4.12 Risk of Foreign Material Flashcards
4.12.2 In all areas, e.g. handling of ____ _______, __________, __________ and ________, where hazard analysis and assessment of _______ ___ have identified the potential for _______ ________, the use of _____ shall be __________. Where the use of _____ cannot be ________, the risk shall be __________ and the ______ shall be in good ________ and ________.
4.12.2 In all areas, e.g. handling of raw materials, processing, packing and storage, where hazard analysis and assessment of associated risks have identified the potential for product contamination, the use of wood shall be excluded. Where the use of wood cannot be avoided, the risk shall be controlled and the wood shall be in good order and clean.
4.12.3 Where ________ - and / or other _____ ________ __________ are required, they shall be __________ to ensure maximum ________of _________ , in order to avoid subsequent __________. Detectors shall be subjected to regular _________ to avoid _________.
4.12.3 Where metal- and / or other foreign material detectors are required, they shall be installed to ensure maximum efficiency of detection, in order to avoid subsequent contamination. Detectors shall be subjected to regular maintenance to avoid malfunction.
4.12.4 Potentially __________ products shall be __________. Access and __________ for further handling or checking for these ________ products shall be carried out only by ______ _______ according to ______ _______. After this check, __________ products shall be treated as ___-_______ _________.
4.12.4 Potentially contaminated products shall be isolated. Access and actions for further handling or checking for these isolated products shall be carried out only by authorised personnel according to defined procedures. After this check, contaminated products shall be treated as non-conforming products.
4.12.5 The appropriate __________ of __________ shall be specified. Checks of proper __________ of __________ shall be carried out __________. In case of __________ or __________ of a ________ and / or foreign ________ _________, corrective actions shall be __________, __________ and __________.
4.12.5 The appropriate accuracy of detectors shall be specified. Checks of proper function of detectors shall be carried out regularly. In case of malfunction or failure of a metal and / or foreign material detector, corrective actions shall be defined, implemented and documented.
4.12.6 In cases where _____ ________ or _______ are used to detect ______ _____, these shall be properly __________ and __________.
4.12.6 In cases where special equipment or methods are used to detect foreign material, these shall be properly validated and maintained.
4.12.7 In all areas, e.g. handling of ___ _______, __________, __________ and __________, where hazard _______ and _________of the associated ___ have identified a potential product __________, the presence of __________ and ______ material shall be excluded. Where the presence of ______ or ______ _______ cannot be avoided, appropriate ________ shall be in place to protect against __________.
4.12.7 In all areas, e.g. handling of raw materials, processing, packing and storage, where hazard analysis and assessment of associated risks have identified a potential product contamination, the presence of glass and brittle material shall beexcluded. Where the presence of glass or brittle plastic cannot be avoided, appropriate measures shall be in place to protect against breakage.
4.12.8 All __________ objects made of or incorporating __________ or __________ present in areas of __________, __________, __________ and __________ shall be listed in __________, including details of __________. An assessment of the __________ of objects on the __________ shall be performed on __________ and __________. __________ of this check shall be justified by __________.
4.12.8 All stationary objects made of or incorporating glass or brittle material present in areas of handling of raw materials, processing, packing and storage shall be listed in a specific register, including details of their exact location. An assessment of the condition of objects on the register shall be performed on a regular basis and recorded. Frequency of this check shall be justified by documents.
4.12.9 Breakages of __________ and ______ _______ shall be __________. Exceptions shall be __________ and __________.
4.12.9 Breakages of glass and brittle material shall be recorded. Exceptions shall be justified and documented.
4.12.10 __________ shall be in place describing the __________ to be taken in case of __________ and / or __________. Such measures shall include __________, __________, __________ and __________.
4.12.10 Procedures shall be in place describing the measures to be taken in case of breakage of glass and / or brittle material. Such measures shall include identifying the scope of goods to be isolated, specifying authorised personnel, cleaning the production environment and release of production line for continued production.
4.12.11 Based on __________ and __________ of __________, __________ measures shall be in place for handling of __________, __________ or __________ in the __________ process (turn over, blow, rinse, etc.). After this process step there shall be __________.
4.12.11 Based on hazard analysis and assessment of associated risks, preventive measures shall be in place for handling of glass packaging, glass containers or other kinds of containers in the production process (turn over, blow, rinse, etc.). After this process step there shall be no further risk of contamination.
4.12.12 Where __________ is used to detect __________, the __________ shall be __________ and __________ shall be performed at an appropriate __________ to __________ of process.
4.12.12 Where visual inspection is used to detect foreign material, the employees shall be trained and operative change shall be performed at an appropriate frequency to maximise effectiveness of process.
