1 (a). Study by Koutsoumanis et al, the survey on time-temperature conditions of the Hellenic pasteurized milk’s chill chain, the data were gathered through the exhaustive survey of temperature and time conditions during transportation to the storage at retail and domestic storage.
The truck’s temperature during transportation had mean of 6.7 and 6.5 median, making the average temperature of 6.66 °C and 2.0 h standard deviation (Koutsoumanis et al, 2010, p.2). The time of transportation is measured with weibull distribution model which is a fully parametric model. Weibull distribution is a more generalized form of the exponential (Wahingtom et al, 2009, p. 269). The mean of 3.7 h, 3.6 h median and 2 h standard deviation was reported in the study for time of transportation (Koutsoumanis et al, 2010, p.2). The temperature in the truck and the transportation is significant to ascertain the growth of L. monocytogenes in pasteurized milk. The retail storage temperature was recorded with a mean of 4.98 and the standard deviation of 2.9. The storage time is measured by log normal which gives a reasonable probability model for this random variable (Hassett and Stewart, 2006, p. 231). The storage time of pasteurized milk at retail locations is with a mean of 20 h and a standard deviation of 20 h which is truncated at the right side at 96 h. truncation of the milk was based on the fact that the fresh pasteurized milk’s shelf life in Greece is by law 5 days, that is 120 h after pasteurization (Koutsoumanis et al, 2010, p.3).
The meaning of truncation is, that the data lower than 96h would only be reported in the study (Hipel and Mcleod, p. 888). However, the model in the study forecasted that in approximately 50 percent of milk cartons, the bacteria will cultivate from the process of production to consumption of milk. Such results specify that the 5 days limit for shelf life cannot ensure the hindered the growth of pathogen in pasteurized milk in the present conditions pertaining to chill chain. The study observed significant differences in temperatures between the different positions of the refrigerators with discrete values for Upper shelf, middle shelf, lower shelf and door shelf with the temperature 0.25, 0.19, 0.05 and 0.51 respectively. The highest temperature was observed at the door shelf (8.4 °C) followed by upper shelf (7.6 °C) and the middle shelves and lower shelves were found to be coldest positions at 6.3 °C and 6.7 °C respectively (Koutsoumanis et al, 2010, p.3). The other researchers also found the refrigerator door to be the warmest. The results for the temperatures at the different positions of domestic refrigerators are very important for pasteurized milk, considering that the door shelf where the higher temperatures were observed is the most frequent position used for storage of this product. The cumulative growth that is by adding the findings of the study, the storage time of 24, 42, 78, 96 and 120 h in domestic storage, the growth of pathogen was found to be 0.23, 0.74, 0.96 and 0.98 (Koutsoumanis et al, 2010, p.7)
1 (b). The possibility of exceeding the criterion for safety is based on the initial level of contamination. For an instance, initial contamination increase per 1 liter from 1 to 100 cells per carton leads to the increase in the cartons number above the safety criterion, from 0.14 % to 1.47%. These results demonstrate the level of non-compliance to the criterion of safety is very low due to the limited shelf life.
1 (c). The figure shows the comparison of total growth of L. monocytogenes in pasteurized milk with shelf life of 5 versus 7 days. The extension of shelf life resulted in a significant growth of L. monocytogenes. The x axis of the graph shows the log CFU of the bacteria with its total growth. The y axis shows the percentage cumulative frequency of the percentage of total growth of the L. monocytogenes in pasteurized milk from production to the time of consumption. The figure illustrates that the decrease of product allowing growth from 65% to 43.2% with the mean total growth in these products decreased from 1.47 to 0.98 log CFU. Log CFU means the log colony forming units per ml of the pasteurized milk.
These results indicate that by excluding the shelf life from domestic milk storage and decreasing the temperature of domestic refrigerators by 2°C for the mean of the distributions for upper, middle and lower shelf temperature by 2°C, the shelf life of pasteurized milk can be extended from 5 to 7 days without affecting the current consumer exposure of pathogen. The growth of pathogen is decreased by decreasing the temperature of domestic storage by 2°C and does not store the milk in the door shelf. This demonstrates that the total growth of pathogen CFU at 1.5 reduces from 95 % cumulative frequency to 79%. The reduction in growth of pathogen happens due to improvement in storage process at domestic level. The growth of bacteria stabilises at 2.3 in existing conditions, however, the reduction of the temperature of domestic refrigerator leads to delayed growth of pathogen at 5 log CFU.
