this point at all. Those who believe that the filtration control is not a critical control point should be able to explain this decision in a risk analysis according to the Codex. For some auditors, the presence of such a risk analysis is a KO criterion. If a later audit shows that an item was only declared as a CP, while the auditor believes it to be a CCP, this will be a deviation requiring re-work and re-assessment. In new systems, a risk analysis must be performed in advance already. However, this is a purely theoretical observation that must be verified by controls. If such a new system has not passed the verification by the corresponding filter tests, this does not mean that the same will be true for the future as well. After all, production parameters may change without the production managers being aware of this. RPZ Category Risk level Measures >50 A critical specific control and monitoring measures – CCP 25-50 B high Control measures must be introduced – CCP? 15-25 C medium General regular control measures – CP 5-15 D low General control measures – CP? 0-5 E very low Risk low, usually no further measures required Table 2 Note: the results marked with "?" can be observed as a "grey zone". (Source: Daniela Palm - SGS Fresenius GmbH, HACCP/IFS, 6 November 2012) Hazard analysis for sterile filtration regarding the Codex Alimentarius (HACCP) Possible contamination risks may be chemical (cleaning and auxiliary agents), biological (bacteria, mould, yeasts) or physical in nature (metal abrasion, glass, defective seals and filters). In the process step "sterile filtration", the following risks must be assessed: regarding their causes, the probability of their occurrence, the possibility of discovering them, the potential consequences and the possibilities of countering these. Based on table 1 and calculation formula, the risk potential figure can be determined. It must be considered that this can only be an approximate. In particular for microbiological risks, the effects in an insensitive product such as a Cola beverage are rather lower, but must be given much higher relevance in a sensitive product like juice-containing drinks, baby food and healing waters. Therefore, we also speak of a local, i.e. individual hazard analysis. Table 2 helps in risk assessment See how to use the codex alimentaius for sterile filter applications in Part 2.
IDM_10_2016
To see the actual publication please follow the link above