2 (a). Business quality management systems lead to continued improvement in quality as they set the raised standards and describe a new level of performance with the new target that yields additional benefits for the stakeholders. These targets are the performance targets for products, processes and the system. These targets do not comprise error levels, like scrap, nonconformities’ and customer complaints. This is the improvement by better control.
2(b). The key business processes for which the findings are to be incorporated in the ISO business system and their interconnection with the business system, system performance indicators of the business findings and method of assessment of the business process resulting from quality improvement project.
2(c). The control process includes statistical process control (SPC), engineering process control (EPC) and operational procedures (OP). SPC refers to the statistical tool that detects the process instability, and is used to monitor output and input variable so that any lack of stability is detected (Control Stage, p.3). EPC refers to automated devices designed to respond to process variations by adjusting one or more process input variables. OP seeks to control the output of the process using operational guidelines for the human inputs to the process.
3. Approved Arrangement – Egg and egg products for export as food must be prepared in an establishment where the occupier has an approved arrangement, The arrangement is approved by the secretary if the establishment contains a HACCP plan identifies each step in the preparation of eggs and eggs products and identifies the means of control of each potential hazard. For each significant hazard, the critical control points and the critical points and the procedures to monitor the potential hazards are identified. Moreover, for approved arrangement, the establishment should document the controls used to ensure the applicable requirements of these orders and identify the applicable importing country requirements, which in this case is Indonesia.
Product Standards – egg and egg products for export as food and ingredients of egg products for export as food must not contain a metal or non-metal contaminants, a natural toxicants in excess of maximum level as specified by toxicant and contaminant in the foods standards code, any agricultural or veterinary chemical and any food additive, processing aid, vitamin, mineral, added nutrient and other matter or substance in an amount that contravenes the requirements of the Food Standards Code.
Traceability – the information is specified to the applied on the outer container of the eggs and egg products. These are: description of eggs and eggs products, registration number of establishment, quantity of eggs and eggs products in container, lot identity of eggs and egg products, and the country of origin of eggs and egg products.
Audit Regime – The audit takes place for the operations for the preparation and export and issue of export permits for eggs and egg products and for the applicable requirements of the Act and Orders and the requirement of any applicable approval. The audit has to be conducted by an authorized officer with the purpose of establishing the status of compliance with one or more of the applicable requirements.
Export Documentation – Audit regime – The approvals for export are also checked in the audit and their status of compliance is established.
Validation and Verification – The validation requires the compliance that egg products for export as food must be heated and cooled as per the approved arrangement and be subjected to the treatment as per the special approved arrangement given the storage, handling, loading and transporting conditions.
Trade Description – The eggs and egg products must have the trade description before they leave their establishment. The trade description includes the description of eggs and egg products, list of ingredients in case of more than one ingredient, their net content, country of origin, registration number of establishment, name and address of exporter or the occupier of the establishment, the identity of the lot, and the directions for the use or storage of eggs and egg products.
Export Documentation – The documentation for export permit requires the filling of the application comprising the name. address, registration number of establishment, dates of their preparation, country of origin of other than Australia, name and address of consignee, intended port or airport, and other information as on the form o export permit along with the declaration of compliance to the food standard and the approved agreement and provides for export inspection. The application for the export permit for eggs and egg products must contain the statement that all information given in the application is true and complete.
Keith W. Hipel, A. Ian McLeod. (n.d.). Time series modelling of water resources and environmental systems. Retrieved from http://books.google.com/books?id=t1zG8OUbgdgC&dq=meaning+of+truncation+time&source=gbs_navlinks_s
Matthew J. Hassett, Donald Stewart. (2006). Probability for risk management. Retrieved from http://books.google.com/books?id=WIP18LwSEisC&dq=log+normal+definition&source=gbs_navlinks_s
Simon P. Washington, Matthew G. Karlaftis, Fred L. Mannering. (n.d.). Statistical and econometric methods for transportation data analysis. Retrieved from http://books.google.com/books?id=-UcWqyWQc-IC&dq=Washington+,+2009+weibull&source=gbs_navlinks_s